Session Abstract – PMWC 2018 Silicon Valley

Session Synopsis: A tremendous amount of work and effort is put into FDA approval of a drug, yet often the necessary accompanying diagnostics are not in place to meet the needs in a timely fashion. Upstream processes, such as tighter collaborations between pharma and diagnostics companies, more robust and earlier assay development, better transition of translational insight into clinical applications, or clinical trial design itself need to be optimized. This session’s dialogue will focus on these aspects and how a critical diagnostics component can be optimally integrated into a commercial strategy to create a more efficient and successful approval and commercialization process.

Session Chair Profile

MBA, President and CEO, MolecularMD
Biography

Mr. Snyder has been at MolecularMD since its inception in 2006 and assumed the role of President and CEO in 2014. With over 17 years of experience in the life science research and diagnostic fields, Mr. Snyder has worked extensively in supporting new product introductions and rapid market adoption for novel proteomic and genomic technologies. He received a BA from the University of Virginia and an MBA from the College of William and Mary.

Speaker Profile

President, Boston Healthcare Associates, Inc.
Biography

Mr. Ferrara has over 18 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics, and health care IT clients in market and business development strategy. He leads the global consulting team with practice areas in reimbursement and pricing, health economics, market analysis, and business development strategy. Mr. Ferrara has extensive experience in the development of novel business approaches designed to capture evidence-based value for innovation health care technologies. Mr. Ferrara writes and speaks extensively on the subject of the value of medical technology innovation, with particular focus on pharmacogenomics, specialty pharmaceuticals, and novel therapeutic devices. Prior to his consulting role, Mr. Ferrara led a joint venture between Boston Healthcare and a non-profit research organization focused on a global electronic medical record network for the purposes of clinical trials and health outcomes research. Mr. Ferrara completed undergraduate studies at the University of Cincinnati and received a master’s degree from Harvard University.

Speaker Profile

Ph.D., M.B.A., Senior Director, In Vitro Diagnostics, Kite, a Gilead Company
Biography

Dr. Astrow has extensive experience in the development of diagnostic assays used by treating physicians and biotech/pharmaceutical companies to assist in cancer therapy selection. She currently leads the translational science efforts for Kite’s T-cell receptor therapy programs in solid tumors, and for the company’s companion diagnostics initiatives. Prior to joining Kite in 2015, Dr. Astrow was Vice President of Research and Development at Response Genetics, a CLIA-certified, cancer-focused, clinical laboratory, where she was responsible for the introduction of novel molecular diagnostic assays and services. Prior to Response Genetics, she held leadership positions at Quest Diagnostics, Pathway Diagnostics, and Impath, Inc. Dr. Astrow received a Bachelor of Arts in Biology and Medicine at Brown University, and her Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. She also holds a Masters of Business Administration from Pepperdine University.

Speaker Profile

Ph.D., RAC, Senior Director and Diagnostics Lead, Oncology Programs, Genomic Science and Technology, Pfizer
Biography

Dr. Perez has over 15 years experience in diagnostic and drug development. He currently oversees companion diagnostic development activities for the oncology portfolio at Pfizer. He previously served as the Director for R&D Diagnostics at Tocagen where he led the preclinical and diagnostic assay development efforts for Toca 511, a gene therapy product for glioblastoma. Prior to Tocagen, Dr. Perez was the Senior Director of Research and Technology at Nodality Inc., a diagnostic company he co-founded. Prior to Nodality, Dr. Perez was the Senior Scientist and Director of the phospho-protein flow cytometry group at the Stanford Proteomics Center in the Stanford Medical Center, overseeing project management for antibody screening procedures, autoimmune clinical studies, and small compound profiling for many major pharmaceutical companies.

Speaker Profile

Ph.D., BSc, President, Tynan Consulting LLC
Biography

Dr Tynan has 20+ years of entrepreneurship in the life science and healthcare industries. She is known for her work on clinical diagnostics innovation, strategy and working with multiple health industry stakeholders to understand and solve complex problems. She has worked on the commercialization of health-related products and services; Market Access; Health Economics; and has the ability to simplify complex clinical practices to optimize product positioning and value articulation.