The Scientific Advisory Services Team

  • Maïté Sillon, MSc, PhD

    Toxicologist Maïté Sillon is responsible for the organization and management of nonclinical safety programs within our Safety Assessment group. In this role, she ensures that all activities are conducted in compliance with relevant regulatory requirements and in accordance with scientific objectives, standards, ethical/professional values, as well as established priorities and practices of our clients. Collaborating with pharmaceutical and biotechnology companies worldwide, she advises on programs and study design, and monitors nonclinical regulatory packages. Ever since completing her PhD in biology focused in pharmacokinetics she has regularly attended training courses and scientific meetings to keep up with industry trends.

    • Four years in academia and 15 years at a veterinary pharmaceutical company prior to her transition to the preclinical CRO environment
    • Project toxicologist for new chemical entities, new biological entities, and veterinary medicines
    • Design, management, and reporting at all stages of candidate development
    • Nonclinical safety and risk assessment, interaction with regulatory authorities and preparation of preclinical documentation for the regulatory authorities to support dossier submission
    • Contributor to numerous scientific publications
       
  • Eddie Sloter, PhD

    Working out of our Ashland, Ohio facility, principal scientific advisor Eddie Sloter collaborates with companies worldwide in the areas of pharmaceutical, biotechnology, agrochemical, and veterinary medicine, advising on programs and study design and monitoring nonclinical regulatory packages. He has worked with various types of products, therapeutic areas, routes of administration, and animal species. As a toxicology consultant and mentor, he lends expertise in specialized areas like developmental and reproductive toxicology, neurosciences, juvenile toxicology, data interpretation, and senior review of toxicology reports. Eddie also partners with business development and client services colleagues to provide scientific representation and support.

    • More than 14 years of experience as study director, senior toxicologist, DART manager, and scientific director  
    • Conducted over 300 studies in developmental and reproductive toxicology, neuroscience, and juvenile toxicology, including mechanistic and mode of action studies, and research using transgenic animal models
    • Published several book chapters and scientific manuscripts in peer-reviewed journals 
    • Adjunct lecturer in applied toxicology for the Department of Pharmacology at the University of Cincinnati and the Biology Department at Ashland University
    • Member of the Society of Toxicology, The Teratology Society, and the Middle Atlantic Reproduction and Teratology Association (MARTA)
  • Samuel S. Chuang, PhD

    An experienced scientist, Sam Chuang collaborates with pharmaceutical and biotechnology companies worldwide, advising on drug development programs and study designs and monitoring nonclinical regulatory packages. He provides scientific and regulatory expertise covering a variety of drug classes (small to large molecule), therapeutic areas, routes of administration, and animal species. He manages multidisciplinary research teams for multiple drug development programs from target identification and drug discovery to preclinical safety programs. Sam is a member of the Society of Toxicology.

    • Over 20 years of academic, biotechnology and preclinical CRO research experience, with 16+ years drug development experience
    • Project toxicologist for new chemical entities, new biological entities, and new vehicles
    • Design, management, scientific and regulatory review, and reporting at all stages of candidate development
  • Nigel Pickersgill, BSc (Hons), C Biol, MRSB

    As a senior toxicologist, Nigel Pickersgill organizes and manages nonclinical safety programs within Charles River Safety Assessment, ensuring that all activities are conducted in compliance with relevant regulatory requirements and in accordance with scientific objectives, standards, and ethical/professional values, as well as established priorities and practices of the customer. He collaborates with pharmaceutical and biotechnology companies worldwide, advising on programs and study design and monitoring nonclinical regulatory packages. He regularly attends training courses and scientific meetings, including those on intranasal administration and intravenous infusion.

