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

venue sponsor

Register

Industry & Firms

$1,199
  • +$400 for non-members
  • +$100 after 9/12/2019

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 9/12/2019

Government

$799
  • +$200 for non-members
  • +$100 after 9/12/2019

Academic

$799
  • +$200 for non-members
  • +$100 after 9/12/2019

Student

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

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.

Agenda

subject to change
 
Curriculum Advisor: 
Daniel Orr, Partner, Womble Bond Dickinson (US) LLP

 

Tuesday, October 1

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
Monica Groat, Associate, Latham & Watkins LLP

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

9:50–11:05 AM
Introduction to FDA Review and Approval of Biological Products
Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC

11:05–12:05 PM
Regenerative Medicine and Advanced Therapies (RMATs)
Emily Marden, Counsel, Sidley Austin LLP

12:05–1:05 PM
Networking Lunch

1:05–2:20 PM
Regulation of Biological/Drug Development
Michael K. Stern, Of Counsel, Covington & Burling LLP

2:20–3:30 PM
Biological License Applications (BLA)
Krista Hessler Carver, Partner, Covington & Burling LLP

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

3:45–5:00 PM
Biosimilar Biological Products

Deborah Yellin, Partner, Crowell & Moring LLP
Mary Anne Schofield, Senior Counsel, Crowell & Moring LLP

Wednesday, October 2

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

8:30–9:45 AM
Post-Approval Safety Issues
Mantej (Nimi) Chhina, Senior Director, Regulatory Policy & FDA Engagement, BioMarin Pharmaceutical Inc.

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

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

11:15–12:30 PM
Regulation of Biological Marketing
Deborah L. Livornese, Of Counsel, Hyman, Phelps & McNamara, PC

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.

Pennsylvania: approved for 13.0 CLE credits

Location and Overnight Accommodations

Course Location

Sidley Austin LLP
1501 K Street NW
Suite 600
Washington, DC 20005

Overnight Accommodations

A block of rooms has been reserved at the Mayflower Hotel for course attendees at the special group rate of $258/night, not inclusive of taxes.  The Mayflower is approximately an 8-minute walk from the course venue.  Reservations can be made online and must be received by September 11, 2019 to receive the group rate. After this date, it is at the hotel’s discretion whether to accept additional reservations, which will be subject to prevailing rates and availability.