Tag: Life Sciences
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After Approval: Running Safety, Real World Evidence, and the Product Lifecycle
This is part 7 and the last part of The Drug Development Playbook. Post‑approval is less about molecules and more about systems, signals, and evidence strategy.
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From Pivotal Data to Approval: The Regulatory Review Strategy
This is Part 6 of The Drug Development Playbook. This article explains how to turn that data and your manufacturing story into an approval.
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Clinical Development: Phases I to III
This is Part 5 in The Drug Development Playbook. In this article we move into clinical trials from phase I to III.
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Preclinical Development and IND/CTA Readiness: making the candidate safe enough to test in people
This is Part 4 of The Drug Development Playbook. We talk about building nonclinical and CMC evidence that lets regulators say yes to first-in-human trials.
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Disease Understanding and Target Identification: Picking the Biology Worth Backing
This is Part 2 of The Drug Development Playbook, an eight-part series on how medicines actually move from idea to patient use and how smarter decisions at each stage change outcomes.
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From Idea to Patient: How Drug Development Actually Works
This is the first article in The Drug Development Playbook, an eight-part series on bringing a medicine from idea to patient use. Part 1 outlines the full journey, key stages, and where most programs fail, setting up practical deep dives into each phase that follow in the rest of the series.
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Why Scalability Matters More Than Breakthrough Biology
The importance of scalability in drug development is emphasized, revealing that many scientific breakthroughs fail due to overlooked manufacturing complexities and costs. Teams should assess scalability early using four key axes: manufacturing, supply chain, cost-of-goods, and regulatory expectations. Practical changes, like embedding manufacturing expertise in early projects, can enhance readiness for commercial success.
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How Genomics Is Changing Drug Target Selection in Big Pharma
The integration of human genetics in pharmaceutical research significantly enhances drug development. By prioritizing targets with genetic support, companies can improve trial efficacy and reduce risks. Utilizing genomics allows for better indication selection, safety predictions, and asset valuation. This strategic approach fosters innovation while addressing ethical considerations in clinical trials.
Aryan Kenia 