Agenda Links: Preconferences/Day 1 | Day 3
AGENDA: DAY 2
THURSDAY, NOVEMBER 7, 2019
7:00 am
Registration Opens; Continental Breakfast in Exhibit Hall
BREAKFAST WORKSHOPS (7:30 am – 8:15 am)
Breakfast Workshop I: Compliance Considerations for Gene Therapy and Ultra Rare Disease Products
Overview of compliance considerations related to pre-approval interactions, disease state awareness, and disease state education
- Discuss rare disease and gene therapy company specific compliance challenges: engagement and interactions with HCPs, unique program offerings, reimbursement strategies, etc.
- Review considerations involving patient interactions, patient privacy, and patient support services
7:30 am
Welcome, Introductions, Discussions and Q&A
Tiffany Cummings-Damiani, MBA
Vice President, Corporate and Healthcare Compliance, Global Compliance, Insmed; Former Senior Director, Global Compliance, Teva, Philadelphia, PA
Vice President, Corporate and Healthcare Compliance, Global Compliance, Insmed; Former Senior Director, Global Compliance, Teva, Philadelphia, PA
Tiffany Cummings-Damiani is the Vice President, Corporate & Healthcare Compliance at Insmed, Inc. In her role, she is responsible for implementing the compliance program, while supporting the company’s first rare diseases product launch. She also has corporate governance responsibilities, including enterprise risk management, corporate policy committee, and enterprise e-learning. Prior to this role, she was in compliance leadership positions at Teva Pharmaceuticals Inc and Shire.
Ali Lyons
Senior Director, Ethics and Compliance, Aegerion Pharmaceuticals, a Novelion Therapeutics Company; Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA
Senior Director, Ethics and Compliance, Aegerion Pharmaceuticals, a Novelion Therapeutics Company; Former Operations Lead, Ethics and Compliance, Eli Lilly and Company, Cambridge, MA
Ali Lyons currently serves as the Senior Director, Ethics and Compliance, at Aegerion Pharmaceuticals. In this role, Ms. Lyons functions as the compliance head for all business activities and initiatives, including Aegerion’s Corporate Integrity Agreement, Deferred Prosecution Agreement, and Consent Decree. Ms. Lyons is also currently the compliance lead for integrating Aegerion Pharmaceuticals with Amryt Pharma as this merger was recently announced. Before joining Aegerion, Ms. Lyons worked at Eli Lilly and Company in a variety of roles and therapeutic areas, and most recently, in the Ethics and Compliance Department as the Operations Lead for the US Affiliate. Prior to her time at Lilly, Ms. Lyons served as the Product and Brand Manager of Liquid Handling and Molecular Technologies at Eppendorf North America.
Elizabeth Jobes, JD
Senior Vice President, Chief Compliance Officer North America, EMD Serono, Inc; Former PCF Co-chair; Boston, MA
Senior Vice President, Chief Compliance Officer North America, EMD Serono, Inc; Former PCF Co-chair; Boston, MA
Elizabeth Varki Jobes is Senior Vice President, Chief Compliance Officer North America.
In this role, she oversees the strategic direction of EMD Serono’s comprehensive compliance program and ensures all legal and regulatory requirements are met.
Prior to her current role, Elizabeth served as Global Chief Compliance Officer and Legal Counsel for Spark Therapeutics, Inc., where she was responsible for building a corporate compliance program supporting the launch of the first-approved gene therapy in the United States. Jobes also held Chief Compliance Officer positions with Auxilium Pharmaceuticals, Inc., and Adolor (Cubist) Corporation, as well as an executive position with Cephalon, Inc.
Elizabeth has more than 25 years of both in-house and law firm professional experience. She started her career as an attorney for the Philadelphia District Attorney’s Office.
In this role, she oversees the strategic direction of EMD Serono’s comprehensive compliance program and ensures all legal and regulatory requirements are met.
Prior to her current role, Elizabeth served as Global Chief Compliance Officer and Legal Counsel for Spark Therapeutics, Inc., where she was responsible for building a corporate compliance program supporting the launch of the first-approved gene therapy in the United States. Jobes also held Chief Compliance Officer positions with Auxilium Pharmaceuticals, Inc., and Adolor (Cubist) Corporation, as well as an executive position with Cephalon, Inc.
Elizabeth has more than 25 years of both in-house and law firm professional experience. She started her career as an attorney for the Philadelphia District Attorney’s Office.
Marci Juneau, MBA
Partner, Helio Health Group, Atlanta, GA (Moderator)
Partner, Helio Health Group, Atlanta, GA (Moderator)
Marci Juneau is a seasoned management consultant with over 16 years of pharmaceutical experience. She specializes in advising life science companies on optimizing operational processes while addressing compliance. Areas she focuses on include aggregate spend/disclosure, patient services support, sales and marketing, medical affairs, and clinical trials. Her extensive experience includes providing pharmaceutical, medical device and biotechnology companies with effective advice on program implementation, operational excellence, change management, data analytics, compliance adherence, and risk mitigation. Prior to Helio, Marci was a Director at Huron Consulting Group’s Life Sciences Practice. Marci began her career in Ernst & Young’s Fraud, Investigation and Dispute Services group focusing on healthcare challenges.
Breakfast Workshop II: HCP Contracting—Benchmarking and Lessons Learned from Thirty-Nine Peer Companies
Earlier this year, Deloitte surveyed 39 Life Sciences manufacturers on the topic of HCP Engagement Solutions to gain insight industry trends in processes, organization and technology employed to manage the HCP Engagement Continuum. During the workshop the panel will discuss findings from the survey and points of view on industry trends.
7:30 am
Welcome, Introductions, Discussions and Q&A
Bryan Timer, MS
Director, Data Analytics & Transparency, Merck & Co., Inc., Kenilworth, NJ
Director, Data Analytics & Transparency, Merck & Co., Inc., Kenilworth, NJ
Bryan Timer is an Associate Director with US Data Analytics and Transparency at Merck. In his current role, Bryan supports Merck’s existing analytics efforts in the US and remains an integral part in ensuring the program is continuously evolving to meet internal and external demands. Bryan is looked at as an advisor for various groups within Merck’s compliance program to assist with developing and growing the company’s analytical capabilities. Prior to joining Merck, Bryan spent seven years as a consultant for two software companies which focused on providing solutions to customers in the Consumer Packaged Goods industry as well as small and medium sized pharmaceutical companies.
Mark Linver, MS
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT (Co-moderator)
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT (Co-moderator)
Mark Linver has nearly 30 years experience in implementing appropriate solutions that solve “real business needs” with expertise in addressing HCP contracting, Needs Assessment, GP Strategies, CRM, Business Intelligence, and Knowledge Management requirements in FDA regulated industries. Mark regularly leads teams that address complex projects requiring process and requirements definition, technology development and integration with the business process; including implementing Aggregate Spend, Needs Assessment and Spend Management Solutions for Pharmaceutical and Medical Device manufacturers.
Laura Skinner, MBA
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Austin, TX (Co-moderator)
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Austin, TX (Co-moderator)
Laura Skinner is an adept consultant working within the healthcare and pharmaceutical industries providing risk-based consulting services. She has led diverse, cross-functional teams in delivering a range of advisory services to pharmaceutical clients in the areas of regulatory compliance and compliance-focused business operations improvement. Laura has obtained a keen understanding of the challenges facing her clients’ organizations across the product life cycle both in operations and in support functions. She is responsible for managing multiple client projects and financials, building sustainable client relationships, and developing internal talent.
Laura is Senior Manager, Life Sciences Advisory at Deloitte. She was previously Director, Life Science Advisory Services with Huron Consulting Group.
Laura is Senior Manager, Life Sciences Advisory at Deloitte. She was previously Director, Life Science Advisory Services with Huron Consulting Group.
Breakfast Workshop III: Navigating Drug Price Transparency Laws and the Role of Compliance
In many ways, the trending of price transparency reporting is already mimicking the evolution of spend transparency, in that it is starting with a few states with different requirements, leading to a pending federal reporting requirement and will ultimately lead to global reporting. Much like spend transparency reporting, companies must not only respond to existing price transparency laws but prepare for the inevitable expansion. With that preparation in mind, this session will discuss the following topics:
- How are companies responding to existing price transparency laws and preparing for the future?
- Are some states harder to comply with than others?
- What role does compliance play in the price transparency world? Given the potential expansion of price transparency, should compliance now have a seat at the pricing committee table?
- What should we all expect in the future? Is this just a fleeting trend? Or is the expansion to federal and global real?
7:30 am
Welcome, Introductions, Discussions and Q&A
Josh Tomas O’Harra, MS, JD
Assistant General Counsel, Eli Lilly and Company, Washington, DC
Assistant General Counsel, Eli Lilly and Company, Washington, DC
As Assistant General Counsel at Eli Lilly and Company, Josh O’Harra has the lead responsibility for advising a diversified, research-based biopharmaceutical manufacturer on all matters pertaining to state and federal healthcare programs, commercial contracting and US government pricing. He was previously Senior Associate with King & Spalding and an Associate Analyst with the Congressional Budget Office.
Mark Scallon, MHA
Senior Principal, IQVIA Global Compliance, Richmond, VA
Senior Principal, IQVIA Global Compliance, Richmond, VA
Mark Scallon is a Sr. Principal in IQVIA’s Commercial Compliance group, operating as a leader in its compliance consulting pillar. Mark has over 20 years of experience providing compliance advisory services to the life sciences industry and focuses on helping companies develop and expand their corporate compliance programs and in executing specific compliance activities such as compliance risk assessments, auditing, monitoring, transparency and third-party management.
Donna White, CCEP
Vice President, Contracts and Compliance, Chiesi, USA, Cary, NC (PCF Co-chair)
Vice President, Contracts and Compliance, Chiesi, USA, Cary, NC (PCF Co-chair)
Donna White is the Vice President, Compliance, for Chiesi USA, Inc. During her long tenure in the pharmaceutical industry, Donna has worked in most functional areas, supporting multiple therapeutic classes in the hospital, retail, rare disease, specialty, brand and generic spaces. Currently, she, along with her team, oversees Corporate Compliance, Pricing, Government Programs, Aggregate Spend, PDMA, Fair Market Value, and Class of Trade, with other responsibilities throughout the organization. At Chiesi USA, Donna chairs the Compliance Committee and the Pricing Committee. She also serves on the Pharmaceutical Compliance Forum’s Leadership Team as a Member Co-Chair.
Kelly N. “Nikki” Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC (Moderator)
Partner, King & Spalding LLP, Washington, DC (Moderator)
Nikki Reeves is an FDA and healthcare regulatory compliance lawyer who advises pharmaceutical companies and medical devices on pre- and postmarket FDA regulatory compliance and enforcement matters. Nikki cochairs King & Spalding’s Life Sciences and Healthcare Industry Group, which is composed of more than 300 lawyers across the firm. Nikki frequently advises on advertising/promotion issues, R&D regulatory compliance, and conducts related compliance assessments. She has been the lead FDA regulatory advisor on more than 100 transactional matters. She is an expert on federal Sunshine, state and international transparency/disclosure laws, and she leads two industry compliance coalitions.
Breakfast Workshop IV: Setting your Five-Year Strategic Compliance Plan
While the job of Compliance Officer can often feel like putting out one fire after another, it is critical in today’s environment to have a long term strategic plan for the Compliance Department. This workshop will help you think through areas that should be addressed in your strategic plan, best practices on obtaining stakeholder buy-in, and benchmarking how other companies are successfully carrying this out.
7:30 am
Welcome, Introductions, Discussions and Q&A
Amy Pawloski
Compliance Officer, Operations, Endo Pharmaceuticals; Former Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Philadelphia, PA
Compliance Officer, Operations, Endo Pharmaceuticals; Former Global Lead, Compliance Risk Mitigation and Monitoring Strategy, Bristol-Myers Squibb, Philadelphia, PA
Amy is the Executive Director, Global Compliance Operations Officer at Endo Pharmaceuticals. She is responsible for oversight of all aspects of the company’s Corporate Integrity Agreement (CIA), Compliance Monitoring and Auditing, Aggregate Spend Reporting, Compliance Policies, and Compliance Training and Communications. Prior to joining Endo, Amy spent 19 years at Bristol-Myers Squibb (BMS). She held various roles of increasing responsibility including Global Lead, Compliance Risk Mitigation & Monitoring Strategy; Head of U.S. Compliance & Ethics Monitoring & Data Analytics; and Director, Compliance & Ethics. Prior to her roles in Compliance, she held various analytical and strategic roles of increasing responsibility in Finance, Operations, Project Management, and Pricing & Reimbursement. Prior to joining BMS, Amy was a Manager in the Audit and Business Assurance practice as well as the Consulting practice at PricewaterhouseCoopers in Philadelphia.
Susan Williamson, MBA, CPA
Senior Vice President and Chief Compliance Officer, Endo Pharmaceuticals, Philadelphia, PA
Senior Vice President and Chief Compliance Officer, Endo Pharmaceuticals, Philadelphia, PA
Susan Williamson is Senior Vice President and Chief Compliance Officer at Endo Pharmaceuticals. In this role, she is responsible for the strategic direction and operations of Endo’s Global Corporate Compliance program. Ms. Williamson previously served as Endo’s Vice President and U.S. and Canadian Compliance Officer where she was responsible for oversight of Endo’s Corporate Compliance program including management of Endo’s Corporate Integrity Agreement (CIA), enterprise wide corporate compliance training and monitoring and Aggregate Spend reporting. Prior to joining Endo, Ms. Williamson worked at Pfizer in Operational Risk Management supporting Pfizer’s CIA. Prior to her employment with Pfizer, Ms. Williamson worked at Wyeth Pharmaceuticals and held key roles in building, developing and implementing a Global Corporate Compliance program. Ms. Williamson began her career in public accounting at Ernst & Young in the Assurance and Advisory Practice.
Breakfast Workshop V: Charitable Organizations and Funding and Criteria for Patient Assistance Programs
Join James Sheehan, Chief, Charities Bureau at Attorney General for a discussion on compliance considerations related to external funding and criteria for patient assistance programs.
7:30 am
Welcome, Introductions, Discussions and Q&A
James Sheehan, JD
Chief, Charities Bureau at Attorney General of New York, Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration, Former NY Medicaid Inspector General, Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania, New York, NY
Chief, Charities Bureau at Attorney General of New York, Former Chief Integrity Officer, Executive Deputy Commissioner, City of New York Human Resources Administration, Former NY Medicaid Inspector General, Former Associate United States Attorney, US Attorney’s Office for the Eastern District of Pennsylvania, New York, NY
Mr. Sheehan was appointed by New York Attorney General Eric Schneiderman in January 2014 as the new chief of the Charities Bureau, the division of the New York Attorney General’s office that supervises charitable organizations. The Charities Bureau is responsible for enforcement activities, trust regulation, oversight and public outreach for over 90,000 New York nonprofits whose employees make up the largest nonprofit sector in this country. Previously, Mr. Sheehan served as York’s first Chief Integrity Office of the Human Resources Administration (HRA), the nation’s largest social services agency with over 14,000 employees. Mr. Sheehan previously served as first New York State Medicaid Inspector General from 2007 through 2011, and pioneered the use of data analysis tools to identify improper claims in the nation’s most generous Medicaid program. He had been the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania (Philadelphia).
8:15 am
Breakfast Roundtable Adjournment
MORNING PLENARY SESSION
8:30 am
Co-chair Welcome and Introductions
8:45 am
An Interview with The Countess of Frederiksborg, Alexandra Christina
Alexandra Christina, Countess of Frederiksborg
Member, Board of Directors and Chairperson, Ethics and Compliance Board Committee, Ferring Pharmaceuticals; Co-author, The Sincerity Edge; Former Poling Chair of Business and Government, Kelley School of Business, Indiana University, Copenhagen, Denmark
Member, Board of Directors and Chairperson, Ethics and Compliance Board Committee, Ferring Pharmaceuticals; Co-author, The Sincerity Edge; Former Poling Chair of Business and Government, Kelley School of Business, Indiana University, Copenhagen, Denmark
Alexandra, Countess of Frederiksborg and former Princess Alexandra of Denmark, currently resides in Copenhagen with her two sons, Prince Nikolai and Prince Felix. Countess Alexandra has a career background in marketing and has held numerous positions in a range of corporate and philanthropic pursuits. The Countess was named Poling Chair of Business and Government at Kelley Business School, University of Indiana in 2017-2018, and was a former patron of UNICEF Denmark, during which time she travelled to Thailand and visited, among others, HIV/AIDS patients. Countess Alexandra is currently a patron of the Danish Parkinson’s Association, and spent 25 years as a Patron of the Danish Association for the Blind. She has been a non-executive board member of Ferring Pharmaceuticals since 2007 and holds the position of Chairperson of the Ethics and Compliance Board Committee.
