Services provided include design, execution and reporting of preclinical toxicology and ADME programs, clinical trial design and execution, regulatory document preparation (INDs, NDAs, white papers, PMAs), regulatory agency interactions (including meeting preparation).
Services for medical device evaluation include design, execution and reporting of biocompatibility studies and toxicological evaluation of medical device components.
Thorough scientific review of potential
out - and in-licensing opportunities, including gap analysis and risk evaluation.
Dr. Handler is the principal of JAH Associates LLC. His training includes a Ph.D in pharmacology from the University of North Carolina at Chapel Hill, postdoctoral training at the National Institute of Environmental Health Sciences, and a MBA from Villanova University. Dr. Handler is also a Diplomate of the American Board of Toxicology.
Dr. Handler has served in roles in increasing responsibility at both large and small pharmaceutical companies for more than 20 years, including positions as Vice President of Research and Development at Dermik Laboratories/Sanofi Aventis Dermatology and Vice President of Drug Development at Melior Discovery. Dr. Handler has published more than 30 peer-reviewed articles, more than 30 abstracts and book chapters, and is a member of the Society of Toxicology, American College of Toxicology, and Roundtable of Toxicology Consultants. He is also a peer reviewer for several scientific journals. Dr. Handler has participated in the successful preparation and submission of more than 25 INDs as well as several NDAs and PMAs in different therapeutic areas.
Dr. Handler has been consulting full-time for more than 8 years, dealing with more than 50 companies ranging from single-person start-ups to large multinational companies. Projects have spanned multiple therapeutic areas including, but not limited to, oncology, pain, reproductive health, dental implants, cardiac implants, Type 2 diabetes, NASH, rheumatoid arthritis, and antimicrobial products. He has also provided regulatory advice, pharmacokinetics and drug metabolism and disposition support, CMC and clinical development support, and regulatory document preparation and agency meeting leadership successfully to multiple companies.