IA is launching a new Advanced Therapy Community for cross-functional discussion of advanced therapy product development from experimental inception through pre-clinical and clinical development, marketing, and beyond. These promising therapies face unique challenges that are often a combination of issues at different functional levels of the overall development program.

However, development programs for these complex therapies – from experimental inception through pre-clinical and clinical development, approval and pricing – are quite unique based on the technology involved and/or the actual product being developed. Such challenges are likely a combination of issues that affect different development aspects, e.g., CMC issues including manufacturing facilities and cold chain logistics, clinical trial operations and patient recruitment, regulatory requirements and licensing, and pricing and reimbursement acceptance, to name a few. Therefore, a solid development strategy and cross-functional team collaboration are imperative for time- and cost-efficient development and market entry of these advanced therapies. Information and experience exchange between developers and approval decision-makers is paramount in developing these game-changing treatments.

To meet these development needs, DIA is introducing a new, cross-functional Advanced Therapies Community to bring together all DIA thought leaders and members in the advanced therapy field, including but not limited to regulatory agencies, biotech and pharmaceutical industry, patients, payers, and academia to discuss the latest advances, challenges and forward-thinking approaches for time- and cost-efficient product development. Everyone interested in advanced therapies and/or actively working in the field is welcome to join.

Online in April