Exploring Ways to Reduce Costs of Developing and Manufacturing Drug Delivery Technologies

Mahesh Chaubal, PhD is a Vice President, Pharmaceuticals R&D at Baxter Healthcare, where he leads a global R&D team focused on developing critical care injectable products. Prior to his current role, Mahesh was VP and Head of Product Quality at Baxter with responsibility for design assurance, risk management and product quality for pharmaceuticals and medical devices. Mahesh has a B.S. in Chemical Engineering from University of Bombay (UDCT) and M.S. and Ph.D. in Chemical and Biochemical Engineering from University of Maryland. He is also an Adjunct faculty member in the College of Pharmacy at University of Illinois, Chicago.

With over 18 years of industry experience, Ryan Doxey is a seasoned, strategic leader in the areas of CMC Regulatory and Pharmaceutical Development and currently, is the Director of Technical Services (CMC, MS&T and Validation functions) at Kymanox, a professional services organization exclusively serving the Life Science Industry. Mr Doxey’s expertise includes Pharmaceutical and Biopharmaceutical Product Development (Formulation | Process | Analytical), Global CMC Regulatory Requirements and Strategy, Technology Transfer (Pre-and Post-Approval), CDMO/CMO Selection and Management, Program and Portfolio Management, and Clinical Supply Manufacturing and Distribution. He has a specialty and passion for identifying, developing, and delivering practical and innovative solutions for complex, non-conventional, product formulations and drug delivery systems throughout a product’s lifecycle.

Wenlei Jiang, PhD, is a Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert and currently serves as a Senior Advisor for Innovation and Strategic Outreach in the Office of Research and Standards/Office of Generic Drugs. Dr Jiang is leading complex drug product classification and research, promoting global harmonization of bioequivalence criteria, developing opportunities for scientific outreach, and coordinating post-market generic drug safety investigation. She is current Chair at Product Quality Research Institute (PQRI) Steering Committee and serves at National Cancer Institute (NCI) Nanotechnology Characterization Laboratory (NCL) Scientific Oversight Committee. She also co-chairs IPRP Nanomedicine Working Group, and supports ICH M13, generic drug cluster, and other global regulatory affairs activities. Prior to joining FDA, Dr Jiang was at Novartis Pharmaceutical Corporation where her responsibilities included formulation development of conventional liquid and solid dosage forms, as well as advanced parenteral drug delivery systems. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry from The Ohio State University.

Raymond Knox, MBA, is the Chief Manufacturing Officer of Lyndra Therapeutics. Since joining the Lyndra team in 2016, Knox has been responsible for all manufacturing operations including establishing the custom-built GMP manufacturing facility in Lexington, Mass. Mr Knox has significant experience and success across multiple sectors of the pharmaceutical and medical device industries and demonstrated leadership in functions critical to successfully bringing these highly regulated products to market.Mr Knox has led the growth of the manufacturing capabilities in Lyndra, expanding from the R&D facility and establishing GMP clinical manufacturing operations at a new location. Mr Knox’s work has been instrumental in leading the development of this new facility, which is designed to be both cost effective and able to operate at a high volume, incorporating advanced manufacturing capabilities including robotics and continuous manufacturing.Mr Knox has devoted his entire career to the medical device and combination therapy world and has played leadership roles in helping to facilitate the successful commercialization of at least 17 products across new launches and line extensions. Prior to joining Lyndra, Mr Knox spent the majority of his early career working with large multi-national organizations. He has served as the vice president of manufacturing solutions for Ximedica; vice president of operation, product development and quality assurance for Biomedical Inc.; vice president of corporate quality assurance for Boston Scientific; R&D manager for Medtronic; and in roles of increasing responsibility related to mechanical and developmental engineering.Since 2003, Mr Knox has focused on combination drug-device or device drug products. For the last 12 years, Mr Knox has focused on scaling manufacturing to support start-up companies, with a specific passion for bringing those technologies to commercial launch. In his current role as Chief Manufacturing Officer at Lyndra Therapeutics, Mr Knox brings together all of these experiences as he is responsible for scaling unique technologies more typical outside the pharmaceutical industry, specifically in the development of the LYNX drug delivery platform, a first-of-its-kind long-acting oral dosage form.Mr Knox holds a Master of Business Administration from Assumption College and a Bachelor of Engineering (mechanical) from University College Dublin, Ireland. Once a very active soccer player and board member of the Worcester Youth Soccer League, he has moved on to enjoying playing golf (sometimes competitively) with his wife Mary.