Blog

Get to Know Aclairo

0

Aclairo

Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance.

 Aclairo’s unique experience and capabilities help our clients’ development programs succeed. Our senior consultants are experienced ex-FDA or industry specialists and can provide expert guidance in the areas of toxicology, regulatory, ADME and clinical pharmacology drug development

Take a closer look at Aclairo’s senior scientific management:

Hilary Sheevers, PhD

President, Senior Consultant

A founding partner of Aclairo, Dr. Sheevers serves as President and a Senior Consultant.  She provides scientific and regulatory advice in toxicology, FDA interactions, due diligence and strategic planning for drug development.  At Aclairo, she designs 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.  Dr. Sheevers is involved in biologic and drug development across all CDER divisions at FDA.

At FDA, Dr. Sheevers served as a primary reviewer and manager.  She built policy expertise at the FDA, and understands the reasoning behind many FDA policies.  She attended industry meetings on an almost daily basis.

FDA Committees, which are responsible for drafting FDA policy, and which Dr. Sheevers served include:

  • Pharmacology/Toxicology Coordinating Committee (PTCC)
  • The Executive and full Carcinogenicity Assessment Committee (ECAC, CAC)
  • Photo-carcinogenicity/Photobiology Working Group
  • Reproductive Toxicity Committee (Co-chair)
  • Pregnancy Labeling Working Group (Co-Chair)
  • Inactive Ingredients Committee
  • Arteritis/Non-Monitorable Toxicities Working Group
  • Thalidomide Working Group
  • Botanicals Committee

Dr. Sheevers works full time from the mountains of Arizona in Prescott.  She enjoys golf and hiking and being in a beautiful environment every day.  She returns to the Washington metro office monthly.  She and her husband, Neil, are supporters and volunteers for the Prescott Coalition for Compassion and Justice, a community-wide response to poverty.

 

Susan Wilson, DVM, PhD

Vice President, Senior Consultant

Dr. Wilson is a founding partner of Aclairo and serves as Vice President and a Senior Consultant, providing scientific and regulatory advice across drug classes based on over 20 years of drug development experience.  In her role as a consultant, she works with clients to develop and implement full toxicology programs, provide interpretation and assessment of nonclinical study results, develop scientific and regulatory strategies to address nonclinical toxicology issues that may arise during the development process, and prepare regulatory documents including INDs, NDAs, CTDs, IMPDs, and briefing packages for meetings. Additionally, she performs due diligence, interacts with the FDA on behalf of her clients, and participates in expert panels. Dr. Wilson has experience with small molecules across FDA divisions, biologics, drug delivery platforms, excipient qualification, and reformulations.

Prior to her career in consulting, Dr. Wilson was a pharmacology/toxicology reviewer at the FDA and, therefore, has experience on both the regulatory and industry sides of drug development. While at FDA, she served on the Immunotoxicology Working Group (co-chair) and the Reproductive Toxicity Committee, was an instructor in the FDA Staff College Immunotoxicology Course, reviewed grant proposals for the Office of Women’s Health, represented the FDA on the Interagency Coordinating Committee for the Validation of Alternative Methods [ICCVAM] – Ocular Toxicity Working Group as well as the Immunotoxicity Working Group, and participated  in the ILSI Workshop as an FDA representative on the Predictivity of Pharmaceuticals in Humans from Animal Data – Hematology Group.

Dr. Wilson enjoys spending time outdoors on her farm with her horses and playing the piano (admittedly rather poorly). She and her husband, David, support and volunteer at the Goochland Free Clinic and Family Services as well as the Lewis Ginter Botanical Gardens.

 

Robert Guttendorf, RPh, PhD

Chief Scientific Officer, Senior Consultant

Dr. Guttendorf is the Chief Scientific Officer and a Senior Consultant at Aclairo.  He has over 25 years of experience directing preclinical and clinical pharmacology and drug metabolism/pharmacokinetic (DMPK) programs, including regulatory interactions, in large pharmaceutical and small biotech companies. Dr. Guttendorf provides advice on scientific and regulatory issues in drug development, due diligence, and strategic planning for drug development.  He has expertise in planning, writing, and using regulatory submissions (IND, NDA, CTD) and position papers to forward client needs at the FDA. He has contributed to numerous successful regulatory submissions, including three approved NDAs in the past two years.

In his role as CSO, Dr. Guttendorf is responsible for managing the Scientific Advisory Group at Aclairo, ensuring that the consultants have sufficient support and resources to serve their clients’ needs, and nurturing an environment of scientific excellence, advancement, and innovation at the company.

Prior to joining Aclairo, Dr. Guttendorf held leadership positions at Parke-Davis and Pfizer, including global scientific strategy advisor, and most recently was Vice President at Advancis Pharmaceutical Corp. and Sequoia Pharmaceuticals leading nonclinical and clinical pharmacology and experimental therapeutics efforts. Dr. Guttendorf has remained actively involved in teaching and mentoring in his role as adjunct faculty member at Duquesne University, University of Maryland University College, and Hood College. He is a registered pharmacist.

Dr. Guttendorf is an avid hiker and bicyclist and maintains a love of the outdoors. He has recently been actively cultivating his long-held interest in photography. He enjoys volunteering, including participating in Habitat for Humanity home builds here and abroad, and has been a volunteer reader at the Metropolitan Washington Ear, a dial-in service for the blind and visually impaired, for 10 years.

 

 Laura Dill Morton, DVM, PhD, DACVP, DABT

Director of Toxicology

Dr. Morton is the Director of Toxicology at Aclairo.  She is board certified in both veterinary pathology and toxicology and has over 20 years’ industry experience in the development of small molecule and biologic drugs and gene therapies.  Dr. Morton has demonstrated leadership in identifying emerging issues in biotherapeutic development and influencing biotherapeutic safety strategy.

Dr. Morton, prior to joining Aclairo, was employed at Baxter, TAP, Pharmacia/Pfizer, and Novartis where she established a record of success in authoring regulatory submissions and responding to regulatory queries.  Her experience in drug development extends from discovery through registration stages and includes a mix of small molecule, monoclonal antibody, fusion proteins and gene therapies, and a range of therapeutic areas including oncology, cardiovascular, infectious disease, metabolic disease and CNS. She also has 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 also has experience with multiple co-development teams and acquisitions.

Dr. Morton is an avid backyard bird watcher and gardener. She enjoys travel, her puppy and photography in her spare time.

 

Tacey E. K. White, PhD

Director of Operations, Senior Consultant

Dr. White is the Director of Operations and a Senior Consultant at Aclairo.  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 developmental and reproductive toxicity (DART), and juvenile toxicity, and assists 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 a 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.

 

Aclairo is a wholly owned subsidiary of Experimental Pathology Laboratories, Inc.

 

Share This:Share on FacebookTweet about this on TwitterShare on LinkedInShare on Google+Pin on PinterestEmail this to someone

Leave a Reply