DIA2015: EXCLUSIVE: One-Size-Fits-All Model for Drug Development “Outdated,” Medidata Solutions, Inc. Exec Tells BioSpace
June 19, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Change is on the horizon for new innovation in clinical trial development and implementation, an executive with Medidata told BioSpace at DIA 2015 this week.
Steve Smith, senior director of Patient Value at Medidata, made the comments in an interview with BioSpace after presenting the panel “Lung-Map: A Future Clinical Trial with a Master Protocol Happening Now and the Value to Patients.” BioSpace chatted with Smith about the overview of a future clinical trial design happening now, including Lung-Map, and what the industry can expect as trials get faster, safer and more effective.
Talk a little bit about where you are with clinical trials?
•It has been encouraging to see so many of the world's drug developers adopt and use modern systems for clinical trials. This is greatly accelerating trial time and increasing chances of trial success so patients have more hope of getting treatments. But there is more work to be done. As a patient advocate, I’ve been fortunate to speak with different stakeholders and listen to their perspectives. What we need is clear: a marriage between safety and speed in clinical trials that will hopefully lead to decreased clinical trial costs, more efficient trials, and ultimately bring new therapies to patients faster.
What’s on the horizon for 2015?
•Change. It is inspiring to see truly innovative trials take hold, including adaptive platform trials, natural history studies, RNA trials, immunotherapies, and trials using new regulatory pathways. In reference to the latter, 21st Century Cures is aiming to establish a process for early interactions and agreement between sponsors and the U.S. Food and Drug Administration (FDA) on trial design to create evidence for accelerated approval. We hope to see shorter timelines to meeting the goal: getting the right medicine to the right patient, at the right time.
How are studies changing?
•The one-size-fits-all model for drug development is outdated. The Lung Cancer Master Protocol (Lung-MAP) is a pioneering clinical trial design that uses a targeted screening method to match patients with drugs according to tumor biomarkers. This collaborative, groundbreaking study is a perfect example of personalized medicine at work. Patients are screened using a comprehensive genomic profiling platform that looks at over 200 cancer-related genes for genomic alterations. Patients are then assigned to one of five sub-studies testing different investigational treatments based on their genomic profile. This improves a patient’s likelihood of receiving a drug targeted at the genetic profile of their particular tumor, and is a great example of where the field is headed. As a key advocate for and contributor to the 21st Century Cures movement, I believe personalized medicine will lead to better patient outcomes and accelerated drug development so we can find medical breakthroughs and deliver them to patients faster.
After AstraZeneca CMO Abruptly Quits, Where Could He Be Headed?
This week the chief medical officer of British drugmaker AstraZeneca PLC abruptly quit his post to become the chief executive officer of an unnamed, smaller biotech company. That’s lead BioSpace to wonder, with his background in R&D and in large companies like Pfizer Inc. , where will Briggs Morrison wind up? We want to know your thoughts.