Biopharmaceutical Supplier Risk Management: What You Need to Know Now

By |2021-10-13T11:12:51-04:0010/13/2021|

The COVID-19 pandemic exposed the risks and fragility inherent in global pharmaceutical and biotechnology supply chains. This isn’t really news though. For some time, these supply chains have lagged other industries in speed, flexibility, agility, redundancy, and diversification. With risk considerations at the forefront resulting from shortages during the pandemic, the US government is [...]

Global Trade Compliance: Why Emerging Biopharmaceutical Company Operations Executives Need to Take Notice

By |2021-09-30T13:18:28-04:0009/27/2021|

Today’s biopharmaceutical supply chains often stretch around the world. Key starting materials (KSM) and API originate more frequently from Asia. Manufacturing is commonly conducted in Europe and North America. And commercial distribution is spread across the globe. This globalization has resulted in increased logistics and global trade compliance (GTC) complexity along with ever-changing import/export [...]

Improving Clinical Supply Chain Management by Establishing End-to-End Visibility

By |2021-08-09T11:48:14-04:0008/09/2021|

Emerging pharmaceutical companies frequently place responsibility for clinical supply chain management on their clinical operations team and CROs. This approach can work initially for small, resource-constrained organizations. However, it does not help companies build the internal capabilities, knowledge, and resources to successfully run their clinical supply chain over time as they grow. One [...]

Building Supply Chain Resilience: The Biden Administration’s 100-Day Supply Chain Review Findings on Pharmaceuticals and APIs

By |2021-06-24T11:32:22-04:0006/24/2021|

On February 24, 2021, President Biden signed an Executive Order on America’s Supply Chains (EO) as a step toward building more secure, robust and resilient supply chains. The EO initiated a 100-Day Supply Chain Review, which detailed an assessment of the strengths and weaknesses of the domestic supply chains for four key product areas, one of which included a review of pharmaceuticals and [...]

The CARES Act & Your Supply Chain: What You Need to Know

By |2021-06-24T11:34:46-04:0006/24/2021|

Jeremy Friedler, senior consultant, and Rashi Gupta, consultant, focus on biotechnology and pharmaceutical operations at Converge Consulting. The COVID-19 pandemic and resulting economic crisis exposed the vulnerabilities of both domestic and global supply chains across multiple industries. Given the complexity and far-reaching global nature of their supply chains, pharmaceutical and biotechnology companies were [...]

Event Recap: Global Logistics & Trade in a Post-Pandemic World

By |2021-05-18T10:58:20-04:0005/18/2021|

The current pandemic is severely impacting life science supply chains. There are supply delays, constrained transportation and cold storage, and reduced demand. As the pandemic begins to ease in some parts of the world, Supply Chain leaders are preparing for the post-pandemic global logistics and trade environment. Our Life Sciences Supply Chain Working Group (SCWG) [...]

Thinking Differently about Safety Stock

By |2021-04-13T11:37:36-04:0004/13/2021|

Inventory comes in many shapes and sizes, quite literally, but for life sciences one thing is certain: effectively managing inventory is a make-or-break moment for delivering patient-centric care. I have seen this value potential play out while working with dozens of emerging companies to build efficient inventory management strategies. Many senior leaders underestimate how [...]

Info Sheet: Scaling & Sustaining Commercial Growth

By |2021-03-22T09:29:03-04:0003/18/2021|

As life science companies advance beyond the first launch of commercial products, strategic focus shifts. Attention moves to expanding the business, regulatory and geographic reach of their treatments. Market expansion, label expansion, and further pipeline development create more opportunities. Companies pursue these efforts in parallel as quickly as possible. The initial supply and [...]

Global Trade & Logistics: The Other Side of Compliance

By |2021-02-22T12:16:26-05:0002/22/2021|

An innovative pharmaceutical company was awaiting FDA approval to launch its first commercial product. They were also increasing their clinical trial activities globally and advancing other programs into the clinic. The complexity of their global supply network was increasing. However, they lacked processes, knowledgeable resources, and organizational understanding of global trade compliance requirements [...]

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