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Meeting highlights:
- Parexel’s Comprehensive 360-degree approach: The company's wide offering of biopharmaceutical services positions it as the partner of choice for companies seeking end-to-end solutions.
- India’s Appeal for Drug Development: Geopolitical advantages, Availability of skilled talent, Cost-effectiveness, Rapid digitalization and value-based pharmaceutical growth beyond biosimilars
- Embracing the industry evolution: Parexel's focus is on advancing personalized medicine, developing new therapies, integrating genomics into clinical protocols, and leveraging digital tools and AI-based models to enhance healthcare.
- The Value of Patient-Guided Drug Development: Parexel is the first top CRO to appoint a Chief Patient Officer, reinforcing a deep commitment to true patient-guided care. Advocacy groups further drive this focus on innovation with the patient always in mind.
- Future Vision for India as an Innovation Hub: India can tap into the capabilities of data and advanced technologies to deliver cutting-edge treatments to more people, building on a trusted and credible position in the global biopharmaceutical ecosystem.
EF: What attracted you to a company like Parexel?
SV: I joined Parexel as Global Business Unit Head for Clinical Trial Supplies and Logistics after 14 years in the life science supply chain at Deutsche Post DHL. My experience managing finished products for patients prompted me to explore the upstream side of drug development. At Parexel, I have been able to bridge this gap and contribute to the entire drug development process.
Parexel is one of the world’s largest CROs offering a comprehensive range of services beyond traditional clinical studies. Parexel provides full solutions, from early-phase trials and regulatory support to post-approval market access.
We also offer comprehensive pharmacovigilance, safety, and clinical trial supply chain services throughout the drug lifecycle. Parexel provides an end-to-end 360° approach to biopharmaceutical solutions from Phase I to IV, including study design, protocol development, data management, biostatistics, regulatory affairs, and clinical trial logistics. With a global presence of over 21,000 employees in 49 countries, we continue to expand our reach and expertise.
EF: Could you elaborate on Parexel’s presence in India, including your focus areas and research initiatives?
SV: India's stable political environment and evolving skill set make it a unique global player. Once primarily known for cost savings, India now offers a significant value proposition. With 6,000 employees, India now represents 25% of Parexel's global workforce and operates across 18 distinct functions. In the last 25 years, India has shifted from focusing on shared services like HR and finance to a fully-fledged clinical research organization or front office for Parexel's global operations. Our India team can now independently manage clinical trials, from protocol design to deployment. We cover clinical operations, project leadership, data management, medical writing, logistics, pharmacovigilance, and regulatory affairs.
India's pharmaceutical sector has grown significantly, shifting from a focus on generics to innovative molecules like New Chemical Entities (NCEs). Innovation extends to advanced areas like cell and gene therapies, including CAR T-cell therapies. For instance, IIT has developed India's first CAR T-cell therapy, and several biotech firms are conducting clinical trials, especially in oncology.
India can develop NCEs and even CGTs at about 30% of current global costs, potentially making them more accessible and affordable. With its 6.5% GDP growth, India is becoming an attractive investment destination, driven by the rapid expansion of healthcare facilities and investigator sites in Tier 1 and Tier 2 cities.
The proposed US BioSecure Act may boost interest in Indian pharmaceutical companies, enhancing India's role in global drug development. India's clinical research market is growing at 7-8% and is expected to reach $2.05 billion by 2025. At the same time, low patient participation in trials remains a challenge and is still under 5% in a 1.2 billion population. Post-COVID, awareness around clinical trials grew and is improving the situation.
Additionally, new regulations from the DCGI (Drugs Controller General of India) introduced in 2019 have aligned India's clinical trial standards with those of the US FDA and EMA, making the process far more efficient.
India has shifted from a back-office destination to a global hub for innovation. Companies across sectors are establishing Global Capability Centers (GCCs) here to leverage India's skilled talent pool. This growth solidifies India's position on the global map.
EF: How are you collaborating with hospitals and other public or private partners to advance innovation in medicine, particularly in areas like cell and gene therapies?
SV: At Parexel, we adopt various approaches to innovation across our 20+ therapeutic areas, including oncology, hematology, rare diseases, and cell and gene therapies. Depending on the area, we use different adaptive trial designs, relying on historical data or real-world evidence (RWE) and real-world data (RWD).
During COVID-19, we accelerated vaccine and therapy development by integrating real-world and clinical data, reducing study timelines, especially in rare diseases, respiratory conditions, and oncology.
India, in particular, is set to play a key role in this innovation. A great example is how the country responded to COVID-19 through digital initiatives. The government’s CoWIN platform digitized the vaccination process for 1.2 billion people, highlighting India’s advanced digitization, even in rural areas. India is taking this innovation to the next level with the Ayushman Bharat Healthcare Mission (ABHA). This initiative aims to connect every hospital and give patients control over their digital health records across facilities. This could enable patient tokenization, allowing individuals to choose who accesses their data.
The integration of real-world and clinical data will revolutionize clinical trials, speeding up therapy development through more efficient data comparison. Though still in its early stages, the mission is underway, and the supporting app is available. This approach also addresses the still-exiting challenge of patient dropout rate, often due to socioeconomic factors, and improves patient recruitment. With access to data from 1.2 billion people, identifying the right patients for studies will be easier. By collaborating with investigator sites for organized data, we can recruit patients more effectively, making trials more efficient and accelerating therapy development.
One exciting area of innovation is the focus on personalized, biomarker-driven trials. At Parexel, we are pioneers in this space. We have developed targeted therapies and have a dedicated division focused on genomics. This team works globally, including in India, collaborating with sponsors to drive drug development using genetic profiles to tailor treatments—a key factor in ensuring the success of any study.
Meanwhile, pharmacogenomic research also plays a key role in tailoring treatments to individual genetics, which is essential for personalized medicine.
EF: How does Parexel contribute to more patient-focused clinical trial processes?
We promote diversity and inclusion through patient advocacy groups, including one in India. Parexel has strategic partnerships with more than 14 Patient Advocacy Groups (PAGs) and is engaged with over 75 PAGs around the world. These groups share their clinical trial experiences, helping us improve transparency, simplify consent, and create a more patient-friendly system.
At Parexel, our goal is to make their experience compassionate and supportive. To enhance this, Parexel was the first top CRO to appoint a Chief Patient Officer. The CPO assists us in designing patient-guided protocols across all trial phases, letting feedback from our advocacy groups directly influence our operations. For instance, a rare disease patient had to travel to the U.S. for treatment due to a lack of trials in India. This insight has driven us to advocate for better access and faster approval processes for orphan drugs.
By bringing patient feedback to regulators, we have helped shape policies like India's "deemed approval" process for orphan drugs, ensuring faster access to critical treatments. Parexel remains committed to transforming clinical trials with patient care and accessibility as top priorities.
EF: How will new digital technologies change the future of clinical trials, and what role will India play in this innovation?
SV: Technology is poised to transform the way we conduct clinical trials. COVID-19 boosted "direct-to-patient" models, leveraging technology for remote patient monitoring and engagement, bringing the studies to the patient’s home.
Additionally, artificial intelligence and machine learning enable predictive trial design, allowing us to use past data from previous studies to forecast the success of new molecules. In the last 5 years, Parexel has conducted 530+ clinical projects. Based on the historical data, we apply machine learning to predict the potential success of new molecules for multiple therapies. We continue to innovate in this area to build more efficiency.
Generative AI opens up many opportunities. At Parexel, we created an internal system to ensure data security. One area of focus is simplifying content generation, such as electronic consent, to make it easier for patients and investigators. We are also exploring whether AI can draft initial medical protocols and assist with statistical programming, and we are looking into improving the search and retrieval processes.
Looking ahead, we are also evaluating the potential of quantum computing and concepts like digital twins to simulate drug effects on a virtual human genome model. An innovation in this realm could significantly impact the drug development process, as one of the major challenges in clinical trials is proving the safety and efficacy of a drug before human trials begin. The technology could help predict common adverse reactions and standard outcomes with greater accuracy.
There are immense possibilities for improving clinical trials through hybrid approaches, which could shorten study lifecycles and accelerate drug development. In recent years, a significant number of biotech startups have emerged in India, many focusing on generative AI, quantum computing, and digital twin technologies.
India's progress is linked to a global ecosystem, requiring partnerships with international organizations. Its large talent pool, which includes many pharmacy graduates and doctors, and its growing digital transformation play a key role in this.
Parexel is already conducting innovation pilots in India, particularly in generative AI, benefiting from lower costs of failure compared to other countries. This context gives India a significant edge as a powerhouse in driving innovation.
EF: Moving away from the term “Pharmacy of the World” -What would be the best nickname for the next phase of India’s growing health ecosystem?
SV: India is emerging as a global innovator in healthcare solutions, evolving beyond generics. Despite challenges in developing new chemical entities due to the high investment needed early on, the government has introduced incentives to boost research and innovation. Government-run institutes in Bangalore, for example, support projects with labs, funding, and manufacturing assistance as they progress.
India is transitioning from 'the pharmacy of the world' to 'the innovator of the world' in life sciences. In five years, we will likely see leading gene and CAR-T therapies coming from India, driven by collaboration between academia, pharmaceutical companies, and CROs.
Although India has long been known for its IT and software development, now, it is making significant strides in other sectors, such as electric vehicles and charging infrastructure, with a goal of carbon neutrality in 10 to 15 years set by the newly re-elected Prime Minister. While I share the optimism, there are still roadblocks. We need more investment in the right areas, and new innovators must be supported properly. India must move beyond the generics mindset and focus on developing new chemical entities (NCEs) and other innovative molecules. Though this shift is underway, Indian multinationals need to take more risks, along with global companies driving innovation.
Notably, many doctors and researchers globally are of Indian origin, and talent is increasingly returning to India. After 18 years abroad, I returned to contribute to this thriving ecosystem, encouraged by favorable policies, support, academia, and talent. Though it is not an overnight transformation, I believe India will be a global leader in innovation within the next three to five years.
EF: Is there any final message that you want to give our readers?
SV: When driving innovation, it is crucial to keep the patient at the center. Whether using generative AI, artificial intelligence, or machine learning, we ensure strong ethical guidelines are in place. We avoid applying these technologies haphazardly and are mindful of biases in machine-learning systems.
Technology should augment, not replace, human capabilities. At Parexel, we emphasize final human oversight and review. We have published our internal AI usage guidelines on our website, focusing on ethical conduct, compliance, data integrity, and patient privacy.
Innovation should benefit patients, simplify their experience, and aid investigators and doctors. Technology must enhance their work, not just be implemented for its own sake. It is similar to how the music industry transformed. Back in the day, we had to walk to the store to buy a cassette. Now, we ask virtual assistants to play music instantly—that is the kind of customer experience digitization that has improved lives. There are some brilliant innovations underway and exciting times ahead!
