James Kronauge

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.

Country

United States

City

Boston

Industry

Pharmaceuticals

Skill

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

Hesperos Inc.

Chief Executive Officer

Hesperos Inc.

LinkedIn
2022-4 - Present · 4 yrs 6 mos

Orlando, Florida, United States

Invicro

Chemistry Consultant

Invicro

LinkedIn
2019-2 - Present · 7 yrs 8 mos

27 Drydock Ave, 7th FLoor, Boston, MA 02210

Invicro

Senior Director of Chemistry

Invicro

LinkedIn
2013-7 - 2019-2 · 5 yrs 8 mos

2 Oliver St, Boston, MA

Direct Chemistry and generate documentation associated with performing in-house and contracted Pre-clinical and clinical Molecular Imaging studies for drug development and companion imaging agents.

Cytosite Biopharm Inc.

Executive Director Process Development

Cytosite Biopharm Inc.

2019-2 - Present · 7 yrs 8 mos
Tomopath Inc.

Co-founder & President

Tomopath Inc.

2019-12 - 2022-4 · 2 yrs 5 mos
Molecular Insight Pharmaceuticals

VP development

Molecular Insight Pharmaceuticals

1999-12 - 2013-4 · 13 yrs 5 mos

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.

Brigham & Women's Hospital

Assistant Professor of Radiology

Brigham & Women's Hospital

1987 - 1999 · 12 yrs

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.

MIT

Graduate Student in Chemistry

MIT

1983 - 1987 · 4 yrs

Cambridge MA

Inorganic Chemistry PhD Thesis "Functionalized Isonitrile complexes of Technetium as Radiopharmaceuticals"

Education

Massachusetts Institute of Technology

Massachusetts Institute of Technology

LinkedIn

Chemistry

1983 - 1987 · 4 yrs

Synthesis and Characterization of Technetium isocyanide compounds as myocardial perfusion agnets

Harvard Medical School

Harvard Medical School

LinkedIn

Nuclear Chemistry, radiopharmacy

1987 - 1999 · 12 yrs
Kent State University

Kent State University

LinkedIn

Chemsitry - Pre-medicine

1975 - 1978 · 3 yrs

James Kronauge's Contact Information

Email

******@***.com

Phone

(**) *** ****

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