    • 35 years of experience in CRO industry
    • New chemical entities, new biological entities, new molecular entities, dermatology, vaccines, and adjuvants
    • Design, management, and reporting at all stages of candidate development
    • Contributor to numerous scientific publications (often concerning infusion models and new techniques)
    • Frequent presenter at various meetings to share his experience in infusion and regulatory toxicology
    • Member of the Royal Society of Biology, a Charted Biologist, and member of the Infusion Technology Organisation
  • Lauren E. Black, PhD
    Dr. Black Headshot

    An ex-FDA reviewer, Lauren Black is now a Distinguished Scientist at Charles River with more than 25 years of experience in drug development, focusing on accelerated translation to Phase I/II clinical trials. She works mainly at the first in human (FIH) stage - in high risk diseases using novel products. Before Charles River, Dr. Black was a reviewing pharmacologist in the FDA’s CDER and CBER, during which time she assessed preclinical data, worked on many FDA guidances, and represented FDA externally on oligonucleotides, safety pharmacology, choice of relevant species, and utilization of PAD as the response index for setting human safety margins. She was a founding co-author of FDA’s Human Start Dose guidance. As a specialist in biologic therapies and targeted agents, she was elected to serve in BIO’s BioSafe committee in leadership roles, resulting in a white paper on selective uses of large animals for human risk assessment. She sits on several government, academic, and industry advisory panels discussing in vitro toxicology, portfolio prioritization, technology transfer/capitalization, and regulatory strategy. Dr. Black received her BS from Carnegie Mellon University and PhD in pharmacology from the Virginia Commonwealth University School of Medicine, where she researched GPCRs.

    • Two years at NIH, 11 years at FDA, and 15 years at Charles River 
    • Specialist in translational research for all products, especially in high risk diseases
    • Focus on immunomodulatory drugs and biologics, vaccines and cell/gene therapies, including specialized combination products and novel delivery technology
    • Expert on regulatory programs, in vitro concept through clinical trial preparation
    • Nonclinical safety and risk assessment 
    • Collaborative design of lean programs, including in animal models of disease
    • Communication strategy with FDA
  • Jos Mertens, PhD, DABT
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    Senior principal scientific advisor Jos Mertens is a board-certified toxicologist with more than 22 years of CRO-experience in nonclinical development of small and large molecules by pharmaceutical and non-pharmaceutical industries. He primarily advises clients and internal stakeholders on nonclinical program and study designs for biopharmaceuticals and small molecules under development for a wide variety of therapeutic areas. In addition to guiding data interpretation when needed, he answers study design questions related to non-pharmaceutical applications such as food additives and agrochemicals and to target animal safety studies for veterinary drugs.

    • Four years of postdoctoral experience at the Division of Pharmacology and Toxicology of the College of Pharmacy at the University of Texas at Austin
    • More than 20 years as nonclinical CRO toxicologist and study director for nonclinical studies  
    • Focus on IND and post-IND phases for human and veterinary pharmaceuticals and mode of action and data registration packages for agrochemicals 
    • Certified in General Toxicology by the American Board of Toxicology
    • Ad-hoc reviewer for peer-reviewed journals
    • Member of Society of Toxicology (Biotechnology, Carcinogenesis, and Immunotoxicology Specialty Sections) 
    • Member of the American College of Toxicology, including service on the organization’s council and Award, Membership and Program committees 
       
  • Nancy Doyle, BS
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    As a principal research scientist with extensive experience in preclinical musculoskeletal research, Nancy designs studies with bone endpoints for a variety of therapeutic areas, in most species (from juvenile to geriatric populations) and routes of administration. She has deep experience in preclinical imaging, bone biomarkers, biomechanics in musculoskeletal research and toxicology, and a wide range of orthopedic and disease models (e.g., osteotomy, critical size defect, spinal fusion, OVX, ORX, CIA, TPTx).

