Regulatory Affairs - A Valued Partner
The life sciences industry has established digital innovation as a business priority. Companies recognize that patient outcomes are enabled by digital innovation, which is why truly patient-centric companies are assessing how to move their organization along the digital maturity continuum.
Digital innovation runs the gamut, from marketing tactics (e.g., apps, websites, digital communities) to relationships with providers/healthcare systems (e.g., EHR); from co-marketing opportunities with digital modalities to non-traditional relationships. And, of course, there is the creation of entirely new products.
In this interactive session, a multi-disciplinary group of experts will provide you with an overview of how the industry is addressing the digital health revolution, why patient engagement must be at the center of the life sciences value chain, and how internal Regulatory Affairs professionals can position themselves as a high value partner to the business during this time of change.
Trends and case studies will be shared from a newly launched book, Managing Biotechnology: From Science to Market in the Digital Age, published by Wiley, which covers the new role of infotech in healthcare and shows how to capitalize on digital technologies, from R&D to market launch.
Another significant issue is establishing dedicated mechanisms for the identification, collection and submission of patient experience data as a component of both the drug approval process and fulfillment of post-approval Phase IV studies. This will require engaging the collective input of all potential stakeholders- pharmaceutical and medical device companies, patient support and advocacy groups, and others in developing new drug development models
President and Founder - Center for Communication Compliance
Ilyssa Levins is president and founder of the Center for Communication Compliance (CCC). The Center focuses on assisting companies with digital initiatives to optimize product development from R&D to market, saving time and money, while managing risk. A published author and award-winning futurist, Ilyssa helps the industry increase risk management and business efficiencies through initiatives that increase cross-functional collaboration.
Visiting Distinguished Professor at Seton Hall Law School Editor-in-Chief - Practicing Law Institute’s Answer Book on Pharmaceutical Compliance and Enforcement
Howard Dorfman is an expert in FDA regulatory law, fraud and abuse, compliance programs, and risk management procedures. Formerly He is the editor-in-chief and contributing author of the Practicing Law Institute’s Answer Book on Pharmaceutical Compliance and Enforcement, and a Visiting Distinguished Professor at Seton Hall Law School. Howard has served as Senior Vice President and General Counsel at Turing Pharmaceuticals, Vice President and General Counsel at Ferring Pharmaceuticals, Inc., and Vice President Assistant General Counsel at Bayer Pharmaceuticals (U.S.).
Francoise Simon, PhD,
Professor at Columbia and the Mount Sinai School of Medicine
Francoise Simon, PhD, is an internationally known author, speaker and consultant with recognized expertise in the digital transformation of healthcare. She is highly experienced in strategy consulting in the Americas, Europe, Asia and Africa, with clients including healthcare leaders, new venture firms, several governments and the United Nations. Dr. Simon’s new book, Managing Biotechnology: From Science to Market in the Digital Age (Wiley), covers the new role of infotech in healthcare, and shows how to capitalize on digital technologies, from R&D to the market.
New models and cases contributed by senior executives combine as a roadmap to best practices at each stage of a patient-centered, digitally enabled, value chain. Dr. Simon’s academic teaching focuses on executive programs. She also chairs symposia at major conferences and she conducts industry seminars globally on digital business strategy, including disruptive innovation, customer experience, precision marketing, multi-channel communications and patient centric organization design.