iJOBS Seminar: Novel approaches to therapeutic development in industry

February 20, 2023

iJOBS Blog

By: Sonal Gahlawat

Welcome to 2023! The beginning of a new calendar year is always special, and the tradition will continue. It’s been almost three years since the COVID-19 pandemic started, which upended lives worldwide at a breathtaking speed. COVID-19 has fundamentally changed our lives and our mindset towards scientists, healthcare practitioners, and let’s not forget vaccines. Hence, on January 10, Rutgers iJOBS invited Dr. James Cappola to learn more about vaccine development (including cancer) and new treatment options for post-traumatic stress disorder (PTSD) in the US.

Dr. James Cappola holds a doctoral degree in Immunology and Microbiology from Rutgers University and a M.D. from Universidad Autónoma de Ciudad Juárez, a joint program between Mexico and the US. Dr. Cappola previously served as the Medical Director and Safety Officer at the Harvard Clinical Research Institute. With 30 years of experience in pharmaceutical drug device industry, Dr. Cappola has spent his career in vaccine development. A few of his major highlights include launch support of the first recombinant Hepatitis B vaccine at Merck & Co. and Tipranavir for the treatment of AIDS while working at Boehringer Ingelheim Pharmaceutical. Currently, he is a biotechnology consultant for global clinical studies for a multitude of companies.

In the first part of his talk, Dr. Cappola discussed the current status of developing a universal vaccine for COVID-19. The push for a universal vaccine came from the “universal influenza vaccine” that was being designed when COVID-19 hit in early 2020. To develop a universal vaccine, one needs to target a “constant antigen,” meaning the virus will not let this antigen mutate or evolve with time. So, even as new strains evolve, the antigen isn’t changed, and the same vaccine will provide protection for all virus variants. In contrast, newer versions of COVID-19 vaccines or booster shots are being developed at a rapid pace because the “spike protein”, which was targeted as an antigen for vaccines, did change over time as the virus evolved. Thus, a universal vaccine can save enormous amounts of time, development costs, and resources, all of which will allow rapid response to evolving public health threats. With the first-in-human trial of the universal influenza vaccine already in progress, the design and development of a universal COVID-19 vaccine had also started at Duke University and Walter Reed Army Institute of Research with promising results. The development of these universal vaccines has the potential to protect the public from both seasonal flu and from a future pandemic outbreak.

Shifting gears towards developing vaccines for treating cancer, Dr. Cappola mentioned several approved vaccines for cancer prevention and therapy. Just like gene therapies, viral vectors are being modified for anti-cancer vaccines, such as Imlygic viral therapy to treat melanoma. To further revolutionize the field of cancer vaccines, scientists at Indaptus Therapeutics are “harnessing innate and adaptive immune responses to cure diseases.” Let’s just take a breath and appreciate such scientific advancements that have the potential to dramatically alter the cancer treatment regime in the coming decades.

In the second part of the talk, Dr. Cappola focused on PTSD. PTSD affects 6-9% of people exposed to trauma worldwide. Exposure to severe trauma at any age can result in “clinically significant distress and impairment of functioning, which causes significant impact on one’s daily life. High incidence of PTSD has been seen among war veterans, teens, and people who have experienced or witnessed a traumatic event. The FDA currently authorizes only two drugs for the treatment of PTSD. While both the drugs take weeks to months to show any effects and offer minimal side-effects, these drugs show a high remission rate (of up to 30%). To reduce the issue of remission, companies have started considering new approaches (such as ketamine therapy) to treat PTSD. On a slightly different note, a study conducted by Harvard University concluded that graduate students are >3X (three times) more likely to experience mental health disorders and depression compared to an average American (1). Several other studied have shown that graduate students suffer from PTSD-like symptoms (2,3,4). For many, graduate school is filled with challenges including long work hours, constantly being ‘on,’ relatively low or non-existent wages, intense labor expectations, and other stressors or mental health issues. So, if you are struggling right now, please utilize mental health resources available at Rutgers University.

As the event was ending, graduate students and postdoctoral researchers did not want to miss this amazing opportunity to get career advice from an accomplished professional in the field. A quick overview of the Q&A session is here.

Question: Any advice to graduate students and postdocs who want to start their own company, focusing on vaccine development and translational research?

A: There’s always room for more. Be creative. Find colleagues who will work with you. Apply for seed funding or federal grant. “Baby steps lead to big steps.”

Question: If an M.D. candidate wants to work in industry, should they complete their residency?

A: Yes. Finish the residency while you are young. There’s no stopping you after your residency so, if you can do it, try it!

Question: Where can I learn more about patent law?

A: Look at the press releases of any biotech firms. Ask for the patent filing and approach the patent agent. Network and do informational interviews! Use LinkedIn extensively.

Question: Do you have recommendations to pursue Medical and Regulatory Affairs?

A: Explore Regulatory Affairs Professional Society and apply for this membership. They offer courses, training programs, and certifications.

Question: What certifications are essential in drug discovery and development?

A: GCP Certification (which is offered by the FDA). Contact the local Data and Safety Monitoring Board to learn more about different certifications. When hired, companies will always train you.

While this might not be a typical iJOBS event, Dr. Cappola’s talk made me aware of the new unconventional ideas and approaches being adopted to cure cancer or PTSD. It made me reappreciate why, like so many other graduate students, I decided to pursue a doctoral degree: in the hope of helping humankind in my own small ways. In Dr. Cappola’s words, use your Ph.D. degree “as a powerful steppingstone” to advance your professional career whether it means trying new things or applying for your dream jobs.

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