Clinical and Translational Science Institute Seminar Series

Fall 2015

For the Fall semester of the 2015-2016 academic year, we have planned an exciting series of lectures titled, "Advancing Regulatory Science and Translational Science: Research, Training and Partnerships."

All of the lectures will take place in the Helen Wood Hall Auditorium (1W-304), from 12:00 pm to 1:00 pm. The series will begin on September 8, 2015, this is the Tuesday immediately after Labor Day.

CTSI will continue to offer live streaming of the seminar series, as well as the option to stream the seminar at a later date. Click on the seminar title to access the video. *Note: Seminars are best viewed using Google Chrome or Mozilla Firefox.

The University of Rochester School of Medicine and Dentistry designates this live educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity. CME credit will only be available for those that physically attend the series. No credit will be given for viewing the series on the web.

Lunch is provided. Please bring your own beverage.

Date Speaker Title


Joan Adamo, PhD
Associate Director for Regulatory Support Services, CTSI
Scott Steele, PhD

Director, Government and Academic Research Alliances

Regulatory Science Research and Core Competencies

9/15/2015 Carol Linden, PhD
Director, Office of Regulatory Science and Innovation, FDA
Advancing Regulatory Science at the FDA
9/22/2015 Michael Rosenblatt, MD
Executive Vice President and Chief Medical Officer, MERCK
Regulating Science and Translational Research: Innovation to meet patients' needs
9/29/2015 Michel Berg, MD
Professor, Neurology
Working with FDA to better understand generic drug equivalence
10/6/2015 Kelly Unsworth, MS, CCRC, CIP
Director of Research Education and Training, OHSP
Coulda, Shoulda, Woulda: Lessons Learned in Conducting Research from OHSP/RSRB Staff & Board Members
10/13/2015 Jean-Philippe Couderc, PhD, MBA
Associate Professor, Medicine, Cardiology Heart Research
Development of International Scientific Resources in collaboration with NIH and FDA: The Telemetric and Holter ECG Warehouse (THEW) case
10/20/2015 No session No session
10/27/2015 Kelley O'Donoghue, MPH, CIP
Associate Vice President for Human Subjects Protection,
Director, OHSP
Not Just Another Acronym: What the NPRM Could Mean For You
11/3/2015 Yuhchyau Chen, MD, PhD
Chair and Professor, Radiation Oncology
Challenges in applying FDA rules to medical countermeasure development for acute radiation exposure
11/10/2015 Emma Meagher, MD
Associate Professor of Medicine, University of Pennsylvania
Developing a Regulatory Science Training Program and Potential Career Paths
11/17/2015 Emily Flagg
Senior Regulatory Specialist, RSRB
A Look Inside: The Roles and Responsibilities of a Coordinating Center
11/24/2015 No session No session
11/25/2015 Karl Kieburtz, MD, MPH
Co-Director, CTSI
Professor, Neurology, Center for Human Experimental Therapeutics
Karen Rabinowitz, JD
Legal Counsel and Associate Director of Collaborations, Center for Human Experimental Therapeutics
CTSI Skill-Building Working - Industry Consulting: The Contract
12/1/2015 Robert Meyer, MD
Director, Virginia Center for Translational and Regulatory Sciences
Real World Evidence and the FDA
12/8/2015 Student entries America's Got Regulatory Science Talent Contest
12/15/2015 Fred Marshall, MD
Associate Professor, Neurology
Frank Sasinowski, MS, MPH, JD
Hyman, Phelps, & McNamara PC
CTSI Skill-Building Workshop - Orphan product pricing issues

Click here to view archived video of past CTSI Seminar Series


NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.