UNDERSTANDING THE DRUG DEVELOPMENT PROCESS
Many postdocs plan to enter industry R&D in Biotech/Pharma, but lack a thorough understanding of the drug development process. In this panel, speakers will discuss the cultural and scientific differences between Academic research and research in Biotech and Pharma. The phases of drug development including discovery, pre-clinical, formulation/CMC, clinical, regulatory, sales and marketing will be discussed with a focus on the common roles that postdoctoral scholars pursue upon exiting their postdocs. Learn how your postdoctoral training may prepare you for a career in industry R&D. Speakers will include scientists and senior management from small startups through large biotech/pharma.
SENIOR CLINICAL SCIENTIST AT VERTEX PHARMACEUTICALS
Cynthia’s career is an example of how you can apply scientific skills outside the lab. She received her PhD in molecular biology from MIT and after completing post-doctoral work at Brandeis University took a regulatory medical writing position at Vertex Pharmaceuticals. During her time as a medical writer she worked on a number of therapeutic areas, including hepatitis C, cystic fibrosis, and pain. As a medical writer she had the opportunity to author a broad range of clinical regulatory documents for Phase 1 through Phase 4 studies, including summary documents for supplemental new drug applications. Cynthia recently transitioned into a clinical scientist role supporting Vertex’s neurology programs. In her current position she contributes to clinical development plans, study design, study execution, and data interpretation.
DIRECTOR OF NEUROSCIENCE AT AMGEN
From 1995 to 2013, Zaven was a faculty member in the department of Neuroscience at the Albert Einstein College of Medicine, Bronx, NY. He directed a research group that made significant contributions to our understanding of molecular mechanisms controlling nervous system development, with a particular emphasis on axon guidance and dendrite branching in model organisms. Zaven joined Amgen in June 2013 as a Director of research and site head for Neuroscience at Amgen’s site in Cambridge, MA (AMA), and currently manages several programs designed to identify novel therapeutics for neurodegenerative disorders and neuropathic pain. He also leads the AMA External Outreach Committee (EOC), which is charged with increasing the visibility and accessibility of Amgen and the Cambridge site, and leveraging the local health sciences ecosystem to absorb and enhance innovation.
Senior scientist at vl37 inc
Chantal Kuhn is Senior Scientist at VL37 inc, an early stage startup company in the immunotherapy space that was founded in 2016 by the Venture Capital enterprise Flagship Pioneering. Hired as first Scientist she has a leading role in developing the research strategy of VL37 to develop innovative immunomodulatory therapies for the treatment of autoimmune diseases, cancer, infectious diseases, transplantation. Chantal holds a PhD in immunology and already focused on immunotherapy of autoimmune diseases and transplant rejection during her PhD and her first postdoc in France. In 2013 she came to Boston to study mechanisms underlying mucosal tolerance induction in the context of autoimmune diseases in the lab of Dr. Howard Weiner at Brigham and Women's Hospital & Harvard Medical School. Additionally to her work as scientist Chantal is very invested in mentoring, having been prominent in consolidating the BWH Mentoring Circles Program over several years and participating as a mentor in this year's AWIS mentoring circles program.
Lyndon J. Mitnaul
DIRECTOR IN THE R&D PLANNING, STRATEGY AND OPERATIONS DEPARTMENT AT REGENERON PHARMACEUTICALS
Dr. Lyndon J. Mitnaul is a Director in the R&D Planning, Strategy and Operations Department at Regeneron Pharmaceuticals, Inc., where he leads a team that supports all technologies, monoclonal antibody (mAb) innovations and platforms that drives research and development at Regeneron. Key support includes the Regeneron Genetics Center, novel gene editing (via CRISPR/Cas9) and CAR-T platforms and collaborations. Lyndon’s team accomplishes this by facilitating several external research collaborations and by managing multiple, cross-functional teams. Lyndon received a B.S. degree in chemistry from Benedict College, in Columbia, South Carolina, a Ph.D in Biological Chemistry from Pennsylvania State University, in Hershey, Pennsylvania, and performed a Postdoctoral Fellowship at St. Jude’s Children’s Research Hospital in Memphis, Tennessee. In 1997, Merck & Company recruited Dr. Mitnaul into the Department of Inflammation Research where he studied HIV pathogenesis and was later promoted to Research Fellow, Biology Program Team Lead, and Principal Scientist in the Division of Cardiovascular Diseases, where he studied lipid metabolism and thrombosis. In June of 2013, Lyndon joined Research Program Management at Regeneron and helped to establish the Regeneron Genetics Center. Dr. Mitnaul’s responsibilities increased in 2016 to include the management of all of Regeneron’s R&D technologies, mAb innovations and platforms in the new R&D Planning, Strategy and Operations Department. In addition to research, Lyndon has a strong passion for increasing diversity in the STEM disciplines and in the Pharmaceutical environment. He is an active mentor to young scientists and future leaders, and he has been recognized with several awards for his efforts.
RESEARCH FELLOW IN TOXICOLOGY/TRANSLATIONAL SCIENCES AT NOVARTIS INSTITUTES OF BIOMEDICAL RESEARCH
Sanjeev Thohan is a highly motivated research scientist who with every move has sought new challenges to overcome with each career-based move. He holds MS and PhD degrees in Pharmacology and Toxicology with concentrations in drug metabolism mechanisms, bioactivation pathways, and systems toxicology. He has actively contributed to: preparation of Pre-IND/IND and proof of concept documentation to support regulatory filings as preclinical development continues; inter-species scaling and projection of FIM dosage algorithm development; metabolic pathway elucidation and structural (SAR) feedback to medicinal chemistry for additional iterations based on biological data streams; high throughput bioanalytical method development/transfer, as well as troubleshooting for rapid method development/implementation. He has also led teams for evaluation of strategic critical pathway development, implementation and execution to provide data frontloading and reduction in time to IND. He is a highly motivated research scientist who has worked at Walter Reed Army Institute for Research, Covance Laboratories, AstraZeneca, Viropharma, Exelixis and as the founder of SARx Consulting and it currently at Novartis in Cambridge, MA. Sanjeev’s track record includes advancement of 27 small molecule compounds through discovery to IND and various stages of active clinical development since 1997. Therapeutic areas in which he has been actively involved are oncology, cardiovascular, metabolic diseases and antimicrobial, as well as antiviral therapeutic areas.