Commercialization strategy for FormaCyte therapeutics: Type 1 diabetes patient insights and regulatory pathway analysis on US FDA's impact on other jurisdictions

• Main Author: Liu, Fanzheng
• Other Authors: Dang Thuy Tram
• Format: Final Year Project
• Language: English
• Published: Nanyang Technological University 2024
• Subjects: Engineering; Medicine, Health and Life Sciences
• Online Access: https://hdl.handle.net/10356/177416
• Institution: Nanyang Technological University

This report aims to strengthen the commercialization strategy of FormaCyte, an innovative treatment for Type 1 Diabetes (T1D), by obtaining firsthand patient insights to bolster a patient-centered development and investigating the US’s regulatory impact for cell therapy on other jurisdictions to support regulatory development efforts. Patient-centric drug development necessitates a profound understanding of patients. However, limited access to real-life experiences of T1D patients and challenges in patient engagement underscore the necessity for innovative outreach methods and focused interviews to enhance patient-centric development, crucial for development success and regulatory strategy. Additionally, existing regulatory literature primarily focuses on regenerative medicine, not specifically CT, and lacks comprehensive insights into the impact of US regulations on other jurisdictions, highlighting the need for a more inclusive review to inform FormaCyte's tailored regulatory approach across diverse jurisdictions. 25 patients are interviewed in this project, and insights on their glucose management method, major pain points, lifestyle and mindset, expenditure, and thoughts on FormaCyte are gathered. Significant market potential for FormaCyte is revealed, though concerns surrounding efficacy, pricing, and safety underscore the need for careful consideration in product development. Regulatory analysis demonstrates the positive impact of the US FDA pathway on selected jurisdictions, namely the EU, China, Japan, Australia, and Singapore, with harmonization efforts found between FDA and many authorities, such as in the EU and Singapore. With Singapore-based developers, FormaCyte stands to benefit from prioritizing FDA approval while leveraging regional strengths and relevant acceleration programs for smooth and expedited market entry across diverse regulatory landscapes.