AGENDA: DAY 3
FRIDAY, NOVEMBER 6, 2020
MINI SUMMITS GROUP V 10:00 am – 11:00 am
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit XXI: Meaningful Board Engagement and Support for Board Oversight of the Compliance Program
- Engaging with the Board: Frequency and approach with and without a CIA
- Advocating for and employing a holistic view of risk management and compliance
- Assessing compliance program effectiveness and risk in the contemporary environment
- Unique considerations for COVID-19 era
- The role of a Board Compliance Expert and its impact on the CCO
10:00 am
Welcome, Introductions, Discussions and Q&A
Thomas Costa, JD
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb; Washington, DC
Member, US Board of Directors, Sanofi; Former Vice President, US Compliance & Ethics, Bristol-Myers Squibb; Washington, DC
Tom Costa is a Compliance Consultant with 35 years of experience in the pharmaceutical industry. Since 2015 he has been an Board member for Sanofi-Aventis Independent U.S. He worked for Bristol-Myers Squibb from 1987 to 2014 in both London and Princeton, N.J. and headed up the U.S. Compliance and Ethics Department.
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, Boards 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 different 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.
Jon Smollen, MA, JD
Practice Professor of Law and Executive Director, Center for Compliance and Ethics, Beasley School of Law, Temple University; Board of Directors, Astellas Pharma, US; Former Executive Vice President and Chief Compliance Officer, Endo; Philadelphia, PA
Practice Professor of Law and Executive Director, Center for Compliance and Ethics, Beasley School of Law, Temple University; Board of Directors, Astellas Pharma, US; Former Executive Vice President and Chief Compliance Officer, Endo; Philadelphia, PA
Jon Smollen serves on the Board of Astellas Pharma U.S. and is a Practice Professor and the Executive Director of the Center for Compliance and Ethics at Temple Law. Mr. Smollen served as Executive Vice President and Chief Compliance Officer for Endo and held leadership positions at Siemens Healthcare and Wyeth Pharmaceuticals. Mr. Smollen also was an advisor to FTC Commissioner Thomas Leary and served as a judicial clerk to U.S. District Judge James P. Jones. He received his J.D. from the University of Virginia, his B.A. from Georgetown and his M.A. from Columbia’s School of International and Public Affairs.
Saul B. Helman, MD, MBA
Partner, Life Sciences Functional Practice Leader, Guidehouse; Former Director, Eli Lilly; Zionsville, IN (Co-moderator)
Partner, Life Sciences Functional Practice Leader, Guidehouse; Former Director, Eli Lilly; Zionsville, IN (Co-moderator)
Dr. Saul B. Helman has over two decades of life sciences experience, both in management roles and consulting. Saul is a Partner and leads Guidehouse’s Global Life Science practice. Saul has actively supported Boards of Directors in Life Sciences over the last decade, as it relates to Compliance Effectiveness Reviews, and has also served as an expert witness in Securities cases related to assertions made regarding the effectiveness of a company’s compliance program. Saul brings a unique combination of clinical, commercial and pharmaceutical management experience to compliance program implementation and evaluation.
Katie Norris, MPA
Director, West Coast Leader, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Senior Director, Compliance & Integrity Programs, NSF Health Sciences; San Francisco, CA (Co-moderator)
Director, West Coast Leader, Life Sciences Governance, Risk Management and Compliance, Guidehouse; Former Senior Director, Compliance & Integrity Programs, NSF Health Sciences; San Francisco, CA (Co-moderator)
Mini Summit XXII: How would you Respond to the DOJ’s Fundamental Question, “Does the Corporation’s Compliance Program Work” in Practice?
In working through the DOJ’s fundamental question “Does your Corporation’s Compliance Program ‘Work’ in Practice?” this session will first review the most recent and active history of the DOJ’s guidance regarding compliance program effectiveness. The session will also share examples of what “work in practice” might look like, across three key dimensions:
- Business Activity Examples
- Compliance Program Operations Examples
- Compliance Program Metrics Examples
The panel will also briefly discuss examples of what NOT working in practice might look like before summarizing key themes to carry forward in evaluating your own program.
10:00 am
Welcome, Introductions, Discussions and Q&A
Cynthia Cetani
Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA
Chief Integrity & Compliance Officer, Indivior; Former Group Integrity & Compliance, Head, Compliance Operations, Novartis International AG; Richmond, VA
Cindy was appointed as Chief Integrity & Compliance Officer for Indivior in October 2018. Cindy’s U.S. and global leadership spans multiple industries (Pharma, Life, Health). Prior to Indivior, Cindy held various roles across her 15 year career at Novartis (e.g., Chief Compliance Officer NPC and U.S. Country Compliance Head, Head of Compliance Operations, Group Integrity & Compliance in Basel, Switzerland). Before joining Novartis, Cindy was Director of Operations, Managed Markets at Pharmacia. Cindy is a Licensed Professional of Ethics & Compliance, and holds a Bachelor of Science, Commerce, Finance – Magna Cum Laude from Rider College, Lawrenceville, New Jersey.
Michael Joachim, JD
Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA
Head of Ethics & Business Integrity, Specialty Care, Sanofi Genzyme, Cambridge, MA
Michael Joachim is the Head of Ethics & Business Integrity, Specialty Care, for Sanofi and is a member of Sanofi’s Global E&BI management team. Mike provides strategic E&BI leadership and ensures the implementation of the Sanofi Global E&BI program within Sanofi Genzyme. Prior to joining Sanofi, Mike worked in the Legal Department at Blue Cross and Blue Shield of Massachusetts and in the Health Care Department of Choate, Hall & Stewart. He is a graduate of Harvard College and Harvard Law School.
