Thursday, December 16, 2010

Partnering for Cures Videos, Session Updates Now Online

Partnering for Cures brought together more than 800 leaders from 694 organizations representing all sectors of the medical research enterprise to participate in outcomes-focused dialogue about the challenges facing medical research. The meeting was held December 14-15 in New York City.

Videos and photos of most panel and plenary sessions, as well as the 31 innovator presentations, are now available online. Please visit regularly over the next week as updates and outcomes are posted.


SOME HIGHLIGHTS:

FDA Releases Guidance: FDA Commissioner Dr. Margaret Hamburg and Director of the Center for Drug Evaluation and Research Dr. Janet Woodcock released guidance for industry codevelopment of two or more investigational drugs for use in combination therapy.


Video: Margaret Anderson, Executive Director, FasterCures, opening remarks at Partnering for Cures 2010




Interview with Fox Business Network's Brian Sullivan: Finding Solutions for Medical Research: FDA Commissioner FDA Commissioner Margaret Hamburg and Milken Institute Chairman Michael Milken on the importance of bringing the medical industry and researchers together.





Video: Opening Plenary Session - Innovation: Where Is It Coming From?

Wednesday, December 15, 2010

Medical Research Leaders Pursue Innovation, Collaboration, and Outcomes in Search for Cures

NEW YORK (December 14, 2010) – More than 800 leaders spanning all sectors of the medical research enterprise – including pharmaceutical and biotechnology executives, academics, policymakers, nonprofit research foundations, and philanthropists – today convened with the shared goal of working together to accelerate the discovery and development of new medical solutions at the second annual Partnering for Cures meeting.

FasterCures, a center of the Milken Institute, convened this two-day meeting to bring together nontraditional allies to jump-start agreements and program development necessary to turn scientific breakthroughs into effective therapies for patients.

“We are at a critical inflection point in current discussions within the biomedical research establishment about what actions need to be taken to push science toward cures where possible,” said Margaret Anderson, executive director, FasterCures. “Patients need to know that we, the collective ‘we’, are doing everything we can to get new preventive, diagnostic and treatment options through the pipeline and into the clinic to improve patient outcomes and quality of life.“

In a plenary session, News From the FDA: Drug Development in the Age of Targeted Therapy, FDA Commissioner Margaret Hamburg, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., presented a guidance for industry codevelopment of two or more unmarketed investigational drugs for use in combination to treat a variety of illnesses including cancer, cardiovascular and infectious diseases, among other important topics.

“To truly advance medical progress and see the return on our national investment in the sciences, we need to seamlessly pass the baton of innovation from one sector to the next -- from the laboratory bench, through the regulatory finish line and into the hands of patients,” said Commissioner Hamburg.

With 16 panels and more than 80 speakers addressing, the meeting addressed mission-critical issues in the life sciences – from innovation to regulation, from drug repositioning to de-risking investments, and from translational research to data networks. A separate track featured 31 innovator presentations: tangible case studies of cross-sector programs that are potentially transformative and scalable across diseases and sectors.

The meeting also featured a customized partnering system that connected participants from different sectors who shared similar goals or had complementary activities. The system allowed participants to schedule free, one-on-one consultations with pioneers in the field.

In 2009, participants at the inaugural Partnering for Cures meeting said it was "game-changing." A year later, that meeting has yielded tangible results including the development of a preclinical stage cancer program collaboration, the creation of innovative mechanisms to advance cancer research and a matching grant program between a pharmaceutical company and a medical research foundation.

Videos, photos, and session summaries are available online at http://www.partneringforcures.org/.

Sunday, December 12, 2010

Medical Research: When Scientific 'Breakthroughs' Get Lost in Translation


Margaret Anderson
Executive Director, FasterCures, The Center for Accelerating Medical Solutions

Every day we see stories in the media about the latest medical "breakthroughs" that could lead to treatments or cures for dreaded diseases. We are overwhelmed with snippets about stem cells, genes linked to Alzheimer's disease, autism and diabetes. We hear that cancer drugs are being tailored to treat an individual tumor. And yet, many breakthroughs like these have not borne fruit for patients.

Whether it's because science is hard and unpredictable, or that resources are limited, or there is lack of prioritization -- too many great scientific ideas sit at the laboratory bench waiting for translation. But, there are successful models that have turned a basic discovery into an effective therapeutic option. These models can provide pathways to a healthier future.