Joe Zimmerman
Vice President and Chief Compliance Officer, US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-chair)
Vice President and Chief Compliance Officer, US, Ferring Pharmaceuticals, Parsippany, NJ (PCF Co-chair)
Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, leadership development, training, management, and sales. He has held his current position at Ferring since 2016. Prior to Ferring, Mr. Zimmerman operated a health care compliance and business operations consulting company. Until late 2015, he served as Senior Vice President and Chief Compliance Officer for two multi-billion dollar publicly traded companies: Actavis (now Allergan) and Forest Laboratories (acquired by Actavis). He held the position of Global Chief Compliance Officer for Forest starting in 2004.
9:15 am
US DOJ and US SEC Update on FCPA Enforcement
Robert I. Dodge, JD
Assistant Director, FCPA Unit, US Securities and Exchange Commission; Former Assistant US Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington, DC
Assistant Director, FCPA Unit, US Securities and Exchange Commission; Former Assistant US Attorney, US Attorney’s Office, Western District of Michigan; Former Assistant Section Chief, Environmental Defense Section, US Department of Justice, Washington, DC
Robert I. Dodge is an Assistant Director in the Securities and Exchange Commission’s FCPA Unit in Washington, DC. Bob has been at the Commission for sixteen years. Prior to his current position, he served as Assistant Chief Litigation Counsel, focusing primarily on FCPA enforcement actions. In that role, Bob was lead trial counsel in the SEC v. Straub and SEC v. Sharef cases. Before joining the SEC, Bob held several positions at the Department of Justice, including as an Assistant U.S. Attorney and Assistant Section Chief in the Environmental Defense Section. He graduated from Columbia Law School in 1987.
David Last, JD
Acting Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
Acting Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice, Washington, DC
David Last is the Assistant Chief of the FCPA Unit, Fraud Section of the Criminal Division of the US Department of Justice. His previous role in this department was as Trial Attorney. Prior to this work, David was Assistant United States Attorney of the Fraud and Public Corruption Section of the US Attorney’s Office. He began his career as an Associate at Sutherland Asbill & Brennan LLP.
Gary F. Giampetruzzi, JD
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY (Moderator)
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer Inc., New York, NY (Moderator)
Gary Giampetruzzi is a partner in the Investigations and White-Collar practice in the Litigation Department at Paul Hastings, based in the firm’s New York office. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, and represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, the Foreign Corrupt Practices Act (“FCPA”), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world’s most prominent biotech, pharmaceutical, and medical device companies.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel and Head of Government Investigations at Pfizer Inc. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs.
10:00 am
AUSA Roundtable
John Claud, JD
Assistant Director, Consumer Protection Branch, US Department of Justice, Washington, DC
Assistant Director, Consumer Protection Branch, US Department of Justice, Washington, DC
John Claud is an Assistant Director at the Consumer Protection Branch of the U.S. Department of Justice. He has litigated numerous civil and criminal matters relating to violations of the Food, Drug, and Cosmetic Act and Title 18 offenses. Before joining DOJ, John was an associate at Cadwalader, Wickersham & Taft, and he started his career as an Assistant District Attorney in the Manhattan D.A.’s Office. John is a graduate of Trinity College (Ct.), holds a master’s degree from the University of Colorado, and is a cum laude graduate of the Catholic University of America Columbus School of Law.
Rachael Honig, JD
First Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice; Former Corporate Counsel, Litigation, Celgene, New York, NY
First Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice; Former Corporate Counsel, Litigation, Celgene, New York, NY
Rachael Honig is the First Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. She rejoined the U.S. Attorney’s Office in March 2018 after serving as Corporate Counsel, Litigation, at Celgene Corporation. Prior to joining Celgene, Ms. Honig worked at the U.S. Attorney’s Office from 2003 to 2016, serving at various times as an Assistant U.S. Attorney, Deputy Chief of the Criminal Division, and Counsel to the U.S. Attorney. Prior to that, Ms. Honig was a litigation associate at Wilmer Cutler Pickering Hale & Dorr in Washington, D.C. and a law clerk to the Hon. Mary M. Schroeder of the U.S. Court of Appeals for the Ninth Circuit.
Amanda Masselam Strachan, JD
Assistant US Attorney and Chief, Health Care Fraud Unit, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Assistant US Attorney and Chief, Health Care Fraud Unit, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Amanda Strachan is the Chief of the Health Care Fraud Unit in the U.S. Attorney’s Office for the District of Massachusetts, where she oversees the Office’s federal criminal health care fraud enforcement efforts. Amanda has extensive experience prosecuting complex cases and investigating corporate fraud. During her tenure in the Office, Amanda has prosecuted several landmark health care fraud cases against both companies and individuals. Amanda led the criminal investigation of New England Compounding Center, the compounding pharmacy responsible for the 2012 nationwide fungal meningitis outbreak, in which over 800 patients were sickened throughout the country, and more than 100 died in the largest public health crisis ever caused by a pharmaceutical drug. The NECC criminal investigation resulted in a 131-count indictment, and led to convictions – following four trials – of 13 individuals. Prior to joining the U.S. Attorney’s Office, Amanda practiced at WilmerHale LLP.
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Moderator)
John Bentivoglio is a partner at Skadden Arps in the life sciences enforcement and regulatory team in Washington, DC. Previously he served as Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
10:45 am
Break
MINI SUMMITS BLOCK A: 11:15 am – 12:15 pm
(Choose one Mini Summit only)
Mini Summit I: Prosecuting Illegal Kickbacks: The Cost of Noncompliance
This discussion will address the Anti-Kickback Statute (“AKS”) and interpreting what services provided by pharmaceutical and medical device companies constitute remuneration or things of value under the statute. Recent qui tam matters and government investigations have been focused on possible AKS violations in the form of patient assistant services (copays, foundation assistance, free replacement drug, etc.), nurse educators, and whitecoat marketing, among others.
11:15 am
Welcome, Introductions, Discussions and Q&A
Michael R. Clarke, CCEP, JD
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior, Inc., Bridgewater, NJ
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior, Inc., Bridgewater, NJ
Michael R. Clarke is the Vice President, Global Chief Compliance Officer for ConvaTec. He manages the global ethics and compliance program, overseeing ethics policy development, employee and third-party education; monitoring sales and marketing practices; third-party due diligence efforts; counseling on OFAC requirements; overseeing internal investigations and implementing processes to mitigate corruption, fraud and bribery risks. Previously, Mr. Clarke was VP. Deputy Compliance Officer for Indivior; VP, Ethics & Compliance – Americas for Actavis plc, now known as Allergan: and Vice President and Compliance Officer for EBI, LLC. He also served as a compliance officer or ethics officer for the University of Medicine & Dentistry of New Jersey and Medco Health Solutions. Mr. Clarke practiced corporate, civil and criminal law as a litigation partner with Drinker Biddle & Reath LLP, as an associate at Hannoch Weisman and Scarinci & Hollenbeck and as an Assistant Deputy Public Defender in Essex County, New Jersey.
Nereyda Garcia, JD
Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Sr. Director, Compliance, Biogen Idec, Cambridge, MA
Global Heath, Ethics and Compliance, Alnylam Pharmaceuticals; Former Sr. Director, Compliance, Biogen Idec, Cambridge, MA
Paul Johnson, JD
Executive Director, US Healthcare Compliance, Amgen, Los Angeles, CA
Executive Director, US Healthcare Compliance, Amgen, Los Angeles, CA
Paul Johnson leads the Amgen U.S. Regional Compliance team. Prior to assuming responsibility for the U.S. Compliance activities, Paul served as Associate General Counsel in Amgen’s Global Commercial Operations legal team with responsibility for advising Amgen’s commercial and medical functions on their interactions with the members of the U.S. healthcare community. Prior to joining Amgen, Paul served as Senior Counsel in the office of Counsel to the Inspector General for the U.S. Dept of Health & Human Services.
Carrie Sarhangi Love, JD
Litigation Partner, Armstrong Teasdale; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Philadelphia, PA (Moderator)
Litigation Partner, Armstrong Teasdale; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Philadelphia, PA (Moderator)
Carrie Sarhangi Love is a partner and trial lawyer in Armstrong Teasdale’s Litigation practice group, primarily serving clients in the health care and life sciences industry, including some of the country’s largest pharmaceutical and medical device companies. She has in-depth experience representing clients in connection with government investigations and inquiries, enforcement proceedings and complex civil litigation, often involving alleged health care fraud and whistleblower statutes; violations of the False Claims Act; claims under anti-kickback, anti-bribery and anti-corruption statutes such as the U.S. Foreign Corrupt Practices Act; patient support programs; and the alleged improper marketing of pharmaceutical products for off-label uses.
Mini Summit II: Reduce Compliance Risk Using a “Portfolio” Approach to Training! (Microlearning Alone is Not the Answer)
Compliance professionals with responsibility for training have bought in to the commonly-held belief that people have shorter attention spans than ever. If you’re unfamiliar with the news stories, the thought is that modern technology is causing our attention spans to shrink. One tidbit repeatedly cited is that the average human attention span is only 8 seconds, shorter than a goldfish’s attention span of 9 seconds. This claim is built on evidence that is at best shaky and falls apart under the rules of sound research.
Nonetheless, “microlearning” has become all the rage, which is leading to the design and launch of shorter-and-shorter training modules, often without regard for whether shorter is actually better. This session advocates the idea of stepping back and employing a “portfolio” approach to compliance training, using a thoughtful mix of training methods appropriate to the subject matter, learning objectives, and audience. The presenters will share practical advice and real examples of compliance training that blends traditional eLearning, live training, video, animation, microlearning, and other modalities to increase learner engagement and reduce compliance risk.
11:15 am
Welcome, Introductions, Discussions and Q&A
Punkaj T. Amin, MS, MBA
Compliance Officer, US Wound Management and US Privacy Officer, Smith & Nephew, Fort Worth, TX
Compliance Officer, US Wound Management and US Privacy Officer, Smith & Nephew, Fort Worth, TX
Punkaj Amin is an experienced Director with 17+ years of broad domestic and international experience within the life sciences industry. He has held progressive positions at global pharmaceutical and medical device companies, a top-tier management consulting firm and a world-leader in the automotive industry. He is currently the Compliance Officer, US Wound Management & US Privacy Officer for Smith & Nephew. He was previously the Director, Communications & Public Relations – North America and Associate Director, Compliance & Ethics – North America for Grifols, a global healthcare company focused upon research and development, manufacturing and commercialization of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products.
Erica Powers
Director, Compliance Operations, Sage Therapeutics; Former Director Corporate Compliance, Vertex, Cambridge, MA
Director, Compliance Operations, Sage Therapeutics; Former Director Corporate Compliance, Vertex, Cambridge, MA
Erica Powers is a Compliance Officer at Sage Therapeutics and head of the Compliance Operations team. Prior to joining Sage, Erica was a Director of Corporate Compliance at Vertex Pharmaceuticals and previously held various operational roles at Genzyme Corporation. Erica has over 15 years of experience in the bio pharmaceutical industry where she has developed global programs to support all areas of a Compliance program, such as auditing & monitoring, investigations, transparency reporting, data privacy, training, and data analytics.
Edward Sleeper, MS
Director, Global Healthcare Compliance Learning & Communications, Celgene, Summit, NJ
Director, Global Healthcare Compliance Learning & Communications, Celgene, Summit, NJ
Edward Sleeper is a tenured leader in compliance with over 23 years of experience directing and performing compliance program and platform implementations. Experience in managing people, operations, P&L, business partner relationships and the essential functions that create profit and growth.
His experiences have included start-up and tenured vendor/partner organizations, as well as direct life sciences industry experience including current role at Celgene as Director, Global Healthcare Compliance Learning & Communications. He has navigated teams through major internal and external business scenarios including mergers, acquisitions and turn-arounds.
His experiences have included start-up and tenured vendor/partner organizations, as well as direct life sciences industry experience including current role at Celgene as Director, Global Healthcare Compliance Learning & Communications. He has navigated teams through major internal and external business scenarios including mergers, acquisitions and turn-arounds.
Dan O’Connor
Senior Vice President, PharmaCertify, a Division of NXLevel Solutions, New York, NY (Moderator)
Senior Vice President, PharmaCertify, a Division of NXLevel Solutions, New York, NY (Moderator)
Daniel O’Connor heads PharmaCertify, the life science compliance training practice of NXLevel Solutions. He has over 30 years of business experience and has spent the last ten years supporting clients in designing and implementing high-impact training solutions that help strengthen compliance cultures and reduce risk.
Mini Summit III: Compliance Considerations for Small to Mid-sized Organizations
MediSpend will lead a roundtable discussion with global industry experts on compliance considerations for small to mid-sized organizations. The panel will provide strategies and best practices to address some of the challenges companies face around reporting structures, limited resources, risk management and monitoring and the role technology plays in mitigating some of these challenges.
11:15 am
Welcome, Introductions, Discussions and Q&A
Joseph Calarco
Chief Compliance Officer, NEOS Therapeutics, Blue Bell, PA
Chief Compliance Officer, NEOS Therapeutics, Blue Bell, PA
In his current position as Chief Compliance Officer, Joseph Calarco frames strategic direction and infuses excellence in all facets of corporate ethics and compliance program operations. He evolves policies, enriches educational initiatives, refines disciplinary guidance, and innovates solutions to promote integrity and encourage change. This includes setting goals, ensuring timely project completion, administering departmental budget, and reports directly to CEO.
He previous experience includes, Director, Compliance & Ethics, US Operations with Bristol-Myers Squibb and Director, Compliance Monitoring and Investigation with Shire Pharmaceuticals.
He previous experience includes, Director, Compliance & Ethics, US Operations with Bristol-Myers Squibb and Director, Compliance Monitoring and Investigation with Shire Pharmaceuticals.
Tim Robinson, JD
Chief Legal and Privacy Officer, MediSpend, Portsmouth, NH
Chief Legal and Privacy Officer, MediSpend, Portsmouth, NH
Tim Robinson is the President of the Regulatory Law Group, PLLC and the Co-Founder, Chief Knowledge Officer of MMIS, Inc. Mr. Robinson assists pharmaceutical and medical device companies in areas of corporate compliance including the development of comprehensive compliance programs consistent with state and federal laws.
MMIS, Inc.is a technology company that develops software solutions to manage all areas of transparency for life science companies, physicians and research institutions. Mr. Robinson has worked with dozens of life science companies to assist with the development of policies and procedures to meet state and federal transparency requirements.
MMIS, Inc.is a technology company that develops software solutions to manage all areas of transparency for life science companies, physicians and research institutions. Mr. Robinson has worked with dozens of life science companies to assist with the development of policies and procedures to meet state and federal transparency requirements.
Meredith Taylor, JD
Vice President Global Compliance and Privacy, Novocure, Malvern, PA
Vice President Global Compliance and Privacy, Novocure, Malvern, PA
Meredith Taylor is the VP, Global Compliance and Privacy at Novocure. In her role she oversees the compliance and privacy functions worldwide. Before joining Novocure, Meredith was the North America Regional Compliance Officer at Teva Pharmaceuticals. She spent 8 years at Teva in the global compliance department. Prior to her roles at Teva Meredith worked as in house counsel and consultant for CIS (now CIS by Deloitte) where she supported clients build compliance programs.
Diana Borges, MBA
Vice President, Compliance Solutions, MediSpend, Miami, FL (Moderator)
Vice President, Compliance Solutions, MediSpend, Miami, FL (Moderator)
With more than 20 years of expertise managing corporate compliance risks and developing global compliance programs for small, midsize and large pharmaceutical and device companies, Diana Borges has provided top pharmaceutical organizations with alternative and practical solutions. Her experience includes developing policies and procedures, creating monitoring programs, conducting compliance audits, CIA implementation, and developing 3rd party due diligence controls. Diana also has extensive experience conducting compliance investigations related to fraud, kickbacks, bribery, drug and device diversion, and record falsification and has participated in enforcement agency investigations involving the FBI, DOJ, OIG and SEC. Diana has held positions such as Senior Director of Global Compliance and Regional Compliance Officer for Latin America at Teva Pharmaceuticals and Director of Corporate Compliance Merz North America. She now is the Vice President of Compliance Solutions at MediSpend, a provider of global compliance solutions for the Life Sciences industry.
