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Drug Development, IND Filing, and Clinical Trials

For the translation of late stage drug candidates into novel experimental therapeutics, scientists at the center can take advantage of the expertise and infrastructure from our collaborating institutions, including:

  • UCSD for pre-clinical ADME tox studies and clinical trials.
  • City of Hope for GMP/GLP facilities, IND filing, and clinical trials.
  • Riverside Community Hospital (Riverside) for clinical trials.
  • Desert Region Medical Center (Palm Springs) for clinical trials.
  • Cedars-Sinai Medical Center (Los Angeles, CA) for clinical trials.

In Vitro and In Vivo ADME Tox Studies

Identification of novel potential drug candidates requires careful fine-tuning on the pharmacological properties of lead candidates, not only to ensure potency and selectivity against the given target in vitro and in cellular assays, but also availability of the drug in vivo.

The center collaborates with the UC San Diego Drug Development Pipeline facilities led by Assistant Professor of Clinical Pharmacology Jeremiah Momper that will provide experimental data including: 

  • Metabolic stability (liver microsomes and hepatocytes)
  • CYP Inhibition or induction
  • in vivo pharmacokinetics
  • Metabolite identification
  • Protein binding
  • Drug Permeability
  • Physicochemical profiling
  • Bioanalytical Chemistry

This data will help our scientists to guide the hit-to-lead optimization process and in the selection of more suitable lead compounds for further efficacy studies in animal models.


GMP/GLP Facilities and IND Filing

For these activities, scientists at the Center for Molecular and Translational Medicine can take advantage of the City of Hope and Beckman Research Institute resources, services or expert consultation. In particular, the Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing resource for small and large molecule therapeutics for clinical trials. The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and in phase I and phase II clinical trials. The facility also provides investigators with a regulatory-compliant, cost-effective route towards bringing promising therapeutics to the clinic.