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  • The impact of COVID-19 on clinical trials in rare disease and oncology

    The impact of COVID-19 on clinical trials in rare disease and oncology

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  • The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

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  • Impact of Real-World Evidence on Payers & Patients3:29

    Impact of Real-World Evidence on Payers & Patients

    Dr. Scott Gottlieb, Former Commissioner of the Food and Drug Administration speaks with Parexel’s Peyton Howell, Executive Vice President, Chief Commercial & Strategy Officer and Sy Pretorius, Executi

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  • See Parexel's latest COVID-19 expert content

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  • Real-World Evidence: The Feedback Loop3:18

    Real-World Evidence: The Feedback Loop

    RWE experts Leanne Larson, Senior Vice President and Worldwide Head, Real-World Evidence and Access and Amy McKee, Vice President, Regulatory and Access dig deeper into the evolving role of RWE.

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  • Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

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  • Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

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  • Navigating the new normal for meetings – now and for the future

    Navigating the new normal for meetings – now and for the future

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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  • Patient engagement: Being heard3:04

    Patient engagement: Being heard

    Parexel has a heartfelt conversation with Lennie & Denny Woods, Parents & Co-Founders of Sara’s Cure (https://sarascure.org/), of their daily fight to find a cure for Clear Cell Sarcoma.

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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Virtual meetings are easy, right?

    Virtual meetings are easy, right?

    Recommendations for navigating the "new normal" and how to prepare for the future.

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  • Parexel on the Pulse1:49

    Parexel on the Pulse

    Paul Bridges on the EU Clinical Trial Regulation (CTR)

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  • How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

    How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

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  • Five points to remember if FDA issues a Form 483

    Five points to remember if FDA issues a Form 483

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  • When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    About the Authors Mansi Shinde, Ph.D. is an Engagement Manager based in the...

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  • Hong Kong Exchange: Nurturing China’s Biotech Valley

    Hong Kong Exchange: Nurturing China’s Biotech Valley

    About the Authors Daniel Huang is an Analyst based in the Hong Kong...

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  • How to interact virtually with health authorities

    How to interact virtually with health authorities

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  • eBook: Biopharma in the COVID-19 World

    eBook: Biopharma in the COVID-19 World

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