Community Spotlight

New Advanced Therapy Community Launching in June

Kirsten Messmer
Richard Dennett

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.

Advanced therapies, which include gene and cell therapies as well as tissue engineered products, have appeared as very promising treatments with many highlighted for their ability to provide a curative effect upon only one application. In recent years, the advanced therapy sector has experienced rapid growth due to the increased interest and development activities. In October 2019, the Alliance for Regenerative Medicine reported growth in clinical trials investigating regenerative medicine products from 2014 to 2018 at 32 percent globally. According to a forecast by BIS Research, the 2018 cell and gene market was valued at more than US$ 1 billion and is expected to grow to approximately US$ 10 billion by 2025, with compound annual growth rate (CAGR) predicted to be more than 36 percent in the forecast period (2019 – 2025).

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

The Advanced Therapies Community website for members to join and start discussions will become operational in early April, with an inaugural online presentation (on the Zoom platform) scheduled for noon EST on 21 April 2020. Zoom connection details will be announced in advance. The Community will be officially launched at the DIA 2020 Global Annual Meeting in June. Starting in July, regular online meetings will be held on the third Tuesday of each month at noon EST, featuring a presentation followed by community discussion. The new community invites all DIA members to join.