From Academia to Industry Leader: Dr. Sathish on Being a Top CRO in India

About Dr. Sathish Sadagopan

Dr. Sathish Sadagopan is the Head- R&D Biologicals at Anthem Biosciences Pvt. Ltd. He has been at Anthem for the past 13 years, successfully taking the organisation to newer heights.

Pharma Now: So, Dr. Satish, welcome to Pharma Now. We had a good discussion before this interview. Now I first wanted to go through the exciting journey of your career. I think that's really fantastic. Can you please start with your younger days and how you started this journey?

Dr. Satish: Yeah, so I was always fascinated with biology. There are two things which human beings cannot conquer: one is space, the other is the human body and mind. So, I have always been fascinated by biology and wanted to choose my career in biology since childhood. Fortunately, God has been great, and I got to work in the same field. I did my undergrad and postgrad in biology and completed my PhD in virology from one of the premier institutes in India.

Then I went for my postdoc in Singapore at the National University of Singapore under the Singapore-MIT Alliance. I was a postdoctoral fellow under the MIT Alliance, working on Parkinson's and Alzheimer's. Later, I moved to Chicago for my second postdoc, where I worked on virus-associated cancers. I was there for about seven years, and in the last two years, I was an assistant professor. My main area of interest was molecular virology, focusing on host-pathogen interaction, recombinant protein production from either viral or host proteins, and studying their interactions.

Subsequently, I wanted to move back to India. Even though we were physically there, our minds and hearts were always in India. It wasn't an easy decision to move back, but we wanted to do it. It was challenging for the kids to get accustomed, but fortunately, by God's grace, everything worked out fine. We've been back in India, and I've been working with Anthem for the last 14 years. I was primarily responsible for establishing the biologicals division and R&D division. Gradually, we moved into large-scale manufacturing of various biologicals as well. It’s been an exciting journey, seeing both academia and industry, with over 10 years in academia and 14 years in industry. Both have been very good to me.

Pharma Now: That's an inspiring journey, Dr. Satish. But I wanted to go back to your US days. I can certainly say that coming back from the US to India required an escape velocity. What was that escape velocity, or how did you get that escape velocity?

Dr. Satish: It was a tough decision, but one reason is that now I think the globe has become very small. You can get everything in India that you can get in the US, and the lifestyles are nearly comparable. Whatever you do there, you can do here, and I would say you are happier in India than in any other country where you were born. I love being in India. Initially, I thought it might be tough moving from the US to India, but it wasn't at all. The first few months were a bit difficult, but after that, it was very smooth, and I am very happy I made this call. One major reason was family support and the desire to be with our parents as they grow older. So, I am happy with the choice we made.

Pharma Now: That's very interesting, Dr. Satish. So, one question that comes to mind: From academia to running a team of 300 R&D scientists, what is your experience, and how is it?

Dr. Satish: Yeah, it was indeed challenging. The team was very small when we set up the biology division at Anthem, starting with only 10 people. We were primarily focusing on discovery biology and drug discovery. My major focus was on generating recombinant clones in E.coli and Pichia, and later in mammalian systems, because of my expertise in cloning, protein expression, and purification. Gradually, we built up the team. Now we have a very good team at Anthem that can take on challenges from generating a clone to processes including upstream and downstream processes, and analytical method development. Our research quality is top-notch, comparable to what is done in the US or UK.

We had to pick and choose people with the right mindset, attitude, and technical acumen, and put them together. Many team members have been working with Anthem for a long time. Creating an environment where people like to work is crucial, and we have been able to do that. Thanks to Anthem’s management, who have been very cooperative in creating this environment, it has been possible.

Pharma Now: That's wonderful. So, being the top two CRO in India right now, first I want to understand what a CRO is all about.

Dr. Satish: Yeah, that's a good question. A Contract Research Organization (CRO) or Contract Manufacturing Organization (CDMO) provides research and manufacturing services. Some companies have only one piece of their work. Clients come to us with a clone and ask us to develop a process using it, as they may not have the process capability. We develop the upstream and downstream processes for them and deliver the product. After that, it's their call whether to do the analytical work and market it.

Some clients come for the entire package, wanting us to develop a clone, a process, and produce a commercially viable product. Clients come to India for cost-effectiveness without compromising on quality. Anthem has grown from a small organization to over 2000 people by maintaining high quality and being cost-effective. As a CRO, we manufacture different pieces for clients, from clone development to process development, analytical method development, and even clinical trials soon. We have also started a clinical arm to assist with clinical trials.

Pharma Now: So that was my question. As a CRO, do you assist companies in getting through FDA approval and clinical trials, or is it in your plan right now?

Dr. Satish: Yes, we do. Anthem has been audited by the FDA five times, successfully each time. Our quality systems are top-notch. We manufacture drugs for six of the top ten global pharma companies, maintaining high standards for FDA, EMA, or ANVISA compliance. We regularly undergo multiple regulatory audits, including Indian regulatory agencies, and have been successful. We support our clients in filing with the FDA.

Pharma Now: I always wondered about the influence of AI in the research area. What is your point of view? How is it impacting you, and how are you adopting AI and deep-tech in your research area?

Dr. Satish: AI and ML are very important and developing rapidly. Anthem has been quick to adopt these technologies. Our IT and automation team is excellent. Quality is key, and AI helps with 21 CFR Part 11 compliance for product traceability and transparency. For example, our fermenters are DCS-controlled, allowing remote monitoring. AI’s influence has enabled us to integrate and automate our processes effectively. AI is crucial for the future, especially in biologicals and fermentation.

Pharma Now: That's really nice. As you are in a very niche area of R&D, what do you think about India’s future in the R&D domain, particularly in pharma? I know we are one of the lowest spenders in R&D compared to South Korea, the US, or Europe, with hardly 1% of our GDP spent on R&D. What do you think about India’s future in R&D?

Dr. Satish: Yes, it's true that India spends very little on R&D, but it has drastically improved compared to 10-15 years ago and is continuing to improve. The investment is less because manufacturing provides a direct return on investment, whereas R&D takes time to yield results. However, it is improving and will continue to do so.