‘‘Currently, we have more than 100 active sites in India’’

Brief us about INC Research’s ongoing activities in India?

Shabbir Rangwala Regional General Manager (India, Sri Lanka, Pakistan & Bangladesh), INC Research

Rangwala: INC Research provides the full spectrum of clinical research services for phase II to IV clinical trials in India. With offices in Gurgaon, Ahmedabad, Gandhinagar and Mumbai, we’re able to support broad worldwide clinical trial strategies and services, including data services, functional services, alliance partnerships, strategic and regulatory consulting, and trial services. We’re also looking to expand our research expertise in Biosimilars. Our Indian hub serves as a centre for our Contracts and Functional Services group, providing global site contract management, regulatory document (eTMF) processing and site payment administration. Additionally, we’ve set up a dedicated biometrics team to help sponsors determine the most efficient way of enhancing their studies using the latest biometrics technologies. We’ve also developed an internationally recognised electronic data collection and organisation system that streamlines data handling.

Presently, INC Research performs phase II to phase IV clinical trials. Do you have any plans to conduct clinical trials on phase I?

Rangwala: We have not conducted any phase I trials in India to date, as current Indian regulations do not permit them at this time. However, as a leading global CRO, INC Research has the capabilities to provide the full range of phase I to IV clinical development services across six continents.

The company has its centre in the SEZ in Ahmedabad-Gandhinagar. What made you choose the SEZ?

Rangwala: We have a dedicated operations centre in the SEZ of Ahmedabad-Gandhinagar Knowledge Corridor, which allows us to rapidly increase staffing to match spikes in demand. Additionally, INC Research has several IT-enabled services in India that fit into the SEZ. We wanted to leverage these services to support future capacity and also set up a back-end operations centre for data management, pharmacovigilance, biostatistics, analytical work, medical writing and clinical research support services.

Globally, which country has the large number of patient pool and why?

Logan: In terms of disease rate per 100,000 residents of a particular country, China has the largest patient pool, but it’s closely followed by India. With a population set to exceed China’s by 2035, India has more than 1.3 billion potential patients and is anticipated to be one of the top three pharmaceutical markets by 2020. This huge population means an incredibly diverse disease base of most major diseases as well as rare diseases, including an endless variety of disease areas from tropical infections to degenerative diseases. While we see huge patient recruitment potential for clinical trials in India we have to recognise that the bulk of clinical trials in the world in 2012 are still conducted in North American and European patients where Good Clinical Practice (GCP) and the pool of scientific and medical expertise are long established. This is certainly changing rapidly, but the local media comment about over excessive use of India patients in clinical trials is much overstated today. INC Research is committed to working closely with DCGI and other authorities in India to ensure that the highest standards of GCP and patient ethics are adhered to in all our studies in India.

In India, INC mainly conducts research on diabetes, HIV, neurology, oncology and psychiatry.

Tell us the reason behind this? Which are the therapeutic areas that INC Research has an expertise in? How will this expertise be deployed in India?

Rangwala: We’ve conducted a lot of research in diabetes, HIV, neurology, oncology and psychiatry because of India’s spectrum of disease, which includes 10 million people with HIV, eight million epileptics, three million cancer patients, and 34 million diabetics. In fact, India is known as the diabetes capital of the world, having the highest number of diabetes patients. It is also estimated that India will have a 500 per cent growth spurt in the number of cancer cases within the next two decades. In fact, the Indian cancer registry data suggests that one in every 10 Indians will develop cancer in his/her lifetime. INC Research conducts clinical trials in these and numerous other therapeutic areas. In addition to the ones mentioned above, we’ve conducted trials in India for rheumatology, cardiology, infectious disease, general medicine, ophthalmology, dermatology, pulmonology, gastrology and pain.

Which are the other therapeutics segments that have growth potential and why?

Rangwala: With a huge population and diverse disease base, both major and rare diseases are prevalent in India. The most dominant therapy areas in terms of potential patient volume and clinical research investment are infectious diseases and women’s health. In addition to the therapeutic areas mentioned above, we also see a lot of potential in the areas of the reproductive and urology disorders.

Indian regulators are trying to make the existing law more stringent in this scenario. How will this move affect you?

Rangwala: Industry would welcome refinement of existing laws as long as implementation follows a regulatory mechanism. The establishment of 12 New Drug Approval Committees (NDAC), which advise on clinical trial approvals of new drugs, has increased the overall approval timelines compared with past processes, but the changing regulatory environment has made study approval rates still difficult to predict. Our close relationships with local regulatory authorities is a major reason why more pharma companies are turning to CRO partners like INC Research, because we’re able to help sponsors navigate this volatile system and unlock the potential profitability to be gained from conducting clinical research in India.

