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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. A biomarker is a measurable indicator of a biological process, disease state, or response to a treatment.

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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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New cell therapy model accelerates cancer treatment development

Drug Target Review

Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinical development. TILs were specifically developed to target solid tumour cancers, Bock explained.

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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. A Global R&D Footprint Backed by Clinical Execution BeOne’s engine of innovation is supported by a vast and diversified global clinical development network.

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Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

At the forefront of this transformation is Dr Ebrahim Delpassand, a nuclear medicine physician and the driving force behind RadioMedix (RMX), a radiopharmaceutical company focused on developing targeted diagnostics and therapies. The founding of RadioMedix was born from a recognition of unmet needs in cancer treatment.

Therapies 100
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Clinical Development of the GluN2B-selective NMDA Receptor Inhibitor NP10679 for the Treatment of Neurologic Deficit after Subarachnoid Hemorrhage [Neuropharmacology]

ASPET

The delayed nature of cerebral ischemia secondary to SAH-related vasculopathy presents a window of opportunity for the evaluation of well-tolerated neuroprotective agents administered soon after ictus. Based on allometric scaling of both toxicological and efficacy data, the therapeutic margin in man should be at least 2.

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The AI model that is changing clinical trial design

Drug Target Review

They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Solving old problems in new ways Herne is well acquainted with the operational inefficiencies that persist across clinical development. Integration is straightforward,” Herne notes.