Mini Summit IV: Interactions with Patients Including Benchmarking on Patient Services Compliance
- Review of the results of Patient Services Compliance Benchmarking Survey.
- Considerations for where patient services activities reside in your company and the types of activities they are conducting.
- Usage of patient data and the associated risks.
11:15 am
Welcome, Introductions, Discussions and Q&A
Stefanie A. Doebler, JD
Of Counsel, Covington & Burling LLP, Washington, DC
Of Counsel, Covington & Burling LLP, Washington, DC
Stefanie Doebler is of counsel in Covington & Burling’s health care and food and drug practice groups. Her practice focuses on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.
Chapman Richardson
Global Head, Data Consumerization, Sanofi; Former Global Head Next Generation Digital, Novartis, Bridgewater, NJ
Global Head, Data Consumerization, Sanofi; Former Global Head Next Generation Digital, Novartis, Bridgewater, NJ
Chapman Richardson is the Global Head of Data Consumerization at Sanofi and is all about extracting value from enterprise data assets. His current responsibilities include defining the overall EIM Strategy for Sanofi with strategic imperatives around Master Data and Data Governance with an emphasis on customer/patient engagement. Prior to joining Sanofi, Chapman was at Novartis for over 10 years mostly serving in global transformational roles in the areas of CRM, Digital Marketing, and Patient Services. He most recently translated his digital engagement experiences into value for personalized medicine in the revolutionary CAR-T therapeutic space. He began his career in consulting with Accenture, IQVIA, and CapGemini where he leveraged design thinking to bring innovation to life for his clients.
Sarah L. Whipple, JD
Vice President, Legal & Chief Compliance Officer, Akebia Therapeutics, Inc., Cambridge, MA
Vice President, Legal & Chief Compliance Officer, Akebia Therapeutics, Inc., Cambridge, MA
Sarah Whipple is the Vice President, Legal & Chief Compliance Officer for Akebia Therapeutics Inc. She is a experienced health care and life sciences attorney with broad expertise in pharmaceutical and medical device advertising, regulatory and compliance matters.
Sarah’s specialties include compliance with Food, Drug & Cosmetic Act and FDA guidance, federal and state anti-kickback prohibitions, PhRMA Code, AdvaMed Code, and federal and state privacy laws.
Her previous experience includes senior leadership positions at Aegerion Pharmaceuticals, AMAG Pharmaceuticals, Inspiration Biopharmaceuticals, Inc., and Biogen Idec.
Sarah’s specialties include compliance with Food, Drug & Cosmetic Act and FDA guidance, federal and state anti-kickback prohibitions, PhRMA Code, AdvaMed Code, and federal and state privacy laws.
Her previous experience includes senior leadership positions at Aegerion Pharmaceuticals, AMAG Pharmaceuticals, Inspiration Biopharmaceuticals, Inc., and Biogen Idec.
Minna Bak, MBA
Senior Manager, Helio Health Group, New York, NY (Moderator)
Senior Manager, Helio Health Group, New York, NY (Moderator)
Minna Bak has over 10 years of experience providing strategic and management consulting services to life science companies. She has assisted pharmaceutical, medical device and biotechnology companies with operational excellence in medical affairs, clinical and commercial operations, and in compliance regarding HCP and patient interactions and regulations.
Mini Summit V: Enhanced Compliance Monitoring
Discuss opportunities to pragmatically evolve compliance monitoring beyond dashboards to deliver more proactive insights. We will highlight existing practices and options across organizations of different size and maturity.
11:15 am
Welcome, Introductions, Discussions and Q&A
Kellie Fidler, MBA, PMP
Director, Global Compliance Risk Mitigation & Monitoring Strategy, Bristol-Myers Squibb, Princeton, NJ
Director, Global Compliance Risk Mitigation & Monitoring Strategy, Bristol-Myers Squibb, Princeton, NJ
Kellie Fidler is the Lead, Global Risk Mitigation & Monitoring Strategy at Bristol-Myers Squibb (BMS), where she collaborates with business partners and Global Compliance in markets to design and deliver an analytics framework. Before becoming part of the Compliance organization, Kellie held various positions within the US Commercial Operations teams. Prior to BMS, she worked for several software companies, including IBM.
Heather McCollum, JD, MHA, CCEP-I
Director Compliance, Shionogi Inc, Florham Park, NJ
Director Compliance, Shionogi Inc, Florham Park, NJ
Heather McCollum has nearly a decade of industry experience, including more than seven years with Shionogi Inc., where she currently serves as Director of Compliance. Her responsibilities span all areas of ethics and compliance, with an emphasis on auditing and monitoring, investigations, privacy, HCP engagement and transparency reporting. She was responsible for the evolution of both the company’s HCP engagement and transparency reporting functions, successfully transitioning from fully manual processes to automated systems. Prior to joining Shionogi, Heather spent three years with Polaris Management Partners (now part of IQVIA), focusing on compliance program assessments, auditing and monitoring, and IRO services. She was named a Rising Star by the Healthcare Businesswomen’s Association (HBA), and currently serves on the Board for the Northern New Jersey Chapter of HBA.
Mark Zaleski, MBA
Director Legal Compliance, Philips; Former Senior Finance Manager, Intel Corporation, Boston, MA
Director Legal Compliance, Philips; Former Senior Finance Manager, Intel Corporation, Boston, MA
Mark Zaleski is the Director of Legal Compliance at Philips with responsibilities focusing in the role of Legal Compliance Operations including; Creating and leading Philips’ global monitoring and analytics program (covering all major markets and over 36 countries), Communications and Training, and Transparency.
Katie Schottmiller, MAcc, MS, CPA
Director, North America Independent Business Monitoring, GSK, Raleigh-Durham, NC
Director, North America Independent Business Monitoring, GSK, Raleigh-Durham, NC
Katie Schottmiller leads GSK’s Independent Business Monitoring (IBM) for North America. Since joining the team in 2017, Katie has facilitated a transition from prescribed CIA monitoring to flexible business partnering focusing primarily on Commercial and Anti-Bribery & Corruption risks. Katie joined GSK in 2011 in Audit & Assurance and led audits across multiple risks and GSK locations. She began her career in public accounting with Arthur Andersen in San Jose, CA and prior to GSK, spent over 6 years with the Advisory team at Ernst & Young in Raleigh. Katie is a Certified Public Accountant in North Carolina and California.
Angela Rodin, MBA
Principal, KPMG; Former Vice President, Global Head of Investigations and Monitoring, GlaxoSmithKline Pharma GmbH, Washington, DC (Moderator)
Principal, KPMG; Former Vice President, Global Head of Investigations and Monitoring, GlaxoSmithKline Pharma GmbH, Washington, DC (Moderator)
Background:
Angela Rodin is a principal in KPMG’s Washington, DC Risk Advisory Forensic Practice. Prior to joining KPMG in April 2017, Angela served a top 10 pharmaceutical company for 17 years in a number of leadership roles including VP, Compliance Officer for global support functions, VP, Head of Global Investigations & Business Monitoring, and Head of Global Internal Audit. In industry, Angela had responsibility for integrating and leading a global audit team, developing and maintaining comprehensive ethics and compliance programs, and providing assurance to the Board and Audit Committee on key risks, auditing & monitoring outcomes, and internal investigations. In her most recent industry role, she oversaw sensitive and privileged investigations, and optimized risk based, objective and proportionate monitoring of key business activities that give rise to bribery and corruption, and commercial practices risk.
Professional and industry experience:
Angela brings experience and provides services with compliance, audit and investigations. Career highlights include:
Angela Rodin is a principal in KPMG’s Washington, DC Risk Advisory Forensic Practice. Prior to joining KPMG in April 2017, Angela served a top 10 pharmaceutical company for 17 years in a number of leadership roles including VP, Compliance Officer for global support functions, VP, Head of Global Investigations & Business Monitoring, and Head of Global Internal Audit. In industry, Angela had responsibility for integrating and leading a global audit team, developing and maintaining comprehensive ethics and compliance programs, and providing assurance to the Board and Audit Committee on key risks, auditing & monitoring outcomes, and internal investigations. In her most recent industry role, she oversaw sensitive and privileged investigations, and optimized risk based, objective and proportionate monitoring of key business activities that give rise to bribery and corruption, and commercial practices risk.
Professional and industry experience:
Angela brings experience and provides services with compliance, audit and investigations. Career highlights include:
- Leading pre and post-acquisition due diligence reviews and investigations across multiple jurisdictions
- Transforming the commercial, operational, financial and IT global audit groups into an integrated, outcomes-driven, client-focused team, providing strategic assurance to executive management.
- Developing and implementing the strategy and vision for an integrated investigations and independent business monitoring unit to reduce risk and strengthen business practices of a $31.9bn organization of 101,000+ people in 150+ countries.
- Reducing global monitoring costs by 46% and increasing assurance through a rigorous focus on key risks, business activities and a restructure of a supporting 3rd party co-source arrangement.
- Successfully negotiating with the Office of the Inspector General (OIG) to replace a Corporate Integrity Agreement Independent Review Organization with risk-based internal monitoring, enabling $2.4m savings.
- Creating and implementing the compliance program for a $1.7bn global business unit, successfully integrating risk management and compliance at the heart of the business strategy and service model.
- Closely coordinating with the legal department, outside counsel and executive leadership on negotiations with the U.S. Department of Justice, Securities and Exchange Commission, OIG and the U.K. Serious Fraud Office.
- Initiating a global Information Protection program, in recognition of the emerging information security risk, and accelerating the creation of the Chief Information Security and Privacy Office.
- Industry focus includes Pharma, Medical Devices, Automotive and Financial Services.
Mini Summit VI: Best Practices Calculating Profit Disgorgement in Preparation for Compliance Settlements
Following years of investigations by FCPA, SEC and DOJ (these investigations have been going on for 3-7 years), and as companies are finalizing the investigations and ready to settle with the SEC and DOJ, AlixPartners is helping companies with settlement. This includes reviewing the products that were the subject of the investigations and the related compliance issues. They then determine the profitability of each product in each country around the world. They calculate a profit disgorgement number and various scenarios around the disgorgement depending on where the SEC or DOJ are going to come in, so the company is prepared well before the settlement negotiations happen. GC’s and CCOs are aware of this.
11:15 am
Welcome, Introductions, Discussions and Q&A
Brad Mroski, CPA, CFE
Managing Director, AlixPartners; Former Assistant Chief Accountant,Division of Enforcement, U.S. Securities & Exchange Commission, Dallas, TX
Managing Director, AlixPartners; Former Assistant Chief Accountant,Division of Enforcement, U.S. Securities & Exchange Commission, Dallas, TX
With almost 20 years of experience as a forensic accountant and financial regulator, Brad Mroski assists companies, counsel, and board members respond to high-stakes government investigations, business disputes, and allegations of fraud and corruption. Previously, he was assistant chief accountant in the US Securities and Exchange Commission’s (SEC’s) Division of Enforcement, where he led investigations into potential violations of federal securities laws and received numerous awards for his work on high-profile enforcement matters. Prior to that, he was a forensic accountant and financial statement auditor at a Big Four audit and consulting firm. Brad has provided expert opinions and testimony in federal and state courts matters as well as in arbitrations and regulatory administrative proceedings.
Patrick Phelan, JD
Partner, Covington & Burling LLP, Washington, DC
Partner, Covington & Burling LLP, Washington, DC
Patrick Phelan is a litigator whose practice focuses on white collar defense and investigations and intellectual property litigation. Mr. Phelan has extensive experience representing major companies in civil and criminal investigations by the Department of Justice and other federal agencies concerning allegations of violations of the False Claims Act, Anti-Kickback Statute, and Foreign Corrupt Practices Act. He has participated in all aspects of case development and strategy and has extensive experience working with experts on sophisticated financial analyses. Mr. Phelan also has significant civil litigation experience through his representation of clients in trademark disputes before federal courts and arbitration forums.
Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, New York, NY (Moderator)
Managing Director, AlixPartners, New York, NY (Moderator)
Yogesh Bahl works with Boards, C-suite executives, and PE firms on issues that will have a significant financial and reputational impact on the company. He co-leads AlixPartners’ Life sciences and Healthcare practice. Yogesh has conducted internal and FCPA investigations, served as an expert in litigation, operationalized CIAs, created meaningful data analytics programs, and provided strategy and operations assistance involving revenue cycle, call plans, product launch, and clinical trials.
Mini Summit VII: Annual Medical Device Roundtable
Join Medical Device experts as they address unique compliance topics impacting medical device companies, including:
- Designing and implementing robust medical device asset management programs.
- Responding to the shift towards value-based contracting.
- Conduct during physician interactions at point of care (e.g., during medical procedure).
- Evolving expectations for compliance investigations.
11:15 am
Welcome, Introductions, Discussions and Q&A
Maya P. Florence, JD
Partner, Health Care and Life Sciences, Skadden Arps LLP, Boston, MA
Partner, Health Care and Life Sciences, Skadden Arps LLP, Boston, MA
Maya Florence represents pharmaceutical, biotechnology and medical device manufacturers in FDA enforcement and regulatory matters, federal and state government civil and criminal investigations, and litigation. Ms. Florence has extensive experience in matters involving advertising and promotion, GMP/QSR compliance, fraud and abuse, federal and state anti-kickback laws, HIPAA and False Claims Act defense, and has counseled numerous pharmaceutical and medical device companies in developing, implementing and assessing their corporate compliance programs. In addition, Ms. Florence frequently conducts due diligence and strategic counseling in connection with life sciences and health care industry transactions, and has advised clients on more than 150 transactional matters.
Since November 2016, Nereyda has served as VP, Global Head, Ethics & Compliance at Alnylam Pharmaceuticals, a Cambridge biotech that recently launched its first commercial drug. Prior to joining Alnylam, she held several Compliance Officer roles at Biogen, supporting the US organization and the R&D and Medical Affairs organizations. Prior to Biogen, she was VP, Legal for PerkinElmer, leading the legal function for the company’s Life Sciences business unit. She began her in house career at Haemonetics Corporation, a medical device company where she held a variety of legal and compliance roles, including Chief Ethics Officer. Nereyda began her legal career as a litigator in a Boston firm.
Since November 2016, Nereyda has served as VP, Global Head, Ethics & Compliance at Alnylam Pharmaceuticals, a Cambridge biotech that recently launched its first commercial drug. Prior to joining Alnylam, she held several Compliance Officer roles at Biogen, supporting the US organization and the R&D and Medical Affairs organizations. Prior to Biogen, she was VP, Legal for PerkinElmer, leading the legal function for the company’s Life Sciences business unit. She began her in house career at Haemonetics Corporation, a medical device company where she held a variety of legal and compliance roles, including Chief Ethics Officer. Nereyda began her legal career as a litigator in a Boston firm.
Jonathan Glazier, MBA, JD
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA
Mr. Jonathan Glazier currently leads the Legal Compliance function in North America for Philips, a health technology company. Jonathan also leads the healthcare compliance domain globally. Prior to Philips, Jonathan was the Senior Director of Corporate Compliance, Privacy and Information Security Officer for Fresenius Medical Care North America, the dialysis and infusion products and services company.
Christine Gordon, JD
Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Director, Board of Directors, ESSA Bancorp, Inc; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Bethlehem, PA
Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Director, Board of Directors, ESSA Bancorp, Inc; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Bethlehem, PA
Christine Gordon is the Deputy Chief Compliance Officer for Olympus Corporation of the Americas. Ms. Gordon joined Olympus in November 2010 after spending 7 years as an Assistant District Attorney in the City of Philadelphia. She was a key leader in developing Olympus’ Compliance program, instrumental in negotiating Olympus’ CIA, appointed by the Board to oversee the implementation of Olympus’ CIA and DPAs, and successfully led Company through a federal Monitorship resulting in the timely dismissal of the complaints.
Nancy S. Travis, MS
Vice President, International Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Vice President, International Compliance and Governance, Advanced Medical Technology Association (AdvaMed), Washington, DC
Nancy Travis is Vice President for International Compliance and Governance for the Advanced Medical Technology Association (AdvaMed). Travis is responsible for the Association’s efforts to advance the highest ethical standards for business interactions in the medical technology sector worldwide.
Travis has more than 20 years of international affairs and economics experience, with a particular focus on Asia-Pacific trade issues. She worked on China and Taiwan’s World Trade Organization accession negotiations, Korea Free Trade Agreement discussions and has been involved in assessing compliance with WTO and FTA commitments. Throughout her career, she has received a number of exceptional performance and superior honor awards.
Travis has more than 20 years of international affairs and economics experience, with a particular focus on Asia-Pacific trade issues. She worked on China and Taiwan’s World Trade Organization accession negotiations, Korea Free Trade Agreement discussions and has been involved in assessing compliance with WTO and FTA commitments. Throughout her career, she has received a number of exceptional performance and superior honor awards.
