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Major Hurdles and Solutions in IND-enabling Studies and Beyond

Tuesday, March 16, 2021

12:00 pm - 1:00 pm

This talk will give a brief introduction to the spectrum of phases of the translation from drug discovery to drug development for FDA approval as a clinically-used product.

The major hurdles in IND-enabling studies of thorough characterization of biopharmaceutical properties and developing clinically relevant formulation of the promising drug candidate from drug discovery, preclinical PK/PD evaluation of the candidate and formulation, and planning for Phase 1 clinical trial will be discussed.

The presentation will highlight the resources, expertise and experiences available on UH campus, including an NIH-funded P20 grant and a CPRIT-funded core facility, which have served scientists/clinicians in TMC and other GCC member institutions. This presentation serves to establish the platform in DDI to connect each PI’s needs to these resources for collaborative research.

About the Speaker:

Dr. Diana S-L. Chow, Ph.D., FNAI, currently serves as the Paula & John J. Lovoi Sr. Endowed Professor of Drug Discovery and Development, Professor of Pharmaceutics, and Director of the Institute for Drug Education and Research.

Dr. Chow is internationally recognized researcher and expert in the field of pharmaceutics, particularly the study of pharmacokinetics/pharmacodynamics, and the development, modeling and analyses of novel drug formulations and drug-delivery systems for the treatment of leukemia, cancer and acute spinal cord injury as well as studying the stability and efficacy of medications used in space flights on the International Space Station. Overall, she has authored/co-authored more than 70 peer-reviewed journal articles, three book chapters and more than 250 abstracts presented at scientific conferences/meetings, as well as delivered more than 45 invited lectures/seminars. She served as Editor of the British Journal of Pharmacology till 2016 and currently as Editorial Board Member for the Journal of Drug Development and Industrial Pharmacy, as well as a reviewer for more than two dozens of other journals.

Dr. Chow’s research has resulted in more than 10 U.S. and international patents, including her co-invention of IV Busulfex® (busulfan), an intravenous conditioning agent for leukemia and other cancer patients undergoing blood, bone marrow or stem cell transplantation. The 100 percent bioavailable agent has resulted in a 10-fold reduction in the three-month, post-transplantation mortality rate of patients. Today, more than 65 percent of all acute leukemia patients transplanted in North America receive the intravenous Bulsufan-based pretransplant regimen, making significant impacts on patient survivals.

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