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Commercialization of regenerative products: the academic/industry partnership.

The Identification of barriers to the successful commercialization of regenerative products is critical to their ultimate delivery to the clinic and marketplace as well as to the establishment of a viable, self-sustaining industry. The 2010 member survey conducted by the Industry Committee of TERMIS-North America (TERMIS-NA) identified the major barriers to academia and industry (start-ups, development stage, and established companies). The most common barriers identified were as follows: (1) funding; (2) technology transfer/intellectual property (IP); and (3) market focus. The data also suggested that enhanced communication among the different stakeholders of regenerative medicine is important for successful product development. Partnering between academia and industry is a key link in the biotechnology value creation chain. These synergies are perhaps even more important in the field of regenerative medicine to achieve efficient and appropriate translation of innovation from academia into industrial laboratories. However, there are several impediments to the development of tissue engineering and cell therapy products. The first of these is that the field is still emerging, despite several notable commercial or technical successes (e.g., Dermagraft or Apligraf as skin substitutes). Nevertheless, this cannot be compared with, for example, the level of deployment achieved by monoclonal antibody technology. This can be seen by using, as a proxy, the values of mergers and acquisitions or billion-dollar range licensing deals involving these biologics. The second major impediment is the still negligible interest that the pharmaceutical industry (‘‘big Pharma’’), as an asset class, has expressed to date for deploying cell therapeutics, with the notable exception of Pfizer, which has sustained their effort in the field since 2008 as highlighted by its 2009 strategic alliance with Athersys. Notably, mid-size Pharma has exhibited more willingness to address the remaining technology risks; this is exemplified by the strategic decisions made by Genzyme and Cephalon, which partnered with Osiris and Mesoblast, respectively, as early as 2009. Taken further, it would appear that identification of the appropriate synergies between academia and industry with relevant partnership strategies would not only accelerate product development but also deliver the ultimate goal of successful commercialization. To address this specific topic, the Academia/Industry partnership, TERMIS-EU (Europe), and TERMIS-AM (Americas) Industry Committees invited: