This presentation will discuss the components and importance of a critical evaluation of an early drug development plan, including discipline-specific gap analyses, for a successful pre-IND/IND phase of product development.  Early consideration of the unmet need and scientific rationale for a product must be adequately understood and aligned with the development plan.  The analysis could include a market landscape assessment, summarization of key data and relevant information from the public domain, regulatory and nonclinical/manufacturing testing strategies, and, importantly, identification of any unresolved risks to an IND or to the broader development program.  The fundamentals of a development plan will also be discussed; briefly touching on the clinical landscape assessment, selection of the indication, nonclinical testing requirements, phase-appropriate manufacturing considerations, potential biomarker identification, clinical trial design, statistical considerations including power analysis and analysis strategy, feasibility, regulatory interactions, and pediatric requirements. The product sponsor will also need to understand the development timeline and costs of development in order to support funding and manage investor expectations, and these can be provided as part of the development plan. Ultimately, the outputs from the gap analysis and development plan work can guide health authority interactions at the pre-IND stage and focus sponsors on the key areas for feedback and agreement ahead of an IND submission.

Presenters: Joshua Taylor and Sheila Plant, Allucent

Joshua Taylor, PhD, RAC

As Senior Director, Regulatory Affairs, at Allucent, Dr. Taylor serves as a regulatory affairs subject matter expert and is responsible for regulatory and clinical strategy support for drugs, biologics, medical devices, and combination products. He has greater than 13 years of research and industry experience as a biomedical engineer and regulatory affairs professional, with experience spanning preclinical, clinical, and postmarketing stages of development, primarily in the US. Josh has experience in regulatory pathways in the US, including pre-RFD/RFD, IND, IDE, and marketing applications and all expedited program options. He received his BS and PhD in Biomedical Engineering from Pennsylvania State University.

Sheila Plant, PhD, MHS, RAC

As Senior Director, Regulatory Affairs, at Allucent, Dr. Plant is responsible for regulatory and clinical strategy support for innovative medical products. She has greater than 25 years of experience in biomedical science including 16+ years in regulatory affairs and clinical research. Sheila has extensive experience working with sponsors to author, compile, and submit initial INDs, IND amendments, NDAs, and NDA amendments. She has led marketing application projects leading to FDA approval for drug and drug-device combination products. Sheila received her PhD in Neurobiology from UNC-Chapel Hill and her Master’s in Health Science from the Duke University School of Medicine. She has been RAC certified since 2011.

 Networking reception 5:30-6:30 pm (in-person only; refreshments included)

Panel Discussion 6:30-8:00 pm (hybrid - Zoom link included in registration confirmation email)

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