The FasterCures Track: August 2013 - Value: whose judgment call is it?

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The FasterCures Track

Value: whose judgment call is it?

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As we are all acutely aware, the healthcare system is changing dramatically and quickly. As controlling costs has become central, the concept of "value" is discussed everywhere, but its definition and the implications for medical research innovation are unclear. Pressure from payers on biopharmaceutical, device, and diagnostics companies for "real-world evidence" is growing. Companies are seeking new ways of enhancing the value of their innovations and proving it to payers and policymakers. Some fear a focus on value will be an innovation killer; others believe it can be a disruptive driver for companies to tackle risky areas of high unmet need and first-in-class therapies.

We have heard these themes from a number of you, a number of times, which spurred us to hold a workshop on value and innovation. You will hear more from us on this in the coming months on this – a report from the workshop will be slated for release in the fall, I'm on the steering committee for a conference convened by Brookings Institution and the Drug Information Association that will advance this conversation, and we look forward to engaging with the Centers for Medicare and Medicaid Services on these issues.

We're focusing on ways to truly define value because whether we like it or not, all stakeholders of the medical research ecosystem are in an unfamiliar position of having to advocate not just for more effective treatments but also for ensuring delivery of care is cost-efficient and streamlined.

As we wrap up the summer months, your team at FasterCures is steeped in the planning of our fifth annual Partnering for Cures meeting to be held November 3-5 in New York. Do register now – we continue to add some truly phenomenal innovators to the program, and we are thinking up ways to make this meeting even more meaningful and productive for all participants.

Enjoy the rest of your summer!

Warm regards,

Margaret's signature
Margaret Anderson
Executive Director
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FasterCures Program Updates

Programs

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Collaboration

Our goal: Stimulate innovative collaborations across all sectors – academia, government, industry, investors, and nonprofits – to speed up the time it takes to get new therapies from the lab to patients.

Value and Innovation illustration

How do we foster innovation in today's cost-conscious healthcare environment?
Two out of three participants in a recent FasterCures workshop believe that patients' needs and priorities are not driving decisions made by payers, innovators, and providers. To have a stronger grasp on the role the patient can and must play in reimbursement decisions, FasterCures and the Cystic Fibrosis Foundation convened a one-day multi-stakeholder workshop, "Value and Innovation: What Will the New Day Look Like for Patients?" Fifty-three leaders participated from venture philanthropy patient organizations, biotechnology and pharmaceutical companies, payers (public and private), and provider organizations. Five themes surfaced during the dynamic discussion:

  1. Patient-relevant outcomes will ultimately drive the definition of value
  2. Innovators and patients need to understand the evidentiary needs of payers
  3. Better data are needed to make better decisions
  4. It's imperative to remove waste from the healthcare system
  5. The concept of value is derived from the total cost of a patient's care, not the cost of an individual product

slide showing the benefits of venture philanthropy in medical research

Anderson highlights venture philanthropy at Tech Transfer Summit
At the recent Tech Transfer Summit in San Francisco, Margaret Anderson, executive director of FasterCures, spoke about patient groups, foundations, and venture philanthropy, and how technology transfer offices and early-stage biotech companies can more effectively partner with these key stakeholder groups.


TRAIN inventory helps collaborators better understand nonprofit disease research foundations

FasterCures has released an update to its TRAIN Inventory, which profiles the 55 participating organizations of The Research Acceleration and Innovation Network (TRAIN). Each profile highlights a common set of metrics, such as research portfolio, collaboration efforts, and financials. We created this inventory specifically to provide a resource to those wanting to know more about nonprofit disease research foundations and how best to engage in meaningful partnerships with them.



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Policy and Process

Our goal: Improve research processes and develop policies that will better support efficient development and approval of new therapies.

Policy Pulse: Summary of Workshop on FDA's Special Medical Use Pathway Proposal
FasterCures' Margaret Anderson was part of a Brookings Institution panel featuring Jim Greenwood (BIO), John Castellani (PhRMA), Jack Lasersohn (The Vertical Group), and Jeff Allen (Friends of Cancer Research). Anderson, providing context to the discussion, pointed out that minus additional budget, the FDA will only be able to go so far. "How much innovation," she asked, "can the agency be expected to handle?"



