Validating Remote FEV1 Monitoring in Moderate Asthmatics to Increase Study Power


Koneksa Health, an early-stage company focused on the integration of real-world data into clinical research, announced today that it will present results of its validation study of remote FEV1 measurements at the American Thoracic Society (ATS) International Conference being held May 18-23 in San Diego, CA.

“Patients contributing pulmonary function measures twice daily demonstrated the potential to detect clinically meaningful changes in FEV1 with fewer than 20 subjects,” said Marcie Ruddy, one of the study’s authors, and Vice President of Clinical Development for Respiratory and Inflammation at Regeneron Pharmaceuticals. “The use of this model in investigational studies may provide signal detection very early in the drug development process.”

The abstract, “Validating Remote FEV1 Monitoring in Moderate Asthmatics to Increase Study Power,” will be presented at the American Thoracic Society International Conference in San Diego at a Thematic Poster Session on “Asthma: Pathophysiology and Clinical Trials” on Monday, May 21.

“The careful validation of new technology for clinical trials is creating digital biomarkers vastly increasing the data available per patient, with potential to even reduce the number of site visits,” said Chris Benko, CEO of Koneksa Health. “The dramatic reduction in sample-size requirements that this study shows is encouraging and reflective of the efficiency that these tools can provide.”

Poster details:
7841 – Validating Remote FEV1 Monitoring in Moderate Asthmatics to Increase Study Power
B65 – Asthma: Pathophysiology and Clinical Trials
Monday May 21, 2018 9:15 AM – 4:15 PM

The complete text of the abstract is available online at

About Koneksa Health

Koneksa Health is a private technology company focused on transforming the way health is measured by incorporating real-world data into clinical research. Koneksa is committed to improving patient care and health outcomes, by opening effective new avenues of data collection through emergent technology. Koneksa works primarily to augment clinical trials with real-world data gathered through mobile, wearable and other digital technologies.

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Koneksa Health Announces Senior Leadership Appointments

Vik Shah Named COO; Elena Izmailova, Ph.D. Named Chief Scientific Officer; Gol Ophir Named Head of Business Development

NEW YORK, Dec. 6, 2018 /PRNewswire/–Koneksa Health, a private company that enables the biopharmaceutical industry to develop new medicines with fewer patients, announced today that three industry leaders have been appointed to senior roles with the company. Vik Shah will serve as Chief Operating Officer; Elena Izmailova, Ph.D., joins as the company’s Chief Scientific Officer; and Gol Ophir is named Head of Business Development.

Vik joins Koneksa with a deep background in healthcare information technology, having spent a decade with Medidata, eventually as SVP of Applications and Platforms. More recently, Vik served as COO at two early-stage technology companies. At Koneksa, Vik’s role will be responsible to scale all facets of the business, driving operational and financial excellence, as well as developing meaningful and mutually productive partnerships.

Elena was most recently Senior Director, Novel Data Streams and Devices, at Takeda, where she established the strategy and road map for digital device implementation and data collection in clinical trials. Previously as a leader in the global translational medicine group, she established the company’s biomarker assay development network to ensure seamless transitions from discovery to development. Her experience in biomarker development and validation extends over fifteen years, since joining Millennium Pharmaceuticals (later acquired by Takeda) from the Children’s Hospital/HMS and Whitehead Institute/MIT in 2003.

Gol brings experience building technology business development capabilities in the financial sector and the pharmaceutical industry. He has deep experience developing new businesses and offerings across a range of industries. At Morgan Stanley, Gol created the first technology business development function at a major Wall Street firm. He also has extensive experience as an operating executive both for Morgan Stanley and Bridgewater Associates, which has been instrumental as he develops new technology-enabled businesses and partnerships. More recently, Gol was EVP and Chief Risk Officer for Business Services at Citizens Bank.

“I’m proud to welcome these three executives, whose diverse backgrounds and depth of expertise will help propel Koneksa as we move into our next chapter of growth,” said Koneksa CEO Chris Benko. “Vik, Elena and Gol each have a unique experiences that complement our team and will prepare us for the future. Vik’s track record helping companies to scale successfully, Elena’s perspective as a translational researcher and industry leader in the emerging field of digital biomarkers, and Gol’s expertise in business development in highly regulated, data-intensive industries – are all powerful additions to our management team. We’re delighted to have them join us and know their leadership will be instrumental as Koneksa takes on new and greater challenges.”

About Koneksa Health

Koneksa Health is a private company that enables the biopharmaceutical industry to develop new medicines with fewer patients. By unlocking the potential of real-world data from remote, wearable, and other digital technologies, Koneksa speeds up the time required to understand how a drug is working and helps to develop real-world evidence for how medicines can impact the daily lives of patients.