Combination Product Regulation for the US Market Workshop

8:00–8:05 am

Welcome

8:05–9:15 am

Combination Product Basics, Part I

• What are drugs, devices, biologics? What is the relevance to combination products?
• What is a combination product? What are the types?
• Primary Mode of Action, algorithm
• Intercenter agreements - current status
• RFD process
• How to find information about OCP actions

Mark D. Kramer, MS, RAC, president, Regulatory Strategies Inc.

9:15–10:00 am

Combination Product Basics, Part II

• What is the role of OCP
• How does OCP review RFDs?
• New RFD guidance, how have things changed?
• How does FDA review combination products?
• How does the consult / collaboration process work?
• What is OCP's role in the review of combination products?
• How can OCP help when the review of a combination product seems to go awry?
• New developments from OCP and affecting combination products: chemical action, classification, companion diagnostics
• What new is OCP working on next?

Thinh Nguyen, director, Office of Combination Products, OC, US FDA
John (Barr) Weiner, JD, associate director for policy and product classification officer, Office of Combination Products, OC, US FDA

10:30–12:00 pm

New Combination Product Guidance Documents

Chemical Action
Stephen Rhodes, MS, senior consultant, medical devices, Biologics Consulting Group, Inc.

Classification of Products as Drugs and Devices
Suzanne O'Shea, JD, counsel, Baker & Daniels LLP

Panel discussion
*Moderated by Brad Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC
Leighton Hansel, MBA, director, regulatory affairs, Abbott Laboratories
Lee H. Leichter, MBA, RAC, president, P/L Biomedical
Suzanne O'Shea, JD, counsel, Baker & Daniels LLP
Stephen Rhodes, MS, senior consultant, medical devices, Biologics Consulting Group, Inc.

1:00–1:30 pm

Post – Approval Changes

Suzanne Kiani, scientist, CMS regulatory affairs, Genentech, Inc.

1:30–2:30 pm

Good Manufacturing Practices (GMPs) for Combination Products

Bradley Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC

3:00–3:45 pm

Adverse Event Reporting for Combination Products

Laurie A. Clarke, JD, partner, King & Spalding

3:45–4:15 pm

Obscure Combination Product Issues

• Cross labeling
• 1 verses 2 marketing applications
• Combination Products and Drug Exclusivity

Suzanne O'Shea, JD, counsel, Baker & Daniels LLP

4:15–5:00 pm

Panel Discussion: Does combination product law serve as a help or hindrance? How should combination law / regulations be changed to improve things?

• Personalized Medicine
• Auto-injector
• Infusion Pump
• Companion Diagnostics
• Contrast Agents

Bradley Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC
Laurie A. Clarke, JD, partner, King & Spalding
Leighton Hansel, MBA, director, regulatory affairs, Abbott Laboratories
Suzanne Kiani, scientist, CMS regulatory affairs, Genentech, Inc.
Lee H. Leichter, MBA, RAC, president, P/L Biomedical
Stephen Rhodes, MS, senior consultant, medical devices, Biologics Consulting Group, Inc.