We are at a critical inflection point in current discussions within the biomedical research establishment about what actions need to be taken to push the science toward cures where possible. We need to take advantage of this moment, and we need to bring patients, the public and policymakers into the conversation. Next week from December 13-15 FasterCures is convening in New York City all of the sectors involved in medical research to do just that. Partnering for Cures is a meeting like no other, a place to forge collaborations and participate in outcome-focused dialogue about the challenges facing medical research. We have always maintained that each of the sectors plays a vital role, whether it is government, industry, philanthropy, academia, finance or the non-profits. And the need for their ability to seamlessly pass the baton from one to the other has never been greater or the stakes higher.

Successful models have integrated all of these sectors. Everyone needs to be at this table. Few life-saving therapies have come to market without the resources of private industry. Increasingly, patients have become more sophisticated and disease groups are ever innovating with new models for collaboration with academia and industry. The U.S. government is recognizing that it can play a special and critical role in providing an environment where successful partnerships can grow and proliferate. Partnering for Cures provides an opportunity for all sectors to productively collide, creating an ultimate open source opportunity to shine a light on these models so others can learn and build on them.

One area of keen interest to us is identifying solutions and models to cross the so-called "Valley of Death" -- an ever-widening gap in funding and support for the kind of research that moves basic science down the path toward treatments.

In a new report released today by FasterCures, "Crossing Over the Valley of Death," we highlight the productivity gap that currently exists today, how research moves from molecule to marketplace, how we can traverse the Valley of Death and what all of the sectors are doing towards that end. Many players are marching into that valley, but we are far from reaching the other side.

The need to keep marching with the resources required to make the passage is recognized by advisors to U.S. National Institutes of Health (NIH) Director Dr. Francis Collins, who have recommended that a new translational medicine and therapeutics development center be created by the federal agency post-haste. This proposed center would bring together existing NIH activities in translational research and medicine and allow greater coordination and collaboration internally as well as externally, and ultimately, we hope, produce greater outcomes.

We need to support this recommendation, which if implemented would shine a light on the critically needed but under-resourced and under-appreciated area of translational research. In our jump to embrace this incredible opportunity, however, we need to ensure that Peter is not robbed to pay Paul. NIH's other strengths include supporting the nation's basic biomedical research enterprise, and that focus cannot be lost or diminished in our impatience with the pace of progress. Basic science is still as important as ever, but we also want and deserve concrete outcomes.

Dr. Robert Beall, President and CEO of the Cystic Fibrosis Foundation often talks about the Foundation's own model for de-risking research as providing "more shots on goal." Never has the need been greater to have all of the sectors implement that same approach, to take bold steps to move forward swiftly.

Our nation's wise and prolonged investment in basic science has produced discoveries that now need translation. Knowledge gained from basic discoveries allows us to take more strategic and informed shots on goal. This new and important focus on translation no doubt makes some in the research community uncomfortable, as they worry about focus, changing research priorities and competition over scarce dollars.

We recognize those concerns, but at the same time, the need for accountability and outcomes prevail. Patients need to know that we, the collective "we" in the medical research system, are doing everything we can to get new preventive, diagnostic and treatment options through the pipeline and into the clinic. The alternative to this change is the status quo -- 15 years for an intervention to go from bench to bedside. Clearly that isn't acceptable. Is it?

Join us at Partnering for Cures, December 13-15 in New York City. .

Thursday, December 9, 2010

Are we optimizing our health IT system to improve patient outcomes?

Dozens of public and private stakeholders in medical research joined FasterCures last week at a forum about health information technology (health IT) policies – what these mean, what these represent, and how these will impact patient outcomes. The discussion focused on our national health IT infrastructure and how it is designed (or not) for clinical research. FasterCures Executive Director, Margaret Anderson, drove the discussion with Adam Clark, Ph.D., Director of Scientific and Federal Affairs at FasterCures. Adam sits on the policy committee of the Office of the National Coordinator for Health Information Technology (ONC) as a consumer advocate.

Key points raised during the forum include:
  • The lack of communication between different sectors of the medical field despite the ever-growing state of health information technology.

  • The current efforts by the ONC to establish standardized electronic health record (EHR) systems as a means of enhancing the quality of clinical care and

  • Utilizing patient data to advance research and development.

  • Addressing the challenges of patient privacy and security in implementing standardized EHR systems.

  • The need for patients to have access to information in EHR systems, not only clinicians and providers.

  • The importance of health information technology encompassing clinical research moving forward, creating effective avenues towards scientific innovation.

This effort is part of FasterCuresThink Research program that supports the utilization of medical records and clinical datasets towards research on the progression of diseases and the development of treatment methods for them. An updated version of the FasterCures’ white paper entitled “Think Research: Using Electronic Medical Records to Bridge Patient Care and Research” will be released in early 2011.