This webinar is part of a four-part series from Bioculture and EARA examining the science, regulation, and responsibility behind the use of non-human primates (NHPs) in biomedical research. The series explores where NHPs remain essential, where new approach methodologies (NAMs) are replacing or complementing animal research, and what a rigorous, transparent path forward looks like for the field, supporting scientific progress and the principles of the 3Rs (Replacement, Reduction and Refinement).
Non-human primates remain one of the few translational models capable of bridging the gap between early discovery science and first-in-human trials. Their close physiological and genetic similarity to humans allows researchers to obtain safety and efficacy information that cannot yet be obtained using other available models alone — such as in vitro, in silico, or rodent. This opening session examines how NHP models function as a translational bridge from bench to bedside, why they continue to occupy a distinct place in drug development, and how their use is continually reassessed as alternative methods to NHP models advance.
The session traces the evolution of NHP use in translational science, from early toxicology studies to today’s more targeted, disease-specific applications across oncology, neuroscience, infectious disease, and metabolic research. Panelists will examine the role NHPs can play in preclinical research, including safety and efficacy assessments, comparing their strengths and limitations with emerging alternatives such as organ-on-chip systems and computational or AI-driven models, with concrete examples of where each approach adds genuine value and where meaningful gaps still remain. The discussion will also explore how researchers evaluate opportunities to replace, reduce and refine animal use, and how scientific, ethical and regulatory considerations inform study design. A dedicated case study will walk through the findings of a real pre-clinical program that relied on NHP models, illustrating how the data generated informed downstream clinical decisions and ultimately shaped the trajectory of a therapeutic programme.
Aimed at a life sciences audience but framed to remain accessible to non-specialists, the discussion will address the scientific, ethical, and regulatory considerations that shape how and when NHP models are used, and where the field is heading as new approach methodologies (NAMs) continue to mature and regulatory expectations evolve. The panel will also explore how researchers and sponsors weigh model selection decisions in practice, balancing scientific rigour, animal welfare, regulatory expectations, timelines, and cost.
Attendees will leave with a clearer, evidence-based picture of where NHPs continue to play a role within modern biomedical research, how that role is evolving alongside advances in NAMs and other emerging technologies, and how responsible, transparent, science-led decision-making supports scientific progress and public trust. The session will provide pratical insight relevant to R&D strategy and investment decisions in a field facing growing public and regulatory scrutiny.
Speakers
Gourav Roy-Choudhury, PhD, DABT, Senior Director, Toxicology, Franklin Biolabs
Gourav is a Board-Certified Toxicologist (DABT), Veterinarian and translational research leader with more than 15 years of experience advancing innovative therapeutics from discovery through clinical development. His expertise spans nonclinical safety assessment, regulatory toxicology and preclinical development of biologics, gene therapies, cell therapies and emerging therapeutic modalities.
Gourav has extensive experience leading GLP and non-GLP toxicology programs in rodent and nonhuman primate models to support FDA Investigational New Drug (IND) submissions. As a Study Director and scientific lead, he has guided complex safety programs involving AAV-based gene therapies, lipid nanoparticle platforms, in vivo CAR-T therapies and other advanced biologics, with expertise in study design, dose selection, biodistribution, safety assessment, biomarker development and regulatory strategy.
Currently, Gourav serves as the Senior Director of Toxicology at Franklin Biolabs, where he provides scientific leadership for multidisciplinary teams developing next-generation therapeutic platforms. Previously, he held leadership roles at the University of Pennsylvania’s Gene Therapy Program, directing nonclinical safety programs that supported the advancement of CNS-targeted and systemic gene therapy programs into clinical development.
Gourav brings a unique combination of expertise in toxicology, neuroscience, veterinary medicine and translational science, enabling effective collaboration across pharmacology, pathology, bioanalytics, regulatory affairs and clinical development teams. His research contributions have been published in leading peer-reviewed journals and have helped advance transformative therapies for rare and neurological diseases.
He holds a PhD in Pharmacology and Neuroscience from the University of North Texas Health Science Center and is a Diplomate of the American Board of Toxicology.