Eileen E. Erdos
Principal, Forensic & Integrity Services, EY, Chicago, IL (Moderator)
Principal, Forensic & Integrity Services, EY, Chicago, IL (Moderator)
Eileen Erdos is a principal in the Life Sciences Fraud Investigation & Dispute Services practice of Ernst & Young. She specializes in assisting life sciences companies and health care providers identify and mitigate risks. Eileen is relied upon by client management teams to assist in identifying enforcement risks, determining vulnerabilities and recommending improvements from both a business and operations perspective.
As a registered pharmacist and active participant in the industry for more than 20 years, Eileen has provided operational, clinical, consulting and litigation services to various segments of the life sciences industry.
As a registered pharmacist and active participant in the industry for more than 20 years, Eileen has provided operational, clinical, consulting and litigation services to various segments of the life sciences industry.
12:15 pm
Networking Luncheon
MINI SUMMITS BLOCK B: 12:45 pm – 1:45 pm
(Choose one Mini Summit only)
Mini Summit VIII: Lessons Learned from Enforcement Actions
Federal Sentencing Guidelines – does a compliance program really help? Lesson Learned from enforcement actions, CIA, DPAs, etc. (e.g., Insys, A-Cell, Mallincrodt, J&J) including a review of data from their CIAs, the first year experience, the most challenging part of CIA implementation and IRO experience. In addition, panelists will provide a practical approach to putting guardrails in place based on recent CIAs (e.g., PAPs, PSPs, practice/marketing support, off-label, DOJ/VA Health Care Fraud Task Force).
12:45 pm
Welcome, Introductions, Discussions and Q&A
Kathleen M. Boozang, JD, LLM
Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ
Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ
Kathleen Boozang has been Dean of Seton Hall Law since July 2015. Dean Boozang began her academic career at Seton Hall in 1990 as the founder of the Law School’s now top-ranked Center for Health & Pharmaceutical Law & Policy, which sponsors life sciences compliance training programs in the United States, the EU, LATAM, Middle East and Singapore.
Thomas M. Glavin, JD
Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire, Center Valley, PA
Chief Compliance Officer for the Americas, Olympus Corporation of the Americas; Former Vice President, US/Americas Compliance Officer, Shire, Center Valley, PA
Tom Glavin is an experienced pharmaceutical, biotechnology and medical device compliance professional and lawyer with a diverse background encompassing many facets of healthcare and corporate compliance, corporate ethics, sales and marketing law and practices, medical, research and development, and regulatory law. Tom has extensive experience in implementing compliance and ethics programs. Tom has served as the Chief Compliance Officer at Olympus Corporation of the Americas (OCA) since September 2016, where he has been responsible for leading the implementation and execution of OCA’s Deferred Prosecution Agreements with DOJ and Corporate Integrity Agreement with OIG.
From 2005 through 2015, Tom was the Compliance Officer for the Americas at Shire Pharmaceuticals. Before Shire, Tom worked in Legal and Compliance positions at Sanofi (previously Aventis and Rhone-Poulenc Rorer), and at law firms in Philadelphia and Pittsburgh.
From 2005 through 2015, Tom was the Compliance Officer for the Americas at Shire Pharmaceuticals. Before Shire, Tom worked in Legal and Compliance positions at Sanofi (previously Aventis and Rhone-Poulenc Rorer), and at law firms in Philadelphia and Pittsburgh.
William Hrubes, MS
Vice President and Chief Compliance Officer, ACell, Inc., Former Healthcare Compliance Officer, DePuy Orthopaedics, Columbia, MD
Vice President and Chief Compliance Officer, ACell, Inc., Former Healthcare Compliance Officer, DePuy Orthopaedics, Columbia, MD
Bill Hrubes has served as Vice President and Chief Compliance Officer at ACell since 2015, after serving as Senior Director of Compliance and Risk Management since 2014. He has more than 15 years of experience in the development, implementation, and management of compliance and ethics programs in the life sciences industry. Mr. Hrubes previously served in compliance leadership roles at Johnson & Johnson, Smith & Nephew, Novation, Gambro, and Fresenius Medical Care North America.
Puja Leekha, JD
Vice President, Chief Compliance Officer, Corporate Compliance, Lundbeck Pharmaceuticals; Former Division Legal Counsel & Compliance Officer, Stryker Corporation; Deerfield, IL
Vice President, Chief Compliance Officer, Corporate Compliance, Lundbeck Pharmaceuticals; Former Division Legal Counsel & Compliance Officer, Stryker Corporation; Deerfield, IL
Puja Leekha is currently serving as Vice President and Chief Compliance Officer for Lundbeck North America, a global pharmaceutical company focusing on neuroscience. Prior to joining Lundbeck, she served as Division Legal Counsel & Compliance Officer for a global division of Stryker, a Fortune 500 medical technology company. She also spent a decade of her career in litigation defending pharmaceutical and medical device companies in product liability matters.
Sarah diFrancesca, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY (Moderator)
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY (Moderator)
Sarah diFrancesca is a partner in Cooley’s Health Care Regulatory and Life Sciences practice. Sarah represents life sciences and health care companies in connection with government investigations, inquiries, settlements and voluntary disclosures. Sarah also advises life sciences companies on a wide range of fraud and abuse, compliance and regulatory matters, including federal, state and local transparency laws; internal compliance reviews and investigations; patient assistant programs; and other enforcement areas of interest.
Mini Summit IX: Compliance Program Operations: Building Effective and Right Sized Compliance Programs
It is vital to have an effective and meaningful compliance program that does not impede the business and works with them to achieve business needs.
Key topics:
- Lessons Learned on what works and what doesn’t work
- How to position compliance as a value add to the business to obtain buy in and build compliance programs that are integrated into the business?
- How to build a compliance program for small- or mid-sized companies or prepare for the first major launch, including areas of compliance to concentrate on first given limited resources?
- Share best practices and a framework for companies to think about at all stages of implementation and development.
Things to Consider:
- What is the best approach to obtain resources?
- What skill sets should you consider?
- How do you prioritize activities due to limited funding?
12:45 pm
Welcome, Introductions, Discussions and Q&A
Kimi Gorman, CCEP, CFE
Sr. Director, Ethics & Compliance – Operations & Government Accountability, Monitoring & Auditing, Novo Nordisk Inc.; Former Compliance Manager, B. Braun Medical; Princeton, NJ
Sr. Director, Ethics & Compliance – Operations & Government Accountability, Monitoring & Auditing, Novo Nordisk Inc.; Former Compliance Manager, B. Braun Medical; Princeton, NJ
Kimi Gorman is a Senior Director in the North American Ethics & Compliance department of Novo Nordisk Inc (NNI), overseeing several teams responsible for strategy and risk, monitoring and auditing and government accountability. Ms. Gorman is also the chief of staff for NNI’s Chief Ethics and Compliance Officer, which involves overseeing departmental operations and collaboration and support of North America and global Ethics & Compliance programs. Ms. Gorman has over 15 years of experience in the pharmaceutical and medical device industry and is a Certified Fraud Examiner.
Cheryl Lee, MBA
Vice President, Worldwide Markets Healthcare Compliance, Global Compliance, Celgene Corporation, Summit, NJ
Vice President, Worldwide Markets Healthcare Compliance, Global Compliance, Celgene Corporation, Summit, NJ
Cheryl Lee is an experienced Compliance leader with 15+ years of experience in creating effective Corporate Ethics & Compliance and Compliance Audit Programs. Her career has spanned across both big (Pfizer) and biotech (Celgene), as well as consulting experience at EY. She has a passion for driving innovation and developing high performing teams and is currently responsible for the execution of the Worldwide Markets Ethics & Compliance Program at Celgene. Some of her successful projects have included the creation of a Healthcare Compliance Audit team, Speak Up culture campaigns, consolidation of Global HCC Policies into principles based searchable mobile and web-based platform, and the automation of high risk manual end to end documentation processes. She currently leads the Celgene Worldwide Markets governance model including the Compliance Governance Board and Compliance network with over 60 colleagues.
Sunitha Ramamurthy, JD
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Sunitha Ramamurthy serves as Head of Compliance and Privacy at Loxo Oncology, a wholly owned subsidiary of Eli Lilly. She has over twenty years of experience in legal and healthcare compliance. In her current role, she provides compliance support through the acquisition by Eli Lilly. Previously, at Boehringer Ingelheim Pharmaceuticals Inc., she oversaw the Office of E&C supporting compliance business partnering, CIA implementation, T&D, ABAC, and compliance operations. She also worked at Eisai Inc., and as a litigator.
Jonathan Wilkenfeld, MBA
Partner, Potomac River Partners, Washington, DC (Moderator)
Partner, Potomac River Partners, Washington, DC (Moderator)
Jon Wilkenfeld is the President of Potomac River Partners, a consulting company focused on healthcare compliance for the life sciences industry. He has been consulting in this industry since 2002 and launched Potomac in 2006. Jon has advised more than 80 life science companies on topics such as transparency, policy development, and auditing and monitoring.
Mini Summit X: Value-Based Arrangements
In this session, the panel will discuss the manufacturer perspective on value-based and outcome-based arrangements, the recent proposed rules under the Anti-Kickback Statute and Stark, and recent trends in pharmaceutical and medical device value-based arrangements.
12:45 pm
Welcome, Introductions, Discussions and Q&A
Jonathan Glazier, MBA, JD
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA
Head of Legal Compliance, Philips North America; Former Senior Director of Corporate Compliance and Privacy Officer, Fresenius Medical Care North America, Andover, MA
Mr. Jonathan Glazier currently leads the Legal Compliance function in North America for Philips, a health technology company. Jonathan also leads the healthcare compliance domain globally. Prior to Philips, Jonathan was the Senior Director of Corporate Compliance, Privacy and Information Security Officer for Fresenius Medical Care North America, the dialysis and infusion products and services company.
Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC
Julie Wagner is Assistant General Counsel at PhRMA with responsibility for compliance, and enforcement matters. Prior to joining PhRMA, Julie served in the Office of the Inspector General at the U.S. Department of Health & Human Services where she worked in the Industry Guidance Branch as an Anti-kickback Statute subject matter expert, advising on fraud and abuse issues.
Meenakshi Datta, JD
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL (Moderator)
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL (Moderator)
Meena Datta is global co-leader of the Sidley’s Healthcare practice and member of the global Life Sciences team, manages key strategic matters for life sciences and healthcare companies throughout the world. Meena specializes in all areas of health care regulatory law for pharmaceutical and medical device manufacturers, including the Anti-Kickback Statute, government pricing and state pricing transparency laws, the Sunshine Act, health care reform, and HIPAA and data privacy and security. Her particular areas of focus include patient support programs, market access, and government pricing. She routinely works with General Counsels, Compliance Officers, and their departments to develop and implement effective compliance programs. Meena serves as outside counsel to a wide range of healthcare clients, including emerging and established biopharmaceutical, medtech, and big data companies.
Mini Summit XI: Challenges and/or Considerations When Performing a Fair Market Value (FMV) Analysis
This discussion will address:
- Why and when Fair Market Value is needed?
- Where are the biggest challenges in determining appropriate compensation for healthcare professionals and other external experts?
- What are some of the challenges with determining the amount to pay patients or patient organization representatives?
- What are bona fide services and why do they matter?
- What best practices are recommended during the contracting phase of the collaboration agreement?
12:45 pm
Welcome, Introductions, Discussions and Q&A
Masha Chestukhin, MSJ
Associate Director, Compliance Officer R&D IA, FMV, Sanofi Genzyme, Jamaica Plain, MA
Associate Director, Compliance Officer R&D IA, FMV, Sanofi Genzyme, Jamaica Plain, MA
Masha Chestukhin has been working for more than 10 years in Pharmaceutical/Biotech industry. She has extensive knowledge in different aspects of Research & Development, Corporate Compliance, Government Pricing, and software validation for the Pharmaceutical industry, and has provided various advisory services related to Pharma companies under Corporate Integrity Agreements. Prior to her work at Sanofi, Masha worked more than 6 years at Deloitte & Touche in Life Sciences/Health care advisory practice. Her specific interests lie in the area of R&D compliance and all aspects of FMV concepts.
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Co-chair)
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD (PCF Co-chair)
Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, Inc, with responsibility for the comprehensive compliance program, including privacy and information security at both Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. She joined Otsuka in January 2011 as Senior Compliance Counsel, overseeing compliance with the Corporate Integrity Agreement, implementation of the company’s Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and recently retired from the Army Reserves.
Julie DeLong, CFA
Senior Managing Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
Senior Managing Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
Julie DeLong is a Senior Managing Director at Ankura Consulting and has over 30 years of experience providing valuation consulting services. Julie has significant experience advising biotechnology, pharmaceutical, and medical device companies on the valuation issues they face. Julie routinely assists clients with valuations for regulatory compliance. This experience includes valuations of fee-for-service arrangements, including bona fide services provided by her client’s customers, such as specialty pharmacies, specialty distributors, wholesalers, group purchasing organizations, etc. Julie’s expertise includes assisting clients with developing and documenting fair market value hourly rates for healthcare professionals for consulting on product development, serving on advisory boards, conducting speaker programs, etc.
CJ DeKreek, CFA
Senior Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
Senior Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
CJ DeKreek is a Senior Director within Ankura Consulting Group, LLC’s Transaction Advisory Services practice. CJ is responsible for valuation analyses and financial advisory services for clients seeking assistance with transaction support, regulatory compliance, financial reporting, strategic decision making, tax compliance, and litigation support. CJ has extensive experience with performing fair market value analyses in connection with fee-for-service arrangements related to life sciences companies and their customers, including bona fide distribution services, specialty pharmacy enhanced services, GPO and PBM administrative fees, speaker programs, sponsorship services, exhibit services, web banner advertising services, e-blast services, and data reporting services.
Mini Summit XII: Patient Support Programs – Helping Patients Access Products
The primacy of the patient and creating a “patient-centric” commercialization approach that ensures access to novel therapies has created significant compliance and legal complexities that are difficult to manage. The risk management needs and personnel engaged often lack the experience and compliance expertise to effectively identify, measure and mitigate risk. During this session, we explore risks and risk management strategies pertaining to:
- Patient Advocacy Funding and Support
- Patient Advocacy Organization Collaborations
- Promotional engagement of Patient Influencers
- Patient Support Programs / Services such as:
- Co-Pay and financial support
- Coordination of care
- Specialty pharmacy programs
- Disease education
- Co-Pay and financial support
12:45 pm
Welcome, Introductions, Discussions and Q&A
Timothy Ayers, JD, MPH
Life Science Compliance Consulting, LLC; Former VP, Chief Compliance Officer, Horizon Pharma plc., Oklahoma City, OK
Life Science Compliance Consulting, LLC; Former VP, Chief Compliance Officer, Horizon Pharma plc., Oklahoma City, OK
Tim Ayers is the sole member and founder of Life Science Compliance Consulting, LLC. He serves as both legal and compliance for various life science companies from start-up to globalization. Previously, he was the Group Vice President, Chief Compliance Officer for Horizon Pharma plc. Prior to that, he was the Vice President, Chief Compliance Officer for Dendreon Corporation. He has held various legal and compliance roles at small oncology biotech companies where he established and implemented the compliance programs, and also provided legal counsel to all areas of the business. Prior to joining the in-house ranks, Tim was an attorney in the healthcare group for the Washington, DC Office of Winston & Strawn, LLP.
Samantha Barrett Badlam, JD
Counsel, Ropes & Gray, Washington, DC
Counsel, Ropes & Gray, Washington, DC
Samantha Barrett Badlam is counsel in the Litigation and Enforcement group of Ropes & Gray. She joined the firm in 2006. Samantha’s practice focuses in the area of white collar defense in criminal and civil matters. Samantha represents clients in the pharmaceutical, medical device, diagnostic laboratory, and dental industries who are facing criminal and government investigations, in addition to providing extensive compliance advice to these clients. Samantha conducts internal investigations in all types of government and regulatory compliance matters including: potential violations of false claims act whistleblower and anti-kickback statutes and of anticorruption and anti-bribery statutes, including the U.S. Foreign Corrupt Practices Act, alleged health care fraud, alleged improper marketing of pharmaceutical products and medical devices for uses for which they have not been approved by the FDA (off-label marketing, pre-approval promotion), and alleged violations of deceptive trade practice statutes. She also dedicates a significant portion of her practice providing advice to clients on compliance matters, and has worked with clients in many sectors including health care, life sciences, energy, and financial services.
