Using IP Strategies to Break Down Barriers to Progress

Intellectual property (IP) protection is critical to driving investment in new products that can help patients as well as create economic value. Some maintain that IP protection can make scientific collaboration, technology transfer, and commercialization more challenging. At Partnering for Cures, five leaders in biotechnology, science, and intellectual property joined together to discuss how IP could aid the pace of innovation and technology to get to patients who most need it.

Moderator Maria Freire of the Foundation for the NIH began by pointing out that some people “go into panic attacks when having to deal with intellectual property … it seems like a big hurdle between basic science research done in universities or companies and getting it to the market.” However, this is not a new issue. The biggest change is that, within the last 10 years, new players have emerged: venture philanthropies. Freire referenced FasterCures’ newest publication, Unlocking Intellectual Property: Principles for Responsible Negotiation, which serves as a useful tool for all parties in biomedical research, in particular these new nonprofit disease groups and philanthropists.

In addition to the arrival of new players, Stephen Johnson of Kirkland & Ellis LLP and One Mind for Research emphasized that the IP landscape has changed due to the arrival of new technology. In the past, IP focus was on patents, but the “focus has moved away from patents and toward data,” he said. He used to see resistance to sharing data among pharmaceutical and biotechnology companies. Now, “there is acceptance of the pre-competitive space,” and companies increasingly embrace the opportunity to work together. “The future of creative collaborations will be balancing openness with incentives,” he suggested. Freire summarized that companies are more willing to share all data in the beginning, but once there is true innovation, they will then put protection around it. Johnson agreed with her assessment and advocated for processes that promote transparency. He said that one of the reasons that companies would be reluctant to share data is that they are worried that someone else who has access to the data is smarter than them.

Stephen Friend of Sage Bionetworks gave an example of another hindrance, stating that “many companies don’t feel like they can share what they’re talking about … and it’s hard to get things financed without a clear IP strategy. Many worry that someone else could come in, grab the idea, and take advantage of them.” He supported extending the pre-competitive space: “Too many post-docs think they are working on the next billion-dollar drug long before it is.” He cited the successful collaboration of Merck, Pfizer, and Lilly, who generated data in China and agreed that they would share the data among themselves for one year and then make the data publicly available.

Teresa Stanek Rea said that the U.S. Patent and Trademark Office also has a cooperative approach: “We are trying to collaborate with companies to find out what they need to do their job.” Like industry, the Patent and Trademark Office is trying to be more precise and more efficient in what they do and sees itself as the innovation agency in the U.S. government. “We are an agency in the throes of change, just as you are,” she said. Rea noted that the America Invents Act, puts forth “great provisions that help the user community because it takes a second look at issued patents, and whether the patent should have been granted.” Rea believes that the act should minimize litigation and not inhibit research.

Steven Tregay of FORMA Therapeutics brought the conversation back to venture philanthropies and emphasized the importance of being “cognizant of whether the patent that covers the product can actually be translated into treatment.” The key is helping people understand the value for society versus owning one possible combination that may be pertinent or may never be turned into a drug. He cited the success of the CoMMpass project of the Multiple Myeloma Research Foundation, a collaborative study that brought together a network to decide how IP will be shared and who has access to it. Tregay has also worked with the Leukemia & Lymphoma Society (LLS), which aggregates data from many organizations at once. LLS is concerned with creating value to patients and creating a path forward, and it shouldn’t be burdened with the “nightmare of bringing universities together,” he said. “That is the power of these disease foundations – that they are really laser sharp in their approach,” said Freire. “They don’t want to fix the world; they want to fix something for that indication. The traditional paradigm may not necessarily apply.”

Friend agreed that traditional ways of doing business may stymie dialogue and interaction. “We are at a spectacular time where we have tools, new approaches in order to innovate, and yet the way we have structured our incentives and our rewards around sharing, around who is getting credit, et cetera, is basically independent to that.” He cited the success of CommonMind, a public-private pre-competitive consortium that generates and analyzes large-scale genomic data from human subjects with neuropsychiatric disease and makes the data and results broadly available to the public. Friend said that university tech-transfer offices had a hard time at first agreeing to share data being generated, but that “the data required to build the models needed to develop the drugs had to be accessible in order to innovate.” The parties created collaboration agreements that allowed investigator data to be shared with others and not kept to themselves. “We must come up with incentives and rewards that allow the data to get out there,” he said.

Joseph DeSimone of the Frank Hawkins Kenan Institute of Private Enterprise at the University of North Carolina agreed that “partnerships are what work the best, and new connections should always be made,” but cautioned that “without really clear IP, it’s getting increasingly hard to get things financed. Having a really clear IP strategy and path to market is going to be increasingly important.” His university has a conflict of interest committee that meets with him and his students who start companies. He believes that transparency of partnerships makes it more successful: “If you are open to that kind of openness, it can be powerful to enable these kinds of connections.”

In closing, the panelists discussed the future of intellectual property protection with regards to innovation. There was a consensus that patenting had gotten more difficult, and Freire ended by saying “Let’s not rediscover wheels. If you can put something in a box, it’s a lot easier. If you want to think outside the box, just make sure that what you have already doesn’t fit in an existing box.”

Related resource:
Unlocking Intellectual Property: Principles for Responsible Negotiation

Imagining improved models of technology transfer

There is a growing realization that the traditional model of technology transfer at universities isn't entirely keeping up with the growing complexity and changing landscape of biomedical research and development. Though agreement structures are still evolving and funding sources are changing, a growing appetite for earlier information sharing and partnering have led to new and creative approaches to collaboration.

At Partnering for Cures, five experts in the field of technology transfer and university commercialization discussed new approaches to innovation and collaboration. Moderator Lou DeGennaro of the Leukemia & Lymphoma Society began the discussion by asking what recommendations the experts had for dealing with the “growing pains around commercialization” and the consequent tension universities have been experiencing with tech transfer.

Louis Berneman of Osage University Partners was quick to designate himself as a “critical lover” of tech transfer and argued that the metric for measuring success should not be how many university start-ups are in existence, but rather how many went on to “induce further investment.” Berneman added that licensing revenue should not be the main concern.

Other panelists agreed that tech transfer needed to be viewed as a comprehensive process. Chris Coburn of Cleveland Clinic Innovations noted that “[Tech transfer] is all about execution and talent—companies can’t just be good at negotiating deals, they must be attentive to details.” Jodi Black of the National Heart Lung and Blood Institute at the National Institutes of Health added that innovators and those in tech transfer offices needed to work together in order to attain the necessary intellectual property expertise. She explained that “these ecosystems should be developed in a way that rewards culture change and values commercializing innovations.”

Regis Kelly of the California Institute for Quantitative Biosciences reminded the audience of the urgency of addressing tech transfer challenges when he stated that he was on a mission, mainly inspired by his wife who has Alzheimer’s. Kelly said that the “rate of getting ideas out of the university and into the marketplace to help people has to be accelerated” and that “tech transfer offices are too focused on faculty” even though the best people to start companies are post-docs, those with “fire in the belly.”

In Robert Urban of Johnson & Johnson’s opinion, tech transfer relies on people, and bringing people together gives technology the opportunity to realize itself. He offered an example from his time at MIT, where he was recruited to help launch an interdisciplinary institute to create a new way to tackle oncology, a field that is “buried alive in data.” Urban asserted that “biologists needed to be put in an area where they could be supported by tech people” so that they are close enough to interact and collaborate. The institute includes biologists, technologists, and mathematicians. In five years, this collection of individuals has created 17 companies, which have raised $300 million in capital.

In closing, the panelists agreed that better project management is a key catalyst to advancing this field. Kelly and Coburn both stated that there was a shortage of information, and Coburn suggested profiling the 75 largest academic medical centers so there would be a central database of information about their medical innovations. Berneman emphasized the importance of not focusing on licensing revenue, but instead on future investment, while Black stated that regulatory and business expertise needed to be “in-house” at research institutions and companies for better decisions to be made. Urban’s advice was to encourage transparency and find personnel that were able to “adapt to the journey [of tech transfer],” even if that means starting the process over from the beginning, if that is what is needed. DeGennaro summarized by saying, “It’s not just about how many new grants there are or how much money has been accumulated, but rather a need for project management [of tech transfer] in a way that hasn’t been thought about yet in an academic setting.”

Releasing Unlocking IP: Principles for Responsible Negotiation

By Elizabeth West, Program Manager, FasterCures

Readers of the FasterCures blog are well aware of the importance of reducing cost, time, and inefficiency in the biomedical research system. One area consistently raised to us as having unnecessarily high transaction costs - both human and financial - is intellectual property (IP) negotiation.

We've long heard how IP can be a roadblock to innovation, but since it's a necessary and critical "cost" of doing business in drug development, we began to wonder if it might be possible to create an agreed-upon culture of responsibility in the practice of negotiating IP for medical research collaborations.

