Explore the regulation of biological products, including biotechnology–derived therapeutic proteins, human tissue, gene, and cell products. Learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation. Case studies, hypotheticals, and ample time for Q&A is provided.
Agenda Highlights
  • Regulatory processes for biologics
  • Review and approval process
  • Regulation of biological/drug development
  • Biologics License Application (BLA)
  • Biosimilar biologic products
  • Post-approval safety issues
  • Regulation of biological manufacturing
  • Advertising and promotion requirements
  • Enforcement tools and procedures
  • Changes to the statutory framework for regenerative medicine
Statutes Covered
  • The 1902 Biologics Act
  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Public Health Service Act of 1944 (PHSA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Prescription Drug User Fee Act and Biosimilars User Fee Act
  • 21st Century Cures Act
Attendee Resources

These valuable takeaways will be provided onsite:
  • A binder of speaker handouts and related reference materials.
  • Access to an electronic copy of the FDCA Statutory Supplement, 2018.
Who Should Attend
  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Previous Agenda

subject to change
Curriculum Advisor: 
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP


Tuesday, April 2

8:00–8:30 AM
Registration and Continental Breakfast
8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI   
8:35–9:35 AM
Overview of Biological Products Law and Regulation
Suchira Ghosh, Counsel, Axinn, Veltrop & Harkrider LLP
9:35–9:50 AM
Networking and Refreshment Break
9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP
11:05 AM–12:05 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Heather Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP
12:05–1:05 PM
Networking Lunch
1:05–2:20 PM
Regulation of Biological/Drug Development
Jennifer Nowak, Associate, Holland & Knight LLP
2:20–3:30 PM
Biological License Applications (BLA)
Priya Jambhekar, Consultant, EAS Consulting Group, LLC
3:30–3:45 PM
Networking and Refreshment Break
3:45–5:00 PM
Biosimilar Biological Products
Scott M. Lassman, Partner, Goodwin Procter LLP

Wednesday, April 3

8:00–8:30 AM
Registration and Continental Breakfast
8:30–9:45 AM
Post-Approval Safety Issues
Sarah Blankstein, Associate, Ropes & Gray LLP 
9:45–10:00 AM
Networking and Refreshment Break
10:00–11:15 AM
Regulation of Biological Manufacturing
Todd H. Halpern, Partner, Venable LLP
11:15 AM–12:30 PM
Regulation of Biological Marketing
Khelin Aiken, Counsel, McDermott Will & Emery LLP
12:30–1:45 PM
Networking Lunch
1:45–2:45 PM
New, Emerging, and Continually Interesting Issues
Kalah Auchincloss, Senior Vice President, Greenleaf Health, Inc.
2:45–3:00 PM
Networking and Refreshment Break
3:00–4:30 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Counsel, Arent Fox LLP
4:30 PM