Message Presenter
Thierry Decelle, DVM, MSc, DipVetLAS, Founder & CEO, DCL Solutions
Thierry Decelle, DVM, MSc, DipVetLAS, is an international expert in laboratory animal science, animal welfare, ethics and governance, with more than 30 years of experience in industry and international organizations. As Founder and CEO of DCL Solutions, he advises institutions worldwide on strengthening animal care and use programs, ethical oversight, organizational Culture of Care and the 3Rs. Previously, he served as Chief Veterinary Officer for Sanofi Group, leading global animal welfare and 3Rs strategies across more than 20 sites in 10 countries.
Thierry has extensive experience in ethical review processes, program assessment, accreditation and stakeholder engagement. A former AAALAC International Board Director and current Emeritus Council Member, he has contributed to international guidance, training programs and initiatives promoting transparency, ethics and continuous improvement. His work focuses on integrating scientific excellence, animal welfare, staff welfare and ethical decision-making into sustainable research programs.
Message Presenter
Andrea Varrone, MD, PhD, Professor of Molecular PET, Department of Clinical Neuroscience, Karolinska Institutet
Andrea Varrone is Professor of Molecular PET at the Department of Clinical Neuroscience, Karolinska Institutet.
He is research group leader on molecular imaging of neurodegenerative disorders and Head of the Division of Imaging Core Facilities.
Andrea Varrone is a nuclear medicine physician, holds a PhD degree in Functional Radioisotopic Imaging and has a broad competence and expertise in translational molecular imaging at pre-clinical and clinical research levels.
In the last 20 years at Karolinska Institutet, Andrea Varrone has conducted pre-clinical and clinical research with positron emission tomography (PET), being responsible for methodological developments in PET quantification using the high-resolution research tomograph (HRRT) system. He has contributed to the development and validation of novel PET radioligands for the study of neurodegenerative disorders with particular focus on Parkinson, Huntington and Alzheimer´s disease.
The main research interest is the development of imaging biomarkers for α-synuclein, immune cell activation, neurodegeneration and synaptopathy in Parkinson´s disease and related disorders. The main goal of Andrea Varrone´s research is to develop imaging markers for early diagnosis of parkinsonism and dementia, for the assessment of disease progression and for their use as biomarkers for clinical trials with disease-modifying treatments.
Message PresenterWho Should Attend?
This session will appeal to:
- Preclinical scientists and translational research leads
- Toxicologists and safety pharmacologists
- R&D leaders, investors and business development leads assessing preclinical model strategy at pharma, biotech, and CROs
- Regulatory affairs and drug development professionals
- Academic researchers working on translational and preclinical models
- Policy, bioethics and science-communication professionals engaging through EARA’s advocacy and transparency network
- Professionals involved in animal welfare, research governance and ethical review
What You Will Learn
Attendees will:
- Explore how NHPs use in translational science has evolved and where it now fits alongside new approach methodologies
- Understand how NHP models complement emerging alternatives, through side-by-side examples
- Walk through a real-world case study illustrating how preclinical data from NHP studies informed clinical decision-making
- Walk away with a practical way to assess when NHP use is justified — and how to make a fair, defensible case for it in your own research
Xtalks Partners
Bioculture
Bioculture is a vertically integrated life sciences group supporting breakthroughs in early-stage biomedical research. Founded in Mauritius in 1985, the company pioneered the ethical breeding of Specific Pathogen Free cynomolgus macaques, turning an ecological threat into an industry standard trusted by researchers worldwide, under its founding ethos of Caring for Life. Bioculture extended its supply chain to the U.S. in 2014 as BC US LLC, and in 2024 acquired majority stakes in Franklin Biolabs (Philadelphia), a preclinical CRO for cell, gene, RNA, and biologics therapies, and ANEWCRO (Florida), an NHP-based preclinical CRO for pharmacology and toxicology. Today, spanning Mauritius and the U.S., Bioculture advances research from Care to Cure.
The European Animal Research Association (EARA)
The European Animal Research Association (EARA), a global communications and advocacy organisation, represents both public and private institutions in the biomedical sector. Founded in 2014, EARA developed and expanded the concept of transparency agreements, first across Europe and now worldwide, encouraging institutions to be open about the use of animals in research. As the only organisation doing this globally, EARA promotes understanding of the ongoing need and benefits of animal studies in advancing disease knowledge and drug development, as well as new approach methodologies (NAMs) that help replace and reduce the use of animals.
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