Jeanmarie Guenot, Ph.D.
President and CEO
Jeanmarie Guenot, Ph.D. has over 20 years of experience in the pharmaceutical and biotechnology industry. She has worked with all stages of companies, both public and private, in pharmaceutical R&D, corporate & commercial development, business development, project & alliance management and venture capital. She has significant expertise and interest in building or rebuilding companies and is currently the President & CEO of Amphivena Therapeutics, Inc., a company that is developing innovative bifunctional antibody therapies for hematologic malignancies.
Prior to her current role, Dr. Guenot founded, built and ran SKS Ocular, a start-up ophthalmic company incubator, focused on dry AMD, sustained release ocular drug delivery technologies and therapeutics for glaucoma, macular degeneration and ocular inflammation. She was a business advisor for Hoffmann-La Roche in Basel and Shanghai, and she was Vice President of Corporate & Business Development at PDL BioPharma, where she led licensing, mergers and acquisitions and alliance management for PDL’s R&D and commercial product portfolios. She led and negotiated the Biogen Idec-PDL 50:50 co-development and co-commercialization strategic collaboration, which involved three Phase 2 cancer and autoimmune disease drug candidates. This $800 M transaction included a $100 M equity investment in PDL and a therapeutic candidate with indications split between Biogen Idec/PDL and Hoffmann-La Roche. She also licensed the ophthalmic indication for the oncology drug to Ophthotech. She has portfolio, project and alliance management experience in the areas of oncology, cardiovascular diseases, autoimmune diseases, neurology and ophthalmic diseases.
Dr. Guenot started her business career at Atlas Venture, where she managed venture capital investments and built life science companies. She started her scientific career as a principal scientist in Preclinical R&D at Hoffmann-La Roche, discovering and developing drugs for metabolic diseases, inflammation, autoimmune diseases and oncology. Dr. Guenot trained in physical and medicinal chemistry, with a focus in quantum mechanical and semi-empirical methods for molecular dynamics, protein structure prediction, X-ray and NMR refinement and drug design. She earned her Ph.D. from the University of California, San Francisco and her MBA from The Wharton School at the University of Pennsylvania.
Lori Kunkel, M.D.
Dr. Lori Anne Kunkel has held executive positions in a variety of companies that have provided her extensive experience in developing and commercializing oncologic/immunologic therapies. Her areas of responsibilities have included clinical, regulatory, medical affairs and licensing. She has participated as a strategic clinical advisor and consultant to several corporations, as well as a consultant for Boston and Bay area Venture Capital firms. She is currently Chief Medical Officer (CMO) at Loxo, Oncology; prior to that she was the CMO at Pharmacyclics. Inc., where she was instrumental in achieving breakthrough designations for the lead product, ibrutinib; and filed the NDA that led to approval. She served as CMO at Proteolix (acquired by Onyx), and at Syndax and ACT. Dr. Kunkel has led numerous agents through EU and US strategic regulatory meetings, INDs, Orphan Drug designations, Special Protocol Assessments, and has filed both NDAs and BLAs. Dr. Kunkel spent ten years in academic/clinical medicine and served as a faculty member in the Division of Hematology/Oncology Bone Marrow transplant unit at University of California, Los Angeles prior to joining the international biotechnology industry in 1995. Dr. Kunkel holds a Bachelor of Arts in Biology from University of California, San Diego; a medical degree from University of Southern California. She has held board certification in Internal Medicine, Hematology and Oncology.
Judith A. Fox, Ph.D.
Judith A. Fox, Ph.D. is Senior Vice President, Research & Development at Amphivena Therapeutics. Most recently, Dr. Fox was Vice President, Product & Preclinical Development at Sunesis Pharmaceuticals, where she led the vosaroxin program in acute myeloid leukemia through early to late stage clinical development. Previously, she was Senior Director in Translational Sciences at Chiron Corporation (now Novartis AG), supporting the development of the company’s novel oncology compounds, and she established the Pharmacological Sciences Department at Genencor International. Dr. Fox’s industry career began at Genentech, Inc. where she contributed to the development of products such as Herceptin®, Xolair®, Raptiva® and Avastin®. Her career has focused on the translation of basic mechanistic understanding of promising drugs into coherent, evidence-based clinical development. Dr. Fox received her Ph.D. in Biological Chemistry from the Massachusetts Institute of Technology, where she serves on the Chemistry Visiting Committee, and an A.B. in Chemistry from Bryn Mawr College. She conducted postdoctoral research at The Rockefeller University.
Jennifer Sims, PhD
Jennifer Sims, PhD is the Managing Director of Integrated Biologix GmbH, Basel, Switzerland, a pharmaceutical consulting company located in Basel, Switzerland. Dr Sims has more than 25 years experience in small molecule and biological drug development, with experience in both the Health Authority and Industry sectors, with a major focus on biological products. Experience in designing and implementing preclinical development plans to secure successful clinical trial approvals, seamless clinical development and marketing authorizations.
Prior to founding Integrated Biologix GmbH, Dr Sims was Head of Biologics Safety and Disposition for Novartis Biologics. Previous industry positions include Head of Toxicology for Biopharmaceuticals at AstraZeneca / MedImmune, and Head Project Safety Assessment group, Preclinical Safety at Novartis.
Prior to joining the pharmaceutical industry, Dr Sims served for 12 years as a senior preclinical assessor with the UK MHRA and was the UK delegate to the CHMP Safety Working Party from 1995-1999.
Dr Sims was a member of the first ICH S6 Expert Working Group and was the Industry Rapporteur for the more recent revised guidance in ICH S6 R(1). She has participated as member / chair of British and European Pharmaceutical Industry Association (ABPI, EFPIA) preclinical expert groups and has acted as Chair of BioSafe, a focused expert science committee within BIO which identifies key scientific and regulatory issues and developments related to the preclinical PK-PD and safety evaluation of biopharmaceutical products. Dr Sims chaired the preclinical working group of the ABPI/BIA Early Stage Clinical Trials task force set up following the Tegenero incident, and which was instrumental in highlighting translational approaches to safety assessment embodied by the MABEL approach.
Susan Dana Jones Ph.D.
Susan Dana Jones, Ph.D., Vice President and Principal Consultant with BioProcess Technology Consultants, is a seasoned biotechnology entrepreneur with experience in product development, outsourcing, and strategic planning. Dr. Jones is a subject matter expert in cell line development and characterization for biosimilar, new biopharmaceutical, and vaccine development programs.
She has broad knowledge of regulatory requirements for manufacturing products for human use and has prepared CMC sections of multiple regulatory submissions. She co-founded two successful biotechnology companies including Serenex, Inc, where she worked with other senior managers to complete a $15M Series B financing. Dr. Jones was formerly VP Manufacturing at Waratah Pharma and has held positions at Dyax, Virus Research Institute (now Celldex), and the Dana Farber Cancer Institute. She currently serves on the Board of Directors of Gene Solutions, the Scientific Advisory Board of Symphogen, and is a member of the Editorial Advisory Board of BioProcess International. She received her Ph.D. in Genetics from the University of California, San Francisco.