Contributing Editors
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An Overview Of The 9 FDA Special Designations For Pipeline Drugs
9/8/2023
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?
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Survey Results Show What Could Finally Make Sustainability Stick
9/8/2023
Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.
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Have You Adopted A Manufacturing Execution System Yet?
9/7/2023
Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.
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Effective Quality CDMO Contracting
9/6/2023
Choosing the right CDMO is a complex and difficult task and, given the regulatory framework within which the industry operates, it is essential that companies seeking a CDMO get the right partner. Let's look at what you should include in RFPs and other key considerations.
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.
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Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development
8/29/2023
There is still no approved antiviral therapy for adults with RSV infections. As drug developers, we need to prioritize developing new antiviral therapies for immunocompromised patients.
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4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage
8/25/2023
It’s no secret that finding pharma/biotech manufacturing talent is challenging, and the lack of workers is having a negative impact on productivity and growth. Here are four effective strategies for recruiting, training, educating, and retaining your workforce.
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Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi
8/24/2023
In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.
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Are KRAS Inhibitors Poised To Cure Cancer?
8/21/2023
The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.
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Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.