Michael K. Loucks, JD
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice; Washington, DC
Partner, Skadden Arps LLP; Former Acting United States Attorney, District of Massachusetts, US Department of Justice; Washington, DC
Caroline H. West, JD
Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Tokyo, Japan
Global Chief Compliance Officer, Olympus Corporation; Former Senior Vice President, Chief Compliance and Risk Officer, Shire; Tokyo, Japan
Jack Tanselle, MBA
Managing Director, Deloitte & Touche LLP, Indianapolis, IN (Moderator)
Managing Director, Deloitte & Touche LLP, Indianapolis, IN (Moderator)
Jack has over 20 years of experience in the life sciences industries, ranging from strategic business planning to enterprise risk management and compliance program effectiveness. Jack has served as an expert to numerous Boards of Directors on the topic of compliance program effectiveness as well as serving as a testifying expert in cases involving compliance effectiveness. Jack currently serves clients on all matters relating to establishing, improving, and modernizing their compliance programs.
Mini Summit XXIII: Best Practices from Enforcement Actions on Fraud and Misuse of Patient Support Programs
The OIG issued guidance as far back as 2005 on the relationship between pharmaceutical companies and independent co-pay foundations. In 2020 the DOJ continues to pursue investigations on this issue, resulting in significant settlements and CIAs. Some companies are now fighting back instead of settling, launching legal and Constitutional challenges. This expert panel will be exploring the implications for these developments on Compliance Programs, including real “war stories” from a company that was investigated by and settled with DOJ.
The objectives of this session are to:
- Educate compliance professionals on co-pay foundation issues with the goal of identifying issues, observations, and trends that can inspire and influence overall Compliance Program design and implementation.
- Review legal and regulatory issues applicable to independent co-pay foundation relationships, including OIG guidance documents.
- Review the history of government investigations, settlements and CIAs.
- Distill 10 key factors that the government may consider when examining your company’s relationship with independent co-pay foundations.
- Review potential models for effective compliance in this area, with focus on the operational design set out in the 2018 Pfizer CIA.
- Review actual company documents disclosed in 2020 court filings to examine the kind of corporate behavior and communications that are still getting the government’s attention in this area.
- Identify issues about employee training, “ethics” vs. compliance, and the need for legal and compliance functions to know about and be involved in business activities.
10:00 am
Welcome, Introductions, Discussions and Q&A
Timothy Roberts, MSJ
Executive Director, Compliance, AbbVie; Former Executive Director, Commercial Compliance -US Medical Aesthetics, Allergan; Budd Lake, NJ
Executive Director, Compliance, AbbVie; Former Executive Director, Commercial Compliance -US Medical Aesthetics, Allergan; Budd Lake, NJ
Tim Roberts is the Executive Director, Compliance at AbbVie. He is a compliance professional with over 14 years of healthcare industry experience in sales, sales management, training, and compliance. Strong knowledge of regulatory, compliance, training, policy, and risk management activities. Mr. Roberts is recognized for a commitment to excellence, innovative approach to improving business processes to reduce potential risk of non-compliance, and outstanding collaborative business approach. He has a proven track record of building strong relationships with internal and external stakeholders throughout all levels of management and is recognized for strong analytical abilities, communication, presentation, and project management skills that allow me to identify areas of potential risk and the root causes in order to provide comprehensive solutions for all stakeholders. He was previously the Executive Director, Commercial Compliance – US Medical Aesthetics at Allergan.
Kevin Ryan, MS, JD
Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Vice President, Chief Compliance Officer, ACADIA; Former Director, Ethics & Compliance, Novo Nordisk; San Diego, CA
Amy Yuda, MSJ, CCEP, CHC, CQA
Compliance Manager, bioMerieux; Former Compliance Officer, PolarityTE; Former Compliance Officer, US WorldMeds; Salt Lake City, UT
Compliance Manager, bioMerieux; Former Compliance Officer, PolarityTE; Former Compliance Officer, US WorldMeds; Salt Lake City, UT
Amy has spent over 15 years in Compliance and Quality Assurance, leading organizations through inspections and investigations. She was the former Compliance Officer at US WorldMeds, Solstice Neurosciences, and HEMA Biologics from 2016 to 2019, and the former Compliance Officer at PolarityTE from 2019 to 2020. Amy has her Masters of Jurisprudence (MSJ) in Pharmaceutical and Medical Device Law & Compliance from Seton Hall University. She is a Certified Compliance & Ethics Professional (CCEP), Certified in Healthcare Compliance (CHC), and a Certified Quality Auditor (CQA).
Craig Bleifer, JD
Principal, Craig B. Bleifer, LLC; Former Corporate Vice President, General Counsel North America, Novo Nordisk; Former Senior Vice President, General Counsel and Secretary, Daiichi Sankyo; Summit, NJ (Moderator)
Principal, Craig B. Bleifer, LLC; Former Corporate Vice President, General Counsel North America, Novo Nordisk; Former Senior Vice President, General Counsel and Secretary, Daiichi Sankyo; Summit, NJ (Moderator)
Craig Bleifer is the former general counsel for Novo Nordisk, Inc., and previously was the general counsel for Daiichi Sankyo, Inc., and served as Counsel at Porzio, Bromberg & Newman. He is now the principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on healthcare industry topics. Craig has over 20 years’ experience in the US and Global healthcare industry and nearly 30 years as an attorney. He is the Past Chair, PhRMA Law Section Executive Committee, and Past Chair, Healthcare Institute of New Jersey. He has been awarded General Counsel of the Year by NJBIZ, and was awarded In-House Legal Department of the Year by New Jersey Law Journal.
Mini Summit XXIV: SEC Compliance: Living in the Material (Non-Public Information) World
Pharmaceutical and medical device companies continue to be a focus for the US Securities and Exchange Commission, when it comes to both disclosure and enforcement concerns. A life sciences company’s treatment of material non-public information, as a disclosure issue and from a securities trading standpoint, can present significant potential liability exposure and reputational risks. In this session, we will consider MNPI from a variety of aspects: ranging from determinations of materiality, ongoing and transactional disclosure considerations, insider trading policies and procedures, opening/closing trading windows, impact on share repurchase programs and current thinking on 10b5-1 plans. And what happens if it all goes wrong.
