In conversation with Akshay Daftary, Director, SIRO Clinpharm

What is the revival growth story of SIRO Clinpharm?

SIRO is the first clinical research organisation established in India. Since its inceptionin1996, it has played a crucial role in developing the sector with more than 250 clinical trials across the medical devices, pharmaceutical and FMCG companies. It has strict quality adherence standards achieved with the help of experienced professionals in the core team and strong SOPs. The clinical research industry experienced a downturn in 2013-14 when new regulatory guidelines affected the Indian CRO space. These strict regulations resulted in large global players exiting the space which reduced the number of clinical trials in India.

SIRO felt the heat in the changing dynamics of the industry as we too were dependent on successful complex studies from international pharma companies. What worked for us for that before this downturn arrived, we had already expanded horizons and ventured into the medial writing vertical to ensure a stable and holistic growthfor the company. This service helped during the period when the clinical research industry was experiencing a business dip. The market shifted again in recently when the new Drugs and Clinical Trial Rules of 2019, created a much awaited and needed positive evolution for the industry. The investor sentiment experienced an optimistic swing which led them back to India for their global clinical trials. The market landscape for the clinical research industry saw significant growth post the aforementioned reforms of 2019.

It was in 2018 that SIRO reworked its core business mission of Helping Lifesavers Save Lives. This brand refreshment and reestablishment of business has helped us stay on the forefront of our constantly evolving industry. Our expansion in to the medical writing space is an opportunity we seized during the industry downturn which propelled our successful survival when the industry experienced a slump. SIRO has been perseverant; we have experienced survival, not revival. Steady perseverance helped us maintain a sturdy position as a clinical organisation to reckon with in the Indian clinical research space. We have been working in expanding and honing our Indian team with a keen eye on establishing presence in the United States of America in the medical writing and biometrics space. With the leadership of Dr Gautam Daftary SIRO has been more focused with easy decision making and disposal of adequate capital. SIRO has the necessary ingredients to feed its hunger for growth into newer geographies, sector and services. A thriving and enterprising second generation with new ideas of business and modern techniques of operations too is a promising and dependable factor for SIRO.

Importance of Clinical research in today’s time and the sector’s evolution, comments?

Clinical research is theenginethat drives the world of drug development. Clinical research is resource intensive endeavour in terms of money and time for a new drug trial and launch. It is not associated with the development of new drugs only due to it being a profitable avenue but the fact that it blends beautifully into almost every area of life. This is what really affects the market size of clinical trials, not its mere importance in the development of new drugs. We at SIRO understand the importance time and money have for producers of new drugs and how saving on these resources could be crucial and beneficial to them. Hence, SIRO operates with the objective of innovation catering to minimising time and money in a new launch. For this we have attempted to bring in intrinsic efficiency in each process of the practice. We have seen a great improvement in making our downstream activities more time effective and resourceful.

Talking about this with respect to the pandemic, we are facing at hand the importance of clinical research and studies should be emphasised heavily. As the race for the vaccine, a possible cure to the deadly virus has united all allied industries, pharmaceuticals, and healthcare, clinical research organisation and government bodies to play a coordinated effort in rolling out a successful vaccine for prevention. As frontline workers are relentlessly doing their jobs there is a need for research to continue in developing lifesaving drugs, treatment, and therapies which most industries are attempting. Keeping this in mind and the trials that are necessitated SIRO has placed certain continuity interventions for the steady maintenance of work processes. We have initiated remote monitoring of sites to ensure deadlines adherence in the virtual new normal workplace. Clinical research has continued its quest despite the pandemic. The development of new drugs for rare diseases has also got an impetus with clinical research significantly contributing to its advancement. . In addition to the new drugs, clinical research plays an important role in bringing generics; difficult generics follow on biologics to the market. In times of rising healthcare costs, one cannot ignore the role of generics. Clinical outcome in the above category of products is vital to ensure the quality of the generics, an assurance that the drugs will behave in the same manner as the reference drug. SIRO caters to the requirement of difficult generics and follows on biologics and to ensure that it can meet all client requirements it has put in place with a strategic alliance with the help of Azidus.

