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Despite what may seem rather clear and obvious, there will still be rogues. We have to be alert: Sanjay Vyas, Managing Director, Parexel India

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Mumbai: Parexel, one of the world’s leading clinical research organisations, is steadily building its operations in India. It has a fourth of its global workforce here, and it is adding its top talent from smaller cities. In a candid discussion, ET Pharma’s Vikas Dandekar spoke to Parexel’s senior leadership team, Sanjay Vyas, Managing Director, Parexel India and Kushal Gohil, Global Chief Strategy Officer to understand how the CROs is giving shape to its Indian business, the challenges it sees and the upcoming opportunities.

ET Pharma: Parexel is among the largest CROs in the world. How do you see the opportunities, the traction? Kushal Gohil: Compared to the other CROs, 5-6 years ago we decided that we wanted to focus on core clinical work. So as a strategy we did not want to dabble into labs, tech, in fact we spun off our informatics division and that is a bit different to how other CROs are thinking about growth. We are doubling down on operational excellence, going back to basics of delivering the best trial possible both in terms of speed, cost and quality.

And I think if you look at the world from that lens, there are a lot of changes.In Russia and Ukraine, we are still running studies. Same applies to Israel, Gaza, we have ongoing studies and on ground staff. However, the geopolitical issues change the dynamics.The reason why I am bringing all this up is I think it all helps India a bit. There is stability here, we do not work on the CDMO side but our owners Goldman and EQT both have one CDMO each. Goldman Sachs owns Aragen, the old GVK bioscience business.

The industry is still growing, like more clinical development work is happening, more trials are coming here. There was a kind of a bump during COVID era where work from start-ups were very high, but a lot of that was just COVID related. I think it has stabilised again and the industry fundamental is very strong. APAC is still very important. Even within that India is super important. 6,000 people work here, that's 25 per cent of our workforce. Sanjay Vyas: Just to add the perspective, sticking to the strategy piece of it, we recently appointed a chief patient officer who is also a patient.

She has gone through an oncology trial, and turned back from death because of the clinical trial support that came through, and she's a strong survivor today. Unfortunately, she's also a caregiver to a rare disease patient - her son, nine-year-old, and even today she has to carry and put him into the bus and still waiting for a solution to come through. So, I think keeping, and this is one of the reasons why our strategy has been focused on to be the subject matter expert in the clinical study conduct and not pivot our thought process because we want to make sure that patient remains at the heart of every decision that we are making and bringing up on the table.

That's one of the core pillars of the strategy. Every decision that we're trying to make, every pivot that we're trying to make on technology, the first question that comes on the table is, how is this going to help our patients at the end of the day? Is it going to make life easier on that perspective? Next, we're also trying to look at avenues of how do we make it easy to do business with whether we are dealing with our investigative sites, whether the sponsors, or whether it is the internal folks as well, which is where we are evaluating technology areas like generative AI applicability and any small incremental benefits that can come into play from that perspective.

Then, of course, leveraging our strengths and capabilities. Whether it is the core capabilities around clinical or the adjacencies like the regulatory, early phase units, or whether it be safety, pharmacovigilance, supply chain, all those core and adjacencies have been developed to support each other in an ecosystem that works as a seamless integrated approach.And to bring it to India, all these functions are very strongly represented here. We have replicated the same knowledge through our patient advocacy group in India, bringing their voice on the table on a regular basis.

And then we have started interacting with a lot of the state government and principal secretaries as well.We have been talking about how to create an ecosystem within the lifesciences industry that will allow us to bring our voice more strongly, whether it is talent, whether it is the upscaling of resources, or whether, even the standard GCP compliance piece of it. I think I do see a very good desire within the country at this point of time, I think including the central and the state governments.

