5 posts tagged “new”

Sally Okun explains the new research collaboration with the FDA

Posted June 16th, 2015 by

Yesterday, we announced a new research collaboration with the U.S. Food and Drug Administration (FDA) that will explore how patient-reported data can lead to new insights about drug safety. It’s the first time the FDA will analyze patient-generated data for pharmacovigilence (aka drug safety).

But we’re no strangers to drug safety. Check out some of the previous work the community has helped to drive:

To learn more about this new (and unprecedented) collaboration, we talked to our very own Sally Okun, Vice President of Advocacy, Policy and Patient Safety.

What will this collaboration do?
Patients’ lives and well-being often depend upon medical products approved and regulated by the FDA. But most of the information we see on safety labels comes from clinical trials, which aren’t typically representative of the actual populations of patients who will take the medication. Working with us, the FDA will be able to see the real-world impact of taking medications over time, which can help identify benefits and risks earlier. The FDA isn’t just talking about patient-centricity; they are partnering with us to work directly with patients, and give them a collective voice as part of the FDA’s surveillance system.

How does the FDA normally hear about side effects?
Right now the FDA uses a voluntary reporting system consisting of individual case safety reports, the majority of which are submitted by healthcare professionals and patients to drug product manufacturers, who then are required to report them to the FDA. Our data are different in that the information is generated by patients themselves, and provide real-time insights about what its like to use medical products over time, like tolerability of the drug and factors that may influence taking the drug as prescribed.

When did PatientsLikeMe’s start gathering information about side effects and adverse events?
We’ve actually been collecting information about patients’ experiences with treatments, including patient-attributed side effects, since we launched the website in 2006. In 2008 we took steps to formalize adverse event reporting by developing a customized version of the FDA’s MedWatch tool for use in a pilot project with our MS community. The pilot set us on a path to develop our future drug safety functionality. By 2009 we had created a fully integrated, standards-based drug safety platform, the first on social media. It enabled industry partners to meet their regulatory obligations.

What’s the future?
It’s pretty exciting! The patient experience can more deeply inform the way medications are regulated. And patient-reported data can ultimately have a greater impact on the way that drugs are developed. This collaboration can lead to all of that.

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PatientsLikeMe Names Michael Evers New Executive Vice President of Consumer and Technology Group

Posted May 11th, 2015 by

CAMBRIDGE, MA., May 11, 2015—PatientsLikeMe today announced it has named Michael Evers the head of its newly-formed consumer and technology group. In this role, Evers will focus on creating value for patients and directing the company’s marketing, engineering, user experience and design, product management, patient advocacy and government compliance teams. He reports directly to CEO Martin Coulter.

Evers joined PatientsLikeMe as Executive Vice President of Marketing in 2012. Since then he has tripled the company’s member base to 325,000 members and significantly increased engagement on the site. He has also developed and expanded the company’s marketing capability and created the strategy and infrastructure for a strong partner network that includes Walgreens, Aetna and numerous other organizations and nonprofits. The new role is a promotion and expands Evers’ responsibilities to include design and development of the company’s website, which is widely lauded as a leading resource for patients to track their health, connect with others and contribute health data for research.

“In the last three years, Michael has been instrumental in driving our member growth and business expansion. His leadership and deep consumer background will ensure that we continue to develop our company and services in ways that helps our members improve their health, and healthspan,” said Coulter.

Before joining PatientsLikeMe, Evers was President of BroadMap, a provider of industry-leading geographic data products. Evers’s geospatial industry experience started at TomTom in 2005, where he was the Global Vice President of Marketing and Business Development for the company’s Tele Atlas business unit. He has also held senior marketing positions at Motorola and AOL Time Warner.

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