Industry leader celebrated for his role in evolving the new-drug development and approval process
Pinnacle 21, a technology consultancy that specializes in optimizing the new-drug development and approval process, announced today that its president and CEO, Max Kanevsky, has been named to the PharmaVOICE 100: an annual list of the 100 most innovative and influential people in the life-sciences industry.
“When we first started, back in 2008, our pie-in-the-sky hope was to flip the industry on its head,” said Mr. Kanevsky. “We still have a long way to go, I think. But maybe this award means that we’re on our way. I’m grateful and humbled to be selected.”
The Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization, was formed in 1997 to collaborate on the development of global standards that could be leveraged to streamline medical research and drug review. This was in reaction to the FDA’s concern that a lack of standard clinical data had led to great inconsistencies from one submission to the next, which led to procedural time drains. The goal was to achieve a standard for clinical data that would be used throughout the life-sciences industry. But, once CDISC began to define these standards, neither they nor the FDA had the means of helping the industry implement them.
But then, in 2008, Mr. Kanevsky created an open source, freely available toolkit that enabled the implementation of CDISC standards, which revolutionized the way the life-sciences industry exchanges clinical data. This was done through a project called OpenCDISC, which, for years, offered technologies and education to help statistical programmers and data managers with the implementation process. In 2011, Max and his partners founded Pinnacle 21 as a commercial extension of OpenCDISC, to generate the resources necessary to keep pace with an industry that was struggling to adapt to ongoing change.
In 2014, the FDA mandated that, starting in December 2016, all new drug applications must be submitted electronically and in accordance with CDISC standards. Some life-sciences companies are already CDISC compliant; but most are far away. The clock is now ticking, and the risks couldn’t be higher. The FDA is threatening to refuse to file (RTF) submissions that don’t meet the new standard. But, Mr. Kanevsky and his colleagues at Pinnacle 21 believe there is time enough.
“It’s mostly a matter of adjusting your mind-set,” Mr. Kanevsky said. “It’s natural to resist change, of course. But now, the industry has no choice. The FDA has thrown down the gauntlet. But, if you embrace the change, if you’re willing to adjust your process, you’ll see that it’s a good thing. All the inefficiencies will fall away, and important new drugs will get approval faster. It’s a matter of evolution now. Those who adapt are going to survive and thrive.”
The PharmaVoice 100 is a special feature that’s compiled once yearly, and is published in the July/August edition of PharmaVOICE magazine. According to the publisher, the professionals selected for the PharmaVOICE 100 Class of 2015 are those who “set industry trends, [because] their passion and conviction create opportunities out of obstacles. They are innovative and have the ability to think outside-the-box. They develop breakthrough strategies, products, and services. They are known for pioneering new paths and lifting their companies to new heights.”
To read the full list of 2015 PharmaVOICE 100 profiles, read the July/August 2015 edition of PharmaVOICE.
About Pinnacle 21
Pinnacle 21 (pinnacle21.net) is life-sciences technology consultancy dedicated to one thing: maximizing the speed and efficiency of the new-drug development and submission process. With singular technologies and unmatched expertise with CDISC and FDA compliance, clinical data quality, and FDA submission readiness, we help new drugs earn FDA approval faster extending their Revenue Earning Period (REP) and maximizing their profitability. In 2008, our founders created OpenCDISC Validator, the most widely used open-source software in the biopharmaceutical industry; and, since 2011, we’ve supported the FDA with enterprise software that screens electronic submission data for standards compliance and data quality.