“More precision, less risk, faster drug development” ISAB CEO Lena Heffler on how clinical validation will power PreciseInhale

  • 28 May, 2019
  • 08:31

(Stockholm, 28 May, 2019) ISAB is making a major investment in validating its flagship aerosol R&D system for clinical use. Why is it such a vital step strategically? And what will validated IVIVC capabilities from the lab to the clinic mean for PreciseInhale, and the company? CEO Lena Heffler explains.

“My experience from 20 years in the business is that the closer you get to the patient, the more interested the market becomes in your product”, says ISAB CEO Lena Heffler, “so validating PreciseInhale for clinical use expands our relevance, making our precision data essential to a whole new stage of the development chain, growing our prospective market share and customers. PreciseInhale makes it possible to generate in vitro and in vivo data for correlation in the same tool, bridging the gap between preclinical and clinical results. We believe that could hugely benefit novel and generic inhaled drug developers, but also Contract Research Organizations. The feedback we’ve been getting from customers on our current CRO research makes us positive about the prospects of validating PreciseInhale for clinical use.”

MAKING IVIVC A REALITY

IVIVC, or In Vitro In Vivo Correlation, has been of great interest to the inhalation industry for several years. Simply put, IVIVC is being able to accurately predict in the preclinical stage how Candidate Drugs will perform in the lungs in later clinical trials.

“IVIVC would mean shorter trials, more cost-effective trials and lower risk of clinical failure” says Heffler. “With the average cost of developing a new drug at 2.6 BUSD (1), only 12% of drugs making it to the clinical phase (2), and the lung being so notoriously complex—we realize that validated, reliable IVIVC data from preclinical all the way through to First Man In tests could be of huge value. We’re looking forward to offering a tool that could help generate such data for inhaled pharma developers. Our preclinical IVIVC capabilities, with modules like our in vitro simulated lung system DissolvIt are well-documented. That kind of predictive precision end-to-end would enable companies to save literally millions of Euros in development, by weeding out poor performers early on, and investing confidently in stronger substances earlier with accurate, reliable data.”

It’s estimated that the clinical validation study will take approx. 15 months, finishing by the end of 2020, the goal being both technical and regulatory validation of PreciseInhale for use in clinical studies. Because the Study will be financed entirely by ISAB all data from the Study will belong to ISAB and can be shared.

Inhalation research, Heffler points out, has never been more urgent, and for ISAB to be taking such an important strategic step on the Anniversary of her first year as CEO is rewarding: “I couldn’t wish for a more positive end to my first year than taking this crucial step for the company. With new airborne particulates and pollutants; COPD, asthma and respiratory illness on the rise, and air quality a clear global priority, the need for improved precision in inhalation science has never been greater—and neither has the opportunity. I’m delighted we’re taking this new strategic step and offering our fellow scientists and researchers these exciting new capabilities.”

(1)  https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

(2)  https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

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