PCI 3.06.26

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Subsection - Neurodegenerative Diseases

From Depression to Deep-Learning: Leveraging iPSC and AI Platforms for Evidence-Based Depression Treatment

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Subsection - Oncology

Essential DMPK Strategies for IND Success

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Subsection - Cell and Gene Therapy

When the Gene Editing Guide is the Drug

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Volume 8 Issue 2

Why Renting Product Inspection Systems Makes Strategic Sense for Pharma Manufacturers

Production lines don’t pause for procurement. When pharmaceutical manufacturers face a sudden spike in demand, new quality control requirements or equipment failure,...
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Volume 8 Issue 2

The Importance of Mass Spectrometry 

Mass spectrometry (MS) has long been a cornerstone analytical technique in the pharmaceutical and biopharmaceutical industries. Its ability to provide detailed molec...
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Volume 8 Issue 2

Plan, Lead, Deliver: A Framework for Regulatory Writing Success 

Q: Is your team simply writing a dossier, or are they following a clear strategy?A: The most effective teams do both, but strategy should come first. Preparing a sub...
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Volume 8 Issue 2

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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Volume 8 Issue 2

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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Volume 8 Issue 2

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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Modelling Retinal Safety: The Era of Predictive In Vitro Toxicology Testing 
Application Notes

Modelling Retinal Safety: The Era of Predictive In Vitro Toxicology Testing 

Bringing a novel therapeutic to market is a complex and costly journey, and toxicity remains a leading reason for failure along the way. Despite remarkable advances ...
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Volume 8 Issue 2

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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Volume 8 Issue 2

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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Volume 8 Issue 2

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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