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


subject to change

Curriculum Advisor:  Patrick C. Gallagher, Partner, Duane Morris LLP

Tuesday, March 31

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 FDA’s Regulatory Processes
Patrick C. Gallagher, Partner, Duane Morris LLP

 9:35–9:50 AM

9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Executive Vice President, Drugs & Biological Products, Greenleaf Health, Inc.

11:05–12:20 PM
Regulation of Biological/Drug Development
Natasha V. Leskovsek, Partner, Cooley LLP

12:20–1:20 PM
Lunch Break

1:20–2:20 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Joanne Hawana, Member, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

2:20–3:30 PM
Biologics License Applications (BLA)
Christina M. Markus, Partner, King & Spalding LLP

3:30–3:45 PM

3:45–5:00 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP


Wednesday, April 1

8:30–9:45 AM
Post-Approval Pharmacovigilance
David L. Rosen, Partner, Foley & Lardner LLP

9:45–10:00 AM

10:00–11:15 AM
Regulation of Biological Manufacturing
Patrick C. Gallagher, Partner, Duane Morris LLP

11:15–12:30 PM
Regulation of Biological Marketing
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP

12:30–1:45 PM
Lunch Break

1:45–2:45 PM
New, Emerging, and Continually Interesting Issues
Scott M. Lassman, Principal, Lassman Law + Policy

2:45–3:00 PM

3:00–4:30 PM
Violations, Enforcement, and International Issues
Beth P. Weinman, Counsel, Ropes & Gray LLP
Joshua Oyster, Associate, Ropes & Gray LLP

4:30 PM




Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.

Ohio: 13.0 Live Interactive General Credits