Rightsizing a Business Continuity Program
Many emerging biopharmaceutical companies neglect to develop business continuity plans because they are operating with constrained resources. Even with the…
Perspective
The Evolving Ecosystem for Biopharma Manufacturing
A significant – even seismic – shift is taking place in biopharma manufacturing and technical operations right now. It is…
Perspective
US-China Trade Tension: Increasing Uncertainty for Biopharma
In recent years, the US government has increasingly leveraged trade policy as a tool for broader U.S. foreign policy. This…
Perspective
Impact of Rejecting Chevron Deference on Biopharma
On June 28, the Supreme Court of the United States (SCOTUS) overruled the most cited legal case in its history, colloquially…
Perspective
Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs
CMC and Finance in emerging biotech companies are important partners, but they often find themselves at odds with one another.…
Perspective
Bridging the Gap between Finance, CMC & Program Management in Emerging Biopharma Companies
The CMC landscape is complex, uncertain, and dynamic, driving the CMC team to constantly adjust their plans and timelines. It…
Perspective
Benefits of Using Foreign Trade Zones for Emerging Biotech Companies
We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D,…