Authors


SamaCare

Latest:

How One Brand Protected Market Share Amid Biosimilar Pressure

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release.


Kamini Anbil

Latest:

Multi-Indication Drug Branding in Today’s Pharmaceutical Industry

As drug development increasingly targets multiple indications, pharma companies must make strategic branding decisions—balancing regulatory requirements, market dynamics, and patient safety—to choose between single-brand or multi-brand approaches.


Matthew Sample

Latest:

Understanding the FDA's Exemption for DSCSA Compliance

In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.


Bob Celeste, C4SCS

Latest:

DSCSA 2024 or 2023 Déjà Vu?

A look at the challenges that need to be addressed during the FDA stabilization period.


Noelle Clifford

Latest:

Challenges in Cell and Gene Therapy Manufacturing, Sterility Assurance

Manufacturers should leverage the knowledge base of personnel working in sterility assurance and in microbiology laboratories.

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