Elizabeth Weiss, JD
Chief Compliance Counsel for Patient Support Services and Payer Access, Pfizer, Peapack, NJ
Chief Compliance Counsel for Patient Support Services and Payer Access, Pfizer, Peapack, NJ
Elizabeth Weiss is the Assistant General Counsel and Compliance Lead for Pfizer’s Global Health & Patient Access group and its Payer & Channel Access group, focused on proactive Compliance support, including risk assessment and mitigation, guidance, and helping ensure CIA compliance for the groups responsible for patient support programs and market access, including Pfizer’s free drug Patient Assistance Program, charitable donations for copay assistance to independent charity patient assistance programs (copay foundations), strategy and oversight of Hub vendors, specialty pharmacies and account management, market access strategy and operations, and payer interactions.
Darren R. Jones, CIA
Senior Principal, Commercial Compliance, Global Consulting Practice Leader, IQVIA, New York, NY (Moderator)
Senior Principal, Commercial Compliance, Global Consulting Practice Leader, IQVIA, New York, NY (Moderator)
Darren Jones is a Senior Principal and Commercial Compliance Global Consulting Practice Leader at IQVIA where he leads the global consulting practice dedicated to supporting client’s compliance risk management needs. He has over 18 years of global experience supporting the broad business and compliance needs of large global pharmaceutical manufacturers, as well as emerging biotech companies and medical technology. Darren has led compliance consulting engagement across all healthcare interaction risk areas, and has developed deep expertise in commercial and medical affairs operations.
Mini Summit XIII: The Opioid Crisis: Compliance and Enforcement Trends
The current U.S. opioid epidemic has been branded as “the worst drug crisis in America’s history” and a “man-made plague.” According to the CDC, the current public health crisis has claimed almost 400,000 lives to opioid overdoses since 1999, including prescription and illicit opioids, with no end in sight. The causes for the crisis are complex, yet an enormous amount of federal, state, and local litigation seeks to hold many of America’s largest pharmaceutical manufacturers, distributors, and retail chain pharmacies accountable. While it can be argued that the opioid crisis is unique and much of the litigation is ongoing, this panel will explore the nature of the crisis and the important lessons already revealed for all pharmaceutical and medical device professionals, regardless of whether their companies are involved with opioids or controlled substances.
12:45 pm
Welcome, Introductions, Discussions and Q&A
Danielle Davis, LLB
Director, Compliance Counsel, Heron Therapeutics, Inc; Former Senior Director Compliance, Sentynl Therapeutics; Phoenix, AZ
Director, Compliance Counsel, Heron Therapeutics, Inc; Former Senior Director Compliance, Sentynl Therapeutics; Phoenix, AZ
Danielle Davis originally launched her compliance career in Seattle, WA in the tribal gaming, before switching to the pharmaceutical industry in 2014. She was hired as the Compliance Director at Insys Therapeutics Inc., and tasked with establishing a culture of compliance while working with various government agencies to bring resolutions to several outstanding investigations. After 5 very long and exhausting years, she welcomed a new role at Sentynl Therapeutics Inc as Associate General Counsel and Senior Director of Compliance. Danielle currently works at Heron Therapeutics as Director and Compliance Counsel.
Michael G. Hercz, JD
Senior Vice President and General Counsel, Sentynl Therapeutics, Inc., Solana Beach, CA
Senior Vice President and General Counsel, Sentynl Therapeutics, Inc., Solana Beach, CA
Michael J. Hercz has more than 20 years of diverse Life Sciences legal, regulatory, compliance and risk management experience. He currently serves as General Counsel and Chief Compliance Officer of Sentynl Therapeutics, Inc. Prior to Sentynl, Michael was a Managing Director in Deloitte & Touche’s Enterprise Risk Services Group. He previously was Victory Pharmaceuticals’ Vice President and Chief Compliance Officer and an Executive Director at Amgen Inc. Michael practiced at Akin, Gump, Strauss, Hauer & Feld LLP and at Hooper, Lundy & Bookman Inc.
Seth B. Whitelaw, JD, LLM, SJD
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA
With more than 30 years working in the industry, Dr. Whitelaw started his career in Life Science Compliance in 1993, when he became the Compliance Coordinator for C.R. Bard, Inc. Present since the inception of life science compliance, his career has encompassed a wide variety of roles from in-house compliance officer (C.R. Bard, Inc., SmithKline Beecham NA, GlaxoSmithKline, and Misonix, Inc.) to industry consultant (Deloitte and Whitelaw Compliance Group) to editor (Policy & Medicine Compliance Update (formerly Life Science Compliance Update)), and finally law professor (Mitchell Hamline School of Law) where he currently teaches students about corporate and life sciences compliance.
John C. Richter, JD
Partner, King & Spalding; Former Acting Assistant Attorney General, Criminal Division , US Department of Justice; Former US Attorney, Western District of Oklahoma, Washington, DC (Moderator)
Partner, King & Spalding; Former Acting Assistant Attorney General, Criminal Division , US Department of Justice; Former US Attorney, Western District of Oklahoma, Washington, DC (Moderator)
John Richter regularly represents companies, Board of Directors, Board committees, and individuals facing white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma. Notably, John has defended clients in trials and investigations involving U.S. Attorneys’ Offices in over fifteen districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general’s offices for all 50 states and the District of Columbia.
Mini Summit XIV: Issues with Medical Device/Combination Products
This will be a roundtable discussion regarding hot topics for medical device and combination product market authorization holders and manufacturers, including pharmacovigilance, QSR, registration, regulatory identity, and engagement with FDA.
12:45 pm
Welcome, Introductions, Discussions and Q&A
Nicholas Mandala
Senior Director, Medical Devices Technical Program Lead, Pfizer, Inc., New York, NY
Senior Director, Medical Devices Technical Program Lead, Pfizer, Inc., New York, NY
Nick Mandala is the Senior Director, Medical Devices Technical Program Lead at Pfizer Inc., and the technical lead for post market device engineering group supporting device lifecycle management. Prior to joining Pfizer in 2017, Nick held various leadership positions in Quality, Engineering, and Validation. With 19 years’ in the medical devices and combination products industry, Nick has depth of experience in validation, risk management, application of design control requirements, and product and process remediation.
John B. Weiner, JD
Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA, Silver Spring, MD
Associate Director for Policy and Product Classification Officer, Office of Combination Products, FDA, Silver Spring, MD
John Weiner is the Associate Director, Office of Combination Products for the FDA. He is responsible for classifying and assigning therapeutic products for regulation and ensuring that regulation is consistent and timely; in addition to legal issues, work concerns a wide range of scientific and policy considerations.
He was previously an Associate with Ropes & Gray LLP and Beveridge & Diamond, PC.
He was previously an Associate with Ropes & Gray LLP and Beveridge & Diamond, PC.
Deeona Gaskin, MPH, JD
Associate, Sidley Austin, LLP; Former Associate Chief Council, US Food and Drug Administration, Washington, DC (Co-moderator)
Associate, Sidley Austin, LLP; Former Associate Chief Council, US Food and Drug Administration, Washington, DC (Co-moderator)
Ms. Gaskin served as Associate Chief Counsel for Enforcement at the U.S. Food and Drug Administration (FDA) and is now an associate in Sidley’s Food, Drug and Medical Device Compliance and Enforcement group. She handles current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), data integrity, product recalls and adverse event reporting matters on several continents, and also represents companies in False Claims Act enforcement actions and investigations.
William A. McConagha, JD
Partner, Sidley Austin, LLP; Former Health Policy Advisor, Health, Education, Labor and Pensions Committee, US Senate; Former Assistant Commissioner, US Food and Drug Administration, Washington, DC (Co-moderator)
Partner, Sidley Austin, LLP; Former Health Policy Advisor, Health, Education, Labor and Pensions Committee, US Senate; Former Assistant Commissioner, US Food and Drug Administration, Washington, DC (Co-moderator)
Bill McConagha, a partner in Sidley’s Food and Drug practice, is a nationally recognized lawyer in Food and Drug law who has a unique combination of experience with enforcement, regulatory and legislative matters. He worked for more than 17 years at the Food & Drug Administration (FDA) in a variety of capacities including as an Assistant Commissioner, a Senior Attorney in the Office of Chief Counsel (OCC) and as a Health Policy Advisor to the Senate Committee on Health, Education, Labor and Pensions (HELP).
Bill has been recognized by Best Lawyers in America for FDA law and Who’s Who Legal for Life Sciences.
Bill has been recognized by Best Lawyers in America for FDA law and Who’s Who Legal for Life Sciences.
1:45 pm
Transition Break
MINI SUMMITS BLOCK C: (2:00 pm – 3:00 pm)
(Choose one Mini Summit only)
Mini Summit XV: Charitable Contributions Compliance Considerations
- Recent regulatory enforcement action and risk considerations for charitable contributions
- Common industry challenges and pain points faced when evaluating charitable contributions
- Key factors and criteria to consider when assessing the appropriateness of charitable contribution requests
- Operational best practices for ensuring compliance in today’s risk environment
2:00 pm
Welcome, Introductions, Discussions and Q&A
Elaina Filauro
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY
Elaina Filauro is a Senior Manager, Deloitte Advisory for Deloitte & Touche LLP. She was previously an Associate in Huron Consulting Group’s Life Sciences practice. She is experienced in assisting pharmaceutical and medical device manufacturers manage complex regulatory environments in areas of sales and marketing compliance, Corporate Integrity Agreement adherence, and state and federal reporting requirements, among others. In particular, Elaina is experienced in conducting compliance program gap assessments, participating on Independent Review Organizations, developing promotional and non-promotional monitoring programs, and acting as a live field force monitor for speaker programs and ride-alongs. Prior to consulting, her past experience includes positions in both sales and compliance for two separate pharmaceutical manufacturers.
Abraham Gitterman, JD
Senior Associate, Life Sciences/Healthcare Regulatory, Arnold & Porter LLP; Publications Peer Review Committee, Food and Drug Law Institute (FDLI); Washington, DC
Senior Associate, Life Sciences/Healthcare Regulatory, Arnold & Porter LLP; Publications Peer Review Committee, Food and Drug Law Institute (FDLI); Washington, DC
Abraham Gitterman focuses on FDA and Healthcare regulatory, compliance, and fraud and abuse matters involving pharmaceutical and medical device manufacturers. He regularly counsels clients on FDA-regulated advertising and promotion, including use of social media; compliant medical affairs activities, including continuing medical education (CME); appropriate interactions with healthcare professionals; and mobile health applications. Mr. Gitterman also assists with extensive reviews of corporate compliance programs, both generally and pursuant to Corporate Integrity Agreements (CIAs) with OIG, for various life science companies and healthcare entities to ensure compliance with the Anti-Kickback Statute; the False Claims Act; and the Federal Food, Drug, and Cosmetic Act.
Prior to joining the firm, Mr. Gitterman was a research associate at a national ACCME-accredited CME provider, where he assisted drafting medical education grant applications and evaluated various conflict of interest policies regarding physician relationships with manufacturers.
Prior to joining the firm, Mr. Gitterman was a research associate at a national ACCME-accredited CME provider, where he assisted drafting medical education grant applications and evaluated various conflict of interest policies regarding physician relationships with manufacturers.
David Heard, JD
Senior Corporate Counsel, Pfizer Inc., Dallas, TX
Senior Corporate Counsel, Pfizer Inc., Dallas, TX
David Heard is a Senior Corporate Counsel for Pfizer Inc. He has a broad range of legal and compliance experience with issues facing pharmaceutical manufacturers and health care providers. His more recent experience has focused on pharmaceutical product advertising and promotional activities and other interactions between manufacturers and integrated health systems.
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Keith Korenchuk is Vice President and Chief Compliance officer at Danaher Diagnostics and Beckman Coulter. Prior to this role, he was a Partner at Arnold & Porter, LLP. Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Seth H. Lundy, JD
Partner, King & Spalding, LLP, Washington, DC
Partner, King & Spalding, LLP, Washington, DC
Seth Lundy is deputy chair of the King & Spalding FDA & Life Sciences Practice Group and resident in Washington, DC. With over 20 years of industry experience, he focuses his practice on federal and state regulation of pharmaceutical, biotech, medical device manufacturers, and distributors, as well as healthcare providers and suppliers, including advising on corporate compliance, government investigations, the AntiKickback Statute, False Claims Acts, the Sunshine Act, the Food, Drug and Cosmetic Act, managed markets, and Medicare and Medicaid coverage, coding and reimbursement.
BJ D’Avella, MBA
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY (Moderator)
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, New York, NY (Moderator)
For over 16 years, BJ D’Avella assisted global clients with program delivery related to compliance and regulatory risks inherent to patient services, sales and marketing, market access, medical affairs, and clinical operations. BJ has led the creation and development of technology enabled services and data-enabled monitoring program execution and reporting tools. He specializes in leading complex projects related to Commercial, Medical, and R&D operations and compliance, especially within the areas of Patient Services and Commercial Compliance Program Design and Management, Clinical/RWE Program Management, Monitoring Program design and execution, Corporate Integrity Agreement (CIA) support, and Fair Market Value (FMV) assessments.
Mini Summit XVI: How do you Modernize your Compliance Program to Prepare for the Future of Health?
As the compliance landscape continues to change, as does the opportunity to invest in technology solutions to automate processes and increase the speed and effectiveness of making sound decisions, the resource model needs to evolve to ensure future operations are supported by the right people and skill sets (e.g., data/analytics expertise) that provide impactful, actionable insights. The diverse panel will evaluate the people and skills, technology solutions, business practices, data analytics and recent regulations all implicated by the concept of modernizing compliance.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Wendy C. Goldstein, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY
Wendy Goldstein is a partner at Cooley where she leads the firm’s Health Care & Life Sciences Regulatory practice. Ms. Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to healthcare and life sciences companies including manufacturers, payors and other ancillary providers. She also represents those entities that invest in such concerns. Ms. Goldstein speaks and writes extensively on issues relating to fraud and abuse, board governance, government program pricing, corporate compliance, government enforcement activity relevant to the life sciences and managed care industries and health care reform. She serves on the board of directors of several non-profit health care associations, and educational institutions. She also is actively involved in pro bono activities relating to the pediatric oncology research and other health care education and access initiatives.
Joshua M. Marks, JD
Vice President and Chief Ethics & Compliance Officer, Boehringer Ingelheim USA Corporation, Ridgefield, CT
Vice President and Chief Ethics & Compliance Officer, Boehringer Ingelheim USA Corporation, Ridgefield, CT
Joshua Marks, JD: Over 22 years of broad legal experience, including commercial, Compliance, GMP/regulatory, litigation and intellectual property, in prominent law firms and in-house senior leadership positions. Served internationally as global General Counsel of an Animal Health business and as Chief Ethics & Compliance Officer of a global pharmaceutical company. Provides clear, pragmatic and business-oriented solutions. Develops employees’ and teams’ potential, enhances culture of engagement through psychological-safety and empathy, and leads global and highly matrixed teams. Uses solid judgment, innovation and smart risk-taking strategies to resolve complex challenges.
Specialties: Compliance, leadership, personnel development, Legal/Compliance strategy, commercial transactions; licensing; pharmaceutical regulatory support; litigation; crisis-resolution; innovation; smart risk-taking; leading teams & global, virtual teams; experience in building new departments and/or functions, and building trusted relationships.
Specialties: Compliance, leadership, personnel development, Legal/Compliance strategy, commercial transactions; licensing; pharmaceutical regulatory support; litigation; crisis-resolution; innovation; smart risk-taking; leading teams & global, virtual teams; experience in building new departments and/or functions, and building trusted relationships.
Vahan Minassian, JD
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Vahan Minassian is a Director and the US Promotional Monitoring Lead in Pfizer’s Compliance Monitoring & Analytics Practice. His team is responsible for continuous review of colleague e-mails, call notes, coaching guides and other unstructured datasets. He also oversees the live monitoring program, including Speaker Program audits and Field Rides.
Ashley Riley, JD
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Charlotte, NC
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Charlotte, NC
Ashley Riley is a licensed attorney with strong analytical, problem-solving and communication skills and experience in aligning compliance processes and documentation to legal, regulatory and industry standards. Ashley manages and oversees engagements related to compliance and risk assessments, compliance program implementation and advisory services interacting with staff at all levels within the legal, compliance, commercial operations and regulatory departments.
