James Kronauge
Chief Executive Officer @ Hesperos Inc.
About
I have been focused in the field of radiochemistry for drug development in both academia and industry. After obtaining a BS in chemistry and spending 3 years as a research assistant at a large pharmaceutical company, I returned to graduate school and obtained a PhD in inorganic chemistry from the Massachusetts Institute of Technology developing Isonitrile complexes of Technetium for myocardial perfusion imaging. After graduation I spent 13 years at Harvard Medical School as an Assistant Professor of Radiology followed by another 13 years at the startup company: Molecular Insight Pharmaceuticals, Inc., engaged in the discovery and commercial development of pharmaceutical products emitting ionization radiation. At MIP my positioned transitioned from Director of Research and Development to Chemical Process Development for pre-clinical and Clinical studies. My experience includes synthetic organic and inorganic chemistry, in vitro cell culture techniques, and animal models of disease, HPLC analysis, pharmacodynamics and metabolism studies, radiochemistry, pharmaceutical production and microbiology testing. At MIP we established in-house GMP facilities and generated clinical active pharmaceutical ingredients for preclinical and clinical testing for 6 new IND applications. Duties included development of ISO compliant facilities using Good Manufacturing Practices (GMP), for process development, Analytical testing and Validation following ICH guidelines, Quality Control and Release of Drug products and the generation of Regulatory submissions in Europe and the US. I have published more than 50 peer-reviewed articles and am inventor or co-inventor of six issued patents and one recently submitted. In July 2013 I joined inviCRO, an image processing and Software Development Company focused in the field of drug discovery and development.
United States
Boston
Pharmaceuticals
Clinical Development, Biotechnology, Pharmaceutical Industry, FDA, Lifesciences, Oncology, Medical Devices, Technology Transfer, Regulatory Affairs, GMP, Clinical Trials, Validation, Drug Development, Drug Discovery, Chemistry, Clinical Research, Cancer, IND, Medical Imaging, HPLC
Experience

Executive Director Process Development
Cytosite Biopharm Inc.

Co-founder & President
Tomopath Inc.

VP development
Molecular Insight Pharmaceuticals
Cambridge MA
Chemical process development and scale up to GMP pre[aration of final drup products and components. Technology transfer to produce late stage clinical testing supplies and commercial drugs. CMC documentation generation for IND and NDA fillings to the FDA and EMEA.

Assistant Professor of Radiology
Brigham & Women's Hospital
Served as on site RSO and Associate Director of the Radiopharmacy in the Joint Program in Nuclear Medicine tasked with the daily supply of routine SPECT radiopharmaceuticals for five Harvard associated clinical nuclear medicine Units. Performed individual research on the synthesis, applications and mechanism of action for various radiopharmaceuticals.

Graduate Student in Chemistry
MIT
Cambridge MA
Inorganic Chemistry PhD Thesis "Functionalized Isonitrile complexes of Technetium as Radiopharmaceuticals"
Education
James Kronauge's Contact Information
Phone
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