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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study.

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The workshop is also discussed in Cell & Gene here and here. Other Questions.

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How Worldwide and Every Cure Are Using AI To Unlock New Rare Disease Treatments

Conversations in Drug Development Trends

As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

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The Power of Bespoke Hybrid FSP/FSO Solutions

PPD

Often, however, a hybrid use case will fit into one of these general categories: 1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services.

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Trends in Oncology Study Design, from Optimus to Endpoints

Conversations in Drug Development Trends

You can learn more about biomarkers and how to use them in oncology studies in this white paper. Optimize Your Oncology Program with Worldwide Matt Cooper and our global team of oncology experts have dedicated their careers to oncology clinical development programs.