In this week’s news, EMA settles into the ‘Dam, US FDA gets real (world) about trial data, experts talk biopharma reactor tech and more…
EMA expects most staff to join it in Amsterdam
The European Medicines Agency says it expects to only lose around 25% of its workforce as a result of its move from London to Amsterdam.
The European Union pharmaceutical regulator made the forecast last week in a statement published to coincide with the official opening of its temporary office in the Dutch capital.
— EU Medicines Agency (@EMA_News) March 15, 2019
It wrote, “close to 350 staff members will have already relocated to the Netherlands. A number of EMA staff will telework from London to allow them and their families a smooth transition to Amsterdam in the second half of 2019. Overall, EMA still anticipates losing approximately 25% of its total workforce of around 900 staff members.”
The prediction fits with the “best case” scenario the EMA outlined in 2017, when it said a retention rate of 65% or higher would have minimal impact on operations, including drug reviews and pharmacovigilance activities.
London was the EMA’s home from 1995 until March 1 this year. The agency’s relocation was prompted by the UK’s decision to withdraw from the European Union, Brexit, which is due to take place at the end of the month.
US FDA’s guidance agenda confirms focus on real-world data
The US Food and Drug Administration (FDA) has indicated “real world data” will be a major focus of activity this year.
The US regulator published details of the guidance documents it plans to issue in 2019 last week. The documents, which are designed to help drug firms ensure development efforts are compliant, cover topics ranging from biosimilars and generics though to labelling and production.
Clinical trials are a major focus area. The FDA will issue advice on the use of clinical trial statistics and patient input. It will also issue guidance on how pharmaceutical companies should use “real word” data (RWD).
Jacqueline Corrigan-Curay, director of the CDER Office of Medical Policy, told RAPS that RWD covers everything from supplementing traditional randomized, controlled trials, or single-arm studies with historical controls, or the use of observational trials, with a registry or retrospective analysis of data.
Ned Sharpless confirmed as acting FDA commissioner
National Cancer Institute Director, Ned Sharpless will take charge at the FDA when current commissioner Scott Gottlieb steps down next month.
The appointment was confirmed in a tweet posted by Gottlieb last week.
I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.
— Scott Gottlieb, M.D. (@SGottliebFDA) March 12, 2019
Biopharma’s steely resolve despite single-use growth
Biomanufacturers will continue to rely on stainless steel bioreactors despite the growth of the market for single-use bioreactors according to industry expert Parrish Galliher from GE Healthcare.
According to a Bioprocess Insider report, Galliher told delegates at BPI West that “We’re going to need them [stainless steel systems] for unmet medical needs, which have potentially very large capacity requirements for these diseases.
“We see stainless steel being a major player going forward and helping us to address the mega-ton capacities that are going to be required.”
Read the full article here.
Also in the news
The CDMO sector is in a ‘golden age’ according to Thermo Fisher. The firm, which entered the space in 2017 when it bought Patheon, told Bioprocess Insider growth of small biotech is increasing opportunities for contractors.
Dutch start-up Pharmaoffer says it can offer drug companies and CDMOs a more straightforward way of finding and assessing raw material suppliers. Read the press release here.
According to the BBC, Italy has banned children who have not been vaccinated from attending school. The move is designed to counter efforts by conspiracy theorists to perpetuate the falsehood that vaccines are dangerous.
Fake medicines tainted with dangerous chemicals cost the lives of 250,000 children every year according to research reported by the Guardian.
FiercePharma reported South Korean prosecutors have raided the Korean Stock Exchange in connection with an investigation of Samsung Biologics. Read the full story here.