U.K. begins trying to rebuild trust in patient database after months of 'confusion, suspicion and anxiety'
The United Kingdom's long history of public healthcare gives it an enviable trove of patient data. Yet this resource, which is perhaps the one true competitive edge possessed by U.K. biopharma, is at risk of being squandered as the project continues to buried by mismanagement and a blizzard of negative publicity.
Any industry that's undergoing as much change as biopharma is always looking for leadership. Old marketing practices are being blown apart, R&D is being subjected to emergency surgery, drug prices surge ever higher, spurring a growing backlash from payers.
In this constantly shifting panorama you'll find a group of executives who are forging new paths for others to follow. This year, the third for Fierce, we present the men and women whose influence is being felt across the industry.
Influence, of course, isn't always a force for good. But it can be. To be truly influential in an industry, you need to be able to persuasively explain new methods that can exert a powerful hold on colleagues in the same global field. Some of this year's group have excelled in that regard.
We hope you enjoy this year's report. And please offer any suggestions you may have for next year's project on the influentials.
Clinical trials have increased in complexity over the past decade, with sponsors working with an increasing number of sites, countries and service providers. These massive globalized studies place new strains on the organization of essential study documents, collectively known as the trial master file (TMF). In response, vendors have pushed a technological solution: electronic TMF systems.
Vendors pitch eTMFs as a way to easily and securely share clinical study documents with internal and external teams, while also realizing many of the benefits electronic systems have over paper-based processes. Whereas paper files can be lost or destroyed and are only accessible where they are physically located, documents stored in an eTMF are less vulnerable to physical damage and can be viewed from anyplace with access to the web.
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Over the past year Google has increasingly extended its tendrils into healthcare, with the creation of Calico and development of smart contact lenses following on from earlier investments in DNAnexus and 23andMe.
The company J. Craig Venter founded in 1998 to challenge the Human Genome Project ran a data center with 70 terabytes of storage. Venter's latest scheme--creating the world's largest sequencing center--will fill that in less than one week.
During a week in which The Guardian revealed that Britain intercepted and stored webcam images from millions of people, the FDA email snooping revealed in 2012 looks relatively innocent. But Republicans investigating the program think the regulator may have violated whistleblower laws by monitoring employees' emails.
The information comes from Genetic Epidemiology Research on Aging (GERA), a cohort of more than 100,000 adults with an average age of 63 years old.
George Washington University and the National Institutes of Health this week took high-speed Internet connections to the next level. The organizations are using their new 100-Gbps links to the Internet2 Network to trial 40-Gbps transfers of genomics data.
Johnson & Johnson was cautiously lauded for its clinical trial data-sharing initiative, but Roche's project was pilloried. Now Novartis has joined its Swiss peer in rolling out an underwhelming transparency program.
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Medtronic is struggling against Edwards Lifesciences in the companies' U.S. battles over transcatheter heart valve patents. But the Minnesota device giant's fortunes in Europe in the bitter fight have taken a significant turn for the better.
International Stem Cell Corp. is inching closer to bringing its stem cell therapy for Parkinson's to the FDA in hopes of eventually reversing the disease's symptoms in people.