Things & Thinks Half & Half Ed. 3
Since the launch of this newsletter, apart from receiving enthusiastic reader responses, a selfish benefit for me has been to get to spend time with people that I enjoy chatting with on everything under the sun!
This month we meet Mahesh Iyer, Vice President, GDO Innovation Lead and GDO Head, India at Parexel. Mahesh is a dear friend and an ex-colleague with whom I worked in many avatars, most recently as a co-founder for our consultancy, Sineflex Solutions. A leader with the gravitas of an eloquent speaker, he brings with him deep expertise in biostatistics, on-the-ground experience in biopharma working across the Pharma R&D lifecycle, all of these underlined with a passion for ogranizational skill development. Let’s dive in!
T&T: Hi Mahesh, thank you for agreeing to be a guest here on Things & Thinks! Let’s start with your backstory?
MI: I was born in Mumbai and growing up in a typical middle-class Tam-Bram family in India , there was this expectation to do well in maths and in science. So that was always a focus area. But even then, I kind of always found maths to be more interesting. Later, at the time of deciding for graduation, I had already started to get disillusioned with the whole engineering/medicine field as the only kind of choices. In an almost rebellious thought against the engineering choice, I dropped chemistry and took up statistics. Since then me and statistics just clicked! I don’t know how it happened, but I changed my entire plan going forward. I got my bachelor’s and my masters in stats and then I decided that I really wanted to go abroad and get my PhD from the US. The plan was to get my Ph.D. in the US, and then come back to India and teach .
T&T: So how was the PhD experience in the US and how did the shift to Healthcare happened?
MI: I was always the kind of person that’s interested in many things simultaneously, and the US was the best place for me at that time! I got involved in hiking, developed my photography skills and tons of other things and would do just enough in my coursework to get by! So that was one of my biggest learnings-my department said ’A-/good enough’ will not work if I want to finish my PhD with good research. I had to take a break from my studies and started working at Boehringer Ingelheim, while thinking on potential future research areas. . This was a great learning experience for me, to understand the depths to which research work needs to be carried out. Subsequently I went back to Temple University to complete my PhD.
As soon as I got into pharma, it was so satisfying- especially as a statistician, you get to design these studies that save people’s lives; one of my first studies I worked on was in depression, and and to be able to see people that are clinically depressed, looking to take their own lives, suicidal intent, and be able to get them to the point where they are able to deal with these challenges; this was phenomenal. I also got to work in the AIDS space; which was another amazing experience. I was working on this drug that cut mother to child transmission of the virus by 95%, almost like a lease of life for the newborn. So I got really really fascinated by this impact that statisticians and overall the pharma industry has on people’s lives. Through this work, I went back and completed my PhD and started working at BMS in the Oncology space where this thought about working as a statistician in pharma solidified. I got the opportunity to take a few drugs to the US FDA, sitting and representing the company for an advisory committee hearing and I definitely knew that this is what I want to do!
T&T: And how did the shift back to India happen? How has that worked in your journey?
MI: In hindsight, I see these distinct decades of my career. The first decade or so was spent on building the educational background and domain expertise while the next decade would bring in building teams and organizations. The then global head of oncology Biometrics and Data management at Novartis approached me and asked if I would like to go back to India to set up such a group in India., This opportunity seemed like a no-brainer; so I packed up my bags, left the US within a month to come back to India; For the next few years at Novartis, I learnt how to setup teams that would provide as much value as their counterparts in the rest of the global organization . So I spent the next 10 years in India with Novartis really trying to bring that kind of expertise and focus on patients. And then I got this opportunity to be part of the Innovation Council at Novartis Hyderabad. The ask was to look at systems and processes that had been part of the clinical trial industry for decades, and see how they could be done differently. When I got into that space, it really gave me a completely different view into what is possible. This led to trying my hands at setting up Sineflex along with you and Dinesh and I continue to work towards that goal at Parexel as the GDO Innovation lead. The focus again is on identifying processes and systems that could be made more efficient by bringing in the new technological advances. So I hope to spend the next decade building thought leadership and operationalizing the current advances in technology, analytics so as to optimize the way we conduct clinical trials.