One of the things regulatory officials say is we shouldn't be doing great quality work because an US FDA team is to come up for an inspection. The quality should be by default. It should be like a given.It's our process, it's our standard. And I think that focus from the central and the state government is probably now jolting a lot of our stakeholders out here to make sure that you don't have a choice. It's not an alternative. It is the way to do business.We're continuing to grow with the double-digit numbers out here as well.

For core clinical, there are clear focus areas. Indian multinationals have a desire to go global. How do we help them and keep India in the mix of their trials?ET Pharma: My concern is here. You still see companies which have allegedly deviated from the best clinical practices. How do quality systems change for Indian organisations? Sanjay: I think it is pretty subjective because I personally, at least with the sponsors of the companies that we have worked with, we have been very careful in terms of the studies that we have chosen or the partners that we have chosen to work with.

So far as I know, the standard multinationals, I would call them as Indian multinationals, who are out there are following the standards. I think at the end of the day, to your question, how do you ensure best quality processes? I think the onus and the responsibility lies with each stakeholder. And I'll give you an example.There was a study that was going on at some point of time and somebody told us at a particular investigative site that we seem that we might want to check - the data seemed to be a little odd because the same results were coming out of a particular process.

Obviously, our medical monitors raised the concern. Even though the sponsor was of the view that we know the standards.But we said, no, we will have to go back and verify this. What our teams did was they went, and they audited both the sites in detail, and we reported and noted everything down. So that once the study gets completed and the US FDA comes in for inspection, we have documented evidence that we checked, we validated this, and this is not a deviation from the standard process.I think this is why I'm coming back to the point that everybody needs to play their responsibility.

So if I as a CRO put my foot down and say, hey, I will not compromise on the ethics and the compliance piece of it. I don't care what does that replication mean or whether your product moves or not.And that's why I said that every, and I think Parexel has been very, very high on those standards as well. We don't buckle down with the pressures just because we have a study. Because at the end of the day, it comes to the point because tomorrow, if something goes wrong, there's a patient at the end of the line and we need to be careful that we are dealing with drugs and therapies that can either influence or in some way or the other.

We've got to be very careful when we are doing studies. And I think we play our role. I think everybody needs to start playing their role from that process.ET Pharma: In picking up studies, you will have a very strong criteria on who you want to work with?Sanjay: Absolutely. Even when we look at the protocol, the first thing that our medical team, when they evaluate the protocol, they look at is how good the science is. What has been the data that has come out of the early phase studies, how are the animal tests and once we come to that, the safety efficacy data and all that stuff, all those considerations come into play while we're designing the protocol.

Once we look at that, we start looking at the feasibility. And then we say, okay, let's go on for this business. This looks good science. Let's evaluate. Plus, we also audit our sponsors regularly, like the way they audit us. Both ways it goes on a regular basis.On the innovation front, just to contrast with China. Once they published their no me-too drug policy, we've seen a real change in the pipeline and not a lot of big phase three biosimilars is coming out of China now. It's really more early phase, innovation therapy.

So I'm not saying one way is right or wrong, but sometimes the regulators also can play a role on how the pipelines evolve. The important point is how do companies get their practices right. Sanjay: I think it starts at the top of the organisation and a culture that is created by the leadership that says doing the right thing is the right thing to do. You know, and it's so clear. A few quick wins and then you get called out. Your business might fail because reputational damage is so substantial.

And if you're in the business for the long run, then you have to take these things seriously. There was an overseas CDMO who's been issued with a US FDA’s 483 observations. Because they were systematically destroying records.When you do these things, at some point you get called and that company will be followed. Absolutely. So, I mean, it's sort of common sense and the companies have failed to understand this.In our sector, which is highly regulated, everyone gets audited multiple times a year.

We don't know how many audits we have in a year, but it's in tens. It's not, once a year or something.I think, where it takes us back to is, as an organization, Parexel recognises that despite what may seem rather clear and obvious to us, still there will be rogues. We just have to be very alert.ET Pharma: I would like to know from you three or four most important challenges that you would face while you actually navigate this whole opportunity here in India.Sanjay: I think one is we have still not been able to enter as we would like into the Tier 3 locations because why would you leave a patient behind.

