Outsourced Pharma Editorial
-
Adapting Clinical Supply Strategies Through The Phases
5/17/2024
Phase-appropriate logistics are essential to manage resources efficiently, maintain regulatory compliance, and ensure timely delivery.
-
New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
5/16/2024
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
-
How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
-
How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
5/15/2024
QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.
-
2024 CDMO Leadership Awards Opening Remarks
5/14/2024
Chief Editor Louis Garguilo opens the 2024 Leadership Awards with an acknowledgement of the vital role CDMOs play, and also an intriquing insight into this year’s data to determine the award winners.
-
Exclusive Interview: WuXi AppTec Responds To BIOSCURE Act
5/13/2024
Rick Connell, WuXi AppTec’s President, U.S. and Europe, agreed to an exclusive interview with Chief Editor Louis Garguilo to address accusations in the BIOSECURE Act. To understand Connell is to understand the shock at WuXi AppTec – and among its customers.
-
Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
5/10/2024
Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.
-
Gene Therapy: Global Market Trends & Notable Developments
5/8/2024
New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.
-
Addressing Challenges In Serialization For Complex Therapeutics
5/7/2024
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
-
Don’t Blame The Molecule; You May Be The Problem
5/6/2024
Ali Pashazadeh has been a healthcare investment banker for 20 years, surgeon for 30, and biotech CEO. Today he leads Treehill Partners. “I can explain our logic in two minutes,” he says of his approach to developing drugs, and targeting diseases.