    • More than 20 years of experience as study director with Charles River’s Musculoskeletal Research group
    • Design and conduct of regulatory toxicity studies with bone endpoints for a variety of therapeutic areas (osteoporosis, diabetes, metabolic disease, arthritis, muscular dystrophy, kidney disease), and from acute to carcinogenicity studies
    • Preclinical imaging, bone biomarkers, biomechanics and histomorphometry in musculoskeletal research and toxicology
    • Wide range of orthopedic (including medical device) and disease models in numerous species
    • Co-author and peer-reviewer of multiple published research papers on the topics of musculoskeletal and cartilage research and toxicology 
    • Co-author of a book chapter on bone toxicology
  • Pete Gaskin, PhD, ERT, MTOPRA
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    Pete Gaskin is a director of scientific advisory services who is experienced in biotechnology and pharmaceutical drug development. With expertise in toxicology, pharmacology, pharmacokinetics, and pharmacodynamics, he has a proven track record for transitioning drug candidates from research into development. His diverse scientific knowledge base guides our clients’ nonclinical development and advice for strengthening and/or accelerating nonclinical programs. Pete specializes in multiple therapeutic areas, including cancer, inflammation, neurology, cardiovascular, and metabolic diseases.

    • More than 25 years of life science, and 18+ years of pharmaceutical program management and consulting experience
    • Management of early development programs to clinical proof-of-concept and leadership of nonclinical programs to market
    • Development of biologics, proteins/peptides, oligonucleotides, gene and cell therapy and small molecules
    • Writing and reviewing nonclinical regulatory documentation and interacting with regulatory authorities
    • Member of the British and European Societies of Toxicology and the American College of Toxicology 
    • UK and European Registered Toxicologist and a member of TOPRA
    • Invited speaker at scientific meetings, and presenter at universities and drug development courses
       
  • Michael V. Templin, PhD, DABT
    Dr. Templin Headshot

    Michael Templin is a senior principal scientific advisor for both biotechnology and pharmaceutical drug development with expertise in the realms of toxicology, pharmacology, pharmacokinetics, and pharmacodynamics. Specializing in numerous therapeutic areas including cancer, inflammation, cardiovascular, metabolic, and viral diseases, he has a proven track record for transitioning drug candidates from research into development. Mike uses his diverse scientific knowledge to guide clients’ nonclinical development programs and to advise on ways to strengthen and/or accelerate their nonclinical programs.

    • More than 15 years in biotechnology and pharma and 5+ years in nonclinical CRO 
    • Lead/team member in nonclinical and early clinical programs for companies ranging from start-up biotechnology to mid-sized pharmaceutical companies 
    • Portfolio surveillance and in-licensing/out-licensing of candidates and therapeutic programs
    • Development of oligonucleotides (antisense, siRNA, miRNA, mRNA), biologics (mAbs, ADCs, bi-specifics, etc.), proteins/peptides, and small molecules.
    • Interaction with regulatory authorities and government agencies, presentations at scientific meetings
    • Member of the Society of Toxicology and the American College of Toxicology and a Diplomate of the American Board of Toxicology
    • Course instructor at universities, CE programs, and drug development courses
       
  • Benoît Ruot, PhD
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    Senior toxicologist Benoît Ruot collaborates with pharmaceutical and biotechnology companies worldwide, advising on programs and study design and monitoring nonclinical regulatory packages. His experience covers several types of products, a variety of therapeutic areas, and multiple routes of administration and animal species. In addition to providing scientific leadership to our Safety Assessment sites and study direction teams, he peer reviews toxicology study reports and prepares the transition to clinic via his contribution to the preparation of preclinical safety documentation for CTA/IND filings.

    • Five years in academia and 12+ years in major pharmaceutical companies, as well as 3+ years in the preclinical CRO industry
    • Project toxicologist for new chemical entities, new biological entities, new molecular entities, dermatology, vaccines, and adjuvants
    • Design, management, and reporting at all stages of candidate development
    • Nonclinical safety and risk assessment, interaction with regulatory authorities (national, EMA, FDA, Chinese), and preparation of preclinical documentation for the regulatory authorities to support dossier submission (under CTD format)
    • Member of the French Society of Toxicology and the American College of Toxicology
    • Certificate in Veterinary Ophthalmology (National CESOV)