PCI – 7th June 2024
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Navigating FDA and USP Regulatory Guidance with LAL Reagents for Bacterial Endotoxin Testing

Navigating the regulatory landscape of the Bacterial Endotoxin Test (BET) involves a thorough review of guidelines from regulatory agencies such as the FDA, USP, and...
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The Impact of Clinical Development Decisions on Time to Market and Development Risk in Oncology 

Key Findings• Every month a programme can accelerate to market adds an estimated $5–6M of net present value per billion dollars of peak year sales• We have identifie...
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Modelling the Bone Marrow Niche In Vitro: A Roadmap for Drug Development 

The bone marrow niche provides a tightly controlled setting where cellular interactions, biochemical signalling, and mechanical stimuli collectively shape the fate o...
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Challenging Targets in Antibody Discovery

Antibodies represent a rapidly growing therapeutic modality, demonstrating clinical success over a wide variety of diseases, including cancer, autoimmune disorders, ...
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Building the Foundation for Biopharma 4.0 Through Strategic Digital Transformation

What is Biopharma 4.0? Biopharma 4.0 refers to the next-generation modernisation approach to biopharmaceutical development, manufacturing, and quality. It integrates...
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TPDs: Developing the Next Generation of Oral Therapeutics

Targeted Protein Degraders (TPDs) are transforming the landscape of modern drug discovery and development, introducing a ground-breaking method for tackling diseases...
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Harnessing the Power of Generative AI: Transforming Life Science Manufacturing

The life science industry faces the challenges of developing and delivering life-changing medicines at an accelerated pace, all while maintaining quality and safety ...
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Building a Global Data Foundation for Scaling AI 

AI use cases are rippling across commercial biopharma, helping companies make faster, more informed decisions. Yet almost 70% of top generative AI (GenAI) users cite...
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Regulatory Impact Assessment is Obvious Next Target for GenAI, Experts Conclude 

When anything changes to a product’s make-up or manufacture, a whole chain of events is triggered, starting with an assessment of the regulatory impact in each regul...
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