About Us

About Us

JLVMI Consulting is a privately held consulting company that supports the development of molecular imaging agents from discovery and development through early stage clinical trials and commercialization. It also specializes in research and laboratory management for total safety and compliance.

  • We provide consulting in the areas of pharmacy, radiochemistry and radiopharmacy of imaging agents, including Chemistry, Manufacturing and Controls, Pharmacology and Toxicology sections of IND’s, ANDA’s and DMF’s, covering PET and SPECT agents as well as other metabolic imaging agents (small molecules, antibodies and fragments, peptides, recombinant DNA proteins).
  • We are expert in scientific, commercial and research analyses related to advanced technologies involving all forms of imaging, isotope supply worldwide and radiation therapy.

 

Jean-Luc E. Vanderheyden, Ph.D.

Jean-Luc is an experienced pharmacist and PhD Analytical chemist who has worked in the biotechnology and pharmaceutical R&D environment for over 25 years. He is a leader in Molecular Imaging, bridging the commercial/research gap, consulting on the current and future trends in molecular medicine, biomarker and ligand development, as well as their relationship to diagnostic and therapeutic applications. He has led teams in the execution of product and assay development, formulation, pharmacology, toxicology and quality control of imaging agents from early research to approval. Jean-Luc manages CRO’s for the manufacturing and testing of organic intermediates, protein biopharmaceuticals and lyophilized components and develops SOP programs with Quality Assurance. He has assured preparation and release of radiolabeled products to meet cGMP standards and supervised laboratory data from clinical trials (pharmacokinetics, immunology). He also provides expertise in the areas of safety and radiation safety, research and laboratory management. He is and expert in scientific, commercial and research analyses related to advanced technologies involving all forms of imaging, isotope supply worldwide and radiation therapy. He advanced research with academic sites, understanding the compliance issues related between investigators and the research agreement cycle. Additionally, Jean-Luc was a Visiting Associate Professor at the University of Massachusetts Medical School, Division of Nuclear Medicine, Department of Radiology. He served as a member of the USP PET Radiopharmaceuticals Advisory Panel focusing on the revision of chapter , and a board member of the Society for Non-Invasive Imaging in Drug Development (SNIDD) and the Multidisciplinary Advisory Council for Non-Invasive Imaging Studies (MACNIS). He also is a reviewer to the Society of Nuclear Medicine, to NCI SBIR for Novel Imaging Agents to expand the Clinical Toolkit for Cancer Diagnosis, Staging and Treatment, to the IMI European funding organization (Innovative Medicines Initiative) and to the Swedish Foundation for Strategic Research, and is a member of the Quantitative Imaging Biomarkers Alliance (QIBA) technical committee on PET, the American Chemical Society (ACS), the Society of Nuclear Medicine (SNMMI) and the European Association of Nuclear Medicine.

Specialties

  • Molecular Imaging
  • Imaging Biomarker
  • Pharmacy
  • cGMP
  • Drug development
  • Clinical trial
  • Technology transfer
  • Radiation Safety
  • Operation Management
  • SPECT and PET imaging equipments
  • Pharmacology
  • Analytical Chemistry