ARTICLES BY CARLA REED
The Need For Digital Networks To Support Cell And Gene Therapies
Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.
Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain?
Understanding the impact and requirements for a clearly defined supply chain strategy and implementing this into the complex environment of cell and gene therapies is not a simple task. It requires dedication and participation from all the stakeholders across the development-to-delivery life cycle. All the details need to be defined, simulation models developed, and risk assessed — and remediation plans put in place.
Recalibrating The Supply Chain For Allogeneic Cell Therapies
In November 2018, I wrote an article about establishing a supply chain for autologous cell therapies — those formulated using a patient’s own cells. This partner piece highlights considerations that need to be taken into account when developing a commercialization and supply chain strategy for allogeneic cell therapies.
Establishing A Critical Supply Chain For Autologous Cell And Gene Therapies
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
8 Critical Elements Of A Supply Chain Strategy — From Discovery To Commercialization
The journey from discovery to commercialization can be long and filled with obstacles and challenges. However, by taking a structured approach to the development of a clearly defined supply chain and distribution strategy, the path toward the ultimate goal can be a clear one.
Selecting Secondary Packaging For Bio/Pharma Products
Secondary packaging, at times an overlooked element of product life cycle management, should provide protection for the material or product across all the process steps, from final packaging at production through consumption, return, and disposal.
Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria
Looking back at the hurricane season from the perspective of supply chain risk — and specifically risks that have impacted the life sciences supply chain — there are many lessons to be learned.
A Life Cycle Management Approach To Developing A Supply Chain Strategy
Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.
5 Proven Steps To Successfully Select & Onboard Outsourced Logistics Partners
In preceding articles in this series, we reviewed some of the challenges and remediation approaches for the storage and distribution of life science products, highlighting some of the specific risks related to storage, transportation, and material control across an extended chain of custody. This brings us to the final article, in which we will discuss best practices for selecting the partners that will be an extension of your staff for monitoring and control across an ever-changing global landscape.
A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution
Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.