INSIGHTS ON CELL & GENE THERAPY LOGISTICS

• Covid-19 Impact On Bioprocessing: PART 3 Long-Term Changes Resulting From The Pandemic

  Changes in the bio/pharmaceutical industry are being accelerated and catalyzed by the responses to the current Covid-19 pandemic. Although suppliers have proven themselves rather robust in their dealing with the pandemic, and business is continuing generally uninterrupted, there will be significant changes.

• Enabling Fast And Appropriate Drug Product Supply For Phase 1 Clinical Trials

  Reducing the timeline from conception to Phase 1 trials can be especially challenging for new and emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. Without the ability to move smoothly from lab concept to the manufacture and delivery of GMP clinical supplies to patients, critical milestones could be missed, potentially delaying funding commitments from investors.

• How a Best-Practice Strategy For Sourcing Ancillary Materials Reduced Risk, Spending and Workload In A Global Diabetes Trial

  It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And as one leading multi-national pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.

• Delivering Clinical Trial Medications Direct-To-Patient

  In a perfect world patients enrolled in clinical trials would live a short distance from the investigator site where they receive their treatment. Unfortunately that is not always the case. In recent years the Direct-to- Patient model, which brings medical procedures to a patient’s home, has emerged as a solution for Sponsors to increase patient recruitment and retention in clinical trials.

• Depot-To-Patient Service Overview

  This infographic provides an overview of Fisher Clinical’s depot-to-patient solution to support decentralized clinical trials in the US.

• Low Risk Frozen Distribution Of Single-Use Bags For Bioprocessing

  This paper will discuss the results of applying an approach using sensors and more suitable material to a frozen shipping study of single-use fluoropolymer bags.

• Considerations For Your First Clinical Trial

  For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming. Tt is important to understand that CROs do not typically manage the comprehensive clinical trial supply chain. This paper reviews seven ‘clinical trial supply best practices’ to help ensure a successful trial.

• Factoring The “What Ifs” Into Supply Forecasting

  Growing urgency in the biopharmaceutical industry to speed new products to market is leading to greater appreciation for supply forecasting as a strategic and highly complex success factor. This paper discusses the aspects to consider when developing a supply plan, the influence of early decisions and impact on outcome as a trial progresses, and how decisions can put patients and the trial at risk.

• VIA Capsule System ‒ Liquid Nitrogen-Free Shipping For Cell Therapy Logistics

  Realize a more controlled, assured and patient focused way of shipping cell and gene therapies with the VIA Capsule™ solution. Easily charge this liquid nitrogen-free system using electricity. Securely load the cell therapy using your defined process, and capture records digitally. Integrate activities across the manufacturer, courier, and clinic while maintaining an electronic record of the shipment conditions, location, chain of custody and identity. If needed, use the shipper for temporary cryogenic storage. When the patient is ready, wheel the shipper in.

• Cell Therapy Logistics: Advanced Therapy Treatment Case Study

  This case study describes work the establishment and testing of a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP).