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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research

PPD

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials.

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How organoids can redefine pre-clinical research

Drug Target Review

This heterogeneity, present within the same structure or between various organoids, could complicate our understanding of specific mechanisms of action when testing novel drugs in vitro. Stem cell-derived organoids and their application for medical research and patient treatment. Nat Rev Bioeng [Internet]. 95: 729–38

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Unveiling neoantigen-directed cancer treatment

Drug Target Review

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.

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How to Fast-Track Clinical Research Timelines

PPD

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. Rather than accepting the persistent delays in clinical research as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.

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Top Clinical Research Conferences of 2024

Vial

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.