Tackling the Increasing Complexity of Manufacturing to Deliver Pipelines

David Chen is CMC Operations Leader at the Bill and Melinda Gates Medical Research Institute based in Cambridge, Massachusetts. Dr Chen’s experience includes various strategic and technical CMC leadership roles in product development, manufacturing, operations, and supply chain for programs across the development lifecycle from IND to licensure and post-approval lifecycle management. Prior to joining the Gates Medical Research Institute, Dr Chen was CMC strategy and manufacturing director at Alexion Pharmaceuticals, the AstraZeneca rare disease business unit. He has also held various scientific and technical roles with Takeda, Pfizer, and Novartis. Dr Chen earned a PhD in chemical engineering from Cornell University.

Julia Rashba-Step, PhD is a Vice President of Research & Development and Alliance Management at Phosphorex. In her current role, she works closely with Pharma and Biotech partners to help advance cutting edge innovative technologies into critical programs. Dr Rashba-Step is a senior pharmaceutical professional with an extensive background in nanotechnology, biotechnology and pharmaceutical industries. Dr Rashba-Step has experience working at both small companies (Epic Therapeutics) and global pharmaceutical companies including Baxter, Wyeth and Pfizer, where she held positions of growing responsibilities, leading formulation, packaging and delivery groups, such as leading Novel Delivery Technologies group at Pfizer. Dr Rashba-Step’s technical background is in pharmaceutical product development with the focus on drug product, advanced formulations, and delivery aspects. Dr Rashba-Step has multiple scientific publications in the field, as well as patents and patent applications and serves on multiple Advisory Boards.

Michael Schmidt is a Senior Director in the Pharmaceutical Research and Development group (PhRD) within the BioTherapeutics PharmSci organization, based in Andover, Massachusetts. In his PhRD leadership role, Mr Schmidt has built a high-functioning team of over 70 members across multiple sites who drive flexible, efficient manufacturing of highly complex processes. This team manages Pfizer’s large molecule internal and external clinical Drug Product (DP) manufacturing capability.  Mr Schmidt’s group is responsible for Clinical DP Manufacturing, which is split into two parts. The first has responsibility for the technology transfer process for BTx DP into GMP manufacturing sites internally and externally. The second part of the group is the Andover Liquid Dosage Manufacturing (AN-LDM) clinical BTx DP manufacturing facility, which is the primary Phase I/II manufacturing facility for Pfizer’s biotherapeutic portfolio. This facility manufactures different product modalities and processes including complex formulations, aseptic formulation of vaccine adjuvants, and lyophilization, as well as Lipid Nanoparticles (LNPs) including RNA. Additionally, Mr Schmidt has provided critical support for drug product technology transfer and the design of a $350 million state-of-the-art Global Biotechnology Center in the Hangzhou Economic Development Area (HEDA) in China.Mr Schmidt has been employed by Genetics Institute/Wyeth/Pfizer since 1999. He has experience and interest in aseptic processing, with a focus on optimization of small-to-mid-scale biologic fills to enable flexible, scalable, cost-effective, timely, and compliant production. Prior to this, he worked at Teva Pharmaceuticals and B. Braun. 

Cornell Stamoran, PhD, serves as Vice President of Strategy and Government Affairs for Catalent, Inc (NYSE: CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, protein and gene therapy biologics, and consumer health products. Dr Stamoran leads Catalent’s strategic planning, market intelligence and government affairs efforts, as well as supporting its global M&A and technology innovation and acquisition activities. He also founded and serves as Co-Chair of Catalent’s Applied Drug Delivery Institute (www.drugdeliveryinstitute.com). Dr Stamoran has spent nearly 30 years engaged with the health care industry, including more than 25 years in advanced drug and biologic delivery and outsourcing. Dr Stamoran was recognized as a top Industry Influencer in Medicine Maker magazine’s 2019 and 2018 Power List. Dr Stamoran is a trustee of the Pharma/Biopharma Outsourcing Association, a trade association for CMOs and CDMOs. He also serves as Treasurer-Elect and on the Board of the Controlled Release Society, and chairs its Industry Advisory Group; the Editorial Advisory Board of Drug Development and Delivery magazine; and several industry conference advisory boards. Dr Stamoran also served on the cross-Industry teams which negotiated GDUFA II and OMUFA I with the FDA. Dr Stamoran has published more than two dozen articles on drug delivery, patient-focused drug design, and pharmaceutical outsourcing, and is a frequent speaker on these topics. 

Sathya Venkataramani, PhD, is currently leading the Biologics group as Director in Pre-Pivotal Drug Product Technology, Process Development at Amgen. Dr Venkataramani has a PhD in Biochemistry/Biophysics from University of Zurich, Switzerland and postdoc from Stanford University, CA. She has more than 15 years of experience in discovery and development of antibodies, nanobodies, fusion proteins, multi-specifics; She was employed at Boehringer-Ingelheim (2012-2017) and Janssen Biotherapeutics J&J (2017-2021). She has led projects in multiple therapeutic areas (Ophthalmology, Immunology and Oncology) and has five therapeutic drugs in clinical trials for indications such as Diabetic Retinopathy and Prostate Cancer. Dr Venkataramani owns several publications.