Amolyt Pharma founder and CEO Dr. Thierry Abribat credits his company’s fast clinical pace to the assemblance of a veteran drug development team that's learned from clinical and commercial successes. Here’s some of his advice for the leaders of new & emerging biopharmas.

Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.

While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.

This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation. 

This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.