Hilary Sheevers, PhD
President, Senior Consultant
Dr. Sheevers, a founding partner of Aclairo, provides scientific and regulatory advice in toxicology, FDA interactions, due diligence and strategic planning for drug development. Dr. Sheevers was a pharm/tox reviewer and/or team leader in the Pulmonary and Dermatology Divisions in CDER at FDA. She provides complete toxicology plans, study monitoring plans and support, regulatory support including data interpretation and presentation, as well as preparation of IND, NDA, CTD, and pre-IND submissions for the FDA. Dr. Sheevers has been involved in biologic and drug development across virtually all therapeutic classes at FDA.
Susan Wilson, DVM, PhD
Vice President, Senior Consultant
Dr. Wilson, a founding partner of Aclairo, serves as VP and Chief Scientific Officer providing scientific and regulatory advice across drug classes based on 10 years of consulting experience. Prior to her career in consulting, Dr. Wilson was a pharmacology/toxicology reviewer at the FDA. Areas of expertise include immunotoxicology and oncology, anti-inflammatory, analgesic, and ophthalmic drug products, imaging agents, large molecular weight products, drug delivery platforms, excipients, and reformulations.
Robert Guttendorf, RPh, PhD
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 select and develop drug candidates.
Laura Dill Morton, DVM, PhD, DACVP, DABT
Director of Toxicology
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.
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.
Tacey E. K. White, PhD
Director of Operations & Senior Consultant
Dr. White is the Director of Operations 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.
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.
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 advises 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.
Jeffrey D. Moehlenkamp, PhD, DABT
Dr. Moehlenkamp is our newest employee, and he joins Aclairo with over 16 years of development experience at Bristol-Myers Squibb. He has a PhD in pharmacology and is a board certified toxicologist. He has extensive study director/monitor experience, led or supported multiple small and large molecule development programs within diverse therapeutic areas, demonstrated expertise in developing compounds in virology, performed nonclinical safety due diligence reviews, and played pivotal operational and managerial roles in both nonclinical toxicology study conduct and CRO oversight. Jeff joins Aclairo as a consultant to design and support nonclinical safety programs including regulatory document preparation and design, monitor, and interpret GLP studies.
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 IND’s and NDA’s.
Aleese Hopkins, BS
Research and QA Associate
Aleese Lublin is a graduate of Florida State University with a Bachelor’s degree in Science. Aleese assists with the preparation and formatting of regulatory documents, including IND’s, NDA’s, CTDs, CTD tables, pre-INDs, and is trained in and performs Quality Assurance (QA). Aleese also performs literature searches to support position papers and other scientific and regulatory documents.
Emilia Kostadinova, BS
Emilia Kostadinova joins Aclairo with over six years of litigation support experience. Emilia serves as the point of contact for existing and future clients on all contractual matters, ensuring timely review and approval of contracts and reconciliation of variations. Emilia also oversees internal office operations focusing on improving company operational systems, processes and policies.