Education Course
Biologics Nonclinical Drug Development

Speaker Bios

Jeanine L. Bussiere, PhD, DABT, ATS

Dr. Jeanine Bussiere is currently Scientific Executive Director in Translational Safety and Bioanalytical Sciences (TS&BA) at Amgen having moved after the acquisition of Immunex in 2002, where she was the Director of Pharmacology/Toxicology for 3 years. Prior to joining Immunex, Dr. Bussiere was a scientist at Genentech for 8 years. Throughout her career, her work has focused on nonclinical safety supporting the development of biopharmaceuticals across a variety of therapeutic areas. Her additional expertise is in the area of immunotoxicology, and she received the Career Achievement Award from the Biotechnology Specialty Section in 2016. She is a Diplomate of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, and is an active member of the Society of Toxicology, serving on several committees, both elected and appointed. She is a member of the ILSI/HESI Immunotoxicology Technical Committee, and the American College of Toxicology and serves on the editorial board for the Journal of Immunotoxicology. She received her Doctorate from Washington State University and did her postdoctoral work at Temple University, with an emphasis in immunotoxicology. 

Joy A. Cavagnaro, PhD, DABT, ATS, RAC, FRAPS

Dr. Joy A. Cavagnaro earned her PhD in Biochemistry at the University of North Carolina, Chapel Hill. Currently, she is the President of Access BIO, L.C., a consultancy she founded, 9/9/99, focusing on science-based regulatory strategies and preclinical development services for translation of novel drug, biologics, and device combinations to the clinic. Dr. Cavagnaro’s career spans academia, government, the Contract Research Organization and biotechnology industries. During her tenure at Center for Biologics Evaluation and Review/FDA she was appointed to the Senior Biomedical Service and served as FDA’s safety topic lead and as rapporteur for the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, ICH S6. She was the first to advocate the “case-by-case” rational science-based approach to preclinical safety evaluation furthering the 3Rs principle of animal welfare. The principles of ICH S6 have supported the progression and evolution of biologics as a field including the translation of novel cell and gene-based therapies into the clinic. She is past Chair of the Translational Science & Product Development Committee and the Clinical and Regulatory Affairs Committee of the American Society of Gene & Cell Therapy. She is also past Chair of the board of the Regulatory Affairs Professional Society. She was a member of the National Toxicology Program Scientific Advisory Committee on Alternative Toxicological Methods and is an advisor and current member of the Grants Working Group of the California Institute of Regenerative Medicine. She is the Founder and Past Chair of BioSafe, an international expert preclinical science committee within BIO. She is a past member of the American College of Toxicology Education and Animals in Research Committees and Past President of the National Capital Area Chapter of the Society of Toxicology. She is a past chair of Chesapeake Research Review LLC, an independent investigational review board and is currently a member of Advarra’s IRB. Dr. Cavagnaro was the recipient of several FDA awards during her tenure including the Award of Merit individual and group awards. In 2011 Dr. Cavagnaro received the Society of Toxicology Biotechnology Specialty Section’s First Career Achievement Award and in 2019 the Society’s Arnold J. Lehman Award in recognition of making a major contribution to risk assessment and. or the regulation of chemical agents, including pharmaceuticals. In 2022 Dr. Cavagnaro received the American College of Toxicology Distinguished Scientist in Toxicology Award and in 2023 the Association of Gene and Cell Therapy Inaugural Catalyst Award in recognition of her extraordinary impact on the translation of gene and cell therapies.

Dr. Cavagnaro’s work on the preclinical safety and development strategies for biopharmaceuticals has been widely published, in the form of both peer-reviewed articles and book chapters. She is the editor of the fields foremost book, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials commonly referred to as the “BioBible. The “New Testament” “Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals- Joy A. Cavagnaro and Mary Ellen Cosenza, eds., CRC Press, 1st Edition was published in 2021. Dr. Cavagnaro currently serves on multiple scientific advisory boards for biopharmaceutical companies and non-profits and consults and lectures internationally on translation and risk assessment of novel biological therapies with particular specialization in genetic medicines.

Mary Ellen Cosenza, PhD, MS, DABT, ATS, ERT, RAC

Dr. Mary Ellen Cosenza is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the US, Europe, and emerging markets. During her 20-year tenure at Amgen, she led the US Regulatory Department, the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety focusing on Early Development, Medical Writing, and Inflammation. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist in Toxicology for the Medical Research Division of American Cyanamid Company (now Pfizer).  