Last week we released Unlocking IP: Principles for Responsible Negotiation to serve as a set of guiding principles and points to consider when engaging in intellectual property negotiations involving biomedical R&D. The principles are a useful tool for all parties in biomedical research, in particular disease foundations, nonprofit disease groups, and philanthropists negotiating IP with academic, industrial, and nonprofit partners. The document includes principles for before, during, and after negotiations, for both new and seasoned organizations engaging in IP negotiations.

Some of the highlights include:

• Do not let fear paralyze you…If the desired result [of a deal] is based on research impact as well as monetary returns, not doing the deal or slowing progress is a far bigger loss to the patient and the public than lower potential economic return.
• Make sure you have the right people at the table at the right time…Think through which stakeholders are needed to  foster innovation, and only exclude a stakeholder group—especially nonprofits—after careful thought.
• Build in “use it or lose it” requirements (interruption licenses)….If you have invested in the IP and the owner is not exercising the rights to use the invention and make it widely available, or if they are using it in a way that impedes progress, ensure you have a way to take it to a party where its value can be maximized.

The principles emerged from a small, expert-led working group convened by FasterCures in July 2012. In addition to developing the principles, the group came to some broader conclusions regarding the intellectual property ecosystem. In particular, it found that there is a fundamentally new landscape in biomedical research resulting from the emergence of venture philanthropy and patient advocacy groups. These groups tend to want to enhance the freedom to operate, versus the limiting model more prevalent in the current environment.  A key conclusion of the working group is that an IP management system is needed that addresses this emerging ecosystem, not reflects the current one. We welcome all of your thoughts on the fundamentals of a forward-looking IP system.

The Webinar – directly from the experts

On Nov. 16, we continued the conversation on IP and the principles through the TRAIN (The Research Acceleration and Innovation Network) Webinar series. The Webinar (available to view here), moderated by Margaret Anderson, was led by an expert panel of individuals with in-depth experience in intellectual property negotiation from a variety of viewpoints.

Maria Freire, of the Foundation for the NIH, laid out the main findings of the working group and gave a detailed overview of the principles themselves, as well as spoke of the increased sense of urgency and interest of many groups in deals that “move towards the goal.” Robert Cook-Deegan of Duke University’s Institute for Genome Sciences and Policy provided the audience with the broader landscape of intellectual property negotiation successes and controversies, as well as analyzed the elements of success through an in-depth case study of Cystic Fibrosis Foundation and the CFTR gene patent. David Lubitz, of Schaner&Lubitz, PLLC, which provides council for many disease foundations, gave a thorough overview of the viewpoint of disease foundations and venture philanthropy groups, including funding goals, trends, and useful IP tools, including  interruption licenses. Many of the questions during the Q&A period focused on the replicability of the Cystic Fibrosis Foundation model, which the panelists agreed would require a foundation with financial resources, technical expertise, and potential commercial partners.

More on IP at Partnering for Cures

We will have more on this topic at our annual conference, Partnering for Cures, in New York City, Nov. 28-30. The IP-focused panel, License to drive (innovation): IP strategies to support, not slow, progress, will explore the evolving IP law and procedures, the IP implications of the movement toward more precompetitive collaboration in biology, examples of responsible IP management practices, and how IP decisions can impact follow-on innovation and patient access. We invite you to join us there!

 

TRAIN Workshop Gets ‘in the Weeds’ on Making Deals

Kristin Schneeman, Program Director, FasterCures

Earlier this month, FasterCures hosted a workshop on “The Nuts and Bolts of Cross-Sector Dealmaking,” bringing together a number of the venture philanthropies in TRAIN (The Research Acceleration and Innovation Network) to learn from and share with their peers the actual strategies and tactics nonprofits and biopharmaceutical companies are using to partner, as well as how foundations can better find and fund the most promising, commercializable research within universities. It was a valuable boots-on-the-ground exchange of specific resources and ideas for further exploration among a cross-section of all the stakeholders involved in medical research – foundations, industry, academia, government, and finance.

The day began with a discussion of a number of nonprofit collaboration models, intended to demonstrate the range of relationships and activities that currently exists among foundations and their academic and industry partners, from building and managing academic consortia for precompetitive and clinical research, to providing “concierge” services for academic researchers interested in commercialization, to investing in small companies through a variety of mechanisms and co-funding with large companies, to nonprofit and virtual biotechs.

