On August 24, 2022 Biotech Connection Los Angeles (BCLA) featured our third and final segment of the R&D Discussion Series focused on Clinical Trials. This week's panelists featured Sandra Thomas, Director of Clinical & Translational Project Development at City of Hope and Janani Krishnamurthy, Director of Drug Development Ventures at City of Hope, and was moderated by Mitch Gross, Associate Professor of Clinical Trials at the Ellison Institute.
The panel discussion was held for 30 minutes, and was centered around what the clinical trial process entailed, from benchtop to bedside. One of the key points mentioned during the discussions was the fact that from preclinical steps through the clinical trial process many moving parts need to work synergistically to bring a new drug on the market. During preclinical steps, scientists need to solidify the necessary data to produce proof of concept for a new drug/ drug target and have the ability to complete an investigational new drug (IND) application to the FDA. At the time of IND applications, scientists should have an idea of how they will acquire funding to push through the vigorous clinical trial phases.
During phase 1 trials, a new drug or treatment is assessed for safety and dosing, and tested to determine possible side-effects; at this point in the study 20-80 patients will be tested to understand initial drug findings. Following successful phase I trials, phase II trials the patient scope is expanded to about 100-300 individuals; if a drug demonstrates very promising results in phase I, this candidate can potentially skip phase II. In phase III trials the drug testing pool will expand to upwards of thousands of patients to compare investigational drugs to standard of care and to further confirm efficacy and safety, once phase III trials are cleared a drug will gain FDA approval and will be available for patient use. Overall, it is generally estimated that clinical trials will take about 10 years to complete, though there are exceptions granted for expedited FDA approvals—what this means for researchers is to ensure a drug can come to fruition a lot of money is required to fund patient trials and years of studies, so it is imperative to secure enough funding early on in addition to a strong proof of concept. Even after a drug is on the market and available to the public, it will be classified as a phase IV clinical trial where it will be monitored and additional data regarding efficacy and safety will be observed for years to come.
In summation, the speakers specifically highlighted the importance of having a strong team to facilitate this clinical trial process for several reasons: 1. Optimizing benefit, minimizing cost of trials, and troubleshooting failed clinical steps either through the forward or backward clinical trial approach; 2. Having the translational ability to communicate with scientists, business partners, and lawyers; 3. Knowing when and how to submit necessary information to FDA panels, including IND and institutional review boards (IRB).
If you are interested in pursuing a translational career in biotech, product/drug developer, project/product manager or professor of clinical trials may be the right career for you. Regarding growth in this intersectional career, our panelist highlighted that having a PhD in the sciences is fundamental and there is a need for engineers in scale up processes, nanotechnology, and electroporation delivery. To explore if a translational science career would be a good fit our panelist also encouraged the audience to pursue post doctoral training in a subject outside of your specialty, or to look into foundations catered to a disease of your interest to understand how they fund research.
We would like to thank the panelists and the moderator for taking their time to be with us and all of the attendees for supporting our series and engaging in the discussion with their questions.