Avoiding Approval Risks at Your CMO Facility
In August 2024, Regeneron received a Complete Response Letter (CRL) from the FDA for its multiple myeloma treatment candidate. 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
CMC Project Plans: A Critical Tool for Early-Stage Biopharma
CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team…
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
Event Recap: Stage-Appropriate Quality Systems
Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for…