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.
Ramachandra (Ram) G. Naik, M.D.
Biostatistics
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Pre-Clinical
CMC, Formulation/Process Development & Sourcing
Medical Device
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy