“There is a growing trend towards outsourcing clinical trials to India”

In an exclusive interview, Dr Mahesh Bhalgat, Managing Director & Group CEO, Veeda Clinical Research Limited shares his vision for the company, latest developments, long-term growth, industry trends and future outlook.

It has been close to six months since your stint began at Veeda Clinical Research. How has been the journey so far and your short as well as long term objectives for the company?

Till date, it has been an exciting journey for me at Veeda. The acquisitions have resulted in substantial increase in number of clinical trial sites globally, which are now part of Veeda’s network. Veeda is now a truly global CRO with multi-national and multi-locational delivery centers across the globe where we have added capabilities in the late-stage clinical trials and are now offering or participating in global clinical trials. We continue to work on restructuring our business operations across the globe, which primarily focus on enhancing operational efficiency and aligning different businesses to work cohesively and achieve results that are in line with expectations of our clients. The restructuring of businesses will enable Veeda to adapt to market dynamics, customer demands, and emerging trends, ensuring its long-term competitiveness and growth in a rapidly changing business environment.

Veeda is now organized under four strategic business units. Firstly, Clinical Trials business comprises operations in Europe (originally Health Data Specialists) and patient-based clinical trials in India. Secondly, the Healthy Volunteer Services portfolio will include operations in Gujarat (India) including clinical bioanalysis for small molecules.  Thirdly, the preclinical and non-clinical testing services of Veeda (based in Karnataka) will cater to clients in pharma and biotech industry along with agrochem and industrial chemicals. This includes our discovery research services in the area of chemistry and biology. Fourth is Biopharma Services based in Bengaluru that will include analytical characterization and functional characterization of biologics along with cell line and process development and clinical bioanalysis of large molecules.

We continue to become strong and versatile in offering impeccable services to our clients.

What are the most significant current trends you are observing in the clinical research industry in India and globally? 

AI and ML are playing a significant role in enhancing various aspects of clinical trials, including patient recruitment, data analysis, and trial monitoring. These technologies are expected to streamline processes and improve the accuracy of trial outcomes. For example, in a recent study, Deep Learning Networks (DLN) were used to repurpose existing drugs with proven activity against SARS-CoV, HIV, and Influenza viruses, and researchers concluded that thirteen of the screened drugs should be investigated further for potential development for fighting other viral diseases. AI is being first used in clinical trial design to collate, harmonize, and reconcile disparate datasets.

The shift towards decentralized and hybrid clinical trials continues to grow. The number of DCTs has surged, especially during the COVID-19 pandemic. For instance, the number of DCTs reported on clinicaltrials.gov increased by 77% between 2019 and 2020, and by another 34% between 2020 and 2021. Approximately 1,300 trials with decentralized or virtual components were initiated in 2022, marking a 28% increase from 2021. These models, which incorporate remote monitoring and digital health tools, are making trials more accessible and efficient.

There is a growing trend towards outsourcing clinical trials to India due to cost efficiency and a large, treatment-naïve patient pool. This is attracting more global pharmaceutical companies to conduct their trials in India.

“In 2020, India accounted for 8.3% of global clinical trial activity, a notable increase from the ten-year average of 6.2%. This growth reflects the impact of regulatory reforms and increased investment in the clinical research sector.”

Has the Indian CRO industry overcome the challenges it faced a decade ago? Has it been able to maintain an edge within the APAC region especially when the CROs in countries like Korea, Australia and China are acting as tough competition?

The Asia-Pacific (APAC) region has continued to thrive as a growing hub for clinical trials in recent years. Despite the pandemic impact, between 2017 and 2022, APAC posted a growth in clinical trials of around 14%, outstripping growth in other major regions including the US, Europe and RoW. APAC’s growth far exceeded the overall average figure of 5.3% per year.

When comparing Indian CROs to other APAC CROs, several factors come into play. In the area of clinical research, data management and biostatistics, India has a large pool of highly skilled professionals vis-a-vis any other APAC countries. In India, access to a genetically diverse and treatment-naïve patient population is a significant advantage and Indian CROs leverage the improved regulatory framework which is conducive for the conduct of clinical trials. Manpower costs and other expenses can vary significantly across the APAC region, with countries like Australia and Japan being much higher than India. Overall, Indian CROs maintain a competitive edge due to cost efficiency and a skilled workforce.

In the last few years, India has introduced regulatory reforms relating to conduct clinical trials.  In 2020, India accounted for 8.3% of global clinical trial activity, a notable increase from the ten-year average of 6.2%. This growth reflects the impact of regulatory reforms and increased investment in the clinical research sector.

How does Veeda Clinical Research position itself in a rapidly evolving clinical research landscape and navigate the complex regulatory environment in India?

Veeda Clinical Research has strategically positioned itself as a leading player in the clinical research landscape by focusing on several key areas. One of these is strategic expansion and capabilities. The company has added capabilities in late-stage clinical trials with the acquisition of European CRO and can now participate in global clinical trials. Recognizing the need for offering integrated services, Veeda is now also offering preclinical services. Recently Veeda launched a biopharma division which focuses on supporting non-clinical services for development of biologics including cell line development, analytical characterization, process characterization, bioanalytical sample testing, and comparability assessments for biosimilars.

Veeda is now partnering to dramatically change the speed of patient recruitment in clinical trials.  Through exclusive access to real world data, patient matching solutions bring Veeda much closer to the right physicians and patients who are eligible for enrolment in clinical trials.

Veeda has aligned itself with international regulatory standards and best practices. We have a strong focus on quality assurance and regulatory compliance, which enhances our credibility. The evolving regulatory landscape in India, including the introduction of the New Drugs and Clinical Trial Rules in 2019, has made the country a more attractive destination for clinical trials. Veeda has adapted to these changes by ensuring compliance with the new regulations.

How has the acquisition of Bioneeds, a pre-clinical CRO in 2021 and Heads, a European CRO in 2024 benefited the company? What is the long-term objective and are there more such acquisitions in the pipeline?

The acquisitions of Bioneeds in 2021 and Heads in 2024 have significantly bolstered Veeda Clinical Research’s capabilities and market position.

The acquisition of Bioneeds allowed Veeda to extend its services from clinical research to preclinical research, offering a comprehensive range of services from drug discovery to clinical development. Bioneeds brought in expertise in toxicology, pharmacology, and other preclinical services, enhancing Veeda’s overall capabilities. This acquisition enabled Veeda to provide integrated solutions to its clients, covering the entire spectrum of drug development.

The acquisition of Heads, a European CRO, expanded Veeda’s global footprint, allowing it to conduct clinical trials across Europe, North America, South America, and the Asia Pacific region. Heads brought in strong expertise in late-stage clinical trials, particularly in oncology, which complemented Veeda’s existing capabilities. With Heads’ operational presence in multiple geographies, Veeda gained access to a diverse patient population, facilitating large-scale, multi-geography trials.

These strategic acquisitions have positioned Veeda as a leading global CRO with comprehensive capabilities, enabling it to offer high-quality, efficient, and integrated services to its clients worldwide.

How many clinical trials were completed and were ongoing by Veeda during the last two years? How does Veeda ensure the highest ethical standards in its clinical trials, especially in diverse regions like India?

Veeda Clinical Research has been actively involved in numerous clinical trials over the past two years. The trials include all phases of development, with a large number of patients recruited.  While the company has been focussed on oncology as its area of expertise, there are other therapeutic areas that Veeda continues to work in.  Veeda’s patient trial experience spans over thousand patients and multiple molecules, including monoclonal antibodies.  While the highest volume of clinical trials focus on Phase 2/Phase 3 trials, Veeda’s relationship with companies also brings them Phase 1, Phase 4 and patient PK plus clinical end-point type studies too.

Veeda strictly follows the Indian Good Clinical Practices (GCP) guidelines and aligns with international standards such as those set by the International Council for Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA). All clinical trials are reviewed and approved by independent ethics committees, ensuring that the rights, safety, and well-being of trial participants are protected.

Veeda conducts regular internal audits and welcomes inspections by regulatory authorities to maintain high standards of quality and ethics. We also ensure that all participants provide informed consent before enrolling in a trial. We invest in continuous training and education for its staff to keep them updated on the latest ethical guidelines, regulatory requirements, and best practices in clinical research.

Veeda Clinical Research has grown significantly over the years. What key factors have driven this growth, and how do you see the company evolving in the next five years?

Over the years, we have maintained strong connections with leading generic companies worldwide, engaging in various capacities. However, our involvement with innovator companies was limited due to a lack of late-phase clinical trial and initial drug development experience. In the last three years, Veeda’ expansion into the preclinical business has positioned us to start engaging more meaningfully in innovative drug development.

Veeda’s global pharmaceutical and biotech clients can now leverage the unique and unparalleled suite of early to late-phase CRO services across Europe, US, and Asia Pacific. Veeda’s ever-growing relationship with large biopharma companies and access to Key Opinion Leaders across multiple countries will accelerate execution of global clinical trials in both the western and eastern populations. In recent years, Veeda has added expertise in the late stage clinical and global trials for large molecules. High quality and efficient clinical trial execution remains the top priority for Veeda.

A unique blend of scientists and researchers, having deep therapeutic area expertise in the Oncology research, will enable us to drive greater efficiency, innovation, and excellence in delivering research outcomes for drug development programs of our clients worldwide. By combining expertise in the late-phase clinical trials with our expanded expertise and infrastructure in pre-clinical and phase I studies, Veeda is aiming to create a more comprehensive and integrated platform that delivers exceptional value to its clients and partners across the globe.

*This interview was first published in the October 2024 edition of BioVoice News eMagazine.