Jack Tanselle, MBA
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Indianapolis, IN (Moderator)
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Indianapolis, IN (Moderator)
Mini Summit XVII: Medical Affairs Proactive Communications, Engagement by Manufacturers
This Mini-Summit will explore current trends in proactive field-based Medical Affairs roles and activities, including strategic areas of focus, permissible content and materials, and related compliance controls.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Casper Partovi, JD
Vice President, Global Commercial Operations Law Group, Los Angeles, CA
Vice President, Global Commercial Operations Law Group, Los Angeles, CA
Casper Partovi currently leads the group of attorneys supporting Amgen’s Global Commercial Operations and US business. Prior to this role, he spent a few years in Hong Kong building and leading Amgen’s legal function in the Asia Pacific region and earlier had responsibility for managing the legal affairs for the Canada, Latin America, Turkey, Middle East and Africa region. He started his career at Amgen working on transactions and alliance management matters, before shifting to advising US commercial operations. Casper joined Amgen from the law firm of Gibson Dunn & Cruthcher where he practiced in the M&A, Transactions and Securities area.
David Earl Smith, MBA
Advisor Ethics & Compliance, Eli Lilly & Company, Indianapolis, IN
Advisor Ethics & Compliance, Eli Lilly & Company, Indianapolis, IN
David Earl has served in the pharmaceutical industry for over 24 years in a host of commercial and leadership roles. He has made contributions in multiple organizations including US Sales, Marketing, Operations, Payer and Global Market Research. He has served as an Advisor in Ethics & Compliance for the past 5 years where he has provided oversight to Oncology, Biomedicines, Patient Services, Medical Affairs and the Grant Office functions. David is actively involved with the Policy Center of Excellence committee where he works to provide interpretation of external requirements and internal business procedures. David earned a B.S. Degree from Tuskegee University and an MBA from Columbia University.
Ann-Marie Tejcek, MA
Senior Director North American Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN
Senior Director North American Ethics and Compliance Officer, Eli Lilly and Company, Indianapolis, IN
Ann-Marie Tejcek has been an employee with Eli Lilly and Company, a global innovation-based pharmaceutical company, for over 25 years. In 2017, Ann-Marie was asked to serve as the Chief Compliance Officer for the US and Canadian Affiliates supporting Medical, Marketing and Sales activities. The mission of her team, and the broader compliance organization at Lilly, is to integrate high performance with high integrity. Ann-Marie began her career at Lilly in San Diego, California where she held numerous roles in Sales, Human Resources, and Managed Care. She later joined the U.S. Evista team where she launched the Osteoporosis treatment indication for that product. Ann-Marie was the US Depression Launch Leader for Cymbalta, was a Neuroscience National Senior Sales Director in the Mid-Atlantic Region, Regional Medical Leader for Integrated Health Systems, and various other US and Global leadership roles in Sales, Marketing and Medical across the organization during her tenure.
Alison Fethke, JD
Counsel, Ropes & Gray LLP; Former Division Counsel, Legal, Regulatory and Compliance, AbbVie, Chicago, IL (Moderator)
Counsel, Ropes & Gray LLP; Former Division Counsel, Legal, Regulatory and Compliance, AbbVie, Chicago, IL (Moderator)
Alison Fethke is a Counsel in the Health Care group of Ropes & Gray and focuses her practice on legal and regulatory matters in the health care and life sciences industries. She provides advice on a wide range of issues, including health care and FDA regulatory matters and compliance program development and support, and works with pharmaceutical and medical device manufacturers, as well as health care providers, domestically and globally. Alison also advises health care and life sciences clients with respect to government investigations stemming from alleged violations of U.S. federal health care program laws, the FDCA and the FCPA.
Mini Summit XVIII: HCP Engagement and Transparency Perspectives
Hear how companies of all sizes are overcoming hurdles to effective HCP engagement and transparency program implementations.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Heather McCollum, JD, MHA, CCEP-I
Director Compliance, Shionogi Inc, Florham Park, NJ
Director Compliance, Shionogi Inc, Florham Park, NJ
Heather McCollum has nearly a decade of industry experience, including more than seven years with Shionogi Inc., where she currently serves as Director of Compliance. Her responsibilities span all areas of ethics and compliance, with an emphasis on auditing and monitoring, investigations, privacy, HCP engagement and transparency reporting. She was responsible for the evolution of both the company’s HCP engagement and transparency reporting functions, successfully transitioning from fully manual processes to automated systems. Prior to joining Shionogi, Heather spent three years with Polaris Management Partners (now part of IQVIA), focusing on compliance program assessments, auditing and monitoring, and IRO services. She was named a Rising Star by the Healthcare Businesswomen’s Association (HBA), and currently serves on the Board for the Northern New Jersey Chapter of HBA.
Mark Zaleski, MBA
Director Legal Compliance, Philips; Former Senior Finance Manager, Intel Corporation, Boston, MA
Director Legal Compliance, Philips; Former Senior Finance Manager, Intel Corporation, Boston, MA
Mark Zaleski is the Director of Legal Compliance at Philips with responsibilities focusing in the role of Legal Compliance Operations including; Creating and leading Philips’ global monitoring and analytics program (covering all major markets and over 36 countries), Communications and Training, and Transparency.
Michael O’Connor
Vice President of Compliance Technology, Porzio Life Sciences, LLC; Former Global Head Compliance and Ethics Operations, Alexion; Former Executive Director, Global Head, IS Business Consulting, Boehringer Ingelheim, New York, NY (Moderator)
Vice President of Compliance Technology, Porzio Life Sciences, LLC; Former Global Head Compliance and Ethics Operations, Alexion; Former Executive Director, Global Head, IS Business Consulting, Boehringer Ingelheim, New York, NY (Moderator)
Michael O’Connor is Vice President of Compliance Technology for Porzio Life Sciences, LLC. In this role, Michael advises life sciences companies on the strategic use of data analytics and technology to drive compliance with governing laws, codes, and industry standards and also leads the development of the Porzio Life Sciences technology solution offerings.
Prior to joining PorzioLS, Mr. O’Connor held executive leadership positions as the global head of compliance and ethics operations at Alexion and as an executive director, global head, IT business consulting at Boehringer Ingelheim. Most recently, Mr. O’Connor was a Principal/Owner at 3rd Wave Compliance, a technology focused consulting company geared toward life sciences companies.
Prior to joining PorzioLS, Mr. O’Connor held executive leadership positions as the global head of compliance and ethics operations at Alexion and as an executive director, global head, IT business consulting at Boehringer Ingelheim. Most recently, Mr. O’Connor was a Principal/Owner at 3rd Wave Compliance, a technology focused consulting company geared toward life sciences companies.
Mini Summit XIX: Compliance – Board Communications: Effective Measurement and Reporting Strategies
This discussion will provide an overview of resources and best practices from recent enforcements (e.g., CIAs) to gain a better understanding of what the government is looking for as part of the compliance professionals’ roles and responsibilities. Panelists will share:
- Recommendations during Routine Communications to the Board to demonstrate the effectiveness of the compliance program and areas of improvement.
- The best way to address irregular communications or one-off issues (e.g., complaints through the hotline)
- Techniques or keys to success to gain better participation or more active involvement by the Board.
- Special Education or Training to the Board to ensure the Board is fully apprised of its responsibilities and the significance of the compliance program and their evaluation of the compliance program.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance and Ethics, Bristol-Myers Squibb, Washington, DC
Over his career, Thomas Costa has provided legal and compliance guidance and advice to pharmaceutical companies as outside counsel, in-house counsel, head of a U.S Compliance team and today as a Compliance Consultant. He has experience leading domestic and international legal and compliance teams worldwide.
Elizabeth “Beth” Kolbe, JD
Associate, Sidley Austin LLP, Washington, DC
Associate, Sidley Austin LLP, Washington, DC
Elizabeth Kolbe is an associate in the Healthcare practice of Sidley Austin in Washington, D.C. She focuses on healthcare regulatory and compliance matters and has experience in federal healthcare program coverage, coding, and reimbursement issues; government price reporting; healthcare compliance programs; government agency and congressional investigations; and healthcare fraud and abuse. Beth has worked with numerous clients, including pharmaceutical, biologics, and device manufacturers, durable medical equipment suppliers, patient organizations, and healthcare professional societies, among others. She also has represented a number of clients on a pro bono basis in matters challenging Medicaid coverage denials and advocating on healthcare public policy issues.
Jennifer McGee, JD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD
Vice President and Chief Compliance Officer, Otsuka America Pharmaceutical, Inc., Rockville, MD
Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, Inc, with responsibility for the comprehensive compliance program, including privacy and information security at both Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. She joined Otsuka in January 2011 as Senior Compliance Counsel, overseeing compliance with the Corporate Integrity Agreement, implementation of the company’s Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and recently retired from the Army Reserves.
Katherine Norris, MPA
Director, Corporate Compliance & Risk Management, Berkeley Research Group LLC, Washington, DC (Moderator)
Director, Corporate Compliance & Risk Management, Berkeley Research Group LLC, Washington, DC (Moderator)
Katie Norris is a Director in BRG’s Corporate Compliance and Risk Management practice. She has 18 years’ experience in corporate governance and compliance in the life sciences industries, both as an industry professional and a consultant. Ms. Norris focuses primarily on compliance program development, implementation and oversight. She routinely provides key support for government-led and internal investigations, compliance with enforcement decrees, and special projects on a wide range of topics.
Mini Summit XX: Best Practices when Transitioning from Healthcare Compliance Risk to Enterprise Risk Assessments
Join this panel for a discussion of risk assessments and how to effectively expand their scope from healthcare compliance to full business enterprise. Discussion points will include best practices in risk assessment design and operational responsibilities, how to effectively define your risk universe, elevating discussions of risk within your organization, and effectively prioritizing and resourcing risk mitigation efforts across functions.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Christie Camelio
Vice President, Deputy Global Chief Compliance Officer, Celgene, Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals, Florham Park, NJ
Vice President, Deputy Global Chief Compliance Officer, Celgene, Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals, Florham Park, NJ
Christine Camelio is Vice President and Deputy Chief Compliance Officer at Celgene Corporation with responsibility for the US Healthcare Compliance Program, the Corporate Compliance Program (Policies, Investigations, Spend Transparency and Due Diligence) and the Enterprise Risk Management Program. She is also Celgene’s Compliance Integration and Divestment lead for M & A activities. Christie started her career in sales and marketing and then went to the agency side leading brand strategy projects for consumer and pharmaceutical companies. She then spent 14 years with Novartis Pharmaceuticals in various positions in Legal, Medical, Commercial and Risk Management.
Christian A. Dingler
Associate Director, Navigant Life Sciences, Richmond, VA
Associate Director, Navigant Life Sciences, Richmond, VA
Christian Dingler is an Associate Director in Navigant’s Life Sciences Governance, Risk Management and Compliance practice supporting US and international Big Pharma, specialty pharma, and device clients. Christian’s focus is on the life cycle of risk, from risk assessment through monitoring and remediation. Christian’s wide-ranging experience includes serving in interim leadership roles (e.g., head of compliance, monitoring lead, etc.), designing monitoring programs and dashboards, conducting compliance program assessments, implementing aggregate spend and HCP engagement systems, and responding to government investigations and Corporate Integrity Agreements.
Jenny McVey, PhD
Associate Director, Risk Strategy and Mitigation, Novo Nordisk, Inc. Former Compliance Officer, Hands International, Princeton, NJ
Associate Director, Risk Strategy and Mitigation, Novo Nordisk, Inc. Former Compliance Officer, Hands International, Princeton, NJ
Jenny M. McVey – Over 14 years of experience combined working and consulting in the life science industry focused on compliance matters. Experiences range from compliance risk assessment and management, mitigation plans, medical affairs and commercial operations, third-party engagement, FCPA/ABAC matters, global commercialization product launches, education and training and device pre-clinical filing studies. Jenny is currently heading Novo Nordisk’s E&C RAMP program, assessing and ranking compliance risks, and developing mitigation plans in accordance with US gov’t expectations.
Kristin Rand, JD, MA
Vice President and Compliance Officer, Seattle Genetics; Former Compliance Director, Policy, Ethics, Training & Communication, Genentech, New York, NY
Vice President and Compliance Officer, Seattle Genetics; Former Compliance Director, Policy, Ethics, Training & Communication, Genentech, New York, NY
Kristin Rand has over two decades of experience in the pharma/biopharma industry. In her current position as Vice President and Compliance Officer at Seattle Genetics she oversees the company’s Compliance Program. Her past experience includes compliance and medical affairs roles at Genentech and Wyeth Pharmaceuticals, as well as serving as General Counsel to a medical communications and education company.
Ann E. Beasley, JD
Director, Life Sciences, Governance, Risk and Compliance, Navigant Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA (Moderator)
Director, Life Sciences, Governance, Risk and Compliance, Navigant Former Senior Vice President, Chief Compliance Officer, Biogen, Boston, MA (Moderator)
Ann Beasley is a Director in Navigant’s Life Sciences, Governance, Risk Management and Compliance Practice. She has over 17 years of in-house experience as a lawyer and Compliance Officer in companies such as Genzyme, Boehringer Ingelheim, Novartis and Biogen. Her experience includes building and managing compliance programs and functions in complex organizations. Her broad international experience brings to her clients deep expertise in identifying risks, developing practical controls and oversight of program framework in the areas of anti-bribery and anticorruption, conflicts of interest, life sciences regulatory matters, and general healthcare compliance and corporate governance. For the past 3+ years as a consultant, she has helped clients build their integrated risk assessment processes, policies and procedures, training modules, codes of conduct, monitoring programs, serving as the IRO for companies under a Corporate Integrity Agreement, third party due diligence processes, internal investigations protocols, and a variety of other program-related activities.
Mini Summit XXI: Medical Device Asset Management Risk Considerations
Asset management is important for healthcare companies regardless of market sector. While this session will focus on the medical device sector, it will be equally applicable to the pharmaceutical and biopharmaceutical sectors. The increasingly stringent regulatory and compliance landscapes, coupled with growing scrutiny surrounding patient and user safety, mean that companies must approach asset management as a business imperative. This session will examine the various facets of asset management, including the design and development of a robust asset management program, the approach to internal engagement, as well as education and monitoring, in order to adopt a company-wide mindset of continuous improvement and overcome the challenges and barriers often encountered along the way.
2:00 pm
Welcome, Introductions, Discussions and Q&A
Punkaj T. Amin, MS, MBA
Compliance Officer, US Wound Management and US Privacy Officer, Smith & Nephew, Fort Worth, TX
Compliance Officer, US Wound Management and US Privacy Officer, Smith & Nephew, Fort Worth, TX
Punkaj Amin is an experienced Director with 17+ years of broad domestic and international experience within the life sciences industry. He has held progressive positions at global pharmaceutical and medical device companies, a top-tier management consulting firm and a world-leader in the automotive industry. He is currently the Compliance Officer, US Wound Management & US Privacy Officer for Smith & Nephew. He was previously the Director, Communications & Public Relations – North America and Associate Director, Compliance & Ethics – North America for Grifols, a global healthcare company focused upon research and development, manufacturing and commercialization of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products.
Heather Young, JD
Compliance Officer – Director for Olympus Corporation of the Americas; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Philadelphia, PA
Compliance Officer – Director for Olympus Corporation of the Americas; Former Assistant District Attorney, Office of the District Attorney, City of Philadelphia, Philadelphia, PA
Heather Young is a Compliance Officer for Olympus Corporation of the Americas. She served as an Assistant District Attorney in the City of Philadelphia for nearly ten years before joining the Compliance Department at Olympus in 2013. She supported the development and implementation of the Company’s current asset management system and has led key initiatives to ensure implementation of compliance controls aimed at risk mitigation, accurate reporting, transparency, efficiency, and ease of utilization.
Kamleh J. Nicola, LLB
Partner, Baker & McKenzie LLP, Toronto, Ontario (Moderator)
Partner, Baker & McKenzie LLP, Toronto, Ontario (Moderator)
Kamleh Nicola, a partner with Baker & McKenzie LLP in Toronto, specializes in intellectual property law, with a special emphasis on disputes within the life science and medical device industries. Kamleh also advises clients on the regulatory aspects of pharmaceuticals and medical devices, including strategic advice relating to product approval and launch, marketing, labelling, compliance and pricing. Kamleh’s commitment to excellence in client service was recognized by Baker & McKenzie’s Global IP Group when she was twice the recipient of an award for being “Passionately Client Driven”. Kamleh is a frequent speaker and writer on topics relating to the life sciences’ industry, as well as IP and litigation.
