String of Pearls Institute (PSI) - Netherlands, Stroke research consortium.

Stroke research consortium.  Seems to be the only one in the world that Faster Cures knows about
http://consortiapedia.fastercures.org/consortia/psi/

At a Glance

• Status: Active Consortium
• Year Launched: 2007
• Initiating Organization: Netherlands
• Initiator Type: Government
• Disease focus:
  Cerebrovascular Accident (Strokes), Diabetes Mellitus, Hereditary Colorectal Cancer, Inflammatory Bowel Diseases (Crohn's Disease And Ulcerative Coli, Leukaemia, Neurodegenerative Diseases
• Location: Europe

• Abstract
• Mission
• Consortium History
• Structure & Governance
• Data Sharing
• Impact/Accomplishment
• Points of Contact
• Sponsors & Partners
•  EXPAND ALL

Abstract

The String of Pearls Institute is a joint project of the eight university medical centers (UMCs, teaching hospitals) in the Netherlands. It concerns a prospective, disease-specific biobank in which anonymous patients’ characteristics are documented and followed over a long period. These data are coupled to a biobank containing patients’ biomaterials such as intestinal mucosa, feces, deoxyribonucleic acid (DNA), and serum. In case of approved scientific studies — and after approved protocol — additional samples and materials may be harvested.

But that’s the way we’ve always done it! Changing organizational culture in medical R&D

This is so true of our fossilized and decrepit stroke associations. But the boards of directors seem not to notice or care that they are fucking failures.
http://www.fastercures.org/events/webinars/show/but-thats-the-way-weve-always-done-it-changing-organizational-culture-in-medical-r-and-d

Many of the behaviors slowing faster progress in the discovery and development of new medical products are things that organizations everywhere have been confronting for decades, if not centuries – lack of effective communication and collaboration, silo-ization of information and expertise, incentives not aligned with the collective behaviors we want to see. What can the biomedical R&D ecosystem learn from the vast literature and learnings from outside the space about how to change organizational culture and behavior to build a more effective, efficient enterprise?
Speakers include:

• Riley Ennis, Co-Founder and Chief Operating Officer, Freenome
• Richard Hamermesh, Senior Fellow, Harvard Business School
• Lyric Jorgenson, Deputy Director, Office of Science Policy, National Institutes of Health
• Margaret Anderson, Executive Director, FasterCures, a center of the Milken Institute (moderator)

Summary

Culture change is more likely to occur if you treat it as a response to opportunity, not a response to failure. That seemingly simple but wise observation from Lyric Jorgenson, deputy director of the Office of Science Policy at the National Institutes of Health, captured the tone of a fascinating Webinar discussion titled “But That’s the Way We’ve Always Done It! Changing Organizational Culture in Medical R&D.” Jorgenson, Harvard Business School Senior Fellow Richard Hamermesh, and Freenome Co-founder and Entrepreneur Riley Ennis brought very different perspectives to the topic. But they agreed that opportunities created by advances in science and technology require change to “the way we’ve always done things” to maximize their potential. This change in scientific research could accelerate progress where decades of talking about the problems have failed.
Since our earliest days, FasterCures has been focused on the ways the culture of medical research can slow progress. We heard from the patient-driven venture philanthropies that became The Research Acceleration and Innovation Network their frustration that “culture eats strategy for breakfast” – or in this case, scientific progress. They saw lack of communication and collaboration and misaligned incentives as being significant drags on progress, as much as the state of the science, and they set out to do what they could as funders to address those cultural issues. “Change starts with small, visible successes that are built on quickly,” Hamermesh noted, and cited venture philanthropies like the Cystic Fibrosis Foundation and the Multiple Myeloma Research Foundation as organizations that have done exactly that.
Start small and build on success. Identify opportunities that can drive culture change. What else do we know about how change happens? Jorgenson cited her experience as deputy director of Vice President Joe Biden’s Cancer Moonshot saying, “A push from the masses plus a pull from a champion,” someone who will challenge people’s assertions about the way we’ve always done things and hold partners accountable, is key. She also acknowledged that a crisis can spark culture change, as happened with HIV/AIDS, but ideally is managed by strong leadership that can allay people’s concerns about the consequences.
Ennis cited how data drive change – and in an era in which we are inundated with data, that is certainly an opportunity. Ennis emphasized the need to have a certain amount of humility, understand why things are done the way they are, and respect the needs of your partners. But “the system needs to be more open-minded and data-driven,” said Ennis. He encouraged the biomedical R&D ecosystem to learn lessons from the technology sector about using real-time feedback loops to improve the quality of data and reduce iteration cycles. He also mentioned that “failure” can catalyze growth – for individuals, for organizations, and for science. This was echoed by Jorgenson when she appealed for a rethinking of how clinical trials can be shifted to a more adaptive, flexible system where we can fail fast and move on. Ennis also raised the utility of data technologies, like artificial intelligence and machine learning, in changing the rules of the game.
What elements of the biomedical R&D culture need to have the levers of change applied to accelerate progress? Several themes emerged across the speakers’ comments:

