Drug development is a complex business. Historically, less than 8% of product candidates are reported to have made it from Phase I to market. One effective way to mitigate risk is to weed out weak...
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Read five ways biotech companies can enhance their value story with advanced analytics.
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Articulating a coherent product value story from the start of development can help companies attract investors.
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial.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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Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"
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Skip Sands, SVP and Senior Medical Officer of Parexel Biotech, discusses practical examples of how to build and maintain a relationship based on mutual trust
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Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.
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Kate Bertolet, Chief of Staff for Parexel Biotech operations, talks about motivating her study teams and the drive to meet the unmet needs of the patients.
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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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Parexel Biotech’s Nate Akers, VP, Business Development, and Vicky Hsu, Head of Operations in Asia discuss the importance of aligning clinical execution with a clearly defined regulatory strategy.
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Learn about the services and approaches that Parexel Biotech offers to help you make an exponential difference in patients’ lives.
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For biotech companies, precision medicine holds tremendous promise for innovation – for newly designed drugs, new technologies for drug delivery, and engineered cell or gene therapies.
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Parexel’s Leanne Larson, Corporate VP and WW Head, Real-world Evidence speaks with Deborah Collyar, cancer survivor and President of Advocates in Research about the importance of Real-world Evidence
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Parexel’s Anita Nelsen, SVP, Translational Medicine and Michelle Hoiseth, Chief Data Officer, Corporate VP speak with Ashley Druckenmiller about caring with her two sons with hemophilia and the benefi
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Learn more about what to look for in the right CRO partner to overcome logistical and operational challenges in cell and gene therapy product development.
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