While talking about clinical research one also needs to be sensitive to the role played by the medical devices industry to the market. With the recent changes in Indian regulations, some devices need to be tested clinically to ensure safety and efficacy. SIRO has contributed with several complex studies to the segment of medical devices. We are pacing ourselves to deliver and support our industry in India within the purview of Indian regulations.

The Consumer health industry has been gaining traction with the paradigm shift towards consumer conscious behaviour. In the new post-pandemic world numerous consumer health companies have been lignin up for conducting trials of much needed immunity boosting health products. The intense scrutiny of advertising claims through increased statutory oversight and regulations are prompting companies to ensure clinical research through trials. This is the best and sure-shot way to communicate with the consumers based on scientific testing and trials. We are helping consumer companies with tailor-made solutions for their products. We strongly feel the curative landscape is changing and clinical research will steadily include AYUSH therapies within its scope of work. The government has been very supportive on this firm like SIRO are ready to support.

How is the company’s expansion and growth story and strategy?

At SIRO, we are firm believers of the additive impact of several small and well thought of initiatives. We have already laidout the core focus areas, what we call as 5 pillars of siro and shared our vision with all employees of the organization through virtual meeting labelled ‘SIRO Vision Series where the company vision was labelled and bucketed into 5 initiatives. An inspiration for this change in perspective is very well conveyed in Jim Collins book, ‘Good to Great’, where he explicitly states “Greatness is not a function of circumstance. Greatness, it turns out, is largely a matter of conscious choice.” This inspired us to believe that the future lay in our hands and we would need to confront the brutal facts to ensure future growth. The core aim of these initiatives was to build on SIRO core competencies in the end to end clinical service provider space by leveraging innovative technologies, redefining internal processes, building stronger employee engagement, and expanding in alternative geographies. We have seen a stark shift in industry towards automation of documents and artificial intelligence which led us to take a conscious choice of adapting some of our processes as well. We have created an Innovation Hub internally which is focussed on leveraging technologies to help us achieve our innate belief of Helping lifesavers save lives.

SIRO is constantly looking for opportunities to grow and expand. We are looking at growing with a three-pronged approach in the near future. These include, expanding in alternative geographies, adding more to service offerings, and automation of services. In terms of geographies, SIRO is looking to expand its operational wing to alternative geographies like the USA and South East Asia for their ancillary service offerings like Clinical Data Management and Biostatistics/Programming. We would be looking to do this through alliances/acquisitions based on compatibility of our current offerings. With our additional service offerings SIRO took the time in COVID-19 to create a new and more targeted solutions approach for the FMCG companies by amending their SOPs and strategy to cater to different requirements of these companies. We would be looking to enter alternative segments with a similar focused and customized approach. To keep up with emerging trends, our organization would also look automate various offerings and documents using AI to ensure the benefits extend to our clients

In Covid times, how has the sector panned out and proved its importance?

During the COVID-19 pandemic, there was limited access to healthcare facilities and state wise regulations in India are an impediment. The pandemic, which has paralysed several industries, has also had a significant impact on the clinical research industry. The primary roadblocks our industry faced were in the areas of opening new sites for trials and the continuation of existing trials in the light of the lockdown restrictions. Keeping this is mind clinical trials had stopped at various sites. Recruitment of subjects for conducting trials in a timely manner was another challenge. Sponsor companies were affected with the delay in the timelines significantly impacting the planned clinical pipelines. COVID has impacted the short-term and long-term timelines.

