Scientific Advisory Services Team
Lauren E. Black, PhD
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
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
Nancy Doyle, BS
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
David F. Fischer, PhD
Executive Director of Discovery Sciences, David Fischer joined Charles River through the acquisition of BioFocus.
He has led numerous early stage drug discovery programs in rare and orphan disease indications. He brings expertise in complex and primary cell-based assays, including iSPC and hESC stem cell models and human primary cell models. David holds a degree in Chemistry and a PhD in molecular Genetics, both from Leiden University.
- Focus areas include cystic fibrosis, Huntington’s disease, ALS, Usher III Syndrome, Duchenne muscular dystrophy, and neurodegenerative disorders (Alzheimer’s and Parkinson’s disease.)
- During his postdoctoral fellowships at the Netherlands Institute for Neuroscience in Amsterdam (an Institute of the Royal Netherlands Academy of Arts and Sciences) and the Free University Amsterdam, he focused on Alzheimer’s and Huntington’s Disease and mentored two graduate students, at the University of Amsterdam and at Leiden University
- Over 50 patent applications and peer-reviewed papers
Pete Gaskin, PhD, ERT, MTOPRA
Pete Gaskin is a senior 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
Sarah Gould, PhD
Senior Principal Scientific Advisor
Sarah Gould is a senior principle scientific advisor with extensive experience (20 + years) in biotech, pharma and as a consultant.
She has a proven track record of delivering toxicology and safety pharmacology programs, individual studies and regulatory documents (IND, IMPD, CTD) for both small and large molecules (proteins, peptides, mAbs, virus vectors) along the development pipeline and has supported over 100 submissions. Sarah has interacted with various health authorities, including FDA, EMA, PMDA, as well as individual European authorities and emerging markets.
- Deep expertise in various therapeutic areas and modalities including vaccines/adjuvants, oncology including oncolytics and miRNA, diabetes including obesity, immunology, cardiovascular, neuroscience, anti-infectives and toxicology evaluations of chemicals
- Presented, organized and chaired toxicology meetings including at SOT, Eurotox, HESI, DIA and Biosafe
- Involved in international scientific collaborations: HESI (vice president- safety of adjuvants; concordance project) and IMI projects (EFPIA rep)
- Contributory author to regulatory guidelines documentation including safety assessment of process residues/contaminants in vaccines (EVM re: TTC, 2012); WHO vaccine guideline (2013)
- Published several scientific papers in peer reviewed journals and co-authored a book chapter titled “vaccine toxicology: nonclinical predictive strategies” and is also an ad hoc reviewer for peer reviewed journals
Noel D. Horton, PhD, DABT
Principal Scientific Advisor
Noel Horton is a principal research advisor at Charles River’s Mattawan, MI facility. His background includes service as a development team representative in the therapeutic areas of oncology, cardiovascular, and CNS.
Noel has directed nonclinical studies with both large and small molecules across multiple species using a variety of administration routes. Additionally, he has interacted with regulators for toxicology programs and provided nonclinical safety support for regulatory filings, briefing documents, and investigator brochures.
- 4 years as a university instructor and administrator
- 12 years in pharmaceutical development
- 4+ years in nonclinical contract research
- Small molecules, oligonucleotides, biologics (mAbs, ADCs, etc.,) and proteins/peptides.
- Interaction with regulatory authorities and government agencies
- Presenter/Instructor at scientific meetings, continuing education programs, and drug development courses
- Member of the Society of Toxicology and the American College of Toxicology, and a Diplomate of the American Board of Toxicology
Raluca Kubaszky, DVM, PhD, DABT
Principal Scientific Advisor
A veterinarian by training and a board-certified toxicologist, Raluca has over 20 years of CRO and academic experience in safety study design and management of complex projects in pharmaceuticals, biologics, chemicals, and agrochemicals.
She obtained her DVM from the Faculty of Veterinary Medicine, University of Agronomical Sciences Bucharest, Romania, then specialized in nonclinical research after completing a PhD in Veterinary Medicine, Endocrinology of Reproduction. She became a Diplomate of the American Board of Toxicology in 2011 and was re-certified in 2016. Based at the Laval site of Charles River in Canada, formerly Citoxlab, Raluca supports clients and colleagues by ensuring that clients’ scientific and strategic commercial needs are understood and efficiently addressed while also meeting regulatory requirements. In particular Raluca works with clients and scientific colleagues to design nonclinical development programs with complex and novel products.
