Knowledge Hub White Papers Category Alerts Case Studies Events News Press Releases Published Articles Regulatory Updates Uncategorized Videos White Papers Date All Dates April 2021 October 2019 June 2018 Clear Filter MARK-WP-04 How to Evaluate a Clinical Supply Chain Partner to Meet Your Vaccine Trial Needs Request a Copy It is essential for pharmaceutical companies to evaluate many factors when choosing a clinical supply chain partner. With today’s global focus on vaccine development, the need for excellence in clinical cold chain distribution and storage has never been more acute. This white paper addresses the key questions to help guide the conversation as you evaluate prospective supply chain partners. MARK-WP-03 Solving Complexities In the Era Of Personalized Medicine Request a Copy Cell and gene therapies are fundamentally different than traditional medicines, from the patient and product journeys to the systems and supply chain that support it. These personalized medicines move through development at a faster pace than traditional drugs, with some reaching approval within four to five years from first-in-human trials. Bringing personalized medicine to market successfully, such as cell and gene therapies, requires industry expertise and a rigorous control process, coupled with advanced technology. Here, in this paper, we outline current challenges, their solutions, and a framework for how to choose a strategic partner in cell and gene therapy supply chain solutions. MARK-WP-02 Utilization of Customs Warehouses in the Clinical Trial Supply Chain Request a Copy The global clinical trial supply chain industry has been seeking new opportunities to improve efficiency for many years. As pressures to decrease cost and reduce time to market continue to rise, the design of the clinical trial supply chain must evolve and change to meet those demands. A European Union (EU) based customs-bonded warehouse may provide solutions for reducing costs while optimizing distribution throughout the clinical trial supply chain. MARK-WP-01 Supply Chain Solutions for the Growing Orphan Drug Market Request a Copy Orphan drug development has seen significant growth in recent years, with many large pharmaceutical companies shifting focus from traditional, mass market drugs to treatments for rare diseases. Orphan drugs are defined by the U.S. Orphan Drug Act of 1983 (ODA) as a drug intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. Corporate Office 1009 Slater Road Suite 120 Durham, NC 27703 Tel: 18006275361 Email: info@marken.com Search Our Site Marken FastTrack Follow Marken © 2021 MARKEN. All Rights Reserved. Legal Web Site Terms & Conditions of Use Privacy Notice Cookie Policy Standard Terms & Conditions Anti-Corruption Compliance Policy Sitemap Cookie Control Icon