The life sciences industry is a booming market segment in not just India but in countries across the globe as well. The immense market potential in this segment has also attracted more and more companies to enter this stratum which has resulted in increasing the competition. While many are struggling to get a proper foothold in the market, EVERSANA is a pioneering business organization that has been able to make impressive strides in the life sciences industry. The company is leading the shift to patient-centered, value- and outcomes-based care. The pharmacovigilance and safety sciences team at EVERSANA supports these therapies developed by pharmaceutical and biotech companies to get their therapies approved by developing their pharmacovigilance system, writing pharmacovigilance management plans to meet regulatory requirements, and even meeting with the Health Authorities on their behalf. Dr. Shraddha Bhange holds the office of Medical Director at the company and under her guidance, EVERSANA has grown to create an impressive clientele that includes over 500 clients ­ from startups to established global pharmaceutical leaders. 

What Motivated You To Venture Into The Field Of Healthcare And Specialize?

During my clinical practice with a hospital based in Thane (Mumbai), I was more fascinated in venturing into new drug development and always thinking about availability of safe drug treatments for patients. When you practice as a doctor, you can help one patient at a time, which is rewarding, but given my interests in clinical research and passion, I thought about PV as best choice to help more than one patient at a time. Also, I am deeply interested in serving my society in educational sector, which was kind of hobby. But clinical practice would not have given me time to explore that. Working in PV and pharma industry gave me a time and opportunity to do both. I volunteer my time out from my job to an NGO working for rural education, Thinksharp Foundation.

Tell Us About The Varied Expertise You Possess In Terms Of Drug Discovery And Pharmacovigilance?

The expertise I have developed, are not just mine but It's a team effort that pans from various departments leadership, regulatory affairs, medical affairs, clinical trials and many more. I have been part of pharmacovigilance since beginning of my career when I started with vaccines that were in discovery phase and further approved for dengue. It's a rewarding experience to work on drug discovery, even though you are a small part of big team.

My overall role and expertise in drug discovery is ensuring the benefit -risk profile of drug under discovery phase is acceptable. I do provide medical expertise for clinical protocol development and medical monitoring of clinical trials and also creation of the safety section in protocols, informed consents, reference safety information and periodic reports (i.e., DSUR). Overall oversight on all the adverse events collected during the clinical trial and analysis of this events. I also act as medical lead for meetings that have to happen with  regulatory authorities, study investigators, IRBs/ECs and data monitoring committee. Leading medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, expectedness, causality, and reportability. My overall role is to ensure the drug's safety profile is monitored continuously and to support clients throughout the drug discovery and approval proves by providing medical inputs on SAEs, protocols, safety of trials, various documents such as REMS/RMPS, USPI/PI.

“As a trained physician, my aim is that the medicinal products we are handling should be 100 percent effective for my patients and as a safety physician, my aim is that they should come with acceptable, treatable and preventable risks for my patients”

In Your Opinion, What Have Been Some Of The Most Significant Milestones That You Have Achieved So Far? What Has Been The Driving Force Behind Your Success As A Business Leader?

Every milestone that has created a positive impact in ensuring we communicate and mitigate any risks associated with drugs/medicinal product is a mile-stone for me. Although it's a team effort, but I feel privileged to be part of such efforts and those efforts feel like milestone to me. A patient taking a medicinal product for his/her disease should benefit from the drug and have minimal or acceptable and preventable side-effects. This side effects should be communicated to healthcare professional and patients so they can make informed decision. And whenever we make this cycle /process more transparent and smoother, it feels like milestone. The driving force as business leader that help me achieve this milestones is the people you work for i.e., patients and the people you work with i.e. my team. Our cultural values at EVERSANA are so easy and yet so important that they drive me to serve my clients and ultimately patients effortlessly and with sense of satisfaction.

How Do You Keep Yourself Well Aligned With The Periodic Evolutions Occurring Within The Medical And Healthcare Industry?

As a medical doctor, we are very well connected on various platforms to help us stay connected on medical front on disease and treatments. Also, the Continuing Medical Education (CME) conferences that are mandatory (renewal of medical license in Maharashtra, India is every five years that requires CME points) to keep our medical license active to practice is also one key element in ensuring we stay on top of current medical trends. For the pharmacovigilance knowledge there are tons of conferences, discussions, and forums that bring lot of discussions so as to ensure we also stay current on PV trends. Working in PV, which is highly regulated by healthcare authorities with their requirements, we have to keep our eyes and ears open and stay on our toes to ensure we met those requirements to ensure our medicinal product stay in market and are safe for patients.

Dr. Shraddha Bhange, Medical Director, Eversana

Dr. Shraddha has worked with Cognizant Technology Solutions, one of the top IT giants as medical reviewer, Sanofi Pasteur (Top Pharma Company). She handled trainings of medical reviewers, handling of vaccine related adverse events and ensuring vaccine safety. She has also worked as pharmacovigilance expert for Novartis Healthcare Pvt Ltd, Hyderabad, India for end-to-end PV activities for Premarketed products. She has worked as a Pharmacovigilance Responsible person (equivalent to QPPV) for India and ROW (Rest of world markets- Africa and Middle east) for generics and anti daibetics for end-to-end PV at Wockhard Pharma Ltd (One of the top Indian Pharma company). She has worked for French Biopharma AB Science as Compliance Manager ensuring the clinical safety and pharmacovigilance of pre-marketed product and was based in Paris, France.