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Tuesday, June 28
 

4:00pm EDT

#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The historic structure of FDA is oriented around the products it regulates. Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal care for the patient, and a patient-centered orientation to reflect the current multimodal approach to patient care is being proposed. Cross-center Institutes of Excellence could help FDA to further advance the promotion of human health. These institutes could foster increased intellectual collaboration and a consistent FDA approach by forming teams of Agency staff with cutting-edge expertise in the treatment and prevention of specific types of diseases. Consolidating disease-oriented activities at FDA may help reduce redundancies within the current FDA Centers and better consolidate core competencies to focus on scientific advancement within the Agency and streamline processes for the review of products to treat high impact disease areas. The benefits of such a restructuring will be explored and discussed by a panel of experts.

Learning Objectives

Describe how the proposed reorganization could affect drug development and review by FDA; Discuss whether the proposed reorganization could benefit patients; Explain path forward and potential challenges associated with the proposed reorganization.

Chair

Margaret A. Anderson, MA

Speaker

Panelist
Wade Ackerman, JD

Panelist
Steven K. Galson

Panelist
Eric H. Rubin, MD

Panelist
Ellen Sigal, PhD


Chair
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration... Read More →

Speakers
avatar for Wade Ackerman

Wade Ackerman

Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
ER

Eric Rubin

Vice President and Therapeutic Area Head, Merck Research Laboratories
ES

Ellen Sigal

Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington... Read More →

Tuesday June 28, 2016 4:00pm - 5:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum
 
Wednesday, June 29
 

2:00pm EDT

#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This forum will identify critical issues and success factors in the evolving field of companion diagnostics, with a focus on addressing operational challenges and delivering benefits to patients through successful business partnerships.

Learning Objectives

Describe the evolving field of companion diagnostics; Identify best practices for successful collaborations between pharmaceutical and diagnostics companies.

Chair

Patrick Phillips

Speaker

Panelist
Robert Bilkovski

Panelist
Kelly R. Pitts, PhD


Chair
avatar for Patrick Phillips

Patrick Phillips

Chief Executive Officer, Health Decisions, Inc.
Dr. Phillips is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice... Read More →

Speakers
avatar for Robert Bilkovski

Robert Bilkovski

Head, Medical and Clinical Affairs, Abbott Molecular
Following medical school (Rosalind Franklin Univ/Chicago Medical School), Dr. Bilkovski focused on research in sepsis and noninvasive hemodynamic management. After 5 years, he identified his zeal for entrepreneurship and pursued his MBA (Notre Dame). His primary focus has been in... Read More →
avatar for Kelly Pitts

Kelly Pitts

Vice President, Research & Development, Site Manager - Colorado Operations, Corgenix, Inc.
Kelly R. Pitts, PhD is Vice President of R&D at Corgenix, Inc., an IVD company specializing in cardiovascular, autoimmune, and companion diagnostics. He previously held leadership positions at Myogen, Gilead Sciences, and Amgen, focused on drug discovery, development, and commercialization... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum