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: IT Roadmaps for Commercial Launch

By |2021-04-08T12:51:45-04:0004/08/2021|

After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for their first commercial launch. As this organizational transformation nears, the focus of the IT organization shifts from infrastructure and help desk support to business enablement as new functions like Sales, Medical Affairs, [...]

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 [...]

Info Sheet: Cell & Gene Therapy Services

By |2021-03-19T11:53:55-04:0003/02/2021|

PDF Available > Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and gene therapies (CGT) requires rethinking traditional business models [...]

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 [...]

Global Logistics & Trade in a Post-Pandemic World

By |2021-03-26T10:28:46-04:0002/01/2021|

Life Sciences Supply Chain Working Group Webinar on 3/25/21 @ 12-1p Request the Presentation Request the Recording We are seeing new global logistics and trade challenges emerging in our "new normal" business environment, which includes fast-changing trade wars, restrictions on cross-border transport, and huge demands for [...]

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 [...]

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