Navigating China IIT Importation Without Losing the Speed Advantage
China IITs Are Unique and Operationally Challenging Across the Clinical Supply Chain China IITs can offer advanced therapy sponsors a…
Perspective
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
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
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
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…
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
Event Recap: Building High-Touch Patient Supply Chains
The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies…
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,…
Perspective
5 Unique Logistics Challenges for Specialty Pharmaceuticals
Many of our clients are innovator companies developing novel treatments that are often complex and extremely high value. As a…