Advinus Therapeutics CEO Rashmi Barbhaiya On Disruptive Innovation And India's R&D Edge: An Interview With PharmAsia News (Part 1 of 2)

Advinus Therapeutics CEO Rashmi Barbhaiya is one of the most visible figures in today's pharmaceutical research in India. Beyond a deep knowledge of life sciences, he is famous for the daring - if not risky - moves that he made nine years ago, when he shifted from his top job in U.S.-based Bristol-Myers Squibb to head Ranbaxy's R&D team, and then spearheaded the research ambitions of India's biggest corporate conglomerate - The Tata group.

Known for his thought-provoking views on transforming Indian pharmaceutical research, Barbhaiya told PharmAsia News' India bureau in an exclusive interview that multinational companies should shed conventional methods when teaming up with Indian companies for true innovation to thrive. This is part one of a two-part interview; look for part two in an upcoming issue of PharmAsia News.

PharmAsia News: India 's Tata group exited the pharmaceutical sector more than a decade ago and now has come back with Advinus Therapeutics - mainly to work on new drug discovery and to collaborate with multinational companies. How is joint drug discovery with multinational companies changing the game in India?

Rashmi Barbhaiya: As far as drug discovery is concerned, the primary motivation of most established companies to come to India centers around cost arbitrage. While many claim that this is not the case, the nature and scope of existing relationships seem to be designed to leverage India's cost advantage and maybe talent in some exceptional cases. Even the so-called risk/reward sharing alliances are structured primarily to leverage the cost advantage. While every industry needs to explore approaches to attain greater productivity, the singular focus on saving costs may be depriving them of many other opportunities Indian companies can offer.

PharmAsia News: Does that mean that Big Pharma does not really see India as a true partner for innovation?

Barbhaiya: Innovation by definition requires risk taking. Any large organization with deep history and multiple layers of bureaucracy can be averse to required levels of risk taking. Indian pharma R&D players, on the other hand, are small, with young talent and with very limited history of past baggage or a set mindset of pursing a problem. They also have a clean slate. Large pharma have justifications and reasons to be conservative in their approaches. For Indian pharma, there is no option but to take risks for innovation.

I have yet to see an example where a company from U.S., Europe or Japan has joined hands with an Indian company with the sole objective of doing drug discovery under a different set of rules. One cannot achieve different results with the same way of doing things. The issue of pharma productivity requires disruptive innovation and new ways of addressing a problem. Take for example the disruptive innovation behind Tata's Nano car. Could Tata Motors have developed the Nano car that sells for $2,000 using GM's or Chrysler's model?

Let me also give an example of Advinus' first proprietary molecule that just finished the Phase I trial. If we had sent the preclinical profile of our glucokinase activator to a typical large pharmaceutical company, I am sure most companies would have asked for human data for any consideration [ (Also see "Advinus Bets On Novel Glucokinase, Claiming Advantages Over Peer Compounds As It Scans For Out-licensing Deal" - Scrip, 9 Sep, 2010.)]. This is because we have a compound profile that is not consistent with the drug discovery manual that most established companies follow for selection of drug candidates for development.

We also do not have multiple committees for selection of drug candidates. As a result, we challenged conventional wisdom and followed an unconventional path to select a compound that yielded data from the Phase I trial that are counterintuitive but consistent with our hypothesis.

PharmAsia News: Is the risk-averse approach that you mentioned also true for many of your partners?

Barbhaiya: By and large, most of our partners do require us to follow the path they pursue in their own laboratories for decisions. At the same time, all our partners have a healthy respect for our scientific know-how and past experience and therefore we do have freedom to design overall discovery programs and paths we intend to pursue.

PharmAsia News: How has the experience been for Advinus on the partnerships side?

Barbhaiya: For any partnerships, there are bound to be agreements and disagreements between two intelligent parties, but in balancing that, I am happy with all our major partnerships. What we are doing is state-of-the-art but if we find partners who are open to fresh thinking, I think we can do even more.

[Editor's note: Merck's Chief Strategy Officer Mervyn Turner discussed Merck's perspective on partnerships in India in an interview with (Also see "Merck's Chief Strategy Officer Mervyn Turner Talks To PharmAsia News About Partnerships And Transformational Research Models" - Scrip, 7 Dec, 2009.) .]

PharmAsia News: Most collaborative work that comes to Indian companies centers mainly on early-stage discovery like lead identification, optimization, etc. Is the value chain limited or is it that the right capabilities are not being tapped?

Barbhaiya: India comes at the early stages of discovery and up to Phase IIa clinical trials; because beyond that we need major investments and a set infrastructure. I am not aware of any Indian company which is geared for such massive undertaking.

India's largest companies are still small dots as compared to Pfizer, Merck or GSK.

Also, for all major indications, Phase III clinical trials are getting very complicated and risky. But if you pick a disease area where the number of required patients to register a drug is very small, like 200 or 300 patients, it may be possible for an Indian company to develop a new molecule through Phase III clinical trials at this time.

PharmAsia News: You have been here in India for the last eight or nine years since shifting from Bristol-Myers Squibb. How has this period been so far?

Barbhaiya: We are moving in the right directions. Past legacies need to be shed and a few important regulatory reforms are badly needed to take India to the next stages.

PharmAsia News: Sometimes the nation's regulatory body - the Drug Controller General of India - takes several months to approve a drug trial, and this is said to hamper further interest in doing research in India. How do you assess this problem?

Barbhaiya: This is not an issue that I think we need to deal with through the media. These are very sensitive issues and I agree that from the government side, the regulators have to safeguard the public, especially poor and illiterate populations, and do enough to ensure that they are not exploited and harmed. The concerns are valid. Nevertheless, there could be an opportunity for India - not just from the commercial angle but also in addressing some global health issues that the industry is trying to address.

- Vikas Dandekar ([email protected])

[Editor's Note: Rashmi Barbhaiya will be speaking at the 2nd PharmAsia Summit: Taking the Risk Out of Asia (Oct. 25-26, San Francisco). For a list of speakers and topics, click here.]