Novel Trial Approaches for Rare Cancer Patients

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

This shifting paradigm may well underestimate the incidence of rare cancers, and further underscores the need for innovative approaches in developing new therapies. Challenges include patient access, biomarker testing requirements, selecting the right endpoints, developing alternative study designs that minimize sample size and improve data outcomes, and an ever-changing regulatory landscape.

This webinar will explore the promise and challenges associated with the planning and execution of rare cancer trials.

Speakers

Rupa Doshi, PhD, Executive Director – Program Strategy, Oncology, Premier Research

Rupa Doshi is an executive director of oncology at Premier Research. With more than 23 years in the industry, Dr. Doshi is an experienced professional with demonstrated leadership skills in clinical operations, global project/program management, customer management and strategy development. Her experience spans the clinical development spectrum from pre-IND to NDA and she has also led global teams in the execution of full service complex clinical trials across all phases.

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Sameena Sharif, PhD, Senior Vice President, Product Strategy, Premier Research

Sameena Sharif is a pharmaceutical executive with 22 years of experience as a leader in drug development, alliance, project and portfolio management. She has broad experience in management of projects at all stages of drug development – as early as target selection, to pre-IND through to NDA/MAA submissions and commercial planning. She has also led large cross-functional teams in global alliances with Amgen, Otsuka, Genentech, Novartis, Onyx and AstraZeneca. She has a special interest in optimization of the drug development and alliance management process in small and midsize companies.

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