Contributing Editors
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Financial Market Tumult Shows The Need For Creative Funding For Life Sciences
6/29/2022
Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
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Your How-To Guide For Mold Investigations Using Biofluorescent Particle Counting Systems
6/27/2022
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime. There's a better way to rapidly identify potential contamination and even confirm remediation in real time.
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FDA Updates Guidance For Investigating OOS Test Results for Pharma Production
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
6/22/2022
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
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FDA Proposes Benefit-Risk Considerations For Product Quality Assessments
6/20/2022
The FDA recently released for public comment Benefit-Risk Considerations for Product Quality Assessments: Guidance for Industry. Mark Durivage breaks down the guidance and how the FDA considers and assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how unresolved product quality issues may be addressed.
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How To Navigate Drug Repurposing And Bridging Studies
6/17/2022
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
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How To Navigate The Patenting Challenges Of AI-Assisted Drug Discovery
6/17/2022
With “low hanging fruit” drugs already in the market, biopharma companies are finding it more difficult to discover the next blockbuster treatment. Artificial intelligence (AI) has become a new arrow in the drug discovery quiver. But how do you patent AI-assisted drug discovery? Attorneys from Haynes Boone provide recommendations.
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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
6/15/2022
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Based on BioPlan Associates’ 2022 Annual Report/Survey, biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
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FDA Publishes Guidance For Biopharma Container And Carton Label Design
6/13/2022
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
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Assessing Extractables & Leachables In Parenteral Drug Products
6/8/2022
Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.