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NAMs and Regulatory Shifts Driving Safer, More Predictive Therapeutic Outcomes
The drug discovery landscape is evolving fast. As the EMA, FDA, and other global regulators push to reduce animal testing, New Approach Methodologies (NAMs) are now more than ever, in the spotlight.
Watch the webinar to gain insights into how translational immunology is central to predictive modeling, and how these shifts are enabling safer, more effective therapeutic development across modalities.
Abstract:
As regulatory agencies accelerate the adoption of New Approach Methodologies (NAMs), the landscape of drug discovery is undergoing a profound transformation. We explore how NAMs, immunology-driven platforms, and emerging technologies are reshaping nonclinical safety and efficacy assessments. We examine key initiatives including the FDA’s ISTAND and DILI programs, the NIH’s Organoid Centre at FDA Frederick, the Memorandum of understanding between FDA and NIH and its implications for collaborative innovation, and recent global regulatory signals from the FDA, EMA and MHRA on data submission practices.
Special attention has been given to the July 2025 FDA-NIH workshop on reducing reliance on traditional methods and the FDA plan to phase out animal testing for Monoclonal Antibodies and roadmap.
Learning objectives:
- Cutting-edge technologies powering NAMs.
- How to integrate NAMs early for faster, smarter drug development.
- Key regulatory, FDA and EMA, updates and what they mean for you.
- Best practices for data submission and compliance.
Dr. Clive Roper | Roper Toxicology Consulting Limited
With over 25 years of expertise in toxicology, Dr Roper has established himself as a leading figure in developing animal testing replacement technologies. His career spans significant contributions to skin absorption, safety pharmacology, drug metabolism, and various toxicology specialties. Dr Roper's innovative work has directly replaced animal models in multiple fields, including skin absorption, dermal toxicology, and inhalation studies. His expertise was further recognized with his 2023 appointment as Vice President of the European Society of Toxicology In Vitro (ESTIV). As a Fellow of the RoyalSociety of Biology and a European Registered Toxicologist, Dr Roper maintains membership in several prestigious professional organizations. His influence extends to board positions with organizations committed to replacing, refining and reducing animal testing, including the UK NC3Rs, US 3Rs Collaborative, and PeptiMatrix, which develops chemically defined animal-free media products. Dr Roper brings valuable insights on developing animal-free testing methodologies that meet scientific standards and regulatory requirements.
Dr. Justyna Rzepecka | Associate Director - Immunology | Concept Life Sciences
Justyna has over 15 years of experience in immunology and cell biology, including more than a decade in drug discovery. She joined CLS in 2014, specializing in building and leading research teams, as well as establishing cellular platforms for target validation, lead selection, compound profiling, and biomarker identification.
Dr. Hayley Gooding | Biology Services Director | Concept Life Sciences
Dr. Hayley Gooding is a dedicated and enthusiastic biologist driven by the art of problem-solving and building efficient solutions. Thriving in dynamic environments, Hayley tackles challenges head-on, developing strategies to drive efficiency and growth. Having earned her Ph.D. in Neuroscience from University of Edinburgh Hayley's research during doctoral studies provided an insight into building model systems for drug discovery and development, which laid the groundwork for the early stages in her career at a University CRO Spin out, Aquila BioMedical. At Concept Life Sciences, Hayley has the privilege of leading a team of passionate scientists, spanning diverse disciplines, to deliver cutting-edge projects for the pharmaceutical and biotechnology industries in the pursuit of novel therapies for diseases such as Cancer and Alzheimer’s, with the potential to impact the lives of millions worldwide.