Compliance Playbook—Leveraging Omnichannel Strategies and Digital Tools to Enhance HCP and Patient Engagement

William Weisiger, Global Omnichannel Strategy Operations at Eli Lilly and Company
Julie DeLong, CFA, Senior Managing Director at Ankura
Joseph DiGiacomo, Healthcare Compliance Officer, Innovative Medicine - Oncology at Johnson & Johnson

PSPs and PAPs– A Look at the Evolution, Risks and Enforcement Activity

Speakers

Donna White

Donna White is the Head of Compliance, North America, for Chiesi (key-ay-zee) USA, Inc., an affiliate of Chiesi Farmaceutici S.p.A headquartered in Parma, Italy. She oversees compliance matters for the Air and Care Franchises located in Cary, NC, Chiesi Global Rare Diseases located in Boston, Chiesi Canada Corporation located in Toronto; and the recently acquired Amryt Pharmaceuticals Inc. Americas region;. During her long tenure in the pharmaceutical industry, she has worked in most functional areas, supporting multiple therapeutic classes in the specialty, rare disease, hospital, retail, and brand and generic spaces. Currently, she, along with her team, support matters related to: Rare Disease programs, Field and Medical Teams, Patient Support Teams, Patient Service Programs, Price Transparency, Aggregate Spend, Sampling, Fair Market Value, Privacy, and amongst other areas.

At Chiesi USA, Donna sits on the Leadership Team and chairs the Compliance Committee, Data Privacy and Security Committee, and the Digital Channels Committee. She also serves on the Pharmaceutical Compliance Forum’s Leadership Team as a Member Co-Chair and Secretary.

Michael Hercz

Michael has over 25 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. He earned his B.A. from the University of Pennsylvania and his J.D. from the University of Southern California.

Samantha Barrett Badlam

Samantha Barrett Badlam is a partner in Ropes & Gray’s litigation & enforcement group. She focuses her practice on white-collar criminal and civil defense and has more than 17 years of experience representing multinational corporations and their executives in internal and government investigations of potential violations of the Anti-Kickback Statute (AKS), False Claims Act (FCA), Foreign Corrupt Practices Act (FCPA) and other fraud and enforcement matters. Samantha dedicates a significant portion of her practice to advising clients on compliance matters and risk mitigation, and has assisted some of the world’s largest companies by assessing and enhancing their compliance programs through a measured, risk-based approach that carefully considers companies’ business models and highest areas of actual risk.

Samantha has represented clients across many sectors, including healthcare, life sciences, oil and gas, energy, manufacturing, academic centers receiving federal grants, and financial services. She has extensive experience working with these clients to develop, implement and enhance domestic and international compliance and risk programs, and to respond to government investigations. Samantha held a leading role on a firm team that acted as independent monitor for a commercial aircraft manufacturer as part of a deferred prosecution agreement with the U.S. Department of Justice and the U.S. Securities and Exchange Commission and is Counsel to the DOJ-appointed FCPA Independent Monitor for one of the world’s largest commodity trading and mining companies.