Having previously explained why early-stage biotechs should avoid overbuilding, Alicia Collins, of Tune Therapeutics, continues the discussion here in part 2, with thoughts on scaling clinical supply, selecting partners, and preparing for future constraints.
- Fast, Secure, And Defensible: Building Decisions That Can Be Challenged Internally And Defended Externally
- Cold Chain Excellence: Safeguarding Biologics, Cell Therapies, And Temperature-Sensitive Products In Complex Logistics
- How AI Can Improve Clinical Supply Chain Visibility
- The Overlap Nobody Talks About: Packaging Decisions And Stability Budgets
- The Biggest Early-Stage Clinical Supply Mistake? Building Too Much, Too Soon.
- Study Start-Up Is Where Clinical Supply Risk Is Actually Decided
- How Clinical Supply Is Shaping The Next Generation Of Cell And Gene Therapies
- Clinical Trial Operations, Investigational Product Management, And The Foundation For Effective Risk Management
ON-DEMAND WEBINARS
This webinar discusses the types of master protocols and how configurable, modern RTSM systems enable fast and seamless mid-study changes to help you efficiently run your master protocol study.
Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.
CGT pioneers require supply chain partnerships that mitigate trial risk and complexity. Explore how to optimize pre-trial and pre-screening activities and reduce trial cost and risk with an IRT solution.
Gain insight into how a patient-centric approach to supply chain innovation in early phase development can accelerate your advanced therapy clinical trial programs.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![supply chain checklist pharmaceuticals-GettyImages-1616023386]( "Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes It")
Unblinding Risks In RTSM: What's Still Going Wrong, And How Korio Fixes ItProtecting study integrity requires more than just luck. Learn how systemic gaps lead to unintentional unblinding and how a proactive, engine-based approach can safeguard your clinical data.
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![GettyImages-1398569507 regulatory]( "5 Ways To Get Ready For IRT Regulatory Inspections")
5 Ways To Get Ready For IRT Regulatory InspectionsPreparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.
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![analytical-timelines-GettyImages-2247278213]( "Compressing Analytical Timelines Without Cutting Corners")
Compressing Analytical Timelines Without Cutting CornersEfficient analytical development speeds decisions and improves risk visibility. Using QbD, digital tools, and strong communication helps teams accelerate timelines while maintaining rigor.
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![GettyImages-820427458 clinical trials]( "Ensure Seamless, Efficient Delivery Of Clinical Trial Materials Worldwide")
Ensure Seamless, Efficient Delivery Of Clinical Trial Materials WorldwideDrug discovery companies, CROs, and CDMOs are under pressure to find supply management solutions that ensure delivery of clinical trial materials while navigating complex study designs and the regulatory landscape.
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![quality control, inventory management, freight transportation, supply chain accuracy-GettyImages-2197425780]( "Optimizing Clinical Supply Management With A One-Team Approach")
Optimizing Clinical Supply Management With A One-Team ApproachSee how NewAmsterdam Pharma managed 11 global studies across 51 countries and 835 sites for 12,000+ patients without overwhelming their internal team.
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![Risk Management-GettyImages-665231256]( "Flexible Integrations To Reduce Risks And Increase Efficiencies")
Flexible Integrations To Reduce Risks And Increase EfficienciesLearn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.
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![GettyImages-1693748594 phone]( "RTSM: Randomization And Cohort Management, IP Inventory Management")
RTSM: Randomization And Cohort Management, IP Inventory ManagementSignant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
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![iStock-1224887299-box-logistics-package]( "Clinical, Commercial Packaging: Delivering Next-Gen Therapies")
Clinical, Commercial Packaging: Delivering Next-Gen TherapiesSee how strategic, agile, and sustainable packaging is transforming drug delivery into a key driver of speed, safety, and patient-centric innovation.
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![GettyImages-1333159166-cold-chain-shipping-logistics-transportation]( "Overcoming Obstacles To Deliver Critical Autologous Cell Therapy")
Overcoming Obstacles To Deliver Critical Autologous Cell TherapySee how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany
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![clinical-trial-supply-challenges-GettyImages-2161372208]( "From Bench To Breakthrough: How Custom Kitting Fuels Precision Trials")
From Bench To Breakthrough: How Custom Kitting Fuels Precision TrialsReduce trial variability and ensure protocol compliance with standardized custom kitting that transforms complex sample collection into a streamlined, strategic advantage for clinical success.
- Can Your Operating Model Grow? Preparing Clinical Supply For What Comes Next
- The Biggest Early-Stage Clinical Supply Mistake? Building Too Much, Too Soon.
- How Clinical Supply Is Shaping The Next Generation Of Cell And Gene Therapies
- First Advisors In: Meet Clinical Supply Leader's Inaugural Board Members
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.