SIRO decided to initiate remote monitoring which enabled studies and trials to continue with remote surveillance. In this light, we have taken many precautions while sending SIRO employees to our offices or sites as and when needed. Technology has been a great enabler in transitioning many undertakings as a virtual activity. Technology has been available for long but nowith its adaptation and penetration into specific aspects of business process has been greatly facilitated by challenging times like the COVID-19. Potentially long lasting impact shall be the continued use of technology to bring about a paradigm shift in how we do clinical trials - virtual clinical trials with real time monitoring through wearables connected to the cloud.At SIRO, We are supporting three types of industry during this period related to COVID-19:

In the Pharmaceutical industry we are working on a few trials where drugs are being tested in a specific set of COVID patients. We have been a part of preliminary deliberations for shepherding full or some parts of the Phase III for an Indian company and for an international company.

In the Medical Device industry we are assistinga medical device company for their claim substantiations concerning the virucidal activity of the COVID virus in the environment and aiding them with their global regulatory and marketing stratagem.

For the FMCG industry SIRO has acknowledged numerous requirements in the last few months to support FMCG companies to validate their assertions for products that they have made associated with the treatment and cure of the on-going pandemic. The Gazette Notification for advertising claims has clearly stated the significance for clinical validation and scientific backing of claims. We are working with consumer health (FMCG) companies in their claim substantiation for claims regarding immunity enhancements in their goods and also in negotiations with the consumer health and Ayurvedic companies for clinically trying the product on immunity factors that it claims for success.

What kind of growth are we envisaging for the clinical sector in the next couple of years in India?

India is developing as a clinical research hub in the international arena which earlier was employed as a fertile ground for a comparative cost advantage for superb quality with a cost-effective and affordable expertise. The Indian story has moved from niche to large corporate CROs, a destination for end-to-end market services in the industry propelled by a diverse and thriving population and supportive regulations. The global Contract Research Organization (CRO) market size was estimated at US$ 34.5 billion in 2018 and is projected to reach US$ 55.3 billion by 2024, growing at a CAGR of 8.2% during 2019 to 2024.Indian clinical trials market size is projected to reach US$ 3.15 billion by 2025. It is projected to record a CAGR of 8.7% over the projection period. This prospect has led to the burgeoning of clinical research organizations as business remains to be subcontracted to India from more developed nations Europe and the USA. According to our judgement and projections of the clinical research industry in India we feel that the consumer health sector is going to play an essential role in the growth of the industry. The claim substantiation demand has been witnessing a steep incline from the consumer health sector. Along with the regulatory aspects pertaining to claims and advertisements by the food industry of their food products and the increased sensitivity of the consumer regarding the consumption of food off market shelves, we expect more CROs to mushroom. Competition is going to tighten the market share for CROs but the overall industry growth is expected to be stellar.

Looking at it purely as a professional sector, it is creating more jobs, attracting more students for a future career and interesting more students to pursue higher studies and research in this field. With the easing of regulatory guidelines more international players are plying into India for their studies and research. At SIRO we have amped up our game, especially during the COVID times when consumer product companies are queuing up to substantiate their immunity bosting claims. We are delivering with prompt professional series and helping them design tailor-made clinical trials to prove the efficacy of the products keeping heath safety as a priority.

What is the ultimate vision?

When the company was conceptualised and started in 1996, the Chairman had a vision for SIRO to be a leading drug development solutions provider by delivering compelling value propositions to the global healthcare industry. The passion for science and learning is what drives this company forward, and enables us to attract some of the best talent in the industry to join us in this journey. The recently incorporated mission of Helping Lifesavers Save Lives, we believe, is core to our DNA and our ambitious goal.

With reference again to Jim Collins book, Good to Great, SIRO hopes that with a mix of the ‘right people on the bus’, dynamic leadership and passionate employees, we could be on the path to becoming a great company - “In each of these dramatic, remarkable, good to great corporate transformations, we found the same thing: There was no miracle moment. Instead, a down to earth, pragmatic, committed to excellence process, a framework kept each company, its leaders, and its people on track for the long haul.” We are committed to taking the company to the next level.

