AM2023: Food, Drug & Cosmetic Law Section Meeting

Topics to be Included:

• FDA Commissioner Califf’s First Year – Initial Focus Areas and What to Expect in 2023
• Catalyst and FDA’s Missed “Legislative Fix” – Impact on Orphan Drug Development
• The changing legal environment around software as a medical device
• Legal attacks on patent thickets and patent settlements– recent efforts to broaden a drug company’s potential antitrust liability

Speakers

Larissa C. Bergin, Esq.,Partner at Jones Day, Washington, D.C.

Julia Tierney, J.D., Chief of Staff of the FDA

Brian Malkin, Partner, McDermott, Will & Emery LLP, Former who spent time in the FDA’s Office of the Commissioner and the Center for Drug Evaluation (CDER)

Aaron Friedman, Senior Regulatory Counsel, FDA Office of Orphan Products Development (OOPD)

Karin Hoelzer, Policy and Regulatory Affairs Director, National Organization for Rare Disorders (NORD)

Janet B. Linn, Tarter Krinsky & Drogin, LLP, New York, NY

Michael Carrier, Distinguished Professor of Law, Rutgers Law School, Camden, NJ

Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property, Biotechnology Innovation Organization, Adjunct Professor of Law at Georgetown Law School

Jordan Paradise, Georgia Reithal Professor of Law and Co-Director of the Beezley Institute for Health Law and Policy, Loyola University School of Law, Chicago, Illinios

Ron Lanton III, Esq., Lanton Law

Victor Morrison, Business Development Executive,Tuzag Inc.

Donney John, Executive Director, NOVA Scripts Central

Kirk Nahra,Esq., Partner, Wilmer Hale

Jonathan Ogurchak, STACK CEO