’We consider external experts engagement and clinical research as a major business area to grow’
Six-year-old D2L Pharma Research Solutions, engaged in drug development process, had started its business with an aim to explore business opportunities in clinical research and pharma business intelligence segment. Within a short span of time, the company has established its client base in the US, the UK and Europe. Dr K Sashi Kiran, Co-Founder and Managing Director, D2L Pharma Research Solutions reveals its success and business agenda with Usha Sharma
D2L Pharma Research Solutions uses the term ‘Discovery to Launch’. Tell us more about it.
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| Dr K Sashi Kiran |
We started with a vision to serve the value chain of drug development process from ‘Discovery to Launch’. A journey that began in 2007 and we have been striding foward ever since. D2L was not an accidental venture; it was a venture of common interest and a defined focus. And three of us i.e. Dr Sashi Kiran, Co-founder and Managing Director, Deepak H, Co-founder and CEO, and Shekhar Gupta, Co-founder and COO, with complementary expertise and business interest came together to start D2L Pharma. Today it is a fast growing integrated service provider serving the needs of the global pharma industry. D2L started its business operations with an aim to explore the opportunities that existed in the business of clinical research and pharma business intelligence.
We, like many modern Indian ventures, have leveraged the economic opportunities of an Indian start-up. At D2L, we have expertise with professional background and hands on working experience in the management team, which is driving the organisation.
Our management team consists of experts from clinical research organisations (CRO), pharma companies and marketing areas and we consider this as an optimum complimentary formula of success for our business. We have our business operations in those markets which gives us better growth from the day of our company’s inception. Since 2007 till date, we have grown from a team of three people to 100+ people.
What are the services offered by the company?
We are a service-oriented company operating in five different business lines viz; clinical research, external experts engagement, market research and analytics, business intelligence and consulting and technology. Under each business lines, we offer a wide range of services.
Out of the five segments, which ones have the most potential and why?
We consider external experts’ engagement and clinical research as a major business area to grow because they have high potential for growth and have better future prospects for D2L. We feel that we are one of the very few companies in India who executes high quality external experts or KOL Research for global markets. Since the last five years we have been working in this domain with several clients from the US, Europe and the UK and this division has become a significant one in terms of revenue. D2L maintains over a million records of physician profiles and is also planning to come up with potential products in this area to cater to the global customers. D2L also works with several big key opinion leader (KOL) firms and medcom agencies of the Western world as a preferred outsourcing partner to leverage the advantages of cost, quality and timelines. Our clinical research is one of the fastest growing services in India. India, being one of the preferred destinations for clinical trials due to multiple reasons from cost, talent, patient pool, disease types, treatment naïve patients, good hospitals, etc, has a tremendous potential in the coming years. Though there has been a dip owing to a variety of reasons, we are convinced that there is good potential. However, it should be noted that for clinical research to move on the fast track, the regulatory scenario has to be streamlined and uncertainty should be addressed. D2L expects the industry to pick up over the next few months. The regulatory scenario in the country is also now getting streamlined after a year long dull period and D2L, with a six-year plus service record, is gearing up to leverage the opportunities in the coming years. D2L also has a good pipeline of projects and serves as an exclusive partner of many pharma/ biotech companies in India.
Why is D2L Pharma’s services a preferred choice for pharma and biotech companies?
D2L works with several companies as a preferred outsourcing partner to leverage the advantages it offers like expertise, innovation in work, cost, quality and timelines. These are the key factors which makes D2L different, and is on the growth path irrespective of fierce competition.
Tell us about the services you offer in the clinical research arena?
We are one of the leading site management organisations in India and provide full support services to the pharma/herbal/ayurvedic/neutraceuticals/FMCG sectors in their product development through clinical studies and study of marketing claims. We also offer services in project management, staffing and recruitment services, site management and solutions, clinical site preparation, trial agreement assistance, site training and staffing, essential documents management, ethical submission coordination, patients recruitment coordination, patients follow-up and study compliance, data compilation and query resolutions, site inventory management and study monitoring as well as site close-out operations.
What parameters do you follow for complying with data safety?
Data safety is of prime importance in this industry. We take all the mandatory and essential steps to comply with safety requirements like site preparation for regulatory audits, internal monitoring at regular intervals to maintain quality data, frequent trainings of site personnel, implementation of site specific SOPs, prevent major findings during an audit, mandate audit follow up actions are implemented within the stipulated timelines, ensure that major findings, if any, are not repeated in future. High level of confidentiality is maintained for the clinical trial data generated, apart from restricted access to clinical trial information, mechanisms for controlled access to our premises, rooms containing clinical trial information are equipped with disaster management tools, server with data backup facilities, individual user name and passwords are also provided. Exchange of study specific information between different teams is not encouraged.
