Kenjie Amemiya, PhD, DABT
Dr. Amemiya brings over 25 years in the pharmaceutical industry as a drug development toxicologist in therapeutic areas including oncology, neurology, anti-psychotics, anti-infectives, cardiovascular, respiratory and inflammation. His experience includes research phase and development project team leadership, extensive experience in GLP compliance, and a specialized focus on reproductive toxicology and its application to patient safety. He has had the opportunity to be part of four market applications – two in oncology, an anti-infective and an orphan drug.
Two of the more recent exciting experiences for Kenjie have been serving as a Clinical Drug Safety Scientist and as a member of the Roche Patient Drug Safety Committee, applying translational skills towards the development of healthy volunteer/patient safety management. He also recently led a SEND cross-functional Genentech team to the successful implementation of a validated submission management tool and business process. Kenjie believes that the most challenging and exciting opportunities in drug development center around ever-increasing expectations to understanding drivers of toxicity, and evermore, the translation of non-clinical safety findings to healthy volunteer and patient safety management strategies.
“Our focus should be on patient safety using all the tools we have in our safety arsenal – extensive application of target biology, in silico and screening tools and finally focused and decision-making animal studies. Having had the opportunity to live in the clinical safety arena after so many years in non-clinical has made me realize that more than ever, conversations between non-clinical and clinical safety scientists and sharing those learnings with health authorities will be the key to developing safer drugs.”
Clifford DiLea, RPh, Pharm.D.
Dr. DiLea has nearly 30 years of experience in the pharmaceutical industry supporting and directing Clinical Pharmacology programs for the purpose of global registration of therapeutic agents from early clinical development through NDA. Cliff is a Clinical Pharmacologist with in depth knowledge of pharmacokinetics, pharmacodynamics and has extensive modeling skills. His expertise is integrating data and developing novel modeling strategies to formulate optimized therapeutic dose regimens.
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.
Stephene H Ford, BS, MBM
Ms. Ford has a wealth of knowledge in regulatory nonclinical studies and development of vaccine and biologic programs up to Biohazard Level 2. Ms. Ford has over 23 years of experience working in the pharmaceutical industry. She spent 15 years as a Study Director at Charles River Laboratories (Reno, Nevada and Mattawan, Michigan sites). Ms. Ford’s procedural acumen was demonstrated by forming and chairing the Institutional Biosafety Committee and serving as the Biosafety Officer. Prior to Charles River Laboratories, she served in various positions at increased levels of development/responsibility including technician, study coordinator, toxicologist, and toxicology supervisor over 8 years at Covance Laboratories in Vienna, Virginia.
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.
John Fulkerson, PhD
Dr. Fulkerson has over 20 years of experience in Biopharma/Biotech advanced research and development of vaccines and biologics, including preclinical, clinical, PD/manufacturing and clinical development. This includes establishing, coordinating, and directing extensive successful biologics development programs with commercial, academic and government partners. This includes all aspects of development and licensure of the ebola vaccine including extensive field safety studies, the second licensed COVID vaccine, the DoD’s biomanufacturing facility and the successful completion of their first commercial programs.
Dr. Fulkerson served as Chief Scientist for SAIC and ran over 90 programs including clinical trials overseas for Chikungunya and other tropical diseases. Prior to this, John ran development of vaccines for Tuberculosis, Malaria and HIV for the Bill and Melinda Gates Foundation at Aeras. Additionally, he oversaw gene therapy programs for Synergene Therapeutics and biodefense programs at the US FDA.
Dr. Fulkerson has extensive experience in animal studies, immunology, toxicology, assay development, PD/manufacturing, regulatory and clinical development of biologics and devices.
Brad Gillespie RPh, PhD
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, CSO
Dr. Guttendorf has over 25 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. 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 most efficiently and cost-effectively selects and develop drug candidates.
Paul J. Kruzich, PhD, DSP, DABT
Dr. Kruzich has more than 10 years of academic and GLP study director experience. Paul has a PhD in neuroscience and is one of a very few consultants that advise on the design and implementation of abuse liability nonclinical studies for experimental pathology. At Covance and BASi, he was a GLP study director for safety pharmacology and general toxicology studies. Paul is board certified in both toxicology and safety pharmacology. Paul joins Aclairo as a consultant to design, monitor and interpret GLP studies, write regulatory preclinical submissions, and design, implement and interpret preclinical abuse liability studies.
