The regenerative medicine industry: From “bench to business”

Author: Sasha (Alexandra) Lisovsky, 08/13/13

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I was very fortunate to win a CCRM (Centre for Commercialization of Regenerative Medicine) scholarship to attend the 6th Annual “Business of Regenerative Medicine: From Stem Cells to the Market Place” at Case Western Reserve University in Cleveland, Ohio. The focus of this year’s course was on opportunities and challenges associated with biologics and, specifically, stem cell therapies.

‘It takes a village to raise a child’ and this course reminded me that it takes a lot of people, with different expertise, to get stem cell therapies into the clinic and out of the research lab.

This course was a fantastic networking opportunity. There were only about 30 attendees and 15 presenters and with most meals shared, this course provided an exclusive opportunity for stimulating conversations and relationship building uncommon at most networking events. The small course size gave me the opportunity to talk one-on-one to academics with successful startup companies, lawyers and consultants specializing in intellectual property and industry analysis, and founders, presidents and directors of regenerative medicine (RM) companies and incubators for commercializing RM technologies.

The small course size gave me the opportunity to talk one-on-one to [RM leaders].

I learned a lot in this course. The presenters covered everything from having an idea to starting a company to making it profitable. Included were the highlights of legal and regulatory hurdles that companies deal with along the way. The quality of the speakers was superb. Company talks were given by presidents and CEOs. Academics who spoke each had several companies successfully spun out of their research labs. Lawyers and consultants had extensive experience in supporting and analyzing the RM industry.

For instance, one of the presenters was Glenn Prestwich, Presidential Professor of Medicinal Chemistry at the University of Utah and a co-founder of seven companies. Dr. Prestwich updated attendees on customizable biomaterials for stem cell therapeutic research and on his collaborations with other RM companies. Michael West, the CEO of BioTime and the founder of Geron, educated attendees on BioTime’s development of well-characterized stem cell populations for targeted disease treatment and the industry’s need to have good science behind stem cell therapies. David Smith, a lawyer with Pepper Hamilton LLP, gave an insightful talk on the potential implications of the U.S. Supreme Court’s decision on Myriad Genetics with regard to current and future patents on cells.

Finally, the most important aspect of this course for me was that I came out of it with a positive outlook on the RM industry. After early RM companies failed to deliver on the initial hype of stem cells, after multiple failed stem cell clinical trials and after Geron’s halted stem cell clinical trial (followed by Geron completely exiting the stem cell business), I was left with a numbing sensation that the RM industry was stuck in the embryonic stage of its development.

This course made me realize that RM companies are starting to fulfill the promise of stem cell research. According to Robin Young, founder and President of Robin Young Consulting Group and a former Wall Street analyst, overall equities of public stem cell companies rose by about 20% from June 2012 to 2013 and the stem cell therapy market is projected to increase from about 195 million in 2012 to an estimated 7 billion in 2020.

The stem cell therapy market is projected to increase from about 195 million in 2012 to an estimated 7 billion in 2020.

Furthermore, stem cell products are already in the market (for example, Trinity Evolution by Orthofix International and Osteocel by NuVasive) and more are in the pipeline going through phase III clinical trials (as an example, Mesoblast has several therapies). Companies are also making a visible impact on patients’ lives.

According to Osiris President and CEO Randal Mills, over 100,000 patients have been treated with their biologics. Osiris’s Prochymal is saving the lives of children with severe treatment-refractory acute graft versus host disease (GvHD), a life-threatening immune reaction to bone marrow transplants. Prochymal works in about 68% of patients with most achieving complete remission, whereas the average survival for a child with GvHD is only 80 days.

In addition to success with stem cell products, there is a rise in organizations such as CCRM, Harvard Stem Cell Institute and BioMotiv, which help to bridge the gap between academic discoveries and commercialization by providing business, legal and regulatory expertise, and financial support. And finally, stem cell products will be able to reach millions of patients because the RM industry is developing both strategic collaborations with large biotechnology companies to support their business growth (for example, Osiris and Mesoblast with Lonza) and small companies to increase their product portfolio (such as Celgene with Tengion).

From this course, I realized that the success of today’s stem cell products will not only help patients, but will drive the development of new companies and biologics. RM therapies do have the potential for disease reversal but only, as Case Western Reserve’s Arnold Caplan says, when we stop saying “Bench to Bedside” and start saying “Bench to Business”. There needs to be a profitable business opportunity in stem cell therapy for it to see the light of day and thus make an impact.

Next year this course will be hosted by CCRM in Toronto in July. I am planning to attend the course again because in addition to getting an update on the RM business landscape, the course will give me the opportunity to talk with the top minds in the RM industry and to further foster my professional network. I hope to see you there!

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Sasha (Alexandra) Lisovsky

Sasha is a PhD student in Biomedical Engineering at the Institute for Biomaterials and Biomedical Engineering at the University of Toronto. She is currently investigating molecular and cellular mechanisms of blood vessels formation in presence of a therapeutic biomaterial to improve wound healing of chronic diabetic wounds. She is a Bylaws chair for the international Society for Biomaterials serving over 20 student chapters, a Director of alumni relations for the Toronto graduate management consulting association and a volunteer for national StemCellTalks and Let’s Talk Science organizations.

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