Dr. Mostafa Ould Elhkim is a regulatory toxicologist with nearly 40 years of experience in toxicology research, regulatory science, risk assessment, and public health. His career combines fundamental research in carcinogenesis and mutagenesis with extensive expertise in the scientific evaluation and regulation of medicinal products for human and veterinary use, chemicals in food and animal feed, as well as cosmetics, biocides, and plant protection products. He has held senior scientific and managerial positions respectively at the French Agency for Veterinary Medicinal Products (ANMV), the French Food Safety Agency (AFSSA), and the French National Agency for the Safety of Medicines and Health Products (ANSM). He has also contributed to scientific activities at the European level through collaborations with the European Medicines Agency (EMA), the European Commission, and international expert working groups. In parallel with his regulatory responsibilities, Dr. Ould Elhkim has served as a lecturer at the University of Paris-Est Créteil (UPEC), where he coordinates the teaching unit on Physico-Chemical Risk Assessment. He is the author of numerous scientific publications and currently serves as a peer reviewer for Food and Chemical Toxicology, having also reviewed manuscripts for several other international peer-reviewed journals. His expertise includes regulatory toxicology, pharmaceutical safety, chemical risk assessment, carcinogenesis, mutagenesis, environmental and occupational health, and evidence-based public health.

Dr. Carsten Goebel is an independent consultant and co-founder of BBCG Toxicology & Safety Science. He is a European Registered Toxicologist (ERT), a certified toxicologist (DGPT), a certified immunologist (DGfI), and provides strategic scientific and regulatory support in toxicology, human safety assessment, and New Approach Methodologies (NAMs). With more than 25 years of experience in regulatory and applied toxicology, Dr. Goebel has held scientific leadership positions at Wella, Procter & Gamble, and Coty, including Vice President, Product Safety & Regulatory Affairs and Research Fellow. He has extensive expertise in cosmetic ingredient safety assessment, particularly hair color safety, and has successfully led SCCS submissions resulting in positive scientific opinions. He also played a leading role in the successful scientific defense of a hair dye substance before the ECHA Board of Appeal. His work focuses on the development and regulatory application of NAMs, including skin sensitization, metabolism, systemic exposure assessment, read-across, and Next Generation Risk Assessment (NGRA). Through Cosmetics Europe, he served as a member of the Skin Tolerance Task Force and Co-Chair of the Safety Assessment Task Force. Dr. Goebel has authored numerous peer-reviewed publications and is internationally recognized for advancing human-relevant, animal-free safety assessment.

Prof Matthew Wright has over 35 years research experience with liver-related drug /chemical metabolism and toxicity. He was the first to demonstrate that stimulating liver myofibroblast apoptosis reversed fibrosis; developed a human single chain antibody to target these cells (licensed to Pharma) and demonstrated an anti-fibrogenic, and anti-inflammatory role for the PXR in the liver. More recent research focussed on in vitro systems to model toxicity in the liver and the potential role of environmental xenobiotics as triggers for the chronic liver disease primary biliary cholangitis (PBC). He has published in excess of300 full research papers and scientific opinions; was an expert for the European Food Safety Authority (EFSA) ANS and FAF Panels (2011- 2024) and Chair for the Working Group pertaining to Article 8 – rapid response opinions on member state/EC concerns). He retired in 2024 and is currently Emeritus Professor of Toxicology at Newcastle University. He is the Editor in Chief for the journal Food and Chemical Toxicology, is an expert member on a variety of EFSA and Committee on Toxicity (UK) working groups and is also a member of the UK Expert Committee on Pesticides (ECP).

Mayla Dornas is a regulatory toxicologist and ecotoxicologist specialist with extensive experience in risk assessment and regulatory strategy for agrochemical products. She is the founder of Soluneer, a consultancy operating between Brazil and Portugal, specialized in regulatory toxicology, ecotoxicology, and integrated product registration and defense strategies. Her work involves the detailed analysis and integration of toxicological and ecotoxicological datasets to support regulatory decision-making. Mayla works with complete evidence packages, assessing study relevance, data consistency, exposure assumptions, and regulatory weight across different endpoints and use scenarios. She designs strategies for complex and evolving regulatory contexts, including dossier structuring, weight-of-evidence reasoning, read-across and alternative approaches, and exposure-driven risk assessments. A significant part of her work focuses on developing technical justifications and regulatory defenses to support product approval, positioning, and long-term regulatory sustainability. Through her consultancy work, Mayla supports industry stakeholders in addressing regulatory uncertainty, responding to authority questions, and building defensible product profiles grounded in real-world use conditions and risk management considerations.

