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:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members



You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.


Subject to change

All times listed are in Eastern Time

2022 Curriculum Advisor:
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.


Preconference Primer

Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Steven S. Tjoe, Senior Associate, Goodwin Procter LLP

Wednesday, March 16

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM
Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Principal for Regulatory Policy, Greenleaf Health, Inc.

12:20–12:30 PM

12:30–1:45 PM
Regulation of Biological/Product Development
Christopher M. Mikson, Partner, DLA Piper LLP

1:45–1:55 PM

1:55–3:10 PM
Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Gail Javitt, Partner, Hyman, Phelps & McNamara, PC

3:10–3:20 PM

3:20–4:35 PM
Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP


Thursday, March 17

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05–12:20 PM
Biosimilar Biological Products
Michelle Divelbiss, Associate, Covington & Burling LLP

12:20–12:30 PM

12:30–1:15 PM
Post-Approval Pharmacovigilance
Abeba Habtemariam, Counsel, Arnold & Porter LLP

1:15–1:25 PM

1:25–2:25 PM
Regulation of Biological Manufacturing
Neil Di Spirito, Partner, Brown Rudnick LLP

2:25–2:35 PM

2:35–3:35 PM
Regulation of Biological Product Marketing
Sarah Blankstein, Associate, Ropes & Gray LLP

3:35–3:45 PM

3:45–5:00 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Partner,McDermott Will & Emery

5:00 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.