Meet the Scientific Advisory Services Team

Dr. Black works mainly at the first in human (FIH) stage - in high risk diseases using novel products. Before Charles River, she 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. Dr. Black 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

Dr. Manu Kohli is a principal scientific advisor with over 20 years of biotechnology and pharmaceutical experience, with expertise in target identification, validation, drug discovery and development. He has led senior scientific research teams in the biotech/pharma sector to advance drugs for a variety of disease indications. Manu has previously headed research programs in small molecules, immunotherapies, biologics, and cell therapies, and has developed research strategies using diverse modalities.

Manu has a PhD in biochemistry/molecular biology from Georgetown University with post-doctoral training from Johns Hopkins University. He has published many research articles in top-tier scientific journals and holds numerous patents.

Specializing in numerous therapeutic areas including cancer, inflammation, cardiovascular, metabolic, and viral diseases, Mike has a proven track record for transitioning drug candidates from research into development. He 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 over 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
  

Pramila is a toxicologist with comprehensive experience in R&D, product development, and safety assessment. She 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

Sam leads a global team of scientists with extensive regulatory and scientific experience in drug development. Sam is an experienced scientist with over 25 years of academic, biotechnology, and preclinical CRO research experience and over 20 years of direct drug development experience. He provides scientific and regulatory expertise covering a wide range of drug classes (new chemical entities, new biological entities, advanced therapies, 505(b)2 packages, excipient developments, vaccines, medical devices, etc.) across a variety of therapeutic areas routes of administration, and animal species.

Sam provides client support in a variety of ways, ranging from the creation of discovery study packages, IND/CTA safety packages, and regulatory interaction strategies to participating in advisory panels and representing Sponsors as their lead toxicologists on toxicology programs. Sam has authored or co-authored one patent, 20 peer-reviewed articles, and over 80 abstracts and oral presentations through his academic and drug development research endeavors.

Sarah 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. She 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

An experienced leader of multidisciplinary teams and complex global portfolios, Stan has collaborated extensively with CROs, industry partners, and academic groups, and has been invited to speak to the FDA, NIH, and the Reagan Udall Foundation. He also advises the Yale Venture Fund, Nucleate, and several biotechnology companies. His pragmatic approach emphasizes early risk identification, mechanistic insight, and resource-conscious designs across a wide range of modalities, including small molecules, targeted protein degraders, antibodies, bispecific antibodies, ADCs, cytokine muteins, peptides, LNP-enabled RNA and oligonucleotide therapeutics, among others.