New Approaches to Achieve Targeted Brain Delivery Without Increasing Toxicity

Alexander (Alex) Josowitz is currently a member of the New Technologies Team in the Formulation Development Department at Regeneron Pharmaceuticals Inc. His work focuses on new technologies including formulation, drug delivery and device evaluations for biologics. Previously, Alex earned his PhD in Biomedical Engineering at Yale University under Mark Saltzman, where he tackled drug delivery to the brain from multiple angles. He investigated the use of polymeric nanoparticles to allow for sustained release of hydrophobic drugs in the tumor microenvironment, local infusion systems and techniques such as Convection Enhanced Delivery (CED), and combination therapies between alkylators and DNA-repair inhibitors to lower systemic toxicity associated with high clinical doses. This is Alex’s first experience with PODD and he is excited to be introduced to this growing community that brings together cross-functional experts to address drug delivery challenges.

Darren Reid is Director of the Synthetics Enabling Technologies group in Pre-Pivotal Drug Product Technologies at Amgen and is responsible for synthetics Dev-Molecule Assessment and form selection, end-to-end solid state process support, and synthetics formulation development for preclinical and parenteral FIH studies. Before joining Amgen, Dr Reid received his PhD in physical organic chemistry from McMaster University and held Postdoctoral positions at the University of Calgary and Pfizer, developing approaches to assess oxidative stability.  He has co-authored over 30 external articles, reviews, and book chapters, and several patents/applications, including for the LUMAKRAS(R) commercial form. His research interests include drug stability, developability assessment, and formulation strategies. Dr Reid is a founding steering committee member for Lhasa Ltd’s Zeneth drug degradation prediction program and an active member of ACS and AAPS.

Dr Shankar Swaminathan is a Team Lead at Astellas Institute for Regenerative Medicine leading drug product development activities for multiple preclinical and clinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer based drug delivery formulations for cancer nanomedicine and delivery of labile small and large molecules. Soon after his PhD, he joined the pharmaceutical industry to work on drug eluting long-acting combination products. He later went on to complete his postdoctoral training in ophthalmic drug product development at the College of Medicine at University of Tennessee health science center, where he focused on creating new treatment approaches for debilitating eye diseases. As a young ophthalmology investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan has supported CMC activities for multiple products/INDs submitted for approvals to various agencies. He has about 15 years of combined industry and academic experience and has successfully overseen product development from early-stage discovery through late-stage submission. He has been associated with ophthalmic drug delivery and development for over 10 years. He is vastly experienced in aseptic drug product development, quality-by-design, advanced drug delivery, cryopreservation technology, CTM campaign execution and management, fill-finish, modified release solid orals and ocular drug delivery. He is an editorial board member in Scientific Reports and serves as a reviewer for over 20 peer reviewed journals. He has published 15+ peer reviewed publications, commentaries and blogs.

Dr Loudon is a Board certified General and Pediatric Neurosurgeon, with 20 years of clinical and biomedical research experience. Graduate training at NINCDS/NIH and MD Anderson Cancer Institute.

Lisa Shafer, PhD, serves as Biogen’s Global Head of Product Development and Reg CMC, Medical Devices and Packaging. In this role Dr. Shafer oversees technical packaging design and development, device development and digital integration, lifecycle management, and regulatory engagement and filings, while driving innovation and technology specific to drug delivery and continuously enhancing the overall patient experience. Dr. Shafer brings deep scientific and device expertise in neuro-immunology with more than twenty-five years of experience across the medical device and pharmaceutical industry, most recently as the Chief Scientific Officer at Cerebral Therapeutics. Prior to Cerebral Therapeutics, she was the Chief Scientific Officer, an early-stage biopharma company in neurological disorders. Dr. Shafer has also held various positions with increasing technical and leadership responsibilities at Teva Pharmaceuticals, Upsher-Smith Laboratories, and Medtronic. She also has a wealth of experience building and leading high-performing teams with a passion for developing people. Dr. Shafer is a neuroscientist by training with a Ph.D. from Loyola University Chicago in Neuroscience/Neuroimmunology and a Bachelor of Science from the University of Minnesota in Genetics, Cell Biology and Development.