In this webinar, Syneos Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
Unique issues arise with each novel immunotherapy treatment, including the selection of relevant endpoints, inclusion of appropriate patients, and surveillance of immuno-modulated adverse reactions. These new immunotherapies pose further challenges for sponsors in ensuring regulatory approvability and compliance, given that there is a separate and very different regulatory framework for each novel mechanism of action. In both the US and EU, distinct regulations apply to cell-based medicinal products, gene therapy, antibodies, and therapeutic vaccines.
Once scientific and regulatory plans have been determined, planning how many sites or how much time it will take to enroll the required number of patients into a trial of a new immunotherapy is sometimes more art than science because there is comparatively little established past history on which to base patient enrollment projections. Therefore, the feasibility processes of estimating the enrollment rate for newer immunotherapies necessarily involves supplementing evidence with the judgment of a multidisciplinary team of experts.
Clinical trials of cancer immunotherapies are, as a result, quite different from those with other cancer therapeutics; they require special planning and are subject to unique medical, regulatory, and operational considerations.
Learning Objectives:
- Review classes of immunotherapies and their associated mechanisms of action
- Understand challenges in protocol design and safety surveillance of new trials of immunotherapies
- Identify potential regulatory approval challenges and regulations applicable to novel immunotherapies
- Understand methods for estimating feasibility and planning on trials of immunotherapy products
Speakers
Joseph O’Connell, MD, Vice President, Medical & Scientific Affairs, Hematology & Oncology, Syneos Health
As the VP for Oncology and Hematology within Medical and Scientific Affairs, Joseph O’Connell provides leadership and strategic input to our Hematology & Oncology therapeutic area to broaden and deepen our medical expertise.
Dr. O’Connell completed his Medical Oncology Fellowship at Memorial Sloan Kettering, where his clinical development experience included work on Phase 1-3 studies in solid tumor. Prior to joining industry he practiced adult medical oncology in community and academic settings, the latter as a member of the Thoracic Oncology Clinic of Yale Comprehensive Cancer Center.
Dr. O’Connell joined Pfizer in 2007 in Clinical Development where he led several Phase 2-3 studies focused in solid tumor. In 2013 he was appointed the Lung Franchise-Clinical Development Lead, leading a team of ten clinicians. Thereafter, Dr. O’Connell worked in Medical Affairs for Pfizer in a field-based role interacting with community and academic HCPs, US payers, and national pathway organizations, supporting both hematologic and solid tumor programs.
Message Presenter
Tony Catka, PhD, Senior Director, Regulatory Policy & Intelligence, Syneos Health
As the Senior Director of Regulatory Intelligence and Policy, Tony ensures that Syneos Health has the tools to provide the regulatory information that the clinical organization needs to stay abreast of changes that affect clinical trials worldwide and provides analysis of regulatory guidance, precedents, and the emerging environment to the clinical and Regulatory Strategy and Consulting organizations to prepare robust proposals and deliver sound regulatory strategies for our clients. He is one of three Syneos Health representatives to ACRO. Tony holds a Bachelor’s degree in Chemistry from the University of Detroit, and a Ph.D. in organic chemistry from the University of Minnesota. Tony has over 30 years’ experience in life science industries with the last 12 spent in pharma and pharmaceutical regulatory consulting.
Message Presenter
Len Correale, JD, Associate Director, Feasibility Optimization & Site Intelligence, Syneos Health
As the lead of the Feasibility Optimization team at Syneos Health, Len spearheads the use of innovative and specialized analytics to provide client-focused risk mitigation, planning, and clinical trial scenario development. Len has over 11 years of clinical research industry experience across a variety of fields, including: strategic partnership development, cross-functional operational engagement, and data analysis to drive strategic decisions. He has co-authored recent and forthcoming thought leadership papers on country selection in clinical trials, enrollment benchmarking, and uses of claims data to inform investigator selection. Len holds a Bachelor’s degree in Psychology from the University of Delaware, and a Juris Doctor from Widener University – Delaware Law School. Prior to his career in clinical research, Len worked with the in-house Litigation department of a multi-national Fortune 100 company.
Message PresenterWho Should Attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device companies working within Oncology and Hematology clinical trials, including the areas of:
- Clinical Operations
- Data Management
- Regulatory Affairs
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Syneos Health
Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.
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