On Friday, Oct. 11, Rob Ellis and Chris Benko of Koneksa were invited to present Research Rounds at the FDA for the Oncology Center of Excellence (OCE), the Office of Hematology and Oncology Products (OHOP), and the Office of Clinical Pharmacology (OCP).
The Clinical Trials Transformation Initiative (CTTI) was created by the U.S. FDA in 2007 with Duke University to solve “a crisis for U.S. clinical research”: Studies took too long to start, not enough patients or investigators were participating, and costs were going up. Today, more than 80 organizations are part of the CTTI, representing government, industry, patient, physician and academia.
Recently, the CTTI unveiled recommendations for the use of mobile technology to improve the quality and efficiency of trials. In mid-July we met at the FDA’s offices in Maryland to discuss them, sharing best practices for how to choose the best technologies, design a protocol, and then capture, manage, and prepare data for the FDA’s review.
I found the meeting incredibly refreshing, because it reinforced the FDA’s position of encouraging innovation from all stakeholders: patients, the pharma industry and its technology partners, as well as academia.
The FDA is proactively engaging industry to find new and better ways to capture functional measurements that matter more to patients. I hear this commitment regularly in the discussions that our partners have with the agency, and I heard it again here.
The project did a great job of balancing both the strategic and mundane, yet important aspects of how mobile technologies can appropriately improve drug development. It’s exciting to consider the ways in which technology can support more patient centric measures and faster efficacy read-outs. At the same time, the data management, infrastructure and validation challenges presented by these tools must be dealt with in way that continues to improve the integrity of the clinical trial process.
The most important message – one I want to help spread – came from Jennifer Goldsack, who helped open the meeting. You can see one of her slides below.
She reminded us that our job is to show as much courage as the patients in these studies do. They’re bravely taking chances in search of medical breakthroughs. We have no excuse not to do the same.
By Chris Benko, CEO, Koneksa Health
Today, Koneksa presented an abstract validating the use of remote measurements for patients with asthma.
On May 14 and 15, Koneksa CEO Chris Benko will present as part of “Wearable Technology – Challenges and Opportunities,” an industry program held by the European Bioinformatics Institute (EMBL-EBI).
I am fortunate to have the opportunity to travel to multiple site initiation visits and trainings for clinical research studies each year. Meeting with the incredibly dedicated study teams is an invaluable experience as I am able to hear from the people who support the front line of clinical research. During a recent training, I sat down with a research coordinator who seemed to be stretched very thin. Noticing this, we took a step back to talk through her hesitations.
Chris Benko first joined Merck when he was but a lad of eighteen, rising through the ranks in HR and talent management to become one of the youngest VPs in the history of the organization, at the age of 34.
But instead of continuing his ascending career into the senior ranks of biopharma, Chris opted instead to scratch the entrepreneurial itch and, after several years in Merck venture capital group, he founded a new company and left Merck to run it.
2016 has been an exciting year of growth and change at Koneksa. Our customer collaborations are growing significantly in both number and scope. The studies we’re developing and supporting are demonstrating that novel approaches to measuring and health can dramatically transform the way new treatments are delivered to patients.