Register today for March 20 Webinar on Building New Patient-Centered Research Networks | 2 new FasterCures reports outline practices/approaches of nonprofit funders of medical research | Baby is functionally cured of HIV, doctors say
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March 5, 2013
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White House to Congress: Exempt FDA user fees from sequester
The Obama administration urged Congress to allow the FDA to spend $41 billion in drugmaker user fees. The sequestration law limits the amount of fee-derived funds that the agency can spend, but experts warn that the agency will not be able to approve new drug and device applications quickly if the funds are subject to sequestration. Sequestration will slow progress toward cures and cost thousands of researchers their jobs, the White House warned. PharmaTimes (U.K.) (3/5), The Philadelphia Inquirer (2/28)
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News from FasterCures
Register today for March 20 Webinar on Building New Patient-Centered Research Networks
Engaging patients in the research process is more complex and exciting now than ever before. Patient-driven organizations are moving beyond simply creating patient registries or serving as a conduit to participants for clinical trials and are marshaling their forces in new and more comprehensive ways. In this FREE webinar, part of FasterCures' ongoing series, you will learn about two new models:
  • The T1D Exchange (Presenter: Dana Ball, CEO, T1D Exchange). Consists of an integrated clinic network of more than 65 clinics across the U.S., a biorepository and Glu, an online community with mobile capabilities for people touched by type 1 diabetes.
  • Registries for All Diseases (Presenter: Sharon Terry, president and CEO, Genetic Alliance). A cross-disease, crowdsourced registry that promises to break down the silos between diseases and gather information from patients in a standardized way.
You may submit questions for the speakers in advance when you register or by sending an e-mail to train@fastercures.org.  Register today.
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2 new FasterCures reports outline practices/approaches of nonprofit funders of medical research
FasterCures has just released two reports that paint a vivid picture of how medical research foundations, also known as venture philanthropy groups, have transformed the research enterprise. These entrepreneurial groups are accelerating medical R&D by tackling science where it needs the most effort and resources, and applying innovative business approaches in the pursuit for a cure. Both resources tell a compelling narrative of how venture philanthropy groups are creating a culture in medical research that is mission-driven, results-oriented and focused on the true bottom line: preventing, diagnosing and curing disease. Read them now:
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Science and Technology
Baby is functionally cured of HIV, doctors say
Doctors have reported the case of a Mississippi girl who was cured of HIV following aggressive care with antiretroviral drugs soon after her birth. Researchers are planning to conduct studies to see whether the treatment can be used for other infants. The New York Times (tiered subscription model) (3/3), Reuters (3/3), USA Today (3/4)
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Researchers make progress on myeloma drugs
Two recently approved drugs promise to turn a multiple myeloma diagnosis from a death sentence to a manageable condition. The drugs, along with four older drugs, have doubled median survival time over the past decade while giving many patients good quality of life, says Dr. Brian Durie, co-founder and chairman of the International Myeloma Foundation. Researchers are working on new classes of drugs, and the Multiple Myeloma Research Foundation is conducting a study into personalized treatment combinations. The Wall Street Journal (tiered subscription model) (3/4)
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Former FDA chief: Reform rules for clinical trials
Changing the FDA's burdensome requirements for clinical trials could help double the number of new drug approvals, former FDA Commissioner Andrew von Eschenbach and University of Chicago public policy professor Tomas Philipson write. Phase III studies are unnecessarily large and cumbersome for more precise and personalized medicine. Adopting smaller, quicker adaptive studies with post-market oversight would mean greater innovation and a better economy. Bloomberg (2/28)
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Alliance aims to ease medical data sharing
Five electronic medical records companies have formed an alliance to facilitate data sharing among hospitals and health care providers. Greenway Medical Technologies, Cerner, McKesson, Allscripts and Athenahealth will work together to develop common platforms and policies. Meanwhile, Verizon Communications announced a plan to build a secure online medical records exchange. Bloomberg (3/4)
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Finance and Economics
Crowd control may be necessary in new funding models
Crowdfunding has the potential to revolutionize fundraising for early-stage life sciences, but the approach carries significant risks and limitations, write two partners and an associate at law firm McDermott Will & Emery. Different models exist, market access may be limited, fees and regulatory burdens are likely to be high, large numbers of shareholder could be problematic, and drugmakers risk losing confidentiality, the authors write. Genetic Engineering & Biotechnology News/BioPerspectives (3/4)
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Drug development and America's favorite pastime
Drug development and baseball involve long development periods followed by short exclusivity periods for the product being developed; limited resources; assets that are traded, bought and sold; and a persistent need to find new ways to win, writes research scientist Kyle Serikawa. As in baseball, better statistical measures are improving drug development, including an emphasis on big data, Serikawa writes. Also as in baseball, "there is no way to guarantee success in drug development, and therefore, the goal is to set up the best processes, with clear measurements and benchmarks; to evaluate constantly but to intervene rarely; to work on increasing the probability of success," he writes. Xconomy/Seattle (3/1)
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Policy and Regulation
Europe supports push to cure rare conditions
The European Commission will spend about $187 million on 26 research projects on rare diseases, involving research teams from 29 countries. The goal is to discover effective treatments for metabolic, immune and cardiovascular disorders, among others. PharmaTimes (U.K.) (3/1)
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Society and Ethics
Annual event raises funds, awareness of rare cancers
"Saturday Night Live" star Seth Meyers, "Top Chef" host Padma Lakshmi and New York Giants linebacker Mark Herzlich were among the famous and not-so-famous participants in the annual Cycle for Survival fundraiser for rare cancer research. The event was launched in 2007 by Dave Linn and his wife, Jennifer Goodman Linn, who died of a rare soft tissue sarcoma in 2011, and has raised nearly $31 million to fund 53 different rare cancer research programs at Memorial Sloan-Kettering. HealthDay News (3/4)
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Poor adherence leads to failure of HIV drug trials
African trials of two pills and a gel designed to protect women from contracting HIV failed because patients did not use the products consistently, researchers reported at the Conference on Retroviruses and Opportunistic Infections. Only about a quarter of patients used the pills or gel correctly, according to blood tests, though 70% said they were doing so. The New York Times (tiered subscription model) (3/4)
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FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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