In this interview Stephanie Pasas Farmer (Ariadne Software, KS, USA), Jeff Hester (KCAS, KS, USA) and Boris Gorovits (Sana Technology, MA, USA) discuss key developments in cell and gene therapy products (CGT). The three opinion leaders address why research into CGT has increased over the last decade and uncover roadblocks they have experienced in CGT assay development, qualification and validation. The current regulatory landscape is also reviewed, highlighting how the bioanalytical laboratory has kept up with the complexity of these products.
- Can you explain why research into CGT products has increased over the last decade?
- What are the challenges associated with developing CGT products?
- What are the major roadblocks with CGT assay development, the qualification and then the validation?
- How has the bioanalytical laboratory kept up with the complexity of CGT products?
- How do you see the development and management of CGT products evolving over the next 5 years?
About the speakers:
Stephanie Pasas Farmer
Stephanie Pasas Farmer is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody–drug conjugate technology. Relying on insights gained over a 20-year career focused on bioanalytical operations across global biopharmaceutical companies, contract research organizations and consulting, Stephanie founded Ariadne Software in 2018 and led development of Red Thread, guiding it from inception to production as an artificial intelligence (AI)-enabled solution for common challenges in bioanalytical data review. Prior to Ariadne Software, Stephanie created BioData Solutions, a scientific advisor firm whose aim is to help sponsors advance early stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning. Before founding BioData Solutions, she led a team of scientists at a global bioanalytical laboratory focused on the support of large molecule and antibody–drug conjugate programs using LBA, LC–MS/MS and cell-based assays. Earlier career roles included management responsibility for quality control functions of bioanalytical laboratory operations, in addition to business development and research scientist positions. Stephanie earned her PhD and MSc degrees with honors in pharmaceutical chemistry from the University of Kansas (KS, USA). She received a BS degree in chemistry from St. Mary’s College of Notre Dame (IN, USA).
Boris Gorovits, PhD, leads In Vitro Pharmacology, Biomarker discovery & Bioanalytical team at Sana Biotechnology, Inc., a group responsible for providing critical research, preclinical and clinical data for a range of gene and cellular therapies developed by the company. Previously Boris worked at Pfizer (MA, USA), where he led teams focused on support of discovery and regulated bioanalysis of biotherapeutics, covering a variety of modalities, including monoclonal monospecific and polyspecific antibodies, enzyme replacement therapies, antibody–drug conjugates, chimeric proteins and gene and cell therapeutics. Boris has built strong ties with various groups within the biotherapeutic development communities, including bioanalytical, immunogenicity of biotherapeutics, gene and cell therapy development. Boris received his master’s degree in chemistry and doctorate in enzymology from the Moscow State University, Russia.
Jeff D. Hester, PhD is currently the Senior Director of the Cell and Gene Therapy Program at KCAS Bioanalytical and Biomarker Services based in Shawnee, Kansas, USA. With over 20 years of experience in the CRO industry, Dr Hester has a successful track record of developing innovative solutions to solve complex business challenges and executing strategies that dramatically improve organizational performance, increase customer satisfaction and accelerate business growth. Previously, Dr Hester was the Vice President of Research and Development at Eurofins ViraCor, Inc., based in Lee’s Summit, Missouri, USA where he was a member of the executive team with P&L responsibility for BioPharma custom bioassays and clinical diagnostics development programs. Dr Hester earned both his BS and PhD in Chemistry from the University of Cincinnati (OH, USA) and has held appointments as both an Adjunct Assistant Professor and Assistant Professor in the Department of Pathology and Laboratory Medicine at the University of Kansas School of Medicine (KS, USA).
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