Biologics Consultants support the translational development of novel biologics through technical recommendations and advice to PI and her/his team. Consultants provide feedback and guidance on project milestones, development strategy, study design, and data interpretation. Each Lead Development Team (LDT) receives support from BPN-Biologics consultants. Consultants are assigned to a project with consideration of the project team's individual needs and consultants' expertise.
Current NIH-contracted Biologics Consultants:
Dr. Marie-Agnès Cassar, Ph.D. (Toxicology)
Dr. Marie-Agnès Cassar has more than 20 years of experience as a toxicologist and nonclinical manager in both the pharmaceutical industry and in a contract research organization. This includes running safety studies (toxicology, reprotoxicology, genotoxicology, safety pharmacology, in vitro studies), having responsibility for the management of a team of Study Directors/Monitors, and preparing all the nonclinical regulatory documentation (briefing packages, IBs, INDs, IMPDs, DSURs, etc.). Prior to joining VCLS, Marie-Agnès worked at Debiopharm, where she developed an expertise in the fields of oncology and anti-infective therapeutics (small molecules and biologics). She also worked for 11 years at Galderma R&D as a nonclinical manager. Dr. Cassar completed a Ph.D. in Pharmacology (« Sciences du Medicament ») at the University Henri-Poincaré Nancy in 1999, followed by two years conducting post-doctoral research and teaching. She was awarded European Registered Toxicologist status in 2008.
Dr. Michael Day, Ph.D. (Regulatory Affairs)
Dr. Michael Day has over 24 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs, and NDAs. Prior to joining VCLS, Dr. Day was the Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences where he was responsible for providing comprehensive regulatory and CMC global strategy to clients at various stages of their product development. Michael has led and attended multiple Agency meetings and interactions with numerous divisions of the FDA, including information requests, pre-IND, end-of-phase 2, pre-NDA, and Type C/Scientific advice.
Dr. Day received his PhD in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City. He also currently serves as adjunct faculty for University of Missouri-Kansas City, School of Pharmacy and is the Vice-President of the Pharmaceutical Technical Exchange Association.
Dr. Clyde Schultz, Ph.D. (CMC and Quality Assurance)
Dr. Schultz has 40+ years of experience in the field of microbiology with expertise in manufacturing of multiple biological therapeutics platforms, including modalities such as purified proteins and antibody-based therapies. His experience includes research in infectious diseases (Meningitis, Dengue, and Leishmaniasis), international regulatory expertise (bringing 10 products to the market), has seven patents and 100+ publications/posters/invitations to his credit. He is experienced with IP matters as a founder of two biotech ophthalmologic products (CNS agents).
Dr. Schultz has expertise in a range of best practices and processes: from large scale experiment design, FDA’s GLP and relevant animal testing rules, to conducting bio-assays, toxicology studies, in-vitro and in-vivo testing, and manufacturing process design including validation practices. Dr. Schultz earned his Ph.D. focused on Microbiology and Immunology, from University of Maryland. He completed his Master’s degree in Biology and received two undergraduate degrees – in Biology and in Chemistry.
Dr. Doug Keller, Ph.D. (Toxicology)
Dr. Doug Keller is a Senior Consultant in ToxStrategies’ Biopharmaceuticals/Pharmaceuticals Practice. He has more than three decades of experience in the pharmaceutical and laboratory sectors, serving as a researcher, study director, senior advisor, director, and global head in a leading pharmaceutical development/manufacturing firm. Most recently, he led a global team of 20 toxicologists conducting small and large molecule projects for development and marketing in CNS, GI, metabolic, inflammatory, rare, and oncologic disease areas at Sanofi. In this role, his responsibilities included approving project strategy and reviewing and approving regulatory compliance documents. He also represented the company on trade organization scientific committees and collaborative consortia. Dr. Keller completed a Ph.D. in pharmacology at Duke University and conducted postdoctoral research at the Chemical Industry Institute of Toxicology.
Dr. Lisa Minor, Ph.D. (Assay Development)
Dr. Minor is President of In Vitro Strategies, LLC, a consulting company involved in assay development and screening strategies, technology evaluation and development, and product marketability assessment. Prior to this, Dr. Minor was a long-term employee of Johnson and Johnson where she managed projects and developed strategies across multidisciplinary teams in areas such as target identification, screening strategy and lead optimization. At Johnson and Johnson, Dr. Minor developed cell-based and biochemical assays for high throughput screening as well as safety screens (hERG patch, hepatotoxicity and functional G-protein coupled receptor assays) for compound profiling. In other roles, she advised therapeutic area teams on data interpretation and follow-up, and participated in technology development projects resulting in marketed products, including Seahorse metabolic profiling instrumentation and Quantigene mRNA detection technology. Dr. Minor is a past board member of the Society for Laboratory Automation and Screening, is on the Board of Scientific Counselors for the National Toxicology Program, and has published the Handbook of Assay Development for Drug Discovery. Dr. Minor is well recognized in the field of high throughput screening, especially for cell-based assays, and has broad drug discovery experience including therapeutic area research, target validation, assay development, high throughput screening and safety profiling.
