By Ann Neuer   

June 22, 2015 | DrugDev, a provider of cloud-based solutions for clinical trials, has tapped Jeffrey Kasher, Ph.D., as Chairman of the Advisory Board.  Dr. Kasher has dedicated his long career to speeding the development and delivery of viable new drugs, a path on which he plans to continue as he assumes leadership of the Board.

“Patients can’t wait any longer. A five to 10 year timeline just isn’t acceptable.  Over the years, it has been frustrating to me to see incredibly smart and passionate people come into drug development, and still work like we did in the 1950s.  In having the opportunity to travel around the world to visit sites, it would hit me frequently that we spend huge amounts of time and money in discovery and development and yet, it seems that we aren’t doing anything about addressing the barriers in our archaic process,” Kasher told Clinical Informatics News.

Prior to accepting this position, Kasher spent 28 years at Eli Lilly, where he worked across the product development continuum, including COO of the development team for Zyprexa, an anti-psychotic and former blockbuster.  He wants to bring what he learned from his positions at Lilly to the DrugDev Board in its pursuit of greater efficiencies in the clinical trial process.

On an optimistic note, he sees innovative technologies, such as those offered by DrugDev, as finally starting to move the needle, especially when these efforts are coupled with greater engagement with patients as development partners.  “We need to bring patients into the discussion for design of better protocols,” he says. 

Kasher is referring to the ongoing discussion in the industry about overly complex protocols that require collection of data that do not support the trial’s primary or secondary outcomes, and can be overly burdensome to patients and staff.  He identifies the challenge of simplifying protocols as a need for behavioral change, “Companies are reluctant to simplify trials for fear of omitting data that could differentiate their molecule, but given our need to speed development, it’s a misplaced fear.”

While at Lilly, Kasher managed a portfolio of innovative clinical development approaches set to achieve 50% cost and time reductions to be realized over a five-year period beginning in 2017.  Although he is not at liberty to discuss specifics, he did point to an intense focus on patient centricity, analytics, and process simplification and optimization as three key elements of the initiative.  He adds, “It starts with understanding the launch label that you want for a molecule and developing a program that is going to be most efficient.  For example, traditionally, we have done things sequentially, and that notion is being re-evaluated.  Also, you want to bring different people into the process earlier.  There will be a changing group of people involved as the molecule moves along.”

Kasher’s beliefs and experience align well with what DrugDev is trying to achieve.  Built around an extensive global network of active opted-in investigators, DrugDev’s solutions seek to optimize site selection and startup, investigator payments and clinical operations, all in an effort to accelerate product development.  This is made possible through the 2013 acquisition of CFS Clinical, a global provider of investigator grant payments, and the 2014 acquisition of TrialNetworks, a clinical trial optimization platform that helps sponsors, CROs, and sites work together more effectively.

Evaluating success of the DrugDev Board should be straightforward, according to Kasher.  “We’ll determine if the Board is providing appropriate challenge to the leadership of DrugDev in terms of what is relevant to pursue. We’ll ask if the Board is providing sufficient advice and guidance to DrugDev to help them deliver. And finally, are recommendations of the Advisory Board ending up as products they are able to commercialize?” 

Kasher sees his new role as Board Chairman as serving his passion for finding new ways to develop pharmaceutical products faster.  Ibraheem (Ibs) Mahmood, President and CEO of DrugDev, believes Kasher’s drive will serve DrugDev well in its efforts to make improvements in the clinical trials process.  “We don't have an opportunity, we have a responsibility to come together as an industry to change the way clinical trials are run,” he told Clinical Informatics News in an email from the DIA meeting. “There is no one better than Jeff to help us fulfill our responsibility to patients by bringing real change to clinical research."