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 are 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 (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Prescription Drug User Fee Act (PDUFA)
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

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Industry & Firms

  • +$400 for nonmembers


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  • transcripts required
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A Valuable Reference

Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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

Curriculum Advisor:  
Michael J. Werner, Partner, Holland & Knight LLP

Wednesday, October 3

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 – 9:05 AM
Overview of Biological Products Law and Regulation
Patrick C. Gallagher
, Partner, Duane Morris LLP

9:05 – 9:35 AM
FDA’s Regulatory Processes
Patrick C. Gallagher, Partner, Duane Morris LLP

9:35 – 9:50 AM
Networking and Refreshment Break

9:50 – 11:20 AM
Introduction to FDA Review and Approval of Biological Products
Teresa Stanek Rea, Partner, Crowell & Moring LLP

11:20 – 12:00 PM
Novel Products and Situations: Beyond the Traditional BLA (Overview)
Barbara A. Binzak Blumenfeld
, Shareholder, Buchanan Ingersoll & Rooney PC

12:00 – 1:00 PM
Networking Lunch

1:00 – 2:15 PM
Regulation of Biological/Drug Development
Natasha Leskovsek
, Partner, Cooley LLP

2:15 – 3:15 PM
Biological License Applications (BLA)
Christina M. Markus, Partner, King & Spalding LLP

3:15 – 3:30 PM
Networking and Refreshment Break

3:30 – 5:00 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP

Thursday, October 4

8:00 – 8:30 AM
Registration and Continental Breakfast

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

9:45 – 10:00 AM
Networking and Refreshment Break

10:00 – 11:15 AM
Regulation of Biological Manufacturing
Priya Jambhekar, Independent Consultant, EAS Consulting Group, LLC

11:15 – 12:30 PM
Regulation of Biological Marketing
Kalie E. Richardson, Associate, Hyman, Phelps & McNamara, PC

12:30 – 1:45 PM
Networking Lunch

1:45 – 2:45 PM
New, Emerging, and Continually Interesting Issues
Anne Marie Polak
, Senior Director, Leavitt Partners, LLC

2:45 – 3:00 PM
Networking and Refreshment Break

3:00 – 4:30 PM
Violations, Enforcement, and International Issues
John Fuson
, Partner, Crowell & Moring LLP

4:30 PM

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Ohio: approved for 13.75 CLE credit hours
Pennsylvania: approved for 13.5 CLE credit hours
Virginia: approved for 13.5 CLE credit hours

Location and Overnight Accommodations

Course Location

Crowell & Moring
1001 Pennsylvania Ave, NW
Washington, DC 20004

Overnight Accommodations 

A block of rooms has been reserved for course attendees at the Renaissance Washington DC Downtown Hotel. The group rate is $279/night plus tax and reservations must be received by Wednesday, September 19th, 2018 to receive the group rate. Reservations can be made online. After this date, rooms will be subject to prevailing rates and availability.


Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.