Preparing for pivotal: solving challenges in scale for cell and gene therapy clinical trials

Published: 6 August 2021
Innovator Insight
Subbu Viswanathan,
Subbu Viswanathan
Compliance Officer and SVP of Quality, Security, and Compliance, Vineti
Richard Gaeto,
Richard Gaeto
Senior Vice President, Technical Operations at Iovance Biotherapeutics
Rich has been a Technical Operations Executive in the biotech and the Cell and Gene therapy industry for over 30 years. He has an extensive background in commercial launches such as Enbrel, Provenge, Neulasta, and Recothrom, global supply chain strategies, and systems integration regarding personalized medicine, Chain of Custody and Chain of Identity. He has held executive positions at Iovance as Sr. Vice President of Technical Operations, Vice President of Technical Operations at ZymoGenetics and Vice President of Commercial Operations at Dendreon. In addition to on-going consulting roles, Rich has recently completed a full-time Head of Operations position at Imvax focusing on CDMO selection, build out of internal manufacturing, and establishment of an integrated solution regarding CRO, Manufacturing, and Patient Scheduling. Prior to these activities Rich has held positions at Amgen, Immunex, and Centocor.
Erin Goodhue Meyer,
Erin Goodhue Meyer
Attending Physician, Transfusion Service and Apheresis Clinic, Nationwide Children’s Hospital and Director of Clinical Research and Development at Terumo BCT
Chris Greenberg,
Chris Greenberg
Associate Director, Clinical CAR-T Systems at Janssen Pharmaceutical companies of Johnson & Johnson
Jim Wise
Jim Wise
Vice President, Head of Center for Immuno-Oncology, Cellular & Gene Therapy at PRA Health Sciences
Jim has long-term experience managing early through late clinical development, with a primary focus on hematology/oncology indications and advanced therapeutics. Currently, he heads PRA’s Center for Immuno-Oncology, Cellular & Gene Therapy which centralizes cross-functional knowledge expertise and global capabilities in these treatment modalities.

Advanced therapies – such as cell therapies, gene therapies, and personalized cancer vaccines – emerge from uniquely advanced science. The clinical studies behind these therapeutics are some of the most complex in the history of medicine, and must overcome the operational challenges inherent in their patient-centric paradigm. In addition, the transformative nature of these treatments means that a promising early result often leads to accelerated status and pressure to scale rapidly.

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