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

venue sponsor

Register by February 20 and SAVE!

Industry & Firms

$1199
  • +$400 for non-members
  • +$100 after 2/20/20

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Government

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Academic

$799
  • +$200 for non-members
  • +$100 after 2/20/20

Student

$99
  • full-time students only
  • transcripts required
Register Now

 

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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.

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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

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

Tuesday, March 31

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

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

9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products

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

12:20–1:20 PM
Networking Lunch

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)
Sara Wexler Koblitz, Senior Associate, Hyman, Phelps & McNamara, PC

3:30–3:45 PM
Networking and Refreshment Break

3:45–5:00 PM
Biosimilar Biological Products

 

Krista Hessler Carver, Partner, Covington & Burling LLP

 

Wednesday, April 1

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

8:30–9:45 AM
Post-Approval Pharmacovigilance

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

10:00–11:15 AM
Regulation of Biological Manufacturing

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

12:30–1:45 PM
Networking Lunch

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

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

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
Adjournment

 

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.

Location and Overnight Accommodations

Conference Location

Duane Morris LLP
505 9th Street, NW
Suite 1000
Washington, DC 20004

Overnight Accommodations

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