Life sciences companies are highly regulated, leaving companies to face a myriad of regulatory and legal challenges throughout the product life cycle. To help you better navigate these challenges, Faegre Drinker is spending the month of November sharing strategies and insights on the most pressing issues in the industry. Join us for weekly webinars that cover a variety of topics including pre-market considerations, post-market recalls, enforcement trends and policy issues. We’re excited to have life sciences industry leaders joining each webinar to share their perspectives on these important topics with you.
Webinars in this Series
Session One – Key Pre-Market Insights and Strategic Considerations
This discussion will explore key pre-market insights and strategies relating to regulatory, commercial and intellectual property issues. The panelists bring unique perspectives based on their years of experience in the industry across an array of companies — from start-ups to Fortune 100 companies.
- Chandra Adams, Vice President, Legal & Intellectual Property, Surface Oncology
- Alison J. Baldwin, Partner, Faegre Drinker
- Jeff Cohn, Sr. Director, Associate General Counsel & Assistant Secretary, Heron Therapeutics, Inc.
- Timothy R. Franson, M.D., Principal, Faegre Drinker Consulting
- Andrew M. McCoy, Partner, Faegre Drinker
- Pablo A. Svirsky, Partner, Faegre Drinker
- Nichole M. Veleyko, Director, IP Legal, Merck
- E. Jay Wilusz, Senior Corporate Counsel, Bristol Myers Squibb
Session Two – Post-Market: Recalls and Litigation
This panel will address the regulatory and litigation issues that companies face when their pharmaceutical products or medical devices are subject to recalls. The discussion will provide a general overview of the recall process and identify challenges and potential solutions to those challenges.
- Catherine Clements, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
- Theodore M. Lis, Counsel, Faegre Drinker
- Chanda A. Miller, Partner, Faegre Drinker
- Susan M. Sharko, Partner, Faegre Drinker
- Jeff Shiffman, Counsel – Life Sciences/Regulatory, W. L. Gore & Associates
Session Three – Life Sciences Enforcement Trends to Watch
This session brings industry leaders and government attorneys together for a discussion of the enforcement priorities, resources and expected trends of federal regulators and prosecutors. Hear what developments are expected as the current presidential term continues and explore life sciences companies’ best practices to avoid regulatory problems.
- Charlene Fullmer, Assistant United States Attorney, U.S. Department of Justice
- Antonio M. Pozos, Partner, Faegre Drinker
- James Petkun, Director, Corporate Counsel, Sun Pharma
- Adam Saltzman, Senior Counsel, Legal & Compliance, Catalent
Session Four – D.C. Policy Climate: Nationalism vs. Internationalism and the Impact on Life Sciences Companies
This discussion will examine the increasingly complex regulatory environment life sciences companies must navigate as a result of the tension between nationalism and internationalism across three key areas affecting R&D and production: privacy, the supply chain and trade. Over the past 20 years, globalization of pharmaceutical and medical device research, development and manufacturing has accelerated, enabling new life-saving products to be brought to the market faster and cheaper. At the same time, the interests and values of national governments may at times be in friction with this globalization, leading to efforts to re-assert national controls over R&D and production.
- Jodie A. Curtis, Executive Vice President, District Policy Group
- Andy Fish, Executive Director, AdvaMed Center for Digital Health, and Head of AdvaMed Sector Initiatives
- Nicolas Guzman, Partner, Faegre Drinker
- Derek Naten, Vice President, Government Affairs & Patient Advocacy, Mallinckrodt Pharmaceuticals
- Justin Pine, Senior Director, International Affairs – Global IP and Data Policy, Biotechnology Innovation Organization (BIO)
Questions? Please contact Mesha Hegna Goodwill or call +1 612 766 7145.