T&T: Is there something you learned in college that’s proved almost wrong?
MI: The one thing that I learned during our formative years, in schools and then in college, is around the importance of the answers, right?
We are not taught the importance of asking the questions; the focus is on the answers. However I spend most of my time now in formulating the right questions, what is it that we are trying to solve.
I feel that is the more important aspect to dwell on and then the answers, while they too take their own time and effort, would follow in a more or less straightforward manner.
T&T: That sounds so true, would you like to share an example from your experience?
MI: I remember this talk by Prof M.K.Bhan where he said the measure of a true leader is the ability to deal with a problem with the level of complexity it deserves’; that statement still stays with me. An example is this famous analytics thought process we have these days about scraping consumer data from social media to recruit patients in clinical trials faster. So we already have a hammer and then are going about trying to find a nail!-we have an answer but have we asked the right questions? So maybe we will be able to get potential trial participants but maybe these don’t fit into the clinical trial requirements? In the end, the right question to ask should be how to find patients from social media scraping but how to find the ‘right’ patients?
T&T: You talked about self-discipline; what are you deliberately practicing these days?
MI: Two things- one professional and another more on the personal front. One trend that has been around for some time is for the so-called thought leaders to talk about innovations and technology. But most of these talks focus on what’s possible… upon reflection, I realized very few of these talks are about actual implementation and learning. And so, I have started focusing on sharing examples deliberately of where I have been able to implement these ideas and my successes and failures from them. If I am not able to share any new insights from these perspectives, I am trying to go back and get those experiences before talking about them; I don’t think science can move ahead with theory alone; it also needs experimentation; and that’s what I am trying to spend more time on.
On the personal side, I am trying to set boundaries on my work and spend time with family, on my interests and hobbies. During the pandemic, we all got into the habit of working in a flux and this ended up dissolving those boundaries so I am trying to recreate those deliberately.
T&T: What’s something new you’ve learnt about yourself in the past 3–6 months?
MI: Yes, this has been in the making for more than a year now; you know me, I have always been driven by purpose. I always believed a solid purpose was absolutely essential for to move in a particular direction or else I would be lost. Since the closure of our consultancy-Sineflex- this has changed- I have started questioning my thoughts about these 5 year-10 year plans all revolving around a solid definition of purpose.
I am trying to reflect on what is the role that such purpose definitions played in my life so far and how can I shape those for the next decade or so. So the questions I am asking myself are-is it ok to not have all those answers come together? Can I wait for those to come to me over time?
T&T: Shifting gears to healthcare, did you have a personal encounter with healthcare in the recent past, as a patient or caregiver? What are your thoughts?
MI: Yes, there is this one incident that taught me about the veracity of data. I took my mother for a doctor’s visit and they gave us a form to fill with questions about her overall health and past history. We were in a hurry and I filled in the basic 2–3 absolutely essential bits of information and then we were ushered in for the doctor’s appointment. After the actual visit, we left. So I was thinking about that incomplete form-while on the one page we are talking about integrated health information systems and getting insights from these data, on the other hand we have this incomplete, almost erratic piece of data lying around. Also this was happening in a nice, urban clinic, where the setting is well-appointed, technology enabled — not one of those stereotyped low resource settings. The learning here is that we need to go several steps to educate patients, clinics and the rest of the ecosystem before we start thinking about real-world insights.
T&T: From your perspective, what will be the biggest challenge for healthcare in the next decade?
