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
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
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
Marci Juneau, MBA
Partner, Helio Health Group, Atlanta, GA (Moderator)
Partner, Helio Health Group, Atlanta, GA (Moderator)
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
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)
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)
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
Mark Scallon, MHA
Senior Principal, IQVIA Global Compliance, Richmond, VA
Senior Principal, IQVIA Global Compliance, Richmond, VA
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)
Kelly N. “Nikki” Reeves, MPA, JD
Partner, King & Spalding LLP, Washington, DC (Moderator)
Partner, King & Spalding LLP, Washington, DC (Moderator)
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
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
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
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
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)
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
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
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)
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
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
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
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)
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
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
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)
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
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
Edward Sleeper, MS
Director, Global Healthcare Compliance Learning & Communications, Celgene, Summit, NJ
Director, Global Healthcare Compliance Learning & Communications, Celgene, Summit, NJ
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)
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
Tim Robinson, JD
Chief Legal and Privacy Officer, MediSpend, Portsmouth, NH
Chief Legal and Privacy Officer, MediSpend, Portsmouth, NH
Meredith Taylor, JD
Vice President Global Compliance and Privacy, Novocure, Malvern, PA
Vice President Global Compliance and Privacy, Novocure, Malvern, PA
Diana Borges, MBA
Vice President, Compliance Solutions, MediSpend, Miami, FL (Moderator)
Vice President, Compliance Solutions, MediSpend, Miami, FL (Moderator)
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
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
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
Minna Bak, MBA
Senior Manager, Helio Health Group, New York, NY (Moderator)
Senior Manager, Helio Health Group, New York, NY (Moderator)
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
Heather McCollum, JD, MHA, CCEP-I
Director Compliance, Shionogi Inc, Florham Park, NJ
Director Compliance, Shionogi Inc, Florham Park, NJ
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
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
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)
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
Patrick Phelan, JD
Partner, Covington & Burling LLP, Washington, DC
Partner, Covington & Burling LLP, Washington, DC
Yogesh Bahl, CPA, MBA
Managing Director, AlixPartners, New York, NY (Moderator)
Managing Director, AlixPartners, New York, NY (Moderator)
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
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
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
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
Eileen E. Erdos
Principal, Forensic & Integrity Services, EY, Chicago, IL (Moderator)
Principal, Forensic & Integrity Services, EY, Chicago, IL (Moderator)
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
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
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
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
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)
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
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
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
Jonathan Wilkenfeld, MBA
Partner, Potomac River Partners, Washington, DC (Moderator)
Partner, Potomac River Partners, Washington, DC (Moderator)
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
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
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)
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
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)
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)
CJ DeKreek, CFA
Senior Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
Senior Director, Ankura Consulting Group, LLC, Atlanta, GA (Co-moderator)
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
Samantha Barrett Badlam, JD
Counsel, Ropes & Gray, Washington, DC
Counsel, Ropes & Gray, Washington, DC
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
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)
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
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
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
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)
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
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
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)
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)
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
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
David Heard, JD
Senior Corporate Counsel, Pfizer Inc., Dallas, TX
Senior Corporate Counsel, Pfizer Inc., Dallas, TX
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
Seth H. Lundy, JD
Partner, King & Spalding, LLP, Washington, DC
Partner, King & Spalding, LLP, Washington, DC
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)
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
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
Vahan Minassian, JD
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Ashley Riley, JD
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Charlotte, NC
Senior Manager, Deloitte Advisory, Deloitte & Touche LLP, Charlotte, NC
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
David Earl Smith, MBA
Advisor Ethics & Compliance, Eli Lilly & Company, Indianapolis, IN
Advisor Ethics & Compliance, Eli Lilly & Company, Indianapolis, IN
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
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)
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
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
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)
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
Elizabeth “Beth” Kolbe, JD
Associate, Sidley Austin LLP, Washington, DC
Associate, Sidley Austin LLP, Washington, DC
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
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)
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
Christian A. Dingler
Associate Director, Navigant Life Sciences, Richmond, VA
Associate Director, Navigant Life Sciences, Richmond, VA
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
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
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)
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
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
Kamleh J. Nicola, LLB
Partner, Baker & McKenzie LLP, Toronto, Ontario (Moderator)
Partner, Baker & McKenzie LLP, Toronto, Ontario (Moderator)
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
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
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)
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)
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
Jessica C. Sergi, JD
Senior Legal Counsel, Neurology & Immunology, EMD Serono, Rockland, MA
Senior Legal Counsel, Neurology & Immunology, EMD Serono, Rockland, MA
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
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)
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
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
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)
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
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
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
Kip F. Ebel, MBA
Principal, Forensic and Integrity Services, EY (Moderator)
Principal, Forensic and Integrity Services, EY (Moderator)
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
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
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
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)
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
Mark A. DeWyngaert, PhD
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT
Managing Director, Deloitte Advisory, Deloitte & Touche LLP, Stamford, CT
Richard Liner, JD, MPH
Senior Counsel, Compliance and Investigations, Bayer Healthcare, Whippany, NJ
Senior Counsel, Compliance and Investigations, Bayer Healthcare, Whippany, NJ
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)
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
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
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
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)
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
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
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
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
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)
6:00 pm
Adjournment
Agenda Links: Preconferences/Day 1 | Day 3