Government

WHITE PAPERS AND CASE STUDIES

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• Clinical Trial Starts Rose At Slower Pace In 2024

  Clinical trial starts grew 5.5% to 10,503 in 2024, a slowdown from 2023’s 9.4% rise in trial starts. Sustained geopolitical and global regulatory pressures on pharma contributed to curbing momentum.

• How To Successfully Scale QC For Rapid Growth

  Learn how one CDMO successfully streamlined and modernized its QC workflows and processes to address challenges related to the increasing demand for cell and gene therapy manufacturing services.

• Single-Use Assembly Capabilities To Keep Pace With Biopharma Dynamics

  Discover how a vendor-independent partner assists global life science companies and CDMOs with innovative single-use technologies to mitigate risks and ensure uninterrupted manufacturing.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• Blending Tradition And Technology For A Water-Resilient Future

  Discover how a desert utility is evolving its operations to safeguard Tucson’s water supply for generations to come.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• Putting The Squeeze In Sponge Cities: Amsterdam's Waternet And The Innovative RESILIO Blue-Green Roof Project

  The RESILIO project has helped Amsterdam repurpose rooftops as smart blue-green roofs to reuse rainwater and prevent localized flooding. This project, along with other sustainable water initiatives like the Amsterdam Rainproof program, continues to position the Netherlands at the forefront of water management.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Municipal Effluent Treatment In India

  Discover how an agency balanced effective disinfection while minimizing environmental impact and ensuring the safety of both the public and workers in its wastewater treatment practices.

• Operationalizing Disclosure Intelligence For Compliance At Scale

  Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.

• Guide To Navigating The Complex And Expanding Regulatory Landscape

  In today’s complex landscape, organizations face growing compliance demands from diverse sources. Learn how a strong compliance system and culture of accountability drive sustainable growth and protect long-term success.