Integrating Market Access Strategy in Preclinical Gene Therapy Development
18 Sep 2025
Commercializing Gene Therapy in 2025
- The importance of aligning early stage development, CMC perspective to pave a path to win market access
- The importance of aligning preclinical design with market access goals - considering urgent needs, patient populations, and payer expectations from the earliest stages
- Early integration of target product profiles with regulatory and health economics insights helps guide decisions of delivery platforms, such as peptide-modified AAVS, to meet future reimbursement requirements
- Engaging stakeholders, clinicians, payers and advocacy groups - preclinically ensures clinical relevance and commercial viability of gene therapies before entering the clinic
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