GUEST COLUMNISTS

• The Upper Nasal Space: Drug Delivery’s Next Frontier

  Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.

• India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022

  To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

• Key Insights From The 2022 PDA/FDA Joint Regulatory Conference

  Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

• Calculating Process Capability Of Cleaning Processes With Completely Censored Data

  Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.

• CDMO Selection In Our Post-COVID World

  In a post-pandemic world, we need to explore a broader view of our new reality. This article shares some of the concepts currently playing out in bio/pharmaceutical outsourcing that will impact your CDMO selection strategy. Additional discussion touches on how new outsourcing players will fit in and the path forward.

• Jump-Start Your Next CDMO Outsourcing Project With This Checklist

  Why does it take so much time between awarding a CDMO contract and initiating of the first activities at the CDMO? Once a project is granted, there are activities that you as the sponsor company can perform before, at, and after the traditional kickoff meeting for best success.

• FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics

  The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

• Autonomous Supply Chain Planning Is Within Reach

  In a fast-paced industry constantly innovating — from personalized medicine to health wearables — life sciences companies must be prepared to adopt transformative technologies that can help them meet the demands of the future of medicine. Autonomous supply chain planning is not science fiction; it's here, and it's now. Building a practical road map will help.