Guest Columns
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What’s Driving The Booming Microbiome Market? 4 Factors Pharma Needs To Know
2/10/2020
Rates of investment in the microbiome category are increasing as both venture capital firms like Seventure and pharmaceutical companies like Johnson & Johnson and Takeda make significant investments and establish partnerships with a variety of start-ups that are commercializing novel offerings in the microbiome space.
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FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?
2/7/2020
At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, recently published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” indicating their undoubted primacy in the Task Force’s overall assumption as to their influence on drug shortages.
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Cell & Gene Therapy Deals: Emerging Trends To Watch
2/6/2020
The pace of deal-making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to what has historically been seen for other innovative therapies. To understand how the landscape is evolving, we reviewed more than 30 deals in the sector and compared them to deals that were executed for mAbs between 1999 and 2013.
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The 10 Phases Of An Effective CAPA
2/5/2020
Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.
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The European MDR: Impetus, Impacts, And Current Status
2/5/2020
This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets. It has been updated through Jan. 30, 2020.
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3 Building Blocks Of Organizational Agility For Pharmaceutical Manufacturing
2/4/2020
Part 1 of this three-series looked at why agility is so important to pharmaceutical manufacturers and their contract manufacturing and development organizations (CDMOs) and is key to reaching the next productivity level of project management. Here in Part 2, we dig deeper into the details of the building blocks of an Agile approach and the methods that can be used to achieve it.
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New FDA Draft Guidance: Qualification Process For Drug Development Tools
2/3/2020
The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.
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The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
1/31/2020
This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.
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Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away
1/30/2020
Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.
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What Will The USMCA Mean For MedTech?
1/29/2020
Analysts appear to agree that the USMCA represents an upgrade — albeit a modest one — over NAFTA for all parties included. This article has been updated with developments through January 2020.