CMC CONSIDERATIONS FOR YOUR IND-ENABLING PROGRAM
Discover how your CMC strategy supports IND-enabling program design and application submission!
As early-stage drug developers transition to IND-enabling toxicology and safety pharmacology studies, the requirements for both test article quantity and quality increase. While many sponsors are focused on nonclinical study design and scheduling, it is equally important to generate the required Chemistry, Manufacturing and Controls (CMC) data to support your IND. An effective CMC strategy and plan can ensure your program meets FDA expectations for IND submission and support your program’s progression into the clinic.
Join us as Exemplify BioPharma and Sinclair Research team up to present our on-demand webinar “CMC Considerations For Your IND-Enabling Program”.
Presented by Exemplify BioPharma’s Chief Scientific Officer, Paul O’Shea, PhD and Sinclair Research’s Senior Scientific Advisor, Tina Rogers, PhD, DABT, this webinar explores how your CMC strategy supports IND-enabling program design and application submission.In our webinar, Sinclair Research and Exemplify BioPharma will help you learn about:
- Test article considerations for IND-enabling programs
- CMC requirements and FDA expectations for IND submission
- CMC strategy and deliverables for an IND program
- Avoiding CMC-related delays
About the Presenters:
Dr. Tina Rogers, PhD, MBA, DABT, is a life sciences executive with 25 years of experience in the CRO industry providing preclinical drug development services to biopharma, NIH and DoD. In her role as Senior Scientific Advisor, Dr. Rogers leads the expansion of Sinclair Research’s nonclinical development services and provides scientific and regulatory guidance to support customer programs. Dr. Rogers holds a PhD in Molecular & Cellular Biology and Pathobiology from the Medical University of South Carolina, an MBA from Auburn University and is a diplomate of the American Board of Toxicology.
Dr. Paul O'Shea, is a senior research leader with more than 25 years of multidisciplinary scientific and operational research and development leadership experience at pharmaceutical developers, CROs and CDMOs. Paul has led the transition of multiple programs from late-stage lead optimization through to First-In-Human clinical studies, including the development of efficient synthetic strategies for analog synthesis in support of Structure Activity Relationships (SAR), assessment of physiochemical properties, phase and form selection and the development of formulations to support preclinical in-vivo and toxicology studies. In his role as Chief Scientific Officer at Exemplify BioPharma, Paul provides expert guidance on integrated, end-to-end program and portfolio-based CMC drug development strategy and deliverables to pharmaceutical and biotech partners. Dr. O’Shea earned both a BSc. and PhD in Chemistry from University College Galway, Ireland and has coauthored 46 peer reviewed publications and holds 22 patents.