When there is an opportunity for someone to get an access to the medication. And the reason for that is because most of these investigators who are actually pretty good in compliance in their GCP process are found in tier I and some tier II cities as well. I think that's one big challenge that we have identified.The second area is education. I think there's still a lack of clear awareness of what does it mean to participate in a clinical trial. Unfortunately, like we have so many public awareness campaigns, but there's not a single campaign that runs on television or newspaper that makes people aware of what's a clinical trial.

Why do you need to look at it only as a last resort but not a standard of care as a part of the process that you're going through a doctor. Even investigator sites, physicians need to be educated.There are times when even the physicians are not aware that there are trials going on with their patients. So, I think those are the challenges that we, at a top level I'm saying, that we are still struggling to conduct trials here in India. And obviously the fourth piece is around skill sets as well.How do you bridge the gap between the academia, what we are producing here, which India is pretty good, the largest number of pharmacy graduates, the largest number of doctors.

But how do you bridge that gap between what the industry is looking out for versus what the academia is producing. Kushal: When we talk at a global level, whether it's perception or reality, we can debate it. But ethical concerns come up and that's the first issue. Given the past, what happened, they just want to make sure that the sites are following the right GCP guidelines. There's no manipulation of data. That I feel, is still our biggest barrier. Secondly, I've grown up in India. Informed consent, the main objective is comprehension of the trial.

But in India, we do have this doctor as a God phenomenon. You can't ask questions. By default, even if you are engaged in clinical care, not trial, if you ask a doctor questions, they'll get upset. I think in issues like informed consent you really need to sit down and explain every question. Culturally, I think we have some issues there. Then, how do we think about data privacy and data exchange. There are no real infrastructures right now. I think there are bright lights. There are clearly leaders in this country who see the opportunity, who see the value that it can bring to India and who are driving very hard to realise that.

Given that a lot had gone wrong in the past on conduct of trials, informed consent adequate compensation, it is tough to ensure patient safety and break the 'guinea pig' barrier. Kushal: Even in the US, some of the same challenges exist. Only 2 per cent to 3 per cent of practicing doctors are participating in clinical trials and the number is going down. I don't think it's an India-only problem. I think we have an opportunity to correct this.Before the pandemic, no one knew how long or how difficult it is to get a new therapy to the market.

This became the top news and topic of dinner discussions. I think as an industry, we need to capitalize on it, explain the value we are adding to the society. Like just compare this to the Black Plague. Half of the world should have been wiped out without the power of clinical trials and vaccines. Even in serious diseases, like oncology, where the need is so substantial, you're talking about single digit percents who get to participate in a trial. It's a crying shame.What's the slowest part of the process of running a clinical trial? That is involving patients.

I mean, we've got this crazy situation where we want patients and they benefit and we've got to bridge the gap. And it's true in India. It's true in the USA. It's true everywhere.ET Pharma: Can you share Parexel’s investments, people strength and do you have any updates? Sanjay: It continues to happen. India still is a double-digit growth story for us.We have added two more new functions to our existing operations in India. We have set up the medical communications team here. We are also looking at the remote monitoring team to be set up in India as we are expanding.

We set up our new Network Operating Centre (NOC). So our IT shared services that technically is responsible for maintaining and supporting all the tickets and all the applications that run our clinical trials. They are now being run from India with 100 people who are recruited for this and we are planning to scale it up to 350 plus. We keep looking at data analytics, and the whole innovation around generative and artificial intelligence is being evaluated.ET Pharma: You spoke about education and awareness of physicians.

Are the regulators really on par with the way science is moving in big establishments? Sanjay: The way it works is you have the Subject Expert Committees and the ethics committee that comes into play. You have to rely on their expertise. Sometimes we do face challenges between the perception and the way a particular individual in the SEC committee looks at that. Sometimes we do see a little bit of a narrow view to a particular drug. Because let's say if the endpoint was defined this way, that's exactly how it is.

