In this week’s news, EU losing ground in cell and gene therapy trials, US FDA wants input on biologics safety monitoring and more…
EU falling behind in cell and gene therapy trials says industry group
Europe needs to streamline trial approvals and cut review timelines to keep attracting cell and gene therapy developers according to an industry group.
The Alliance for Regenerative Medicines (ARM) issued the warning last week, explaining clinical development activity in Europe is slowing with sponsors looking to North America and Asia instead.
According to the organisation “On a global scale, the number of new clinical trials with ATMPs increased by 32% during the 2014-2018 period. There was an overall marked increase in North America (+36%) and Asia (+28%), but not in Europe (2%).”
Citing a survey, ARM attributed the decline in European cell and gene therapy studies to regulations surrounding such research which it said were prompting developers to look elsewhere.
“ARM members, via the survey, indicated the most important criteria for selecting a clinical trial site and a country is the expertise and the skills of the clinical centres and healthcare professionals, followed by the speed of approval, the quality of review, and the expertise of regulatory authorities.”
Read the full survey here.
Swissmedic vows to align with EU on device-drug combos
Swissmedic says it will align its rules on drug device combination products with those being developed by the EU.
The EMA shared its thoughts on the subject in June, in draft guidelines outlining how it will regulation such products. In a statement last week Swissmedic pledged to align its approach with the EMA’s, including the authorisation requirements for drug-device combos.
Read the full statement here.
US FDA wants input on biologics safety monitoring
The US FDA wants industry input on rules covering postmarket safety monitoring for biologic drugs.
The US regulator issued the call last week in “best practices” draft guidance. It said the aim is to find an alternative to periodic summary analyses it used to put together prior to the 21 Century Cures Act
The agency said, “The drug safety surveillance principles and best practices detailed in this document build upon lessons learned in preparing and publicly posting the summary analyses of adverse drug reaction reports.”
EU, Japan and US mull alignment on antibiotics and anti-bacterials
The EMA, the PDMA and FDA have talked about ways to encourage the development of new antibiotics.
The regulators released details of their September meeting last week. They said the aim was to find out what impact closer alignment could have on fostering the development of antibiotics.
The EMA said, “To facilitate multi-regional anti-infective medicine development, communication and collaboration among scientific and public health bodies involved in such activities are key and options for harmonisation are strongly encouraged,”
The Amsterdam-based agency also said it would meet with its US and Japanese counterparts next year to further discuss the topic.
Also in the news
GEN looked at the challenges facing cell therapy manufacturers. Some contributors likened the practice to “building the plane while flying it.”
Bioprocess Insider reported on trends in the antibody drug conjugate sector. According to the article, biopharma is showing renewed interest in drugs combining mAbs and cytotoxic warheads.
Lachman Consultants examined dynamics in the generic drug sector. Apparently, new formulation and manufacturing technologies are becoming key to success.
Outsourcing-pharma spoke with ACRO about data, digital health and US healthcare policy.
Some developments of note in the contract development and manufacturing sector:
Lonza CEO Marc Funk outlined the firm’s interest in data, automation and AI for GEN. He stressed that although such advances improve productivity, there will always be a place for skilled technicians.
Thermo Fisher has announced plans to invest $24 million in its media production facility in Scotland. The firm cited growing demand from the biopharmaceutical industry.
Catalent Biologics has launched its GPEx “Boost” cell line development technology. See press release.
Finally Cognate BioServices has agreed to buy Cobra Biologics. The US firm cited Cobra’s capabilities in plasmid DNA and viral vector production capacity as the main motivations.