November 4-6, 2019 | North Bethesda, MD

Agenda

Our agenda is quickly progressing. Don’t miss your chance to be part of the solution at GRx+Biosims 2019. Submissions are unlimited but must be submitted by June 28th. Additionally, to show how much we value your participation, we plan to reward topic suggestions with a special gift. We look forward to seeing your ideas!

Learning Tracks

  • Quality Applications
  • Generic Industry Outlook
  • USP in the Supply chain: more than Monographs
  • Quality of Generics
  • Complex Generics
  • Inspections/Compliance
  • Combination Products
  • Quality Metrics
  • Emerging Technology and Continuous Manufacturing
  • Data Standards and Quality/Data Integrity
  • GDUFA III
  • Labeling Workshop
  • Commercializing Biosimilars: Discussion with Biosimilars Industry Leaders
  • Biosimilars Action Plan Scorecard – Is the FDA Helping Adoption?
  • The Importance of Global Regulatory Harmonization for Biosimilars
  • Payer Strategies to Drive Biosimilars for Patient Access & Savings
  • Federal Focus on Biosimilars: A Lot of Bark and No Bite
  • Overcoming Anti-Competitive Tactics to Biosimilars Adoption
  • Interchangeable Biologics: Are They Really the Silver Bullet?
  • Biosimilars Education Evolution: Changing Perspectives in the Face of Increasing Costs
  • Drug Pricing in the States and Update on State Legal Issues
  • The Changing Landscape of Patents and Hatch-Waxman
  • Biosimilars at the Bar
  • Rebalancing U.S. Trade Policy

Conference Program

Day 1

Monday, Nov 4

7:30 a.m.

Registration

7:30 – 8:30 a.m.

Networking Breakfast

8:30 – 9:00 a.m.

Welcome and Introduction

Chester “Chip” Davis, Jr., JD
President & CEO, AAM

9:00 – 10:00 a.m.

General Session

Keynote Address

The Honorable Alex Azar, II (Invited)
Secretary, United States Department of Health and Human Services

Commissioner Keynote Address

Norman (Ned) Sharpless, M.D. (Invited)
Acting Commissioner, FDA

10:00 – 10:30 a.m.

Networking Break

10:30 – 12:00 p.m.

General Session

CMS Keynote Address

Seema Verma (Invited)
Administrator, U.S. Centers for Medicare and Medicaid Services

CDER Keynote Address

Patrizia Cavazzoni, M.D. (Invited)
Deputy Director for Operations, CDER, FDA

OGD Keynote Address

Sally Choe, PhD
Director, Office of Generic Drugs (OGD), CDER, FDA

12:00 – 1:30 p.m.

Networking Luncheon

1:30 – 3:00 p.m.

GRx+Biosims Tracks

3:00 – 3:30 p.m.

Networking Break

3:30 – 4:30 p.m.

GRx+Biosims Tracks

5:00 – 6:30 p.m.

Welcome Reception

Day 2

Tuesday, Nov 5

7:30 – 8:30 a.m.

Networking Breakfast

8:30 – 10:00 a.m.

General Session

ORA Keynote Address

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Office of Regulatory Affairs (OFA), CDER, FDA

Biosimilars Keynote Address

Sarah Yim, M.D.
Acting Director for Therapeutic Biologics, Office of New Drugs
Therapeutic Biologics and Biosimilars Team, CDER, FDA

OC Keynote Address

Donald Ashley, JD (Invited)
Director, Office of Compliance, CDER, FDA

10:00 – 10:30 a.m.

Networking Break

10:30 – 12:00 p.m.

General Session

OPQ Keynote Address

Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA

The USP of Today

Ronald Piervincenzi
Chief Executive Officer, United States Pharmacopeial Convention

12:00 – 1:30 p.m.

Networking Luncheon

1:30 – 3:00 p.m.

GRx+Biosims Tracks

3:00 – 3:30 p.m.

Networking Break

3:30 – 4:30 p.m.

GRx+Biosims Tracks

3:30 – 5:30 p.m.

GRx+Biosims Exposition

4:30 – 6:00 p.m.

Biosimilars Council Meeting

5:30 – 6:30 p.m.

Networking Reception

6:30 – 9:30 p.m.

Dinner & Entertainment

Delicious Dinner + Suspenseful Speakeasy

The Roaring Twenties – it was a time of lively flappers, notorious gangsters and secret speakeasies. Join us as we turn back the clock for an entertaining evening at The Bees Knees, a speakeasy where GRx+Biosims event attendees can get away from the clutches of prohibition for a few hours. It’s all fun and games until a patron runs into foul play. You and your dining companions will be called on to help solve the mystery and identify the culprit… if you can.

Day 3

Wednesday, Nov 6

7:30 – 8:30 a.m.

Networking Breakfast

8:30 – 10:30 a.m.

General Session

Keynote Address

Scott Gottlieb, M.D.
Former Commissioner, FDA

10:30 – 11:00 a.m.

Networking Break

11:00 – 12:30 p.m.

GRx+Biosims Tracks

12:30 – 1:30 p.m.

Networking Luncheon

1:30 – 2:30 p.m.

GRx+Biosims Tracks

2:30 p.m.

GRx+Biosims Concludes

GET THE LATEST UPDATES

Receive the latest event information about key speakers,
sponsorship opportunities and exhibiting.