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:

Who Should Attend

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

Register

Industry & Firms

$1299
  • +$400 for non-members

Non-Profit

$899
  • +$200 for non-members

Government

$899
  • +$200 for non-members

Academic

$999
  • +$200 for non-members

Student

$99

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Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th 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.

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.

Agenda

subject to change
All times are in Eastern Time


Curriculum Advisor:

Scott M. Lassman, Principal, Lassman Law & Policy

 

Tuesday, October 5

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:15 PM
Overview of Biological Products Law and the Regulation and FDA’s Regulatory Processes
Nathan A. Beaver, Partner, Foley & Lardner LLP

1:15–1:25 PM
Break

1:25–2:40 PM
Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.

2:40–2:50 PM
Break

2:50–3:50 PM
Regulation of Biological/Drug Development
Natasha V. Leskovsek, Of Counsel, Cooley LLP

3:50–4:00 PM
Break

4:00–5:00 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Nathan Beaton, Associate, Latham & Watkins LLP

 

 

 

Wednesday, October 6

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:15 PM
Biologics License Applications (BLA)
Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International

1:15–1:25 PM
Break

1:25–2:40 PM
Biosimilar Biological Products
Alexandra Valenti, Partner, Goodwin Procter LLP
Steven S. Tjoe, Senior Associate, Goodwine Procter LLP

2:40–2:55 PM
Break

2:55–4:05 PM
Post-Approval Pharmacovigilance
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

4:05–4:20 PM

4:20–5:00 PM
New, Emerging, and Continually Interesting Issues
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

 

 

 

 

Thursday, October 7

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:20 PM
Regulation of Biological Manufacturing
Christina M. Markus, Partner, King & Spalding LLP

 1:20–1:30 PM
Break

1:30–2:45 PM
Regulation of Biological Marketing
Kevin M. Madagan, Partner, Reed Smith LLP

2:45–3:00 PM
Break

3:00–4:30 PM
Violations, Enforcement, and International Issues
James R. Johnson, Partner, Sidley Austin US LLP

4:30 PM
Adjournment

 

 

 

 

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.