PPD in the News
Rebadging gains momentum amidst COVID
The authors discuss the benefits and challenges of rebadging for companies that perform clinical trials and other pharmaceutical/biotech services.
The evolving patient journey
PPD’s Brittany Erana discusses how clinical teams should be responding to the impact of technology and its use post-COVID-19 to improve the clinical patient experience.
Decentralized clinical trial adoption: Lessons learned from the pandemic
Regulatory affairs experts Ilse-Maria Nolan and Aneta Tsolovska discuss the role regulatory intelligence functions have played in developing decentralized clinical trials strategies that have helped maintain continuity during the pandemic.
Current trends in regulatory outsourcing models
The authors provide an overview of the more common models that can be deployed for the outsourcing of regulatory services.
Data integration strategy: The cornerstone of a successful regulatory submission
The authors discuss how a submission can be both exciting and daunting, from the initial discovery at a lab to first in-human testing to the completion of Phase III program.
Considerations for regulatory application of RWD-generated external comparators
Debra A. Schaumberg and K. Jack Ishak investigate the considerations needed for use of RWE for construction of external comparators to support regulatory decisions.
Measuring mild-to-moderate acute pain – A regulatory perspective
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.
Complex biomolecules require analytical evolution
William Bakewell and Marc Wolman of PPD® Laboratories’ GMP lab discuss how the structure and activity of complex biotherapeutic molecules require sensitive analytical technologies.
Spearheading the fight against infectious diseases and emerging outbreaks
The authors explain how high throughput molecular biomarker technologies combined with bioinformatics have been successfully used to assess infectious agents.