Newsletter | May 21, 2024

05.21.24 -- Key Trends In Outbound, Inbound Biopharma Supply Chains

SPONSOR

Biotech Submits NDA After Risk-Based Mock Inspection

An emerging biotech company recently took a preventative approach to mitigate risks, identify potential concerns before an FDA inspection, and submit their NDA. See how these proactive measures accurately addressed gaps within its application and led to a successful submission.

FEATURED EDITORIAL

Trends To Track: Outbound, Inbound Biopharma Supply Chains

Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.

INDUSTRY INSIGHTS

Key Considerations When Selecting Packaging Components

Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.

RTSM: Randomization And Cohort Management, IP Inventory Management

Examine how the SmartSignals RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

Effective Use Of IRT In Decentralized And Hybrid Clinical Trials

Uncover the ways interactive response technologies are helping trial sponsors manage the distribution of medications, forecast trial supply, and integrate workflows with other technology platforms.

A Supply-Chain Experience Applicable To All Therapies

Joseph Graskemper, Founder & Principal of the newly formed Pathways Pharma Consulting, LLC, describes how he worked out supply chain gyrations with CDMOs to overcome some thorny challenges.

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

SOLUTIONS

Advanced Cold Storage For Advanced Therapies: 3PL Services

Global Advantage With Free Trade Zones In China