Tell us about your domestic and international clients?
Till now we have worked with more than 75 clients in the last six years, with many of them where D2L have long-term service-level agreements (SLAs). The majority of our clients are from the US, the UK, Europe and many Indian clients for our clinical and market research divisions.
Can you share some of your clients’ success case stories?
We are successful only when our clients are happy and they also achieve the end results. There have been many such instances in the last six years. One of our clients acquired a company for $2 billion, based on the market forecast and opportunity analysis done by us. Similarly, one of the clients got a vaccine pre-qualified by WHO for global supplies. It always makes us happy when we see that our clients are able to bank on us for their success.
Do you think your services are cost effective and how?
Yes, our services are cost effective when we compare with the cost of such services in the Western world. We are also cost effective than many of our global competitors.
How many players are there in this sphere presently?
We have a very good competition in India for our clinical research services though we are one of the leaders in site management services. There are many companies in the market offering similar services. However, we feel that since the clinical research industry is becoming more and more stringent and streamlined, the smaller companies will fade out and companies with experience and capabilities which follow “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) guidelines and Drug Controller General of India (DCGI) regulations in India will endure. In the other business lines, there are very few companies (four to five) in India who provide such offshoring services. D2L is a very niche player in these segments.
What is your opinion on the role played by market research and analytics in the pharma industry?
In today’s fast changing competitive world, pharma companies have realised the importance of understanding consumer insights, the prescribers’ perception to their brands, sales of their own and competitors’ products, sales and marketing, forecasting, marketing mix, etc. This is where market research along with high-end analytics play a huge role. The big-data and analytics opportunity is exciting in complex business settings, experiencing an explosion in the types and volumes of available data.
Which are the complex and important areas when it comes to market research analysis?
Data driven analysis provides meaningful insights but the challenge here is to obtain consistent and reliable data. Once the data is available, the next level of challenge is to manage and integrate them seamlessly across the value chain (from discovery to real world use after regulatory approval) so as to enable companies to leverage the same for their business needs. In our view, end-to-end data integration – be it internal or external, proprietary or publicly available data – is crucial. Typically, companies deploy a two-step approach – first, they prioritise the specific data types to address (usually clinical data) and secondly create additional data warehousing capabilities as needed. The strategy is to first analyse the most important data and leverage it for business decisions within a short time span. In many cases this process could take a year and calls for significant infrastructure and procedural changes. Post this stage, firms develop an approach for the next level and prioritise data including scenario analysis, ownership, as well as expected costs and timelines.
How many projects have been accomplished so far and for which therapeutic areas?
In the clinical research segment, we have finished more than 50 trials in India across various therapeutic areas. The market research and analytics division has conducted multiple market research surveys across all specialities, targeting all kinds of healthcare professionals or patients, requisite for an identified objective. We have conducted over 75 different kinds of market research projects across different therapeutic areas using several platforms including web-based applications. D2L has a panel of over 20,000 physicians in India who are easily accessible for all our studies. One of our strongest areas is external experts engagement services. D2L has successfully completed over 115 global KOL projects and over 25 global nominator surveys. We have researched and ranked more than 50,000 experts across several therapeutic areas and disease states.
How many projects do you have in the pipeline?
We have quite a good number of projects lined up in the clinical research for this and the next financial year. For other segments it is more of long-term service level agreements (SLAs) with full time engagement (FTE) models and hourly models. It is difficult to define the pipelines as usually they come quickly and have to be delivered very quickly as well. Overall, we see very good business lined up this year and we expect to meet our revenue targets.
How many people are associated with the company and how skilled are they?
We recently shifted to a new state-of-the-art facility near ITPB Whitefield which can accommodate 150+ people. Our people are from diverse backgrounds like life sciences, clinical research, biotech engineering, management, pharmacy, statistical, medical, and IT. Our people are experienced in handling global clients in terms of understanding their needs to execution and delivery of the projects. The company imparts regular training to all employees in various areas to enhance their project management and soft skills.
What are your corporate plans?
At this point our plans are very simple but at the same time very aggressive to expand our external experts engagement, market research and analytics, business intelligence and consulting services to the US and the UK markets. We have plans to launch few product lines in this space to add new growth avenues. We are constantly evaluating new service lines and products. As said earlier, the clinical research industry grew slowly during the last one year, however, it is now reviving and we hope that the business will pick up soon. The company aims to touch the $10 million mark by 2016.
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