Or we will not allow you to do the trial. Whereas a flexible endpoint was allowed by the EMEA (European) regulations.Sometimes bridging that practicality becomes a little bit of a challenge. But I believe they are trying to do the right thing. And then the efficacy piece comes into play as well. I think somewhere standardizing our approach with the global regulators, I think that's still needed with the way we look at studies. The question is how do you globalise regulatory processes? Why don't you compare your notes with a publication that has come up.

That is a little bit of an uphill battle right now. But I think we will get there. The other thing to bear in mind of course is the agencies talk to each other. I think the agencies are savvy enough to know that the way that the companies that they are regulating work globally, they too have to take a global perspective. And then the other thing I would add is that science breaks steadily. So from an idea emerging to becoming something that will be put in front of regulatory agencies. We're talking years, not days and weeks.

Which means they have to have a radar system. The Indian regulator is just as capable of seeing what's coming and speaking to the other agencies and being ready when it arrives. I think it's also unfair to expect a lot in a short time. None of us would be able to cope up with the advancements that are happening now. I think we all have to keep learning from each other and that's exactly the attempt that needs to continue to happen. I think as long as the regulatory agencies are coming together, which I think DCGI is doing pretty well.

Actually, they're trying to connect with the other regulators. ET Pharma: In terms of ratio, would you still have the bulk of your work coming from MNCs versus Indian companies? Sanjay: I say yes. The challenge is we're still struggling with the novel innovation. I think you alluded to that in the beginning as well. Most of it is biosimilars that are popping up, which is not bad actually. That's where the forte is.But then having said that, we're also seeing a lot of our Indian biotech companies looking at cell and gene, cardio therapies, which are coming up as well.

But having said that, bulk of our studies are still coming from foreign multinationals who are looking at India as a site for conducting their global studies, where other sites are also included globally. But India is also a part of that process as well.But with so many Glocal Capability Centres coming and setting up, des it not kind of wade into your territory? Sanjay: It does. And I would not deny the fact that they're probably trying to recruit very similar roles. But then they still have certain part of the expertise, the pressures in terms of where is it that they want.

For example, issues like signal management for a drug. There are still some physicians that they need in-house to evaluate the final call. The final call will still be taken by the sponsors. So they still need some medical professionals or medical writers to look at the initial protocol while we have the outsourced major part of the protocol design with the CRO. I think that will continue to happen.I think it's only going to benefit India overall. I call them the captive sponsors who are trying to look at setting up their captive centers here.

But the outsourcing will still continue to happen. As I said, the difference between what core they want to keep versus what are the non-cores they want to outsource. You take the rough with the smooth. And on that, I think we're in a much better place today because of that than we were 20 years ago in India. Kushal: I think we've just scratched the surface right now. Because all these GCCs, it's Bangalore, Hyderabad, Mumbai, but the government is investing so much on tier two cities like, Mohali.

So there will be waves of other hubs that will blossom as these areas get saturated. That's why we went to a tier two university for educating and training fresh hands. We purposely went to a Chitkara University. Because one, I think the level of dedication and the desire to learn is so much more stronger than the tier two, tier three universities. They're all looking out for opportunities. When I interact with those students, its amazing how eager they are to be a part of this ecosystem. So I think Jaipur, Jodhpur, Calcutta, the northeast part of it, we still have so much of areas to be explored and developed.

Every time I go to Chandigarh, Mohali, I'm so fired up to see the young people around. We are the largest employer right now in Chandigarh, Mohali for clinical and pharmacovigilance. We have people now joining from Bhopal, Mizoram. But we want to explore those areas as well. So I think there are absolutely brilliant opportunities right now. Which is why I said I think we need to spread our focus. Go to cities like Dharwad, Hubli, Mysore.