The US FDA’s recent initiative to reduce and ultimately replace animal testing requirements, beginning with monoclonal antibody therapies, marks a pivotal shift in nonclinical drug product development. This effort emphasizes integrating New Approach Methodologies (NAMs), such as in vitro and in silico models, into regulatory submissions. In this webinar, Biologics Consulting will share insights into FDA’s roadmap for NAMs adoption, current regulatory expectations, and practical strategies for incorporating alternative data into regulatory submissions. Through real-world examples and expert perspectives, attendees will gain actionable guidance on how sponsors, contract research organizations (CROs), and regulatory advisors can integrate NAMs into evolving nonclinical strategies.
Registration Fees & Deadlines
Learning Objectives
- Understand FDA’s evolving regulatory framework for NAMs, including the rationale for prioritizing monoclonal antibody therapies
- Learn about current and developing NAMs to reduce or replace certain in vivo animal studies
- Gain practical insights from regulatory consultants on integrating NAM data into FDA submissions, supported by real-world case examples and industry perspectives
- Identify key challenges and opportunities in integrating NAMs alongside traditional in vivo studies across biologics and small-molecule programs
Who Should Attend?
- Regulatory Affairs Professionals
- Nonclinical Scientists Toxicologists
- Individuals Involved in Drug Research, Development, And Regulatory Strategy
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
David Pepperl
Principal Consultant, Biologics Consulting Group
David Pepperl is a pharmacologist and toxicologist with over 25 years of experience in the early stage development of small molecule drugs and biologic products. He received his BS in Biochemistry from Michigan State University, and his PhD in Pharmacology and Toxicology from the University of Arizona. In his current role as Principal consultant at Biologics Consulting, David develops nonclinical programs and GLP study designs for clients and routinely provides nonclinical regulatory guidance to both nascent and established biotechnology companies. He routinely authors nonclinical sections of regulatory submissions including INTERACT, pre-IND, IND dossiers and NDA/BLA submissions. David has deep expertise with numerous product types including small molecules, proteins, peptides, monoclonal antibodies, vaccines, cell and gene therapies as well as tissue engineered and live biotherapeutic products, providing scientific and regulatory input to help clients move novel therapeutics into the clinic.
L. Bruce Pearce
Principal Consultant, Biologics Consulting Group
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
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