Industry Insights
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Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng.
2/1/2024
The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She details how manufacturers can get ahead of addressing time-to-treatment issues typically experienced at launch. They cover obtaining adequate investment dollars, and much more.
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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.
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Gene Editing Versus Gene Therapy: Is There A Difference?
1/31/2024
This article navigates the nomenclature that underlies gene therapy and gene editing technologies and explores the latest advancements in genome medicine.
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Relational Risk Analysis For The Bio/Pharma Industry
1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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Picking The Best Virus Sample Prep Method In Process Development
1/26/2024
Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.
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FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products”
1/26/2024
Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”
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21 New Downstream Technologies Being Considered To Fix Capacity Problems
1/25/2024
Downstream bottlenecks are a growing problem for legacy chromatography processes that can't keep pace with more robust upstream output. BioPlan has been tracking alternatives and discusses them here.
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FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance
1/25/2024
The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.
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Shaping A Digitally Enabled Commercialization Road Map For Your Cell/Gene Therapy Company
1/25/2024
For cell and gene therapy companies, it is critical for commercial, marketing, and digital leaders to understand key business decisions that shape the digital backbone of your commercialization road map.
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Driving Pharma/Biotech Capacity With Smart Manufacturing
1/24/2024
It is time for pharma/biotech manufacturers to consider a new approach to capacity management, one that can not only resolve today’s challenges but also position the enterprise to drive innovation and resilience in the future. You can leverage a smart manufacturing approach in three vital ways.