Overview

Title: Addressing Key Challenges in the Clinical Development of Combination Immuno-oncology

Date: Tuesday, May 15, 2018

Time: 11:00 AM ET

Duration: 1 hour


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Summary

Immuno-oncology (I-O) has emerged as one of the most promising areas of cancer research. New immunotherapies have dramatically benefited thousands of patients, demonstrating improved median overall survival and an acceptable toxicity profile. A confluence of shared—and sometimes competing—interests are driving extraordinarily fast and significant progress, boosted by regulatory approval timelines frequently shortened by priority reviews, breakthrough designations, orphan designations and the support of innovative trial designs.

With the expectation that combination strategies hold more potential than monotherapy, we are setting up combination trials as early as possible in clinical development. From the early phases through to approval, clinical development of I-O combination agents poses significant complexities that can be challenging to address. In this webinar, we explore approaches we have applied to four challenges in I-O combination trials:

  • Planning for programs that are typically large, multinational, resource-intensive and highly specialized
  • Designing innovative modernized trials
  • Activating sites and enrolling patients in a competitive landscape
  • Managing pseudoprogression, immune-related responses and immune-related adverse events

Speakers

Jai Balkissoon

Jai Balkissoon, M.D., FACS
Vice President, Immuno-Oncology
PPD

As vice president of immuno-oncology in PPD’s global product development group, Jai Balkissoon, M.D., provides medical, scientific and product development expertise to clients, internal PPD clinical operations and business development teams. He provides leadership in clinical development strategy from Phase I studies to registration Phase III trials, and discusses clinical development programs with the U.S. Food and Drug Administration on behalf of clients. His development consulting includes investigational new drug submission and clinical input toward protocol development, with the inclusion of adaptive designs when feasible. Dr. Balkissoon has 24 years of clinical oncology experience, including Phase I-III clinical trials. Prior to joining PPD, he was vice president of clinical research at Oxigene and assistant medical director at Genentech. Dr. Balkissoon is board certified and continues to see patients in his oncology clinic. His experience spans many oncology therapeutic areas, including breast, melanoma, colorectal, ovarian and thyroid cancers. He currently is the director of the Bay Area Tumor Institute Melanoma Center, where he manages a multidisciplinary tumor board that evaluates patients with advanced melanoma and reviews current treatment options, which often include enrollment in clinical trials. Dr. Balkissoon earned a Bachelor of Science degree in biology from Beloit College, a Doctor of Medicine from Howard University College of Medicine and completed a surgical oncology fellowship at the National Cancer Institute.

Veronica Vlad

Veronica Vlad, M.D.
Director, Hematology/Oncology
PPD

Veronica Vlad, M.D., is a director in the global project management group supporting hematology/oncology teams at PPD. She has overall responsibility for the strategic direction and operational delivery across the strategic partnership programs and assigned franchise studies and serves as the executive point of contact. With proven success records managing large complex matrix teams, Dr. Vlad successfully liaises with internal departments, sponsors and third-party vendors (data management, central electrocardiogram, central lab, central imaging, IXRS/IVRS, supplies, IDMCs/DSMBs, patient recruitment and retention, etc.). As a subject matter expert in the conduct of both oncology and immuno-oncology studies, Dr. Vlad works together with the PPD Immuno-Oncology Center of Excellence Working Group (IOWG) team to develop strategies to ensure quality performance and to optimize the execution of immuno-oncology trials. Dr. Vlad joined PPD in 2016 with 21 years of research experience, including 16 years dedicated to managing clinical trials in the pharmaceutical and CRO environments and five years as a research physician and clinical trials investigator. Her therapeutic experience in oncology is extensive, including expertise in solid tumors and hematological malignancies, across Phase I-IV studies in adults and children. She brings a breadth of immunooncology experience in early phase, first-in-human, adaptive design, as well as novel-novel combinations studies and translational and exploratory medicine sub-studies of biomarkers. Dr. Vlad is also experienced in quality assurance initiatives including ICH-GCP audits and FDA and EU Regulatory Authorities’ inspections. Repeatedly recognized for exceptional performance throughout her career, Dr. Vlad is an executive with a unique combination of medical and scientific knowledge, global operations expertise, excellent leadership skills, and an ability to communicate easily and effectively at all levels to ensure successful outcomes.