Open Source graphic

Understanding open science
John Wilbanks, senior fellow at FasterCures, discusses in his latest blog how an open approach can benefit life sciences: "Every new instrument we've invented to examine the human body has shown us only more complexity and interconnection. The failure of all of our new technologies to translate rapidly into drugs has demonstrated that we're the folks in the parking lot looking under the lamppost for our keys not because that's where they might be, but because that's where the light is."


IP Intersection features sample agreement templates

IP Intersection

Do you want to make informed decisions about your intellectual property (IP) management, but don't know where to start? Check out the sample agreement templates on TRAIN's IP Intersection, where you can view material transfer agreements, model deal documents, license agreements, and more.


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Capital

Our goal: Facilitate greater access to and more strategic allocation of capital to support
results-driven medical research.


Opal Group

Stevens moderates panel on investing in healthcare
During the Opal Financial Group's "Family Office & Private Wealth Management Forum" in Newport, R.I., Melissa Stevens, deputy director of FasterCures, moderated a panel that discussed the current state of investing in medical R&D, the disruptive force of nontraditional investing models, and the financial landscape. The conference attracts family offices, private investors, money managers, and private wealth service providers from around the globe.
Related resources:

  • Check out FasterCures' Giving Smarter Philanthropy Toolkit which presents donors with a framework for evaluating giving decisions built upon a clear understanding of research and philanthropic opportunities, and aligned with their own personal goals.

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Patients

Our goal: Increase patient engagement in research.


Patient-Driven Foundation Shepherds Sight-Saving Approaches from Bench to Bedside
In this month's TRAIN Innovator Spotlight, William Schmidt, CEO of Foundation Fighting Blindness, describes the foundation's challenges, goals, and accomplishments and highlights the work it's done to address the needs in the field and its focus on translation and driving therapeutic development projects through the pipeline.



photo and quote of AnneMarie

Celebrating two years of advocacy and action
Seven years ago, AnneMarie Ciccarella was diagnosed with breast cancer. Her mother, a breast cancer survivor herself, sat in the room and cried. This diagnosis changed her life, and naturally got her thinking about the future and her family. She told Time Equals Lives last year, "I don't want to be in that role with my own daughter."

  • Have you shared your story with Time Equals Lives yet? Join patients, family members, researchers, industry professionals, investors, and advocates by telling us why medical research matters to you.


Partnering for Cures


Register for Partnering for Cures, Nov. 3-5 in New York
Need a reason to participate in medical research's most forward-thinking and outcomes-oriented event? Here are five, plus a look at who's talking at this year's meeting:

  1. Find the partner who could make a difference. Whether you're looking for an investor or a collaborator, a customized partnering system allows you to easily find potential allies from all sectors of medical research.
  2. See collaboration in action. Hear case study presentations from 30 cross-sector programs with innovative paths to advance their R&D goals. A unique opportunity to get a pulse on trends and best practices in real time.
  3. Problem-solve with medical research leaders. Every panel discussion will be focused on addressing some of medical research's top concerns in concrete ways. The goal of each panel is not just to inform (or entertain) – but to leave you with real transformative ideas you can run with, best practices you can emulate, and lessons learned you can build from.
  4. Get expert advice to help you make informed decisions. Whether it's structuring collaborations or deals, developing marketing strategies, or crafting appropriate intellectual property policies, experts will be available on-site for one-on-one, free consultation sessions to help address your challenges.
  5. Share your ideas openly. Expand your echo chamber and significantly increase your friends and family list. Speeding medical progress requires unconventional approaches from nontraditional allies. Partnering for Cures provides you with a safe haven to explore the possibilities.




Tools You Can Use



Translational Research
Translational Research

Why Translational Resarch Matters
According to the National Institutes of Health, 80 to 90 percent of research projects fail before they ever get tested in humans. By industry's reckoning, the number may be even higher – for every 5,000-10,000 compounds tested, only 5 make it to clinical trials, and only 1 is ever approved by the Food and Drug Administration. Half of all experimental drugs in Phase III trials never become approved medicines. Learn more about why translational research matters.

Until next issue

If you have questions or would like more information about any of the items above, please contact info@fastercures.org.

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