Preparing for Pivotal: Solving Challenges in Scale for Cell and Gene Therapy Clinical Trials



Tuesday, June 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

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Event Overview:

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 may result in accelerated status and pressure to scale rapidly.

With more than 1070 advanced therapy clinical trials operating world-wide, the need for solutions that simplify and scale cell and gene therapy studies is urgent. In this webinar, veteran experts will share proven solutions for clinical scale.

Key Learning Objectives:

  • Understand some of the unique operational aspects of advanced therapy clinical trials, including combined study phases and accelerated timelines.
  • Analyze the importance of pivotal trials for cell and gene therapies and how the unique features of advanced therapy clinical studies affect preparations for pivotal trials.
  • Evaluate solutions that simplify and optimize preparations for pivotal trials in cell and gene therapies.

Who Should Attend:

People who attend the webcast should have the following job titles/keywords in their title:

  • Systems
  • Information Systems
  • Supply Chain
  • Manufacturing
  • Technical Operations
  • Tech Ops
  • Operations
  • Clinical Operations
  • Chief Medical Officer
  • CMO
  • Chief Scientific Officer
  • CSO
  • Logistics

For any questions please contact Kelsey Barry:


Moderator: Subbu Viswanathan
Compliance Officer and SVP of Quality, Security, and Compliance

Subbu Viswanathan’s area of specialty is compliance in the cloud, from GxP to data privacy and security regulations (such as HIPAA, GDPR); he now leads this effort for Vineti. Additionally, he has led software development, process automation, agency inspection preparedness, agency compliance, and remediation efforts for a variety of life science companies.

Rich Gaeto
Technical Operations Consultant

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 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.

Jim Wise
Vice President, Head of Center for Immuno-Oncology, Cellular, & Gene Therapy
PRA Health Sciences

Jim Wise has long-term experience managing early through late clinical development, with a primary focus on hematology/oncology indications. 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.

Chris Greenberg
Associate Director, Clinical Supply Chain Systems
The Janssen Pharmaceutical Companies of Johnson & Johnson

Chris Greenberg is the business owner within Clinical Supply Chain Systems for all systems supporting the CAR-T program at Janssen. He is responsible for the design, development, and implementation of CAR-T systems, and is a subject matter expert for the implementation of IVR/IWR systems. He has over 19 years of experience developing IVR/IWR systems for use in clinical trials working on the supplier side and the sponsor side and over 16 years of personnel and vendor management experience. He is a key contributor to the implementation of the Medidata Balance product within Janssen.

Erin Goodhue Meyer, M.D.
Attending Physician, Transfusion Service and Apheresis Clinic, Nationwide Children’s Hospital
Director of Clinical Research and Development, Terumo BCT

Dr. Erin Goodhue (nee Meyer) is a national leader in therapeutic apheresis. She is the Director of Clinical Research and Development at Terumo BCT and is leading a team of Clinical and Laboratory Scientists who will collaboratively evaluate, prioritize, and implement developed strategy including clinical trial protocol development and post market studies. Dr. Goodhue continues to work part-time as an attending physician at Nationwide Children’s covering the Transfusion Service and Apheresis Clinic. In her previous position as the Executive Medical Director of Direct Patient Care at the American Red Cross, she developed Red Cross’s national educational offerings surrounding therapeutic apheresis, hematopoietic stem cell, and immune effector cells. In collaboration with her medical office colleagues, Red Cross therapeutic apheresis procedures increased significantly through her tenure to over 15,000 procedures per year. Dr. Goodhue was part of the core team launching Red Cross’s COVID-19 convalescent plasma collection program in 2020. Dr. Goodhue received her medical degree from the University of New England College of Osteopathic Medicine. She then went on to dual residencies in Anatomic and Clinical Pathology as well as Preventative Medicine at the Dartmouth-Hitchcock Medical Center while earning her MPH at the Geisel School of Medicine at Dartmouth College. Dr. Goodhue then completed a fellowship in Transfusion Medicine and Apheresis at the Joint Program in Transfusion Medicine at The Harvard Medical School. Her first position was as a transfusion medicine and apheresis attending physician at Emory University and Children’s Healthcare of Atlanta.

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