Delivery Challenges from the Oncology Pipeline

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.

Ronak Savla is Director, Strategic Ventures at Catalent Pharma Solutions. In his role, Dr Savla is responsible for expanding and nurturing the company’s strategic partnerships with life science venture capital firms, biotechnology incubators, consulting firms, and academic technology transfer offices. Dr Savla also manages the Catalent’s fund-of-funds representing the company’s limited partnership positions. Previously, Dr Savla led the Medical Affairs and Competitive Intelligence functions at a biotechnology company harnessing the innate immune system to develop novel therapeutics. Dr Savla supported the commercial launch of a novel agent for a rare leukemia and was responsible for all aspects of Medical Affairs including medical information, medical education, medical science liaisons, investigator-sponsored clinical trials, Phase 4 post-marketing safety study, and KOL engagement. Dr Savla also built the Competitive Intelligence and New Product Planning function to drive business decisions regarding asset prioritization and indication selection. Outside of his professional role, Dr Savla is an Angel Investor with the HealthTech Capital group focused on funding and mentoring startups to disrupt healthcare delivery.Dr Savla is also an Adjunct Associate Professor within the Department of Pharmacy Practice at Rutgers University. Dr Savla has a PharmD and PhD from Rutgers University and a MBA from Johns Hopkins University – Carey Business School.

Theresa Scheuble is Head of Enterprise Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.

Dr Shankar Swaminathan is an associate director at Astellas Institute of Regenerative Medicine leading drug product development and technical transfer activities for multiple preclinical cell therapy candidates. Dr Swaminathan obtained his doctoral degree in pharmaceutics focusing on creating new polymer-based drug delivery formulations for cancer nanomedicine. 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 investigator, he obtained independent grant funding for supporting his ideas before successfully transitioning to the biopharmaceutical industry. Dr Swaminathan led 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 submissions and validation. He is currently supporting multiple cell therapy projects, including immuno-oncology modality from development through GMP technical transfer and manufacturing. 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.