Choosing a partner to successfully navigate the next five years
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The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need...
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Innovation is the lifeblood of research and development in any industry. Scores of industry efforts spanning digital therapeutics, data sciences and decentralized clinical trials represent the...
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.
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A major challenge in drug development is the translation of candidate molecules from the preclinical phase to the clinical setting. The key elements to be considered are the pharmacology,...
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In a patient-centric clinical trial, we focus first on patient needs, finding ways to make participation simpler, more comfortable, and less invasive...
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Why a programmatic approach yields better results
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Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry conferences, executives, regulators, and investigators lauded new...
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The recent Asia Pacific Meeting of ISMPP held from 10–11 September 2021 was attended by professionals from pharmaceutical firms, medical communication agencies, and academic journal publishers to...
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For successful integration, you’ll need technical, logistical, and therapeutic expertise
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Example of an Oncology Lifecycle Management (LCM) Strategy
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Two real life examples of R&D and Commercial Strategy
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Two real life examples from 2019 and 2020
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Two examples from 2019 and 2020
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A rare disease — and a part-time job — showed Lisa Dilworth what she was meant to do.
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During the twenty years I served as a chief medical officer for small and emerging biotech firms, selecting the right contract research organization (CRO) was one of the most important decisions I...
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The average length of a clinical study cycle is on the rise and has been for decades. Look at any five-year period: cycles are seven to 10 percent longer than in the five years immediately prior.
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The ASCO Annual Meeting gathers oncology professionals from around the world to discuss the latest in cancer research and treatment. This year’s five-day event included more than 2,500 abstract...
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Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.
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