Back to: FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
Presentations
An Oncology Drug Development Mindset – First Steps
Jeff Summers, MD
Associate Office Director
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Overview of CDER Regulatory Resources CMC for pIND/IND Submissions
Paresma Patel, PhD
Division Director
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Overview of CDER Nonclinical Resources and Guidance for Approaching First-in-Human (FIH) Studies
Emily Wearne, PhD
Pharmacologist/Acting Nonclinical Team Leader
Division of Hematology Oncology Toxicology (DHOT)
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
CDER’s Clinical Consideration for First-in-Human Trials
Caitlin Tydings, MD
Pediatric Hematologist/Oncologist
Medical Officer, Division of Oncology 3
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This webinar features presentations from experts at the FDA’s Center for Drug Evaluation and Research (CDER), offering crucial insights into oncology drug development. Jeff Summers highlights that innovation often originates from academic investigators and small oncology startups, emphasizing the FDA Oncology Center of Excellence’s mission to approve safe and effective anti-cancer therapies. He strongly advises innovators to inform themselves by reading relevant FDA and ICH guidance documents and considering competent regulatory consultants, noting the FDA’s extensive educational resources and willingness to engage. Paresma Patel details Chemistry, Manufacturing, and Controls (CMC) considerations, explaining the evolving nature of CMC information throughout drug development and outlining requirements for Investigational New Drug (IND) submissions. She stresses the importance of assuring the quality, safety, and efficacy of every dose and advises early and consistent communication with FDA to prevent clinical holds. Emily Wearne focuses on non-clinical data requirements for first-in-human (FIH) studies, highlighting the significance of GLP-compliant toxicology studies and adherence to ICH S9 guidance for determining a safe starting dose. She also encourages pre-IND meetings for addressing study design questions. Finally, Caitlin Tydings provides clinical considerations for FIH trials, advocating for collaboration with expert trialists and detailing essential aspects like dose escalation strategies, defining dose-limiting toxicities, and comprehensive safety monitoring. Across all presentations, the speakers emphasize the numerous FDA resources available and the agency’s commitment to supporting innovators in advancing oncology patient care.