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Alliance for Regenerative Medicine’s Immuno-Oncology Clinical & Patient Education Roundtable

Alliance for Regenerative Medicine’s Immuno-Oncology Clinical & Patient Education Roundtable

On May 24, 2016, Friends cohosted the 2016 Immuno-Oncology Clinical and Patient Roundtable with the Alliance for Regenerative Medicine. This roundtable consisted of experts in the field of immuno-oncology and regulatory health policy, as well as patients. Panelists came from diverse backgrounds, including academia, industry, and government. The event aimed to educate and inform major stakeholders in cancer research about the most recent scientific breakthroughs and the challenges faced by researchers and policymakers in the field of immuno-oncology.

The roundtable began with opening remarks from Ryan Hohman, J.D., Managing Director, Public Policy and Affairs at Friends, and Morrie Ruffin, Co-Founder and Managing Director of the Alliance for Regenerative Medicine. Both Hohman and Ruffin noted that while scientists are making major strides in developing innovative cancer treatments, there is still much work to be done, and this panel is critical to convening key players and sharing valuable information. Three informational and complementary panels followed the opening remarks.

Panel One – The Clinician and Patient Relationship

  • Jamie Goldfarb, Melanoma Survivor & Patient Advocate; Research Advocate, National Cancer Institute
  • Steven Rosenberg, M.D., Ph.D., Chief, Surgery Branch; Senior Investigator; Head Tumor Immunology Section, Center for Cancer Research, National Cancer Institute

The first panel discussed the history and theory behind immuno-oncology and provided insight on the treatment process from the viewpoints of both the patient and the doctor.  Dr. Rosenberg has been Chief of Surgery at the National Cancer Institute for 40 years, and is a pioneer in the field of immuno-oncology. Dr. Rosenberg explained that immuno-therapy means developing treatments that stimulate the body’s own immune system to fight a disease. For cancer, this means identifying and isolating T-cells, and using adaptive cell therapy to train the T-cells to recognize and attack the cancer. Dr. Rosenberg used immuno-therapy to cure Jamie’s Stage 4 Melanoma. Dr. Rosenberg noted that nearly 60% of Melanoma patients will respond to this treatment, and the cancer almost never returns. Both Dr. Rosenberg and Jamie expressed their excitement over these groundbreaking medical advances, but also described the challenges that remain. Dr. Rosenberg explained that this is a very complex and expensive process; a new therapy has to be developed for each patient, and the therapy does not always work. Jamie said the system would greatly benefit by creating a patient education component. Much of the literature is confusing for those outside the medical field, and Jamie doesn’t want patients to have to rely on their doctors as gatekeepers for information on clinical trials.

Panel Two – Immuno-Oncology in Cell & Gene Therapies

  • Tina Albertson, M.D., Ph.D., Medical Director, Juno Therapeutics
  • Renier Brentjens, M.D., Ph.D., Director, Cell Therapy Center, Memorial Sloan Kettering Cancer Center
  • Shawn Leland, Pharm.D., Senior Director, Corporate Development and Strategy, Argos Therapeutics
  • Kimberly Noonan, Ph.D., Research Associate, Johns Hopkins School of Medicine
  • Madhusudan Peshwa, Ph.D., Chief Scientific Officer, Executive Vice President, Cellular Therapies, MaxCyte (Moderator)
  • Isabelle Rivière, Ph.D., Director, Cell Therapy and Cell Engineering Laboratory, Memorial Sloan Kettering Cancer Center

The second panel discussed recent developments and challenges in immuno-oncology in cell and gene therapies. At Memorial Sloan Kettering Cancer Center, doctors have been able to manufacture CAR T-cells for patients to treat their cancer. This has led to a breakthrough and orphan drug designation. Dr. Brentjens noted that we now “need industry to move this into something that can get to patients.” Dr. Albertson added that Juno Therapeutics is working to make discoveries in immuno-therapy that allow treatment to be “brought to the masses.” Juno is combining CAR T-cells with checkpoint inhibitors to develop therapies that work in more patients. All panelists agreed on the importance of streamlining and improving the drug manufacturing process and developing meaningful partnerships between academic institutions and industry. Dr. Albertson explained that “the pharmaceutical industry can bring infrastructure needed to make CAR T-cell therapies efficiently and available at more cancer centers.” Dr. Brentjens added that “partnering academic technology with the pharmaceutical industry is not a choice of if, but when.” Several panelists stressed the importance of having an open dialogue with patients and reaching out to advocacy groups to ensure that patients are a part of this process and are aware of new trials and treatments that could benefit them.

Panel Three: The Three P’s: Politics, Policy, & PDUFA

  • Jeff Allen, Ph.D., Executive Director, Friends of Cancer Research (Moderator)
  • Raj Puri, M.D., Ph.D., Director, Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA)
  • Marc Theoret, M.D., Lead Medical Officer, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
  • Michael Werner, J.D., Co-Founder & Executive Director, Alliance for Regenerative Medicine

The third panel focused on the policy and future of immuno-oncology, and was moderated by the Executive Director of Friends, Jeff Allen, Ph.D. Dr. Allen began by asking the panelists if they were surprised at the state of science today or if it’s what they expected. Dr. Theoret said he was “surprised with the rapid development over the recent years.” Dr. Allen then asked about FDA guidance and what it means to co-develop. Dr. Puri commended the FDA for being forward thinking, specifically on the guidance document, and on the close collaboration between CBER and CDER. Dr. Werner added that “the agency goes out of its way to be transparent and collaborative,” and he feels that the collaboration within the FDA is good. Dr. Puri also noted that new policy councils and an office of combination products have been created at the FDA to help facilitate collaboration between centers. This requires more people and interaction with industry to help speed approvals. The panel discussed breakthrough therapies next. Dr. Theoret commented that preliminary breakthrough therapy discussion offers the opportunity with a review team to discuss a specific product and see if the evidence is supportive of a breakthrough therapy designation. “Folks want to optimize this process. Quite a bit of progress has been made in manufacturing,” added Dr. Puri. Dr. Werner also addressed the need for patient inclusion in these processes, and said that “there’s been an effort over the last several years to include greater patient voice in clinical development.” The panel closed with a discussion of how to balance the needs of the patients with the rules and regulations of the FDA.

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