Grantors & Exhibitors
We thank the following Grantors and Exhibitors for their support in helping to make this conference possible.
Deloitte Risk and Financial Advisory helps organizations effectively navigate business risks and opportunities—from strategic, reputation and financial risks to operational, cyber and regulatory risks—to gain competitive advantage. We apply our experience in ongoing business operations and corporate lifecycle. We leverage next-generation solutions in our Ventures Fund and Managed Services and Products business to help clients become stronger and more resilient. Our market-leading teams help clients embrace complexity to accelerate performance, disrupt through innovation and lead in their industries.
For more information, Click Here.
Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In the life sciences industry, compliance issues and risk factors need to be addressed at every turn, from research and development to marketing strategies and supply chain integrity, while the scrutiny of regulators and customers alike is increasing and rapidly changing. Our professionals understand the complex issues facing pharmaceutical, biotechnology and medical device companies. We have established experience helping companies evaluate and manage those aspects of their businesses that pose the greatest potential risks. Our dedicated team includes CPAs, certified fraud examiners, licensed pharmacists, former pharmaceutical executives, ethics and compliance officers as well as government auditors, investigators and prosecutors. For more information, please contact Kris Curry, Americas Leader, Life Sciences Forensic and Integrity Services, at (732) 516-4855 or firstname.lastname@example.org.
By bringing together the brightest minds from AHM and Polaris, IQVIA has created a global compliance and HCP engagement powerhouse to help you succeed at every stage of your company’s growth trajectory. Simplify, streamline, and integrate to meet the challenges of global compliance demands.
Learn more at www.iqvia.com/commercialcompliance.
AlixPartners is a results-driven global consulting firm that specializes in helping businesses respond quickly and decisively to their most critical challenges – from urgent performance improvement to complex restructuring, from risk mitigation to accelerated transformation. These are the moments when everything is on the line – a sudden shift in the market, an unexpected performance decline, a time-sensitive deal, a fork-in-the-road decision. We stand shoulder to shoulder with our clients until the job is done, and only measure our success in terms of the results we deliver. We partner with you to make the right decisions and take the right actions. And we are right by your side. When it really matters.
For more information visit www.AlixPartners.com.
Ankura is a business advisory and expert services firm defined by HOW we solve challenges. Whether a client is facing an immediate business challenge, trying to increase the value of their company or protect against future risks, Ankura designs, develops, and executes tailored solutions by assembling the right combination of expertise. We build on this experience with every case, client, and situation, collaborating to create innovative, customized solutions, and strategies designed for today’s ever-changing business environment. This gives our clients unparalleled insight and experience across a wide range of economic, governance, and regulatory challenges. At Ankura, we know that collaboration drives results.
For more information visit www.ankura.com
For more than a century, Armstrong Teasdale has forged long-term relationships with clients large and small around the globe. With roots in the Midwest, we have grown to be one of the 200 largest law firms in the U.S., with offices across the country. Our attorneys work together to guide clients through virtually every challenge, from day-to-day operational decisions to some of the most complex legal matters. Our deep experience servicing the pharmaceutical industry has resulted in representations of nearly a dozen of the world’s largest health care and life sciences companies.
For more information visit www.ArmstrongTeasdale.com.
Baker McKenzie has extensive experience in the complex and fast-paced world of life sciences, advising and representing clients from startups to multi-nationals throughout a product’s life cycle. Our lawyers have served as trusted advisors to some of the world’s leading life sciences companies for over 50 years.
Strategic alliances and other life sciences transactions are critical for development and commercialization. We work with clients on cutting edge and dynamic collaboration, licensing, regulatory, M&A, joint venture, divestiture and other strategic transactions for the research, development and commercialization of biopharmaceutical and medical device products and technologies.
Our group also encompasses experienced professionals with former high level government experience, former business experience, and comprehensive legal support to help navigate issues with the US Food and Drug Administration and, as the case may need be, with the US Department of Justice. Our global teams have similar experience in the European Union, United Kingdom, China, Japan, Australia, Southeast Asia, Canada, South and Central America, and the Middle East among other jurisdictions.
Baker McKenzie. Bringing extensive experience and responsiveness to every matter to help our clients leverage their talent, financial and technology resources to reach their strategic goals.
