By Pranbihanga Borpuzari
Nidhi Saxena's background is probably unique among the current crop of young Indian entrepreneurs. Saxena is a trained pilot, has an MBA from the Mumbai-based S.P. Jain Institute of Management and Research and has spent a considerable part of her working life in the IT-BPO industry.
It was by understanding the nuances of how a BPO firm operates that Saxena slowly realized and then scoped out the life sciences space. "Within life sciences, I thought clinical research was an interesting space to look at, given that I came from an IT-BPO background where we handled patient diary management, and clinical data management," says Nidhi Saxena, Founder, President, and CEO at Karmic Lifesciences, a Clinical Research Organization (CRO).
Past perfect
Saxena, 39, says she had an independent streak for as long as she could remember and that the corporate gig was stifling, thus pushing her to look for an exit. Even as she retained the job, Saxena went on to register a company-Karmic Lifesciences.
The reason for starting while working was simple; she needed to save money until she could commit herself to the project. Finding the time even as she worked through the day‚ Saxena started talking to a number of doctors and people she knew to get things moving. The hard hours paid off, for in 2008 she bagged her first deal from pharma major Novartis. "I told them I had a startup and was ready to quit my job if I got the deal. Also, that I had three investors who were willing to put money in the company," she says.
Till 2008, Saxena says, a lot of hard work went into starting the company. While having investors on board and getting a good deal were a strong base to start up with, there was a lot of de-risking and planning involved before jumping in to become an entrepreneur. "The deal was a low budget Phase IV study which included back-office data management. We developed a system in 35 days and presented it to Novartis. They liked the system and things were on course," says Saxena. Today, the improved version of the same system is held under a global patent by Karmic.
The Karmic way
Karmic's value proposition is to provide end-to-end services. When a pharma company has a drug and wants to take it through the new drug approval process and market it, Karmic will create the scientific design to prove that the drug has primary efficacies.
The firm would then create the dossier based on what data has been compiled-which includes animal testing data, manufacturing data‚ safety data‚ data from previous trials, among others-and then submit it to regulatory authorities. "It takes about three-four months to get initial approvals. Once the approval is received, Karmic will provide medical staff with necessary training to administer medicines and carry out the test or in certain cases‚ operate the device," she says.
There are several phases to a drug test. As clinical tests are conducted and data is compiled, Karmic claims it ensures that no data is fudged and that protocols are followed when it comes to patient's rights and information to government and ethics committees. This data is analyzed, converted into reports and submitted to the US Food and Drug Administration (USFDA) for approval in an electronic format.
"Timelines, rapid patient recruitment, ethical conduct, quality of data, compliance are all necessary. There are also audits by USFDA where one has to prove everything. The role of a CRO is extremely critical, responsible and fiduciary in nature," says Saxena.
Tech edge
According to Saxena, what sets Karmic apart from others in the CRO space is the technology that she has deployed. "Our system has project management and electronic data capture technology. The beauty of the system is that when data is captured, a computer code enables a company to produce reports according to the prescribed formats of regulatory agencies," she says. This is in contrast to other existing systems available world over‚ where "data which is compiled after research has to be physically converted into prescribed forms."
Saxena says the clinical IT solutions market alone is worth about $7 billion-$8 billion and with this product, the company is looking to approach the market aggressively. The company is also looking at innovative technologies for the iPad or PDA-based eCRFs (Electronic Case Report Forms), ePROs (Electronic Patient Reported Outcomes) with linguistic validation for Indian languages, retinal scans for patient identity establishment, and nano cards for subject drug compliance, amongst others.
The key aspect here, says Saxena, is that they are looking at technologies which are disruptive in nature and could change the way clinical trials are currently run.
Eye on future
According to Saxena, the clinical trials space in India is growing at a rate of 20 percent compared to a global rate of 30 percent. The company achieved growth of 250 percent last year to touch Rs. 15 crore in revenues and in FY14, it plans to touch Rs. 56 crore to Rs. 60 crore. "We are looking at organic and inorganic growth to become a Rs. 150 crore company by 2015," says Saxena.
A senior official of a leading Korean pharma company, which is a client of Karmic, speaking on the condition of anonymity, says the Karmic team delivered results with great speed, and handed out proper responses. "Moreover, they have good experience in the industry and profound knowledge of the subject. Nidhi is a proactive CEO," he says. The official adds that reliability, honesty and a strong knowledge of the industry are some of the advantages that Karmic enjoys over others in the market-important are the first two (reliability and honesty), given the highly competitive and secretive ways of drug research.
Anil Joshi of Mumbai Angels says when Saxena approached them in 2009, they did not have the bandwidth to understand what she was offering. "When we got involved with Karmic on a larger scale, we started to understand the sector. We made an investment of about Rs. 3 crore [$600,000] in 2010," he says.
According to Joshi, the size of the market for Karmic to operate in is quite large, but regulatory and statutory hurdles continue to be a problem. "The government needs to come out with the correct policies to help the sector," he says. Sanjiv Maheshwari, General Partner and CFO at Basil Growth Corporation, says Karmic has grown at almost 100 percent per annum. "From a small company, they now have a huge visibility in terms of pipeline." Commenting on the external environment, Maheshwari adds, "Currently, it is not very conducive. At the moment, there are a lot of regulatory hurdles in the country and this has created a scare with regard to conducting clinical trials in India. However, the company has also looked at operations beyond India‚ so that business is not affected."
Indeed, regulatory failures have raised serious questions about the sector. There have been serious lapses and corruption in the functioning of ethical committees that are required by law for each trial by the Central Drug Standard Control Organization. The issue of patient rights and patient compensation is also under a lot of discussion. "Growth has slipped due to temporary bottlenecks. We are optimistic about the future. With the Supreme Court seized of the matter, they are asking the right questions and we hope to get a speedy redressal to all problems," says Saxena.
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