Life Sciences Supply Chain Working Group Webinar on June 29 @ 11a-12p Request the Presentation Request the Recording The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed in March 2020, provides emergency assistance and health care response for individuals, families, and businesses affected by the [...]
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) [...]
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 [...]
Roundtable with 4G Clinical on 6/2/21 Register for the Roundtable Clinical supply professionals are charged with getting the right drug to the right patient at the right time - at the lowest possible cost and resource allocation. While the supply chain itself has held up well during the pandemic, [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]