Regulatory Affairs 101: Navigating the FDA Process

When: Tuesday, November 12, 2013, 1:00-5:00pm
Where: Wolstein Research Building Auditorium

Featured speakers included:Theo Gana, MD, PhD; Phil Cola, MA; Jenna Stump, MS, CCRP; Ray Onders, MD, FACS
Workshop Moderator: W. Blair Geho, MD, PhD

Videos from the event:

The Food and Drug Administration has numerous regulations and guidance documents for investigators in their responsibilities for conducting FDA regulated research; investigators should have a thorough understanding of their role and responsibilities and how it relates to the protection of research participants. Research professionals are continuously challenged by the evolving regulatory landscape and the increased risk associated with the complexity of research protocols.

This workshop is designed to provide investigators with awareness of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects. The desired outcome from this workshop is that researchers be able to understand the function of the FDA and Investigator responsibilities for those holding Investigational New Drug (IND) applications or Investigational Device Exemptions (IDE) or those investigators conducting research under and IND or IDE.

Learning Objectives:

  1. Describe the structure and function of the FDA
  2. Identify ways investigators can interact with the FDA to improve protocol compliance and monitoring of participant safety.
  3. Identify federal and local regulations and institutional compliance issues related to FDA
  4. Identify local FDA resources
  5. Discuss the FDA regulatory sciences agenda
  6. Identify risks associated with complex research where an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) is required.


Theophilus Gana, MD, PhD Theophilus Gana, MD, PhD
Presentation Topic: Overview/Introduction to Structure, Function and Process of FDA [PDF]

Theo is the founder and president of Biopharmatech Consulting, Inc., a Leesburg, Virginia-based company that provides strategic and clinical drug development consulting services to the biopharmaceutical industry in the United States and Canada. Prior to his consulting career, he was Senior Director, Clinical Development at Biovail Corporation (now Valeant Pharmaceutical International). To-date, he has been involved in the development, filing and approval of 7 NDAs in the U.S. and 4 NDSs in Canada; filing of numerous INDs in the U.S. and CTAs in Canada and the E.U; and a co-inventor on 4 pharmaceutical patents. Prior to joining the pharmaceutical industry, Theo was at the Department of Surgery, St. Michael's Hospital, University of Toronto and the Department of Surgery, University of Alberta in Canada.

Philip A. Cola, MA Philip A. Cola, MA
Presentation Topic: Development of an IND/IDE Regulatory Knowledge Support Core [PDF]

Philip A. Cola, MA is a research administrator with 20 years of experience in the fiscal, legal, scientific and ethical reviews of research conducted in an academic medical center. Presently, Mr. Cola is the Vice President for Research and Technology Management at University Hospitals Cleveland Medical Center where he has the overall responsibility for Hospital based research administration including the Institutional Review Board, clinical research compliance, grants administration, and clinical research education and training. Additionally, he holds an appointment as Adjunct Assistant Professor of General Medical Sciences at the Case Western Reserve University School of Medicine.

Phil has given numerous presentations and lectures locally and nationally on the responsible conduct of research, human subject protections and grant administration. In addition, he has extensive experience writing grant applications as well as conducting and overseeing psychiatric clinical trials as a research psychologist. Phil also has contributed as a co-author on many publications in the areas of psychology, psychiatry, and research administration. He is an active member of a number of professional organizations including Public Responsibility in Medicine and Research (PRIM&R), the Association of Clinical Research Professionals (ACRP), and the Society of Research Administrators International (SRA). In 2009, he received the prestigious Excellence Award from SRA for his contributions to expanding the knowledge of Research Administration. In 2011, he was designated SRA Distinguished Faculty.

He currently serves as the Director of the Regulatory Knowledge and Support Core for Cleveland CTSA and participates on the national Regulatory Key Function Committee. In 2010, he was named the Champion of Change for the Cleveland CTSA. He has been an AAHRPP Site Visitor since 2008. Mr. Cola holds a Master's Degree in Experimental Psychology and Research Method and Design from Cleveland State University. He is currently a PhD Candidate in Management and Sustainable Systems at the Weatherhead School of Management, Case Western Reserve University.

Jenna Stump, MS, CCRP Jenna Stump, MS, CCRP
Presentation Topic: Development of an IND/IDE Regulatory Knowledge Support Core [PDF]

Clinical Research Regulatory Specialist
Center for Clinical Research and Technology
University Hospitals Cleveland Medical Center

Jenna is a Clinical Research Regulatory Specialist for University Hospital Cleveland Medical Center, Cleveland Ohio. Under the direction of Philip A. Cola, CTSA Champion of Change and Director, Regulatory Knowledge and Support Core, her primary role is assisting and supporting those investigators throughout University Hospitals Cleveland Medical Center who plan to submit an application to the Food and Drug Administration for the approval of an IDE or IND, in addition to any/all other ancillary FDA related matters.

Ray Onders, MD, FACS Ray Onders, MD, FACS
Presentation Topic: Real World FDA Experience

Director of Minimally Invasive Surgery, University Hospitals Cleveland Medical Center
Founder, Synapse Biomedical

Ray Onders' advancements in the technology of pacing the diaphragm have lead to patents and he is a co-founder of Synapse Biomedical with Case Western Reserve University and University Hospitals Cleveland Medical Center. Synapse Biomedical is helping to bring this technology to patients. This company in 2003 was the Runner up for TIIME, Case Western Reserve University/Weatherhead Business School Business Launch Competition in the Bioscience Category and Best in Show- 2003 Cleveland Growth Association/COSE Business Plan Challenge. Through the work and help of JumpStart and Bio-Enterprise with venture capital investments from California, Synapse Biomedical continues to grow with expanding sales worldwide in helping patient breathe and improving their quality of life. Future pipeline products will help any patient on a ventilator in the intensive care unit.