While at Amgen, Dr. Cosenzawas responsible for both early- and late-stage development programs resulting in numerous successful IND, CTA, NDA, MAA, and BLA submissions in a broad variety of therapeutic areas and modalities. In addition, she played a key leadership role in preparing teams for global health authority meetings with FDA, EMA, and regional country health authorities, including several FDA Advisory Committee Meetings.

Dr. Cosenza is recognized as an expert in preclinical biologic drug development and is a founding member of BIO’s BioSafe Preclinical Expert group. She was also a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonization (ICH) for ICH M3(R2). Dr. Cosenza is well published in the field of biological drug development and authored several chapters on this topic and recently co-edited a book on Translation Sciences focused on biologics and innovative products such as cell and gene therapies. She was also a co-editor of a Toxicological Pathology book for non-pathologists.

Dr. Cosenza is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences (current President), member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS) and holds Regulatory Affairs Certification for both the US and EU. Dr. Cosenza is a European Registered Toxicologist (ERT) via the Royal Society of Biology, UK. She is also Treasurer of the International Union of Toxicology (IUTOX). Dr. Cosenzais a member of the American College of Toxicology (ACT) where she has served as a member of the ACT Education Committee, as Councilor, and as Treasurer and then President. She is an adjunct at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology and undergraduate classes on drug development and toxicology.

Dr. Cosenzareceived her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.

Helen Haggerty, PhD

Dr. Helen Haggerty has extensive drug development knowledge and experience bridging from discovery to development in translational safety stemming from over 30-year career in the pharmaceutical industry. While at BMS for 27 years, Dr. Haggerty was the Department Head of Immuno- and Molecular Toxicology, where she built and industry-leading Immunotoxicology laboratory and served as Therapeutic Area Head for Immunoscience and Fibrosis portfolio within Drug Safety Evaluation. For several years she also served as Development Team Leader, responsible for nonclinical research, FIH submission, and initiation and progress of clinical trials through Phase 2 for several immunology drugs. In August of 2020 she joined J&J Innovative Medicines as the Nonclinical Safety Development Therapeutic Area Lead for Immunology and in 2021 became Preclinical Sciences and Translational Safety (PSTS), Vice President and Global Head, Nonclinical Safety Portfolio Scientific Leadership. Dr. Haggerty is responsible for the strategic development of the team that determines and drives nonclinical safety strategies and assessments across the J&J portfolio – covering internal and externally partnered pipeline projects that cross all therapeutic areas, all modalities, and all portfolio stages. In addition, Dr. Haggerty is responsible for ensuring the team’s talent pipeline and drug development experience is strong and its science and regulatory influence continues to be industry leading.

Dr. Haggerty is recognized across the industry for leadership in the immunotoxicology and biologics areas. She has published extensively in immunology journals and is a highly sought speaker for international symposia and forums.  She has held numerous industry leadership roles, including as a PhRMA ICH S6 Deputy topic leader and a member of the executive committee for BioSafe. From the Society of Toxicology, she received in 2018 the Career Achievement in Biotechnology Award and in 2021 Mentoring Award for her leadership and service for mentee career development opportunities and influence on the growth of scientists entering the field of toxicology. Dr. Haggerty earned a bachelor’s degree in biology from the University of Richmond, a PhD in Pharmacology and Toxicology from the Medical College of Virginia and continued to specialize in immunology during a postdoctoral fellowship at the University of Pennsylvania.

Wendy Halpern, DVM, PhD, DACVP

Dr. Wendy Halpern is a Veterinary Pathologist with 24 years of experience in the Biopharmaceutical Industry. She earned her DVM and MSc in Veterinary Pathology from the Ohio State University, and then completed a PhD in Biomedical Sciences at the University of New Mexico. She is currently a Senior Fellow at Genentech, where she supports individual biopharmaceutical and small molecule programs at all stages from pre-IND through post-market, and across both oncology and non-oncology indications. Over the past 15 years, she has focused on nonclinical approaches to better understand and interpret reproductive and developmental toxicity, including dedicated support of pediatrics. She has been a BioSafe contributing member for >20 years and served as the BIO representative on the ICH S11 working group from 2015-2020. She is also an active member of the HESI DART Technical Committee and of the Society of Toxicologic Pathology, where she is currently a councilor on the Executive Committee. Additional professional affiliations include the American College of Veterinary Pathologists, Birth Defects Research and Prevention, and the Safety Pharmacology Society.