Dr. Sanjay K. Srivastava is a University Distinguished Professor and Chairman of the Department of Immunotherapeutics and Biotechnology at the Texas Tech University Health Sciences Center (TTUHSC). He is also James ‘Buddy’ Davidson Endowed Professor of Pediatric Pharmacology and Oncology. Dr. Srivastava served as the Associate Dean for Research for six years as well as Associate Dean for Graduate Program for 4 years at TTUHSC. He received the honor to be elected as the Fellow of American Association for the Advancement of Science (AAAS), a very prestigious scientific organization. He was also elected as the Fellow of the Royal Society of Biology (RSB) this year. He has extensive research experience in the field of cancer chemo prevention, cancer therapeutics and immunotherapy. Dr. Srivastava is a serial innovator with several patents to his credit. His inventive contributions are supported by an excellence in research. Named in Stanford University’s list for the World’s Top 2% Scientists from 2020-2024, Dr. Srivastava has a track record of being a productive scientist, authoring around 200 research articles in high impact journals with close to 13,000 citations and holding an H-index of 61, demonstrating just how impactful his research contributions have been over 35 years. His research has been funded by National Cancer Institute, NIH or other agencies, and he has received numerous prestigious awards including President’s and Chancellor’s Excellence in Research in 2010 and 2024 respectively. The major focus of his laboratory is on delineating the signaling mechanisms responsible for tumor growth, angiogenesis and metastasis in different cancer models including pancreatic, ovarian, breast, melanoma and glioblastoma. He had been working on cancer chemoprevention using phytochemicals. His recent research focuses on understanding the mechanism of chemotherapeutic drug resistance in melanoma, breast and glioblastoma. For the last 15years, he has also been repurposing existing non-cancer drugs for cancer therapy. For example, his group has shown the anticancer effects of few anti-psychotic drugs for breast cancer, brain cancer, and pancreatic cancer therapy. He also showed the anti-tumor effects of anti-malarial and anti-helminthic drugs for drug resistant breast, pancreatic and brain cancer. Dr. Srivastava has mentored numerous trainees (undergraduate students, post- doctoral fellows and graduate students), who are now established researchers/faculty at different places. His research has been highlighted by media and news agencies. Dr. Srivastava is in the editorial board of several prestigious journals and is the member of societies including AACR, SOT, AAAS and AAPS. He serves in the grant review panels of National Institute of Health (NIH), Department of Defense and other agencies.

Mark Crosswhite holds a master’s degree in Business Management and is currently finalizing his dissertation for a Ph.D. in Organization and Management Leadership from Liberty University School of Business (Lynchburg, VA). Dr Crosswhite also holds master’s and Ph.D. degree in Analytical Chemistry from The Florida State University (Tallahassee, FL). His career began at The Florida Department of Agriculture and Consumer Services where he collaborated extensively with the US Food and Drug Administration on food safety topics. In 2017, Dr. Crosswhite transitioned out of government and entered the tobacco industry, where he worked 2 years at Altria followed by 4 years at JUUL Labs, supporting potentially harm-reduced products and their navigation through an FDA regulated pathway. In 2022 Dr. Crosswhite founded ConsulticX Sciences and has been consulting in the pharmaceutical, medical device and tobacco industry focusing on chemistry and related regulatory strategies.

Dr. Barry Hardy is Chief Executive Officer of Edelweiss Connect GmbH and President of the OpenTox Association. He is internationally recognized for his contributions to predictive toxicology, computational toxicology, next-generation risk assessment (NGRA), and the development of knowledge infrastructures supporting safer and more sustainable product design. Throughout his career, Dr. Hardy has led numerous international initiatives focused on predictive toxicology, safety assessment, and evidence-based decision-making, including OpenTox, eNanoMapper, OpenRiskNet, EU-ToxRisk, NanoCommons, ACEnano, and Risk-Hunt3r. His work has contributed significantly to the advancement of New Approach Methodologies (NAMs), Integrated Approaches to Testing and Assessment (IATAs), and Safe-and-Sustainable-by-Design (SSbD) frameworks. Dr. Hardy obtained his Ph.D. in Computational Science from Syracuse University and has held research positions at the FDA Center for Biologics Evaluation and Research and the University of Oxford. He continues to support the translation of innovative toxicological methods into industrial and regulatory practice through international collaborations spanning academia, industry, and regulatory science.

Venkatesha Udupa MVSc, MSc, PhD, ERT, DABT, DSP With over 28 years of industrial experience, Dr. Venkatesha Udupa serves as the Senior Vice President and Head of Toxicology at Ichnos Glenmark Innovation (IGI), Mumbai. His role at IGI involves providing scientific input into the design and execution of early— and late-stage nonclinical toxicology evaluations for new chemical and biological entities. He also provides scientific leadership and guidance in toxicology, pathology, and safety pharmacology investigations for the drug discovery team. Dr. Udupa has broad experience in both small-molecule and large-molecule development, including tri specific and multi specific antibodies. He is a well-known pathologist who develops and executes pathology strategies for non-clinical safety assessment, including investigations and GLP studies, and supports the resolution/de-risking of pathology issues to advance projects. Dr. Udupa's expertise extends beyond drug discovery and development. He also plays a pivotal role in 505(b) (2) type applications, nonclinical requirements for branded generic development, fixed-dose combinations, safety assessment of impurities, and health hazard assessment of pharmaceutical products. Dr. Udupa's passion for developing drugs for both small and large molecules is inspiring. His work on several targets related to oncology, immune-oncology, metabolic disorders, infectious diseases, COPD, pain, and inflammation, among others, is a testament to his dedication and interest in the field. He has worked at the R&D centers of Ranbaxy Laboratories Limited, Maccine (Singapore), Himalaya Drug Company, and Rallis India Limited (now Adgyl Lifesciences). Significant achievements mark Dr. Udupa's academic journey. He completed his bachelor’s degree in veterinary science, his Master’s degree in Veterinary Pathology from the Veterinary College, Bangalore, and his Master’s degree in Toxicology from the University of Surrey, UK, as well as his PhD in Biochemistry from SHIATS, Allahabad, India. He is a Diplomate of the American Board of Toxicology (DABT), Diplomate of Safety Pharmacology (DSP), and European Registered Toxicologist (ERT). He is a member of STPI, STP, ESTP, SPS, ACT, and SOT. He has organized several conferences and workshops for the Society of Toxicologic Pathology India (STPI) to train pathologists, held positions including General Secretary and President, and is currently the STPI President. Dr. Udupa has 20 international publications in peer-reviewed journals, 16 national publications, three patents, and is a coauthor for a book chapter on topics in Discovery and Regulatory Toxicology in the Pharmaceutical Industry.