Dr. Marc Lemaitre, Ph.D. (CMC)
Dr. Marc Lemaitre has a very long experience and deep with oligonucleotide therapeutics, mainly focusing on Chemistry, Manufacturing and Control [CMC]. Dr. Lemaitre holds a Master’s degree in Organic Chemistry and a Ph.D. in Biochemistry, both from the University of Liège [Belgium]. Dr. Lemaitre was also research associate in the laboratory of Nobel Laureate Dr. Luc Montagnier at the Institut Pasteur in Paris. With over 20 years of experience in the fields of Biotech research, production, QA, development, especially with oligonucleotides for therapeutic applications, he has extensive training and specialization in Nucleic Acids. When being CEO of Girindus America [now Avecia Cincinnati], a manufacturer of active pharmaceutical ingredients (API’s), with a focus on Therapeutic Oligonucleotides), he did supervise the manufacturing of more than 30 oligonucleotides for clinical trials. He authored several CMC parts for innovative drug applications [IND] and/or their European counterparts and published more than 50 papers. Dr. Lemaitre is member of the USP Expert Committee BIO-1.
Dr. Gene Williams, Ph.D. (ADME and Clinical Pharmacology)
Dr. Williams has more than 25 years of experience in strategic planning and review of drug metabolism and pharmacokinetics-related elements of comprehensive drug development programs (from nonclinical IND enabling studies through NDA/BLA submission and post-marketing studies). Gene worked on over 600 different drugs as a Clinical Pharmacology Team Leader at FDA and over 400 as an FDA Primary Reviewer. Molecule types included non-biologics of all types, peptides, oligonucleotides, glycoprotein mixtures, antibodies and antibody-drug conjugates, liposomes, and nanoparticles.
As a consultant, Gene has advised several dozen clients regarding drug metabolism and transport, interpretation of non-clinical and clinical pharmacokinetics, investigational dose regimen selection from First-In-Human to Phase 3, drug interaction and specific population dosing, and bioavailability/relative bioavailability. Molecule types included non-biologics of all types, antibodies and antibody-drug conjugates, and cell and gene therapies.
Dr. Paul G. Pearson, Ph.D. (Pharmacokinetics)
Dr. Pearson is President and Chief Executive Officer of Pearson Pharma Partners, a consulting organization that specializes in pharmacokinetics, drug metabolism and translational science for biopharma and venture capital companies. In prior positions, he served as Global Head and Vice President of Pharmacokinetics and Drug Metabolism at Amgen and as Executive Director of Preclinical Drug Metabolism at Merck Research Laboratories where he was responsible for drug metabolism support for drug discovery and development programs. Dr Pearson has published extensively in the areas of pharmacokinetics, drug metabolism, reactive drug metabolites, drug-drug interactions and drug-induced toxicities, as well as co-edited the Handbook of Drug Metabolism. His research interests are focused on pharmacokinetics and drug metabolism, including the understanding of factors that influence the pharmacokinetics, metabolism, efficacy and safety of novel therapeutic agents in humans. For a period of almost 20 years, Dr Pearson has made major contributions to the approval of important new therapeutics to treat cancer (Camposar, Vectibix), Parkinson’s disease, hematological disorders (Nplate), HIV (Isentress) and fatal fungal infections (Cancidas).
Dr. Mark Gauthier
Dr. Gauthier is a Senior Director in Regulatory Science at VCLS. He is responsible for assisting clients to define the regulatory strategies for the global development and registration of drugs, biologics & cell and gene therapy products, especially those for life-threatening diseases.
Mark has more than 32 years of experience in the regulatory arena including preparation and submission of INDs, NDAs, BLAs, ODDs, and post-approval submissions of all types. Mark’s professional industry experience encompasses the oncology area, hemostasis, AIDS, neuropharmacological disorders, colony-stimulating factor, and ophthalmology therapeutic areas. He has worked on products in all phases of development (pre-IND through Phase 3 clinical trial) and has extensive experience in supporting rare and ultra-rare biological product development programs.
Dr. Gauthier is recognized as an expert in the regulatory aspects of development of cell and gene therapy products. Specific experience includes:
- Cellular therapies for the treatment of hematologic malignancies, pancreatic cancer, Covid-19 ARDS, metastatic renal cell carcinoma, prostate cancer,
- Gene therapies for the treatment of Batten disease (CLN2), Parkinsons disease, Limb Girdle Muscular Dystrophy, Multiple Sclerosis, retinitis pigmentosa, sickle cell disease, β-thalassemia, others.
Dr. Parveen Kaushal
Bio coming soon.
Dr. Cecile Rousseau
Bio coming soon.