10:00 am
Welcome, Introductions, Discussions and Q&A
Scott A. Thompson
Associate Regional Director, United States Securities and Exchange Commission, Philadelphia Regional Office, Philadelphia, PA
Associate Regional Director, United States Securities and Exchange Commission, Philadelphia Regional Office, Philadelphia, PA
Amy J. Greer, JD
Partner, Baker & McKenzie LLP; Former Regional Trial Counsel (Philadelphia), US Securities and Exchange Commission; New York, NY (Co-moderator)
Partner, Baker & McKenzie LLP; Former Regional Trial Counsel (Philadelphia), US Securities and Exchange Commission; New York, NY (Co-moderator)
Amy Greer serves as the co-chair of Baker McKenzie’s North America Financial Regulation & Enforcement Practice, which provides clients with a full range of regulatory advice and enforcement counseling. Previously, Amy served as chief trial counsel at the US Securities and Exchange Commission’s (SEC) Philadelphia regional office and managed a team of lawyers overseeing a wide variety of enforcement matters.
Amy advises all manner of SEC reporting companies and financial industry clients in connection with regulatory enforcement investigations and examinations, as well as internal investigations. Drawing on her experience leading an SEC regional office trial program, Amy provides practical and forward-looking guidance to clients, who seek her advice on matters as diverse as conflict of interest disclosures, sales practices concerns, insider trading/market abuse, financial reporting and accounting issues, securities offerings, investigations into complex products and trading, and whistleblower concerns.
Amy advises all manner of SEC reporting companies and financial industry clients in connection with regulatory enforcement investigations and examinations, as well as internal investigations. Drawing on her experience leading an SEC regional office trial program, Amy provides practical and forward-looking guidance to clients, who seek her advice on matters as diverse as conflict of interest disclosures, sales practices concerns, insider trading/market abuse, financial reporting and accounting issues, securities offerings, investigations into complex products and trading, and whistleblower concerns.
Carol B. Stubblefield, JD, LLM
Partner, Baker & McKenzie LLP, New York, NY (Co-moderator)
Partner, Baker & McKenzie LLP, New York, NY (Co-moderator)
Mini Summit XXV: Reflections on a Successful Co-Promotion Partnership
Co-Promotions continue to be a hot and enticing strategic business option for drug and device makers, big and small. The attraction of co-promotes has intensified with the proliferation of specialty products and markets as manufacturers seek ways to maximize their resources and optimize selling and marketing efforts. Since co-promotes involve more than one organization, the associated compliance risks are intense and require a great deal of thought and coordination—more so compared to a unilateral commercial initiative. This experienced expert panel will share personal experiences with co-promotes, draw on insights, and provide the latest updates. Attend this session to learn from a cross functional group consisting of Pharma and Medical Device outside counsel, an experienced life sciences consulting expert, and three Chief Compliance Officers from small, midsized, and large companies. This impressive panel has extensive first-hand experience in all aspects of company co-promotions.
Topics covered include:
- How to work with your partner
- Early considerations
- Examples of successes and areas for improvement
- How to handle “deal fever”
- Policies and procedures
- Conflicts
- And more
10:00 am
Welcome, Introductions, Discussions and Q&A
Anisa Dhalla
Global Chief Compliance Officer, UCB, Atlanta, GA
Global Chief Compliance Officer, UCB, Atlanta, GA
Anisa Dhalla is Chief Ethics and Compliance Officer at UCB. She oversees, develops, and evaluates the effectiveness of UCB’s global ethics and compliance program. As a member of the U.S. leadership team and global legal leadership team, Anisa’s commitment to leading ethical and compliant behavior at UCB helps deliver value to patients. Anisa joined UCB in regulatory affairs in 1998 and moved to the compliance team in 2010. She was appointed as chief ethics and compliance officer in 2020. Prior to joining UCB, Anisa spent twelve years in regulatory affairs roles at other companies performing a variety of roles. She was responsible for oversight of promotional material review, labeling, and global dossier management during her time in regulatory affairs. Today, Anisa is a member of UCB’s Diversity, Equity and Inclusion core team and previously served as chair of UCB’s Women in Leadership Steering Committee from 2014 to2016.
Gregory S. Moss, LLB
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY
Executive Vice President, General Counsel and Corporate Secretary, Chief Compliance Officer, Kadmon Holdings, New York, NY
Laura Skinner, MBA
Director, Life Sciences Consulting Group, Paul Hastings LLP, Austin TX
Director, Life Sciences Consulting Group, Paul Hastings LLP, Austin TX
Joe Zimmerman
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Parsippany, NJ
Vice President, Chief Compliance Officer & Privacy Officer, Ferring Pharmaceuticals, Parsippany, NJ
Joseph Zimmerman has over two decades of experience in the pharmaceutical industry in leadership roles of increasing responsibility in such areas as corporate compliance, privacy, leadership development, training, management, and sales. Since 2016 he has been with Ferring Pharmaceuticals, Inc., where he currently serves as Vice President, Chief Compliance & Privacy Officer, and Head of U.S. Government Affairs.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
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, where he established the corporate function and managed the teams providing compliance support for numerous new product or indication approvals, branded drug launches, and through various M&A activity.
Mr. Zimmerman is a regular participant in government and industry Chief Compliance Officer roundtables, and periodically speaks to compliance professionals at industry conferences.
Mark Gardner, MBA, JD
Managing Attorney, Gardner Law, PLLC; Adjunct Professor, Drug & Device Law, Mitchell Hamline School of Law; Stillwater, MN (Moderator)
Managing Attorney, Gardner Law, PLLC; Adjunct Professor, Drug & Device Law, Mitchell Hamline School of Law; Stillwater, MN (Moderator)
Mark Gardner, Managing Attorney, Gardner Law, PLLC, is a drug and device lawyer. He’s an Adj. Professor of Drug & Device Law and Health Law Institute Advisory Board member at Mitchell Hamline School of Law. Mark is a member of the ABA, FDLI and MSBA. Former: product manager, Chair of the Minnesota State Bar Association Food, Drug, & Device Law Section, and Chair of Medical Alley Regulatory Special Interest Group.