For more information, visit www.BakerMcKenzie.com.
Berkeley Research Group is a leading global strategic advisory and expert consulting firm that provides independent advice, data analytics, valuation, authoritative studies, expert testimony, investigations, transaction advisory, restructuring services, and regulatory and dispute consulting to medical technology and pharmaceutical companies, providers, insurers, and counsel. BRG healthcare corporate compliance and risk management professionals have experience with C-suite corporate compliance, government enforcement, and advanced transactional data analysis; and a strong understanding of the operational, technical, and legal challenges that our clients must address.
BRG professionals provide innovative, data-driven, cost-effective, and practical solutions to enhance operational efficiency, inform business decision making, and address and remediate key legal risks proactively. An important building block is our understanding of how healthcare organizations operate and interact with stakeholders in the healthcare continuum. Our reports and findings have been used to resolve critical business, regulatory, and legal challenges.
For more information visit www.thinkbrg.com.
For over 40 years, Cooley lawyers have played an instrumental role in the growth of many of the industry’s leading healthcare and life sciences companies. Our client base includes hundreds of public and private companies, based in the United States and abroad, and spans the full spectrum of industry sectors including pharmaceuticals, R&D, therapeutics, drug delivery, drug formulation, and medical devices and technologies.
We deliver an unparalleled combination of innovative legal expertise, deep industry knowledge and practical understanding of our clients’ business needs. Cooley is counsel to more than 1600 public and private life sciences companies across the globe and serve as counsel to more than 50% of the companies on the NASDAQ Biotechnology Index. Cooley has a leading group of health care and life sciences regulatory lawyers who understand the challenges and opportunities facing the industry. In an environment filled with an increasing number of evolving laws and regulations, our team has the depth of experience necessary to navigate the ever changing rules of the marketplace for providers, manufacturers, suppliers, payors, technology companies and investors in this space.
For more information, please visit www.cooley.com.
Covington & Burling LLP offers one of the largest and most comprehensive life sciences practices in the world. We represent biotech, pharmaceutical and medical device companies in the U.S., Europe, Asia and other major and emerging markets. Our lawyers are adept at seamlessly integrating the firm’s strong regulatory, corporate, investigations, litigation, policy, competition, and intellectual property practices, among others, to meet the specialized needs of life sciences companies around the world. Our team features numerous alumni of the FDA, HHS, and other key regulatory agencies in the U.S., Europe, and Asia, as well as two former general counsels of pharmaceutical companies. Our broad background and depth of experience ensures that when clients come upon a problem that they have not seen before or anticipated, chances are that we have.
For more information visit https://www.cov.com/en/practices-and-industries/industries/life-sciences.
Cutting Edge Information (CEI) is a market research company that specializes in collecting and analyzing global FMV data. To CEI, collecting and analyzing FMV data is not an ancillary function, but our primary focus.
Our in-house team of statisticians and research analysts worked with life science industry experts to develop the patent-pending methodology. This market-based FMV approach includes a rigorous annual collection of FMV data and a proprietary statistical process (including blending with salary data, where available) resulting in the most accurate FMV rates on the market. Our FMVConnect database includes more than 120,000 individual data observations from around the world—allowing us to provide data in more countries and on more HCPs than anyone else.
We are proud to provide FMV data to more than 150 organizations in the life sciences industry, including 22 of the top 25 pharmaceutical companies in the world.
For more information visit www.cuttingedgeinfo.com.
Those of us in the Davis Wright Tremaine health care practice group devote nearly all of our time to industry-specific matters. This allows us to develop niche practices within the field that serve needs unique to the health care market. We also understand the business issues and regulatory developments that affect health care delivery and compliance, and as a unified team we can match the attorney with the niche expertise that best addresses client needs. For more information visit our website at www.DWT.com.
Dovetail Consulting Group combines relevant industry experience with consulting discipline and structure. We bring our experts to engagements and will only accept work to which we can dedicate our full attention. Our focused approach enables us to design and implement the right-sized solution for each client’s needs.
