Our Experts

Dr. Cary is a recognized expert in histopathology with a +30 year track record in preclinical development and safety assessment of pharmaceuticals/ biopharmaceuticals and medical devices, as well as +15 years of business and consulting experience. Dr. Cary has handled implementation of nonclinical programs, including problem solving/development issues, Expert Report preparation, regulatory documentation preparation for numerous projects (100s of studies) performed in Europe, USA and Asia involving biologics or NCEs. Somewhat unusual for a pathologist, he is also experienced in outsourcing as he was Head of Outsourcing (toxicology) in Europe for Novartis (Switzerland). This has led to his special interest in optimizing the performance and reporting of preclinical safety/risk assessment studies. Dr. Cary is the author of the chapter, “Contract Research Organizations” in the book, “Pharmaceutical Toxicology in Practice: A Guide for Non-Clinical Development” (John Wiley & Sons, Inc.).

Dr. Soldati is an expert veterinary pathologist with a broad experience in experimental, toxicologic and diagnostic pathology.

She obtained her D.V.M. degree at the University of Milan, Italy in 1999. After working in a combined residency program of the University of Milan, Italy and Bern, Switzerland, she obtained the ECVP diploma and the Ph.D in pathology of genetically engineered mice as a model of human cancer both in 2005.

She worked in academia (University of Milan, Mouse and Animal Pathology Laboratory (MAPLab) and University of Bern), pharmaceutical company and private diagnostic lab, gaining experience in all fields of pathology, from efficacy and toxicological studies in laboratory animals and evaluation of novel gene therapies in genetically engineered animals to spontaneous diseases in laboratory and domestic animals and AI development projects for digital pathology. Thanks to her entrepreneurial background and experience as a member of international companies’ bodies, Dr. Soldati has an interpretive and problem-solving approach to issues arising in preclinical development and experimental medicine.

She is author and co-author of peer-reviewed publications and currently serves on the ECVP Council as Secretary.

Eric van Esch is a Board Certified Toxicologic Pathologist with over 35 years of experience in the field of toxicologic pathology in the pharmaceutical industry and in various CRO settings. He has experience in a broad range of toxicity studies, varying from short term to carcinogenicity studies, and from studies in rodents to studies in dogs, minipigs and non-human primates, using different routes of administration. In addition to toxicologic pathology, he also gained experience in the field of clinical pathology for several years.

Through his employment at Organon NV for more than 25 years, well-known for the development of products in the field of female and male reproduction, he gained broad expertise in those areas.  This specific knowledge is recognized internationally through his participation in INHAND working groups as well as in several pathology working groups. He always strives to put the data into perspective by considering possible mechanistic implications and the overall human risk relevance. By this means he is able to take the data one step further.

With his sense for subtle, sometimes unexpected morphologic changes he, as independent peer reviewing pathologist, often supports study pathologists in refining, and improving the accuracy and quality of the final pathology data and overall interpretation. He can perform his activities (primary slide reading, peer review) under full GLP as he is OECD GLP accredited since 2012.

​Dr. Bolon is an experienced pathologist (toxicologic neuropathology) with special interest in genetically engineered and developing animals. He has written or co-authored over 200 articles and book chapters, has edited or co-edited 4 books, and is a frequent invited speaker at national and international meetings on mouse pathology.

Dr. Bolon has B.S., D.V.M. and M.S. degrees from the University of Missouri, “enjoyed” an anatomic pathology residency (1986-1989) at the University of Florida, and obtained a Ph.D. (1993) from Duke University while completing postdoctoral training at the Chemical Industry Institute of Toxicology.  He was employed by Pathology Associates International as associate director of the Molecular and Immunopathology Division (1993-1994) and later as staff pathologist at the National Center for Toxicological Research (1994-1996) before moving to Wyeth-Ayerst Research (1996-1997) as a senior scientist.

Dr. Bolon served as an experimental pathologist at Amgen (1997 to 2004) responsible for evaluating engineered rodents and the efficacy of novel biopharmaceuticals.  He subsequently founded an experimental pathology consulting practice (GEMpath, for “Genetically Engineered Mouse Pathology”), working there from 2004 to 2011.  Dr. Bolon worked for a time as an associate professor at The Ohio State University College of Veterinary Medicine (2011-2015), after which he returned to re-launch GEMpath (2015 to date).  Dr. Bolon is a Diplomate of both the American College of Veterinary Pathologists (ACVP, anatomic pathology; 1991) and American Board of Toxicology (ABT; 1996, re-certified 2001, 2006, 2011, 2016) and is a Fellow of both the Academy of Toxicological Sciences (ATS; 2011) and the International Academy of Toxicologic Pathology (IATP; 2007).

Dr. Lodola obtained his degree in Applied Biochemistry from the University of Bath (GB) and his PhD from the University of Bristol (GB). After completing a post-doctoral fellowship at Bristol he was appointed to a lectureship in biochemistry at the University of Kent (GB).

In 1986 he joined Pfizer at their Amboise Research Center in France, where he became head of General and Reproductive toxicology. During this time he gained expertise in all major aspects of nonclinical drug development, a wide range of toxicology study types (oral, iv, infusion, dermal, inhalation), risk identification and management, preparation and review of regulatory documents and interaction with regulatory authorities. He was involved in the nonclinical development of a number of marketed drugs including: Fluconazole, Eletriptan, Voriconazole, Dofetilide and Viagra. In 1999 he joined Pfizer Global Research and Development (PGRD), in New London, Connecticut, USA, where he was a member of the Toxicology Worldwide-Executive Team, the governance body for Pfizer toxicology sites (Europe, USA, Japan) and all aspects of nonclinical toxicology for the Pfizer drug development portfolio.

After  returning to France, in 2005 he established himself as a toxicology consultant  proving  expertise in nonclinical riskassessment, risk management, toxicology strategy development and the resolution of toxicology issues.  In addition, as a reviewer for AFSSAPS (the French health products safety agency, now renamed the ANSM) he provided a toxicological risk assessment for over 60 clinical trial applications (Phase I, II and III).

Dr Lodola has over 60 publications in peer reviewed scientific journals. In 2010 he published a chapter , “Developing combination drugs in preclinical studies”,  in “Drug Safety Evaluation. Methods and Protocols”, Humana Press, which he updated in 2016. The same year he was lead editor for a book “Toxicology in Practice. A guide to nonclinical development” published by John Wiley & Sons Inc.

Andy Makin has more than 40 years of practical, hands-on experience in design, management, conduct and overview of preclinical programmes and individual studies. He has broad experience across a wide spectrum of product types within the pharmaceutical, biopharma and medical device industries. And, being experienced in management and overview of studies including report writing, review and data interpretation, he is ideally placed to help and advise companies both small and large with their preclinical projects. Having worked with clients and projects in all the major regions of the world, he has a fundamental understanding of the needs of client companies globally.