Overview

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

Register

 

Industry & Firms

$1199
  • +$400 for non-members

Non-Profit

$799
  • +$200 for non-members

Government

$799
  • +$200 for non-members

Academic

$799
  • +$200 for non-members

Student

$99
  • full-time students only
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A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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

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

Wednesday, October 14

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
Jason F. Conaty, Senior Associate, Hogan Lovells US LLP

2:40–2:50 PM
Break

2:50–3:50 PM
Regulation of Biological/Drug Development
Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC

3:50–4:00 PM
Break

4:00–5:00 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Heather C. Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP

Thursday, October 15

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

12:05–1:15 PM
Biologics License Applications (BLA)
Matthew Hegreness, Special Counsel, Covington & Burling LLP

1:15–1:25 PM
Break

1:25–2:40 PM
Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP

2:40–2:55 PM
Break

2:55–4:05 PM
Post-Approval Pharmacovigilance
David L. Rosen, Partner, Foley & Lardner LLC

4:05–4:20 PM
Break

4:20–5:00 PM
New, Emerging, and Continually Interesting Issues
Scott M. Lassman, Principal, Lassman Law +Policy

 

Friday, October 16

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

12:05–1:20 PM
Regulation of Biological Manufacturing
Howard R. Sklamberg, Partner, Arnold & Porter LLP

1:20–1:30 PM
Break

1:30–2:45 PM
Regulation of Biological Marketing
Sarah F. Blankstein, Associate, Ropes & Gray LLP

2:45–3:00 PM
Break

3:00–4:30 PM
Violations, Enforcement, and International Issues
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

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.