ISPE-CaSA 2020 Webinar Series - Innovative Approaches Needed in Cell & Gene Therapy Production
June 3, 2020 1:00 - 2:30 p.m.
Applying Innovative PM Principles in Accelerating Cell and Gene Therapy Programs
By Michael Gorman, PMP, LSSBB, Principal Consultant, DPS Group
Uncertainty and complexity present innovators with countless challenges in developing early-stage cell and gene therapy programs. With a “patient, product, process” mindset, companies must navigate countless trade-offs to deliver safe and efficacious therapies appropriate for the product lifecycle stage. This presentation will discuss program management approaches seeking to find effective, harmonious solutions utilizing both traditional “left to right” milestone-based planning & controls with flexible, agile principles which foster innovation and enable flourishing through the expected unexpected.
Michael Gorman has over 20 years’ experience in guiding life science companies in navigating a risk-managed, best-value path from pre-IND to commercialization. With balanced experience as both manufacturer and service-provider, Mike has directed multiple, diverse cross-functional teams through the technology transfer process. At DPS, Mike helps clients develop strategy and systems for their technology transfer, CMC, manufacturing supply chain, and alliance management programs, so they can quickly and effectively deliver quality therapeutic products. He works with DPS clients across a spectrum of technologies and modalities, with a focus in biologics – including both traditional and advanced therapeutic cell and gene therapies.
Application of the FDA Guidance to Process Validation
By Ramesh Maragh, Lead Technical Consultant, DPS Group
This presentation will focus on application of the 2011 Process Validation Guidance and its importance to manufacturing robus and compliant products. It will draw in a case study on its relevance to the Life Science industry and show the interdependencies of the complex regulatory compliance, process develop and life-cycle management relationships.
Ramesh Maragh is a passionate and dedicated engineer, scientist, and leader that models the way to define the current manner that highly scientific, technical, and regulated drug products are formulated, scaled, and optimized for routine commercial manufacturing including technology transfers. With over 20 years of industry experience Ramesh has worked within Analytical Research and Development, Manufacturing Science and Technology, Quality Assurance, and Operations with expertise in process development, optimization, validation (PPQ), and commercial product support (Deviation/CAPA management). Ramesh enjoys mentoring teams on application of compliance and science to produce the best medicines for the betterment of mankind.
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