5 posts tagged “collaboration”

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.

Share this post on Twitter and help spread the word.


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


A new collaboration and the work ahead: An interview with PatientsLikeMe Co-founder and President Ben Heywood

Posted April 11th, 2014 by

Earlier this week, PatientsLikeMe announced a five-year collaboration with Genentech. Our goal? To bring your experience – the patient experience – to a company that wants to learn more from the people who are living with serious diseases, and to better integrate your insights into their decision-making as they develop new medicines. PatientsLikeMe Co-founder and President Ben Heywood talks more about the work ahead.

So, why Genentech? What do you hope to achieve through this partnership?

Genentech is a leading biotech company and an acknowledged leader in oncology (which is where our initial focus will be).

We spoke with their teams for quite some time before embarking on this collaboration and I have to say that we just really like their approach. We’re very much aligned in our goals of defining a more patient-centric approach to research, development, and care delivery.

Their goal in working with us is to explore the use of our PatientsLikeMe network to develop innovative ways of researching peoples’ real-world experience with disease and treatment. I think we also hope and expect this collaboration will encourage broader engagement of others involved in the delivery of healthcare to support a stronger voice for patients like you.

How does this differ from your other collaborations?

What’s different with Genentech is that we’ll be exploring on a broader scale how the use of our patient network might develop new ways to research the patient experience. The broader access should allow for more agile, real-time use of the data and help align the strengths of the platform with Genentech’s priorities. This collaboration also helps PatientsLikeMe expand our cancer community, and we’re excited to be partnering with such a leader in oncology research and development on that.

How does this move “put patients first?”

Genentech is a forward-thinking company that is continuously working to patients at the center of their decision-making. By providing Genentech access to the health data shared by the members of our network, it will help them learn more from patients like you and better integrate your insights into their decision-making as they develop new medicines.

Is the focus on cancer new for PatientsLikeMe?

We have a community of people with cancer that have been using the site since we opened it up to people with any condition in 2011; many right now list cancer as a secondary condition, although some list it as their primary. Part of this collaboration is about using resources to enhance the tools within our network to help make the site even more useful for cancer patients. Of course what we build for one community will benefit all, much like we’ve done all along. The end result is a website that better serves people’s needs.


Social media users say ‘yes’ to sharing health data

Posted January 23rd, 2014 by

There are some new survey results that just came out from the Institute of Medicine’s Evidence Communication Innovation Collaborative (ECIC) that show social media users give the stamp of approval to sharing health data. (A big, public shout out to the more than 2,000 PatientsLikeMe members who participated in the survey.) It’s very exciting to see the voices of so many in the community having such an impact.

Check out the results below and read more about it in the PatientsLikeMe newsroom.

 


PATIENTSLIKEME AND R.A.R.E PROJECT UNITE TO FIND AND CONNECT ONE MILLION RARE DISEASE PATIENTS

Posted November 8th, 2011 by

FOR IMMEDIATE RELEASE

Nonprofit and “Not Just for Profit” Announce Collaboration at PartneringForCures Event

NEW YORK, NY – November 7, 2011 – Today, PatientsLikeMe and R.A.R.E Project, a nonprofit advocacy and support group for patients with all rare diseases, announce a new partnership to find and connect 1 million rare disease patients to share and learn everything possible about their conditions.  The organizations, co-presenting at the PartneringForCures event today in New York, are launching an international rare disease awareness campaign in 2012.

PatientsLikeMe's New Partner, The R.A.R.E Project

“There are 35 million patients in the U.S. with 7,000+ rare diseases and we want to find them, connect them and support them in sharing and learning by their specific disease and across all rare diseases,” says Dean Suhr, Chief Innovation and Community Development Officer at R.A.R.E.  “We’re excited to work with PatientsLikeMe because their open patient registry allows patients to contribute to research, while getting immediate benefits, like improved quality of life, from sharing this information with others.”

The goal of this collaboration between R.A.R.E and PatientsLikeMe, an online health community that started in 2005 for rare disease patients and is now open to everyone, is to allow for better shared learning and acceleration of discovery by rapidly connecting patients to researchers, companies, nonprofits and patients like them. The partners will combine resources to provide patients with the opportunity to make online and local in-person connections, engage nonprofits and local specialists, and contribute their health data to the open patient registry at PatientsLikeMe. Unlike other registries, PatientsLikeMe allows patients to query the data to compare their medical data to others with similar diseases, symptoms, or therapies so they can also compare their data across other diseases.

“The key to accelerating research for any patients, although particularly powerful for those with rare conditions, is to have efficient access to well characterized patient populations willing to be part of research,” adds Jamie Heywood, Co-founder and Chairman of PatientsLikeMe. “It’s terrifying to think you’re alone and manage your rare illness with a doctor who might not have ever seen another patient like you. We will change that.”

For more about the R.A.R.E Project, including current awareness campaigns, go to: http://rareproject.org.  For patients and nonprofits that want to join PatientsLikeMe, go to http://www.patientslikeme.com.

ABOUT R.A.R.E PROJECT

The R.A.R.E. Project exists to raise rare disease awareness, unify and empower a vibrant global rare disease community, and fund innovations to support ‘in-their-lifetime’ rare disease research.

ABOUT PATIENTSLIKEME

PatientsLikeMe® (www.patientslikeme.com) is the world’s leading online health data sharing platform. PatientsLikeMe® creates new knowledge by charting the real-world course of disease through the shared experiences of patients. While patients interact to help improve their outcomes, the data they provide helps researchers learn how these diseases act in the real world and accelerate the discovery of new, more effective treatments. [Follow company news on www.twitter.com/PatientsLikeMe and http://blog.patientslikeme.com]

PatientsLikeMe member lscanlon