11:00 am
Transition Break
MINI SUMMITS GROUP VI 11:15 am – 12:15 pm
(During Congress broadcast, attendees may move among Mini Summits)
Mini Summit XXVI: Managing Communication Issues and Leadership during a Crisis or an Emerging Post-Crisis Environment
Ethics & Compliance Leaders address workforce stress during and post a crisis to:
- Ensure the right messages aren’t distorted as the business is under pressure to resume operations.
- Ensure a risk assessor is at the virtual table and that ethics & compliance leaders are aligned with emerging risk?
- Guard against reputational risk and ensure everyone plays the role of risk manager?
- Share the best means of communicating across, up, and down the org chart?
- Reach team members in an overstimulated virtual world with less personal interactions.
- Effectively communicate ethical expectations in a virtual environment and discuss difficult issues without putting someone on the defensive?
11:15 am
Welcome, Introductions, Discussions and Q&A
Hollie K. Foust, JD
Senior Vice President, Legal and Compliance, Cardinal Health; Dublin, OH
Senior Vice President, Legal and Compliance, Cardinal Health; Dublin, OH
Hollie Foust, is the Senior Vice President, Ethics & Compliance, and International Legal for Cardinal Health, Inc. Cardinal Health distributes medical and pharmaceutical products and manufacturers a wide range of medical products from exam gloves to cardiovascular stents. Cardinal Health also provides customized pharmacy solutions, patient access and support programs through its specialty pharmaceutical HUB, and medication management programs. As the head of the Ethics & Compliance Department and International Legal, Hollie is responsible for the development and implementation of Cardinal Health’s global ethics and compliance program and delivering quality legal support and guidance to the business. Hollie has significant experience in both domestic and international laws, regulations, and industry requirements, including: the Foreign Corrupt Practices Act, UK Bribery Act, U.S. False Claims Act, Stark and Anti-Kickback Statute, International Trade Regulations, Anti-Competition Laws, EU General Data Protection Regulation, HIPAA, HITECH Act, Physician Payment Sunshine Act, and the PhRMA and AdvaMed Industry codes.
Gary F. Giampetruzzi, Esq.
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer; New York, NY
Partner, Paul Hastings; Former Vice President and Assistant General Counsel, Head of Government Investigations, Pfizer; New York, NY
Jill Mason, JD
Chief Compliance Officer, Orthofix; Former Senior Global Compliance Director, St. Jude Medical; Dallas, TX
Chief Compliance Officer, Orthofix; Former Senior Global Compliance Director, St. Jude Medical; Dallas, TX
Jill Mason has served as the Chief Ethics and Compliance Officer for Orthofix Medical, Inc. since 2015. Orthofix is a global medical device and biologics company with a spine and extremities focus. Throughout her career, Jill has helped companies successfully navigate through corporate integrity agreements, deferred prosecution agreements and government-appointed monitors. She received her Bachelor of Arts in political science from Texas A&M University in 1997 and her Juris Doctor degree from Baylor University School of Law in 2001.
Kristin Mykulak, JD
Assistant General Counsel, Litigation & Compliance, Dr. Reddy’s Laboratories, Princeton, NJ
Assistant General Counsel, Litigation & Compliance, Dr. Reddy’s Laboratories, Princeton, NJ
Kristin Mykulak has 13 years of legal and compliance experience in private practice and serving as in-house counsel for Dr. Reddy’s Laboratories, Inc. While in private practice, Kristin provided compliance counseling and strategic legal representation to pharmaceutical and healthcare companies. At Dr. Reddy’s, Kristin manages the US litigation portfolio and leads the compliance team in the US, Canada and LatAm, providing compliance advice to the branded specialty, generic and over-the-counter pharmaceutical businesses, custom pharmaceutical services business, and active pharmaceutical ingredient supply business.
Richard T. Bistrong, MA
Chief Executive Officer, Front-Line Anti-Bribery LLC; Contributing Editor, FCPA Blog; Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ; Former Cooperating Witness, City of London Police, HMRC and CPS, UK; New York, NY (Moderator)
Chief Executive Officer, Front-Line Anti-Bribery LLC; Contributing Editor, FCPA Blog; Former Confidential Human Source (CHS) and Cooperating Witness, FBI and US DOJ; Former Cooperating Witness, City of London Police, HMRC and CPS, UK; New York, NY (Moderator)
As quoted in the Financial Times, The New York Times, Forbes, CNBC, and The Wall Street Journal, I now share my journey, where I bribed foreign officials, cooperated with international law enforcement & went to prison. Having been a member of the OECD Secretary General’s High-Level Advisory Group on Integrity and Anti-Corruption, I share my front line experience for the benefit of those who confront overseas corruption risk in the field & for those compliance professionals tasked with helping them to manage that risk. My clients include brands as diverse at the Volkswagen Group, Microsoft, Kraft-Heinz, Takeda, Airbus, and Mastercard among numerous global Fortune 100 and 500 multinationals. My consultancy, Front-Line Anti-Bribery, LLC is based on my unique experience which includes 10+ years as an International Sales Executive & an extended period of covert cooperation with U.S. & UK law enforcement.
Mini Summit XXVII: Fair Market Value Calculations, Benchmarks and New Standards in a Virtual World
Join Eric Bolesh of Cutting Edge Information and panelists from Pharmaceutical and Medical Device companies for an engaging discussion of FMV rates for HCPs. Learn best practices for making sure your company is staying within the acceptable range for payments and surrounding issues such as tiering, travel, rate distribution and more. Hear how your peers are handling the complications of the virtual “new normal”.
