Aligning For 505(b)(2) Success: Oncology Combination Product First-In-Class Treatment Success

By Ruth Stevens, PhD, MBA, Strategic Advisor

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct…

• Regulatory pathway,
• FDA center,
• Key Opinion Leaders (KOLs),
• Target Product Profile (TPP) inclusions,
• Data to rely on,
• Studies to conduct,
• Indication and patient population,
• Commercial strategy, and much more.

When sponsors consider these as individual questions as they arise instead of taking a holistic view of a program from the beginning, they run the risk of missing out on time and cost savings during development and on revenue potential after launch. Beginning with the end in mind means having the right regulatory and commercial plan in place early on based on sound science and medical, regulatory, and commercial assessments.