3:00 pm
Break
MINI SUMMITS BLOCK D: 3:30 pm – 4:30 pm
(Choose one Mini Summit only)
Mini Summit XXII: Responding to CCPA, GDPR and the Tumultuous World of Data Privacy
This session will cover the practical issues that data privacy officers are dealing with on a day to day basis to address the rapidly evolving data privacy regulatory landscape in the EU and the US, with a special focus on the California Consumer Privacy Act (CCPA), which goes live on Jan 1, 2020. Topics include,
- How do you stay on top of the emerging data privacy laws
- Considerations for drafting Privacy Notices
- Defining data privacy priorities and issues dominating the dialog in-house
- Education and coordination with cross-functional stakeholders in IT, Legal and the business units
- Data maps, the use of technology and handling Data Subject Access Requests
- Budget, executive support and resources for data privacy initiatives
3:30 pm
Welcome, Introductions, Discussions and Q&A
Jennifer Chillas, JD
Senior Corporate Counsel, Bristol-Myers Squibb, New York, NY
Senior Corporate Counsel, Bristol-Myers Squibb, New York, NY
Jennifer Chillas is Senior Corporate Counsel for Bristol-Meyers Squibb. In this role, she supports the U.S.pharmaceuticals division, focused on sales, marketing and medical activities, as well as philanthropic activities, including support of product launches, social and digital media, market access, patient assistance, and charitable giving. Prior support to Medical Imaging division’s global business operations.
She was previously and Associate with Ropes & Gray LLP where she advised pharmaceutical companies, academic medical centers, hospitals, insurance companies and physician practices on a wide range of legal issues including fraud and abuse, Stark, HIPAA, state privacy, Medicare Part D application filings, medical/clinic license requirements, incorporation. Reviewed and negotiated clinical trial agreements, EMR licenses and research collaboration agreements.
She was previously and Associate with Ropes & Gray LLP where she advised pharmaceutical companies, academic medical centers, hospitals, insurance companies and physician practices on a wide range of legal issues including fraud and abuse, Stark, HIPAA, state privacy, Medicare Part D application filings, medical/clinic license requirements, incorporation. Reviewed and negotiated clinical trial agreements, EMR licenses and research collaboration agreements.
Catherine Williams, JD
Director, Privacy Office, Novo Nordisk; Former Assistant General Counsel, Privacy & K-12, Corrections & Leisure, Aramark, Plainsboro, NJ
Director, Privacy Office, Novo Nordisk; Former Assistant General Counsel, Privacy & K-12, Corrections & Leisure, Aramark, Plainsboro, NJ
Catherine Williams serves as the Director of Novo Nordisk’s Privacy Office, a global pharmaceutical company. In this role, she leads the Privacy Program for the North America affiliates and maintains a comprehensive program by providing proactive guidance to the enterprise on its data-driven initiatives. She advises the enterprise on compliance with privacy and data security laws, regulations, and industry best practices; develops and maintains policies and procedures related to the processing of personal information; directs investigations relating to Privacy and Security Incidents; and manages the development and delivery of privacy awareness and training programs. Before transitioning to the Director of the Privacy Office, Catherine was Novo Nordisk’s Privacy Counsel. Prior to joining Novo Nordisk, Catherine served as in-house Privacy Counsel for Aramark and, before that, was a white-collar litigation associate at Morgan Lewis & Bockius, LLP
Adam Greene, JD, MPH
Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP; Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS, Washington, DC (Co-moderator)
Partner and Co-chair, Health Information & HIPAA Practice, Davis Wright Tremaine LLP; Former Senior Health Information Technology and Privacy Specialist, Office for Civil Rights, HHS, Washington, DC (Co-moderator)
Adam Greene is a partner in the Washington, D.C. office of Davis Wright Tremaine and co-chair of its Health Information Group. Adam primarily counsels health care providers, technology companies, and financial institutions on compliance with health information privacy, security, and breach notification rules. Previously, Adam was a regulator at the U.S. Department of Health and Human Services, where he played a fundamental role in administering and enforcing the HIPAA rules. At HHS, Adam was responsible for determining how HIPAA rules apply to new and emerging health information technologies and was instrumental in the development of the current HIPAA enforcement process. Adam has been recognized as one of the top ten influencers in health information security, one of the top 50 healthcare IT experts, and is a frequent speaker and author on health information privacy and security issues.
Rena Verma, MBA
Senior Managing Director, Information Governance, Privacy and Security Practice, FTI Consulting, New York, NY (Co-moderator)
Senior Managing Director, Information Governance, Privacy and Security Practice, FTI Consulting, New York, NY (Co-moderator)
Rena Verma is a Senior Managing Director in FTI Technology’s Information Governance, Privacy and Security Practice. Rena has been providing advisory solutions to Fortune 500 legal departments and law firms in information governance, data privacy, electronic discovery, legal technology and legal operations for nearly two decades. Rena’s clients include some of the largest pharmaceuticals companies, banks, insurance, transportation and technology companies. Rena works closely with her clients to understand their challenges, needs, costs and risks associated with managing the exploding volumes of email and data in information systems and delivers sustainable solutions focusing on their long-term goals and vision for the legal and compliance environment.
Mini Summit XXIII: Social Media Engagement by Manufacturers
In the past two decades, how companies communicate with their customers and stakeholders has changed dramatically. Social media has played an increasingly large role in marketing and promotional efforts. At the same time, rarely a news cycle goes by without some discussion of the benefits and perils of using social media. Using social media presents a special challenge for pharmaceutical and medical device manufacturers, especially as FDA’s regulatory framework has not kept pace with changing technologies. Companies must develop their own roadmaps on how to take advantage and mitigate the risks of new platforms and tools based on non-binding guidance and FDA enforcement action. Panelists will review the current regulatory framework, discuss the ways in which they use social media, and share their lessons learned from trying to navigate the murky world of social media in an unclear but highly regulated landscape.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Joanne Kwan, JD, PhD
Corporate Counsel, Commercial, Exelixis, San Francisco, CA
Corporate Counsel, Commercial, Exelixis, San Francisco, CA
Joanne Kwan is a Corporate Counsel at Exelixis, Inc., an oncology-focused biotechnology company. In that role, she provides legal and compliance support to Commercial, Medical Affairs, and Corporate Communications functions, and areas of focus include marketing and promotions, social and digital media, access and reimbursement, and complex commercial arrangements. Prior to joining Exelixis, she was an associate in the health care group at Ropes & Gray LLP, representing pharmaceutical manufacturers, academic medical centers, hospitals, physician groups and other health care providers and advising on transactional, regulatory and compliance matters.
Jessica C. Sergi, JD
Senior Legal Counsel, Neurology & Immunology, EMD Serono, Rockland, MA
Senior Legal Counsel, Neurology & Immunology, EMD Serono, Rockland, MA
Jessica Sergi is Senior Counsel at EMD Serono, Inc. and advises the US Commercial, Medical, and Patient Support functions within the Neurology and Immunology therapeutic area. In this role, Ms. Sergi provides advice, education, and training regarding advertising and promotional matters, patient assistance, reimbursement and support programs, appropriate interactions with HCPs, patients and others, fraud and abuse laws, and the Anti-Kickback statute. Prior to her work at EMD Serono, Ms. Sergi practiced at Mintz Levin Cohn Ferris Glovsky & Popeo, as a litigator with an emphasis on government investigations with a particular expertise handling disputes under federal and state False Claims Acts. She also worked in the Federal Public Defenders Office and served in the Massachusetts Office of the Attorney General, Special Investigation and Narcotics Division. As part of the Mintz rotation program, she was a Special Assistant District Attorney and investigated, prosecuted and tried numerous cases for the Middlesex County District Attorney’s Office.
Seth B. Whitelaw, JD, LLM, SJD
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA
President and Chief Executive Officer, Whitelaw Compliance Group, LLC; Editor, Life Science Compliance Update; Senior Fellow and Adjunct Professor, Life Sciences Compliance at Mitchell Hamline School of Law, West Chester, PA
With more than 30 years working in the industry, Dr. Whitelaw started his career in Life Science Compliance in 1993, when he became the Compliance Coordinator for C.R. Bard, Inc. Present since the inception of life science compliance, his career has encompassed a wide variety of roles from in-house compliance officer (C.R. Bard, Inc., SmithKline Beecham NA, GlaxoSmithKline, and Misonix, Inc.) to industry consultant (Deloitte and Whitelaw Compliance Group) to editor (Policy & Medicine Compliance Update (formerly Life Science Compliance Update)), and finally law professor (Mitchell Hamline School of Law) where he currently teaches students about corporate and life sciences compliance.
Beth Weinman, JD
Counsel, Ropes & Gray LLP; Former Associate Chief Counsel, US Food and Drug Administration, Washington, DC (Moderator)
Counsel, Ropes & Gray LLP; Former Associate Chief Counsel, US Food and Drug Administration, Washington, DC (Moderator)
Beth Weinman is Counsel in Ropes & Gray’s FDA regulatory practice group. Beth represents clients in investigations concerning alleged violations of the Federal Food, Drug and Cosmetic Act (FDCA) and False Claims Act (FCA). She also provides regulatory and compliance counseling related to marketing practices, good manufacturing practices, good clinical practices, compounding, and product recalls and withdrawals. Beth recently joined Ropes from FDA’s Office of Chief Counsel, where she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies on FDCA and FCA investigations and enforcement. Beth started her career as a litigation associate in a large New York law firm where she focused on investigations and securities litigation, often involving pharmaceutical companies.
Mini Summit XXIV: Conducting R&D Compliance Risk Assessments
Join panelists as they discuss emerging risks and issues and share best practices for conducting an R & D Compliance Risk Assessment.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Jeffrey (Jeff) Fleming, JD
Assistant General Counsel, Pharma R&D, GlaxoSmithKline, Philadelphia, PA
Assistant General Counsel, Pharma R&D, GlaxoSmithKline, Philadelphia, PA
Jeff Fleming is an Assistant General Counsel, Pharma R&D at GlaxoSmithKline in the Greater Philadelphia area. In this capacity, Jeff provides legal support to several R&D clients, including Research, Regulatory Affairs, Clinical Operations and several Medicine Development Teams. Jeff previously was the Vice President & Chief Compliance Officer at Vertex Pharmaceuticals in Boston, MA. In that role, he was responsible for leading the Vertex global compliance program and chaired the company’s Compliance Committee. Jeff brings more than 20 years of legal and compliance experience to his role. Prior to joining Vertex, Jeff was the VP Compliance North America for AstraZeneca, an attorney in the Legal Department at AstraZeneca and its predecessor companies, an associate at Morgan Lewis and a federal law clerk.
Gregory S. Moss, LLB
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, Inc., New York, NY
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, Inc., New York, NY
Mr. Moss serves as Executive Vice President, General Counsel and Corporate Secretary to Kadmon Holdings, Inc., (NYSE: KDMN) a biopharmaceutical company based in New York City. He also serves as Chief Compliance Officer. In this role, he is responsible for the development and implementation of legal and compliance programs and for a broad range of corporate and general legal and compliance matters. Mr. Moss joined Kadmon in 2012 and focuses his professional practice on solving business, legal and compliance issues to permit the relevant stakeholders to better focus their attention on operations, development and growth. Mr. Moss has experience defining compliance standards via policies and procedures, training, auditing, investigating and monitoring. He has advised our Board of Directors and management on corporate governance and compliance matters and has provided counsel in connection with a number of major corporate and commercial activities, including the 2015 spinoff of Kadmon’s gene therapy platform into MeiraGTx. Prior to joining Kadmon, Mr. Moss represented, and provided advice to, financial services providers, insurers, banks, pharmaceutical and medical device companies, corporations, small and medium sized businesses and individuals on a broad range of complex matters as a member of the Corporate Risk team at one of Australia’s leading law firms and at a boutique law firm and hedge fund in New York City. Mr. Moss is a graduate of Macquarie University, Sydney, Australia and is admitted to practice as a solicitor of the Supreme Court of NSW, Australia and the High Court of Australia. Additionally, Mr. Moss is a member of the New York State Bar with admission to practice before the Supreme Court of the United States and the Southern District Court of New York. Mr. Moss also serves on the Board of Directors of Vitls, Inc., a privately held medical device/tech company headquartered in Houston, TX and previously served on the Board of Directors of Nasdaq-listed MeiraGTx until June, 2019.
Kelly N. “Nikki” Reeves, MPA, JD
Partner and Co-chair, Life Sciences and Healthcare Industry Group, King & Spalding LLP, Washington, DC (Moderator)
Partner and Co-chair, Life Sciences and Healthcare Industry Group, King & Spalding LLP, Washington, DC (Moderator)
Nikki Reeves is an FDA and healthcare regulatory compliance lawyer who advises pharmaceutical companies and medical devices on pre- and postmarket FDA regulatory compliance and enforcement matters. Nikki cochairs King & Spalding’s Life Sciences and Healthcare Industry Group, which is composed of more than 300 lawyers across the firm. Nikki frequently advises on advertising/promotion issues, R&D regulatory compliance, and conducts related compliance assessments. She has been the lead FDA regulatory advisor on more than 100 transactional matters. She is an expert on federal Sunshine, state and international transparency/disclosure laws, and she leads two industry compliance coalitions.
Mini Summit XXV: Ensuring a Smooth Transition of Compliance Programs During Mergers & Acquisitions
Industry professional’s share their experience throughout the lifecycle of mergers and acquisitions, including:
- The role of Compliance during preacquistion due diligence,
- Key considerations, concerns, and lessons learned during the integration process, and
- Guiding principles that lay the framework on how to map the organizations together.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Christie Camelio
Vice President, Deputy Global Chief Compliance Officer, Celgene, Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals, Florham Park, NJ
Vice President, Deputy Global Chief Compliance Officer, Celgene, Former Executive Director, Head of Risk Management Center of Excellence, Novartis Pharmaceuticals, Florham Park, NJ
Christine Camelio is Vice President and Deputy Chief Compliance Officer at Celgene Corporation with responsibility for the US Healthcare Compliance Program, the Corporate Compliance Program (Policies, Investigations, Spend Transparency and Due Diligence) and the Enterprise Risk Management Program. She is also Celgene’s Compliance Integration and Divestment lead for M & A activities. Christie started her career in sales and marketing and then went to the agency side leading brand strategy projects for consumer and pharmaceutical companies. She then spent 14 years with Novartis Pharmaceuticals in various positions in Legal, Medical, Commercial and Risk Management.
Karen Johnson, MBA
Executive Director Compliance and Ethics, Corporate Ombudsman, Bristol-Myers Squibb, Princeton Pike, NJ
Executive Director Compliance and Ethics, Corporate Ombudsman, Bristol-Myers Squibb, Princeton Pike, NJ
Karen Johnson leads the Education, Communication, Procedural Document and Ombudsman Center of Expertise within Global Compliance and Ethics function at Bristol-Myers Squibb. Currently she is responsible for the development and execution of the Global Compliance & Ethics communication and education plans, development and delivery of the BMS Principles and Integrity to all employees, and oversight of the framework and governance of company procedural documents. As the Ombudsman, Karen is a confidential, informal, independent, neutral and impartial resource for BMS employees worldwide to ensure organizational justice and to find fair and equitable solutions to workplace concerns that cannot be resolved through established channels.
Sunitha Ramamurthy, JD
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Head of Compliance, Loxo Oncology, wholly owned subsidiary of Eli Lilly; Former Executive Director, Office of Ethics and Compliance, Boehringer Ingelheim Pharmaceuticals, Stamford, CT
Sunitha Ramamurthy serves as Head of Compliance and Privacy at Loxo Oncology, a wholly owned subsidiary of Eli Lilly. She has over twenty years of experience in legal and healthcare compliance. In her current role, she provides compliance support through the acquisition by Eli Lilly. Previously, at Boehringer Ingelheim Pharmaceuticals Inc., she oversaw the Office of E&C supporting compliance business partnering, CIA implementation, T&D, ABAC, and compliance operations. She also worked at Eisai Inc., and as a litigator.
Kip F. Ebel, MBA
Principal, Forensic and Integrity Services, EY (Moderator)
Principal, Forensic and Integrity Services, EY (Moderator)
Kip Ebel is a principle in Ernst & Young LLP’s Forensic and Integrity Services practice where he specializes in conducting global compliance assessments, assisting in the development of compliance structures, and performing investigations in the life sciences industry. Mr. Ebel works with legal counsels, internal audit and compliance functions on global matters arising under the US Foreign Corrupt Practices Act, as well as numerous other country-specific anti-corruption laws. Mr. Ebel brings an international perspective to his clients and project teams through his field experience with pharmaceutical and medical device industries in over 40 markets around the world.
