Susan Wilson, DVM, PhD
President, Senior Consultant
Dr. Wilson, a founding partner of Aclairo, serves as 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.
Hilary Sheevers, PhD
Executive Vice 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.
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 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 Reproductive Toxicology, 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.
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.
Kenjie Amemiya, PhD, DABT
Dr. Amemiya brings over 25 years in 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 development of healthy volunteer/patient safety management. He also recently led a SEND cross-functional Genentech team to 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.”
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 brings over 16 years of development experience with 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.
Ric Stanulis, PhD, DABT
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 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 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.
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.