Process validation is essential for the manufacturing of advanced medical therapies, but inherent limitations contribute to variation and uncertainty in industry and regulatory approaches to development, approval and launch of new products, writes Mark Witcher. He outlines ways process validation concepts can be modified to better manage the next generations of biopharmaceuticals.
Functional service providers save pharmaceutical manufacturers money by providing staffing solutions, but companies should look at FSPs for technology that can save time as well, writes Michael Jones, vice president of clinical FSP client engagement for IQVIA. "A clinical research organization partner capable of providing a centralized solution with real-time data analytics and AI/ML-enabled workflows can help study teams more efficiently improve data quality, ensure site compliance, and stay on top of patient and site risk management," Jones writes.
Researchers at the University of California at Riverside are using a machine learning tool to create a database of compounds that could be used to develop COVID-19 treatments. The technology identifies any potential toxicity and FDA-approved compounds.
The European Commission and AstraZeneca have finalized a vaccine deal that involves the acquisition of a minimum of 300 million doses of the company's COVID-19 vaccine, including an option for an additional purchase of 100 million more doses.
Novavax announced Friday that it received an order of 60 million doses for NVX-CoV2373, its coronavirus vaccine candidate, from the UK. A late-stage trial will be launched by the UK government and the company that will include about 9,000 adults in the UK.
The FDA has released final guidance detailing the civil monetary penalties for companies that violate federal regulations requiring the complete and accurate registration of clinical studies and results reporting on clinicaltrials.gov. The statutory minima for penalties are up to $10,000 for all violations adjudicated in a single proceeding and up to $10,000 per day after notification that a violation remains uncorrected.
Thermo Fisher Scientific is partnering with Jiangsu Hengrui Medicine's subsidiary Hengrui Therapeutics to advance development of a companion diagnostic test that can identify lung cancer patients with HER2 mutations who are eligible to use Jiangsu Hengrui Medicine's pyrotinib.
Pluristem Therapeutics and the Abu Dhabi Stem Cells Center based in the United Arab Emirates signed a nonbinding memorandum of understanding with the aim of developing regenerative medicines and cell therapies to treat severe diseases, including COVID-19. No financial details were disclosed.
Although travel continues to be reduced or restricted worldwide, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual event providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders. Full Story:iSpeak Blog
ISPE announced its 2020 ISPE Europe Annual Conference, taking place virtually Sept. 15-16, 2020, will feature a diverse mix of global health authorities providing insights on COVID-19. Twenty regulatory experts representing 10 countries will share perspectives and lessons learned on the pandemic impacting drug shortages, distant assessments, and good manufacturing practices reliance. Full Story:ISPE News