Michael W. Leach, DVM, PhD, DACVP

Dr. Michael W. Leach is the President and Owner of Trident Toxicology, Inc. He is a veterinary pathologist, toxicologist, and drug developer with 3 decades of experience in the biopharmaceutical industry. Dr. Leach received his DVM from Purdue University, his PhD from the University of California-Davis, and is a diplomate of the American College of Veterinary Pathologists. He has worked for Schering-Plough, BASF Bioresearch Corporation, Abbott Bioresearch Center, Wyeth, and Pfizer with involvement in non-GLP early efficacy studies, in GLP-compliant toxicity studies and regulatory interactions supporting all phases of clinical development, in post-marketing activities, and in due diligence and licensing activities. He is an author/co-author on over 80 peer-reviewed papers, invited reviews, and book chapters.

His responsibilities and roles in various nonclinical drug safety organizations have included acting as a Study Pathologist, as Study Director, as a Therapeutic Area Head/Lead, as the Licensing and Acquisitions Lead, as the Biotherapeutics Safety Lead, and as the departmental representative to the Large Molecule Candidate Quality Guideline Committee; he also founded and led the Biotherapeutics Safety Leadership Team at Pfizer. Dr. Leach has previously served on the BioSafe Preclinical Safety Leadership Committee, the nonclinical safety committee within Biotechnology Innovation Organization (BIO). In 2023, Dr. Leach received the Career Achievement in Biotechnology Award from the Society of Toxicology Biotechnology Specialty Section. Dr. Leach has given over 40 invited presentations. He is a member of the American Veterinary Medical Association, the Society of Toxicology, the American College of Toxicology, the Society of Toxicologic Pathology, and the American College of Veterinary Pathologists. In his spare time, Dr. Leach enjoys scuba diving and underwater photography.

Hervé Lebrec, PharmD, PhD, DABT

Dr. Hervé Lebrec is Vice President, Development Sciences at Sonoma Biotherapeutics where he oversees nonclinical safety, Immunogenicity, pharmacokinetics and clinical pharmacology functions. Sonoma Biotherapeutics is developing engineered regulatory T cells for autoimmune diseases.  Prior to joining Sonoma Bio, he worked in Translational Safety and Bioanalytical Sciences at Amgen Inc. where he most recently served as Executive Director of Translational Safety. He was responsible for leading a team of toxicologists and laboratory-based scientists responsible for the nonclinical safety assessment of multiple types of products (small molecules, antibodies, oncolytic viruses, siRNAs, engineered T cells) from lead optimization through post-marketing phases. In that function, Dr. Lebrec also contributed to the preparation of first-in-human oncology clinical study protocols for proper integration of nonclinical data and translational safety information. He also supported oncology related business development efforts through fit-for-purpose evaluations. Prior to this, Dr. Lebrec was a Principal Scientist and Scientific Director in translational safety at Amgen where he served as Project Team toxicologist.

Prior to joining Amgen, Dr. Lebrec served at 3M Pharmaceuticals, initially as Research Specialist, then as Pathology and Toxicology Department Manager, with a focus on the nonclinical safety assessment of small molecule Toll-like receptor agonists.

Prior to joining industry, Dr. Lebrec served as Assistant Professor at the University Paris XI. Dr. Lebrec received his Doctorate in Pharmacy and his PhD in Toxicology from the same University Paris XI. Dr. Lebrec is a diplomate of the American Board of Toxicology.

Dr. Lebrec’s research work and scientific interests have mainly focused on immune-related safety issues; he co-chairs the Immunosafety Technical Committee of the non-profit HESI (Health and Environmental Sciences Institute) and is Vice President Elect of the Biotechnology Specialty Section of the Society of Toxicology.

Mark N. Milton, PhD

Dr. Mark Milton retired in March 2022, after almost 31 years in the pharmaceutical industry. Over the course of his career, he has managed a GLP-compliant bioanalytical laboratory, provided nonclinical and clinical support to LMW compounds, biologics, cell therapies, and gene therapies. He now provides gene therapy and biologics nonclinical and clinical consulting services through Lake Boon Pharmaceutical Consulting, LLC.

