Perspective
Today’s landscape combines heightened uncertainty spanning scientific, regulatory, clinical, and operational risks with an economic environment where many emerging companies…
Perspective
TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back…
Perspective
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
Perspective
On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…
Perspective
When a biopharma company is bringing up a new manufacturing or warehouse facility, there are many standard operating processes/procedures (SOPs)…
Perspective
Every emerging biotech company has the unique opportunity to establish itself as a reliable partner to patients, physicians, and payers…
Perspective
The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years…
Perspective
Preparing for commercial launch is a complex process for most any life science company. Adding to the challenge, many emerging…
Perspective
Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance…
As DSCSA enforcement in the US becomes a reality after years of phased implementation, the FDA continues incorporating nuances to…
Biopharmaceutical firms face an array of challenges in commercializing innovative therapies. Business risk is high. There are daunting technical hurdles,…
After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for…
As life science companies advance beyond the first launch of commercial products, strategic focus shifts. Attention moves to expanding the business,…