UK Regulators Back Away from Trials Location Requirement as Brexit Looms

January 14, 2019

UK regulators have backed away from a proposed post-Brexit requirement that drug sponsors have a point of contact in the UK to conduct clinical trials.

The MHRA had floated a requirement that anyone sponsoring a trial in Britain or Northern Ireland had to have an office in the UK. But “stakeholder feedback” convinced officials to reverse course. The new rules would allow sponsors to run trials in the UK as long as they have an office in one of several approved countries, which — for now — will include EU countries.

Without some kind of agreement, the UK will leave the European Union on March 29. The Brexit vote has already disrupted the clinical trials industry in Britain and Northern Ireland. Last year, an analysis by Fitch found that new trials in the UK had declined 25 percent since voters approved a referendum to leave the EU. The European Medicines Agency already is moving its headquarters from London to Amsterdam.

Parliament is scheduled to vote on Prime Minister Theresa May’s proposal for a new European trade agreement on Jan. 15.

University of Washington Researchers Develop App that Detects Opioid Overdoses
A smartphone app that uses sonar to monitor a patient’s breathing rates has proven effective at rescuing patients from opioid overdoses, researchers at the University of Washington have found in a clinical trial.

The Second Chance app uses sonar to monitor someone’s breathing rate to help determine whether they’ve overdosed. It can track breathing from up to three feet away. In a recent trial, researchers induced anesthesia in 94 patients to create “simulated overdoses.” The app accurately detected overdose-related symptoms about 90 percent of the time, researchers announced.

The research team has applied for FDA approval for the app and has created its own company to market it.

MD Anderson Officials Announce Two New Partnerships for Cancer Trials
Officials at the MD Anderson Cancer Center have announced two new strategic collaborations with private companies to hasten cancer drugs through clinical trials.

The first has MD Anderson leukemia researchers using Ascentage Pharma Group’s Protein-Protein Interaction drug discovery technology platform to test four different Ascentage candidates in single-agent and combination trials.

The second alliance will recruit 132 patients to test 4D Pharma’s lead oncology candidate, MRx0518, in an open label phase I study in combination with Merck’s Keytruda. MD Anderson also plans to run its own trials for several of 4D’s oncology drugs.

Terms of the two agreements were not disclosed.

First “Right to Try” Patient Receives Brain Cancer Treatment
The nation’s first patient to gain access to a trial medicine under the “Right to Try” laws is being given an experimental treatment for aggressive brain cancer, researchers at the University of California announced last week.

The patient is taking ERC-USA’s ERC1671, an immunotherapy currently in a phase II trial being run by the University of California. ERC1671, known in Europe as Gliovac, is a cell-based vaccine being tested in a randomized, placebo-controlled combination study of patients with glioblastoma multiforme and gliosarcoma.

The patient was diagnosed with recurrent glioblastoma, the most aggressive form of brain cancer but didn’t meet the inclusion criteria for the trial. The patient applied for treatments under California’s Right to Try laws, which were passed in 2017, and began receiving ERC1671 last November, University of California officials said.

President Trump signed a federal version of Right to Try last year.

FDA Announces New Drug Development Office
The FDA will create a new office focused solely on drug development, Commissioner Scott Gottlieb announced last week.

In a video presentation at the J.P. Morgan Healthcare Conference in San Francisco, Gottlieb said the Office of Drug Development Science will operate within CDER’s Office of New Drugs and work to standardize the review process.

Gottlieb said the office will have a staff of 51 and will be charged with helping sponsors and regulators streamline trials and agency review. He compared the new office to the 2003 creation of the FDA’s modeling and simulation office, which also was the result of the agency seeing a tool become more important within drug development and incorporating it into the development process. “The goal of these new offices is recognizing these tools becoming more integral components of the drug review process,” he said.

“Applications will be cloud-based and instead of taking the sponsors’ charts and tables and evaluating [them], we’ll be pulling down their bottom-line data and formatting it through our own assessment tools and creating our own charts and tables to do the evaluation,” Gottlieb said.