Clinical trials are the first step in our never-ending fight against diseases such as cancer, autoimmune conditions, neuro degenerative disorders like Alzheimer’s disease etc.

Charuta Upadhye, our next pathbreaker, works as Life Sciences Analyst at Instem, a firm that specializes in preclinical trial data analytics and genomics based studies which are necessary to determine the safety, tolerability and efficacy of a drug.

Charuta talks to Shyam Krishnamurthy from The Interview Portal about always wanting to pursue her career in a field that paired her interest in life sciences with medicinal research.

For students, the last 2 decades have seen an exponential growth in applications of IT in the field of Clinical Research, and this traction will continue with advancement in AI technologies !

Charuta, tell us about your background?

I was brought-up in a small suburb in Mumbai. My father managed cotton import-export for a semi-public concern, while my mother was an office superintendent for customs.

I have loved reading since I was a child, and was always fascinated by foreign languages. I did well in my studies. Creative writing was my special interest. I did get some accolades in essay competitions. 

What did you do for graduation/post-graduation?

Being curious and inclined to research, science was a natural choice for my graduation. My elder sister (herself a PhD) inspired me to choose science stream after 10th , and then chemistry for my Bachelors, I then continued to do my MSc in Bioanalytical Science from Mumbai University.

What were the influences that led you to such an offbeat, unconventional and uncommon career?

My elder sister has a PhD in pharmaceutical Sciences, which further fueled my keen interest in medical sciences. As it is, my mind was always inclined to science and research. I chose a field that paired my graduation in chemistry with my interest in medicinal research. Medicinal Science was the choice of career for me. 

How did you plan the steps to get into the career you wanted? 

During my graduation, my interest towards pharmaceutical sciences and pharmacology grew. I wanted to pursue a career in this field and hence decided to apply for post-graduation. However, while choosing subjects in science stream for a Master’s degree, I found that most of the subjects offered were generic in their approach towards meeting the needs of the life sciences industry. My search for a better curriculum in the analytical field ended with a course (Bioanalytical sciences) introduced by Mumbai University. I was slightly apprehensive about joining this course since it would be their first batch from university, but the syllabus and exposure, and the interactions with the life sciences faculty from industry that the course ensured was too lucrative for me to step back. I appeared for the entrance exam and successfully qualified for the course. This course had exposure to all the analytical aspects in every life sciences or allied stream like microbiology, biochemistry, pharmacology and clinical research which were the most sought-after projects in analytical or clinical trial industry.

During my post-graduation, I had interned at a clinical research lab with major business in clinical trials.  

I completed my post-graduation to join as an analyst in quality control and regulatory affairs submission in the pharmaceutical industry. I worked for 3 years in drug testing laboratories and pharmaceutical manufacturing plants. I worked on quality control measures and tests to establish the efficacy of any drug. These 3 years lay the foundation of my expertise in bioavailability and bioequivalence. 

After working in the drug analysis sector, I realized there is more to explore in the drug development process. Drug analysis involves only the processes when the drug is already produced in a manufacturing plant. These processes are highly standardized and belong to the quality control sector to ensure the quality of the formulation (drug in the form of tablets, capsules, injections etc.) is maintained as per the defined standards. However, the research relevant to the drug design, design of clinical trials, their approvals is a part of clinical research or drug discovery process. Hence, I decided to delve more into clinical research.

I then took a career break after and continued studying clinical research. 

How did you get your first break?

Historically, clinical research has always been heavily regulated, with newer guidelines getting introduced every now and then. On the one hand, pharma companies have to comply with these regulations and on the other hand there are market and competitive pressures to ‘Get to Market’ first. The IT industry was developing on its own trajectory. The advancement and availability of technology has led to applications in clinical trials as well. It has automated many of the manual processes including development of CR (Clinical Research) specific software, and putting quality checks in place. Regulators too adapted to this change and started accepting trial data in electronic format which further boosted the use of IT in the clinical trials Industry.

After my role in QC, I saw an opportunity to grow in this sector by leveraging my subject matter expertise and so I joined Cognizant in 2010. Following my inclination, I focused on clinical data submission standards like CDISC, SDTM and relevant regulations. These are mandatory compliances to launch drugs in markets like the USA. I leveraged my experience in clinical research (CR) and further enhanced my capabilities in IT applications in CR.

Challenge-1-This transition was tough considering that standard training courses were not available. Information was scattered across the spectrum. It was mostly exploration along with some of my senior colleagues. 

