Rodney JY Ho

University of Washington, USA

Title: Next-Gen innovations to bring targeted HIV and cancer combination therapies that are long-lasting and accessible: A case study of New Paradigm in Academic Public-Private Partnership

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Biography

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Abstract

The advances in medical and pharmaceutical sciences have enabled the translation of knowledge in biomedical discoveries of physiologic, cellular molecular, and genetic abnormalities into drugs and vaccines for treatment and prevention.  The collective response of scientists in academic, governments, and pharmaceutical companies to collaborate to leverage on the accumulated “know-how” have made the Covid-19 vaccines and antiviral therapies that are now approved under Emergency Use Authorization (EUA) the US Food and Drug Administration.  Many of the pharmaceutical and technological advances accumulated over the years, including drug/protein/DNA/RNA/CAR-T cell formulation, delivery and scale up as well as regulatory and clinical sciences in the translation of the concept into pharmaceutical and vaccine products, have allowed rapid deployment of Covid-19 vaccine and anti-viral product scaling, non-clinical and clinical evaluation programs as well as product launch logistics world-wide. Even with the best effort, Covid-19 mono-drug therapy is not 100% effective. In the case of Hepatitis C treatment, a combination of at least 2 drugs is needed to eventually clear the virus in the liver. Most of the cancer (e.g., breast and pancreatic) types would need multiple drugs given in sequence or a combination to reduce the rate of progression and recurrence.  In the case of HIV, which exhibit high viral sequence mutation rate, and unlike Covid-19 (SARS-Cov-2), effort to develop an effective vaccine for HIV continue to elude us. While 2 or 3 HIV drug combination in a one-pill-a-day dosage can reduce the HIV virus levels to undetectable in the plasma, the patient must take daily pills of multiple drugs for life.  Pill stoppage will lead to nearly immediate rebound within a week or so and at risk of progression to AIDS. With the discovery and demonstration that oral dosage forms of multiple HIV drugs have limited localization and retention in HIV host cells, our research team at TLC-ART (Targeted-Long acting Therapeutic) program has discovered a novel platform technology to co-localize drug combination into HIV host cells, which are concentrated in lymph nodes and lymphoid tissues. With support from NIH public and private sources, our TLC-ART team has taken systems approach to develop a drug combination nanoparticulate platform technology targeted to HIV host and metastatic cancer cells under an innovative regulatory path to human testing. The research findings and innovations-including developmental and regulatory processes necessary in translation of the short-acting oral drug combinations into long-acting injectable dosage forms targeted to HIV hosts and cancer cells will be presented.