Subsequent sessions focused on sharing strategies for finding partners (“the dating game”); the nitty-gritty of negotiating relationships, from licensing and royalties to milestones and data-sharing; and finally, what’s needed to sustain and replicate these relationships.

There were far too many valuable bits of information to relay in a brief blog post, and we will be working on a longer summary of the discussion, but I’ll highlight a few key takeaways:

• Lawyers and tech transfer officers shouldn’t run the show, but should absolutely be part of the team to craft terms that support the goals of a collaboration and help trouble-shoot any problems that might arise. It is critical to understand the legitimate needs of all partners.
• Communication is key, and there are so many ways we can communicate informally that we don’t – e.g., sharing non-confidential information with potential partners, holding non-binding legal roundtables to talk through issues such as the distinction between commercial and non-commercial research, etc.
• Industry-quality project management is fundamental to keeping programs on track and developing an asset that will be attractive to industry partners.
• Collaborations need to develop legs of their own and not depend on individuals within companies and foundations to sustain them. Building in surrogate markers of success that show progress over time (not just that “research is happening”) can help expand the circle of champions.

There were also many ideas for actions that would be helpful in smoothing the creation and sustenance of these collaborations, including:

• More transparent information about points of contact within companies, nonprofits, and academia;
• Education of tech transfer offices about what criteria potential partners are looking for (other than the Association of University Technology Managers data points they have historically been judged against);
• An effort to require more sharing of data about “failed” research efforts (and perhaps rebranding them as something other than “failures”); and
• Working with the IRS to better define “program-related investments” in the medical research space (outside of global health) to increase foundations’ comfort level with making such investments.

One of the most important outcomes of the day was a collection of resources that participants brought to share with one another and with the broader research community. These included template agreements of all sorts; due diligence guides; publications on collaborative models, venture philanthropy royalties, and charitable investing; and much more. This treasure trove of new tools will be available very soon on TRAIN Central Station.

Who decided that “top 10” lists should have 10 things on them?

By Kristin Schneeman, Program Director, FasterCures

For five years now FasterCures has been producing its “Top 10” list of medical research trends to watch in the coming year. And every year we have to go through the painful process of deciding what to leave on the cutting room floor.

We relish the opportunity to tell people about some of the interesting trends, ideas, initiatives, events, and people that we think are worthy of attention in the 12 months ahead. But there is more that we’re thinking about, of course. The Top 10 list tends to be focused on things that we think are likely to be the subject of action or debate over the coming year, but there remain big, critical issues that span across years for all of us to focus on and work on together.

We’re concerned about the financial sustainability of the whole research enterprise. We’re hearing that venture capital is fleeing from life sciences, and those who are sticking around are investing in less risky opportunities. We’ll be fortunate if government funding remains flat – we’re not predicting any big increases in the current fiscal environment. So if more money isn’t likely to be pouring into the system anytime soon, what new sources of funding are out there, and what new financial models might be applied? Could constrained resources be an impetus for greater focus and efficiency in the research process?

The “business model” of university innovation is changing, and we’re working to understand the landscape of new approaches to commercializing university inventions: Who are the new partners? What are the new sources of capital? Do we have the human capital needed? What are the new intellectual property policies? When is the right time to license?

We’re interested in what appears to be an increasing openness on the part of big pharma to the need for new business models of their own, not just doing things better the same old way. They’re groping their way toward it – embracing more truly “open innovation,” more pre-competitive collaboration, new ways of interacting with academia, working more closely with patient groups – but the pressure is on to “evolve or die.”

Supporting and improving the FDA will continue to be a major focus for us. We’d like to see FDA be able to better leverage NIH’s research capacity to improve its ability to evaluate the new science coming down the pipeline. We’d like to see the Reagan-Udall Foundation established on firm footing so it can become the kind of resource that the Foundation for the NIH has become for the NIH. We’d like to see more patient-driven research foundations engaging in a conversation with FDA about patients’ needs and priorities. And we’ll be doing our best to ensure a productive public dialogue about the role and record of FDA; a “blame game” doesn’t serve any of us well.

As if our mission weren’t ambitious enough, we’re also considering how the states on either end of the medical R&D continuum – prevention/wellness and the delivery of care – fit in with our work to improve the system that discovers and develops treatments for disease. And we are considering what the impact of an increasingly global research enterprise, as well as global sources of capital, could have on the U.S. biomedical research system.

With so much work to be done, there is no time to waste!

