Principles of CAR T Cell Therapy and the Pathway to Regulatory Approval

Life Sciences, Drug Discovery & Development, Commercialization & HEOR,
  • Tuesday, June 18, 2019

For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as “CARs”. The CAR enables the final product to produce chemicals in the hopes that the “enhanced” product or cells will bind to the cancer cells and kill them.

The industry has seen successes in using CAR T therapy in several blood cancers, including acute myeloid leukemia, acute lymphoblastic leukemia and lymphoma. Some of these unique therapies have already been cleared by the US Food and Drug Administration (FDA), but the pathway to the clinic comes with several challenges.

In this free webinar, learn about the principles of CAR T cell therapy and the ways these technologies can reach patients.


Brian D. Marks, Premier Research

Brian D. Marks, BSc, DC, Senior Director, Project Delivery, Oncology, Premier Research

Dr. Brian Marks has worked in clinical research for more than 20 years, and his extensive background covers the spectrum from single-site studies to large, multinational trials. He joined Premier Research in 2018 to oversees and manages the Oncology Franchise (Business Unit) to ensure program progress is according to client and Premier Research requirements and recommends and drives necessary courses of action to keep program on track.  Brian oversees and chairs OMCs and Joint Steering Committees as key team member with customers, monitors the health and growth of missioncritical accounts and assists in the creation, development and nurturing of key strategic customer relationships.

Prior to joining Premier Research, Dr. Marks was a Director of Strategic Initiative Management, Director of Project Management and a Senior PM at ICON clinical research.  At GlaxoSmithKline, Brian Marks was a Manager of Study Management, Program Lead and a Lead study Manager.  Brian was also a Clinical Research Monitor at both Ingenix Pharmaceutical Services and PPD.

Brian Marks Received his Doctorate in Chiropractic as well as his Bachelors in Science in Human Biology from Logan College of Chiropractic.  Brian also received his Bachelors in Arts in Psychology from the State University of New York at Albany.

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Ashley Jones, Premier Research

Ashley Jones, MSc, Project Lead, Project Management, Oncology, Premier Research

Ashley joined the Premier Research team as a Senior Project Manager in 2017. Prior to her tenure with Premier Research, she worked for Quintiles for approximately seven years, with four years in project management and three years in clinical management. Ashley was integral in the creation of the Stem Cell Center of Excellence at Quintiles, and currently helps develop strategies for CAR-T and other immuno-oncology opportunities at Premier.

Ashley’s primary area of therapeutic expertise includes phase 1-3 oncology studies conducted in the US and globally with a special interest in pediatric hematopoietic stem cell transplantation and graft versus host disease, as well as phase 1 and 2 acute lymphoblastic leukemia studies and phase 1 and 2 studies in advanced malignancies.

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Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

In this webinar, attendees will explore:

  • Principles of CAR-T cell therapy
  • FDA-approved CAR-T cell therapies
  • Operational and clinical pathways that bring CAR-T cell therapies to patients
  • Challenges with clinical application

Xtalks Partner

Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech, specialty pharma, and medical device companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,100 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.

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