Event Recap: Building High-Touch Patient Supply Chains

By |2022-03-18T10:36:32-04:0003/18/2022|

Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]

Advanced Planning: Developing Supply Risk Mitigation Strategies

By |2022-05-20T15:00:55-04:0002/09/2022|

Advanced Planning: Developing Supply Risk Mitigation Strategies Download the PDF Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing [...]

Implementing a Serialization Program Successfully on the First Try

By |2022-02-04T11:33:53-05:0001/18/2022|

Implementing a Serialization Program Successfully on the First Try An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members had commercial [...]

Are You Ready for Serialization Implementation?

By |2022-01-11T09:56:18-05:0001/11/2022|

Are You Ready for Serialization Implementation? A 7-Point Checklist for Emerging Pharma Companies Serialization implementation is probably on your radar already if you’re an executive at an emerging Biopharma company. Manufacturers need to implement a serialization management solution to fulfill today’s requirements under the Drug Supply Chain Security Act (DSCSA). So [...]

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies

By |2021-12-07T11:14:42-05:0012/07/2021|

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Info Sheet: Clinical Supply Chain Services

By |2021-11-09T11:51:19-05:0011/09/2021|

PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

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