Featured Editorial

81. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

82. Post-Pandemic Planning: Using Direct-To-Patient Deliveries For Supply Chain Management 2/23/2024

    UCB Vice President – Head of Global Clinical Science and Operations Tero Laulajainen gets us up to speed on direct-to-patient (DTP) trials and how UCB is leveraging it today.

83. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

    This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

84. The Impact Of Protocol Design On An IRT System 1/31/2024

    DTP and home treatment studies can get expensive — and be a hassle to patients — if the IRT element isn’t well planned for during trial design. In their SCOPE Summit presentation, Irina Grishina and Kelsey Kern of CSL Behring plan to share their personal anecdotes and lessons learned from both types of trials as they pertain to IRT. 

85. Donating Surplus Clinical Trial Supplies Is Sustainability's “Low-Hanging Fruit” 1/29/2024

    ClinOps professionals know all too well the waste that occurs with leftover trial kits that are destroyed at the end of the trial. Explore donation as a way to give those kits a second life.

86. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

87. Cryo-Shippers: Challenges, Controls, And Logistics 1/3/2024

    Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.

88. Clinical Trial Supply Market Outlook, Developments, & Technology Trends 12/26/2023

    The clinical trial supplies market is estimated at $3.9 billion in 2023 and is projected to reach $6.3 billion by 2028. Explore more insights from Markets and Markets.

89. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

    While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

90. 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.