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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. A surrogate endpoint is a marker used in clinical trials as a substitute for a direct clinical outcome.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Conversations in Drug Development Trends

Transforming Drug Development with Biomarkers and Streamlined Regulatory Pathways The growing focus on addressing unmet medical needs has prompted regulatory agencies to streamline pathways to expedite access to transformative therapies. As a cornerstone of the 4P model, PGx plays a transformative role in advancing personalized care.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. Patients and caregivers also assess the benefits offered by different therapies, weighing the progression-free survival with their off-target effects.

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First clinical trial for MDMA and LSD combination set to go ahead

The Pharma Data

The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation.

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Biomarker identification in the realm of rare diseases

Drug Target Review

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials.

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