On Huffington Post: Top 10 Medical Research Trends to Watch in 2012

Margaret Anderson, Executive Director, FasterCures

1. NCATS: Who moved my cheese?This year, the National Institutes of Health will establish its new National Center for Advancing Translational Sciences (NCATS), created to speed the translation of basic discoveries into therapies that will improve public health. In light of our current fiscal reality (and limitations), we breathed a sigh of relief to see it up and prioritized in the appropriations process. Solutions can be tough to develop, and tougher to implement. How will NIH translate its translational focus to its cadre of basic research-focused scientists? Will NCATS strengthen and streamline existing efforts at the 26 other institutes and centers? Will it help to move discoveries out of the lab and to patients more quickly? NCATS is one way to get moving (and, as we know, "movement in a new direction helps you find new cheese"). The stakes are high with more than 100 million patients waiting for meaningful treatments options. But with Dr. Francis Collins as the visionary behind this effort, the same man who defied expectations by completing the Human Genome Project ahead of schedule and under budget, we like the odds.

2. FDA: The science of failure.Companies usually turn to the FDA to help them succeed (and with 35 approvals in FY2011, it helped many succeed), but perhaps it can also help them fail, faster. Commissioner Hamburg seems committed to having FDA play a role in improving R&D efficiency for all. FDA is sitting on mountains of data, and she has made it a priority -- through the agency's Strategic Plan for Advancing Regulatory Science and specific efforts like the PACES Initiative -- to figure out how to share more of it, particularly from compounds that were not approved, to help researchers and companies learn from failures. Will the industry see its self-interest in this and allow data to be shared -- and recognize that there is a business case for opening up the file cabinet?

3. Intellectual property: Keep it simple, stupid.Everyone in medical research seems to agree that intellectual property is a significant issue slowing progress, from disagreements over the value of discoveries to the time it takes for agreements to be negotiated, and the aversion to standardized contracting. We say, why does this need to be so complicated? Can't we come up with a simple set of guiding principles or values that we all agree to abide by -- something along the lines of Google's "Don't be evil"? Ideas, anyone?

4. Cures on the stump.Last time we checked, 2012 was a presidential election year. Will life sciences make an appearance on the agenda? The Obama Administration is working on a National Bioeconomy Blueprint to "harness biological research innovations to address national challenges in health, food, energy, and the environment" -- oh, and of course to "grow the jobs of the future." What commitments will the candidates make to support this critical economic driver -- whether NIH funding, tax policies for industry, workforce training, etc.? Can we make innovation in the life sciences a topic du jour in the election season?Venture capital investment in life sciences is on the wane, but venture philanthropy investment in drug development is on the rise. We're hearing discussion in several quarters about the idea of blending venture capital and venture philanthropy in some sort of hybrid investment fund. The wider world of social entrepreneurship has been experimenting with business models and forms of capital all along the spectrum from not-for-profit to for-profit for some time; the field of medical research is slow to catch up. We'll be watching for the launch of one or more of these efforts in 2012. Look for more discussion of financial innovations for translational research from FasterCures in 2012 as well.

5. 2012: Year of the Patient?TIME magazine notably called 2011 the "year of the protester." Could 2012 be the "year of the patient"? We offered up a roadmap to effective activism in 2011, built on the example of the HIV/AIDS advocacy movement. We identified its ingredients for success as attention, knowledge and solutions, community, accountability and leadership. Many of us point to the successes this movement created in HIV/AIDS drug development. Thirty years later, will more groups seize the mantle and make 2012 as much about changing the research and regulatory paradigm as about raising more money and awareness?

6. Reimbursement is the new approval.Even if we are successful at getting new treatments through the R&D and approval process, the question remains whether payers (government and private) will be willing to pick up the tab. Insurance coverage decisions -- and insurers themselves -- are playing a role farther upstream in the R&D and investment process, as companies begin to craft their research priorities and programs to maximize the possibility of reimbursement. Can payers position themselves as part of the solution to getting truly innovative therapies to patients? CMS is currently seeking comments on a revamp of its "coverage with evidence development" program. Could this become a model for other insurers to get patients access to new treatments while continuing to generate data about its effectiveness? Will smaller companies start reading the tea leaves and work with payers to avoid "failure to launch"?

7. HIT: If we build it, will research come?The federal government has succeeded in driving a doubling of providers' adoption of health IT over the last two years through its stimulus funding. But their interest in ensuring all this data is available for research to drive new, more effective treatments for patients is still not evident. "Meaningful use" of electronic health records (EHR) to qualify for federal funding seems to have been an effective carrot/stick combination for driving adoption of EHR systems for patient care. Let's use it in the service of research by requiring that using EHR systems for clinical trial screening and matching be included as a measure for meaningful use in the next round of definitions. Unlike the "Field of Dreams," just because we built the infrastructure, research use will not magically appear.