11:15 am
Welcome, Introductions, Discussions and Q&A
Kari K. Loeser, JD
Senior Corporate Counsel & US Healthcare Compliance Officer, Relypsa; Former Investigator, US Department of Health & Human Services; Former, Policy Analyst, American Medical Association; Redwood City, CA
Senior Corporate Counsel & US Healthcare Compliance Officer, Relypsa; Former Investigator, US Department of Health & Human Services; Former, Policy Analyst, American Medical Association; Redwood City, CA
Kari Loeser advises client groups on legal and compliance matters pertaining to sales, marketing, corporate affairs, and promotional matters for the renal-cardiology portfolio, in addition to advising on legal and compliance matters for medical affairs including field medical, clinical/research, publications, and health economic outcomes research, and managed care and reimbursement activities. She oversees all compliance-related matters, including training, investigations, and also manages a team responsible for federal/state aggregate spend reporting (transparency) and compliance field monitoring. Prior to Relypsa, Kari worked at Jazz Pharmaceuticals as senior counsel and also worked in medical affairs and healthcare compliance at Genentech, a member of the Roche Group. She has published various articles and a book chapter on E-Health and Ethics. She currently authored an article in the International In-House Counsel Journal on client centricity, and authored a book chapter in CANCER POLICY: PHARMACEUTICAL SAFETY entitled “Anatomy of Risk Evaluation and Mitigation Strategies (REMS)”. She is a licensed attorney, and is certified in Healthcare Compliance.
Heather McCollum, JD, MHA, CCEP-I
Senior Director, Compliance, Shionogi, Florham Park, NJ
Senior Director, Compliance, Shionogi, Florham Park, NJ
Eric Bolesh
Chief Operating Officer, Cutting Edge Information, Research Triangle Park, NC (Moderator)
Chief Operating Officer, Cutting Edge Information, Research Triangle Park, NC (Moderator)
Mini Summit XXVIII: Compliance Monitoring in a Virtual World
This session will provide practical strategies for companies to adapt their monitoring programs in virtual world including:
- This session will provide practical strategies for companies to adapt their monitoring programs in virtual world including:
- Providing consistent communication to business partners
- Leveraging structured and unstructured data and AI for proactive risk identification
11:15 am
Welcome, Introductions, Discussions and Q&A
Meenakshi Datta, JD
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL
Partner and Global Co-leader, Healthcare Practice, Sidley Austin LLP, Chicago, IL
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.
Denis Jacob, MBA
Vice President, Deputy Chief Compliance Officer, Orthofix; Former Director, Ethics & Compliance, International, BD; Lewisville, TX
Vice President, Deputy Chief Compliance Officer, Orthofix; Former Director, Ethics & Compliance, International, BD; Lewisville, TX
Denis Jacob is the VP, Deputy Chief Compliance Officer at Orthofix, a global medical device company dedicated to improving patients’ lives through superior reconstruction and regenerative spine and extremity solutions. Prior to joining Orthofix, Denis worked for Becton Dickinson, where he held the position of Global Director, Ethics & Compliance. Denis previously worked for Covidien (later acquired by Medtronic), as Compliance Manager for South Latin America, and Becton Dickinson, as Corporate Internal Audit Manager, conducting numerous international financial, operational and forensic audit projects, including, but not limited to, ethics and compliance investigations. Prior to joining BD, Denis also worked for Deloitte and Citibank Brazil.
Vahan Minassian, JD
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Director, US Promotional Monitoring Lead, Pfizer, Philadelphia, PA
Alexis Stroud, CQA, CCEP
Director, Ethics & Compliance: Auditing, Monitoring, and Risk Assessment, Boehringer Ingelheim; President, Fairfield County, CT Chapter, Healthcare Businesswomen’s Association, Stamford, CT
Director, Ethics & Compliance: Auditing, Monitoring, and Risk Assessment, Boehringer Ingelheim; President, Fairfield County, CT Chapter, Healthcare Businesswomen’s Association, Stamford, CT
Alexis started her career in the life science industry working at QPharma where she conducted computerized system validation, regulatory training, 21 CFR Part 11 assessments, equipment qualification, quality system development, and auditing for over 30 life science companies. After spending over a decade in quality and regulatory compliance, Alexis made the switch to healthcare compliance 10 years ago, working in the Ethics & Compliance department of Purdue Pharma, where she was able to transform and optimize the auditing and monitoring function. Alexis currently serves as the Director of Ethics & Compliance for Boehringer-Ingelheim where she is responsible for the design, implementation, and continuous improvement of BI’s compliance program, with primary responsibility for risk management and compliance auditing and monitoring. In addition to her extensive compliance experience, Alexis is President of the Fairfield County, CT Chapter of the Healthcare Businesswomen’s Association and has been volunteering with the HBA for over 10 years.
Bryan Timer, MA
Director, Data Analytics & Transparency, Merck, Kenilworth, NJ
Director, Data Analytics & Transparency, Merck, Kenilworth, NJ
Bryan Timer is the Director of 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 other groups within Merck’s compliance program and assists with developing and growing the group’s analytical capabilities. Prior to joining Merck, Bryan spent seven years as a consultant for two software companies which focused on providing software solutions to clients in the Consumer Packaged Goods industry as well as small and medium sized pharmaceutical companies. Bryan holds a Management of Information Systems degree from Muhlenberg College and Master Business Analytics from Syracuse University’s Whitman School of Management.
Tiffany Tang
Associate Principal, Global Compliance Consulting, IQVIA; Former Senior Manager, Ethics and Compliance, Novo Nordisk; New York, NY (Moderator)
Associate Principal, Global Compliance Consulting, IQVIA; Former Senior Manager, Ethics and Compliance, Novo Nordisk; New York, NY (Moderator)
Mini Summit XXIX: Fraud and Abuse Risks Related to COVID-19 Relief
Key topics to be discussed include:
- Fraud and abuse risks related to COVID 19 relief, within all of our organizations.
- Government relief provided through the CARES Act including the Provider Relief Fund, Paycheck Protection Program, etc.
- Other types of relief that has been provided such as private donations, customer/vendor related relief, etc.
- Compliance programs – how they are viewed by the regulators and how to think about adjusting them as a result of COVID 19.
- The new fraud and abuse risks that are generally emerging from the pandemic such as virtual business meetings, employee donations, etc.
- Useful guidance that has come out in these important areas.
