Info & Opinion
February 19, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Theorem Clinical Research (once known as Omnicare) appointed Adam Serody as VP of global business development. Serody previously worked at PharmaNet and Paragon Biomedical, according to a news release.
Parexel will augment its commercialization services group. "Biopharmaceutical companies need to address commercialization goals as early as possible to develop products and acquire the right data to receive reimbursement approval,” said Gadi Saarony, corporate VP and worldwide head of the firm's consulting and medical communications group. Here's a release.
The FDA is postponing an approval decision on a first-in-class diabetes drug being developed by Bristol-Myers Squibb and AstraZeneca. The firms and regulators are studying the degree to which dapagliflozin is linked to an elevated risk of bladder cancer, according to Business Week.
A British startup, TrialReach, has secured additional funding. Founded in 2009 with help from Novartis and other top-tier firms, the company is using the internet, video and other communications techniques to help patients locate and understand clinical trials that may be appropriate for them. The company will collect fees when serving as an intermediary between patients and sponsors. "Thousands of patients have signed up for studies through our website, and hundreds of them have been put in contact with the investigators after passing a strict triple-filter process," said Pablo Graiver, TrialReach's cofounder and CEO. The site doesn't work perfectly, returning highly random search results. But its overall design is pleasant and inviting.
There is a new three-way alliance between PatientsLikeMe, patient recruitment firm BBK and the American Diabetes Association. The partnership has launched a website to funnel patients toward PatientsLikeMe. The effort will also facilitate people with diabetes trumpeting their medical experiences on the major social networking sites. That sharing, it is hypothesized, will build awareness of the disease. “We've seen firsthand, when patients become empowered through online peer interaction, they take control of their conditions and improve their outcomes,” comments Ben Heywood, co-founder of PatientsLikeMe.
Private investors remain interested in biotech, according to a new Ernst & Young report. The third review of the industry in as many years, this year's document can be found here. "There is now a widening gap between large, established companies and those at earlier stages for whom access to capital continues to be difficult,” said Glen Giovannetti of Ernst & Young. The top fifth of companies collecting investments in 2010, Ernst & Young says, grabbed 83 percent of all funds invested; the bottom fifth of companies got less than one percent of the money available. As one bullet point, Ernst & Young suggests revamping the current paradigm for clinical development. "Everyone would be better off if we ditched the rigid Phase I-II-III-approval model and went to more adaptive trials and conditional approvals with large patient registries to collect robust safety and efficacy data," the company says. Here's a blog post about the same report.