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Phases of Clinical Research: A Detailed Overview

Advarra

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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What the FDA’s guidance on diversity means for rare disease sponsors

Conversations in Drug Development Trends

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Looking to diversify the reach of your orphan drug trial?

Disease 52
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Three Financial Conversations Biotech Leaders Need to Have in 2024

PPD

According to Jeffries Equity Research, funding totals exceeded $15 billion in January and February, marking the best monthly tallies in over a year. Strategic partnerships with trusted contract research organizations (CROs) can significantly enhance the appeal of biotech companies to investors.

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Eli Lilly Designs P-Tau Biomarker Assay for Early Alzheimer’s Disease Diagnosis

The Pharma Data

Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November. Jeff Dage, Ph.D., But, as Iwatsubo cautioned, “We are at the early stages.

Disease 52
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How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.