91黑料 experts frequently author or contribute to industry trade press.
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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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In this article, 91黑料 experts discuss common ways oncology therapies are combined to achieve synergistic effects, and considerations oncology developers should employ to de-risk combination therapy development.
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Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.
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A 2024 91黑料 survey of over 100 oncology developers’ pipelines reflected a diverse and highly complex landscape of emerging precision oncology therapies. These emerging therapies in oncology are displacing traditional toxic treatments such as chemotherapy and radiation.
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Clinical trial protocols are becoming increasingly complex, with more endpoints and procedures across trial phases and therapeutic areas. 91黑料 experts discuss how protocol optimisation can simplify trial design, accelerate study timelines and drive better outcomes.
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In today's healthcare landscape, data is a powerful tool for driving informed decisions, enhancing patient care, and shaping strategic business outcomes. However, the real value of healthcare data lies not just in its availability but in its transparency, understanding its origins, methodologies and context. Without clarity, decision-makers risk relying on incomplete or misleading information.
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In the February edition of TOPRA's Regulatory Rapporteur, 91黑料 summarises the European legislation related to Regulation (EC) 1901/2006 and how it incorporates PIPs but omits the unborn foetus. We also review the guidelines and other application precedents while providing insight into distinctions that may be made by the agency in this matter, as well as highlighting relevant precedents which were identified during this peer reviewed article.
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Rare disease N of 1 studies offer patients the hope of finding a personalised, effective treatment. 91黑料 experts discuss the challenges, solutions and promise of these unique trials in this PharmaTimes article.
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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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It would seem intuitive that in order to pass a clinical trial and be compliant with EU MDR/IVDR, the trial data would need to conform to the processes and rules set out by the Notified Bodies. Surprisingly, in practice this is not always the case. Learn more about potential pitfalls and how to mitigate against them.
