(You can see my first post here about the White House Precision Medicine Initiative Summit: I shared why I was going & the perspectives I planned to share. MM&M also shared this article from me on how precision medicine will impact healthcare marketing.)
You could feel the energy in the room at the White House Precision Medicine Imitative Summit in D.C. on Thursday.
(Not in the least, everyone could probably see the excitement emanating from me, as Howard Look, the CEO of Tidepool (an open source nonprofit dedicated to improving diabetes data sharing) and dad of a teen with type 1 diabetes, sat on stage and told the President of the United States about the DIY artificial pancreas I have built and that more than three dozen people worldwide are using.)
Before the panel with the President, the room was highly engaged as speaker after speaker poignantly articulated the very reasons why precision medicine is needed. Retta Beery spoke about a drug that helped a young teenager go from using a wheelchair to playing on his high school tennis team, because their family had researched and shared online how this drug had helped their two children. The drug was originally used to treat Parkinson’s disease. Matt Might, a computer scientist, described his journey to medical research after his son was diagnosed with missing the enzyme NGLY1, and he searched for compounds to treat the enzyme – eventually finding them on Amazon.com. He’s on sabbatical from the University of Utah, now serving as a visiting professor at Harvard Medical School to continue this work, and shared that he found potentially 70 molecules that might serve as alternative treatments, too. 14 of those are already approved by the FDA. And Eric Dishman, Vice President and Intel Fellow for Health and Life Sciences for Intel, dropped jaws as he explained how he went from dealing with cancer and kidney failure to standing on the stage in front of us, with no cancer – segueing into explaining Intel’s commitment to precision medicine with the “All In One Day” project by 2020. The goal of “All in One Day” is to enable genomic sequencing in a single day – rather than weeks or months – and allowing clinicians to develop and discuss targeted treatment plans for patients in the same day that they were sequenced.
(If you’re interested in seeing all of these moving stories and announcements, you can see the full video from the event here.)
Intel wasn’t the only one making significant announcements and commitments to the Precision Medicine Initiative (PMI). Six EMR vendors have announced that they will enable patients to donate data directly to the national research cohort that is being built by part of the initiative. A pilot program at Vanderbilt will test programs to enroll patients into the national research cohort. The PMI is also putting together a specific Institutional Review Board to review related projects. The IRB will consist of many of the movers and shakers that were at the Summit.
One notable addition: John Wilbanks is joining the IRB. (Disclaimer – John and I met for the first time yesterday in person, but have had multiple conversations via Twitter about the current status quo of IRBs in clinical research studies and from my perspective, the sometimes challenge and barrier they present to patient-driven and –led research.)
After the roundtable breakout sessions, John shared with me one of his ideas for the IRB: template proposal documents and forms to guide how to submit to the IRB, explain what the process will be (and how long), and help people get the meat of their projects reviewed and approved, rather than spending too much time worrying about what’s on the form.
This is huge, especially for enabling more patient researchers and organizations who are dipping their toes into clinical trials to be able to submit to an IRB and get approval for moving forward with a clinical trial or study.
And it’s not surprising that John is bringing this perspective as he joins the IRB, since he comes from Sage BioNetworks. It is a nonprofit (local to me in Seattle!) that promotes open science and patient engagement in the research process. In particular, they’re working to redefine how complex biological data is gathered, shared and used – and one of their current projects is around modernizing the informed consent process. And as part of the round of commitments announced at the Summit, they’ve committed to getting shared data into use through their new “Qualified Researcher Program”. Qualified researchers will have ID validation, ethics assessment, sworn oath and data use statement before using data submitted by patients. This is all the details they’ve shared so far, but I’m looking forward to finding out more (expecting to learn more at the end of next week.)
The roundtable discussions were not aired on the livestream. Attendees from the summit were broken up into several rooms for discussions, with each room focusing on different topics. The room I participated in was moderated by White House Senior Health and Health IT Advisor Claudia Williams. We focused on a few key questions:
- What does the 2.0 research experience look like for patients and caregivers? Discussion ranged from reflecting on the current experience for research – everything from how research participants from underserved communities engage to how the research agenda is set – to suggesting that we need to start training current students (future researchers) in the new models that we’re designing. Respect of participants was a key theme.
- What are the challenges to getting to the 2.0 research experience, and what collaborations are needed? This also generated a wide-ranging conversation. Representatives from the FDA spoke up, alongside a clinician startup founder and patient representatives from diabetes, cancer, and multiple rare disease communities.
The roundtables weren’t intended to come up with answers, but to start and further collaborations that will help meet the objectives of the Precision Medicine Initiative. This is where an opportunity exists for our clients at W2O Group. There is much attention focused on the PMI, and President Obama is highly engaged in efforts to move it forward. The healthcare organizations we work with can take advantage of the excitement and momentum in making and sharing their commitments to the PMI, as well as finding new collaborations to help achieve their goals and advance the movement of precision medicine. If our clients are looking for stakeholders to partner with, we’ll be able to help – as a result of attending these types of events and meeting the movers and shakers, in addition to utilizing the MDigitalLife ecosystem tools to drill down and identify the right partners through their activities online.
I’m looking forward to seeing what collaborations form in the coming year, and seeing the progress made to making precision medicine a reality.