Initiating first-in-human studies after an Investigational New Drug (IND) clearance — how are the experts doing it in 2022? This Endpoints Studio panel of drug developers will discuss innovative trial designs, on-demand manufacturing, communicating between clinical partners, prepping a strong regulatory submission and enabling faster decision making in your phase I trial.
Stephen Tindal is Director of Science and Technology at Catalent, where he plays an important role within the company’s research and development team by providing advice to clients in Europe and Asia-Pacific on the early phase drug development and delivery technologies to progress their small molecule programs. His work is largely focused on preclinical to phase 1 development and is based on the assessment of preclinical data to help define any challenges to dosage form development. Tindal has more than 30 years’ experience at Catalent where he has held roles of increasing responsibility, and has demonstrated expertise in root cause investigation, technology innovation and in supporting business development. He holds a bachelor’s in Chemistry and Analytical Science from Loughborough University, Loughborough, U.K.
Dr. Timothy Yap is a Medical Oncologist and Physician-Scientist based at the University of Texas MD Anderson Cancer Center. He is an Associate Professor in the Department for Investigational Cancer Therapeutics (Phase I Program), and the Department of Thoracic/Head and Neck Medical Oncology. Dr. Yap is the Medical Director of the Institute for Applied Cancer Science, a drug discovery biopharmaceutical unit where drug discovery and clinical translation are seamlessly integrated. He is also the Associate Director of Translational Research in the Institute for Personalized Cancer Therapy, which is an integrated research and clinical trials program aimed at implementing personalized cancer therapy and improving patient outcomes. Prior to his current position, Dr. Yap was a Consultant Medical Oncologist at The Royal Marsden Hospital in London, UK and National Institute for Health Research BRC Clinician Scientist at The Institute of Cancer Research, London, UK.
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.