In the rapidly evolving landscape of healthcare and pharmaceuticals, the integration of medical expertise with clinical research and business acumen is paramount to advancing patient care and medical innovation. Dr. Sinha exemplifies this convergence, bringing a unique blend of clinical knowledge, research prowess, and strategic leadership to the forefront.
As a Senior Vice President and Medical Head at Hetero Labs (Hetero group of companies), a leading pharmaceutical company, and also as an Adjunct Faculty at Kasturba Medical College (KMC) and Hospitals, Manipal Academy of Higher Education (MAHE), Manipal, Dr. Sinha has made significant contributions to both the pharmaceutical industry and medical education. He is also a practicing family & general physician with special interests in Diabetes and in infectious diseases, having cared for more than 5000 patients at his practice over the last two decades.
Dr. Sinha’s leadership role at Hetero Labs, a globally recognized, India’s leading pharmaceutical organization known for its innovation in pharmaceutical research and manufacturing, focus and dedication to healthcare, positions him at the helm of clinical research Pharmacovigilance, Medical strategy and Medical affairs. With a robust background in medicine and a keen understanding of the pharmaceutical landscape, Dr. Sinha drives the clinical development and patient safety during the implementation of the clinical trials, focusing on and enabling highest standards of efficacy and safety. His leadership in clinical development is instrumental and pivotal in enabling the availability of cutting-edge treatments to the market and improving patient outcomes worldwide.
A Leader in Pharmaceutical Excellence
Dr. Sinha reflects on his illustrious 24-year career, progressing from a Medical officer at BYL Nair Hospital at Mumbai to a Medical advisor at Glenmark to a Senior Vice President and Head of Medical at Hetero group of companies, he has traversed through top pharmaceutical companies such as Vimta Labs, Dr. Reddy’s, Glenmark, Alquest LLC, Indigene Pharmaceuticals and Organon, in various roles.
He led a team of over 100+ professionals across various domains, including Clinical Trials, Pharmacovigilance, Data Management, Biostatistics, Project management, Preclinical studies and Medical Affairs, significantly contributing to the development of Biosimilars, chemical generics, and also new chemical entities. He has also led to the establishment and growth of pharmacovigilance and patient safety capability, focus and expertise. His regulatory expertise spans multiple countries, and he has led more than 300 regulatory presentations, multiple regulatory audits, thousands of clinical and preclinical sections of regulatory dossiers globally.
Dr. Sinha had played a pivotal role in the clinical development of multiple life-saving COVID-19 drugs and a vaccine during the pandemic. He led the clinical development of several Biosimilars in oncology, rheumatology, heart and kidney diseases and other inflammatory diseases.
During his tenure as a Head of functions and departments across various organisations, he has provided job opportunities to numerous budding and also emerging experienced professionals in his domains.
His scholarly contributions include nearly forty original articles in indexed & medical journals, a book chapter in medical textbook used in MBBS curriculum and two books for medical professionals.
He has also facilitated the setup and/or growth of multiple contract research organizations (CROs) earlier (Vimta Labs, Alquest, Adpharma etc.) and actively participated in guiding the setup of clinical research and ethics committees in medical institutions of repute.
Wide and Diversely Qualified Clinician, Researcher, Academician and Speaker
Dr. Sinha’s qualifications include a range of qualifications including MEDICAL (MBBS, MD from Seth GSMC& KEM Hospital and TNMC & BYL Nair Hospital respectively (both reputed government medical colleges in mumbai), Fellowship in diabetes {UK}, PG diploma in infectious diseases {Australia}), Diploma in Diabetes {Apollo Medvarsity}, Fellowship College of general practice {FCGP} from Indian medical association {IMA}); PUBLIC HEALTH (Fellowship Royal Society for public health {FRSPH}, UK and a Ph.D. in public health) and MANAGEMENT {MBA-Hospital and Health Services management (HHSM) {BITS-PILANI} and an Executive Management Program, IIM- Calcutta). These past and other current ongoing academic and clinical pursuits have all contributed to his deep understanding of the medical and business aspects of pharmaceutical products, as well as medical education and patient care. All these varied assignments have helped him grow as a reputed medical, scientific leader, and a people’s person.
He is an erudite speaker at over a 100 conferences organized by medical associations (IMA, IRA, CSI, ACCP, IPS, ISRPT, ACPCI, SOPI etc.), pharmaceutical industry (e.g., CPHI, IMAPAC, Terrapin, Bluetech etc.) and other research associations.
