Despite technology advances that have improved the ability of bench scientists to rapidly identify new drug targets, translating laboratory discoveries into marketable products remains a frustratingly slow process that often leads to dead ends. But by establishing an early dialogue with the FDA—when potential products are still in preclinical testing—companies can gain valuable insights that could boost their chances of success. 

In 2019, the FDA announced a new effort to modernize drug development, which included helping companies to streamline the preclinical phase of the process. The agency expressed an interest in working with companies to identify technology tools that can be used instead of animal trials to test toxicity, for example, and to improve the detection of biomarkers that might enhance patient selection for clinical trials. 

This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process. 

Topics include: 

  • Strategies for determining the best timeline for approaching the FDA with a new drug candidate 
  • A review of new technologies designed to speed up preclinical testing 
  • How fast is too fast? Ensuring the proper balance between streamlining preclinical research and gathering enough data to satisfy regulators 

Featured Speakers

Manu Vohra

Managing Director, Life Sciences
Box

Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After 2 decades of deploying ECM solutions in a regulated industry, I'm spending my efforts supporting Life Sciences companies to ride the Digital Transformation wave and fully leverage the micro content service offerings of a modern Content Platform at Box.

Lauren Black, PhD

Senior Scientific Consultant
Charles River Labs

Lauren holds a B.S. from Carnegie Mellon University in Molecular Biology and a doctorate in Pharmacology/Toxicology from the Virginia Commonwealth School of Medicine. She spent two years in postdoctoral research at NIH, evaluating dopaminergic drugs and GPCRs. Lauren served in both FDA, CDER and CBER for 11 years, focusing on preclinical assessment of transplant drugs, oligos, monoclonals for autoimmune disease, treatment vaccines, and cell therapies. She was a contributing author or committee chair for a number of FDA guidances, including immunotoxicology, oligos, xenotransplantation, and human starting doses. Since 2002, she has worked at Charles River in the Scientific Advisory Services group, where she advises both internal scientists working on IND programs, and pharmaceutical firms at all stages of development.

Dr. Rodney Ho

Executive Director
WE-REACH

Dr. Rodney Ho is the executive director of WE-REACH (the Washington Entrepreneurial Research Evaluation and Commercialization Hub) and a professor and presidential entrepreneurial fellow of the University of Washington, with additional appointments at the Fred Hutchinson Cancer Research Center. He is an expert on pharmacology and systems approaches to drug targeting and antiviral therapy. His research aims to improve the therapeutic efficacy and safety of viral and cancer drugs, medical diagnostic agents, and vaccines. 

Dr. Cheryl Rowe-Rendleman

CEO and Managing Consultant
Omar Consulting Group, LLC

Dr. Cheryl Rowe-Rendleman is a clinical research and development professional, serving as CEO and Managing Consultant of Omar Consulting Group, LLC (Princeton NJ ǀ Durham, NC). Omar (ophthalmic management and research) is a practice that specializes in regulatory and clinical consulting for drugs and devices in the US, Europe, Japan and China.

Dirk Brockstedt, Ph.D.

Chief Scientific Officer
RAPT Therapeutics

Dirk joined RAPT Therapeutics in January 2018, bringing over 20 years of experience through all stages of discovery, translational and clinical development, as well as a deep knowledge of immunology and the tumor microenvironment. He joined RAPT from Aduro Biotech, where he served as Executive Vice President of Research and Development. Prior to Aduro, Dirk held positions of increasing responsibility within the immunology department of Cerus Corporation, most recently serving as Director of Immunology. Prior to Cerus, he served as a scientist at Aventis in the immunotherapy and anti-angiogenesis group, developing novel therapies against cancer.

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