At SIRO, it is a firm belief that CROs play a vital role in the drug development process, and we yearn to continue to support other sponsor companies to bring their novel drugs to market. We would continually bring innovative scientifically backed solutions to our clients while leveraging the latest technologies to enhance quality of the deliverables. The lofty ambition is to create a path to increase our global reach through geographic expansion in Southeast Asia and the US through acquisitions and strategic complementary alliances.

How did the idea germinate in your mind to start this company?

This company was conceptualised by the Chairman, Dr Gautam Daftary who has been involved in the pharma sector for the last 40 years and started several companies in niche areas. Prior to starting SIRO, he realised there was a large gap in the research sector in India with no prominent players providing this expertise. Learning as he went, he began expanding his team, conducting pilot studies and creating SOPs. Over the years, as the sector evolved, he set his ambitions on establishing SIRO as an end to end provider for full scope clinical studies. Thus, he mandated the starting of data management, medical writing, medical services, biostatistics and programming teams over years. Since then, we have conducted over 250+, around 300 studies in India and other geographies, with over 15+ therapeutic areas and around 50+ indications.

How old is the company and in terms of expansion, how far do you think will it go?

We have been fortunate to work with some of the large global Pharmaceutical companies on complex studies and molecules like other industries and companies, we too had our own share of hurdles to overcome in operations during the pandemic. Taking these challenges in our stride, we decided to use this time to chart our future outlook and build our portfolio and geographic reach. In this regard, we entered into a strategic alliance with AZIDUS to widen our service offerings with healthy volunteer BA/BE studies

AZIDUS is a CROfor the conduction of BA/BE studies in healthy volunteers and has operations in India (Chennai, Brazil and USA thoroughly wholly owned subsidiaries or affiliate companies. Like SIRO, Azidus has an excellent track record for conducting challenging BA/ BE studies with complex design and bioanalytical requirements for US / EMA and other regulatory authorities.

With SIRO’s focus on patient studies and Azidus focus on healthy volunteer studies, this alliance will help SIRO expand its product offering to its clients. With similar value systems around ethics, quality, integrity, and compliance, with this added capability, we look forward to serving the customer needs for any studies in healthy volunteers. Both the partners have been having very interesting discussions with their customers and if the early signs are an indication of the times to come, we see a very interesting partnership ahead.

In fact this has propelled us to explore more such alliances with complimentary service providers which are the key to drug development activities.

You provide various services, which do you consider is your best forte?

We provide full scope as well as standalone services, and currently the entire operational team works from our offices in India. Being one of the few full scope providers in India, it gives comfort to sponsor companies knowing that all tasks in a clinical trial can be performed by one company. This leads to an increased inter-departmental collaboration and enriches the quality of deliverables. Standalone services are seen as beneficial by our customers, as it provides them with a focused approach on tasks they cannot maintain in-house. We have one of the largest teams for medical writing in India, with over 100 medically qualified writers across safety writing, regulatory medical writing and publications. The Biometric team (Biostats, Programming and Data Management) can also be beneficial in providing standalone services for CDISC projects across various softwares. We have experience across business models, including Full Time Equivalent (FTE), Full Service Provider (FSP) as well as individual project outsourcing models.

Additionally, SIRO has a clinical trial supplies facility that is GMP-compliant-. This new facility was inaugurated in 2019, and is strategically located in Thane, Mumbai. It is approximately 23 km (14 miles) from the airport, and is well connected to all corners of the country. It has three storage compartments maintaining three different temperature zones of frozen, cold and ambient storing drugs, pharmaceutical products, vaccines, nutrition supplements and medical devices

Lastly, what message would you like to give to our readers?

We would like to spread knowledge about the importance of clinical research in our everyday lives. SIRO will continue to work behind the scenes, tirelessly, to assist pharma companies in their drug development endeavours. Our passion for helping lifesavers save lives will be evident from the personalized approach that we offer to each of our clients. The end goal is to ensure that the products that eventually reach consumers are safe to use.