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"Accelerated Approval Pathways Pose Commercialization Risk"

Accelerated approval pathways create an additional layer of complexity in the chaotic oncology marketplace, leaving manufacturers of all sizes seeking a new commercialization model for launch success.

With 30% of drug approvals by the FDA occurring in the oncology and hematology space, there is considerable focus by biotechnology manufacturers to fulfill the unmet need of cancer therapies that can extend throughout the span of the patient’s life. This unmet need, and the pace of the biotechnology industry, can lead these high-science brands to participate in accelerated approval pathways.

Accelerated approval pathways create an additional layer of complexity in the chaotic oncology marketplace, leaving manufacturers of all sizes seeking a new commercialization model for launch success.

This article will explore:

• The risks associated with accelerated approval pathways
• Why the traditional go-to-market playbook is not sufficient for launching in today’s oncology market
• Why small and large pharma companies should outsource with one accountable partner
• How a next gen commercialization model addresses challenges in the oncology drug pipeline, caters to tumor type and therapy needs and provides manufacturers the flexibility and expertise to customize their strategies

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