In this week’s news, US FDA unveils data plan, EU outlines efforts to boost Covid-19 vaccine production and more…
US FDA to modernize its handling of drug industry data
The US FDA plans to modernize how it handles data by identifying tech, developing consistent best practices and expanding internal expertise.
The US regulator shared details this week, explaining the “Data Modernization Action Plan” will focus on “the stewardship, security, quality control, analysis, and real-time use of data to accelerate the path to better therapeutic and diagnostic options.
“Data have always formed the basis of science-based regulatory decision-making. These data may come from traditional sources—for example, measurements submitted to FDA from clinical trials or observations from FDA field inspections.
“As technology becomes more sophisticated and our world becomes more connected, data from many new sources can help us understand how medical products are performing, pinpointing the source of foodborne illness, or understand emerging public health threats.”
The plan will involve driver projects – in which FDA staff will be tasked with identifying data management technologies – the development of repeatable data practices and building internal data science expertise.
PDUFA VII talks focus on cell and gene therapy sector
In other FDA-related news, industry and the agency have discussed how PDUFA VII will impact the cell and gene therapy sector.
According to meeting minutes releases this week, a CBER Breakout subgroup talked about how to enhance capacity to support development and approval of cell and gene therapy products.
“Discussion focused on revisions of commitment language for the CGTP and Industry’s proposals including: Patient Focused Drug Development, Leveraging Knowledge, Novel Approaches to Development of Cell and Gene Therapy, and Expedited Programs for the Development of Regenerative Medicine Therapies. “
Pharmacopoeias key for industry during pandemic says WHO
The WHO says collaboration between pharmacopoeias has been key to supporting the drug and CDMO sector during the Covid-19 pandemic.
The Geneva-based public health body made the comments this week, writing that “The availability and use of well-conceived international norms and standards – for performing clinical trials, producing a vaccine, a therapeutic, a medical device or diagnostics test or testing of their quality – are essential.”
The WHO cited the global alert system – initiated by the Brazilian, British, Chinese, European, Indian, International, Japanese, Mexican, US and Vietnamese pharmacopoeias – as example of the collaborative efforts.
“This has resulted in a dashboard listing of COVID-19 investigated medicines mapped to available monographs published in the various world pharmacopoeias. This listing is now available to allow easy identification of quality control specifications for therapeutics under consideration for COVID-19 treatment,” the WHO wrote.
Also in the news
Arcline Investment Acquires ChargePoint Technology.
NPR covered the US Government’s role in convincing Merck & Co to help produce J&J’s vaccine and use its facilities to get it into vials.
The EU wants to increase COVID-19 vaccine production capacity to 2-3 billion doses per year by the end of 2021 according to Reuters.
Packaging Digest reported that Amgen has invested in an artificial intelligence based packaging inspection system.
Science looked at difficulties conducting a global trial of potential coronavirus treatments.
Some developments of note in the contracting sector:
Novavax, Fujifilm, and Biocon have called for standardized processes and simplified regulations after a survey showed improving manufacturing agility is a major priority for biopharma-focused CDMOs.
Alteogen has hired Merck Bioreliance to produce recombinant biologics for the development and clinical evaluation of next-generation therapeutics of monoclonal antibody drugs. See press release.
Avid Biosciences has started the second phase of expansion of its facility in Myford, California. See Bioprocess Insider story.
Celonic Group has signed a long-term lease agreement for a new production site and office at the Novartis-operated Life Science Park Rheintal, Switzerland.
Cell therapy CDMO GC Cell has obtained a license to manage human cells biopharmaceutical manufacturers in Korea. See full Business Korea report.
Sterling Pharma Solutions, has begun construction on a cutting-edge bioplant enhancement at its Cramlington site to boost the sustainability of its operations.