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 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.

3. 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.

4. 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.”

5. 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.

6. 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.

7. Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials 11/11/2016

   Clinical News Roundup for the week of November 7, 2016 with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.

8. UPS Expands Clinical Life Science Opportunities With Marken Acquisition 11/7/2016

   UPS has entered into a definitive purchase agreement to acquire Marken, a global, privately-held provider of supply chain solutions to the life sciences industry. The transaction, which provides UPS with growth opportunities across the life sciences customer base, is expected to close by December 31, 2016, subject to customary conditions and regulatory approvals.

9. CROs Can Be Indispensable As Pharma Companies Focus On Value 9/15/2016

   The healthcare industry’s transition to value-based care is putting a lot of pressure on pharmaceutical companies in terms of margins and the need to demonstrate improved outcomes at lower costs. In attempting to create breakthrough therapies and “beyond the pill” solutions with fewer resources, companies are demonstrating an increased appetite for outsourcing functions – and Contract Research Organizations (CROs) could be the beneficiaries.

10. Phase I Clinical Supply Landscape: Trends, Demarcation And Security 8/30/2016

    The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.