Dr. Milton received a BSc in Biochemistry and Soil Science from UCNW, Bangor, an MSc in Toxicology and PhD in Biochemical Toxicology from the University of Surrey, England. Dr. Milton started his career at GD Searle in Skokie, Illinois before moving to Millennium Pharmaceuticals in Cambridge, Massachusetts. He then moved to Tempo Pharmaceuticals (Cerulean Pharmaceuticals) before joining Novartis in Jan 2009 where he held leadership positions in ocular PK/IG, the PK/PD/IG of Biologics, and Gene Therapies, as well as representing PKS Sciences on the Cell & Gene Therapy Steering Committee and Novartis’s First in Human review board. Dr. Milton held a leadership position in the AAV Immunogenicity Task Force and the Immunogenicity Advisory Group. Dr. Milton supported many of Novartis’s Gene Therapy projects, supported many of Novartis’s anti-complement programs, wrote the nonclinical PK summary for the Kymriah BLA, was involved in the in licensing of Luxturna, and the acquisitions of Avexis and Gyroscope, and provided nonclinical and clinical PK and immunogenicity support to Zolgensma post-market and for intrathecal administration of OAV101.

Dr. Milton is a past-chair of the BioSafe PKPD EWG, a member of the BioSafe LC, IQ Board of Directors, a member of the AAPS pre-existing antibody and Immunogenicity Risk Assessment Working Groups and was the BIO observer to the ICHS3A Q&A WG.

He has published over 30 peer-reviewed publications and book chapters and presented extensively on the development of NCEs, Biologics, and Gene Therapies. His interests include the PK/PD and immunogenicity of biotherapeutics, the contribution of PK (biodistribution) and IG to the development of gene therapies, ocular immunology, the selection of the clinical starting dose based upon the MABEL calculation, and alternative designs for FIH clinical trials of monoclonal antibodies in healthy volunteers.

Jay Tibbitts, DVM, PhD

Dr. Jay Tibbitts joined Lycia Therapeutics as Head of Nonclinical Development in October 2024. Prior to joining Lycia, he led Nonclinical PKPD organizations at Abbvie, UCB, and Genentech and led Nonclinical Development at Surrozen, Inc. As Project Leader, Dr. Tibbitts successfully guided Surrozen’s lead program, SZN-043, into clinical development. He has dedicated much of his career to the quantitative pharmacology and development of both small and large molecule drugs across multiple indications; and has contributed to the filing of more than 20 INDs and several BLAs. Dr. Tibbitts received his PhD in pharmaceutical chemistry from the University of California, San Francisco and a DVM from Ohio State University.

Marque Todd, DVM, MS, DABT

Dr. Marque Todd is a board-certified regulatory toxicology expert. Dr. Todd trained as a veterinarian and completed post-doctoral work in molecular immunology and cancer biology. She has more than 25 years of experience working in the biopharmaceutical industry. Dr. Todd has extensive nonclinical development experience with a variety of biologic modalities including monoclonal antibodies, bi-specific antibodies, Fc and other fusion proteins, antibody-drug conjugates, cytokines/interleukins, protein replacement therapies, nanoparticles, cell therapies, oncolytic viruses, and therapeutic vaccines. Dr. Todd has been involved in the preparation and submission of nonclinical sections of early and late-stage regulatory documents including INDs and BLAs/NDAs and has participated in numerous successful health authority meetings.

Dr. Todd is currently a regulatory toxicology consultant to several large, mid-size and small biopharma companies. Prior to becoming an independent consultant, Dr. Todd was a Research Fellow at Pfizer and served as a Principal Scientist at Amgen and Chiron. Dr. Todd also served as an Adjunct Professor with the University of California San Diego Extension, where she co-taught a course on nonclinical toxicology and drug development with sessions focused on the nonclinical development of biotherapeutics and oncology products.

John L. Vahle, DVM, PhD, Diplomate ACVP

Dr. John Vahle received his veterinary medical degree from the University of Missouri in 1988 and his doctorate in veterinary pathology from Iowa State University in 1996.  He became a Diplomate of the American College of Veterinary Pathologists in 1995 and joined Lilly as a senior pathologist in 1996. He currently serves as a Senior Research Fellow at Lilly.

Dr. Vahle has over 25 years of experience in pathology and toxicology and has served in a variety of roles including study pathologist, project pathologist, toxicology project leader, and regulatory toxicology advisor.  His areas of interest include carcinogenicity assessments, biotherapeutics development, bone toxicology and pathology. Dr. Vahle is active in various professional societies and consortia and is a past Councilor of the STP, past Chair of the BioSafe Organization, and a member of the steering committee for the international toxicologic pathology nomenclature initiative, INHAND.  Based on his experience in carcinogenicity testing, Dr. Vahle served as a member of the ICH Expert Working Group assessing carcinogenicity testing paradigms for pharmaceuticals. Dr. Vahle’s publications have focused on toxicologic pathology of the endocrine and musculoskeletal systems as well as approaches to carcinogenicity assessment.