The Indian IT industry, being a service provider, has challenges of its own. Earlier I had worked for an Indian client and was directly responsible for the deliverables, checklists, and compliance with QC. Dealing with international clients needed a different set of soft skills like client management, communication, navigation, and cultural sensitivity skills. I successfully delivered on roles like defect management, managing client expectations, communication, status updates to senior leadership.

Challenge-2- After pursuing roles as SME (Subject Matter Expert), I was assigned a role as a tester in another project in Cognizant. IT testing of CR is a different ball game altogether. While I was familiar with CR and analytical tests, I had to get myself acquainted with programming/ coding and necessary software test cycles and standards/SDLC. I started from scratch and learnt test scenario building, test planning execution, reporting, analysis and conclusion.

Where do you work now? Tell us about your current role

After leaving Cognizant, I kept myself up to date with relevant courses like biostatistics and regression analysis which are useful for understanding the design of clinical trials.

Having worked with giants like Cognizant, I joined Instem Inc. which is specialized in preclinical trial data analytics and genomics. They are a niche player across the globe in this domain. Preclinical studies, also known as non-clinical studies, involve the testing of drugs on animals like rat, mice, rabbits, dogs etc. These in-vivo studies are necessary to determine the safety, tolerability and efficacy of a drug and to determine whether the drug is safe to be transposed to human body for further evaluation. The main intention is also to determine the route, frequency, and duration of exposure of the drug and ultimately support the intended clinical trial design in humans.

This really appealed to the natural inclination of my mind. I further specialized in CDISC SEND standards. These are the guidelines for data refinement and submission of non-clinical trials (animal studies). I mastered the target safety assessment, end-to-end submission of a study including the SEND compliant data and other deliverables like Nonclinical Study Data Reviewer’s Guide (nsdrg), define document using P21 tool, etc.

In my next assignment, I switched to an even more specialized and interesting area of genomics. It deals with curation of genes, assessment of its therapeutic and adverse effects, and exposure to different therapeutic areas like oncology, neurology, immunology, diabetes, etc.

What’s a typical day like?

My typical day starts with the evaluation of a gene using abstracts/research papers from open sources like PubMed/NCBI etc. Recent decades have seen an exponential growth in research in genetics. But whenever new research is to be conducted, it helps to know the earlier work done in relevant areas. As a research analyst, I review the earlier research work done and provide inputs to further research in terms of risk analysis.

How does your work benefit society?

Longevity and quality of life is the never-ending goal of the healthcare industry. As we conquer diseases and eliminate some leading/prominent causes of death like bacterial infections, some other causes become prominent causes for death. 

There is a never-ending fight against diseases such as cancer, autoimmune conditions, neuro degenerative disorders like Alzheimer’s disease etc. 

My work becomes the input to the larger fight against cancer and neurocognitive diseases. My work contributes to clinical trials for these diseases and for finding better, faster or cheaper cures of proven treatments.

Tell us an example of a specific memorable work you did that is very close to you! –

  • USFDA (U.S. Food and Drug Administration) needs data in specific format. It is a critical process which if not done correctly will lead to unnecessary delays and huge financial costs. During one of my projects, the client provided us some scarce training material; it was totally inadequate to fulfill the need. It was left to us to get it working. We formed a task force, got hands-on expertise on SDTM standards, refined the training contents, and established a center of excellence with this core group.

This core team further trained numerous other team members, and the client appreciated my knowledge and appointed me as one of the mentors for other team members. This boosted my confidence early in my transition to the IT industry.

  • Pace and accuracy are critical in pharma as in any other industry. I bring in the best of both worlds, through my experience in Pharma QC and understanding of IT tools. This enables me to consistently deliver more volume with better quality. Instem also acknowledged this and awarded me in recognition of my outstanding contribution to the deliverables.

Your advice to students based on your experience?

  1. Never be afraid of change, face challenges with your full potential. Every new thing you learn is a new opportunity for growth. 
  2. Be ready for the next opportunity, keep your knowledge up to date and skillset sharpened. Learning never stops, 
  3. Every task/ job you do shapes your career. My experience in pharmaceutical laboratories helped me in shaping my career in IT. So be eager to explore and learn as much as possible in your work profile.

Future Plans?

Change is the only constant in life, more so in the field of clinical research. Last 2 decades has seen exponential growth of IT in clinical research. I foresee Artificial intelligence as the next stage of evolution of IT in clinical research. Data Analytics can be done on a real time basis. Applications of AI will lead to quicker and more efficient statistical analytics and thus accelerated decision making. 

I plan to leverage my core SME skills along with the technical aids to become a functional expert in the domain of drug development.