Chapters - Americas - Committees - Industry
- Michael Francis - Chair
- Suzanne Tabbaa - Past Chair
- Kiki Hellman (Emeritus)
- Bill Tawil
- Claire Jeong
- Sandy Williams
Scientific and medical progress in tissue engineering and allied disciplines has given rise to novel therapeutic strategies for functional repair or replacement of human tissues and organs, often summarized as ‘regenerative medicine.’ However, to translate discovery research into medical practice and to support and sustain the many emerging and established companies working toward development of products, certain common challenges must be addressed. Those include: 1) rigorous experimental studies and definitive clinical trials; 2) processing and manufacturing controls and quality systems development; 3) licensing of intellectual property – a critical bridge to commercialization and subsequent patent protection; 4) regulatory evaluation and product approval from relevant authorities required for marketing products; 5) cost recovery and reimbursement; and 6) the positive perception of the different publics which provide funding for supporting the entire enterprise and, ultimately, market acceptance.
There is currently no entity that is addressing these challenges in a cohesive, focused manner and/or engaging the many diverse and varied constituencies. Since TERMIS-AM represents individuals and organizations from many different sectors, i.e., academe, institutes, industry, government, working toward the goals of advancing the science as well as developing therapies to meet clinical needs, it is proposed that a Committee on Industrial Development be established within the society to address the challenges and needs facing the industry. Given the scientific progress over the last several years, the time has come for such entity/group to aid the members in meeting these challenges and in building as well as representing the regenerative medical industry to the appropriate constituent communities.