The pharmaceutical industry has been struggling for numerous years to produce breakthrough drugs, especially in areas of high unmet need. However, the allure of Regenerative Medicine promises to redefine medical treatment by providing breakthroughs and hopefully curing numerous (possibly thousands) of diseases. With patient outcomes top of mind, Kineticos Chief Commercial Officer, Kevin Hampton, sat down with 3 CEOs leading Regenerative Medicine companies to discuss the current and future state of the field. Below is a condensed and edited version of Part 1 of the dialogue.
- Susan Nichols – CEO, Falcon Therapeutics
- Flagg Flanagan – CEO & Chairman, Discgenics
- Bob Hutchens – CEO, StemBioSys
Kineticos: I think all of us can agree that regenerative medicine has come on very strong over the past several years but thinking back a bit, what would you define as the genesis of Regenerative Medicine? Was there something in particular that happened in the space that gave you the sense that it was about to take off?
Bob: To me, it is a natural evolution of a lot of work from the 80’s and 90’s in the cellular biology space. What seemed to happen, when we got into the financial crisis around 2008, was a dip in investment because there was not capital available for venture and exploratory funding. We’ve seen a strong comeback since then in Regenerative Medicine and we are starting to see good progress with an encouraging number of active clinical trials. However, we are not quite ready to say fasten our seatbelts. The science is hard, and the regulatory environment is hard, but we will get there.
Kineticos: I started really paying close attention to Regenerative Medicine 6-7 years ago and I have to agree – there’s been some great progress but there’s still a lot of work to be done.
Flagg: The regulatory pathway for manipulated cell therapy products and 351 regulated products continues to evolve and has a unique cadence and process to it. Extensive preclinical and clinical work are required of products going down an IND and BLA pathway to demonstrate safety and efficacy. While it can seem like a slow process at times, we understand that it is absolutely necessary and in the best interest of the patients. As we get into human trials, we are starting to see successes in cell therapy and gene therapy. We are not at takeoff yet, but we have the engines ready. The industry has seen some amazing initial results in gene therapy applications and rare diseases. We are also starting to see results around stroke and other phases of end-stage disease where cell-based technology can have an impact.
Kineticos: We have seen a lot come through even in the past couple years. There are the CAR-T approvals from Kite and Novartis as well as Novartis and Bluebird seeing recent approvals in rare diseases. Additionally, there was Brammer Bio and Paragon Bioservices, both CDMOs in the gene therapy space, being acquired for more than $1B each. There’s a tremendous amount of activity and more waves are forming.
Susan: One of the most interesting things I have seen in the past year, are people looking around at various technologies and identifying other approaches and techs to complement their own. More than ever, I see people building unique capabilities along with collaborations as well as mergers and acquisitions. People are starting to combine different technologies and go out to find other platforms and tools to expand their pipeline and enhance their therapy. This activity is a sign of maturity and it is great to be able to witness all of it.
Kineticos: That points to the fact that we are not nearly as nascent as we once were. We have learned that some things alone don’t work, or combined approaches work better than they do alone. We have made progress, but there are still learnings ahead of us.
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