Tell us how INC Research regulatory team in Gurgaon is helping the New Drug Advisory Committee and its subsidiaries?

Rangwala: Our regulatory team in Gurgaon maintains close relationships with the NDAC and its subsidiaries, enabling us to keep abreast of India’s continual regulatory updates. As an applicant, INC Research is required to submit proposals to the committee, which reviews it independently. Typically, CROs and sponsors are allowed to present their trials for approval by explaining scientific, logistics and administrative strategy to conduct the study in India. The Committee then independently weighs the merits of the proposed study and grants approval.

According to INC Research, what are the regulated elements that should be considered by an Indian biopharmaceutical company before finalising its CRO selection. How important is it?

Rangwala: Indian biopharmaceutical companies should look for CRO partners that can assist them in complying with complex regulatory requirements and provide them with lower costs and access to new patient samples. When selecting an outsourcing vendor, most biopharma companies today are interested in developing long-term strategic relationships as opposed to simply maintaining a transactional arrangement and Indian biopharma companies are no exception. The most important characteristics to look for when selecting a CRO partner are local experience, the ability to provide consistent quality, high fidelity, superior service, and an extensive network of regional offices.

Recently, CDSCO has drafted the guidelines on quantum of financial compensation to be paid in case of clinical trials related injury or death? What is your comment on same?

Kelvin Logan President Asia Pacific INC Research

Logan: With support from the industry, most countries are starting to address this issue. Draft guidelines are evolving and while this is a good start, most in the industry expect some unresolved issues around causality/ relatedness/ worsening of underlying diseases to remain. INC Research is committed to complying with the emerging CDSCO guidelines on financial compensation for patients that are negatively impacted through participation in clinical trials. It should be acknowledged however that patients in late phase clinical trials are, by definition, suffering from an illness and often a series of illnesses from which they may suffer adverse conditions during the time they are participating in a clinical trial, but which have no relation to the trial itself. There are long-standing international medical standards for assessing drug or trial-related serious adverse events that have been adopted in all countries of the world. There is a concern by patient groups and the industry in India that extending financial compensation to all adverse events, even those unrelated to the drug or clinical trial in question, will have a serious impact on the availability of new medicines to patients in India.

What are the differences that exist in India when it comes to domestic vs. multi-national CRO scenario?

Rangwala: Indian pharma companies previously conducted the majority of their research within India because local CROs provided a cost-competitive advantage. However, their desire to reach a more global market has led to international CROs becoming more attractive. While global CROs are able to offer services on a larger scale, the pharma industry is constantly seeking new ways to drive down drug development costs, meaning opportunities still exist for local CROs in India to grow. However, they must continue to distinguish themselves as leaders in their areas of specialty through high-quality services. In the past, monitoring was a key focus in India for the CRO industry. Now CROs provide a full spectrum of services at different stages of drug development, including project management, medical affairs, regulatory affairs, quality assurance, data management and statistical analysis. This trend has brought large-scale outsourcing business to the country, particularly in the area of data management and statistical analysis.

Which countries have more friendly regulations?

Logan: The US, Australia, Canada, Western Europe and other countries in Asia such as Korea and Japan have more evolved regulatory expertise, and therefore offer more clear-cut pathways in terms of their regulations. Australia, in particular, offers an extremely time-efficient regulatory process. The Australian government also recently introduced R&D tax incentives for its local entities, as does the government in France. Eastern Europe has also evolved more clear guidelines and processes, which has led to an increase in clinical development. Until recently India clinical trial regulations were considered to be relatively straightforward, marking the country as an equal for running clinical trials with the aforementioned countries. Recent guidelines, however, have caused some consternation and confusion within the industry that has had a negative impact on some company’s decisions to bring new medicines for trial in India.

How many sites does INC Research have and how many are in the pipeline?

Rangwala: Currently we have more than 100 active sites in India and we will activate 70 more sites in the next few months.

How many trials are currently going on and in which therapeutic areas?

Rangwala: INC Research is currently involved in approximately 18 clinical studies in areas such as CNS, infectious diseases, oncology, endocrinology and pain management.

Overall, how many people have been employed in INC Research in India? Do you have plans to increase the number of employees?

Logan: INC Research currently employees approximately 140 clinical research professionals in India and we anticipate substantial further growth over the coming three to five years, subject to government support of clinical trial regulations in the country.

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