He has received a Lifetime achievement award (2021), a Bharat Gaurav Puraskar (2024) and an Indian medical award (2024) for his contributions to medical science, medical and pharmaceutical research.
Fostering Collaboration and Growth: Building Trust Through Mentorship
Dr. Sinha thrives as a leader who is equally adept at being a team player. He acts as a mentor and guide to numerous colleagues, supporting their career development and on-the-job learning. This collaborative approach fosters trust and confidence within the team, ultimately leading to increased productivity and optimal results.
Identifying Potential Beyond Qualifications
When evaluating candidates, Dr. Sinha looks beyond qualifications and experience. He prioritizes a candidate’s “professional hunger”—their desire for growth and eagerness to learn. This focus on potential allows Dr. Sinha to consistently build successful teams, both in his current role and in previous organizations.
Overcoming Obstacles
Dr. Sinha highlights a critical challenge facing medical professionals: the need for continuous education and updates in medical knowledge to ensure effective patient treatment. Despite the plethora of medical associations offering continuing medical education (CME) programs, both free and paid, and the availability of online resources, there are significant gaps in the authenticity and quality of these educational tools. Many of these resources lack standardization, and there is often no authoritative body to verify their credibility in India and, in some cases, globally. This inconsistency poses a significant barrier to medical professionals seeking reliable and up-to-date information.
Another major obstacle is the rapid pace of pharmaceutical advancements, which are often not fully integrated into the practices of many healthcare professionals. New pharmaceutical treatments are discovered and developed swiftly, but these innovations do not always reach the practitioners who could most benefit from them. Only a select few professionals who are involved in research or clinical trials have early access to these advancements. The broader medical community typically gains this knowledge only after the new treatments have been marketed by pharmaceutical companies, creating a delay in the dissemination of potentially life-saving information. While pharmaceutical companies may present some of their research efforts at conferences and therapeutic meetings, these efforts are often insufficient to bridge the knowledge gap for the wider medical community.
In the face of these challenges, there is a pressing need for more systematic and standardized methods of continuing medical education and knowledge dissemination. Ensuring that medical professionals have timely access to the latest advancements in pharmaceutical treatments is crucial for improving patient care and outcomes.
By addressing these obstacles, the medical community can better keep pace with the rapidly evolving healthcare landscape, ultimately leading to more effective treatments and improved patient health outcomes.
Dr. Sinha says that, as stated, the current communication channels are inadequate and often leave gaps rather than bridge them. The formal modes are often the medical and research conferences, which have increased manifold but are far less than desired. However, there has been an explosion of information channels via the scientific internet and publications, which, if used and applied judiciously, can lead to much better knowledge exchange.
The Perfect Solution
Dr. Sinha emphasizes that medical expertise is fundamental to the quality of clinical trials as well as excellent patient care. The core of a clinical trial revolves around a well-defined medical hypothesis focused on patient or healthy subject endpoints and outcomes, which medical experts must meticulously craft. Critical elements such as inclusion and exclusion criteria need careful consideration by the medical team to balance the requirements of quality research and patient care. Safety issues arising during clinical trials must always be closely monitored under medical supervision to ensure the safety, well-being, and rights of study participants. Furthermore, the medical data generated must maintain integrity and quality, underscoring that expert medical oversight is essential for the success of clinical studies.
He further emphasizes that digitalization, automation, and AI are slowly taking over data generation and analysis. Hence, medical and research professionals must acquaint themselves with and apply these in their daily professional lives. Pharmaceutical organisations have started gaining speed and traction in their research through such integration. It will be a norm in the future for both research and medical practice.
Removing the Roadblocks
Stating the biggest roadblocks to successfully recruiting and retaining diverse patient populations for clinical trials, Dr. Sinha says that the clinical trials are best served by diversity of patient/ subject data. This is also a regulatory requirement across countries. However, the economic and social conditions are different and variant and pose different challenges for the study and its participants subjects.
Chronic disease-related studies require multiple visits and long-drawn clinical trial steps, which pose a lot of disturbances and inconveniences in the patient’s lives. Often, these diseases are life-threatening and have increased morbidity. In countries and regions with challenging life conditions, the patients often drop out of the study. In regions that are significantly well off, such as Europe and the USA, subjects are difficult to recruit as there is no pressing economic need to enter a trial or any lack of healthcare setup or funds. Additionally, these latter regions have high litigations, leading to the sponsor’s disinterest beyond regulatory mandatories of the requirement of data from these patient populations.
