5 posts tagged “release”

PatientsLikeMe and the FDA Sign Research Collaboration Agreement

Posted June 15th, 2015 by

WASHINGTON D.C., June 15, 2015—PatientsLikeMe and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety. Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management. The announcement was made at the start of the Drug Information Association’s (DIA) annual meeting in Washington D.C.

PatientsLikeMe Co-Founder and President Ben Heywood said the agreement is an unprecedented step toward enhancing post-market surveillance and informing regulatory science. “Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time. We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”

The cornerstone of the FDA’s post-approval drug safety surveillance is a spontaneous reporting system consisting of individual case safety reports. Reporting adverse events to the FDA is mandatory for drug product manufacturers but voluntary for healthcare professionals and patients. The majority of these individual case safety reports are submitted by healthcare professionals and patients to drug product manufacturers, who then have regulatory requirements to report them to the FDA. The PatientsLikeMe data are generated in a different context by patients themselves, and provide important real-time insights into the nuances inherent in patients’ experiences over time, including drug tolerance, adherence and quality of life.

PatientsLikeMe is the largest and most active patient network online, with 350,000 members reporting on their real-world experiences with more than 2,500 conditions. The company’s drug safety initiatives began in 2008 with a pilot program that allowed patients living with Multiple Sclerosis (MS) to report adverse events directly to the FDA. One year later the company launched the first drug safety platform on social media, enabling industry partners to meet their regulatory obligations. In all, PatientsLikeMe has collected more than 110,000 adverse event reports on 1,000 different medications, data that the FDA will now be able to access and analyze as a supplement to traditional sources, including FAERS.

While this is the first time that PatientsLikeMe has formally worked with the FDA, the collaboration adds to a foundation the company has built as an active participant in the regulatory science process. PatientsLikeMe has worked with, provided counsel to and co-authored discussion papers with a range of government groups, including the Institute of Medicine, the National Institute of Health, the Centers for Disease Control and Prevention and the U.S. Department of Health and Human Services, as well as nonprofit organizations such as the Patient Centered Outcomes Research Institute (PCORI).

About PatientsLikeMe
PatientsLikeMe® (www.patientslikeme.com) is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 350,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 60 peer-reviewed research studies. Visit us at www.patientslikeme.com or follow us via our blog, Twitter or Facebook.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Contact
Margot Carlson Delogne
PatientsLikeMe
mcdelogne@patientslikeme.com
(781) 492-1039


PatientsLikeMe Appoints Jason Johnson Executive Vice President and Head of R&D

Posted May 18th, 2015 by

CAMBRIDGE, MA, May 18, 2015—PatientsLikeMe today announced it has appointed Jason Johnson, PhD, as Executive Vice President and head of research and development (R&D). Johnson leads the company’s research, data science, and informatics teams, which focus on analyzing and merging patient-reported and other data types to develop models of disease progression and generate new insights about disease, treatments, and health. Johnson reports directly to CEO Martin Coulter.

“Jason comes to us at a time when the industry is putting patients at the center of healthcare, and using more patient-reported data to guide business and operational decisions,” said Coulter. “Our research and informatics teams bring the data to life by extracting insight and meaning about the patient experience, and helping our partners see which medicines and therapeutic approaches will benefit patients the most. The combination of Jason’s leadership and our scientifically-validated data will be a powerful source of insight to guide discovery, development, and treatment decision making.”

A renowned computational biologist and information science strategist, Johnson comes to PatientsLikeMe after spending 14 years at Merck, most recently as Associate Vice President for Scientific Informatics. In this role, Jason helped build Merck’s informatics and analytics capabilities and was responsible for applied math and modeling, scientific computing and research software engineering. Johnson held various leadership roles during his tenure at Merck within R&D and information technology (IT), and led teams responsible for early clinical development and discovery research IT, computational biology, molecular profiling, and genomics research. Prior to joining Merck, Jason worked at Rosetta Inpharmatics, a biotechnology company in Seattle, and at Pfizer.

“PatientsLikeMe’s ability to bring patients together to share data and insights can transform the way healthcare is practiced and substantially increase value to patients,“ said Johnson. “I’m excited to be working on healthcare informatics from the perspective of the patient. I believe that amassing and analyzing relevant health and medical information from many people with similar experiences and patterns of data can deliver research insights that improve healthcare decision making and patient health.”

Johnson is the author of more than 35 peer-reviewed research publications. He holds bachelor’s degrees in physics and philosophy from Stanford University, a master’s degree in physics from the University of Cambridge in the United Kingdom, and a PhD in biophysics from Harvard University.

About PatientsLikeMe
PatientsLikeMe® (www.patientslikeme.com) is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 325,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 60 peer-reviewed research studies. Visit us at www.patientslikeme.com or follow us via our blog, Twitter or Facebook.

Contact
Margot Carlson Delogne
(781) 492-1039
mcdelogne@patientslikeme.com