8. CTSAs: Who you gonna call?The first five years of NIH's Clinical and Translational Sciences Awards (CTSA) program are over, and by many accounts the focus at most of the 60 institutions has been on standing up the program on their own campuses, not on maximizing the power of the network. That may start to change in 2012 with the creation of a new Coordinating Center at Vanderbilt, which is already ramping up development of tools and resources, such as a shared IRBs, contract language, IP database and research data capture. Its director, Gordon Bernard, wants to make it a "virtual institute of drug development," a one-stop shop for companies, investors or nonprofit funders looking for academic partners. At Partnering for Cures 2011, he invited participants to contact him with their needs, saying that until the right partners are in place "we'll own that problem." So give him a call.

9. Putting old wine in new bottles.Enthusiasm continues to grow in academia and among patient groups for the idea of repurposing existing compounds. Companies, if they're interested at all, are looking for some sort of exclusivity mechanism to allow them to make money. NIH sees this as a central opportunity for NCATS (see #1), and NIH's TRND program is piloting a repurposing effort with the Leukemia & Lymphoma Society and the University of Kansas as partners, with the aim of recruiting an industry partner. But pilots won't be enough; there needs to be funding sources identified, IP policies sorted out and regulatory pathways clarified. Could 2012 be the year we create a business model to support repurposing? Tick tock goes the clock. Patients are waiting.

10. Convergence of venture capital and venture philanthropy.Venture capital investment in life sciences is on the wane, but venture philanthropy investment in drug development is on the rise. We're hearing discussion in several quarters about the idea of blending venture capital and venture philanthropy in some sort of hybrid investment fund. The wider world of social entrepreneurship has been experimenting with business models and forms of capital all along the spectrum from not-for-profit to for-profit for some time; the field of medical research is slow to catch up. We'll be watching for the launch of one or more of these efforts in 2012. Look for more discussion of financial innovations for translational research from FasterCures in 2012 as well.

Read FasterCuresTop 10 lists from previous years:

• Top 10 Medical Research Trends to Watch in 2011

• Top 10 Medical Research Trends To Watch In 2010

For more by Margaret Anderson, click here.

Infusing Life into the Valley of Death

Medical research leaders and patient advocates yesterday participated in a forum that spotlighted the Cures Acceleration Network (CAN) provision of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010. Speakers and participants were eager to discuss CAN and its potential to transform the medical research enterprise by supporting efforts specifically designed to bridge a gap in the therapeutic development pipeline between basic and clinical research.

Senator Arlen Specter (D-PA) introduced CAN to bridge this gap, often referred to as the “Valley of Death,” where research lies dormant and ideas come to a halt because the necessary next steps to take basic research discoveries and turn it into a safe and effective therapy are not taken. The forum was convened by Parkinson’s Action Network and FasterCures.

According to Amy Rick, CEO of PAN, “the business of taking a discovery and pursuing it for its full therapeutic potential is dramatically different than the business of basic research.” It includes considerations like FDA, legal issues, intellectual property, and the timing structure and milestones are different, as well. Appropriate incentives need to be in place to fill the valley of death.

CAN, as authorized, will be established within the Office of the Director of National Institutes of Health (NIH) and would award grants through NIH to biotech companies, universities, and patient advocacy groups. John Schall, deputy CEO of PAN, provided details of this provision, including:

• CAN is designed to accelerate the development of high need cures, including through the development of medical products and behavioral therapies. “Medical product” in this context means a drug, device, biological product, or any combination of the three.
• A diverse, 24-person board will be convened to advise the Director of the NIH on the conduct of the activities of the CAN. This board will represent multiple sectors including at least four individuals from the venture capital community and at least eight patient advocates.
• CAN is subject to the appropriation of funds.

John Myers, Senior Health and Science Policy Adviser to Sen. Arlen Specter (D-PA), encouraged patient advocacy groups to stay involved throughout the appropriations process already underway and build on the momentum of the health reform law, to ensure the potential of the CAN provision can be realized. Learn about how you can support this effort.

The forum, moderated by Margaret Anderson, Executive Director of FasterCures, elevated questions and discussion items that will likely continue as the process to implement the new health reform law unfolds.

This conversation will continue online at FasterCures TRAIN Central Station. Join the discussion.