Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Navigating The Complexities Of Pre-Filled Syringe Manufacturing

  Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• Soil Testing: From Filtration To Fertilizer To Food

  Soil analysis offers a clear view of the factors that influence land productivity while helping identify contaminants that could threaten safety. Understand the indicators to support sustainability decisions.

• Can Your Biopharma Team Keep Unplanned Downtime At Bay?

  Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

• Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation

  Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.

• Patient-Defined Recruitment: The Movement Advanced By COVID-19

  The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.

• Improving Patient Health and Safety: Quality and Analytical Scientist

  Explore how an analytical scientist enhanced quality and compliance for a pharmaceutical company by managing complex analytical testing and vendor interactions.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Innovative ASD Technology Improves Abandoned Cancer Medication

  Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

• How Syneos Health Tackles Protocol Complexities

  Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.