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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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The rising impact of biomarkers in early clinical development

Drug Target Review

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers. To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drug development.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.

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Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. These measures ensure both the efficacy and safety of the final product.

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Revolution Medicines Secures $2B Funding from Royalty Pharma for RAS(ON) Cancer Drug Development

The Pharma Data

Unlike traditional royalty deals, where investors purchase rights to a portion of revenue from marketed products, this synthetic royalty structure allows Royalty Pharma to provide upfront capital in exchange for a defined share of future revenue, subject to agreed terms and caps.

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Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

As a result, drug developers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. As risks are identified, customized action plans are created and provided to clinical teams to keep studies on track.