Sharing leads to more robust data on biomarkers, FDA says | For more: | Jay Bradner brings his open-science mindset to Novartis
April 28, 2016
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Developing the science of patient input
Momentum is building to include patient perspectives in biomedical research and development so that products and services better meet patient needs, reduce unproductive care, and improve individual and public health, FasterCures Executive Director Margaret Anderson and Managing Director Kimberly McCleary write in the cover story of this week's Science Translational Medicine. They track more than 70 collaborative initiatives across six categories that are defining and shaping the science of patient input. "No longer is patient engagement a fanciful notion as it was at the start of our journey in 2003, and the rush of activity is welcome and vital," they write.
Science magazine (free content) (4/27) 
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Science and Technology
Sharing leads to more robust data on biomarkers, FDA says
Researchers should share data on biomarkers used in drug development, experts said at the FDA's Predictive Safety Testing Consortium. The Critical Path Institute, TransCelerate Biopharma and others are developing methods for pooling biomarker data from multiple sources, but questions remain unanswered, such as who will have access and how to change the context for a given biomarker.
Regulatory Focus (4/26) 
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Jay Bradner brings his open-science mindset to Novartis
Celebrated Dana-Farber Cancer Institute researcher Jay Bradner has long been an advocate of open science and data sharing, and he brings that mindset along as he takes the helm at the Novartis Institutes for BioMedical Research. Bradner says that "pharmaceutical companies, truthfully, are much more interested in public-private partnerships, in open modes of discovery than ever before. ... I think that the culture of science at the basal level, where it's performed by investigators, is just this hope of being connected to a great idea and then seeing it through to completion."
STAT (4/26) 
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Study shows refined cancer treatment effective for 93% of leukemia patients in trial
Twenty-seven of 29 patients diagnosed with B-cell acute lymphoblastic leukemia who were treated with a refined cancer treatment at the Fred Hutchinson Cancer Research Center in Seattle were found to be cancer-free, according to a study in the Journal of Clinical Investigation. The B-cell ALL clinical trial, which started in 2013, involved treating the patients with genetically re-engineered T cells harvested from their bodies that would target a protein on the malignant B cells' surface.
The Seattle Times (4/25) 
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Technology enables broad research for precision medicine
New clinical data platforms enable broader population-based, multi-omic studies by linking electronic medical records with powerful data analytics, writes Novaseek Research CEO Kate Torchilin. New technologies and methodologies are automating the collection of both clinical information and biospecimens, creating "a virtual, sustainable, and more efficient ecosystem on which to base precision medicine research," she writes. "And because patient engagement is so critical for all such programs, providing a convenient way to patients to participate, including right in the community where they live and are accustomed to receiving healthcare, is important," she adds.
Genetic Engineering & Biotechnology News (4/25) 
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Finance and Economics
UBS Group AG raises $471M to invest in development of cancer treatments
A total of $471 million has been raised by UBS Group AG to invest in cancer research. The Zurich-based financial services company's Oncology Impact Fund plans to make up to 20 investments to develop new cancer treatments. The fund will pay a portion of performance fees and royalties that result from any new drugs into the UBS Optimus Fund, which backs programs for children in developing countries.
The Wall Street Journal (tiered subscription model) (4/27) 
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IPO could bring in $85M for Intellia Therapeutics
Intellia Therapeutics has filed updated plans for an initial public offering with the goal of raising $85 million. The Cambridge, Mass.-based firm uses CRISPR-Cas9 technology for the development of gene-editing treatments.
GenomeWeb Daily News (free registration) (4/27),  Renaissance Capital (4/27) 
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DOD grants $2.7M for development of peripheral ischemia treatment
The Defense Department awarded a $2.7 million grant to biomedical engineers at the University of Texas at Austin for their work on an injectable, regenerative gel containing proteoglycans and a growth factor to stimulate the growth of blood vessels and restore blood flow in patients with peripheral ischemia. The condition, most closely linked to smoking and diabetes, restricts lower-limb blood flow and can lead to amputation.
Patch.com/Austin, Texas (4/27) 
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Beware the drawbacks of equity crowdfunding
Regulations for equity crowdfunding look to be expensive and burdensome for startups, writes Alex Mittal, co-founder and CEO of FundersClub. "Given where it's at today, it's likely that Title III funding is slated to become the startup option of last resort," Mittal writes.
Mattermark (4/25) 
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Policy and Regulation
Protections for US companies' trade secrets passed by Congress
Congress passed and sent to President Barack Obama a bill to strengthen protections for US firms' intellectual property, including trade secrets, computer methods and manufacturing processes. The Defend Trade Secrets Act was unanimously passed by the Senate earlier this month and passed in the House on Wednesday by a vote of 410-2. The White House supports the measure.
Reuters (4/27) 
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