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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. 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. Relative to other areas of medicine (e.g.,

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New cell therapy model accelerates cancer treatment development

Drug Target Review

In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.

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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. Cost management: Cost management in CGT trials is complex due to the advanced requirements of these therapies.

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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. These measures ensure both the efficacy and safety of the final product.

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J&J’s Dual-Target CAR T-Cell Therapy Shows Promise in Large B-Cell Lymphoma

The Pharma Data

The data were presented during the 2025 European Hematology Association (EHA) Congress (Abstract #S239). Standard single-target CD19-directed CAR T-cell therapies typically enable long-term remissions in roughly 40% of patients, emphasizing a significant unmet need for new and more effective treatment strategies.

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Designing antibodies to think before they bind

Drug Target Review

Antibody therapies have transformed cancer treatment, yet their limits are becoming increasingly clear – particularly when tumours evolve, evade immune detection or develop resistance to existing drugs. For Dr Jhong-Jhe ‘JJ’ You, Vice President of Antibody Discovery at AP Biosciences, these challenges are not setbacks.