Preliminary Agenda

2024 Curriculum Advisor:
David R. Joy, Partner, Keller and Heckman LLP

All times are in Eastern Time

Preconference Primers

Preconference Primer (Virtual) (60 Minutes)
Overview of Drug Law and Regulation
Alan G. Minsk, Partner, Arnall Golden Gregory LLP

Preconference Primer (Virtual) (75 Minutes)
The New Drug Approval Process: Basic Concepts
David R. Joy, Partner, Keller and Heckman LLP

Tuesday, November 19

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:15 PM
The New Drug Approval Process: New Drug Research and Development
Justin Coen, Partner, Venable LLP

12:15 PM–12:30 PM
Break

12:30–1:50 PM
The New Drug Approval Process: NDA Submission and Review
Nathan A. Beaver, Partner, Foley & Lardner LLP

1:50–2:05 PM
Break

2:05–3:25 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Kathleen Treaster, Partner, Goodwin Procter LLP

3:25–3:40 PM
Break

3:40–5:00 PM
Post-Approval Issues  
Julia Marré, Principal Program Lead, Pharma Biotech, NSF Health Sciences

Wednesday, November 20

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:05 PM
Biologics and Biosimilars 
Christopher M. Mikson, Partner, DLA Piper LLP (US)

12:05–12:20 PM
Break

12:20–1:20 PM
Regulation of Over-the-Counter (OTC) Drugs
Deborah L. Livornese, Director, Hyman,Phelps & McNamara, PC

1:20–1:35 PM
Break

1:35–2:35 PM
Regulation of Drug Manufacturing
Paula Katz, Of Counsel, Covington & Burling LLP

2:35–2:50 PM
Break

2:50–3:50 PM
Regulation of Drug Marketing
Marc J. Scheineson, Partner, Alston & Bird LLP
Devaki Patel, Associate, Alston & Bird LLP

3:50–4:00 PM
Break                                        

4:00–5:00 PM
Violations and Enforcement
Marc Wagner, Associate, BakerHostetler

5:00 PM
Adjournment