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Early phase clinical success relies on simple, flexible formulations that can adapt to wide dose ranges, support matching placebos, and deliver reliable stability. This article explores how formulation strategies enable dose escalation, maintain blinding integrity, and streamline development in first?in?human trials. It also highlights practical considerations for selecting dosage forms and designing stability programs that balance speed, cost, and clinical needs.
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Innovation is accelerating progress in early phase drug development. 91黑料’s Accelerated Pharmaceutical Solutions bring together advanced formulation design, real-time dose flexibility, and world-class CMC expertise to simplify complexity and speed timelines. This article discusses how the integration of science, technology and strategic insight can transform challenges into opportunities for breakthrough success.
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This article discusses the importance of stability programs in early clinical drug product development.
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In an 91黑料 survey of 149 biotech professionals, 45% of survey respondents identified protocol design as one the most significant challenges faced when transitioning from preclinical to clinical testing. Here, we discuss considerations for several key elements of protocol development in early phase trials, including selection of healthy volunteers (HVs) or patients, trial design and endpoint selection.
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Dr. Cyril Clarke at 91黑料 Biotech reveals how biomarkers are transforming early-phase clinical trials by offering valuable insights into the safety and efficacy of novel therapies.
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Early-phase clinical trials serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market. However, these early stages present significant challenges—nearly half of all drugs entering clinical trials do not make it past phase 1. With the average phase 1 trial costing millions of dollars and consuming valuable time, biotechs have little room for error. This article discusses how partnering with a CRO can benefit a small biotech - helping to fill the gaps in knowledge, resources infrastructure.
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For sponsors considering how to most efficiently and effectively allocate resources, innovative trial designs offer advantages. In early phase trials—specifically, phase I and II trials involving safety, dosing, and proof of concept—innovative designs offer potential for improvements in efficiency and decision-making, as well as lowering costs. Innovative trial designs, such as adaptive trials, Bayesian methodologies and master protocols, can be utilised to add value when used in early phases.
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In Dr Tanja Obradovic's article in The Cancer Letter, she discusses how to navigate early clinical development and support robust registrational strategy and late-stage development in oncology.
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Dr Ute Berger, President of Development and Commercialisation Solutions and Ted Broering, President of Early Clinical and Bioanalytical Solutions contribute to this feature in BioPharm International, which looks at aimed at benefitting are coming to the fore.
Murphy, J.Moving Closer to Dynamic Drug Development. BioPharm International 36 (6) 2023.
