How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
- The Small Biotech's Checklist For FIH Trials
- How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield
- Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
- Should You Be Using Unique Container Identification?
- A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services
- Scaling RNA Production From The Lab To The Clinic
- Clinical Trial QA Strategies In Low- And Middle-Income Countries
- The Real Cost Of Poor Quality — And What You Should Do About It
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective
Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.
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Managing Complex Global Drug Distribution And Expiry
A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.
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Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.
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The Dual Sourcing Approach
Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.
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A Supply Chain Management Solution Designed for Clinical Research
In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.
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Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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Inside A Gene Therapy Facility, Commercialization & Industrialization Project
An inside look at a clinical-stage company focused on bringing its gene therapy from the lab into a clinical setting for patients and families devastated by rare neurological genetic diseases.
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Distributing Clinical Supply In The EU For Compassionate Use Programs
Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.
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What Are Decentralized Clinical Trials (DCTs)?
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes.
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Data-Driven Adaptive Trials Enhance Safety, Progress, And Economics
By offering guidance on optimizing ROI from extensive data collections and various endpoints in clinical studies, learn how IRT technology can enhance the data-driven approach for sponsors.
CATALENT CORNER
Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.