In the News

Debra A. Schaumberg and K. Jack Ishak investigate the considerations needed for use of RWE for construction of external comparators to support regulatory decisions.

The PPD authors discuss how the assessment of pain and pain relief is challenged by the complexity of the medical presentations, the subjective nature of the measurements and the desire to have a single solution to demonstrate efficacy in our evidence-based regulatory environment.

William Bakewell and Marc Wolman of PPD® Laboratories’ GMP lab discuss how the structure and activity of complex biotherapeutic molecules require sensitive analytical technologies.

The authors explain how high throughput molecular biomarker technologies combined with bioinformatics have been successfully used to assess infectious agents.

The authors discuss some steps organizations must take now to ensure readiness for the application of the EU Clinical Trial Regulation.

The authors discuss how the increase in regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

PPD’s Les Enterline explains that COVID-19 has accelerated the need for clients to have rapid access to additional highly trained professionals to support their pipelines in what already was a highly competitive market.

PPD held a grand opening ceremony for its new multipurpose laboratory in Suzhou, China, to support Western and China-based pharmaceutical and biotech companies managing China research studies.

The 67,000-square-foot facility offers bioanalytical, biomarker and vaccine laboratory services to support trials across all phases of pharmaceutical development.