- Areas of expertise include radiation safety, cell and gene therapy, biological therapeutics as well as small molecule test items
- Raluca has experience of designing and conducting general toxicology, reproductive and juvenile toxicity studies
- Member of the Radiation Research Society, the Society of Toxicology (SOT) and American College of Toxicology (ACT) and elect member of the ACT Outreach committee
Jos Mertens, PhD, DABT
Senior Principal Scientific Advisor
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
Christopher L. Murriel, PhD
Principal Scientific Advisor
Christopher Murriel is a Principal Scientific Advisor in Discovery Oncology with extensive experience and expertise in oncology drug discovery.
Prior to Charles River, Dr. Murriel was an Associate Director in the Department of Research at OncoMed Pharmaceuticals where he directed preclinical study efforts aimed at determining the efficacy, MoA, and pharmacodynamic effects of OncoMed’s pipeline of small molecule and biologic research and development programs involving cancer stem cell, anti-angiogenic, immuno-oncology, and autoimmune diseases. In addition, Chris has diverse expertise in developing cancer mouse models including PDX, syngeneic, genetically engineered, and humanized models, as well as those involved in autoimmune disease research.
- 20+ years of life science and over 12 years of biotechnology industry-related research experience in cancer biology, immuno-oncology, autoimmune disease, and cardiovascular research
- Expertise in establishing, utilizing, and managing pre-clinical in vivo studies to support biologic and small molecule therapeutics development: relevant models include syngeneic, genetically engineered, patient-derived (PDX), humanized and autoimmune disease mouse model platforms
- Demonstrated accomplishment of major contributions towards advancing numerous biologics and small molecule therapeutics against WNT, NOTCH, R-spondin, TIGIT, and GITRL-Fc from discovery to IND-enabling studies
- Experience with in vitro high-throughput RNAi and synthetic lethal interaction screens
- Accomplished external speaker and collaborator as evidenced by numerous invited presentations and publications
Nigel Pickersgill, BSc (Hons), C Biol, MRSB
Principal Scientific Advisor
As a principal scientific advisor, 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
Eddie Sloter, PhD
Principal Scientific Advisor
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)
Keith Sutton, PhD
With a BSc (Hons) in immunology and a PhD in virology, Keith Sutton is a biologist with over 20 years of specialist knowledge in the areas of molecular biology, physiology and immunology.
He has a broad familiarity with a range of model systems relevant to the development of cell and gene therapies, together with a deep understanding of analytical approaches and their application in a regulatory environment. Having worked in both commercial and academic environments across the UK, US, and Australia he has worked in multidisciplinary drug development teams with colleagues from a broad range of backgrounds and experience. His project management experience encompasses delivery by both internal and external relationships. Keith is a speaker at international conferences, has authored several primary research articles, many commentary review articles (including publications in Cell and Nature Cell Biology) and is co-author of a patent (Enkurin and the uses thereof).
- His broad experience in comparative physiology is regularly employed by clients and colleagues in relation to both assay development and the interpretation of toxicology findings on the basis of mode of action
- Broad experience with cell and gene therapies including viral and non-viral vectored gene therapies, gene editing technologies, stem cell therapies, CAR-Ts
- He also has experience in the design of PK and PD assessments for cell and gene therapies, mAbs, and ASOs
- Experience with analytical design and support of clinical programs for cell and gene therapy products
- He is the Head of Charles River’s molecular biology Center of Excellence and a member of the Edinburgh site biosafety committee
Michael V. Templin, PhD, DABT
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
Alan Young, PhD
Alan Young is Senior Director for the Respiratory and Inflammation therapeutic area in the Scientific Advisory Services team.
He is a pharmacologist and a very experienced drug discovery scientist who has led discovery projects and delivered over 20 respiratory candidate drugs into early development. He has also worked within the broader early development organization to progress compounds to phase IIB and phase III clinical studies. Alan has briefed and coached the senior management teams of several clients regarding respiratory drug discovery and helped develop skills, expertise and technology required to fulfill key project aims. He has also established scientific advisory boards for key clients to address key questions around compound progression and has also been invited to serve on clients scientific advisory boards. His background covers experience and expertise in respiratory, gastrointestinal, rheumatoid and skin diseases, with an interest in systems physiology.
- 25+ years of pharmacology experience and drug discovery
- Line management of multiple teams of scientists, matrix management of very large project teams
- Experienced discovery project leader, having delivered candidate drugs through to phase IIb clinical studies
- Skills in respiratory and inflammation drug discovery, both in vitro and in vivo, including understanding of PK/PD relationships and how to establish and interpret and more specialized knowledge around lung function and physiology
- Experience in writing and reviewing nonclinical regulatory documentation and interacting with regulatory authorities (UK, USA, Japan)
- Over 200 publications, patents and presentations in the Respiratory and Inflammation area
- Regularly presenter at the American Thoracic Society and European Respiratory Society and has been an invited participant and leader at ERS workshops