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.
Pensacola, FL – Nov 15, 2016 - ActiGraph, a leading provider of clinical-grade wearable activity and sleep monitoring solutions, has announced the launch of the CentrePoint technology toolkit, which enables clients to leverage the company’s ecosystem of hardware and software tools in the development of proprietary remote patient monitoring (RPM) systems and other home healthcare delivery solutions.
This week’s news that Takeda Pharmaceuticals inked a deal with Koneksa Health, a digital health startup that uses wearables and connected devices to gather patient data, reinforces the point that pharma companies have found a place for digital health tools in drug development. Koneksa Health CEO Chris Benko said he views the natural place for the use of these technologies in clinical studies either in early phases or as an exploratory addition in later phases in a phone interview with MedCity News.
Cambridge, Mass. , and New York, NY, USA, November 7, 2016 – Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and Koneksa Health, Inc. (“Koneksa”), an early stage company focused on the integration of real world data into clinical research, today announced an ongoing strategic collaboration to utilize new digital health tools in clinical trials.
There is an exciting paradigm shift happening in industry sponsored clinical trials, particularly for the patients contributing to research. Prior to joining Koneksa I worked for one of the highest enrolling clinical ophthalmology sites in the country, where over 25 studies were conducted at a time. I’ve experienced first-hand the significant burden placed on participants in clinical trials, with study visits lasting well over six hours.
I joined Koneksa Health three months ago and for the first time, I had the opportunity to work with a full blown “industrial application”, as our CTO likes to refer to it. Although I worked in tech and have an engineering degree, I only started to delve into web development when I joined Women Who Code NYC in the Fall of 2014.
We weren’t able to make it to CES this year, but we were keeping a close eye on the new digital health announcements to see if anything really impressed us. Amongst many new wearables and sensors that seemed to bring marginal improvement, there were a few hardware / software announcements that we are looking forward to testing and bringing to our customers.
On January 30th of this year President Obama announced a $215 million precision medicine initiative to improve health and disease. This initiative is part of a broad trend towards disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles. Fulfilling the promise of precision medicine will depend on high quality evidence linking patient measurements and health. But what makes for high quality evidence?
One of the common challenges we see at Koneksa is the tendency of the research community to gravitate toward evaluating novel measures or endpoints for concurrence with older and very limited ‘gold standards.’ Previously I discussed the lack of an underlying conceptual framework for activity measures that rely on patient reported outcomes (PROs). However similar challenges also emerge with more objective performance measures.
Product starts and ends with design. Many times, the design process starts with a series of questions:
- What do you want to build? (Product, service, etc.)
- Who is building something similar?
- Who are you building it for?
From here, every line you draw and decision you make has to be optimized for the best user experience. Understanding your target customer is the key for building a product people will value.
As an engineer (by training) and physician-scientist, I need to quantify things.
With websites like FitDay, I can easily track my food intake, and with devices like glucometers and ketone meters, I can use my blood glucose and ketone levels to assess my physiologic response to food, exercise, and my morning drive with just a prick of the finger. Exercise, however, has eluded me for years, both professionally and personally.
I joined Koneksa to run technology in May 2014. I’ve spent many years building systems for financial services and, to some, extent consumer industries. I joined healthcare motivated to apply my skills after watching how technology was changing the conversation in my father’s last months of life. The journey has not disappointed.
In this post I share two themes I’ve noticed over the last year.
Recently we attended the Clinical Trials and Internet of Things forum, held in Boston’s Longwood medical area. It was an exciting two days of biopharma, technology companies and CROs coming together to discuss the potential of wearables, sensors, and mobile devices to transform clinical research. However one speaker, Jack Whelan, struck us as a unique voice in the conversation.