Every startup requires capital to fuel ambitious ideas. While funding catalyses progress, it is the experience of the team, the quality of the asset and the available data, along with…
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For the first time, FDA has declared that one pivotal trial plus confirmatory evidence will be its default pathway for drug approval—effectively ending the informal “two-trial” expectation that has shaped…
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The traditional 3+3 dose escalation design has dominated Phase I oncology trials for over two decades (Le Tourneau et al., 2009, Kurzrock, 2021). Three patients per cohort, fixed escalation increments,…
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The field of inflammation and immunology has historically revolved around monotherapy—single cytokine blockade or single pathway inhibition. IL-23 inhibitors, TNF-alpha antagonists, and IL-6 receptor blockers: each represent a single point…
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Navigating AI in Professional Services: Adnovate’s Confidentiality-First Approach Artificial intelligence offers the potential for tremendous productivity gains for consulting firms, but must be used cautiously and responsibly. At Adnovate, we…
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Challenging Early-Stage Fundraising Environment Requires a Change in Thinking Biotechs setting out on their fundraising journey will benefit from thinking deeply about the most appropriate indications for their assets. Indication…
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Challenging Early-Stage Fundraising Environment Requires a Change in Thinking Clinical Development Plans (CDPs) are developed using multidisciplinary expertise. Early input from clinical development experts with the relevant therapy area and…
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Challenging Early-Stage Fundraising Environment Requires a Change in Thinking In the current tightly-constrained funding environment, a carefully thought out TPP created utilizing cross-functional expert input that details the differentiated positioning…
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Recent breakthroughs in Ribonucleic Acid (RNA)-based drug design and, more recently, the use of mRNA vaccines against COVID-19 have inspired a revival of interest in the therapeutic potential of RNA.…
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“Regulatory flexibility” allows some drugs to be approved based on a single adequate and well-controlled clinical trial with confirmatory evidence. This regulatory pathway can be highly valuable when developing drugs…
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