Patient centricity and decentralization are the most effective solutions to overcome these hurdles and maintain high recruitment.
According to Dr. Sinha, the design of the clinical trial is like the heart of the body; it ensures that the study is alive. An optimum design ensures optimal trials. The designs need to enhance the clinician’s knowledge and provide the subject with high-quality medical care.
The study’s endpoints should answer clinically relevant questions, target unmet medical needs in the patient, and balance regulatory requirements.
The Equilibrium
Dr. Sinha says researchers should involve medical professionals right from the start of a clinical trial’s planning and strategies to improve communication with them about the purpose and potential benefits. Pharma companies often form medical scientific committees to this effect. Besides these, the data and safety monitoring board(DSMB) must be constituted early to involve the relevant key opinion leaders and researchers in the appropriateness of the trials.
He further insists that balancing between generating profits and ensuring access to affordable treatments for patients is crucial. All pharmaceutical companies are in the business of selling profitable medicines. The profitability should be such that this benefits both the companies and the treated patients. Especially in clinical trials, the effort should be to reduce the costs of the study operations and optimize payment outflows for these studies.
If the cost of research and development is well controlled, companies will not hesitate to pass on the savings to patients.
Additionally, many companies undertake special drug availability schemes after marketing, especially for life-threatening diseases such as cancer and cardiovascular diseases.
Promoting Ethical Practices
When asked about the role business leaders can play in promoting ethical practices within the pharmaceutical industry, Dr. Sinha highlights the critical importance of ethical conduct in clinical research and pharmacovigilance. At his current organization, there are strict directives from management to uphold ethical standards in all clinical trials. These directives are cascaded down to department heads and team leaders to ensure implementation. Key aspects of ethical practices include obtaining approvals from registered ethical committees at all participating sites and ensuring optimal medical care for all subjects during and after the trials. Additionally, clinical trials must adhere to all regulatory guidelines and quality processes to maintain data integrity and quality, underscoring the pivotal role of ethical adherence in the pharmaceutical industry.
The Potential Benefits
The pharmaceutical industry and the medical practice fraternity are more dependent on each other than previous eras due to the explosion of knowledge generation and the availability of a plethora of medical products. Medical professionals have better pharmaceutical alternatives than ever before for the benefit of their patients. Hence, without such collaborations, medical practice as well as well as clinical research will find it difficult to evolve.
Pharmaceutical leaders must ensure such high-quality research environments and infrastructure to develop and produce high-quality products.
Bridging the Gap
Dr. Sinha suggests some innovative approaches to bridge the gap between the business and scientific aspects of pharmaceutical development:
The business of pharmaceutical development must be based on solid scientific principles and unmet medical needs. The best approach is to involve the highest medical authorities early in product ideation and development, which we do regularly and efficiently at my current organisation.
Access to the most updated research should be available so that the right molecules/ products are chosen for development.
According to Dr. Sinha, healthcare and pharmaceutical development require updated medical knowledge and science for the best product selection and business strategies. The industry relies heavily on the experience of its qualified scientific employees for all activities, from research to development to marketing.
Aspiring entrepreneurs must acquire and develop these qualities and resources, in addition to their monetary base, and utilize their financial resources smartly and wisely.
Dr. Sinha adds that the relationships between medical expertise, pharmaceutical research, and business in the healthcare industry have already evolved. One cannot develop without the other’s development.
However, as much as the research and pharmaceutical industry seek medical expertise, the medical fraternity must make an equal effort to get involved and be willing to participate more than ever so that advanced therapeutics can evolve out of the pharmaceutical industry for the benefit of patient care.
Looking Ahead
The industry’s future belongs to targeted therapies, immunotherapies, and complex biologics, such as bispecific antibodies and antibody-drug conjugates.
Furthermore, pharmaceutical products such as complex generics, single-molecule biologics, and biosimilars must continue to be targeted as before, and perhaps more.
The prospects in clinical trials include studying decentralization and patient centricity, implementing AI in operations, and capturing and managing data in Pharmacovigilance, regulatory, and medical writing operations.
For more information, please email drsinhaiimc@gmail.com.