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.
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.Message Presenter
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.Message Presenter
Who Should Attend?
Managers and above at oncology 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
This webinar will explore the impact of scientific advances on the operationalization of rare oncology clinical trials, examining these topics:
- Optimizing your product development to improve planning and execution of rare cancer trials
- Small patient populations, and the impact on trial outcomes
- Predictive biomarkers and companion diagnostics
- Rare cancer trial designs amid a shifting regulatory landscape
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.