Services provided to compliance and risk departments in the pharmaceutical, biotechnology, and medical device industries include:
• Long-term functional strategy and vision
• Annual strategic and operational planning
• Interim staffing and management solutions
• Board of Director expert services and training
• CIA readiness assessment and remediation
• Custom program builds for emerging companies
• Policy, procedure, and process development
• Monitoring and auditing strategy, planning, and design
• Merger and acquisition support: target review, transaction support, and integration assistance
• Enterprise risk assessments and management solutions
• Compliance risk assessments
• Patient support program assessments
• Compliance culture and change management services
• Programmatic compliance gap assessment
For more information, please go to: www.dovetailcg.com.
FTI Technology solves data-related business challenges, with expertise in legal and regulatory matters. As data grow in size and complexity, we help organizations better govern, secure, find, analyze and rapidly make sense of information. Innovative technology, expert services and tenacious problem solving provide our global clients with defensible and repeatable solutions. Organizations rely on us to root out fraud, maintain regulatory compliance, reduce legal and IT costs, protect sensitive materials, quickly find facts and harness organizational data to create business value.
Learn more at www.FTITechnology.com.
Helio Health Group specializes in providing consulting and data science services to clients within the life sciences industry. Helio works with clients across all stages of development from established global pharmaceutical companies to new, burgeoning gene therapy companies. Helio works with key stakeholders to provide strategic and operational compliance insights. Helio’s experts assist commercial, medical, and patient services teams with our deep industry consulting experience coupled with unique small data engineering techniques.
Helio frequently conducts risk and gap assessments to analyze the current state of our clients’ commercial, clinical, medical, and compliance operations including, but not limited to, a thorough review of process designs, system configurations, workflows, documentation, and HCP and patient touchpoints. Upon completion of such an assessment, Helio develops business and/or technical requirements and roadmaps to provide guidance on how to augment and operationalize the company’s compliance and strategic initiatives. Helio also implements desired program enhancements and serves as a Project Management Office (PMO) and strategic advisor throughout the implementation. Other areas of compliance assistance include monitoring and auditing, transparency strategy, validation and reporting services, and patient services programs and data privacy.
For more information visit www.heliohealthgroup.com.
Navigating complexities in the life sciences and health care industries is no easy task. Successfully competing in the space requires increasingly creative strategies and integrated solutions that protect and support your business day in and day out.
For life sciences innovators of all sizes, anywhere in the world, Hogan Lovells is that partner — from cutting-edge start-ups and boutique venture funds to world-renowned research institutions and health systems to global biopharmaceutical conglomerates.
Your business and your challenges don’t stop for oceans or disappear at national borders. Neither does Hogan Lovells. Our team of 500 life sciences and health care lawyers is located around the world but operates as if everyone is working from the same office — providing a seamless experience everywhere you do business.
And no matter the challenge — from creation to commercialization of a life-saving therapy, regulatory compliance to an international patent dispute, the formation of a strategic alliance to a complex, global merger — we’ve been there before and we understand how to prepare you for what happens next, helping you to anticipate risks and address future issues before they arise.
Celebrating more than 130 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with over 1100 lawyers in 20 offices in the United States, Europe, the Middle East and Asia. King & Spalding knows the pharmaceutical and medical device industry—the technologies, products and business models. Our attorneys and consultants provide sophisticated counsel to our clients in a wide range of areas, including fraud and abuse, compliance, intellectual property, regulatory, transactional, policy and litigation matters. We are a premier firm ranked by Law360 (Life Sciences “Practice Group of the Year” in 2016-2018), U.S. News & World Report (“Law Firm of the Year” for FDA Law in 2017), LMG Life Sciences, Chambers USA and The Legal 500.
For more information, please visit www.kslaw.com/capabilities/life-sciences-and-healthcare.
KPMG LLP is dedicated to assisting businesses of all sizes from biotechnology start-ups to large multinational pharmaceutical companies with their business strategy and compliance needs.
For more information Click Here.
MediSpend is a global leader in cloud-based compliance software for the life sciences industry. MediSpend is the compliance system of record for some of the world’s largest life sciences companies. We help pharmaceutical, medical device, dental, and emerging biotech companies comply with global healthcare laws while reducing risk and lowering costs. The MediSpend Compliance Cloud enables life science companies to manage and monitor physician engagement, aggregate and analyze enterprise data, and comply with global data privacy and transparency reporting regulations. Our employees are committed to customer success, innovation, and exceptional product development. Our customers are located in the United States, Europe, Asia, and Latin America. MediSpend is headquartered in Portsmouth, N.H., with offices in Minnesota, New York, and Pennsylvania.
