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Tuesday, June 28 • 2:00pm - 3:15pm
#242: Regulatory Challenges in the Development of Combination Products Involving Digital Technology

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-556-L04-P; CME 1.25; IACET 1.25; RN 1.25

Digital technology is being integrated with drugs, biologics, and devices in an effort to improve treatment monitoring and management. This session will examine regulatory challenges of these combinations from the perspective of industry and FDA.

Learning Objectives

Recognize FDA requirements for approval of combination products involving digital technology; Identify challenges faced by industry in developing these products and by FDA during their review; Describe how industry and FDA are addressing these challenges.

Chair

Todd Paporello

Speaker

Determining the Regulatory Classification of Software Used in Tandem with Pharmaceuticals
Bradley Merrill Thompson

Tool to Product: An Interactive Case Study in the Evolution of a Pharma App from Clinic to Commercial
Anthony D. Watson, MBA, MS

CDRH Perspective
Bakul Patel

Office of Combination Products Perspective
John Barlow Weiner, JD

CDER Perspective
Ashley Boam



Chair
avatar for Todd Paporello

Todd Paporello

Vice President and Head of North American Regulatory Affairs, Bayer HealthCare Pharmaceuticals
Todd Paporello is Vice President and Head of North American Regulatory Affairs Pharmaceuticals and Consumer Health. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche / Genentech and Merck / Schering-Plough. Todd holds pharmacy (PharmD) and business (MBA) degrees from Rutgers University and Fairleigh Dickinson University.

Speakers
avatar for Ashley Boam

Ashley Boam

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Ashley serves as acting Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including application review & inspection. Prior to joining CDER, Ashley spent nearly 20 years in the Center for Devices and Radiological Health. She holds bachelor's and... Read More →
avatar for Bakul Patel

Bakul Patel

Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical device software. He is the FDA liaison between the FCC and the ONC and chairs the International Medical Device Regulators Forum (IMDRF) "software as a medical... Read More →
avatar for Bradley Thompson

Bradley Thompson

General Counsel, Combination Products Coalition, Epstein, Becker and Green P.C.
BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Mr. Thompson also advises such companies on the unique aspects of combination product development and manufacturing.
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in the Center for Devices and Radiological Health of the FDA He has a BS in Engineering from United States Naval Academy and a MBA and MS in Management Information... Read More →
avatar for John Weiner

John Weiner

Associate Director, Policy and Product Classification Officer, OCP, OC, FDA


Tuesday June 28, 2016 2:00pm - 3:15pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA