In the News

The companies jointly developed a systemic lupus erythematosus (SLE) assessment review process to simplify operationalizing clinical trials for the chronic autoimmune disease.

Sean Schofield, William Waggoner and John Joines write about the processes and considerations for developing and maintaining an in-house regulatory intelligence database.

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.

Jan-Maarten Kroodsma and Timothy King discuss how a tailored functional service partnership model can provide expertise and flexibility for biotechnology companies.

PPD experts discuss how the critical need for COVID-19 therapeutics has helped to underscore an ongoing urgent need for more innovative clinical 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.

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.

PPD’s Stephen Gacheru comments on the cell and gene therapy methods he sees the industry using in the future.

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.