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The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). For use as endpoints, biomarkers must be correlated to a valid clinical outcome.

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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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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. RWE is transforming rare disease drug development, providing the insights needed to overcome unique challenges.

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BeOne Medicines Presents Transformative Oncology Portfolio at Research & Development Day

The Pharma Data

With more than 40 clinical and commercial-stage assets in active development, BeOne Medicines is demonstrating a scale of ambition matched by few in the field. BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drug development continuum. Global Head of R&D. “We

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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. He stresses the importance of recognising organisational strengths and weaknesses: “No single company is fully expert in all aspects of drug development.”

Therapies 100
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From siloed data to breakthroughs: multimodal AI in drug discovery

Drug Target Review

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

Drugs 64
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Good things come in 3s

SugarCone Biotech

Amgen’s clinical development studies of tarlatamab include the DeLLphi-305 trial in ES-SCLC testing a first-line maintenance regimen following durvalumab plus chemo (Amgen markets the anti-PD-L1 checkpoint inhibitor durvalumab). The tarlatamab results have of course triggered a stampede of development of DLL3-targeted therapies.