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In the News
Facilitating bioanalytical studies
Over the past 30+ years, the PPD® Laboratories Bioanalytical Lab has helped bring thousands of compounds to market and the company continues to invest and expand its facilities to meet the ever-increasing needs of customers.
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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.
![regulatory focus logo](https://www.ppd.com/wp-content/uploads/2020/01/reg-focus-final-e1578492744897.jpg)
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.
![regulatory rapporteur logo](https://www.ppd.com/wp-content/uploads/2019/12/RegulatoryRapporteurlogo-e1578492898260.jpg)
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.
![pharmaceutical technology logo](https://www.ppd.com/wp-content/uploads/2019/12/PharmaceuticalTechnologyLogo.jpg)
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.
![ebr logo](https://www.ppd.com/wp-content/uploads/2019/12/EBR-April2014.jpg)
Preparing for data transparency requirements of the new EU CTR
The authors discuss some steps organizations must take now to ensure readiness for the application of the EU Clinical Trial Regulation.
![regulatory rapporteur logo](https://www.ppd.com/wp-content/uploads/2019/12/RegulatoryRapporteurlogo-e1578492898260.jpg)
Development strategies for cell and gene therapy methods
The authors discuss how the increase in regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
![BioPharm International](https://www.ppd.com/wp-content/uploads/2019/12/BioPharmInternationalLogo.jpg)
CRO industry update
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.
![Contract Pharma](https://www.ppd.com/wp-content/uploads/2019/12/Contract-Pharma-e1578492947862.jpg)
PPD cuts the ribbon on new clinical research lab in Suzhou, China
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.
![Fierce Biotech](https://www.ppd.com/wp-content/uploads/2020/06/logo-biotech-thumbnail.jpg)