This webinar will provide insight into some of the current issues in progressing oncology compounds from the pre-clinical arena through early clinical development in humans, with specific focus on three areas of early oncology research that can make or break these critical first-in-man studies.
Given the increasing R&D spend and regulatory hurdles that must be navigated in getting new drugs to global markets, and particularly the high failure rate of Phase 3 studies in oncology, setting the right course early in clinical development is critical. The framework for deciding to progress to human studies, and the goals and expectations of early clinical development requires critical appraisal. The overarching hypothesis to be presented is that consideration of the issues presented in this webinar could provide additional insight for better decision making in the early development of oncology compounds.
This webinar will examine:
- The current landscape, trends, and challenges of early clinical development in oncology
- Future approaches to improving Phase I oncology studies
- Leveraging patient selection in early oncology studies through molecular profiling of potential subjects
The audience can expect to gain the following insights:
- An understanding why decisions made in early clinical development can either increase or mitigate risks at Phase III
- Factors to consider in the decision to advance an oncology compound into humans
- Approaches to maximize and extract value from early clinical development studies
- The importance of studying selected patient populations in early clinical development
- The value of creating a pool of molecularly pre-profiled patients in early clinical development (e.g., understanding critical execution risk areas of Phase I oncology studies)
- Considerations for determining your biomarker strategy in early phase
- How to maximize data quality and reach critical go-no go decisions faster in Phase 1 Oncology trials
Philip Breitfeld, MD, Vice President and Therapeutic Strategy Head, Oncology Therapeutic Area, Quintiles
Dr. Breitfeld has over 25 years of work experience in oncology, including 20 years of experience in academic medical institutions in the US, and 7 years of experience in the pharma industry focused exclusively on oncology drug development and execution of clinical programs.
Prior to joining Quintiles he held senior oncology clinical development positions at BioCryst and Merck Serono. He has around 50 peer-reviewed publications in the scientific literature, and was a Visiting Scientist at the Whitehead Institute at MIT.
Expertise: Clinical oncology, clinical trial design, clinical program design and leadership, clinical science-operational delivery integration; background in molecular biology and informatics.
Dr. Breitfeld received his undergraduate degree from Princeton, his MD from the University of Rochester, and was a clinical and research fellow (Pediatric Hematology-Oncology) at the Dana-Farber Cancer Institute at Harvard. He completed a second fellowship in Medical Informatics sponsored by the National Library of Medicine. He was a Visiting Scientist at the Whitehead Institute at MIT.
Eric Groves, MD, PhD, Vice President, 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.
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, he 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, he Learn authored and led the implementation of three separate investigator-initiated clinical trials. Dr. Learn is also a Certified Project Management Professional.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 25,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.