Industry Insights

41. Embracing And Implementing Computer Software Assurance Guidance 5/18/2023

    Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.

42. Rethinking Manufacturing Processes To Identify Green Opportunities

    Reducing the carbon footprint of your pharmaceutical fine chemicals manufacturing process requires a shift from the traditional process development approach. Sustainability requires revolutionary changes.

43. Multifactorial Disease Models: De-Risking Topical Formulation Development 10/20/2025

    Traditional drug models fail to predict performance in human skin. Advanced, multifactorial ex vivo disease models directly address inflammation and infection to de-risk formulation development.

44. Key Takeaways From The FDA's New Continuous Manufacturing Guidance 3/15/2019

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

45. The Science of Being Wrong 2/8/2016

    Most of us like to think that we’re good sports about it. If it’s a little thing, we may laugh it off good-naturedly. If it’s a major mistake, we shoulder responsibility, accept consequences, and correct course. As scientists, most of us probably think we have a healthier than average relationship with our human tendency to err. We are, one could argue, obsessed with the possibility of being wrong. We are wrong far more than we are right on the path to knowledge. Ninety-five percent of drug candidates fail during development. Our egos are buff. We dust off, and keep going.

46. How To Use DMF Content To Support Your Application To The FDA 4/30/2021

    A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?

47. Biotech 2016 To 2022 And A Look Ahead 8/30/2022

    The last five years have been disruptive regardless of sector, yet biotech managed to weather the storm. This article looks at the past five years in the industry from a macro view and shares what biotech executives should consider in the months ahead.

48. Creating A Compliant eCTD: Avoiding Common Regulatory And Technical Pitfalls On The Path To Submission 7/27/2020

    Failure to comply with the regulatory and technical requirements when creating your eCTD could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotechs. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.

49. Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021 3/8/2021

    This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. 

50. Small Molecule Drug Discovery: Can AI Do It All? 4/27/2022

    The hope is that AI can solve the single most challenging problem at the heart of modern drug discovery: the reliable prediction of novel small molecule drugs that potently bind to a disease-causing protein and alter its function. This article discusses the challenges and how we can position ourselves to navigate them.