The Pharmacology and Drug Development Scientific Core will be headed by Dr. Diane Heck, Professor and Chair of the Department of Environmental Health Science and Acting Chair of the Department of Epidemiology, Biostatistics and Community Health in the School of Health Sciences and Practice at New York Medical College. Dr. Heck is an expert in Toxicology and Environmental Health and is recognized for her work on mechanisms underlying chemical toxicity. She has worked in collaboration with medicinal chemists for more than twenty years in drug discovery and lead optimization. Joining Dr. Heck in her Development Team is Dr. Jules Mitchel, an Adjunct Professor in the Rutgers School of Pharmacy and President of TargetHealth, a full service CRO specializing in Regulatory Affairs, FDA interactions and all submissions. Clinical Research Management, Biostatistics and Data Management, Internet-based Clinical Trials, Medical Writing, Good Manufacturing Practices and other support services to the pharmaceutical industry. He has broad base pharmaceutical experience in drugs, biologies, devices and diagnostics including multiple regulatory submissions, many FDA meetings and IND/IDE submissions, and strategic planning. Dr. Mitchel has been working with our Center since its inception and has presented talks at CounterACT meetings. Key collaborators for the Core include Drs. John Graham, an expert in sulfur mustard model development at the US Army Medical Research Institute of Chemical Defense (USAMRICD) and Christopher Molloy, Dean of the Earnest Mario School of Pharmacy at Rutgers University and a former Senior Research Fellow/Team Leader, Inflammation &Pulmonary Diseases, Johnson &Johnson Pharmaceutical Research and Development, LLC. The Core will also be assisted by Dr. Michael Gallo from UMDNJ who has consulted for the eye care industry and will provide expertise in advancing ocular hydrogels developed by our CouterACT Center. The overall role of the Pharmacology and Drug Development Core is to facilitate the advancement of therapeutics for treatment of injury resulting from exposure to toxic chemicals that could be used in a terrorist attack, principally sulfur mustard, nitrogen mustard and mechanistically related agents. This includes assay development, compound evaluation and assisting investigators to prioritize drug candidates to be advanced. Two countermeasures developed over the last grant period have demonstrated very promising activity against sulfur mustard wounded skin (an Indomethacin-Ester-Carbonate prodrug) and eye injuries (doxycycline loaded hydrogels);these will be advanced for further development and IND-enabling studies through the CounterACT Preclinical Development Facility (CPDF). In addition, the Core will continue working with J&J Pharmaceutical Research Institute to advance TPOmp into an IND as an orphan drug for the treatment of sulfur mustard and radiation-induced thrombocytopenia.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
2U54AR055073-06
Application #
8210207
Study Section
Special Emphasis Panel (ZRG1-MDCN-J (54))
Project Start
2011-09-09
Project End
2016-06-30
Budget Start
2011-09-09
Budget End
2012-06-30
Support Year
6
Fiscal Year
2011
Total Cost
$1,152,149
Indirect Cost
Name
University of Medicine & Dentistry of NJ
Department
Type
DUNS #
617022384
City
Piscataway
State
NJ
Country
United States
Zip Code
08854
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