This week we spotlight Dr. Manoj Jadhav, founder, and CEO of ISHA Therapeutics and former assistant professor at KEM Hospital in Mumbai, India.
“Contributing to the spirit of drug development”
Dr. Jadhav founded ISHA Therapeutics with the goal of “contributing to the spirit of drug development,” a slogan that can easily be found at the top of his company’s website. So, what exactly does that mean?
“I chose this slogan because drug development is such a complex process and needs contribution from several stakeholders across drug discovery, non-clinical, clinical, and Chemistry, Manufacturing, & Controls (CMC) expertise. Many small, start-up and mid-size companies do not have all the expertise available to steer their drug development strategies in the right direction. Here, we wish to catalyze early-stage drug development programs. Our ultimate aim is to contribute to developing treatments that can aid in alleviating suffering throughout society.”
Dr. Jadhav’s company is also working on repurposing drugs, some of which could theoretically be used to treat patients with COVID-19. “Our focus is two-fold, which is unique for a company like ours. We are helping some of our clients speed up their drug development programs, while also working on repurposing compounds for communicable diseases and as preventative therapeutics in-house. One of our programs is currently focused on COVID-19, with in vitro studies ongoing and building several new partnerships to develop formulations and test them in the clinic. Our other projects are focused on dermatological indications.”
To do this, Dr. Jadhav relies on a very specific strategy, one he’s implemented wholesale since he founded ISHA Therapeutics:
“While repurposing drugs under the 505(b)(2) regulatory pathway in the United States, one needs to be very critical. For example, we need a detailed understanding of the safety and efficacy of the approved molecule for its current indication as well as new changes that need to be implemented, like increasing solubility, changing dosage form, reducing the dose or dosing frequency, and improving patient compliance. You also need to assess how feasible it would be to run the clinical development program efficiently with minimum subjects being enrolled in the studies. I personally reach out to the FDA, discuss the complete repurposing program with them, gain specific insights, advise, then make a detailed analysis of what is feasible and what amount of time and money is needed to run that specific program. Once you have such a detailed analysis, the sponsor can make a go/no-go decision on the project.
It’s also important to consider the current players in the market and the expected business share. One of the most important things to consider is how you’re generating intellectual property, which is not always obvious. This is a complex process and requires expertise across multiple domains. Fortunately, ISHA Therapeutics has all these experts available to us.”
“Our ultimate aim is to contribute to developing treatments that can aid in alleviating suffering throughout society.”
Founding ISHA during the pandemic
Surprisingly, Dr. Jadhav managed to start his company quite recently, in the midst of the pandemic, a particularly dangerous situation in terms of both health and economics. However, after encountering a few delays, he’s managed to get it off the ground.
“This is a once in lifetime situation the world is going through, and I am no exception. There were some procedural delays in registering the company—we wanted to have a nice office then make a grand opening—but the current situation did not let that happen. On the business front, potential clients were only speaking with us and getting as much information as possible, but they were not willing to sign contracts. That sometimes gave us low energy, though I knew we were on the right track, even as the world runs through so much turbulence. With my spiritual practices, I realigned my thoughts, telling myself that success is not too far along and that I need to keep my energy focused in one specific direction and keep trying as much as possible.”
Dr. Jadhav also opened up to me about some of the immediate changes that have occurred since the company became a reality, both positive and negative, due to the pandemic.
“Due to COVID-19, we’ve had to put on hold two of our major projects as the facility that was running them had to be closed. However, on a better note, I’ve had more time to read in detail about these projects and have enriched our overall understanding of these programs going forward. We’ve also had many more discussions with our scientific advisers to come up with a better development strategy.”
When it comes to reaching out to the FDA, he mentioned that since the pandemic, they’ve never been more accessible. “For some of our clients, we approached the FDA, and believe me, they are extremely fast at responding to your queries. You may not believe that on a Sunday afternoon, I wrote an email to the FDA’s Coronavirus Treatment Acceleration Program, and to my super surprise, I got a reply in three hours flat. They are a professional body and doing things with the public health at large in mind.”
A lifetime in pharmaceutical sciences
In founding ISHA Therapeutics, Dr. Jadhav has brought a wealth of experience to the table, spending nearly his whole life in pharmaceutical sciences. From India to the United States, he’s done it all in terms of both research and drug development.
“I studied in India at prestigious universities in Pune, Delhi, and Mumbai, and received my Bachelors, Masters, and Ph.D. degrees all in Pharmacy. Throughout the years, I had excellent opportunities to research and develop liposomal transdermal drug delivery systems, testing their efficacy in vitro and in vivo. The turning point for me was during my Ph.D., where I helped develop the first Indian liposomal amphotericin B. This led to two randomized, controlled clinical studies, one in HIV/AIDS patients with cryptococcal meningitis as a systemic fungal infection and one in patients with leukemia.”
Through his research on liposomal amphotericin B, Dr. Jadhav gained enough exposure to both pre-clinical and clinical development to begin working as an assistant professor at the Infectious Diseases Department of KEM Hospital in Mumbai, where he became involved in teaching and guiding students from diverse backgrounds to pursue degrees in pharmaceutical medicine. Soon after, he moved to the United States as a post-doctoral fellow at the University of Florida, continuing his research in pharmacy.
“In Florida, I became interested in the p-glycoprotein transporter and contributed to several clinical studies led by Dr. Anthony Bavry, who was my post-doctoral mentor. In the last five years, though, my focus was on integrating this knowledge and applying it to real-world drug development strategies and regulatory interactions.
I contributed to over ten early drug development programs for New Chemical Entity (NCE) as well as repurposed drugs. I had an opportunity to interact with the FDA, in various divisions like anti-infectives, dermatology, cardiovascular and renal products, CNS, and oncology. However, with all my translational drug development experience, I thought it was time to do something on my own and move on. Hence, ISHA Therapeutics was born.”
So, what’s next for Dr. Jadhav and his company?
“Every day is a new challenge. I have to have the utmost clarity on what we want to achieve and how we wish to do so. This job is about multitasking and communicating with scientific experts, who always want to challenge your neurons as well as your business strategies. I’m enjoying this new role a lot, and when I think about realizing our dreams, all this hard work and effort will be forgotten, buried by our success!”