2025 Access to Medicines Intern with Roivant’s Regulatory Affairs and Drug Safety Team
Calla Lily Clinical Care, Med Aditus, Roivant Sciences, and Roivant Social Ventures (RSV) have partnered to host the Access to Medicines Internship and Fellowship Program, providing real-world drug development experience to talented PharmD students who are passionate about leveraging their career development to expand healthcare access to underserved patient groups.
This summer Anirudh "Ani" Kalathil is serving as a Regulatory Strategy Intern for Roivant's Regulatory Affairs and Drug Safety (RADS) team, where he is:
Creating a reference tool that outlines the requirements for investigational new drug (IND) applications globally, developing a helpful visual of the differences in requirements.
Investigating historical endpoints in therapeutic areas of interest and providing progress updates on validation plans for novel endpoints.
Reviewing drug promotional guidance and crafting recommendations for external communications related to investigational drugs.
Compiling key information from the FDA Summary Basis of Approvals for new drugs/indications.
We sat down with Ani to learn more about what drives his work and how his summer internship at Roivant is impacting his career development.
What has inspired your interest in developing medicines?
"I was, and still am, passionate about organic chemistry, so I was quite happy to hear that my undergraduate research work would be investigating alternative binding sites of both mu-opioid and CB1 receptors in order to combat pain medication addiction. I was completely unaware of the drug development process, so I asked the principal investigator how long he thought it would take for a drug that targets these sites to be developed. I was shocked to hear that it could take more than fifteen years before approval, assuming we screen for a viable molecule! This was my first introduction to the drug development process, and I came to understand the small but important role I played. I also recognized that this process involves the collaboration of many individuals, each contributing their knowledge to bring a therapy from bench to bedside."
What type of impact do you hope to create with your work?
"From the early spark of curiosity from my research experience to witnessing firsthand the impact of healthcare disparities during a visit last summer to my ancestral home in Kochi, India-- I have come to understand that my passion for increasing access to medicine for underserved patients is deeply personal.
The lengthy process of drug development is teaching me that even small contributions matter in bringing life-changing therapies from bench to bedside. Meanwhile, the stark contrast between my own access to treatment and the challenges faced by those in need inspires me to bridge the gap in healthcare access. This blend of scientific inquiry and empathetic experience drives my commitment to ensuring that life-saving medications are not just a privilege for the few, but a fundamental right for all."
What are some of your biggest learnings from your RADS Internship with Roivant this summer?
"It's incredible to see how many people work on the process to get a drug into the market, and more accessible to a wider audience. I am getting to be involved and contribute to not only the scientific aspect, but the patient consideration aspect, and the counseling aspect of developing medications. You know, a lot of work goes into this process and the the drug label that pharmacists eventually reference.
In school we concentrate on learning how to take the information from that drug label and give it to, or present it to, a patient. Through this work you start to see and realize how many hard skills and soft skills come together from individuals that contribute to the regulatory and and drug safety process."
What were your favorite takeaways from the "Making Medicines" class you took prior to your internship?
"My favorite takeaway was learning how individuals with different skillsets can meaningfully contribute to the development of medicines. It's not just people with expertise in research or even pharmaceuticals. I got to interact with people who had backgrounds business, public health, and legal, and each of them has joined in to make a difference for patients through the drug development process."
Access to Medicines Internship/Fellowship Program
During the Spring 2025 semester the 2025 Access to Medicines PharmD Interns and Fellows all completed "Making Medicines" at the UNC Eshelman School of Pharmacy, the top ranked School of Pharmacy in the United States. This innovative course was designed to introduce PharmD students to the new drug approval process and key issues in drug discovery, pre-clinical testing, clinical trials, FDA approval, and global access to medicines.