Industry Insights

91. Data Integrity In A Cloud-Based World: Regulations & Best Practices 5/11/2020

    There was a time when cloud computing was thought of skeptically by the life sciences community, through both the critical observations that are typical of science-based industry and the ingrained cultural resistance to change that comes along with a heavily regulated environment. But today, cloud solutions are ubiquitous in the industry.

92. 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.

93. Change Impact Assessments: How To Fix Something Without Breaking Everything Else 5/1/2019

    It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.

94. Immunogenicity Assessments – Frequently Asked Questions 5/20/2024

    Through a deeper understanding of immunogenicity, researchers can harness the full potential of advanced therapies, paving the way for a future of safer and more effective treatments for diseases.

95. Alternatives To Testing Sterility In Cell- And Tissue-Based Products 3/28/2025

    Testing depletes precious product, and regulators increasingly support using other methods if they're backed by robust validation data.

96. CBER Takes On More Oversight Of Biologic Biosimilar Master Files 8/11/2020

    For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.

97. Future-Proofing Peptide MAM By Ensuring Scalability And Deployment 2/22/2022

    Knowledge gained through liquid-chromotography-mass spectometry can be transformed into single multiplexed assays for monitoring attributes across development, manufacturing, and release.

98. The FDA, Device Cybersecurity, And What To Expect In 2019 1/7/2019

     The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?

99. 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0 3/6/2024

    On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.

100. Finding The Cloud's Sweet Spots For Pharma 2/23/2016

     How outsourcing to the cloud overcomes tight IT budgets and legacy infrastructure.