Aclairo Pharmaceutical Development Group, Inc.
The team has a vast array of experiences and we will work together to provide the services, expertise and experience that you need to develop your drug.
Rick Adler DVM, PhD, DACVP
Dr. Adler is a board-certified veterinary pathologist with more than 33 years of large Pharma company drug discovery and development experience. Throughout his career, he applied Pathology, Toxicology, and aligned scientific disciplines to advance innovative medicine portfolios from earliest target idea stage through registration and post approval lifecycle management, inclusive of numerous due diligence and regulatory interactions across that spectrum. Immediately prior to joining Aclairo, he was the US Head of Discovery and Regulatory Pathology for GSK and has also learned from multiple roles growing his career, and applying his leadership skills and strategic agility toward problem-solving and scientific issue resolution with Pfizer, Marion Merrell Dow, and MPI Research as Study Director, Study Pathologist, Therapeutic Area Leader, and while serving in multiple senior management roles. His experience covers diverse therapeutic areas including cardiovascular, metabolic, immune and infectious disease, neuroscience, dermatology, and oncology.
Rosonald Bell MSc, PhD, DABT, ERT, FRSB
Dr Bell is a highly qualified and experienced Board-Certified Toxicologist (Diplomate, American Board of Toxicology (DABT), Inc), European Registered Toxicologist (ERT), and Fellow of the Royal Society of Biology (FRSB) with over 30 years of experience in the pharmaceutical/biotechnology industry who helps drug candidates progress from discovery to development and approval/label negotiations. He held leadership positions at Searle/Pfizer Inc, Indivior Inc, Epizyme Inc, and most recently was Vice President of Toxicology at Viridian Therapeutics. He is an expert in drug development, specifically nonclinical toxicology and safety processes. He has broad experience with small molecule and large molecule (monoclonal antibodies, toxin conjugates) drugs in multiple therapeutic areas, including oncology, neurology, anti-inflammatory, cardiovascular, and rare diseases. Strong strategic skills, designing and leading programs from discovery through late-stage clinical development. Demonstrated success in leadership/authorship of numerous global submissions (IND, CTA, PIP, scientific advice, Type B, Type C, IB, regulatory response, NDA, etc.) in a nonclinical and regulatory affairs capacity. Expertise in identifying and mitigating critical program issues and enabling data-driven decisions. Dr Bell is an experienced manager, mentor, and cross-functional team leader who has excellent communication and presentation skills, extensive experience in partnered and multi-site internal programs. Broad knowledge of guidelines, regulations, requirements, and standards (GLP, OECD, FDA, and ICH). Experienced in program prioritization, budgeting, and due diligence activities. Accountable for the quality and execution of toxicology deliverables (toxicology plans, study protocols, reports, stage-gate documents, regulatory submissions, and due diligence). Provide toxicology expertise to R&D programs via participation in governance bodies. Proven track record of identifying and characterizing high-quality drug candidates. Known for a collaborative and influential management style. Strong work ethic and deadline oriented.
Uyen Dinh, PhD
Dr. Uyen Dinh has experience in discovery research, regulatory nonclinical studies, and translational development of therapeutic programs including cell and gene therapies, miRNA, exosomes, extracellular vesicles, biomaterials, and small and large molecules. Dr. Dinh has supported toxicology program planning, study monitoring, data analysis, and interpretation. Uyen has authored or co-authored over 25 peer reviewed publications and has expertise in technical writing and review of study reports and regulatory submission documents.
Dr. Dinh has also served as principal investigator, consultant, and subject matter expert in supporting drug development programs from discovery through clinical trials and licensing. Uyen participated in founding a university-based biotechnology start-up focused on stem cell and exosome therapies with two lead candidates progressing to first-in-human Phase 1 trials.
Jeri El-Hage, PhD
Dr. El-Hage was a pharmacology/toxicology reviewer and supervisor in the Center for Drug Evaluation and Research at FDA. Leadership positions included supervisory pharmacologist in the Division of Metabolism and Endocrinology Products (DMEP) and Associate Director of Pharm/Tox. Dr. El-Hage is an expert on drugs indicated for the treatment of endocrine and metabolic diseases and has extensive experience with biotechnology, biosimilar products, and carcinogenicity study evaluation and planning. Her consultation as a regulatory toxicologist covers all CDER divisions.
