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FDA REGULATED RESEARCH: INNOVATION & COMPLIANCE

FDA Regulated Research: Innovation & Compliance

Date: March 3, 2017

The Office of Responsible Research Practices in collaboration with the Center for Clinical and Translational Science and Nationwide Children’s Hospital hosted an FDA-focused conference entitled “FDA Regulated Research: Innovation & Compliance” on March 3, 2017 at The Ohio State University Biomedical Research Tower.

The conference included a number of speakers from industry, regulatory experts, The Ohio State University, OSU Wexner Medical Center, OSU Comprehensive Cancer Center, and Nationwide Children’s Hospital. Select the presentations you would like to watch below in the agenda or watch them all here. | Download agenda/speaker bios

Agenda

8:15 - 8:45am: Welcome and Introduction

Rebecca Jackson, MD, Director, OSU Center for Clinical and Translational Science | Watch the video

8:45 - 9:30am: Investigator Perspective: Drug Development & Innovation

John Byrd, MD, Director, Division of Hematology, Department of Internal Medicine | Watch the video

9:45 - 10:45am: Discovery Development and Approval of Exondys 51

Ed Kaye, MD, President and Chief Executive Officer, Sarepta Therapeutics | Watch the video

10:45 - 11:45am: Investigator Perspective: Device Innovation

Ali Rezai, MD, Director, Neurological Institute (no video available)

12:45 - 1:45pm: Novel Strategies and Treatment Modalities for Orphan and Complex Diseases

Amy Rosenberg, MD, Director, Division of Biotechnology Review and Research, Office of Biotechnology Products, CDER, FDA | Download the presentation (no video available)

1:45 - 2:30pm: Leveraging Comparative Oncology to Maximize Translational Outcomes

Cheryl London, DVM, PhD, Director, Clinical Trials Office, College of Veterinary Medicine | Watch the video

2:45 - 3:45pm: Panel Discussion: Investigator Responsiblities for FDA Regulated Research

Watch the video

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