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.
Laura Dill Morton, DVM, PhD, DACVP, DABT
Dr. Morton is a board-certified toxicological pathologist (DVM/PhD) with significant industry drug/device/biologic experience from her time at TAP, Searle/Pfizer, and Novartis. Deep and broad expertise with more than 20 years industry experience that includes drug development from discovery through registration stages and includes a mix of small molecule, monoclonal antibody and gene therapies; oncology, CVM, infectious disease and CNS disease areas, as well as 3 years of device and blood product development experience, experience in conducting and managing nonclinical safety due diligence for a variety of small molecules, nucleic acid products, biologics and biologic platforms; and cell therapy.
Dr. Morton has demonstrated leadership in identifying emerging issues in biotherapeutic development and influencing biotherapeutic safety strategy. Demonstrated success in authoring regulatory submissions and responding to regulatory queries. Experience with multiple co-development teams and acquisitions. Excellent communication, organization, influencing and collaboration skills.
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.
Ric Stanulis, PhD, DABT
Vice President Toxicology, Senior Consultant
Dr. Stanulis is a board-certified toxicologist with approximately 20 years of experience in pharmaceutical drug development. He has been the head of nonclinical safety assessment for three biotechnology companies (most recently Acorda Therapeutics), a project team toxicologist for a mid-size pharmaceutical company, and a CRO study director. He has lead multiple development programs, across a spectrum from discovery/pre-IND through NDA/post-approval, for both small and large molecules.
Dr. Stanulis has been responsible for the design, oversight, and interpretation of studies for nonclinical development programs; addressing issues that arise in the development process; and writing nonclinical sections of regulatory documents, including regulatory agency correspondence. Ric also has extensive experience with the in-licensing evaluation of potential pipeline opportunities, as well as supporting the out-licensing of internal programs. One of Ric’s strengths is understanding the unique perspective and needs of small biotech companies as they maneuver through the drug development process.
Heath Thomas, DVM, PhD, DACVP
President, Senior Consultant
Dr. Thomas is a board-certified veterinary pathologist with over 20 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 due diligence exercises.
Karen Walthall, ME
Consultant & Scientific Writer
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.
Tacey E. K. White, PhD
Reproductive and Juvenile Toxicology Lead, Senior Consultant
Dr. White is the Director of Reproductive Toxicology and a Senior Consultant at Aclairo Pharmaceutical Development Group. She has been a consultant in the pharmaceutical industry since 2012. She advises pharmaceutical and biotech companies on nonclinical safety assessment strategies throughout the entire drug development process, including creating customized nonclinical strategies, placing and monitoring studies, developing human risk assessments for toxicology issues, addressing regulatory questions, and contributing to regulatory documents. Dr. White has deep regulatory and investigative expertise in development and reproductive toxicity (DART), and juvenile toxicity, and assist clients with FDA Pregnancy Labeling (PLLR) and pediatric development plans for EMA (PIP) and FDA (PSP).
Prior to her position at Aclairo, Dr. White spent 14 years as a DART study director at Sanofi; a safety assessment project team representative, DART study director, and DART investigative lead at GlaxoSmithKline; and Global Director of Small Animal DART at Covance, where she gained experience with many classes of therapeutics regulated by CDER and CBER. She has served as a toxicology project team member, as well as a strategic advisor on FDA interactions, for DART and general toxicity issues, mechanisms of action, and nonclinical study planning and management. Dr. White has extensive experience in all aspects of nonclinical toxicology and safety pharmacology assessments for small and large molecules, with particular emphasis on DART and juvenile toxicity.
Dr. White is the sitting Past President of the US Teratology Society (Vice President: 2014-2015, President: 2015-2016), and actively participates in the ILSI/HESI DART sub-team, including co-organization of the FDA Pregnancy and Lactation Label Rule workshop, and participation in the Neonatal Pediatric Therapeutics workgroup.