Featured Pharma Online Editorial

  1. 5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them

    Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.

  2. Pharmaceutical Transport Validation — Where To Begin?

    This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.

  3. Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

    From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

  4. FDA’s First DSCSA Warning Letter — A Closer Look

    The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.

  5. FDA’s DSCSA Pilot Project Program — Should You Participate?

    The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?

  6. Big Data And AI In Pharma Development And Manufacturing: An Inside Look

    Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.

  7. 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.

  8. 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.

  9. 2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches

    Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.   

  10. The Difference Between Logistics Management And Logistics Control In Life Sciences

    Life science products have a distinct logistical profile; the nuances between a fine chemical and a medical compound or medical devices and computer hardware have significant regulatory differences. When determining the logistics plan for a product it is critical to remember that it is not just a box. By Paddy Hanlon, Senior Director, Business Development, Marken