‘Clinical research services at most leading pharma and biotech companies contain at least one outsourced component’

Karan Daftary, Director, Business Development and Akshay Daftary, Director, Business Development, Siro Clinpharm, speak on the current trend sin the CRO market, changing templates of pharma-CRO relationships, role of technology in transforming CROs and more, in an exclusive interview with Lakshmipriya Nair

What are the dynamics and trends in major pharma markets that are swaying the current scenario and will influence the future status of the India CRO market?
The country’s pharma industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach $55 billion. India’s pharma exports stood at $17.27 billion in FY18 and have reached $10.80 billion in FY19 (up to October 2018). There has been an increasing healthcare spend by the government. Moreover, private sector investments in R&D and acquisitions are also on the rise. In FY18 – pharma companies invested 8.8 per cent of their sales on R&D. (Source: IBEF Report)

All of these will influence the CRO market in country. Apart from these, the  following factors will also generate more business for the CROs in the country:

• Increased number of trials that need to be conducted during the drug development phase. Pharma companies tend to focus more on the R&D aspect while outsourcing the trials to other companies who have the capabilities.
• Shift of focus from generics to biologics. According to a report prepared by the Department of Industrial Promotion and Policy (DIPP), Government of India, the global biologics market is expected to be around $290 billion by 2020 accounting for an estimated 27 per cent of total pharma sales. Unlike generics, they require clinical trials. While the overall drug development pathway for biologics remains the same as small molecules, starting with identifying the target, validating the information, screening and testing, followed by pre-clinical and clinical trials before its commercial approval. Therefore, the scope and cost of each trial is generally higher and even large generic companies need to keep up with changes in industry.
• Trials need to now be conducted in the FMCG sector for claims, which will also directly impact the CRO market in terms of increased volumes.

How has digitalisation changed the way that CROs operate? What are the new competencies that CROs need to develop to leverage the true potential of these transformative technologies? Give us a few examples of your efforts in this direction.
There are thousands of data points per patient in a clinical trial — that’s a lot of data. So, in order to aggregate all that data, automation of some of the services will help streamline their processes and bring in better efficiencies. The increase in investment into digitisation of clinical trial elements is to reduce cost and optimise the time taken for trials as well as post study wrap up timelines.

Siro Clinpharm has invested significantly in technology and enhanced its capabilities to further progress. Some of our endeavours in this direction include:

• Besides having expertise in paper-based studies, we have developed capabilities to do digitalised version of this using various homegrown and acquired EDC platforms for e-diary use to track patients in the trial and give sponsor results on digital platform. It leads to less maintenance of paper including trial master files (set of essential documents required before, during and post clinical trial)
• Initiated automation of narratives – it would reduce turnover time and chances of errors.
• Electronic handling of data helps us in reducing manual handling and potential data integrity issues
• Adoption of cloud-based processes to make the trial process more efficient and cost friendly

How is the relationship between CROs and pharma companies changing? What are the factors driving these changes? What would be the template/s of a successful pharma-CRO relationship in future?
Large pharma and biotech companies either find and manage their own vendors for clinical trials or hire a CRO to take over the relationship between sponsor and vendor. The work for a specific R&D activity is not continuous in nature for a pharma company; hence, engaging full time employees for such kind of activities is troublesome for a pharma company. Additionally, outsourcing helps a pharma company to have specialised people working from a CRO on specific activity, thereby providing efficient solutions.

According to some estimates, 70 per cent of clinical research services at the leading pharma and biotech companies contain at least one outsourced component. However, strategic partnerships between sponsors and CROs require robust governance structures and mechanisms to ensure:

• Important decisions that need to be made are identified and effectively framed
• Optimal decisions are made by the right people, with access to relevant and accurate data
• Accountability exists to ensure important decisions are effectively implemented
• Problems are quickly identified and escalated to the right parties for efficient and effective resolution

How is Siro metamorphising into a ‘CRO of the future’?
Siro Clinpharm is undertaking several endeavours to become future-ready CRO. Some of them are as follows:

• Innovation and advancement of technology to automise processes that would decrease chance of human error – significant investments are being made by SIRO into testing for these changes
• Global approach: developing sales and operational unit in the US to increase on-ground presence there
• Building of robust databases to make patient recruitment more seamless and efficient, shortening of timelines with quicker recruitment
• Develop a specialised model to cater to the large and ever growing FMCG segment that includes sub areas like nutrition, cosmetics etc.
• Continue to develop long-term strategic relationships with global companies with end-to-end data services
• Adapt to recent regulatory changes in 2019 that have made trial timelines shorter as well is make India more favourable for clinical trials
• Expertise in the outsourcing model of trials and data services. We have a sound understanding of processes and challenges around it and our team of experienced, highly qualified subject matter experts ensure smooth functioning of trials and deliverables.
• Our long-term strategic partnerships or preferred vendor status with large pharma companies
• Consistency in high quality deliverables and simple communication models have led to repeat contracts awarded by large global sponsor companies

Continuous and proactive changes being implemented by the government to improve the clinical trial industry in India. This will go a long way in rebuilding trust to conduct trials in India. The ease in submission of trials and approval processes continue to bring India at par with global standards.

What will the next five years bring for the India CRO industry? Where do you see the industry heading?
The next five years will bring:

• Increased digitalisation of vital processes
• India as a destination for trials: large database, diverse demographics, patient pool and variety of diseases, patient pool, English speaking population and investigators, sizeable medical faculty trained in western world, medical treatment at par with western world
• Large influx of trials from global MNCs who have started offshoring back into India as the country is heading towards regulation and governance that is at par with global standards (GCP guidelines)
• FMCG sector expansion which would lead to more clinical trials needed to be conducted
• Growth in nutrition sector and health claims related to consumer products
• Trials for FDC in category B&D that could require more information that can only be retrieved through trials – several large companies have several products that come under these two categories
• AYUSH guidelines for testing of Ayurveda products to ensure safety and efficacy of use. They are coming under stringent regulation.

All these would lead to the outsourcing of large chunks of work to move focus back to R&D and generate a lot of opportunities for the CRO sector.

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