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Veristat and CITELINE hosted a webinar on the topic: Single-Arm Studies for Use as a Registrational Study in Oncology
What You Will Learn
Randomized, controlled clinical trials (RCTs) are the FDA-preferred approach for registrational studies in new drug and biologics development, there are circumstances in oncology wherein a single-arm trial may be appropriate due to disease severity, unmet medical need, and concerns about the feasibility of an RCT. Such settings can expedite the development of new treatments for oncology indications, reduce time to product approval and patient access, and demonstrate clinical benefit of novel product(s) on fewer patients.
Join Veristat experts during a live webinar as they discuss single-arm oncology registrational studies, success stories, and lessons learned. The following considerations will be discussed during the webinar:
- How to know if there is an unmet medical need that may allow for a single-arm registrational study
- How to develop a single-arm study design for registration, including:
- Defining the population
- Selecting study endpoints and defining a clinically meaningful benefit
- How to determine a regulatory strategy, including:
- Accelerated approval vs. full approval
- Planning for agency interation - when and how to approach the US FDA and what key questions to ask
Meet the Speakers
Robin Bliss, PhD
Vice President, Strategic Consulting, Veristat
Robin Bliss, PhD joined Veristat in 2011, and is currently Vice President, Strategic Consulting. In her role, Robin oversees and executes Strategic Clinical Development Consulting, collaborating with Regulatory Consulting, Clinical and Medical Consulting and Statistical Consulting. A statistician with 15+ years’ experience, Robin is skilled in planning and implementing complex study protocols, planning and executing study analysis, marketing applications, and providing statistical and strategy representation at regulatory agency meetings. Prior to joining Veristat, Robin worked with Brigham and Women’s Hospital Orthopedic and Arthritis Center for Outcomes Research and with Boston University School of Public Health Environmental Health Department. Robin earned her PhD and MA in Biostatistics from Boston University, US.
Debora Manning, MPH
Strategic Consulting Fellow, Biostatistician, Veristat
Debora Manning, Strategic Consulting Fellow and Biostatistician at Veristat, is a strategic contributor, providing consulting services on study-specific and global programs, including input towards clinical development plans, protocols, study design, biostatistical plans and analysis, and regulatory submissions, and offering expert guidance and support throughout a product’s lifecycle. Her wide-ranging therapeutic expertise includes oncology, neurological disorders, immunodeficiency disorders, and rare diseases. Debora has played pivotal roles in leading interactions with regulators and developing successful marketing applications (NDA, BLA, MAA). Debora received her BA in mathematics from Wheaton College (MA), her MPH in biostatistics from Boston University School of Public Health, and her graduate certificate in regulatory affairs and health policy from the Massachusetts College of Pharmacy and Health Sciences.
Toni Marie Nearing, BS
Principal Regulatory Strategist
Ms. Nearing’s career spans over 30 years of regulatory experience: sixteen and a half (16.5) years as Senior Director in Global Regulatory Affairs within global CROs, 13 years at the FDA in regulatory affairs and legislative policy, primarily with the Center for Drug Evaluation and Research, and five (5) years of Industry experience as Director of Regulatory Affairs in mid-size and large pharma. A key focus of her efforts has been the development of regulatory strategy from proof of concept through successful product registration, launch, and lifecycle management. This has resulted in a successful registration track record, including 505(b)(1) and 505(b)(2) applications and a biologics marketing application.
Toni Marie has been involved in pre-and post-marketing global strategies across numerous therapeutic areas such as (but not limited to): Oncology, Dermatology, Antivirals, Antidepressants and Antipsychotics. She holds a Bachelor of Sciences degree from the University of Maryland, College Park, and has received numerous awards at FDA and in the Industry.
Learn More
- View our Expedited Pathways Infographic
- Learn more about our Regulatory Consulting Expertise
- Download our IND Infographic