Deadpool: regenerative medicine’s very own mascot/superhero
By what measure do we determine whether an industry “has arrived?”
Goldman Sachs issued a report in 2017 with a section titled “The Coming Age of Regenerative Medicine” and media were quick to report this. A Business Insider headline stated that “money is pouring in to a hot new area of science that could change the way we think about aging.”
It goes on to say that “venture capital in companies pursuing regenerative medicine increased from USD$296 million in 2011 to USD$807 million in 2016,” an increase of about 34 percent year-over-year. As mentioned in the article, the Goldman Sachs report also states: “We see regenerative medicine as one of the most compelling areas for venture investment.”
Investor enthusiasm and funding. Check.
What about approved therapies? We’ve got those too.
A tipping point has emerged with the seminal approval of Novartis’ Kymriah in the U.S. and Europe, its USD$475,000 list price by the Centers for Medicare & Medicaid Services, and the growing catalogue of high-value company acquisitions we’ve seen in the sector (for example: Kite Pharma and Cell Design Labs by Gilead, Calimmune by CSL Behring, Dimension by Ultragenyx, Juno by Celgene and Bioverative by Sanofi).
According to the Alliance for Regenerative Medicine, “There were 977 clinical trials underway worldwide at the close of the second quarter of 2018” based on data generated by cell therapy, gene therapy, tissue engineering and other regenerative medicine companies worldwide. That’s a lot of trials for a lot of therapies. This is an exciting time for the cell and gene therapy field! And let’s not forget that the Nobel Prize was awarded to Professor Shinya Yamanaka and Sir John Gurdon in 2012 for their work with induced pluripotent stem cells, which have been used in a variety of regenerative medicine approaches, notably by BlueRock Therapeutics. Consider that significant award to be more affirmation and corroboration that perhaps regenerative medicine has finally “come of age.”
Or has it?
To meet the increasing demand for newly-approved and upcoming therapies, there is still a long inventory of challenges to overcome, from manufacturing, supply chain, regulatory, reimbursement, market accessibility, a talent shortage and more. Ethical issues will also require thoughtful consideration and guidance. That sounds like years of work to iron out the kinks. Perhaps we’ve only begun to scratch the surface?
Signals has assembled thought leaders, leading organizations in the field and some popular bloggers to tackle the question “Has the regenerative medicine industry come of age?”
Clinician Sven Kili, VP and Head of Cell & Gene Therapy Development for GSK Rare Diseases, is firmly in the “it’s getting there” camp. Read why.
CCRM’s partners at OIRM and Stem Cell Network make a compelling case for progress that has been achieved, but you’ll have to read their blogs to see how they vote.
And then there is CIRM. It has the pulse on regenerative medicine in California – a leader in the sector on par with many countries – so how does CIRM answer the question?
Two of Signals’ bloggers were keen to weigh in on this topic. Jovana Drinjakovic gives gene therapy a firm “no” – for now anyway. Samantha Payne, a PhD student, examines the research and is mostly optimistic.
You are encouraged to read all of the blogs and then come to your own conclusion. Tell us how you would answer the question in the comments below. Or share with us on Twitter @Signalsblogs, on Facebook or LinkedIN. We would love to hear from you!
Stacey Johnson
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