Visit MediSpend online at www.medispend.com.
Navigant Consulting, Inc. (NYSE: NCI) is a specialized, global professional services firm that helps clients take control of their future. Our life sciences and healthcare consultants help you navigate the complex regulatory environment of Pharmaceutical, Biotech, Medical Device and Diagnostics industries. We apply our deep industry knowledge, technical expertise, and strategic approach to offer solutions and deliver powerful results. From the synthesis of highly complex transactions, rules, regulations, data, documents and business practices to bring meaningful value to the co-development of a dispute, regulatory, compliance or investigation strategy and execution. We help clients build, manage, and protect their business interests.
For more information visit www.navigant.com.
Paul Hastings provides innovative compliance and legal solutions to many of the world’s top pharmaceutical and life sciences companies – large and small – across global markets. The firm has grown steadily and strategically along with our clients and has an established presence in Asia, Europe, and Latin America. We continue to be a leader in these regions, and in the last few years have significantly expanded our support for clients in Brazil and other emerging markets of Latin America.
Paul Hastings offers a complete portfolio of services to support our clients’ complex, often mission-critical needs—from tackling among the most significant global, anti-corruption enforcement matters and resolving complex U.S. healthcare investigations, to structuring first-of-their-kind transactions, to protecting critical intellectual property, to advising on unique data governance issues, IoT development and roll-out, and proactive privacy/cybersecurity assessments, to providing the savvy compliance and legal counsel that keeps business moving forward.
For more information visit www.PaulHastings.com.
Through its PharmaCertify™ division, NXLevel Solutions helps life sciences compliance professionals reduce risk and build stronger compliance cultures through training. We are not compliance consultants who happen to develop training and we are not trainers who dabble in compliance. We are training experts who live and breathe the world of life sciences compliance.
Our offerings include the Compliance Foundations™ curriculum of eLearning modules, the Compliance Reality Challenge workshop, microlearning modules, and custom learning development. For more information, contact Dan O’Connor at 609-483-6875, or visit www.pharmacertify.com.
Porzio Life Sciences provides compliance tools, timely information and customized services related to the PDMA, anti-kickback statutes, aggregate spend reporting, dispute resolutions, OIG and CMS guidances, OPDP promotional violations, False Claims Act and FDA regulations to enable life science companies to comply with federal, state and global marketing and sales.
For more information visit www.pbnlaw.com.
Potomac River Partners is a specialized management consulting firm focused on compliance for the life science industry.
Our team serves as an extension of your compliance program. We are experts on the laws and regulations, but we don’t provide purely academic or legalistic recommendations. Instead, we listen to your objectives and then implement real change that reduces risk for your organization in a smart, efficient way.
Our core service areas include:
• Policies & Procedures
• Training & Communication
• Auditing & Monitoring
• Aggregate Spend
For additional information, call (703) 430-5944 or visit our website at potomacriverpartners.com.
We routinely advise clients on developing effective compliance policies to avoid the debilitating effects of government investigations, regulatory enforcement actions, or other litigation based on alleged noncompliance with applicable laws and regulations. Our command of FDA regulatory, health care compliance, research compliance and global anti-corruption issues is critical for clients operating in these highly regulated industries. For companies that are the subject of government investigations, our understanding of the enforcement landscape enables us to defend complex proceedings involving simultaneous civil, criminal and administrative actions.
This depth and breadth of experience, coupled with our interdisciplinary team of leading regulatory, compliance, litigation, government enforcement, and anti-corruption attorneys, has established us as the “go-to” firm when it comes to avoiding and successfully resolving litigation and government investigations. Our integrated practice, including our corporate transactional department, also allows clients to eliminate the inefficiencies associated with hiring multiple, independent firms.
For more information please visit www.ropesgray.com.
