Patient Advocacy Summit 2014: Patient-Centered Benefit-Risk Assessment, Why It Matters to You

Advocates at this year’s 2014 Global Genes Patient Advocacy Summit will have an exclusive chance to learn how their voice can make a difference in the fight for faster cures. For critical patients and their families, the risk versus benefit of new treatments has been a simple decision. Although many are ready to take a chance on a new drugs, the complex course of procedure and legalities has presented a sizable barrier to putting medication, treatments, and medical devices into the hands of patients who need them now.

But things are changing.

A 2012 law that governs the Food and Drug Administration created the agency’s first Patient-Focused Drug Development Initiative. The center in which medical devices are reviewed is also beginning to incorporate patient preferences into decision-making.

This session will introduce you to the world of drug development and how patient advocates can play a crucial role in influencing the FDA’s decision making process. There is growing movement towards the acceptance of value that can come from eliciting, understanding, and incorporating patient preferences for benefits and tolerances for risks at every stage– from early clinical development to marketing medical products.

Learn from FasterCures’ Director of Strategic Initiatives, Kim McCleary, about what these programs mean for rare disease advocates. You’ll hear how patient organizations are mobilizing their communities to help inform decisions made by the FDA and industry sponsors so that treatments move more swiftly from the lab to the patients who need them. Tools created for this purpose will be shared, including lessons learned at the frontlines of two communities that have participated so far.

Introducing Kimberly McClearly

Kimberly McCleary, Advocate and Director of Strategic Initiatives at FasterCures, is leading the charge on key programmatic areas including how the FDA evaluates risk and benefit for patients, medical innovation and how we determine value and reimbursement. She helped found the Chronic Pain Research Alliance and joined with other leaders and Pfizer to establish the Campaign to End Women’s Pain in 2010. McCleary helped design and launch the Unite Narcolepsy initiative to educate, engage and empower narcolepsy patients and their advocates to participate effectively in the PFDDI meeting held in September 2013.

Introducing FasterCures

FasterCures, a center of the Milken Institute, is an action tank driven by a singular goal — to save lives by speeding up and improving the medical research system. The organization seeks to save time in the processes of searching for discoveries, turning those discoveries into therapies and bringing those therapies to patients.

FasterCures puts the interests of the patient at the center of everything they do. Their programs objectively figure out what’s working and what isn’t in the research ecosystem, and share that knowledge so that every sector – and every patient – can benefit.

The Milken Institute is a publicly supported, nonpartisan, independent think tank whose work makes a difference in the lives of people worldwide by helping create a more democratic and efficient global economy. Visit the Milken Institute’s website.

Can’t attend in person? You can’t afford to miss this! Our new Livestream component will allow up to 5,000 interested advocates from around the globe to attend virtually. The event will be broadcast live with opportunities for patients to participate from afar using social media, including twitter and Facebook. Follow using #2014GGSummit

To view the full schedule of events click here.

To register to attend the summit in person, click here.