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 [...]

Benefits of Early Launch Planning

By |2021-03-18T14:03:38-04:0003/03/2021|

Preparing for commercial launch is a complex process for most any life science company. Adding to the challenge, many emerging life sciences companies operate as very lean organizations with limited resources. Specialty products in particular can be one-of-a-kind and require unique launch processes and procedures. In some cases, team members are also doing it [...]

Building Agility into the Clinical Supply Chain

By |2021-02-10T19:17:56-05:0002/09/2021|

There are incredibly innovative trends taking place in clinical supply right now. Clinical trials are being "brought to life" from synopsis to final protocol to FPI in a few weeks. Direct-to-patient shipments and remote patient monitoring are becoming essential practices for dealing with difficult situations. There continues to be inherent risk and uncertainty in [...]

DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

Stage-Appropriate Quality Systems

By |2020-10-22T12:18:12-04:0010/22/2020|

Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]

Improving Demand & Supply Planning for Emerging Life Science Companies

By |2020-09-25T09:09:06-04:0009/24/2020|

Improving Demand & Supply Planning for Emerging Life Science Companies Todd Applebaum, Managing Director Our Demand & Supply Planning Maturity Model aligns key aspects of the planning process to each company's lifecycle. Improving demand and supply planning is crucial for Life Science companies. This is especially valuable when dealing with [...]

4 Trends in Commercial Supply Chain Launch

By |2020-09-14T12:03:18-04:0009/14/2020|

Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance preparing the supply network and launch materials with the uncertainties of clinical development and regulatory progress. In addition, they must manage the risks of commercial uptake and demand. These challenges hold true whether [...]

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