Industry Insights

  1. Using AI In Drug Discovery Isn't The Golden Solution You Think It Is — Yet. 7/17/2023

    Before we realize the true potential of advanced artificial intelligence (AI) and machine learning (ML) technologies to treat disease, we need to start by developing technologies that can generate the massive amounts of reliable, high-quality biological data that make up the fundamentals of any AI/ML approach.

  2. Compelling, New Workplace Opportunities For Life Sciences Companies 9/29/2023

    In order to increase the likelihood of positive interactions across office teams and tenure, companies are building out more social spaces, focus nooks, and collaboration spaces for their employees.

  3. How To Leverage Modeling And Simulation In The Candidate Development Stage

    Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.

  4. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

  5. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

  6. Segments: Next-Generation Tablet Press Technology 10/7/2025

    Segments increase press output by up to 25% and cut setup time by 88%. Learn the benefits, drawbacks, and manufacturing needs of this rapidly growing tablet press technology.

  7. New And Improved Third-Party Submissions 9/11/2012

    One of the many opportunities enhanced by the America Invents Act (AIA) patent reform legislation, enacted in September 2011, is the expanded submission of prior art references into pending patent applications of third-parties, such as marketplace competitors and non-practicing entities. Given the broad footprint the AIA is making in the patent turf, this topic deserves at least a second column following our July 10, 2012 AIA overview. Let us turn to pre-issuance third-party patent submissions. By Jeffrey A. Wolfson, Partner, Haynes and Boone, LLP

  8. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

    Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

  9. A Semi-Continuous Operations Model For Solid-Dose Manufacturing 11/1/2017

    The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.

  10. Enhancing Patient Adherence Through Autoinjector Access

    As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.