11:15 am
Welcome, Introductions, Discussions and Q&A
Ethan Davis, JD
Partner, King & Spalding LLP; Former Acting Assistant Attorney General, Civil Division, US, Department of Justice; Washington, DC
Partner, King & Spalding LLP; Former Acting Assistant Attorney General, Civil Division, US, Department of Justice; Washington, DC
Ethan Davis focuses on white collar government investigations, litigation, and compliance counseling, particularly in the health care and life sciences industries. Until September 2020, Ethan served at the Department of Justice in a number of senior roles, including Acting Assistant Attorney General and Principal Deputy Assistant Attorney General for the Civil Division, the Department’s largest litigating division. In those roles, Ethan supervised the Justice Department’s investigations and litigation under the False Claims Act and the Food, Drug, and Cosmetic Act. Ethan is a former clerk to Justice Neil M. Gorsuch of the U.S. Supreme Court.
Christine Gordon, JD
Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Former Assistant District Attorney, Philadelphia District Attorney’s Office; Bethlehem, PA
Deputy Chief Compliance Officer, Olympus Corporation of the Americas; Former Assistant District Attorney, Philadelphia District Attorney’s Office; 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. Ms. Gordon is a member of the Pennsylvania Bar and earned her degree from Villanova University’s Charles Widger School of Law.
Matthew Kleinhans, MS
Compliance Officer, U.S. Home Services Group and Continence Care, ConvaTec; Former Chief Compliance Officer, US Healthcare Supply, LLC; New York, NY
Compliance Officer, U.S. Home Services Group and Continence Care, ConvaTec; Former Chief Compliance Officer, US Healthcare Supply, LLC; New York, NY
Matthew (Matt) Kleinhans is the Compliance Officer of the ConvaTec Home Services Group (HSG) and Continence Care franchises. The HSG is ConvaTec’s medical equipment distribution unit which focuses on direct-to-consumer service of disposable medical products. Matt has more than 11 years of experience in Healthcare Compliance. He was previously employed as the Compliance Director of US Healthcare Supply LLC. Matt holds a Master’s degree in Finance from Villanova University and a Bachelor’s degree in Economics from the Pennsylvania State University. Matt also holds a CHC certification. He enjoys traveling, volunteering, and engaging in outdoor activities.
Eric Siegel, MBA, JD
Vice President, Head of Compliance US, Idorsia Pharmaceuticals US; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA
Vice President, Head of Compliance US, Idorsia Pharmaceuticals US; Former Chief Compliance Officer, Jazz Pharmaceuticals; Former Senior Investigator, Office of the Inspector General, City of Philadelphia; Philadelphia, PA
Eric is an attorney and compliance professional with more than twenty-five years of experience in the life sciences industry. He currently serves as Vice President, Head of Compliance US for Idorsia Pharmaceuticals US Inc. in Radnor, Pennsylvania. Prior to joining Idorsia, Eric served as Vice President and Chief Compliance Officer for Jazz Pharmaceuticals in Philadelphia, Pennsylvania. Before that, he held the roles of Executive Vice President, General Counsel as well as Chief Compliance Officer for Incyte Corporation, a global biopharmaceutical company located in Wilmington, Delaware. Earlier in his career, Eric served in senior management Legal and Compliance roles for EMD Serono, Solstice Neurosciences and Cephalon. He began his career in the pharmaceutical industry at GlaxoSmithKline.
Kathleen McGovern, JD
Global Investigator, Healthcare & Crisis Management Advisor, EY; Former Senior Deputy Chief, Fraud Section, US Department of Justice; Washington, DC (Moderator)
Global Investigator, Healthcare & Crisis Management Advisor, EY; Former Senior Deputy Chief, Fraud Section, US Department of Justice; Washington, DC (Moderator)
Kathleen is a Principal in the Ernst & Young LLP (EY) Forensic & Integrity Services practice. Kathleen is a former U.S. federal and state prosecutor with more than 25 years of investigative, litigation and trial experience, with expertise in Foreign Corrupt Practices Act (FCPA) violations; governmental program fraud, including health care (HCF) and disaster relief fraud; and securities and financial fraud, including money laundering.
She serves as the Forensics Healthcare Practice leader (East) and leads the sole team currently providing all CARES Act guidance to the firm’s U.S. clients, across all service lines.
Before joining EY, Kathleen was the Senior Deputy Chief in the U.S. Department of Justice (DOJ), Criminal Division, Fraud Section. Kathleen also served as the DOJ’s representative to the US delegation for the Organization for Economic Co-operation and Development (OECD) Working Group on Bribery and Corruption. Prior to DOJ, Kathleen was a state prosecutor in New York for 11 years, holding various senior level positions.
She serves as the Forensics Healthcare Practice leader (East) and leads the sole team currently providing all CARES Act guidance to the firm’s U.S. clients, across all service lines.
Before joining EY, Kathleen was the Senior Deputy Chief in the U.S. Department of Justice (DOJ), Criminal Division, Fraud Section. Kathleen also served as the DOJ’s representative to the US delegation for the Organization for Economic Co-operation and Development (OECD) Working Group on Bribery and Corruption. Prior to DOJ, Kathleen was a state prosecutor in New York for 11 years, holding various senior level positions.
Mini Summit XXX: Research and Development Compliance Challenges
- Data Integrity in the Clinical Trial Context
- Significance of data integrity in the clinical research context
- Impact of data integrity issues
- Strategies for addressing data integrity issues, including disclosure
- Research and Commercial Transactions
- Breadth of AKS
- How to manage strategic partnerships with commercial and research elements
- How to maintain separation between commercial and research components
- Other Areas of Interest
11:15 am
Welcome, Introductions, Discussions and Q&A
Masha Chestukhin, MSJ
Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; Jamaica Plain, MA
Associate Director, Compliance Officer R&D, IA, FMV, Sanofi Genzyme; Former Senior Manager NA Compliance, Sanofi; 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 and Corporate Compliance. Masha’s specific interests lie in the area of research Data integrity and all aspects of FMV concepts. Prior to her work at Sanofi, Masha worked at Deloitte&Touche in Life Schiences/Health care advisory practice. Ms. Chestukhin has a Master of Law in Health Care &Life Science Compliance from Seton Hall Law School, M.S. in Life Sciences (Moscow State University), and strong background and expertise in Accountancy.