Jeff Ferguson, PhD
Dr. Ferguson has more than 30 years of regulatory toxicology experience in the pharmaceutical, chemical and CRO industries. As head of toxicology in a large pharma company, he has contributed to multiple drug development programs for both small and large molecules in a variety of therapeutic areas. He has been responsible for the appropriate design, conduct, interpretation and reporting of non-clinical safety and pharmacokinetic/toxicokinetic studies. As a safety assessment representative to many drug development teams, Jeff has been responsible for developing and managing the respective non-clinical safety testing plans including addressing safety-related issues and writing nonclinical sections of regulatory documents. Jeff has broad-based experience working with CROs and external development partners both as a sponsor and a consultant and has conducted due diligence on assets in various stages of development.
Brad Gillespie RPh, PhD
Senior Consultant Clinical Pharmacology/DMPK
Brad has over 25 years experience in the pharmaceutical/biotech industry and federal institutes focused on the development and regulation of biologics and small molecules. His core expertise is in the strategic planning, conduct, analysis and interpretation of early clinical development programs. He began his career as a pharmacokinetic reviewer at the U.S. Food & Drug Administration, then rose to higher levels of responsibility at Pharmacia and Amgen followed by a return to government service, leading virtual development efforts at NCATS/NIH (rare and neglected disease) and the Department of Defense. Over the course of the past several years, he has pivoted to strategic regulatory affairs, supporting the development, submission and defense of multiple IND, BLA and NDA.
Robert Guttendorf, RPh, PhD
Vice President, Senior Consultant Clinical Pharmacology/DMPK, CSO
Dr. Guttendorf has over 34 years of experience directing preclinical and clinical DMPK programs, including regulatory interactions, in large pharmaceutical and small biotech companies. He has directed ADME/PK/Clinical Pharmacology from discovery through NDA, across therapeutic areas, with numerous regulatory submissions and approvals. He has extensive experience in planning, writing, and using regulatory submissions (IND, NDA, CTD, BLA, etc.) and position papers to advance regulatory strategies in development. He held leadership positions at Parke-Davis and Pfizer, and most recently was Vice President at Advancis and Sequoia Pharmaceuticals. He has expertise in developing unique strategies to select optimally developable drug candidates efficiently and cost-effectively.
Weili Huang, PhD
Consultant Clinical Pharmacology/DMPK
Dr. Huang has over 20 years of experience in pharmaceutical and regulatory sciences. She obtained her Ph.D. degree in the Department of Pharmaceutics at the University of Washington in 2016 and began her career as a pharmacologist reviewer of the Center for Drug Evaluation and Research (CDER) at the FDA. Before joining Aclairo, Dr. Huang served as an independent consultant for companies in the pharmaceutical industry, where she was contracted to oversee various projects in drug discovery/development and provided expert advice and strategies. She has expertise in the areas of clinical pharmacology and DMPK (drug absorption, metabolism, drug transport and drug-drug interaction). Dr. Huang is also an expert in drug knowledgebases and drug databases.
Dwayne A. Lavoie, BS
Dwayne Lavoie has over 26 years of toxicology experience across multiple disciplines including Inhalation Toxicology, Safety Pharmacology, and General Toxicology. Dwayne has a Bachelors of Science Degree in Biology from Bethany College. He has extensive study director/monitor experience and has been responsible for the design, conduct, oversight, and interpretation of GLP studies for nonclinical development in both the pharmaceutical and chemical/agrichemical industries.
More recently, Dwayne was a project manager in Nonclinical Regulatory Affairs for GlaxoSmithKline leading the preparation and authoring of Investigator Brochures as well as the preparation of nonclinical modules supporting US IND and NDA submissions and EU IMPD and Marketing Authorization Application submissions.