Sidley’s global life sciences practice comprises a team of multidisciplinary lawyers with a deep understanding of the issues innovators face—from the science and technology to the business realities. We tackle the hardest problems and offer solutions that account for not only the direct risk but also the substantial relational capital at stake. Harnessing our breadth of experience, we represent prominent pharmaceutical, biotechnology, medical device, dietary supplements, life sciences investors and food clients on a range of regulatory, compliance and enforcement issues. The Life Sciences group is consistently ranked highly in Chambers across the Global, United States, Europe and Asia regions. For more information, please visit www.Sidley.com.
With approximately 1,700 attorneys in 22 offices in the Americas, Europe and Asia Pacific, Skadden serves a broad range of clients in all sectors of the health care industry, including pharmaceutical, biotechnology and medical device companies; hospital and health care systems; and long-term care facilities. The firm advises on the full spectrum of corporate matters, including acquisitions, financings and restructurings; and all manner of litigation and regulatory matters, including government investigations, mass torts and product liability litigation, intellectual property counseling and patent litigation, and FDA and health care compliance. Skadden has assisted many companies in developing and implementing global anti-bribery and anti-corruption compliance programs and represented numerous companies in related government investigations.
For more information visit www.Skadden.com.
Verisys leverages data and technology to screen, verify, and monitor individuals and entities for healthcare clients in order to enhance enterprise-wide compliance controls across their organizations. For over 25 years, Verisys has supplied comprehensive technology platforms and services to the industry that utilize primary source data to ensure proper credentialing, registrations and licensure for individuals and entities. Furthermore, Verisys protects clients from fraud, waste, and abuse by identifying current and historical sanctions on providers, employees, vendors, distribution networks, etc.
For more information visit www.Verisys.com.
Imagine a Compliance Analytics Warehouse that contains all of the answers you need to drive your compliance operations and strategy.
Visit Cresen Solutions and find out how we are revolutionizing Compliance Operations in the cloud.
Our clients leverage our software platforms, analytics capabilities and technical skills to bring together disparate, mastered and unmastered data into a Compliance Analytics Warehouse that gives the Chief Compliance Officer the insights and answers they need whenever and wherever they need it.
We also host the industry’s only 100% Free CMS Open Payments analytics platform: PowerCMS
Learn more about DataEZ, Monitor-Mate, PowerCMS, EmPower Analytics and how all of these cloud-based solutions work together at www.cresensolutions.com or visit our exhibit today.
DMH Ethics & Compliance Advisors is a recognized leader in the creation and delivery of real-world ethics & compliance training for commercial. marketing and medical teams in the life science industry.
Our training design is based on industry best practices and behavioral ethics to enhance ethical leadership skills and value-based ethics & compliance programs.
In 2019 DMH successfully launched the Ethical Leadership Academy’s Ethical Self-Awareness Course for Senior & Mid-Level Leaders. Stop by our booth to see a demonstration.
DMH is celebrating its 11th year of helping companies build ethical leaders. For more information visit www.dmhethics.com.
Grant Thornton’s Life Sciences practice – consulting, audit, tax services – can help you achieve a competitive advantage, now and into the future. With dedicated professionals, our depth of industry knowledge, combined with our commitment to client service, make us the firm of choice for life sciences companies.
For more information visit www.GT.com.
Independent Commercial Compliance™ (ICC) is a health care compliance agency focused on promotional compliance related matters in the pharmaceutical industry. At ICC we specialize in Field Sales Force and Speaker Program Monitoring, building tailored processes to ensure effective monitoring solutions. ICC maintains an established infrastructure of over 40 highly experienced professionals geographically dispersed throughout the continental United States to monitor sales and marketing field activities. The geographic dispersion allows for reduced monitoring travel costs and increased client efficiencies, and delivers monitoring for hundreds of live events each year. Further information on ICC can be found at www.independent-commercial-compliance.com, and contact Shawn Reardon of ICC at (908) 370-4085.
Policy and Medicine Compliance Update and Policymed.com is a monthly publication from www.policymed.com providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. P&M Compliance Update examines important news and analysis, with input from top compliance officers and healthcare attorneys across the industry. The P&M Compliance Update offers practical insight into:
• False Claims Act and Qui Tam Developments
• Health Care Fraud Alerts and Enforcement Trends
• Corporate Integrity Agreements
• Physician Payments Sunshine Act
• FDA Guidance and Warning Letters
• International Regulations and Enforcement
• Best Practices For Compliance
For more information visit https://complianceupdate.policymed.com.
qordata is a data analytics and integration startup specializing in pharmaceutical, biotech and medical device industries. With a DNA in data integration and analytics, qordata provides software and tools to extract insights for decision making from a variety of publicly available data sets. Our consulting services enable pharma, biotech and device companies to operationalize the use of data based decision making across business functions such as compliance and marketing.
