A CTSI Skill-Building Workshop Series
Good Advice: Case Studies in Clinical Research, Regulation, and the Law
Sponsored by the CTSI, the Training Grant in Experimental Therapeutics, and the
Office of University Counsel
This Seminar Series is designed for individuals pursuing training in clinical research including those
students, residents, fellows, and junior faculty in the CTSI TL1 training program, URMC KL2 Clinical
Scholars Program, the Experimental Therapeutics of Neurological Disease program, the Empire
Clinical Research Training Program (ECRIP) and those who are recipients of a federal or foundation
career development awards (as well as preceptors, mentors, and others with clinical research
interests).
The series focuses on opportunities, challenges and obstacles that face researchers working on clinical
research for which legal and regulatory counsel are essential. The following terms and topics will be
covered: intellectual property, liability, confidentiality, conflict of interest, conflict of commitment,
misconduct and fraud. In addition the processes for publication, publicity, marketing, research
budgeting & spending, regulatory applications (e.g. INDs), and creating independent consultative
agreements will be covered. The format include a presentation of a “case study” ---- an actual issue
which an investigator has confronted or a clinical study which presented challenges (15 minutes),
followed by a dialogue with a legal/regulatory/compliance expert in the legal issues that might or could
have, should have, or actually did help resolve the issue (about 15 minutes), followed by discussion
with the audience. The dates of individual speakers are tentative.
2014 – 12:00 – 12:50 PM, Helen Wood Hall 1W304 Auditorium
Intellectual Property: Opportunities for Residents and Fellows. The process of
October 22
filing a patent 15 ago and its sequel. Tom Guttuso, MD, former Neurology
resident and fellow, now Associate Professor of Neurology at the University of
Buffalo. Scott Catlin, JD, Associate Vice President of Innovative Technology.
November 19
DSMB: Qualification, Confidentiality and Indemnification. Karl Kieburtz, M.D.,
MPH. Karen Rabinowitz, JD
Retracted Papers --- Why They Continue to be Heavily Cited and What To
Do About It. “There Ought to be a Law…” Jennifer Griggs, MD, Steven Engel,
PhD
2015 – Location to be announced
Drug Supply for Clinical Trials: Contractual Issues with Drug Supply.
January 21
Cornelia Kamp, MBA, Director, Clinical Materials Services Unit (CMSU) and Pat
Bolger, CMSU Director Clinical & Business Affairs
December 17
February 25
Clinical Trials of Devices and FDA Approvals: Arthur Moss, M.D.
March 25
Discoverability, Freedom of Information and the Clinical Investigator:
Robert Dworkin, Ph.D. and Gail Norris, JD, Vice President and General Counsel.
April 29
Copyrights and commercialization: Patient Outcome Measure Development .
Chad Heatwole, MD, and Scott Catlin JD, Associate Vice President of Innovative
Technology.
Clinical Trial Misconduct: Case Study: Repercussions for changing data,
supplying missing data, fabricating data. Rachel Biemiller, MD and Aileen
Shinaman, JD, Office of Counsel.
Patent Infringement: COX Fighting. Kerry O’Banion, MD, PhD, and Thomas
Jackson, JD, Immediate past University of Rochester President (Tentative).
May 27
June 17
September 30
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Industry Consulting: Karl Kieburtz, MD, MPH. (Part 1)
Entering into consulting arrangements with industry, discussing CDAs and
consulting agreement negotiations, liability, confidentiality
October 21
Industry Consulting—Part 2. The contract: Entering into consulting
arrangements with industry, discussing CDAs and consulting agreement
negotiations, liability, confidentiality. Karl Kieburtz, MD, MPH, and Karen
Rabinowitz, JD, Center for Human Experimental Therapeutics.
November 18
Patient Consents: For protecting the patient? Or for protecting the
investigator and institution? Carl D’Angio, MD, and Kelley O'Donoghue, MPH,
CIP, Director, Office of Human Subjects Protection.