Lauren M. Mihalcik, PhD, DABT
Lauren M. Mihalcik received a BSE in Chemical Engineering from Princeton University and a PhD in Pharmacology from the University of Virginia. She is a diplomate of the American Board of Toxicology. Currently, she is a Senior Consultant for Aclairo Pharmaceutical Development Group Inc, an Experimental Pathology Laboratories Inc (EPL) company. Prior to her position with Aclairo, she was a Senior Scientist at Amgen and a Senior Toxicologist in the Division of Metabolism and Endocrinology Products in the Office of New Drugs at the Food and Drug Administration (FDA). At the FDA, Lauren was the pharmacology/toxicology reviewer for more than 90 programs and contributed to policy development for many drug classes. She was co-chair of the Information Technology Subcommittee and the primary FDA lead for the development of the Standard for Exchange of Nonclinical Data (SEND). At Amgen, Lauren was responsible for the nonclinical safety strategies for more than twenty programs across a wide range of indications, including large and small molecules, biosimilars, and oligonucleotides. She established the nonclinical safety strategy for the Amgen oligonucleotide platform, mentored junior toxicologists, and represented Amgen in the EFPIA Oligonucleotide Working Group and the Oligonucleotide Safety Working Group. She has been active in professional organizations, including the American Society for Pharmacology and Experimental Therapeutics, the Society of Toxicology, the Oligonucleotide Therapeutics Society, and the American College of Toxicology. She is also a member of the organizing committee for the Applied Pharmaceutical Toxicology meeting. Lauren has more than 15 years of experience in industry and government and has authored or co-authored numerous peer reviewed publications and book chapters.
Emily Noonan Place, PhD, MPH
Emily is a Senior Consultant at Aclairo Pharmaceutical Development Group. Prior to working with at Aclairo, she started her career consulting as a Senior Nonclinical Consultant at Biologics Consulting Group out of Arlington, VA.
She made a transition to consulting from her position as Senior Pharmacologist, at the FDA/CDER’s Office of Oncologic Diseases where she worked for over 8 years. At FDA, Emily worked on a team that supported a division reviewing applications in benign heme and hematological malignancies, and a team in a division reviewing applications in solid tumors. While in the oncology office she performed nonclinical review of Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologic License Applications (BLA), and Cross Center Consults. Emily has reviewed over 120 pre-INDs, 225 commercial and research INDs and 75 NDAs, BLAs and/or supplements. Emily has an expertise in oncology products and oligonucleotide therapeutics. She co-chaired the Pharmacology/Toxicology Subcommittee for Oligonucleotide Therapeutics for 7 years, for which she performed consults, provided education to review staff, developed internal regulatory practice, and oversaw the safety and activity of drug applications for Oligonucleotide Therapeutics in all therapeutic divisions across the Office of New Drugs. She is currently a member of the Oligonucleotide Safety Working Group and chairs their subcommittee on Carcinogenicity.
Emily has a bachelor’s in science in Biology from State University of New York at Binghamton, her PhD in Cell Biology from University of Connecticut, and an MPH in Epidemiology at the University of California at Berkeley. Following her PhD, she was an Associate Investigator at San Francisco VA Medical Center from where her research focused on miRNA dysregulation in prostate cancer. She completed a postdoctoral fellowship at Stanford School of Medicine testing chemotherapeutics in a translational model of NHL and was a Cancer Prevention Fellow at the National Cancer Institute in the Laboratory of Human Carcinogenesis where her research involved examining the role of extracellular plant small RNA communication in human carcinogenesis. Her research has culminated in several publications in peer-reviewed journals and book chapters. She is also currently Faculty at the University of California at Berkeley, School of Public Health, in the Division of Biostatistics and teaches Biostatistics in the Master’s in Public Program.
Judith Prescott, DVM, PhD, DACVP
Dr. Prescott has over 25 years of experience in nonclinical drug discovery and development and is a board-certified veterinary clinical pathologist. She has held leadership positions at Merck and GSK with a demonstrated track record of accountability, commitment, and good decision making, and most recently was Associate Vice President and head of a global team responsible for the strategic and logistical oversight of all nonclinical discovery and development safety programs across the Merck portfolio. This included oversight of programs in the Infectious Diseases, Oncology, Immunology, Cardiometabolic, Neurosciences, and Vaccine Therapeutic Areas and oversight of several product registrations for small molecules, biologics, and vaccines. In addition to breadth and depth of experience in nonclinical toxicology and drug development from discovery through registration and life-cycle management, Dr. Prescott is experienced in the resolution of complex scientific and regulatory issues and development of global regulatory strategies.