MI: I saw how in the previous episodes of T&T, Aakash and Ashima talked about aspects such as technology and patient-provider angles in healthcare over the next decade. I would like to chat about clinical development-how we do drug development, how we conduct trials, how do we show drug effectiveness. So from that perspective, one of the biggest challenges will be to evaluate drugs in real world situations. Today, we are almost done with the era of one drug/ treatment being the answer for the entire disease spectrum. Now we are moving towards personalized treatment. There was a time when we used to say we will biopsy a tumor sample and identify the biomarker; a few years later, as our understanding of the disease improved, we started observing that biopsy of two portions of the same tumour may get both a positive and negative result for that biomarker! So for us, to reach the true personalization of drug treatments is going to be tremendously hard. We haven’t yet considered all the complexities, all the variabilities and all the uncertainties that truly real-world evidence would require, An analogy often cited is with the fin-tech revolution. But our side is tremendously more complex, grappling with everyday life, the much complex variables and uncertainties with these variables, we are looking at an exceedingly hard problem!
T&T: If you are asked to bet on something about healthcare in future, what will that be?
MI: This is in line with what I said earlier-I foresee that patients’ ways of decision making would have a huge influence on how we shape our innovative solutions. We would need to consider the complexities with which patient journeys happen/will happen and our models have to incorporate that subjectivity and irrationality of patients being part of the decision making process.
T&T: and conversely, is there something that you would bet against?
MI: There was a lot of chatter about how the pandemic has accelerated adoption of new technologies, real-world evidence and so on; I would bet that this change would not be as radical or as ubiquitous over the next decade or so. I feel we have a long way to go there!
T&T: What can the rest of the biopharma industry learn from the CRO industry?
MI: One thing I have learnt for the last 1 year at Parexel is the importance of measuring returns from where we invest our resources. I feel this is quite important especially for the innovation space-from running ideas to Proof-of-concept or an ideas graveyard, how would we measure our advances? If I am going to create a new real-world evidence analytics solution, we should start asking questions like — by implementing this solution, were we able to bring the drug to the market faster by ‘x’ number of years, or were we able to save ‘y’ number dollars. This will be essential to move all these PoCs to actual solutions.
T&T: There is almost a fear of asking such questions in large biopharma organizations, right?
MI: Absolutely; for example, in biopharma, we hear a lot about patient centricity. But do we measure how a new solution makes it easy for patients to use our drugs? There is hardly any evidence or even measurements to do these kinds of things.
T&T: Flipping the question, is there something the CRO industry can learn from biopharma?
MI: yes, one big thing CROs can learn is about productivity of people. Very few CROs provide any thought on discretionary efforts by people. A lot of effort goes behind tracking how busy people are and what’s the output. This somehow becomes counter-productive in the innovation space. The large biopharma seem to have done this well-they give you this space to bring out new ideas, and the time to work on those ideas. So while the ROI/measurement piece can be learnt from the CROs, the CRO industry should try to strike this balance.
T&T: What is your most cherished grudge in healthcare?
MI: In clinical development, I have two and kind of related grudges! One of them is the noise about how pharma R&D is highly regulated and the other one is how we deal with patients’ lives ; I feel we use both these as crutches to not try new things, to not change the status-quo. While these two aspects are definitely complex realities of our business, we cannot continue to use them constantly as reasons not to innovate.
T&T: What’s the best piece of advice you could give to someone starting their first healthcare job now?
MI: My suggestions to anyone new in healthcare will be to be patient, not to necessarily look for quick wins when solving problems-try to figure out what is the right problem to solve.
Let us try to look at the problem in its entirety. Lets not simplify complex problems to the smallest-simplest levels and lose the crux of those problems.
I would suggest that we dont lose sight of that larger problem while challenging the status quo.
T&T: Finally, what are your thoughts on the innovation ecosystem in India?
MI: A couple of observations/reflections-there are a large number of Indian start-ups that are trying to solve problems for the Indian market from a pure cost perspective. For me, many of these might not be sustainable, as the global start-ups working on these solutions will come to India and work out the cost challenge because of the scale. So just the cost arbitrage without any other value-adds might be only a short-term strategy.
The other issue concerns the stretch on innovation resources including funds and talent. Healthcare innovation, esp. on the product side, can require large infusions of capital without which it will be difficult to proceed with truly innovative products. But due to the dissipation of me-too ideas, there is a resource issue for the truly innovative start-ups.
T&T: Mahesh, thank you so much for your time for sharing your reflections!
