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Ethics and Determination: The Two Constants for Success

16th Mar, 2020
Ethics and Determination: The Two Constants for Success

Sir C.V. Raman was one of the greatest scientists in India. His contributions such as the Raman Effect is still celebrated around the world. In fact, 28 February every year is celebrated as National Science Day to mark the discovery of this effect. This year, the nation celebrated the women in science. In the same spirit, we reached out to Dr Nomita Bhandari to celebrate the women in Cadila working in the field of science and research.

In the pharmaceutical industry, ensuring the safety of the drugs that are being created is an important factor. An organization whose vision is to ensure the highest quality of drugs, testing the effectiveness and the safety of these drugs through clinical trials becomes all the more crucial.

To shed more light on this topic and for the next segment of our blog series in “Women mean Business”, we had a conversation with Dr Nomita Bhandari, Vice President, Contract Research Operations (CRO).

Q- Can you please tell us in brief about your role and responsibilities?

Our team in CRO is responsible for pre-clinical and clinical studies of new products that Cadila Pharmaceuticals plans to bring to the market.

The purpose of pre-clinical studies is to understand the initial safety and efficacy signals of new drugs in a living physiological system.

Clinical research operations is the gateway for the arrival of new medicines. Once the initial toxicology study of new drugs is completed, the drug passes through stringent passage of 3 phases. Phase 1, where the safety studies are conducted in healthy volunteers. Once the safety is established, the Phase 2 studies are initiated where different doses are explored in proposed indications in patients with those ailments where the drug is expected to work. Once the presence of efficacy is known, Phase 3 studies are conducted in greater number of patients in hospitals across the country. These are confirmatory studies about efficacy of the drug in proposed indications in the selected doses. The data is then submitted to regulatory authorities and sent for further process.

This long and arduous journey of pre-clinical and clinical development which informs us about the effects of a drug on our body, passes through stringent quality control under the supervision of the ethics committees and regulatory authorities.

We also conduct the Bio-availability and Bio-equivalence studies for our generic products in our 66 bedded clinical facility and state-of-the-art Bio-analytical laboratory which is well equipped with advanced LCMS-MS machines.

We have a team of experts (zoologists and veterinarians) who manage the pre-clinical studies in the state of the art GLP facility and scientists, medical doctors, clinical research associates, Bio-analytical experts, Bio statisticians, data management and Quality Assurance auditors who conduct the BA-BE studies and clinical trials.

We design, execute and monitor all these studies as per the regulatory requirements of regulatory agencies of different countries and support the growth of our business.

Q- R&D is an exciting field. What is the one thing you like best in R&D in the pharmaceutical business?

The best thing I like in R&D in the pharmaceutical business is the opportunity of impacting the lives of thousands of people. In addition to this, my work gives me a sense of responsibility and purpose since it creates an impact in the world.

Q- As we see today that AI is taking over everything, do you think R&D can ever be replaced by technology?

Artificial intelligence through different tools and data analytics will surely accelerate the process of drug discovery and empower the scientists to process large volume of data. AI is likely to help revamp our delivery strategies to create data-science driven interdisciplinary teams that is likely to support business sustainability.

Having said that, human mind is no less than a super computer. The decision making will continue to be the forte of scientists and nothing will replace the human mind.

Q- What are the current projects you are working on that are exciting?

We are working on multiple projects which will be an initiative to transform the healthcare sector. Currently we are working on a new Rabies Vaccine which we feel will revolutionize and change the way consumers perceive rabies vaccination. This will be an effective way to administer the drug in shorter time. Products for psoriasis, acne and diabetes mellitus are also in the pipeline.

Q- A leader is as good as their team. What are the qualities you look for in your team members?

Ownership and accountability are two attributes which are extremely important for me. Being in clinical research, it is equally important to have a scientific temper, positive outlook and adherence to ethics and integrity. These attributes make for an ideal team engaged in scientific research.

Q- What is it about Cadila that you like the most?

People across Cadila work with the determination to take on challenges. This spirit drives all of us. When you have a team working with the same level of enthusiasm and determination, projects become more exciting.

Q- Apart from work, how do you like to spend your free time?

In my free time I unwind by taking frequent vacations to various locations with my family. One of my dreams is to see all the architectural marvels of the world. I have already visited the Great Pyramids in Egypt, Leaning tower of Pisa, Grand Canyon, Great Colosseum, Taj Mahal and I look forward to seeing the rest.

Q- Any message to our women leaders?

In this tough and competitive world, I would ask all the women leaders to just believe in themselves and be confident. The rest will follow. One advice I want to give all women professionals out there is to help each other. Strength lies in unity. When we all will stand together, it will become easier to fight for our rights in society.