• More sharing of data. The opportunity of precision medicine is upon us, said Hamermesh. But without large, broadly available datasets to drive insights, it will fail to become reality. “Let’s not have data hoarding,” he pleaded. Ennis advocated for centralizing data for queries. We may be swimming in data, but if we can’t aggregate, access, and analyze them, they don’t matter.
• Greater diversity of experiences and perspectives. Hamermesh invoked the power of crowdsourcing to bring fresh expertise and ideas to solving biomedical research questions, asserting that “change will come from outside the system.” Jorgenson talked about the need to empower non-traditional partnerships and multi-disciplinary teams in order to crack the complexities of biology today. Additionally, we should give researchers training opportunities that expose them to other ways of thinking.
• A person-centered approach. All speakers talked about the ways in which a focus on the individual patient and person will disrupt the way we do things. Hamermesh believes that when people understand their own health data, and share them with open datasets for research, a revolution will occur – a view that Jorgenson shared. Precision medicine is, of course, a person-centered endeavor. Ennis talked about the importance of removing complexity by focusing on the things people care about – making their data actionable and giving them real-time feedback that informs their choices impacting their health. Patient-reported outcomes are a critical feedback loop to improve data quality, in Ennis’s view. 

What incentives are needed to foster the changes in behavior we say we want to see?

• Jorgenson hit on the need for institutions to reward researchers for data quality and methodological rigor with citations and recognition that build their careers. Data that are not of high quality, not shared, or not reproducible are not of high value to the enterprise. 
• Individuals need to be incentivized and enabled to acquire, understand, and share their health data. Hamermesh cited lessons to be learned from direct-to-consumer businesses like Rent the Runway and Uber about engaging with and adding value for consumers. 

When asked by FasterCures’ Executive Director Margaret Anderson how we can accelerate culture change in medical R&D, all three speakers came back to the centrality of individual people and patients driving disruption in the system, as they have in so many other sectors. Hamermesh summed it up by saying, “Start by going directly to the patients. Free up their data, and they will change the system, ask better questions, and create a sense of urgency.” And Ennis put it simply, “Treat users as people, not patients.”

Find Patient-based Organizations and their Research Assets in FasterCures’ Patients Count Network

A person would think this would be useful for our stroke associations. But two words in here disqualifies our fucking failures of stroke associations. Patient-based is not something our stroke associations are doing. Stroke survivors are just pity props to pull in donations.
http://fastercures.tumblr.com/post/154690204079/find-patient-based-organizations-and-their
If you were looking for organizations that have patient registries and that partner with industry, where would you search? FasterCures has a resource for that! We have partnered with AltaVoice, (formerly PatientCrossroads) to create the Patients Count Network, a dynamic, digital directory to showcase nonprofit research funders and their research assets.
Patients Count Network is open to patient-based organizations worldwide that seek to accelerate medical progress. Organizations of all sizes, scopes and stages of growth are invited to participate! 

Opportunities for the Next Administration to Advance Biomedical Innovation

Every single stroke hospital and stroke association should be sending members to this. But they won't because they don't want to tackle any of the stroke BHAGs(Big Hairy Audacious Goals) . They are lazy and useless.  I would tackle every single one and get them solved and I am brain-damaged.


Thursday, December 8, 2016 | 1:00 PM to 2:00 PM Eastern | Webinar

Biomedical innovation is vital to America’s health and economic well-being. President-elect Donald Trump has the opportunity to lead in this area and construct policies to maintain the system’s strength and productivity. FasterCures engaged our unique network of stakeholders across the R&D ecosystem to interview more than 150 thought leaders across eight sectors. We synthesized these insights into the “Rx for Innovation” report, which presents 26 recommendations for how the next administration can translate the ideas we heard into meaningful action. Join FasterCures for a free Webinar to discuss “Opportunities for the Next Administration to Advance Biomedical Innovation,” on Thursday, Dec. 8, 2016, from 1 to 2 p.m. Eastern.

Speakers include: Patrick White, President, Act for NIH Mary Dwight, Senior Vice President for Policy and Patient Programs, Cystic Fibrosis Foundation Margaret Anderson, Executive Director, FasterCures, a center of the Milken Institute (moderator)

Register Here

Unable to attend? Please click here

Collaboration 2.0: Exploring the Future of Research-by-Collaboration in Medical R&D

There are many ways our fucking failures of stroke associations could collaborate with researchers and survivors, this is just one if we had ANY stroke leadership at all. I have to assume our stroke associations have NO intention of doing anything for survivors other than press releases and stroke groups. Fucking pathetic.

Collaboration doesn’t always come easily, but it is a major key to success in the biomedical research and development environment. Despite the explosion of research consortia around the globe, the consortia landscape has gone largely unmapped, resulting in confusion about the efforts and how to participate. Over the last two years, FasterCures’ Consortia-pedia project has been mapping and analyzing the breadth and scope of approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. In the first FasterCures Webinar of 2016, a panel of experts addressed how to ensure that these collaborations maximize their value to the ecosystem and create thoughtful, productive partnerships.

Moderated by Margaret Anderson of FasterCures, speakers Jane Larkindale of Critical Path Institute, Dalvir Gill of TransCelerate BioPharma and ShaAvhrée Buckman-Garner of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) spoke on key themes that lead to success when starting a consortium, ensuring a productive work stream and facilitating outputs to use in the regulatory space.

Starting a New Consortium

To discuss laying a strong foundation for a consortium, Larkindale drew on her experience in leading the Duchenne Regulatory Science Consortium (D-RSC), founded in August 2015. One of the major lessons learned in establishing this collaboration was the importance of gaining buy-in from all stakeholders for the project. Larkindale spoke of the importance to look beyond just the needs of different stakeholder groups and consider what incentives will drive their participation and what timeline will work for their needs.

Not only is listening to the stakeholder community important, but also, Larkindale noted, “Educating the community and understanding what incentives they’re after was very important for getting the buy-in.” She gave the example of groups in the Duchenne space who may have a great deal of experience and knowledge related to the disease and its progression, but have little experience with working with regulatory bodies that endorse the model. Taking the time to educate them about the regulatory process and how it fits into the work the consortium is going to take on was a crucial step.

Larkindale also spoke to the nuts and bolts of getting stakeholder agreement through governance, project management and legal agreements. Since different partners bring different assets to the table, she noted the importance of balancing governance to be equal to each group’s contributions. Finally, all of the needs for each stakeholder group needs to be reflected in the legal agreements. A major issue arose when Larkindale’s team initially developed the agreements for D-RSC with companies in mind. These agreements were unacceptable to state universities, which sent them back to the drawing board.

Critical Factors for a Successful Collaboration

TransCelerate BioPharma is a unique consortium model, representing a single stakeholder group, biopharmaceutical companies. In the last three years, the collaboration has grown to 19 member companies and 14 active initiatives. Gill outlined the five strategic priorities created by the founding member companies, which assess industry challenges and align with all current and future initiatives of the group. Gill said it is important for TransCelerate to remain focused on these priorities because “in order to fulfill the promise of today’s science, we need to be more efficient with what we have.”

Despite having a single stakeholder group represented in TransCelerate’s membership, the consortium interacts with other stakeholders who have the same goal of improving clinical trials. This includes other industry initiatives, investigator sites, the research and contract research organization community and regulatory bodies.

To guide its work internally and externally, Gill outlined three critical factors that lead to success for TransCelerate: leadership, focus and discipline. A strong level of commitment from the membership companies has allowed the consortium to develop the laser-sharp focus and key strategic priorities that have led to major accomplishments in risk-based monitoring and other areas. Another learning moment for TransCelerate was in seeing that many consortia often try take on more work than is feasible, which often leads to failures. Gill said this pattern drove TransCelerate to focus on a small number of projects and generate successes before branching out into further initiatives. Finally, discipline in project management, budgets and accountability throughout the partnership ensures delivery of the consortium’s goals and does not allow projects to linger, wasting the time and resources of its members.

Where Have We Been and Where are We Going?

Buckman-Garner reflected on the history of the consortium model in order to show what is possible and what the consortia world needs for the future. In 2004, FDA launched the Critical Path Initiative, and a 2006 report called for increased infrastructure in the areas of biomedical informatics, biomarker development and interoperable clinical trials. In the following 10 years, a variety of consortia were founded to engage in these efforts and draw upon the power of uniting multiple stakeholder groups. As a result, CDER built several tools to engage with these collaborative models, including the Critical Path Innovation Meetings, the Drug Development Tool Qualifier Program and dedicated program staff to facilitate technology transfer.

Biomarker development is a hot topic in the medical research arena, and Buckman-Garner presented an ideal model where individual data from labs or consortia could be aggregated and shared through a biomarker database to ease and speed up the biomarker qualification process. She noted, “The more that we are able to start to aggregate information, share that information and make that information available to support qualification review,” this information can have more utility for the FDA. This kind of data sharing and aggregation is applicable in other areas of research and could have many of the same benefits it would bring to biomarker development and qualification.

Buckman-Garner pointed out other ways to advance consortia, such as improving approaches for consortia to share information with each other, like the Consortia-pedia Catalogue. “This society for consortia to share improved approaches with each other is critical,” she noted. Developing a willingness to share information from both successful and failed studies through data repositories and enhanced adoption of data standards will help prevent consortia from duplicating efforts and wasting resources. Finally, Buckman-Garner is looking for new models to train future generations of regulatory scientists through interdisciplinary approaches and new reward systems that value team success over individual successes. With these improved approaches to collaboration, the medical research community can band together in an effort to deliver faster and better treatments for patients.

This strong team of speakers reflected on the power of collaborative research models and where consortia work can continue to improve the field in the future. FasterCures has been dedicated to enhancing collaboration since day one and will continue to analyze, enhance and facilitate partnerships for the benefit of all patients.

Related resources:

• Watch the archive of the webinar
• Find more than 400 consortia in FasterCures' Consortia-pedia Catalogue