In the News
Advantages of developing and deploying an in-house regulatory intelligence
Sean Schofield, William Waggoner and John Joines write about the processes and considerations for developing and maintaining an in-house regulatory intelligence database.
Fulfilling a great promise
Evidera’s Jonca Bull comments on how cell and gene therapies hold such great promise, despite being among the most complex clinical trials in terms of design and execution.
Embracing a functional service partnership model for rapidly growing biotechs
Jan-Maarten Kroodsma and Timothy King discuss how a tailored functional service partnership model can provide expertise and flexibility for biotechnology companies.
How to address—and overcome—operational challenges in master protocol studies
PPD experts discuss how the critical need for COVID-19 therapeutics has helped to underscore an ongoing urgent need for more innovative clinical designs.
The slow – but desperately needed – evolution of oncology clinical development designs
Jürgen Hummel outlines how adaptive designs at the early stages of development can not only accelerate timelines and reduce costs, but also can help focus development on the most promising agents at the right doses in the right indications for the right patients.
Selecting the right outsourcing model for emerging biotech
Timothy King and Elisha Talley-Roithner discuss how smaller and emerging biotech companies are able to take advantage of a range of flexible outsourcing models.
Can cell and gene therapies achieve their full potential?
PPD’s Stephen Gacheru comments on the cell and gene therapy methods he sees the industry using in the future.
A brief guide on designing a comprehensive cell and gene therapy bioanalytical strategy
PPD’s Panteli Theocharous, Janine Micheli and Catherine Vrentas outline how the application of cell and gene therapy offers the promise of significant long-term health benefits to people suffering from a wide range of diseases.
Complying with lab data integrity practices during COVID-19
PPD’s John Maier discusses how accelerated startup and overall timelines of COVID-19 trials have presented a significant challenge to ensuring compliance with lab data integrity regulations.
