There is a need to leverage technology in a much bigger way, including ways to reform regulatory processes, to ensure that new medications reach market in a much lesser time, Biocon executive chairperson Kiran Mazumdar-Shaw said on Tuesday. Speaking at the Global Technology Summit here, Mazumdar-Shaw said that it takes years to take an idea to the market and even after that the probability of failure remains very high.
“I, for one, believe that technology has a very, very important role to play in the future of biotechnology and the way we develop products,” Mazumdar-Shaw said. She noted that it would be great to see an idea to go from laboratory to market in less than a year.
“Now, how do we do that? The way we do that is to really look at, you know, completely reforming our regulatory process,” she stated.
She also noted that the regulations currently depend a lot on iterative processes, trial and error, and of course, human subjectivity and interpretation of that data.
“Just think about how you can actually turn it on its head if you use technology. The iterative process can be made much more predictable. By just using generative AI, data analytics to really come up with algorithms that allow you a greater probability of success, a greater predictability in how you’re going to deliver on these products,” she stated.
Mazumdar-Shaw said regulators have been very slow adopters of technology in leveraging technology for product approvals.
“..tech savvy regulators are very, very crucial to what we’re trying to do. If you do not have technically skilled and technology aware regulatory reviewers, I don’t think we can really deliver on this promise of accelerated approvals,” she noted.
Citing the example of the IT sector, Mazumdar-Shaw noted that the regulations governing the segment allows one to take an idea to the market in a very short period of time.
“That’s why investors are very excited because they’re willing to back new ideas because either it works or it doesn’t work…in our sector, it takes years, you know, sometimes even 10 years to take an idea to the market… And that makes it very difficult for investors to back these new ideas in biotech,” she stated.
She further said: “I think technology can compress these timelines.”
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