Optimizing iPSC therapies: strategies for safe, cost-effective, and scalable manufacturing

Kevin joined RoslinCT in 2019 as Chief Operating Officer, where he oversaw the company’s growth from 50 to 220 staff, establishment of a new manufacturing facility and acquisition of the company’s commercial manufacturing licence from the MHRA. He has recently moved to the role of Chief Technology Officer and is responsible for developing and enhancing the company’s services and capabilities by leading the technology vision and strategy.

Kevin has more than 20 years working within the biotech industry, with a focus on cell therapy development and manufacturing, specifically with pluripotent stem cells. Before joining RoslinCT, Kevin held positions in Operations, Quality, R&D and commercial development.

He has been in the Roslin family for over 16 years and played a key role in development of Roslin Cells’ clinical-grade pluripotent cell lines and GMP translation and manufacture of cell therapies for both pre-clinical and clinical development. More recently, as COO at Censo Biotechnologies, he established the operational capability for the European Bank for Induced Pluripotent Stem Cells and was responsible for Censo’s stem cell generation, genome editing and assay development operations for drug discovery.

Dr. Kapil Bharti obtained his Ph.D. from J.W. Goethe University, Frankfurt, Germany, graduating summa cum laude. His Ph.D. work involved research in the areas of molecular chaperones and epigenetics. He did his postdoc at the National Institutes of Health, where he published numerous papers in the areas of transcription regulation, pigment cell biology, and developmental biology of the eye. His lab at the National Eye Institute recently received started the first U.S. phase I/IIa trial to test autologous iPSC-derived RPE patch in AMD patients. Currently, he is co-developing a dual RPE/photoreceptor cell therapy with Opsis Therapeutics. He has published over 100 peer reviewed manuscripts and reviews, given over 30 keynote and named lectures, won several awards including the two times winner of the Public Service Award for the International Society for Stem Cell Research (ISSCR), two times winer of the NIH Director’s award, NEI Directors Dr. Karl Kupfer Visionary award, and Sayer Vision Research lecture at NEI for his pioneering role in advancing the field of stem cell based therapies. He has filed 18 patents; six have been issued already. He serves on the advisory board (pro bono) of several stem cell therapy-based companies and patient-advocacy groups. His current work as a Senior Investigator at NEI involves understanding mechanism of retinal degenerative diseases using induced pluripotent stem cell derived eye cells and tissues, and developing cell-based and drug-based therapies for such diseases. He is the Scientific Director of the NEI Intramural Research Program where he oversees 21 research labs, 6 core facilities, and a staff of over 350 people.

Ivana Barbaric completed her DPhil at the University of Oxford in 2006. She then joined Professor Peter Andrews’ group at the University of Sheffield to study the mechanisms that underlie human pluripotent stem cell (hPSC) fate. She was appointed to a Group Leader position at the Centre for Stem Cell Biology, Sheffield in 2014. Her research is focused on the basic biology of hPSCs and their applications in disease modelling and cell therapy. In particular, her group is investigating the causes and consequences of genetic changes in hPSCs, including the impact of mutations on stem cell fate decisions and lineage specification during early development. Her work on culture-acquired genetic changes in hPSCs is also informing strategies for reliable detection and minimising the occurrence of genetically variant cells, necessary for safe and efficient clinical translation of hPSC-based therapies. As a member of the Steering Group of the ISSCR Task Force on Standards for Stem Cell Research, Ivana co-chaired the Working Group on Genomic Characterization of stem cells. She is Chair of the International Stem Cell Initiative, the General Secretary of the British Society for Gene and Cell therapy and a member of the ISSCR Manufacturing, Clinical Translation and Regulation Committee.

Pete is senior director of Cell Therapy Engineering at bit.bio, where he is responsible for derivation of gene engineered iPSC lines for cell therapy. Pete has over 20 years experience in stem cell research. He completed a PhD at the University of Sheffield (UK) and Post-doctoral research at the Lunenfled-Tanenbaum Institute (Toronto) studying somatic cell reprogramming to iPSCs and transgenics. Pete continued to follow his passion in stem cells and regenerative medicine with positions at Centre Commercialisation Regenerative medicine (CCRM, Toronto) and BlueRock Therapeutics, where he led the establishment of clinical-grade iPSC platform.

As a Principal Scientist at RoslinCT, Dr. Flynn brings nearly two decades of valuable research and manufacturing expertise in the fields of gene and stem cell therapy, cultivated through experiences in both industry and academia.

In his prior role as the Head of Pluripotent Sciences at Censo Biotechnologies, he led iPSC manufacturing, gene editing, and innovation projects for biotech and pharma clients in the US and EU.

Prior to joining Censo, Dr. Flynn developed gene editing strategies for academic and industrial partners as part of the StemBANCC project at the University of Oxford where he also conducted independent research in motor neuron disease using genetically modified iPSC-derived cell models.

As a fellow at the University of Washington in Seattle, he demonstrated the efficacy of HD-Ad viral vectors in delivering therapeutic transgenes to treat cardiovascular disease and reverse atherosclerosis in large animal models and developed a cell-therapy-based strategy for the treatment of dystrophic epidermolysis bullosa using genetically modified iPSC-derived keratinocytes. Dr. Flynn holds a PhD in Molecular Physiology, an MSc in Biotechnology and a BSc in Microbiology.

Dr. Ressler is responsible for managing the Analytical Development, Process Development, and Manufacturing Sciences & Technology (MS&T) teams. The mission of these teams is to create robust, GMP-compliant processes and assays for RoslinCT’s partners, and to facilitate transfer to Manufacturing and QC.

Prior to her role as Vice President of Manufacturing Process Sciences at RoslinCT USA (formerly Lykan Bioscience), she was Senior Director of Process Development at Mustang Bio, and Director of Cell Manufacturing at Editas Medicine. She has helped move several cell and gene therapy (CGT) products into the clinic and has contributed to three licensed CGT products, including a recently successful biologics license application for RETHYMIC®. Dr. Ressler is passionate about completing the monumental work required to bring life-saving CGT products to market. She strives to build quality data sets that can be used to drive decisions and deepen our understanding of our partners’ products and processes.

Dr. Ressler started working in the CGT industry when there was only one FDA-approved product, and she looks forward to being involved in several more approvals as the industry grows. She has a B.S. in biomedical engineering from Northwestern University and an S.M. and Ph.D. in mechanical engineering from the Massachusetts Institute of Technology.