The previous article discussed the potential but also the struggles faced by development of therapies in the regenerative medicine sector. In theory, they promise to solve an array of clinical constraints such as organ transplants and improving therapeutic outcomes for patients with heart conditions. However, the financial and engineering hurdles have hampered the immediate success that these therapies were expected to have. On a positive note, the current status of regenerative medicine shows that the future is bright and new trends are pushing the development of these technologies.
One important trend is the increasing number of phase II trials. Phase II clinical trials are notorious for being a risky phase in therapeutic development. Increasing the number of products in this phase automatically increases the odds of launching new therapies on the market. Ultimately, after phase III, some of these therapies will become clinically validated and obtain regulatory approval. This observed increase in clinical trials will also highlight key bottlenecks in manufacturing and bioprocessing. Lack of efficacy and safety issues will also be encountered, and the learnings from these trials will enable better design of the next generation of regenerative technologies. As these technologies progress, larger companies will be more and more interested in acquisitions and mergers, pushing new technologies to the market.
Manufacturing, supply chain, and distribution will all become further optimized to accommodate the development of these new technologies. Development of new tools capable of streamlining the manufacturing process, as well as decentralization of manufacturing enabling shorter distribution chains, will play a key role in the upscaling of regenerative medicines.
Finally, another noticeable trend is the shift from highly personalized and often extremely expensive technologies to increasingly standardized, so-called “off-the-shelf” technologies. Indeed, many of the therapies in the regenerative medicine space utilized patient cells to manufacture tailored treatments. While this approach may work on a case-to-case basis, it is not scalable. Between the time required for bioprocessing patient cells and the cost of such individualized manufacturing, this has proven to be a crucial hurdle to the growth of the regenerative medicine sector. Companies like Elastrin Therapeutics, capable of manufacturing technologies in a standardized and thus significantly more scalable manner, are considered as the future of regenerative medicine.
Mao, A.S. and Mooney, D.J., 2015. Regenerative medicine: current therapies and future directions. Proceedings of the National Academy of Sciences, 112(47), pp.14452-14459.
Gurtner, G.C., Callaghan, M.J. and Longaker, M.T., 2007. Progress and potential for regenerative medicine. Annu. Rev. Med., 58, pp.299-312.