In this week’s news, US looks at melding science and drug R&D, Trump wants flu vaccine sector to modernise, FDA develops predictive tech for biologics and more…
US FDA aims to bridge gap between innovative science and drug R&D
The US FDA has shared more details of its efforts to modernise. This time the focus is on how scientific advances are being factored into decision making.
In an update last week, the agency noted the current disconnect between innovative research and drug development and outlined its plan to address the situation.
“Recent scientific and biomedical advances—from genomic sequencing to development of cell and gene therapies and nanotechnologies— have brought the promise of significant improvements to the health of many millions of Americans.
“To date, however, we have seen little of this promise in our day-to-day lives because a large and persistent gap separates important scientific advances and the technologies needed to translate those advances into new therapies for patients and new ways to protect the public health.”
The FDA’s solution is the Technology Modernization Action Plan (TMAP), which it called “an important step FDA is taking to address and close this gap.”
The document describes the agency’s plan to modernise its IT infrastructure, enhance and ramp up communication with developers and patients.
US develops tech that predicts antibody response to biologics
The TMAP plan also outlines the FDA’s intention to enhance its ability to “develop technology products to support its regulatory mission.”
In related news, the agency announced the development of a mathematical tool that predicts whether the body will produce antibodies that block the activity of protein drugs.
The technology – known as TCPro – models how the body’s CD4+ T cells respond to biotherapeutics. It also predicts if the body will make anti-drug antibodies.
Details of the technology were discussed in a research paper last month.
According to the authors “Using TCPro, we can test virtual pools of subjects based on [major histocompatibility complex class II] (MHCII) frequencies and estimate immunogenicity risks for different populations.”
US Government orders flu vaccine sector to modernise
US President Donald Trump has issued an executive order that encourages the influenza vaccine sector to modernise.
The order is designed to improve the US’s ability to prepare for future influenza pandemics and to develop better seasonal vaccines.
It is also intended to support industry development of a universal flu vaccine and help industry to adopt faster production methods.
According to analysis by the White House Council of Economic Advisers, more effective, rapidly produces seasonal influenza vaccines could result in significant savings for the US Government.
See Nature’s coverage here.
Also in the news
The US FDA’s office of generic drugs (OGD) has issued a manual setting out how it conducts pre-abbreviated new drug application (ANDA) meetings.
The FDA has “downplayed” the risk antacids could contain the carcinogen NDMA according to pharmacy chain Valisure. Read the full STAT report.
Lachman consultants examined continuous manufacturing from a regulatory standpoint.
Bioprocess Insider looked at how new Chinese laws will impact the country’s CDMO sector.
Drug industry use of biomarkers in R&D is becoming more sophisticated according to experts quizzed by PMLive.
Some developments of note in the contract manufacturing sector.
PCI Services has opened a centre of excellence at its clinical services facility in Rockford, Illinois. The site will provide primary and secondary packaging, labelling, and 2-8°C cold chain storage services. See press release.
QPS has set up clinical research facilities in the Netherlands, China and India. See release here.
SK Holdings has set up SK pharmteco, a U.S.-based CMO. The Sacramento, California-based organisation is a combination of SK biotek in Korea, SK biotek in Ireland, and AMPAC Fine Chemicals (AFC) in the US. See press statement.
Taiwan-based CMO Bora reported that its modified-release and solvent production facility in Zhunan has passed an inspection by the US FDA. See Contract Pharma report.