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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In this blog, our experts explore how to develop multi-purpose, patient-centric lay language summaries with the patient audience firmly in mind.
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Recently, RBQM experts offered ideas of what’s ahead. RBQMLive, hosted by CluePoints, featured 18 industry leaders and welcomed more than 700 attendees from 27 countries. We discussed the current...
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During the past year, patients around the world waiting for new treatments have taken heart that clinical trials have been ongoing, despite the enormous logistical challenges posed by the...
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In this infographic, we share five tips for building an effective reimbursement strategy for your oncology product.
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We have created this guide to simplify the terminology of real-world evidence (RWE) and outline some of the strategic options available.
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Drug- Drug Interaction (DDI) is a crucial aspect in new drug development due potential impact on patients’ safety. Pharmacokinetic interactions at the level of absorption, distribution, metabolism...
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The COVID-19 pandemic brought into sharp focus the vulnerabilities in supply chains for medical products and the importance of ensuring their integrity to provide patient access to critical...
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In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics...
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