Dr. Jose W. Rodriguez Zayas is an Associate Professor of Biomedical Sciences at Universidad Ana G. Méndez, Cupey Campus, Puerto Rico, with over 20 years of experience in toxicology and immunotoxicology. His research focuses on understanding how environmental exposures and emerging materials impact the immune system, with particular emphasis on the immunological and toxicological effects of engineered nanomaterials. His work investigates the size-dependent toxicity of nanoparticles, including titanium dioxide, and examines key mechanisms such as oxidative stress, inflammation, and immune dysregulation relevant to human health risk assessment. Dr. Rodriguez Zayas is also engaged in the identification of biomarkers for early detection of toxicological effects and the development of translational strategies to evaluate immune responses in both environmental and therapeutic contexts. His research integrates experimental and translational approaches to better understand the interface between toxic exposures and immune function. In addition to his research, he is committed to graduate education and mentorship, training future scientists in toxicology and biomedical sciences. His work aims to advance precision toxicology and contribute to improved safety evaluation of emerging compounds and materials.

Mark A. Nedelman, MS, MBA, is President & CEO ANEWCRO, a nonclinical contract research organization (CRO), dedicated to delivering innovative solutions and discovery support for clients across the biopharmaceutical industry and academic institutions. With more than 40 years of experience in drug discovery and development, Mark leverages his extensive expertise to position ANEWCRO as a trusted research partner, offering tailored services and expert guidance that redefine the role of contract research organizations in today’s evolving landscape. Mark’s vision to foster collaboration between researchers and industry, paving the way for groundbreaking advancements in medicine, started at Massachusetts General Hospital where he headed the Nuclear Medicine research lab under Dr H. William Strauss. Since then, Mark has held pivotal roles in R&D at Centocor and CeleCor Therapeutics contributing the discovery of a number of new drugs including abciximab, infliximab and zalunfiban. Mark has served as General Manager at Charles River Laboratories (CRL) and later as President & CEO of Ekam Imaging. His most recent role before founding ANEWCRO was as the CEO of Biomere, where he spearheaded a growth strategy that successfully led to the company’s acquisition by Joinn Labs in 2019. This extensive experience in both corporate and research environments allow Mark to understand the unique challenges faced by biopharmaceutical companies and to provide solutions that are both practical and innovative. Mark has co-authored over 50 peer-reviewed publications and contributed to three book chapters. He also serves as a Trustee of the Xenotherapeutics Foundation. Mark holds a Bachelor of Science in Biology and a Master of Science in Biology from the University of Cincinnati, as well as an MBA from Northeastern University.

Svetolik Spasić, M.D., Ph.D., is an electrophysiologist and biomedical researcher specializing in pathophysiology, neuroscience and intracellular electrophysiology, as well as translational neurophysiology. He currently holds a position of an Assistant Professor at the Faculty of Medicine, University of Belgrade and is a Course Director of Medical Pathophysiology. From 2022 to 2024, he was a Postdoctoral Scholar in the Department of Otolaryngology at Stanford University, where his work focused on otology and neurotology and mechanisms of hearing loss spanning noise trauma, drug ototoxicity and tumor secretome. Dr. Spasić earned his medical degree in 2011 and completed his doctoral training in Physiological Sciences in 2020, with a dissertation on excitatory mechanisms in Retzius neurons and the excitotoxic effects of environmental amino acids. His research integrates advanced electrophysiological methods, including intracellular and current clamp recordings, with investigations into cyanotoxins and their impacts on neuronal activity, and their relevance to neurodegeneration. He has contributed to national and international projects addressing neurodegeneration, excitotoxicity, and cyanobacterial effects. He has lectured at Petnica Science Center, coordinated Brain Awareness Week workshops, and participated in advanced training programs across Europe and the United States. His teaching and mentorship have been recognized with commendations for excellence, alongside awards for his doctoral dissertation and student achievements. Dr. Spasić is a member of the Serbian Neuroscience Society, Federation of European Neuroscience Societies, and the European MD-PhD Association, where he serves as Serbia’s national representative. His career reflects a commitment to rigorous, inclusive science and the advancement of translational medicine.