Health Economic Outcomes/Comparative Effectiveness Research/Health Technology Assessment Track at DIA's 49th Annual Meeting

TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA) Learning Objectives:  Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical products How can clinical trial design impact reimbursement potential?

How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

What are the pharma, safety, and patient perspectives on big data methodology?

2012 US Payer Landscape survey looks at CER and EBM use in coverage decision making.

What are benefits and outcomes of collaborations between payers and pharmaceutical companies?

How can we utilize EMRs as an  innovative methodology for evaluating Therapeutic Effectiveness?

What are different ways for incorporating patient-centered approaches in model development?

What are pros/cons of using observational methods to support comparative effectiveness research?

How can information sharing  be facilitated across Sponsors, Regulatory and HTA Agencies?

How do Public and Private Payers translate CER into Medical Payment Policy?

Clinical Operations Track at DIA's 49th Annual Meeting

 

• What are the emerging challenges with patient registries? 
• What do you need to know about statistics?  Variability~confidence intervals~hypothesis testing~p-values
• What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?
• How do you ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV?
• How do different enrollment metrics/analyses benefit different stakeholders (site/sponsor/recruiter)? 
• Do you know how to shape your cost with hard and soft coverage analysis trends?
• How can investigator sites pave the way for running successful Clinical Trials?
• Is this trial worth it? Finding answers for Site and Project Managers.
• How should you tailor existing patient recruitment programs to engage parents for Pediatric Trials?  
• How do you establish metrics for Optimal Patient Recruitment and Retention?  
• What global requirements are needed in the Informed Consent Process? 
• What are the Domestic and Global trends in Clinical Trial budgeting?  
• How can we use Big Data to design smarter clinical studies? 
• Can a mathematical algorithm used in point-of-care risk assessment id and screen Clinical Trial subjects?  
• How do you build Patient engagement to make Clinical Research better for everyone?  
• Learn to apply innovation, avoid controversy and implement best practices in Clinical Trials 
• How can site metrics be used to improve enrollment timelines?
• Can you identify Pharmacy-directed outreach and Patient  Recruitment strategies for your Clinical Trial? 
• What do you need to maintain regulatory compliance with continuously evolving import/export processes? 
• How do you solve key challenges to running efficient investigator meetings during Clinical Study startup? 
• What impact will FDASIA have on your need to recruit diverse clinical subjects?  
• What 4 pillars support comprehensive operational feasibility assessment for Clinical Trial planning?  
• Fed Up with tracking pointless Metrics? Learn how to select and use Metrics that work.  
• What are the challenges and requirements of implementing Central Statistical Monitoring? 
• What unique challenges are associated with pediatric trial recruitment, retention and blood sample collection?  
• What are the Diverse Operational Approaches to generating evidence in the Late-phase Environment? 
• What are the areas of potential risks when undertaking Global Clinical Trials in Emerging Markets? 

New Initiative Takes on Multiple Sclerosis with Big Data

GNS Healthcare, a big data analytics company, has formed a new alliance with non-profit patient and research groups intended to uncover the genetic and biologic causes of the complex autoimmune disease multiple sclerosis and other diseases.

Backed by a $5.4 million sponsorship from Janssen Research & Development, Orion Bionetworks will use GNS Healthcare’s Reverse Engineering and Forward Simulation platform to analyze patient data pieced together from alliance members including the Accelerated Cure Project for Multiple Sclerosis, the Institute for Neurosciences at Brigham and Women’s Hospital, and PatientsLikeMe. The Marin Community Foundation’s Multiple Sclerosis Project Fund will coordinate the project and Magali Haas, currently chief science and technology officer of the non-profit One Mind for Research, will lead Orion.

“I think data-driven models like this are the future of discoveries in healthcare and the development of new drugs. It’s just too slow otherwise,” says Colin Hill, CEO of GNS. “People accepted that before, because there just wasn’t any other way. Now I think the walls of the industry are going to come crumbling down, replaced by something much more data-driven and hypothesis-free, something that’s desperately needed.”
http://www.burrillreport.com/article-new_initiative_takes_on_multiple_sclerosis_with_big_data.html

Junar gets $1.2M to make open data more useful - from Gigaom.com

The open data movement holds that much of the information garnered using public funds should be freely accessible to interested parties as long as what they do with that information is also made available to everyone. Organizations that are opening up at least some of their data include NASDAQ, the New York Stock Exchange, the UK’s data.gov.uk, and Data.gov.

“A ton of data has been opened up by governments, think tanks, academia, NGOs — it’s an iceberg of data,” said Junar CEO Diego May in an interview last week. The issue is finding the right ways to look at that data to attack real-world problems. Open data projects have grown around genomic data, other public and private health data, even around food data.

“Many organizations are opening their data up to be more transparent, to foster collaboration, to help innovation … Many put out HTML tables or PDFs on their web sites, but they do a crappy job and it’s not really their fault. The tools [for really good visualization] are lacking,” May said.