For more information visit www.qordata.com.
Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues posed by health and pharmaceutical law. As a nationally ranked Health Law program, the Center fosters informed dialogue between policymakers, consumer advocates, the medical profession, and industry in the search for solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arena.
In addition, the Center is a leader in providing healthcare compliance education and training in the U.S., Europe, Asia-Pacific, Latin America and Middle East on national and international mandates that apply to the safety and promotion of drugs and devices. The Center also hosts conferences and educational programs, inviting leading experts from the public and private sectors to examine cutting edge policy issues.
Launched in 2007, the Center extends Seton Hall Law School’s national reputation in health law to the life sciences arena and offers a challenging health law curriculum through its M.S.J., J.D., and LL.M. degree programs, online Graduate Certificates, and online M.S.J. The Center draws upon the intellectual strength of the Seton Hall Law School faculty and research fellows who bring to the Center’s work nationally-recognized expertise in health and pharmaceutical law, not-for-profit governance, intellectual property law and bioethics, among other areas.
The Society of Corporate Compliance & Ethics (SCCE) is a non-profit, pan-industry association dedicated to improving the quality of corporate governance, compliance, and ethics.
Our magazine and enewsletter can keep you informed about how to manage the latest issues. Come to our conferences to build out your network and hear directly from other professionals, at a discounted, members-only rate. The Compliance Academies can provide you with intensive training in the essentials of managing a compliance and ethics program. They are also excellent training for obtaining the Certified Compliance and Ethics Professional (CCEP) designation.
Can’t travel? Our blog and social media can keep you up to date with the latest compliance trends and best practices – www.complianceandethics.org. You can also join a web conference and learn right from your desk.
For more information, visit us at www.corporatecompliance.org, and join more than 5,000 other professionals as members of the SCCE.
Xybion is a leading software, services and consulting company dedicated to helping corporations solve business problems. Through intelligently designed systems and business processes, we help companies become more efficient, reduce costs and manage compliance, regulatory adherence and mitigate risks.
Serving more than 150 customers in 16 countries, we have the global scale and expertise to bring employees around the world to help companies in life sciences, healthcare, manufacturing, and government.
Our software and services include US patent-pending software solution:
• Real-time Compliance & Risk monitoring & predictive analytics
• Compliance & Risk process automation
• Third party accreditation, audit management, and compliance scorecard
• Complaints management solution
• Ethics & Compliance monitoring
• Quality management solution
Ever since its inception in 1977, Xybion has supported most of the top 20 global life sciences companies. Our unique solutions focus on GxP compliance, GRC, quality management, third party audits, integrated nonclinical lab management, drug discovery, digital lab management, and employee health & safety solutions.
For more information visit www.xybion.com.
RiskVUML fraud detection software and award-winning AI predictive analytics helps pharmaceutical and life sciences companies dramatically reduce exposure to fraud and bribery events. By implementing machine learning based protocols and data science driven strategies, RiskVUML’s solution manages overall risk profiles by continuously identifying, evaluating and analyzing anomalies to reveal fraudulent activity prior to irreversible costly consequences.
• RiskVUML’s core machine learning predictive analytic technology was recently awarded “Best AI – Based Solution” for 2018 by the AI Breakthrough Organization.
• Predicts non-compliant events (violations) before they become a problem – can achieve a 90% success rate in predicting fraudulent behaviors
• Positive and negative events are fed back for supervised machine learning ensuring continuous improvement
Our leading-edge pharmaceutical and life sciences predictive fraud detection platform is the perfect defense when you are dealing with and negotiating with regulatory agencies. This proactive technology approach to non-compliant behaviors is an essential insurance policy for any company under a CIA agreement to mitigate and minimize negative impacts of the agreement.
For more information visit www.zealgroup.tech
Interested in becoming a Grantor or Exhibiting?
Click Here for more information or contact Justin Sorensen at 206-452-0609.