The Road to Approval: Navigating the Clinical Drug Development Process

The Road to Approval: Navigating the Clinical Drug Development Process The journey of a drug candidate from preclinical development to New Drug Application (NDA) approval is a critical and complex...
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Bridging the Gap: How Fractional CMOs Propel Biotech Success

Bridging the Gap: How Fractional CMOs Propel Biotech Success In the dynamic and high-stakes world of biotechnology, early-stage companies navigate a complex landscape of scientific innovation,...
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EMA Policy 0070: A New Era of Transparency in EU Regulatory Affairs

EMA Policy 0070: A New Era of Transparency in EU Regulatory Affairs The European Medicines Agency (EMA) has ushered in a new era of transparency with the reinstatement of Policy 0070 in late 2023....
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Skin in the game: targeted dermatology drug development

Intro Dermatology, once a therapeutic category largely served by emollients, topical corticosteroids and small molecule immunosuppressants, is an increasing focus of targeted drug development. First...
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The Hidden Pitfalls of Unconscious Bias in Drug Development

Please be assured this is not a woke rant dealing with micro-aggressions or cultural stereotyping, but about something potentially much more impactful on drug development outcomes. It deals with the...
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The Perils of Misaligned Incentives: Why Drugs Fail Late in Development

Intro The journey of a drug from conception to market is notoriously fraught with challenges. In the high-stakes world of biotech and pharmaceutical development, it can be particularly damaging to...
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Using rNPV analysis in deal term negotiations

Intro We are often asked by clients how they can use a risk-adjusted net present value (rNPV) for deal term negotiations for an asset. The rNPV methodology is discussed in depth in several of our...
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Extracellular vesicle (EV) therapeutics: good things in small packages

Extracellular vesicle (EV) therapeutics: good things in small packages Once considered simply as byproducts of cellular recycling and waste management, extracellular vesicles (EVs) have become the...
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Disease Indication Strategy for Anti-Fibrotic Drugs

Introduction: Anti-fibrotic drug candidates, prior to entering clinical development, often have a mechanism of action that may be beneficial for treatment of multiple diseases. Early strategic issues...
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Obesity: Beyond Getting Slim Quick & GLP-1s

Looking Beyond GLP-1s Currently, much of the pharmaceutical industry and up to a quarter of the population of the developed world are captivated by get-slim-quick drugs known as GLP-1 agonists, and...
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The financing dose-response curve: how much is too much?

For biotechs, how much is too much? We’re all too aware of the rate of biotech company failures at the moment. This includes venture-backed companies that have raised well in excess of $100m,...
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What’s Bugging You? The Next Chapter for Microbiome Drugs

Depending on your perspective, live biotherapeutic products (LBPs) are either a promising, newly emergent class of therapeutic agents that utilize live microorganisms to prevent or treat various...
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