Seizing the Future in Oncology: Improving the Clinical Development of Immunotherapies

Recent development of drugs targeting immune checkpoint proteins have shown high efficacy and long term patient benefit. As a result, there is great excitement in the pharmaceutical and oncology fields as these drugs promise to truly restore immune anti-tumor activity to broad patient populations across many indications. Cancer vaccines have also shown promise based on advances of adjuvants, combinations, biomarkers and new targets. However, the complexity of the immune system and tumor biology as well as comorbities and concomitant therapies may slow progress in immune-oncology clinical development. One early example of the impact of this complexity is seen in the challenges of patient enrichment and companion diagnostic development for PD-1/PD-L1 targeted drugs especially in combination studies. Another important lesson learned is determining the most appropriate endpoint for an immunotherapy as early use of the RECIST confounded investigators. Nevertheless, the immune system offers many future targets for immune checkpoint inhibitors, targeted immunomodulators and drug combinations including cancer vaccines.

The landscape for immunotherapies in oncology is expected to expand greatly in the near future as the initial checkpoint inhibitors come to market while development continues on broad immunomodulators and cancer vaccines. Follow-up checkpoint inhibitors targeting LAG3, OX40 and other novel proteins and novel combinations may provide new options for cancer patients. The complexity of the immune system and tumor biology also offers a wealth of biomarkers and potential targeted indications and patient populations. New diagnostic tools such as more powerful and better standardized flow cytometry and nex-gen sequencing can better profile immune response and utilize the immune repertoire for patient selection. Application of these tools in clinical development and patient care has yet to be fully exploited. Optimal clinical strategies including drug dose and schedule to mimimize risk of toxicity and the most appropriate clinical endpoints must address the unique mechanisms of action of these drugs.

As the field moves beyond initial successes, it will be important to explore these biomarker opportunities as well as address the critical questions in clinical trial design to best advance immuno-oncology clinical research.

This webinar will discuss key considerations in the development of immuno-oncology therapeutics including:

• The commercial and drug development landscape including immunomodulators, immune checkpoint inhibitors and cancer vaccines.
• Technologies and biomarkers for pharmacodynamic and patient enrichment strategies
• Options for measuring patient response and study endpoints for immuno-therapies
• Current and future therapeutic approaches and combinations for improving immune anti-tumor activity and patient outcomes

The audience can expect to gain the following insights:

• A high level overview of the current state of immuno-therapies in oncology
• Insights into future opportunities for new immuno-oncology targets, biomarkers, therapeutic approaches and precision medicine
• An understanding of the scientific and clinical considerations in designing immuno-therapy studies and treatment options
• An appreciation for the requirements for translating a biomarker and assay into a companion diagnostic

Speakers

Chris Learn PhD, PMP, Senior Clinical Project Manager , Quintiles

Dr. Learn is a Senior Clinical Project Manager at Quintiles Oncology, where he leads numerous global oncology studies and regional trials, assuming full operational and financial accountability for each. Additionally, Chris is the curator for the Quintiles Oncology Journal Club, a forum of collaboration on clinical and scientific trends in cancer research and patient management for Quintiles’ clinical and operations oncology experts across more than 30 countries. Prior to Quintiles, Dr. Learn has worked on research for molecular immunotherapies for malignant glioma at the Division of Neurosurgery at Duke University Medical Center, Durham, NC. In this role, Dr. Learn authored and led the implementation of three separate investigator-initiated clinical trials. Dr. Learn is also a Certified Project Management Professional.

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Brad Smith, PhD, VP of Translational Medicine, Quintiles

Brad Smith currently is a VP of Translational Medicine within the Integrated Clinical Services Group at Quintiles Transnational, the leading global CRO supporting drug development, consulting and commercial solutions. In this position, Brad supports laboratory, clinical and diagnostic strategies for drug development as well as the development of innovative tools for targeted drugs and companion diagnostics. Previously, Dr. Smith led Corporate Development at Cell Signaling Technology Cell, an innovative biotechnology company in the life sciences field. In this position, Dr. Smith focused on new diagnostic and clinical partnerships and markets. His previous positions at Cell Signaling Technology include management of research and clinical technology development departments and laboratories. Previous to Cell Signaling Technology, Dr. Smith directed product development and production at Santa Cruz Biotechnology, helping to build that company into one of the largest supplier of research tools for basic research. Dr. Smith’s scientific background includes research positions at Stanford University and University of California, San Francisco focused on cellular signaling mechanisms of disease. Dr. Smith holds a Doctoral degree from Stanford University and Master’s and Bachelor’s degrees from University of California, Santa Cruz.

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Eric Groves, MD, PhD, VP, Center for Integrated Drug Development, Quintiles

Dr. Groves is board certified in oncology and internal medicine and has over 26 years experience in drug development as senior manager/corporate officer, clinician and researcher. Dr. Groves experience in oncology clinical development covers a variety of senior leadership roles in clinical and pre-clinical development of oxaliplatin, rasburicase, IL-2, tirapazamine, immunotoxins, bexarotine, ONTAK, AVINZA, and thrombopoietin. This work has resulted in five successful US registrations, four for Europe, multiple INDs, and creation of new clinical and project management groups for Pharmaceutical companies, start-up to multi-national. His research experience ranges across proteins and small molecular in oncology, inflammation, pain, dermatology, and other areas.

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