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
Helen-Marie Dunmore, ERT
Principal Scientific Advisor
Helen-Marie Dunmore is a principal scientific advisor who has significant experience with regulatory requirements in the nonclinical development of advanced therapy medicinal products (cell and gene therapies) and a wide range of large and small molecules.
Prior to joining Charles River, she served as a senior nonclinical assessor at the MHRA reviewing nonclinical data packages (pharmacology, toxicology, and toxicokinetic) submitted in support of clinical trial authorization applications (Phases I-IV) or marketing authorization applications across therapy areas.
Helen-Marie also has experience with presenting nonclinical findings and making recommendations to UK/EU Advisory Committees (e.g., CHM and CHMP) and providing scientific/regulatory advice (on behalf of the MHRA and/or CHMP) to various stakeholders. She was also involved in reviewing regulatory guidance and representing the MHRA on working groups.
Helen-Marie has a master’s degree in applied toxicology from the University of Surrey (United Kingdom) and is a registered toxicologist in the UK and Europe.
- Over 15 years of experience in the industry (nine years at MHRA)
- Specialist in authoring and reviewing nonclinical regulatory documentation
- UK and European regulatory authority interactions and strategy
- Experience with early access schemes (e.g., EAMS)
- Has experience presenting, lecturing at universities, and training
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
Manu Kohli, PhD
Principal Scientific Advisor
Dr. Manu Kohli is a principal scientific advisor with significant biotechnology and pharmaceutical experience in addition to expertise in target identification, validation, and early drug discovery.
He has led senior scientific research teams in the biotech/pharma sector to advance drugs for a variety of disease indications, with a focus on oncology and infectious diseases. Manu has previously headed research programs in small molecule discovery, immunotherapy, and biologics discovery/development.
Manu has a PhD in biochemistry/molecular biology from Georgetown University and conducted post-doctoral training at Johns Hopkins University. Most recently, He was the Scientific Program Manager in Experimental Therapeutics at the National Cancer Institute (NCI). He has published many research articles in top-tier scientific journals and holds six patents.
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.
- 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
Pramila Singh, PhD, DABT
Senior Principal Scientific Advisor
Pramila Singh is a senior principal scientific advisor with global expertise in safety assessment and nonclinical drug development of biologics, biotechnology products, and pharmaceuticals.
She is a toxicologist with comprehensive experience in R&D, product development, and safety assessment. Pramila has worked with the US government for research on disease models of allergic asthma and cell signalling, and in global industry positions managing product safety testing and evaluation teams.
She has led study directors and scientific teams in regulatory toxicology, product safety, and preclinical development. Pramila is also a consultant on nonclinical development strategies for small molecules, vaccines, large molecules, antibody therapies, oligonucleotides, and gene therapy products in support of clinical trials.
Dr. Singh has a PhD in pharmaceutical sciences/technology from the University of Louisiana, Monroe and a bachelor’s degree from Louisiana State University. She is a member of the American College of Toxicology, the Society of Toxicology, and other scientific organizations, and is also a Diplomate of the American Board of Toxicology.
- Former Senior Director of Toxicology, with in-depth knowledge of nonclinical operations, study management, data evaluation, and reporting
- Provides consulting support on nonclinical development strategies for small molecules, vaccines, large molecules, antibody therapies, oligonucleotides, and gene therapy products in support of clinical trials
- Was a scientific project lead in expert areas such as ocular gene therapy, mechanistic toxicology, inhalation, carcinogenicity, and oncology providing in-depth scientific advice on study design, analytical support, and data interpretation
- Previous experience reviewing and preparing nonclinical sections of INDs, IMPDs, BLAs, and NDAs, and meeting with regulatory authorities in the US, Canada, Brazil, UK, Austria, and Japan
- She is an author of scientific publications, ad hoc reviewer for peer-reviewed journals, serves on scientific committees, and regularly presents at international scientific meetings
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 molecular biology at Charles River 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