By Carla Reed, president, New Creed LLC Cell and gene therapies are game changers. Critical health conditions that were once chronic or terminal are now being addressed, which is exciting news for patients and caregivers. But these therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level […]
By Carla Reed, president, New Creed LLC Life sciences companies engaged in the transition from clinical to commercial scale are challenged by the ability of current suppliers to meet the demand for materials and services as the volume of source ingredients is increased and production capacity and yield are stabilized. In the case of cell and […]
By Carla Reed, president, New Creed LLC 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, in which cells […]
Taking the First Steps: Where to Focus and What Resources Are Needed Both U.S. and European mass serialization regulations require an integrated flow of information across the end-to-end supply chain, with related technology components for labelling, data capture, control and reporting. Irrespective of the regulations and the business drivers for a safe and secure supply […]
14 August, 2018 by Carla Frances Reed, President, New Creed In 2011, I wrote a paper titled,” Beyond the Mandates,” with the intent of outlining how the proposed regulations for mass serialization (imminent for implementation with different global timelines) could provide additional value for overall supply chain visibility. Seven years later, the debate in terms […]
By Carla Reed, president, New Creed LLC The road from discovery of a promising molecule through the stages of clinical trials and final approval can be a challenging one. The rewards, however, are great — bringing a life-saving drug product to the point where it fulfills the promises of the early days of exploration cannot be […]
By Carla Reed, president, New Creed LLC The life sciences industry has undergone many changes over the last decade, with consolidation, mergers, and acquisitions across both small and large pharmaceutical and biotech companies. One result of these changes is complex supply chain models, with a combination of in-house and outsourced research, product development, and commercial […]
By Carla Reed, president, New Creed LLC 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 […]
By Carla Reed, president, New Creed LLC Once a small or large molecule product has passed the various hurdles in clinical trials, it faces important considerations related to market acceptance and commercialization. Irrespective of the nature or formulation of the product, there is always a heavy focus on the primary packaging element — the final […]
By Carla Reed, president, New Creed LLC 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 […]
