Depot-to-Site Supply Strategy: 10 Key Considerations for Clinical Success
Depot-to-site clinical supply strategy ensures that the investigational product (IP) is available at the right site, in the right quantity,…
Perspective
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
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
Drafting SOPs for a Facility that Does Not Exist Yet
When a biopharma company is bringing up a new manufacturing or warehouse facility, there are many standard operating processes/procedures (SOPs)…
Perspective
What Emerging Companies Need to Know about PAI Readiness
Pre-Approval Inspection (PAI) is a crucial step for emerging companies and ensuring PAI readiness is a vital set of activities…
Perspective
Essential Elements of Commercial Mock Launch for Emerging Biotech Companies
Every emerging biotech company has the unique opportunity to establish itself as a reliable partner to patients, physicians, and payers…
Perspective
Managing a Tech Transfer Redesign Post-Acquisition
Managing a Technology Transfer (TT) is often complex, and redesigning an existing TT process even more so. Companies will generally…
Perspective
Event Recap: Digitization of the Supply Planning Process
Many emerging and mid-sized biopharma companies work to digitize their supply planning process as they grow, as part of larger…
Perspective
ERP Implementations: How to Ensure a Successful Business Go-Live
This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the…
Perspective
Event Recap: Avoiding Common Traps in Commercial Launch
The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years…
Perspective
Navigating Stage-Appropriate Quality System Design
Our emerging biotech and biopharma clients often request support from our skilled consultants and practitioners to develop a “Stage-Appropriate cGMP Quality…
Perspective
ERP Implementations: Understanding Technical Versus Business Go-Live
Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business.…
Perspective
Event Recap: Supply Chain Planning for Today’s Uncertain World
Uncertainty and risk have been consistent themes inherent to biopharmaceutical supply chains. The recent pandemic has only amplified this notion.…