The BIOSECURE Act: Safeguarding U.S. Biotechnology
The BIOSECURE Act is a pivotal U.S. legislative measure designed to safeguard national security by restricting federal contracts and funding…
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
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
Highlights from Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Webinar
2024 is a crucial year for the life science industry. November marks the end of the DSCSA stabilization period and…
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
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
Last Mile Logistics: How Manufacturers Can Help Ensure Product Integrity for Patients
Last mile logistics, the final leg of the supply chain from distribution centers or pharmacies to the point of administration,…
Perspective
Life After DSCSA Compliance
In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The…
Perspective
Converge Perspective on the FDA Delayed Enforcement
On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges…
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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
DSCSA Implementation & Readiness Efforts for 2023
2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full…
Perspective
Minimizing COI & COC Risk: 3 Essential Components for Autologous Cell Therapy Facilities
Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into…
Perspective
What Commercial Companies Need to Know about S&OP
Sales and Operations Planning (S&OP) is an iterative planning process. It ensures cross-functional alignment on sales forecast and performance, as…
Perspective
Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers
To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks…