The FDA Group’s CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.

They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field.

Discussion points include:

» Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego.

» The evolution in drug delivery systems, such as the shift from hospital-based treatments to self-administration of drugs at home and the introduction of auto-injectors and on-body devices for efficient, patient-friendly drug administration.

» Addressing human factors and compliance to ensure products are user-friendly—and the importance of human factor studies in product development.

» The advantages of subcutaneous drug delivery, including reduced side effects, improved pharmacokinetic profiles, and patient convenience.

» How Halozyme’s one-team approach fosters a culture of curiosity, flexibility, and feedback.

» Aligning individual and organizational goals to drive innovation.

Dr. Knowles has deep pharmacovigilance and medical affairs experience gained over a career spanning almost 20 years. Dr. Knowles joined Halozyme in January 2018 as Vice President, Drug Safety & Pharmacovigilance. He is responsible for the Medical, Regulatory and Drug Safety organizations.

Prior to Halozyme, Dr. Knowles served as Senior Medical Director, Global Patient Safety and Benefit Risk Management at Eli Lilly & Co. where he led the global safety physician/scientist group responsible for overseeing the safety profiles and benefit risk management of medicines across all therapeutic areas and phases of development and supported numerous BLA and MAA submissions. During his 16 years at Lilly, he held positions in Medical Affairs and from 2005 to 2017 he held roles of increasing responsibility within Global Patient Safety. Prior to these roles, Dr. Knowles spent more than 17 years in clinical practice in the UK in both hospital-based and general practice roles.

Dr. Knowles received his Bachelor of Medicine and Surgery degrees (MB.BS) from the University of Newcastle Upon Tyne and is a Member of the Royal College of Physicians (MRCP) and a Member of the Faculty of Pharmaceutical Medicine (MFPM).

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Drug Delivery System Innovation and Leadership with Steve Knowles

The Life Science Rundown