Mini Summit XXVI: Investigations: Properly Executing a Compliance Investigation Initiated by a Whistleblower
Many conferences speak to Qui Tams and how to handle them, but most of the Qui Tam issues like off-label marketing and product promotional issues are handled by a team of compliance investigators. Discuss the things you need to consider when handling a whistleblower investigation that differs from a regular investigation.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Heather McCollum, JD, MHA, CCEP-I
Director Compliance, Shionogi Inc, Florham Park, NJ
Director Compliance, Shionogi Inc, Florham Park, NJ
Heather McCollum has nearly a decade of industry experience, including more than seven years with Shionogi Inc., where she currently serves as Director of Compliance. Her responsibilities span all areas of ethics and compliance, with an emphasis on auditing and monitoring, investigations, privacy, HCP engagement and transparency reporting. She was responsible for the evolution of both the company’s HCP engagement and transparency reporting functions, successfully transitioning from fully manual processes to automated systems. Prior to joining Shionogi, Heather spent three years with Polaris Management Partners (now part of IQVIA), focusing on compliance program assessments, auditing and monitoring, and IRO services. She was named a Rising Star by the Healthcare Businesswomen’s Association (HBA), and currently serves on the Board for the Northern New Jersey Chapter of HBA.
Richard H. Walker, JD
Partner, King & Spalding; Former Director of Enforcement, US Securities and Exchange Commission, New York, NY
Partner, King & Spalding; Former Director of Enforcement, US Securities and Exchange Commission, New York, NY
The former SEC Enforcement Director and General Counsel, Dick Walker is a Partner in King & Spalding’s Special Matters & Government Investigations practice group. As part of the firm’s Securities Regulation and Enforcement practice, Dick specializes in crisis management, government and internal investigations (including cross-border), complex financial litigation matters, including litigation assessment, corporate governance, and compliance issues. Dick represents banks, law firms, accounting firms, regulated entities and public companies who benefit from his ten years as a high-ranking SEC official and almost fourteen years as Global General Counsel for Deutsche Bank.
Prior to joining Deutsche Bank, Dick served as the Director of the Division of Enforcement and prior to that, as General Counsel of the Securities and Exchange Commission after starting his career as Regional Director of the Northeast Regional Office. He is the only person in history who has served the SEC as both Enforcement Director and General Counsel.
Prior to joining Deutsche Bank, Dick served as the Director of the Division of Enforcement and prior to that, as General Counsel of the Securities and Exchange Commission after starting his career as Regional Director of the Northeast Regional Office. He is the only person in history who has served the SEC as both Enforcement Director and General Counsel.
Mehreen Zaman, JD
Senior Attorney, Novo Nordisk; Former Director of Investigations, Endo Pharmaceuticals; Plainsboro, NJ
Senior Attorney, Novo Nordisk; Former Director of Investigations, Endo Pharmaceuticals; Plainsboro, NJ
Mehreen Zaman started her legal career representing Philadelphia children in abuse and neglect cases as a Staff Attorney at the Support Center for Child Advocates. She later joined the Internal Investigations & White Collar Defense group at Post & Schell in Philadelphia where she conducted internal investigations and defended corporations, officers and individuals facing civil and criminal investigations. Mehreen left private practice and joined Endo Pharmaceuticals as the Director of Investigations where she oversaw all US compliance related investigations. Mehreen is currently a Senior Attorney at Novo Nordisk, Inc.
Susan Markel
Managing Director, AlixPartners; Former Chief Accountant, Division of Enforcement, US Securities and Exchange Commission, Washington DC (Moderator)
Managing Director, AlixPartners; Former Chief Accountant, Division of Enforcement, US Securities and Exchange Commission, Washington DC (Moderator)
Susan Markel is a Managing Director for Alix Partner and oversees matters involving corporate financial reporting, regulatory investigations, whistle-blower actions, Foreign Corrupt Practices Act (FCPA) enforcement, and internal controls. Formerly at the US Securities and Exchange Commission (SEC), she served as chief accountant of the enforcement division. Susan has received several awards including the SEC’s Distinguished Service Award in 2006 and The National Law Journal’s 2014 “Governance, Risk and Compliance Trailblazer and Pioneer”. She is a speaker nationally and internationally on public reporting and accounting related to financial fraud investigations and other enforcement actions involving the SEC and other government entities.
Mini Summit XXVII: Compliance Interactions with Specialty Pharmacies
This session will focus on understanding the relationships between life sciences companies and specialty pharmacy business partners, as well as the legal, regulatory and compliance risk areas that may arise. This session also will discuss better practices for identifying and minimizing risks in these relationships.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Timothy Ayers, JD, MPH
Life Science Compliance Consulting, LLC; Former VP, Chief Compliance Officer, Horizon Pharma plc., Oklahoma City, OK
Life Science Compliance Consulting, LLC; Former VP, Chief Compliance Officer, Horizon Pharma plc., Oklahoma City, OK
Tim Ayers is the sole member and founder of Life Science Compliance Consulting, LLC. He serves as both legal and compliance for various life science companies from start-up to globalization. Previously, he was the Group Vice President, Chief Compliance Officer for Horizon Pharma plc. Prior to that, he was the Vice President, Chief Compliance Officer for Dendreon Corporation. He has held various legal and compliance roles at small oncology biotech companies where he established and implemented the compliance programs, and also provided legal counsel to all areas of the business. Prior to joining the in-house ranks, Tim was an attorney in the healthcare group for the Washington, DC Office of Winston & Strawn, LLP.
Mark A. DeWyngaert, PhD
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT
Dr. DeWyngaert, Managing Director at Deloitte & Touche LLP is part of Life Sciences Team serving global biotechnology, medical device and pharmaceutical companies in meeting their regulatory and valuation challenges.
He was previously Managing Director in the Pharmaceutical & Life Sciences Advisory Practice at Huron. Mark trained as a molecular biologist and has been actively involved in both research and business development roles for the past 30 years. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He specialized in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks, valuing intellectual property and litigation support.
He was previously Managing Director in the Pharmaceutical & Life Sciences Advisory Practice at Huron. Mark trained as a molecular biologist and has been actively involved in both research and business development roles for the past 30 years. He has provided operational, clinical, managerial, consulting, and litigation services to various segments of the health care industry. He specialized in assisting pharmaceutical manufacturers, biotechnology, and medical device companies with identifying and mitigating regulatory risks, valuing intellectual property and litigation support.
Richard Liner, JD, MPH
Senior Counsel, Compliance and Investigations, Bayer Healthcare, Whippany, NJ
Senior Counsel, Compliance and Investigations, Bayer Healthcare, Whippany, NJ
Richard Liner is Senior Compliance Counsel for Bayer’s Pharmaceuticals Division. He advises on a broad spectrum of complex fraud and abuse and compliance issues, including anti-kickback, anti-corruption, off-label promotion and HIPAA privacy. He routinely works on the development of policies, procedures and guidance for the Bayer pharmaceutical business and manages both external and internal compliance investigations. Richard joined Bayer in 2009 after spending six years at the law firm Arent Fox in Washington, D.C., where he counseled and defended manufacturer and healthcare provider clients on a variety of fraud and abuse and regulatory matters.
Sarah diFrancesca, JD
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY (Moderator)
Partner, Health Care and Life Sciences Regulatory Practice, Cooley, LLP, New York, NY (Moderator)
Sarah diFrancesca is a partner in Cooley’s Health Care Regulatory and Life Sciences practice. Sarah represents life sciences and health care companies in connection with government investigations, inquiries, settlements and voluntary disclosures. Sarah also advises life sciences companies on a wide range of fraud and abuse, compliance and regulatory matters, including federal, state and local transparency laws; internal compliance reviews and investigations; patient assistant programs; and other enforcement areas of interest.
Mini Summit XXVIII: Practice Development Programs (e.g., Free or Discounted Marketing Services)
When does provision of free or discounted marketing services and practice development support to healthcare providers violate the Anti-Kickback Statute and thereby the False Claims Act? Panelists will provide an overview of the risks involved with these services, current enforcement environment (e.g., Covidien case), OIG guidance, and implementation and controls to minimize risk.
3:30 pm
Welcome, Introductions, Discussions and Q&A
Noël (Giglio) Denice, JD
Legal Counsel, Legal Compliance, Philips North America, LLC, Andover, MA
Legal Counsel, Legal Compliance, Philips North America, LLC, Andover, MA
Ms. Denice is Legal Counsel at Philips North America. She was previously the Assistant General Counsel with Olympus Scientific Solutions Americas where she supported the sales and manufacturing of industrial and life science equipment in the United States and Canada.
Keith Korenchuk, MPH, JD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Vice President and Chief Compliance Officer, Danaher Diagnostics and Beckman Coulter Diagnostics, DANAHER Corporation; Former Partner, Arnold & Porter Kaye Scholer, Chevy Chase, MD
Keith Korenchuk is Vice President and Chief Compliance officer at Danaher Diagnostics and Beckman Coulter. Prior to this role, he was a Partner at Arnold & Porter, LLP. Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented “hands-on” educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.
Arjun Rajaratnam, JD, MS
Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Raleigh, NC
Chief Compliance Officer, Smith & Nephew; Former Compliance Officer, US Pharmaceuticals, GlaxoSmithKline; Former Member, PCF Executive Committee, Raleigh, NC
Arjun Rajaratnam has spent over 25 years in Corporate Compliance Programs. His positons have included: Global Chief Compliance and Ethics Officer, Chief Risk Officer and Executive Committee member for Smith & Nephew, a large medical device company and U.S. Pharma Compliance Officer for GlaxoSmithKline, a large pharmaceutical company.
Arjun has built from the ground-up both a Global and a US Corporate Compliance program including: Board and senior management oversight and reporting; Code of Conduct and related global policies and procedures, ethics communications and training; global and market risk assessments; compliance monitoring and auditing; health care professional and third party controls, and investigation processes.
He has managed and overseen resolution of more than a thousand internal investigations, and has negotiated terms and operated under three separate corporate integrity agreements and one deferred prosecution agreement with the U.S.government, where he successfully completed the external monitor phase in 18 months or half the possible duration.
Arjun has built from the ground-up both a Global and a US Corporate Compliance program including: Board and senior management oversight and reporting; Code of Conduct and related global policies and procedures, ethics communications and training; global and market risk assessments; compliance monitoring and auditing; health care professional and third party controls, and investigation processes.
He has managed and overseen resolution of more than a thousand internal investigations, and has negotiated terms and operated under three separate corporate integrity agreements and one deferred prosecution agreement with the U.S.government, where he successfully completed the external monitor phase in 18 months or half the possible duration.
Thomas Beimers, JD
Partner, Hogan Lovells; Former Senior Counsel, Office of Counsel to the Inspector General; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC (Moderator)
Partner, Hogan Lovells; Former Senior Counsel, Office of Counsel to the Inspector General; Former Special Assistant United States Attorney, US Attorney’s Office, Eastern District of Michigan, Minneapolis, MN and Washington, DC (Moderator)
Tom Beimers is a member of the health care practice group at Hogan Lovells US LLP, where he counsels clients on fraud and abuse, compliance, and risk management issues, and assists clients with False Claims Act and other health care fraud investigations. Tom focuses a significant portion of his practice on complex Anti-Kickback Statute matters. Tom was previously senior counsel with the Department of Health and Human Services’ Office of the Inspector General, where he was a member of the Pharma Team. In that capacity, Tom investigated False Claims Act and other fraud matters, and negotiated and monitored corporate integrity agreements with pharmaceutical manufacturers. Tom is a frequent national speaker and author on topics related to healthcare fraud and abuse, white collar criminal defense, and compliance matters.
4:30 pm
Transition Break
CLOSING PLENARY SESSION
4:45 pm
What Pharma/Medical Device Industries Can Learn from the Opioid Cases
Rachael Honig, JD
First Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice; Former Corporate Counsel, Litigation, Celgene, New York, NY
First Assistant US Attorney, US Attorney’s Office, District of New Jersey, US Department of Justice; Former Corporate Counsel, Litigation, Celgene, New York, NY
Rachael Honig is the First Assistant U.S. Attorney at the U.S. Attorney’s Office for the District of New Jersey. She rejoined the U.S. Attorney’s Office in March 2018 after serving as Corporate Counsel, Litigation, at Celgene Corporation. Prior to joining Celgene, Ms. Honig worked at the U.S. Attorney’s Office from 2003 to 2016, serving at various times as an Assistant U.S. Attorney, Deputy Chief of the Criminal Division, and Counsel to the U.S. Attorney. Prior to that, Ms. Honig was a litigation associate at Wilmer Cutler Pickering Hale & Dorr in Washington, D.C. and a law clerk to the Hon. Mary M. Schroeder of the U.S. Court of Appeals for the Ninth Circuit.
John C. Richter, JD
Partner, King & Spalding; Former Acting Assistant Attorney General, Criminal Division , US Department of Justice; Former US Attorney, Western District of Oklahoma, Washington, DC
Partner, King & Spalding; Former Acting Assistant Attorney General, Criminal Division , US Department of Justice; Former US Attorney, Western District of Oklahoma, Washington, DC
John Richter regularly represents companies, Board of Directors, Board committees, and individuals facing white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma. Notably, John has defended clients in trials and investigations involving U.S. Attorneys’ Offices in over fifteen districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general’s offices for all 50 states and the District of Columbia.
5:15 pm
The Changing Face of the Qui Tam
Meredith S. Auten, JD
Partner, Morgan Lewis; Co-chair, White Collar Committee, Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA
Partner, Morgan Lewis; Co-chair, White Collar Committee, Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA
As part of her comprehensive white collar litigation practice, trial lawyer Meredith S. Auten concentrates her practice on Civil False Claims Act (FCA) and qui tam actions involving a range of corporate clients, including those in the pharmaceutical, healthcare, and defense contracting industries. Meredith regularly defends corporations in complex government investigations and related civil litigation. Meredith has been involved in a number of no-charge decisions involving both Fortune 500 companies and individuals. Clients rely on her to conduct often-sensitive internal investigations on their behalf. She collaborates with her clients, helping them to develop and regularly review and update their internal compliance and ethics programs—particularly those in the healthcare field. Meredith publishes and lectures frequently on numerous white collar litigation topics, including issues related to internal investigations and the FCA. She currently serves as the national co-chair of the ABA’s Criminal Justice Section White Collar Committee Qui Tam Subcommittee.
Marc Stephen Raspanti, JD
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP; Co-chair, White Collar Committee Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP; Co-chair, White Collar Committee Qui Tam Subcommittee, ABA Criminal Justice Section, Philadelphia, PA
Marc S. Raspanti is a partner in Pietragallo Gordon Alfano Bosick & Raspanti, LLP. He is the Founder of the firm’s Qui Tam/False Claims Act practice group and White Collar defense group. He also focuses on health care fraud defense and complex commercial litigation. He is a fellow of the American College of Trial Lawyers and a former Philadelphia prosecutor. Mr. Raspanti has been recognized as one of the most experienced qui tam attorneys in the United States. He has served as lead counsel for whistleblowers that have resulted in over $2 billion in recoveries for federal and state taxpayers.
Virginia “Ginny” A. Gibson, JD
Partner, Hogan Lovells LLP; Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator)
Partner, Hogan Lovells LLP; Former First Assistant U.S. Attorney, Eastern District of Pennsylvania, US Department of Justice, Philadelphia, PA (Moderator)
Ginny Gibson is there when the whistleblower calls, the subpoena lands, or the agents appear at the door with a warrant. She helps companies and executives ferret out compliance issues to self-correct. She defends against accusations of fraud and regulatory violations. Ginny helps clients resolve enforcement problems with minimal pain.
A trial lawyer for 30 years, and at Hogan Lovells for the last five, she has defended clients under federal and state scrutiny and found solutions to legal issues and regulatory uncertainty while advancing business objectives. Because Ginny was a federal prosecutor for over 20 years, and the First Assistant U.S. Attorney and Civil Chief in two federal districts, she knows the language to engage with the enforcement team to get results. She defends clients against federal and state investigations, working in tandem with clients to achieve declinations or dismissal while counseling on compliance improvements that defuse the government’s concerns.
A trial lawyer for 30 years, and at Hogan Lovells for the last five, she has defended clients under federal and state scrutiny and found solutions to legal issues and regulatory uncertainty while advancing business objectives. Because Ginny was a federal prosecutor for over 20 years, and the First Assistant U.S. Attorney and Civil Chief in two federal districts, she knows the language to engage with the enforcement team to get results. She defends clients against federal and state investigations, working in tandem with clients to achieve declinations or dismissal while counseling on compliance improvements that defuse the government’s concerns.
6:00 pm
Adjournment
Agenda Links: Preconferences/Day 1 | Day 3