“India continues to remain a key destination for clinical trials”

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry dedicated to creating intelligent connections that deliver unique innovations and actionable insights.

This edition of ‘Face to Face’ features Jinu Jose, Vice President, Head – Sales and Clinical Operations, R&D Solutions, IQVIA India who in an exclusive interaction with Rahul Koul, Chief Editor, BioVoice News shares his views on the company’s current operations, market scenario, future outlook and much more:

What have been your unique experiences amid the ongoing Covid-19 pandemic? Any key learnings that are fit to be implemented in the near future?

During the pandemic, it was great sense of pride and achievement for us in helping bring new drugs and vaccines for COVID-19 to the market. Despite all the challenges and restrictions brought on by the lockdown by the central and state governments at various intervals during the last two years, our team worked relentlessly and with determination to meet stringent timelines and ensure our commitment to customers was on track.

Conducting trials during the pandemic gave us a great opportunity to implement and experience the power of digital to enable clinical trials in a remote environment – from regulatory reviews and remote monitoring to patient follow-up and safety oversight – positively impacting trial timelines, while ensuring quality and safeguarding patients. We worked closely with regulators, sites and our sponsors to use digital health platforms and create innovative pathways for approval.

We are excited about the potential to use the learnings from the pandemic to fast-track clinical trials in the future, reduce the overall cost of drug development and help bring drugs to market faster.

Tell us about the ongoing projects being spearheaded by IQVIA R&D Solutions in India? 

Our focus in India is the same as elsewhere within IQVIA. Connected Intelligence™ is our innovative approach to enabling our customers discover powerful new insights, drive smarter decision-making, and get treatments to patients faster. It is about intelligently connecting data, technology and analytics to optimize clinical trials so that our customers can deliver life-changing therapies faster.

We also believe there is a great opportunity, catalysed by the pandemic, to make Decentralized Clinical Trials a reality in India. There are various industry and professional organisations working in partnership with the regulators and other important stakeholders to create the required regulatory and other pathways for this to happen. IQVIA is an important contributor to these discussions given our extensive global experience in Decentralized Clinical Trials.

In addition to our standard solutions and offerings, we will continue our focus on our India Local Solutions offering, which is a customised, fit for purpose clinical trial offering to meet the unique needs of emerging biopharma companies in the country.

Key products and services for R&D offered by IQVIA and who are your major clients? 

We offer a complete end to end solution in research and development from clinical research strategies and clinical trial design to regulatory submission and post-marketing studies. Our customers cover a wide range of organisations including biotech, medical device and pharmaceutical companies, and not for profit organisations.

Which are the major areas of innovation that you intend to keep focusing on and why? Any new products in the pipeline?

At IQVIA, innovation is embedded in the DNA of our organization and we are committed to fostering a culture of innovation across our business. We are focused on making intelligent connections for customers across the entire healthcare ecosystem whether that means partnering with novel technology companies to boost patient engagement, leveraging artificial intelligence and machine learning to accelerate results or using decentralized trials to reach the right patients wherever they are.

As the healthcare industry continues to evolve, we will continue to innovate and expand our services and offerings to tap into a deeper understanding of diseases, human behaviors, and scientific advances, in an effort to meet the growing needs of our customers and advance their path toward cures.

Which are the top priority areas for the company currently? 

Our focus will continue to be on Connected Intelligence™ and intelligently connecting data, technology and analytics to optimize clinical trials so that our customers can deliver life-changing therapies faster.

What are the upcoming trends for top therapy areas of clinical trials in India?

The last two years have been dominated by COVID-19 related clinical trials, including vaccines and other therapies. The trend is likely to continue in 2022 with new trials for COVID-19 vaccine boosters, mixing of various COVID-19 vaccines, self-testing kits and immunity boosters.  Fueled by the successful use of mRNA vaccines in COVID -19, RNA therapeutics are expected to make large strides. Vaccines for other infections like seasonal influenza vaccine, pneumococcal vaccines, Hepatitis, RSV vaccines are also likely to undergo clinical trials.

We also foresee a resurgence in respiratory tract infections and respiratory tract inflammation clinical trials this year.  In the generic market, clinical equivalence studies for respiratory diseases (COPD/Asthma) are likely to demand a big space with several inhaler drugs going off-patent in the coming years.

The top indications for oncology clinical trials include breast, lung, ovary, and colorectal carcinomas. Immunotherapy, targeted therapies, and personalized medicine have the largest interest, and these have been used for many solid and hematological cancers, including pediatrics.

Changes in treatment modalities towards targeted anti-cancer drugs due to resistance, refractoriness and survival benefits have led to a steady rise in novel therapeutic approaches. Many different targeted therapies have been approved but are being further evaluated as mono and combined therapies for cancer treatment.

Immuno-oncology clinical trials with PD-1 and PD-L1 inhibitors are seeing increasing interest by investigators. We also expect an increase in trials using biomarkers to stratify patients, indicative of personalized cancer treatments in the future.

There is also an increasing interest in early clinical development from industry, academia and regulatory bodies.

Another emerging area of focus is personalized medicines, including cell and gene therapies. With various research institutions developing CAR-T cell technology platforms and regulators providing a clear framework for CAGT studies, this could be a potential niche area of growth that will also address unmet medical needs, especially in rare diseases.

What factors might affect the competitive nature of the clinical trials market in India?

The introduction of the New Drugs and Clinical Trials Rules, 2019 has been a positive step but we need to build further on this to ensure that we continue to advance the clinical trial ecosystem in India, focus on making decentralized clinical trials a reality and improve overall access to healthcare.

The regulatory environment is certainly more positive, but rebuilding trust and confidence is a slow process. What has been extremely encouraging is the inclusive approach adopted by the Indian regulators and we are confident that the momentum will continue.

The conduct of a clinical trial requires expertise across multiple domains, including, pharmacology, statistics, chemistry and microbiology. There is limited availability of talent who are ready for the demands of the industry. The industry and academic must work together to ensure that these gaps are bridged, and we improve our research acumen and availability of talent at the grass roots.

We must continue to evolve and augment clinical research capabilities (process, technology, people) at clinical trial sites and institutions to strengthen the quality of data from sites.

 Digital is the future of clinical trials, and we need to encourage more digital and tech adoption to benefit all stakeholders in the clinical trial ecosystem, most importantly patients.

Clinical trials are a much-debated topic and COVID-19 has put product development and clinical trials firmly in the public domain and we believe that this will contribute towards a more informed patient community which is much needed. Overall, there needs to be a shift in communication and transparency around clinical trials. Better public education around clinical trials must be the starting point.

Future outlook for the Indian biotech and healthcare sectors? 

We are optimistic about the future of the biotech and healthcare industry in India. The pandemic has fostered tremendous innovation in the industry and created a whole new healthcare start-up ecosystem focused on innovation and digital adoption which augurs well for the growth of healthcare in the country.

India will continue to remain a key destination for clinical trials in infectious diseases along with other therapeutic areas such as oncology, metabolic diseases, gastroenterology, rheumatology, ophthalmology, and respiratory disorders. India will also continue to leverage existing capabilities and lead in clinical trials for biosimilars and complex generics.