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Expedited Pathways Comparisons - US EU CHN

Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

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Biosimilar Development: Are therapeutic clinical trials needed?

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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What to know about FDA INTERACT meetings

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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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

David Brown, Global Head of Epidemiology, summarizes the three FDA guidances related to data sources, data standards, and regulatory considerations in RWE/RWD and benefits of early engagement.

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Communicating Value to Providers and Payers

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Pragmatic Trials: Targeting evidence generation to inform market access and meet payers’ needs

For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Read how pragmatic trials can help >

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In this article, Parexel experts outline five approaches that foreign companies with limited resources should use to gain a foothold in the Chinese market.

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Making Expedited Regulatory Pathways Work for Global Drug Development Programs

Article from December 2021 edition of Applied Clinical Trials. Parexel regulatory experts offer top tips for working with regulators on a global scale.

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Articulating a coherent product value story from the start of development can help companies attract investors.

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Biosimilar Development: Are therapeutic clinical trials needed?

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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In this article, Parexel regulatory outsourcing experts explore five competencies companies can use to manage post-marketing regulatory requirements better and more efficiently.

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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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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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Five competencies for operational excellence in cell and gene therapy clinical trials

What is different about cell & gene therapy trials, and what does it take to operationalize them effectively? We break it down into five competencies you need for success.

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Three ways to improve your chances that insurers will pay for a new CGT

When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

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How market exclusivities can affect your development program

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Parexel regulatory expert, Mark Birse, gives an update on BREXIT.

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