Repositioning existing drugs to treat new diseases - both rare and common - is an attractive prospect to a large contingent of the pharma industry seeking to shorten development timelines and economize development costs. Building on existing research and development efforts means that potentially groundbreaking therapies can achieve approval and reach patients faster, with significant savings for drugs that have already undergone extensive preclinical and clinical safety assessments. However, the process of drug repurposing, whether as a monotherapy or as part of a combination or cocktail, still leads to significant scientific, financial and regulatory challenges, including the reevaluation of dose and dosing regimen along with questions around efficacy with a new patient population. Join our panel of experts who will discuss the challenges of advancing a repurposed drug to market and how to overcome them to achieve strategic success.
Kelly Davis has over 25 years of global quality and regulatory affairs experience including CDMO and product ownership. As a regulatory expert, she has been involved with global regulatory strategy development and implementation for sterile pharmaceutical and biological products including combination products as well as medical devices. In addition, Kelly has successfully worked with technical experts to develop innovative initial and post-approval regulatory strategies, authored rolling BLAs and supported EUA submissions. She strategically utilizes Ministry of Health interactions to continually build current regulatory submissions and meet Ministry of Health expectations for successful product launches. Throughout her career, Kelly has had the opportunity to support facility sites including GMP and regulation interpretation/application, global Ministry of Health site inspections and change controls.
Dr. Cameron Durrant is Chairman and CEO of Humanigen, a Nasdaq-listed clinical stage biopharmaceutical company developing monoclonal antibodies for COVID-19, CAR-T, GvHD, oncology and other serious and life-threatening conditions.
Throughout his career, Dr. Durrant has shown a propensity for turning around startups, raising hundreds of millions of dollars for brands, business units and companies both private and public. He has overseen four exits, including Akorn’s $640MM Hi-Tech Pharmacal acquisition and the subsequent divestment of ECR Pharmaceuticals by Akorn to Valeant.
Prior to joining Humanigen, Dr. Durrant held several C-level and board member positions at pharmaceutical and life sciences companies.
Dr. Durrant earned his MD from the Welsh National School of Medicine, his DRCOG from the Royal College of Obstetricians and Gynecologists, his MRCGP from the Royal College of General Practitioners, his DipCH from the Melbourne Academy, and his MBA from Henley Management College.
Donald E. Ingber,MD,PhD is the Founding Director of the Wyss Institute for Biologically Inspired Engineering at Harvard University, Judah Folkman Professor of Vascular Biology at Harvard Medical School and the Vascular Biology Program at Boston Children's Hospital, and Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. He received his B.A., M.A., M.Phil., M.D. and Ph.D. from Yale University. Ingber is a pioneer in the field of biologically inspired engineering, and at the Wyss Institute, he currently leads scientific and engineering teams that cross a broad range of disciplines to develop breakthrough bioinspired technologies to advance healthcare and to improve sustainability. His work has led to major advances in mechanobiology, tumor angiogenesis, tissue engineering, systems biology, nanobiotechnology and translational medicine, with his most recent pioneering contribution being the development of human Organ-on-Chips as replacements for animal testing. He also has made great strides in translating his innovations into commercial products and many are now either in clinical trials or currently being sold. He has authored more than 500 publications and over 165 issued or pending U.S. patents, founded 5 companies, and has been a guest speaker at more than 550 events internationally. Ingber is a member of the National Academy of Medicine, National Academy of Engineering, National Academy of Inventors, American Institute for Medical and Biological Engineering, and the American Academy of Arts and Sciences.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.