Junar’s Open Data Platform promises to make it easier for users to find the right data (regardless of its underlying format); enhance it with analytics; publish it; enable interaction with comments and annotation; and generate reports. Throughout the process it also lets user manage the workflow and track who has accessed and downloaded what, determine which data sets are getting the most traction etc.

The most direct competitors to Junar’s software as a service are Tableau and Google visualization tools, and Socrata but those products focus on the display/visualization piece of the solution, not all the other components, May said.

http://gigaom.com/cloud/junar-gets-1-2m-to-make-open-data-more-useful/

Presidential Innovation Fellows: Open Data Initiatives | The White House

Presidential Innovation Fellows: Open Data Initiatives | The White House

The Presidential Innovation Fellows will pair top innovators from the private sector, non-profits, or academia with federal government employees to collaborate on game-changing solutions that aim to deliver significant business results in just six months.

Open Data Initiatives

Stimulate a rising tide of innovation that utilizes government data to create tools that help Americans better navigate their world, whether it’s finding the right health care provider, identifying the college that provides the best value for their money, saving money on electricity bills through smarter shopping or keeping their families safe by knowing which products have been recalled, and much more.

Stay updated, follow @ProjectOpenData on Twitter.

Description

The Open Data Initiatives program aims to “liberate” government data and voluntarily-contributed corporate data to fuel entrepreneurship, improve the lives of Americans in many tangible ways, and create jobs. As a model, decades ago, the National Oceanic and Atmospheric Administration began making weather data available for free electronic download by anyone. Entrepreneurs utilized these data to create weather newscasts, websites, mobile applications, insurance, and much more. Similarly, the government’s decision to make the Global Positioning System (GPS) freely available has fueled a vast array of private sector innovations ranging from navigation systems to precision crop farming, creating massive public benefit and contributing significantly to economic growth. More recently, the Health Data Initiative, launched by the Institute of Medicine and the U.S. Department of Health and Human Services in 2010, has opened growing amounts of health-related knowledge and information in computer-readable form from the vaults of the government and publicized the availability of these data to entrepreneurs and innovators. Hundreds of companies and nonprofits have utilized these data to develop new products and services that are helping millions of Americans and creating jobs of the future in the process.

for more details, see http://www.whitehouse.gov/innovationfellows/opendata

Big Data can discover things it would take years for human researchers on their own to discover - from Vancouversun.com

B.C. health care on the cutting edge of Big Data

Read more: http://www.vancouversun.com/news/health+care+cutting+edge+Data/6575625/story.html#ixzz1uBYdApSg

Big Data can discover things it would take years for human researchers on their own to discover, if they ever could.

Big Data can reveal the overlooked negative effects of a drug or, conversely, unexpected benefits and new treatments. It can lead us to insights into how a drug has worked over a vast population, enabling researchers to determine which doses are most effective, which are wrong-headed or perhaps dangerous.

Tracking Big Data can help you find out if a medical procedure really gets the results we think and desire. Or it might reveal diagnostic and treatment mistakes we are making and suggest overlooked ways of improving health care. Plug in genetics, a factor that often influences how medicines and treatments work on an individual basis, and you are looking at the possibility of bespoke, genomic medicine — health care tailored to an individual, in much the same way as a tailor customizes a suit or dress.

Big Data can and will save lives. And it will almost certainly save money.

The McKinsey Global Institute has estimated that Big Data could lead to $300 billion of savings in the U.S. health care system. John Wilbanks, a senior fellow at the Kauffman Foundation, says in his latest report that “combining larger data sets on drug response with genomic data on patients could steer therapies to the people they are most likely to help. This could substantially reduce the need for trial-and-error medicine, with all its discomforts, high costs and sometimes tragically wrong guesses.”

Yet almost every B.C. researcher you talk to will lament British Columbia is not using its public health data resource to the degree it should be. The question is why not?

Read more: http://www.vancouversun.com/news/health+care+cutting+edge+Data/6575625/story.html#ixzz1uBYSg2yO

US Unveils $200 Million Big Data Initiative, The Burrill Report

The Obama Administration has launched a Big Data Research and Development Initiative in conjunction with six federal departments and agencies, making a $200 million commitment to improve the tools and techniques needed to access, organize, and glean discoveries from the huge volumes of data being generated around the world.

“In the same way that past federal investments in information technology R&D led to dramatic advances in supercomputing and the creation of the Internet, the initiative we are launching today promises to transform our ability to use Big Data for scientific discovery, environmental, and biomedical research, education, and national security,” says John Holdren, assistant to the President and director of the White House Office of Science and Technology Policy.

The National Institutes of Health and the National Science Foundation will be among the top recipients of funding, along with the Departments of Defense and Energy, and the U.S. Geological Survey. Besides advancing the development of technologies needed to collect, store, preserve, manage, and analyze the growing volume of digital data being generated on a daily basis, the initiative aims to harness the knowledge gleaned to advance scientific discovery, strengthen national security, and transform teaching and learning. Money will also be allocated to expand the skilled workforce needed to make sense of it all.

for more:
http://www.burrillreport.com/article-us_unveils_200_million_big_data_initiative_.html