Chris Sheth, PhD
Dr. Sheth served as a pharmacology/toxicology reviewer and supervisor at the FDA in CDER’s Office of Hematology and Oncology Products for nearly 7 years. He reviewed or oversaw over 250 pre-INDs, 1,000 INDs and 175 NDAs, BLAs and/or supplements. As a result, hundreds of compounds entered Phase 1 clinical trials and 40 new molecular entities and 4 biosimilars entered the market, including 21 with pediatric indications. He has extensive regulatory experience in all aspects of nonclinical toxicology and safety pharmacology assessments for small and large molecules, with an emphasis on the vast array of drugs and biologics indicated for the treatment of malignant and nonmalignant hematological conditions.
Prior to his position at Aclairo, Chris gained experience in GLP animal studies while working as a report coordinator and assistant toxicologist at Covance, then received PhD training in immunotoxicology at the Medical College of Virginia, and worked in the EPA’s IRIS Program writing the Toxicological Reviews that provide a foundation for setting air and water quality standards and clean-up levels for contaminated manufacturing facilities, processing plants, landfills, and mining sites.
At Aclairo, Dr. Sheth’s FDA experience will provide clients with insights on regulatory toxicology related to drug and biologic product development across the CDER divisions. His additional capabilities include design of complete safety assessment strategies including development and reproductive toxicity and carcinogenicity, reformulations, route of administration switches, and expert guidance on requests for waivers.
Heath Thomas, DVM, PhD, DACVP
President, Senior Consultant
Dr. Thomas is a board-certified veterinary pathologist with over 25 years of experience in drug development from time spent with SmithKline Beecham, Dupont Pharmaceuticals and GlaxoSmithKline as well as several years of consulting experience with Experimental Pathology Laboratories. He served as VP of Safety Assessment and Head of Pathology for many years at GSK covering multiple different therapeutic areas. He also served as Head of the IACUC at GSK for several years. He has directed or consulted on numerous drug development projects from early discovery through filing along with many due diligence exercises.
Karen Walthall, ME
Karen Walthall is a scientific writer with over 19 years’ experience in drug development consulting. Karen has a Master’s Degree in Biomedical Engineering from the University of Virginia. Ms. Walthall was part of the Aclairo team from 2004 to 2011 and subsequently worked as an independent consultant from 2012-2016. In 2017, she returned to Aclairo part-time as a consultant and scientific writer.
Ms. Walthall has authored scientific literature reviews regarding the postnatal development of bone and the GI system in animals and humans. Ms. Walthall routinely conducts literature searches, writes scientific literature reviews, white papers, Investigator Brochures, and various regulatory documents including, briefing packages (pre-IND, pre-NDA, and end of Phase 2), and nonclinical sections of INDs and NDAs.
Jennifer Wheeler, PhD
Dr. Wheeler comes to Aclairo following 5 years in the Immuno- and Molecular Toxicology group in Drug Safety Evaluation at Bristol-Myers Squibb. She obtained her PhD in Toxicology from the University of Rochester. As a subject matter expert in immunotoxicology, Dr. Wheeler’s technical expertise includes flow cytometry analyses, antigen challenge models, as well as immunotoxicology and immunopharmacology assessments for both small molecules and biologics. Dr. Wheeler is experienced in the management of laboratory personnel and has worked closely with contract research organizations to develop assays, execute technically challenging assessments on IND-enabling studies, and provide data interpretation to assess the immunotoxicology safety and pharmacology of diverse compounds.
Dr. Wheeler is also an experienced technical writer, having authored and reviewed protocols, reports, and critical submission documents for nonclinical portions of IND, NDA, and BLA submissions.
Brittany Winner, PhD
Dr. Brittany Winner is a trained pharmacologist and toxicologist with a strong background in molecular neuroscience. Dr. Winner has ten years of toxicology experience beginning with her PhD at Michigan State University in the Department of Pharmacology and Toxicology and Institute for Integrative Toxicology, where her thesis work centered on molecular mechanisms of protein quality control and neurodegeneration in neurotoxicant models of Parkinson disease. As a postdoctoral fellow, she developed countermeasures against botulinum neurotoxin and served as principal investigator to study the therapeutic potential of augmenting endocannabinoid signaling following nerve agent exposure at the United States Army Medical Research Institute of Chemical Defense. Prior to her position at Aclairo, Dr. Winner served as a technical specialist for a patent law firm and as a nonclinical consultant with another company. At Aclairo, Dr. Winner provides project team toxicologist services, to include: design and oversight of nonclinical studies, evaluation of study data, gap analysis, meeting package preparation, and IND/NDA writing for small and large molecules.