Tuesday February 5, 2013
7:30 am
Main Conference Registration and Continental Breakfast
8:30 am
Chairman’s Welcome and Opening Remarks
Steven Hamburger Ph.D.
Head, Regulatory Strategy and Intelligence
Millennium Pharmaceuticals
8:45 am
Keynote: Protecting and Promoting Public Health — Look Inside FDA’s New Guidance and Process of Preparing for An Advisory Committee Meeting
Michael Ortwerth Ph.D.
Director, Advisory Committee Oversight
U.S. Food and Drug Administration
9:45 am
How to Prepare for an FDA Advisory Meeting — Important Steps to Follow to Ensure a Successful Meeting
Susan Resnick Ph.D.
Consultant
3D Communications
Rachael Roehrig Ph.D.
Consultant
3D Communications
10:30 am
Networking and Refreshment Break
11:00 am
Understand the Impact of Panel Review on FDA Decision Making
Eric P. Brass M.D., Ph.D.
Professor of Medicine, David Geffen School of Medicine at UCLA; Director
Harbor-UCLA Center for Clinical Pharmacology
11:45 am
Panel: Rx to OTC Switch Process and Planning for Advisory Board Committees
Eric P. Brass M.D., Ph.D.
Professor of Medicine, David Geffen School of Medicine at UCLA; Director
Harbor-UCLA Center for Clinical Pharmacology
Edwin L. Hemwall Ph.D.
Vice President, Rx-to-OTC Switch and New Opportunity Evolution
Merck Consumer Care
Roger Berlin
Principal, Pharmaceutical Strategy Consultant
1.618 Consulting LLC
John Dent Ph.D.
Senior Consultant
NCI Consulting LLC
12:30 pm
Networking Luncheon
1:30 pm
Roundtable: Meet the Expert Session — Obtain Answers to Your Questions about FDA Advisory Committee Preparations
Greg Connel
Senior Vice President, Strategic Communications
ProEd Communications, Inc.
Mary Rofael M.D., RAC
Strategic Officer, Global Regulatory
ProEd Communications, Inc.
2:30 pm
FDA Advisory Board Meeting Room Logistics — What to Expect the Day of a Meeting
Andrew Howard
Director, Program Management
Baxter Healthcare
3:15 pm
Networking and Refreshment Break
3:45 pm
The Who, What, When, Where and How for Successful Outcomes to a FDA Advisory Committee
Lisa Keilty CMP, HCC
Vice President
PMC2
Richelle Nelsen
Medical Meeting Professional
Independent Consultant
Glenn Goettler
Senior Vice President, Operations
Xplore
Joseph Barie
Healthcare Meeting Producer
Xplore
5:45 pm - 6:45 pm
Networking, Wine and Cheese Reception
Wednesday February 6, 2013
7:30 am
Continental Breakfast
8:00 am
Chairman’s Review of Day One
Steven Hamburger Ph.D.
Head, Regulatory Strategy and Intelligence
Millennium Pharmaceuticals
8:15 am
Effectively Present Safety Data to FDA Advisory Committees
Peggy Berry
Vice President, Head of Regulatory and Quality
Amarin Corporation
9:00 am
Optimize the Impact of Clinical Meaningfulness in Presentations
Kevin Malobisky
Associate Vice President, Global Regulatory Affairs
Sanofi Aventis
9:45 am
Present with Poise — How to Effectively Prepare Presenters and Facilitators to Control the Stage
Greg Connel
Senior Vice President, Strategic Communications
ProEd Communications, Inc.
Mary Rofael M.D., RAC
Strategic Officer, Global Regulatory
ProEd Communications, Inc.
10:30 am
Networking and Refreshment Break
11:00 am
Panel: Evaluate Post Meeting Outcomes Across Multiply Therapeutics and Diseases
Martha Arnold
Principal
PharmApprove
Martin L. Rosenberg M.D.
Executive Director, Global Clinical Development, Diagnostic Imaging
Bayer Healthcare Pharmaceuticals, Inc.
Jessie Y. Lee Ph.D., RAC, ASQ-CMQOE
Manager, Regulatory Affairs
Takeda Global Research & Development Center
Howard Yuwen
Executive Director, Regulatory Affairs North America
Alexion Pharmaceuticals
11:45 am
Take Steps to Ensure a Successful and Beneficial Q&A Session
Philip Johnson
Deputy Director, Regulatory Affairs
Bayer
12:30 pm
Networking Luncheon
1:45 pm
General/ Non-Product Specific Advisory Board Committee Meetings
Jeffrey Sherman
Chief Medical Officer
2:15 pm
An Integrative Approach to FDA Advisory Committee Preparation
Roger Berlin
Principal, Pharmaceutical Strategy Consultant
1.618 Consulting LLC
3:00 pm
The Importance of Inter-Departmental Communications in FDA Advisory Board Committee Preparations
Howard Yuwen
Executive Director, Regulatory Affairs North America
Alexion Pharmaceuticals
3:45 pm
