Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important.
What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a potential site have the requisite expertise in multicenter dose escalation studies and the ability to collect the appropriate patient pharmacokinetic and pharmacodynamic biomarker samples? What options are available for a suitable dose-escalation design strategy: Rules-based design (e.g. 3+3 or Rolling-6) or Model-based design (e.g. CRM, etc.)?
In this webinar, speakers will provide a detailed checklist of the key factors to consider in both the US and the EU.
Speakers
Abie Ekangaki, PhD, Vice President, Statistical Consulting, Premier Research
Abie Ekangaki is responsible for bringing expertise in biostatistics to shape clinical trial design strategies and methodologies for regulatory submissions and otherwise and provides broad biostatistical consulting for both internal and external clients. He advises on efficient trial designs for clinical trial programs and applies his statistical expertise, drug development, and operational experience across different therapeutic areas.
With more than 25 years of experience as a biostatistician, Dr. Ekangaki has worked as a research scientist with the World Health Organization in Switzerland, as a statistics lecturer at Macquarie University in Australia, and has over 19 years in the pharmaceutical industry in both large pharma and CROs, where he has held several lead technical and senior leadership positions.
Message Presenter
Peter Larson, MD, Vice President, Medical Affairs, Premier Research
Peter Larson is the Vice President of Medical Affairs at Premier Research. Dr. Larson supports the drug development work of the innovative biotech companies that compose most of Premier Research’s customer base, bringing to the role over 20 years of clinical development and medical affairs experience. He has a background spanning large pharma, startup biotech, and contract research.
Larson’s therapeutic expertise includes hematology, oncology, transfusion and cellular therapies, hereditary coagulation disorders, acute myelogenous leukemia, acute lymphocytic leukemia, multiple myeloma, solid tumors, and virology. His product platform experience includes small molecules, biological products including monoclonal antibodies, cellular therapies, and gene transfer technologies. Prior to joining the industry, he was an assistant professor of pediatrics at the University of Pennsylvania.
After earning a bachelor’s degree in biology and an M.D. from the University of North Carolina, Larson trained in internal medicine, transfusion medicine, and blood banking.
Message Presenter
Meghan Shea, Manager and Solutions Lead, Premier Research
Meghan Shea is a manager and solutions lead, overseeing staff and driving the regulatory/start up strategy for phase I-IV global trials. Shea has overseen clinical trial submissions in over 30 countries. Her key therapeutic experiences are within oncology, dermatology, endocrinology, paediatrics, and rare diseases. Prior to Premier Research, Shea worked as a global regulatory lead at a CRO and contributed to preclinical laboratory research for a biotechnology company focused on novel therapies for treating diabetic nephropathy.
Message Presenter
Federica Vinciati, PhD, Senior Regulatory Start-Up Manager, Premier Research
Federica Vinciati is a senior regulatory start-up manager responsible for leading first-in-human and phase I-IV trials in the EU, North America and Asia Pacific regions. She is responsible for the global regulatory start-up strategy for each given project for products or medical devices in psychiatry, rare disease, cardiology, rheumatology and oncology indications. Vinciati is a Neuroscientist by training with a publication record in neurodegenerative disorders.
Message PresenterWho Should Attend?
Managers and above at biotech and specialty pharma companies with job functions including but not limited to:
- Clinical Operations
- Medical Affairs
- Project Management
- Regulatory Affairs
What You Will Learn
In this webinar, participants will learn about:
- Medical Informatics: Benchmarking similar trials via proprietary and public domain sources to project accurate timelines, anticipate enrollment rates, and identify potential sites
- Site Selection: Vetting identified sites based on their expertise in conducting multicenter phase 1 oncology dose-finding studies, specific relevant capabilities, and local regulations
- Study Design: Considerations for dose-escalation design
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.
As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.
Visit premier-research.com.
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