Joy Cavagnaro, PhD

Joy Cavagnaro, PhD

Joy Cavagnaro's career spans academia, the CRO and biotechnology industries and government. During her tenure at CBER/FDA she was appointed to the SBRS, served as FDA’s safety topic lead and rapporteur for “ICH S6.” Prior to joining FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance. Dr. Cavagnaro is Past Chair of RAPS and the National Capital Area Chapter of SOT. Currently she is a member of the Biotechnology Specialty Section of SOT and recipient of the section’s first Career Achievement Award. Dr. Cavagnaro is Founder and Past Chair and currently a member of the leadership committee of BioSafe, an expert preclinical science committee within BIO. She is Past North American Chair of DIA’s Biotech SIAC and current Research and Development SIAC Liaison to the ACNA Executive Committee. She is Past Chair of the Clinical and Regulatory Affairs Committee and current member of the Translational Science & Product Development Committee of the ASGCT. Dr Cavagnaro was the US BIO representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce. She is currently a Chair of CRRI, an independent IRB. Dr. Cavagnaro serves on SAB’s and consults and lectures internationally. She has recently edited and authored chapters in Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials published by John Wiley & Sons, NJ, 2008.

Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

 

EU Regulatory

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, Rph., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

Rob Walsh, MD

 

QA/QC

Christopher Kotsopulos, MS

Joshua Sharlin, Ph.D

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Robert Kaster, Rph., ASQ-CQA

 

Medical Writing/Regulatory Submissions

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA