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The rising impact of biomarkers in early clinical development

Drug Target Review

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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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

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs. Learn more The post How FSP Models Help Biotech Companies Augment Their Clinical Development Needs appeared first on PPD. FSP outsourcing is growing faster than FSO.

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Managing CGT trials: the role of IRT from discovery to clinical development

Drug Target Review

The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment.

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The AI model that is changing clinical trial design

Drug Target Review

Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. Today, we are focused on scaling AI-driven clinical solutions that help sponsors optimise their clinical programmes,” Herne says.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

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Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

This dual role enables him to bridge research and clinical practice, ensuring scientific innovation is directly informed by patient care. “As Delpassand’s clinical experience plays a key role in shaping the research pipeline. This is where the SPICA Center comes in.