Paul has 34 years of experience in the pharmaceutical and biotech industry, and has worked in preclinical microbiology, anti-infective and oncology clinical research, project management, and managed a Phase I Research Clinic. He has previously worked at Warner-Lambert/Parke-Davis, DepoTech, Agouron, Pfizer, Trius Therapeutics, Progenity, and Amplyx Pharmaceuticals, Inc. While at Pfizer he served as a Research Team Leader and Exploratory Development Director leading several oncology drug development teams. He has been involved in a number of successful drug development programs including Penetrex®, Sparfloxacin®, Cefzon®, Viracept®, Sutent®, Inlyta®, and Sivextro®. Paul received his BS in microbiology and public health from Michigan State University and his MS from the University of Michigan in clinical trial design and statistical analysis.
Ed Castellana, PhD., is Senior Director of Portfolio Development at Evofem Biosciences. Previously Ed was Senior Director of Product Development at Sienna Biopharmaceuticals Inc. (Sienna). Prior to its acquisition by Sienna, Ed was head of R&D and member of the management team at Sienna Labs, Inc. where he was responsible for advancing the development of two topical products based on the science of plasmonic resonance through early stage clinical development into pivotal trials. Additionally, Ed oversaw the development of a transdermal delivery device and managed the production and distribution of clinical supply. With over 10 years of industry experience, his career encompasses a wide range of R&D and leadership activities centered on early product development in the medical device and diagnostics industries. Prior to Sienna, Ed has held R&D positions with several startups focused on developing biosensor platforms and devices for the healthcare sector, was a Research Professor at the University of Texas at Dallas, and a Postdoctoral Fellow at Texas A&M University. Ed received a BS in mathematical physics and chemistry from SUNY Fredonia and a PhD in chemistry from Texas A&M University.
Shawn Flanagan is a highly accomplished and influential scientific leader with diverse knowledge of drug development and translational research. Shawn has creatively advanced a variety of large and small molecules of several therapeutic areas including endocrine (diabetes and obesity), infectious disease, cardiovascular, neuroscience, and oncology from Discovery/Pre-IND, proof of concept, NDA approval, and post-marketing. Shawn holds a PhD in pharmaceutical chemistry from University of California, San Francisco and has over 20 years of experience at such companies as Amylin, Cubist, Ligand, Lilly, Merck, Orexigen, and Trius. Shawn was responsible for all aspects of Biopharmaceutic, Clinical Pharmacology, and Pharmacokinetic (DMPK/ADME) studies, reports, and original regulatory submissions for BYDUREON®, CONTRAVE®, and SIVEXTRO®, and significantly contributed to the development, prescribing information, and/or regulatory submissions of several other approved medications.
Dr. Giegel has over twenty-five years of experience in drug discovery at large pharmaceutical companies and small biotechnology companies. He is currently the President and CSO at TissueNetix, Inc. TissueNetix is developing a next-generation cardiac toxicity test for use during the drug discovery process. Prior to founding TissueNetix, he was Senior Director of Molecular Sciences at Celgene, where he was responsible for overseeing the in vitro drug discovery efforts of the company’s San Diego research site. Dr. Giegel has also held management positions at MitoKor, Pfizer and Parke-Davis. Dr. Giegel received his M.S. and Ph.D. (Biological Chemistry) from the University of Michigan and a B.S. degree (Chemistry) from Miami University (Ohio).
Michelle Higginson, RDN, CD