INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Risk Mitigation For Single-Use Cold Chain Distribution

  In this recorded webinar, we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.

• Ancillary Supplies: Clinical Trial ‘Must-Haves’ That Require Early Planning

  Ancillary supplies are a necessary component in every clinical trial, though these products are often perceived as secondary in importance to investigational medicinal products (IMPs). Janet Williams, senior director, global supply chain management, and Julie Hoffman, senior director of commercial strategy and execution, discuss why ancillaries are as essential as IMPs, and why sponsors should devote as much attention to early planning for ancillary supplies as they do for study drugs.

• How To Select the Best Courier Around The Globe

  As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Additionally, cost pressures demanded a tighter supply chain with better control over inventory levels, and there was a need for increased temperature monitoring of clinical supplies in transit. Learn how data-driven decisions allowed them to realize cost & performance improvements across the supply chain.

• Early Licensure Of A Breakthrough Cancer Drug Gives Hope To Patients

  No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options. Read how named patient and expanded access programs helped speed the licensure of a breakthrough cancer drug.

• Business Continuity Program Helps Maintain Operations In The Face Of Crisis

  Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.

• Key Considerations For Labeling Your Cell Or Gene Therapy

  As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

• Transportation Solutions For Cell And Gene Therapy Supply Chains

  Developing a strong supply chain for your cell and gene therapy can make your company a more attractive target for acquisition as well as a more competitive player in the commercial environment.

• Managing Temperature Excursions - Key Pointers That Must Be Addressed

  The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides top tips on the best course of action to take, and provides summary recommendations for Sponsors on how to handle cold chain or temperature sensitive IMP across the supply chain, up until delivery to the investigator site.

• Cold Chain Industry Trends - Planning Tips to Create a Robust Supply Chain

  The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides an industry overview and a framework for discussion. The importance of a robust supply chain is addressed. It includes planning recommendations for biopharmaceutical companies preparing to scale up to global vaccine trials.

• Evaluating And Qualifying Temperature Managed Shippers

  The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber—from packaging, handling, storage & distribution of temperature sensitive Investigational Medicinal Products (IMP), all the way to the investigator site. This eBook provides insight into how we qualify shipping options with a case study example of a ‘return and reuse shipper pilot’ which delivered very positive results