Supply Chain Integrity Featured Articles

1. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

   How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

2. How To Avoid Delays In Clinical Supply: Strategies For Comparator Sourcing 5/5/2022

   Learn about the ways in which sponsors can work effectively with clinical suppliers for accurate forecasting and comparator sourcing.

3. How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial Needs 1/1/2022

   When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.

4. Compelling Advantages Of Creating A Patient-Centric Supply Chain 1/1/2022

   Marken’s Nina Vas, discusses everything from global regulatory and trade compliance proficiency to the importance of a secure, closed-loop environment with regard to developing a patient-centric supply chain.

5. Accelerating Timelines By Planning For Clinical Supplies In Advance 7/21/2020

   Discover approaches in support of accelerated development timelines, including adopting a single vendor approach, engaging experts earlier in the development cycle, and performing timeline steps in parallel versus linearly.

6. Cell & Gene Therapies Require the Right Tracking Solution 10/11/2019

   In cell therapy trials, the ability to track a patient’s cells is essential. When you have over 100 patients, and the cells will require multiple shipments, using a spreadsheet is not possible. “For the safety of our patient, accurate tracking is a must,” says Gerald Garrett, VP of clinical operations for MarkerTherapeutics. “We need to know exactly where the product is at any step of the way.”

7. Supply Chain Success Relies On Collaborative Decisions 4/24/2019

   If you work in clinical operations, you’re probably aware of how closely that function must work with manufacturing. There are numerous decisions that have to be made around clinical packaging, interactive response technology (IRT) software, labeling of the clinical supplies, and the actual logistics of getting the supplies to the right place at the right time.

8. 10 Things To Remember About The QP Role And Process 9/19/2017

   The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.

9. Clinical News Roundup: Should Cancer Patients Find Their Own Trials? 6/2/2017

   Clinical News Roundup for the week of May 29, 2017 with information on cancer patients finding their own trials, Marken launching a new hybrid clinical trial service, a call for clinical trial overhaul, and Califf making a new start with Verily.

10. Are Your Cell Therapy Samples Getting The Preservation They Deserve? 1/17/2017

    With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.