Noël Denice, JD
Legal Counsel, Philips North America, LLC; Former Assistant General Counsel, Olympus Scientific Solutions Americas; Boston, MA
Legal Counsel, Philips North America, LLC; Former Assistant General Counsel, Olympus Scientific Solutions Americas; Boston, MA
Ms. Denice is Legal Counsel at Philips North America. Her practice focuses on anti-bribery and anti-corruption in the med-device space. Ms. Denice is responsible for the North American Market, primarily supporting the sales function across the full suite of medical devices and solutions. 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.
Seth B. Whitelaw, JD, LLM, SJD
President and Chief Executive Officer, Whitelaw Compliance Group, LLC, Editor, Life Science Compliance Update Senior Fellow & Adjunct Professor, Life Sciences Compliance, Mitchell Hamline School of Law; West Chester, PA
President and Chief Executive Officer, Whitelaw Compliance Group, LLC, Editor, Life Science Compliance Update Senior Fellow & Adjunct Professor, Life Sciences Compliance, Mitchell Hamline School of Law; West Chester, PA
Dr. Whitelaw has almost 30 years of industry experience in the life sciences and health care sectors, as an attorney, compliance officer (C.R. Bard, Inc., GlaxoSmithKline, and Misonix, Inc.) and industry consultant (Deloitte, Whitelaw Compliance Group LLC.). Most recently, he served as a compliance expert in the Opioid MDL litigation. In addition to being a Food and Drug Law Institute (FDLI) fellow and having worked for both the FDA’s Office of Chief Counsel, he has a J.D. from Washington & Lee School of Law, an LL.M. from George Washington University Law School, and a doctorate in Health Law from Widener University School of Law. Currently, Dr. Whitelaw is the Editor of the Policy & Medicine Compliance Update and teaches corporate governance and compliance at Mitchell Hamline School of Law where he is the Senior Fellow & Adjunct Professor, Life Sciences Compliance.
Raj D. Pai, JD
Partner, Sidley Austin LLP; Former Attorney, Office of Chief Counsel US Food and Drug Administration; Washington, DC (Moderator)
Partner, Sidley Austin LLP; Former Attorney, Office of Chief Counsel US Food and Drug Administration; Washington, DC (Moderator)
12:15 pm
Transition Break
DAY III CLOSING PLENARY SESSION
1:00 pm
Co-chair Welcome and Introductions
1:15 pm
Roundtable on Implications of the Election for Lifesciences, including Pricing and Cost Containment Policy
Robert W. Dubois, MD, PhD
Interim President and CEO, National Pharmaceutical Council (NPC); Former Chief Medical Officer, Cerner LifeSciences; Washington, DC
Interim President and CEO, National Pharmaceutical Council (NPC); Former Chief Medical Officer, Cerner LifeSciences; Washington, DC
Robert W. Dubois, MD, PhD, is the interim president and CEO of the National Pharmaceutical Council (NPC), which sponsors and participates in research on the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. Dr. Dubois is continuing to serve as NPC’s chief science officer, a position he has held since 2010. Dr. Duobois, who is board certified in internal medicine, brings more than 25 years of experience in health care research. Dr. Dubois received his AB from Harvard College, his MD from the John Hopkins School of Medicine and his PhD in health policy from the RAND Graduate School.
Dan Mendelson, MPP
Founder, Avalere Health; Operating Partner, Welsh, Carson, Anderson & Stowe Board, Centrexion Therapeutics Corp., Washington, DC
Founder, Avalere Health; Operating Partner, Welsh, Carson, Anderson & Stowe Board, Centrexion Therapeutics Corp., Washington, DC
Dan Mendelson is Founder and former CEO of Avalere Health, a vibrant community of innovative thinkers dedicated to solving the challenges of the healthcare system. He is also Operating Partner at Welsh Carson, a private equity firm focused on healthcare and technology investments. Prior to founding Avalere in 2000, Dan served as Associate Director for Health at the Office of Management and Budget in the Clinton White House, where he was responsible for the full healthcare portfolio including Medicare, Medicaid, NIH, CDC, and FDA.
Dan presently serves on the boards of Champions Oncology (CSBR), Centrexion Corporation, Audacious Inquiry, and Partners in Primary Care. He is Adjunct Professor at Georgetown University’s McDonough School of Business, and a founding member of Guidon Partners.
Dan is a leading national thought leader on healthcare business issues, is often quoted in the press and enjoys speaking.
Dan presently serves on the boards of Champions Oncology (CSBR), Centrexion Corporation, Audacious Inquiry, and Partners in Primary Care. He is Adjunct Professor at Georgetown University’s McDonough School of Business, and a founding member of Guidon Partners.
Dan is a leading national thought leader on healthcare business issues, is often quoted in the press and enjoys speaking.
Susan Dentzer
Senior Policy Fellow, Duke-Margolis Center for Health Policy; Former Editor in Chief, Health Affairs; Former Health Correspondent, PBS NewsHour; Washington, DC (Moderator)
Senior Policy Fellow, Duke-Margolis Center for Health Policy; Former Editor in Chief, Health Affairs; Former Health Correspondent, PBS NewsHour; Washington, DC (Moderator)
2:00 pm
Using Data Analytics and Automation to Drive Smarter, More Effective and Cost-Effective Compliance Programs
Joshua Marks, JD
Vice President, Chief Ethics & Compliance Officer, Boehringer Ingelheim; Former Executive Division Counsel, Corporate Compliance Officer & Assistant Secretary, Ben Venue Laboratories; Ridgefield, CT
Vice President, Chief Ethics & Compliance Officer, Boehringer Ingelheim; Former Executive Division Counsel, Corporate Compliance Officer & Assistant Secretary, Ben Venue Laboratories; Ridgefield, CT
Joshua Marks currently serves as VP, Chief Ethics & Compliance Officer for Boehringer Ingelheim Pharmaceuticals. Prior his role as CECO, Josh served as an ex-pat at BI Corporate in Germany as global General Counsel of BI’s Animal Health business, and later established a new organization within the Legal Department entitled ‘Global Legal Solutions’ which was charged with providing pragmatic, timely and efficient legal services for Contracts & Healthcare Compliance Group, Global Information Governance, Trademarks and legal support for Global Sourcing. Before that, Josh served as General Counsel for BI’s sterile injectable manufacturing facility and as an associate at several law firms, where his practice focused on commercial contracting, commercial litigation, IP licensing and patent litigation.
Jenny McVey, MS, PHD
Compliance Risk Strategy & Management, Novo Nordisk, Compliance Lead, Hands International Editorial Board Member, Policy & Medicine Compliance Update, Princeton, NJ
Compliance Risk Strategy & Management, Novo Nordisk, Compliance Lead, Hands International Editorial Board Member, Policy & Medicine Compliance Update, Princeton, NJ
Jennifer is Vice President and Global 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.
Natasha Trifun, JD
Executive Director, R&D, Quality, Operations, External Funding and Global Medical Compliance, Alexion; Former Brazil Compliance Officer, Pfizer; Boston, MA
Executive Director, R&D, Quality, Operations, External Funding and Global Medical Compliance, Alexion; Former Brazil Compliance Officer, Pfizer; Boston, MA
Parth Chanda, JD, MPA
Founder and CEO, Lextegrity; Former Chief Compliance Counsel, Oncology, Pfizer; New York, NY (Moderator)
Founder and CEO, Lextegrity; Former Chief Compliance Counsel, Oncology, Pfizer; New York, NY (Moderator)
2:45 pm
Annual AUSA Roundtable
Matthew J. Lash, JD
Assistant Director, Consumer Protection Branch, US Department of Justice, Washington, DC
Assistant Director, Consumer Protection Branch, US Department of Justice, Washington, DC
Matthew Lash is an Assistant Director with the Department of Justice, Consumer Protection Branch in Washington, D.C. Mr. Lash represents the United States in criminal and civil cases implicating the Food, Drug, and Cosmetic Act and other statutes impacting American consumers. Mr. Lash graduated, cum laude, from Georgetown University Law Center in 2006.
Gregg Shapiro, JD
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, US Department of Justice, Boston, MA
Gregg Shapiro has been an Assistant United States Attorney in the District of Massachusetts since 2005 and is currently Chief of the Affirmative Civil Enforcement Unit. His work primarily involves health care fraud, including kickbacks and Medicare and Medicaid price reporting violations. Prior to joining the United States Attorney’s Office, Gregg worked in private practice and in the Consumer Protection Bureau of the Federal Trade Commission.
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, Esq.
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)
3:30 pm
The Post-Pandemic Compliance Department of the Future: Virtual, Ethics, Integrity and More
Michael R. Clarke, JD, CCEP
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior; Bridgewater, NJ
Vice President, Global Chief Compliance Officer, ConvaTec; Former Vice President, Corporate Compliance, Indivior; Bridgewater, NJ
Michael Clarke is the Global Chief Compliance officer for ConvaTec, Inc., a global medical technology company. In his over 17 years as a senior compliance leader, Mr. Clarke has created or managed global ethics & compliance programs, by educating employees and third parties on compliance policies and procedures; monitoring HCP interactions by sales, marketing and medical affairs employees; conducting and overseeing third party due diligence efforts; counseling on OFAC requirements; overseeing internal investigations; and implementing corruption, fraud and bribery risk mitigation processes. He has been a panelist or moderator for numerous ethics & compliance presentations on creating and managing global ethics & compliance programs, including presenting at the Seton Hall Law School Healthcare Compliance Certification Program. He became a Certified Compliance and Ethics Professional in December 2018.
Michael G. Hercz, JD
Senior Vice President & General Counsel, Sentynl Therapeutics; Former Vice President, Law & Chief Compliance Officer, Victory Pharma; Former Executive Director, Enterprise Risk Management, Amgen; Los Angeles, CA
Senior Vice President & General Counsel, Sentynl Therapeutics; Former Vice President, Law & Chief Compliance Officer, Victory Pharma; Former Executive Director, Enterprise Risk Management, Amgen; Los Angeles, CA
Michael has over 23 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 served in senior roles at Deloitte & Touche (Managing Director), Victory Pharmaceuticals (VP and Chief Compliance Officer), and Amgen Inc. (Executive Director). He also practiced at Akin, Gump, Strauss, Hauer & Feld LLP and Hooper, Lundy & Bookman Inc. where he represented exclusively life sciences and healthcare entities.
Tara D’Orsi, JD
Executive Vice President, Chief Compliance Officer and General Counsel, Kyowa Kirin North America; Former Senior Counsel, Reliant Pharmaceuticals; New York, NY
Executive Vice President, Chief Compliance Officer and General Counsel, Kyowa Kirin North America; Former Senior Counsel, Reliant Pharmaceuticals; New York, NY
Tara D’Orsi, EVP, Chief Compliance Officer and General Counsel joined Kyowa Kirin in September of 2017. Prior to joining Kyowa Kirin, Ms. D’Orsi was a member of the Life Sciences Group at Lowenstein Sandler LLP, where she advised biotech and pharmaceutical companies on legal and compliance matters through a medicines’ lifecycle from development through commercialization. Prior to Lowenstein Ms. D’Orsi served for 4 years as the General Counsel of Robert Wood Johnson Univ. Hospital in Rahway. Ms. D’Orsi also spent 6 years as Sr. counsel of Reliant Pharmaceuticals, one of the nation’s largest privately held pharmaceutical companies before it was acquired by GlaxoSmithKline in 2007. She began her career with a judcial clerkship in the NJ State Superior Court followed by positions in the Life Sciences and Healthcare groups at Gibbons PC and K&L Gates LLP. Throughout her career Ms. D’Orsi has played a leadership role in providing legal and compliance advise designed to minimize risk and achieve her clients’ business objectives.
Paul Silver
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte, Atlanta, GA (Moderator)
Principal, Regulatory & Compliance Life Sciences Leader, Deloitte, Atlanta, GA (Moderator)