Oncology Phase 1 Trials:
The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

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.

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.

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.

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.