My timelines are not pessimistic.They’re realistic.
Agile development uses the concept of “velocity.” You can use your team’s known velocity to estimate the amount of time it takes to deliver future products. Let’s take a look at Replicel’s velocity.
2003 - McKelwee injects fluorescent DSC cells into mice and proves they create new follicles and stimulate existing follicles to grow thick hair.
2009 - McKelwee (Replicel) designs his first study in humans - Phase 1/2a
2010 - Approval to perform study granted, First patients are injected.
2011 - Final patients injected - 24 month followup began
2012 - Phase IIa scheduled to begin. However, the study never commences because Replicel needs to invest it’s limited funds in other areas in order to hedge it’s bets in case it’s hair growth fails. Otherwise investors will get cold feet and pull out.
2013 - First study in humans concluded. Shiseido enters into agreement to license the technology.
2014 - Shiseido sets up facility in Kobe Japan in order to fast track product to market.
2018 - Shiseido’s target delivery date for availability of product to the public.
As we can see, Replicel’s velocity to deliver it’s product is projected to be 15 years from the proof of concept studies through to market availability. Of course, the research could hit a snag and take longer or not be delivered at all. But let’s say the product is delivered at the 15-year mark. What can we expect in 2018?
Probably between zero and 25% increase in density with additional density being provided through additional treatments. However, the 25% responders are outliers, just as the zero responders will be. The typical increase in density will be about 10% to 15% per treatment with results possibly tapering off through time (maybe only 7% density increase in treatment 2, etc). Future versions of the product will bring increased density per treatment, which would offset the taper-effect.
Replicel’s treatment looks promising. However, it will be nowhere near the Brad Pitt cure via a single procedure people are expecting. Reason being, the fundamental hurdles to this process have not been fully overcome.
As for Dr Terskykh, he has no funding, he’s still studying mice, and he’s nowhere near starting a trial in humans. People who think his research will be available to the public in a year or two need to take a look at his velocity to date and base their projections on that. We can learn from Gho, Replicel, Aderans, and Intercytex that velocity in mice occurs relatively quickly. The problem is maintaining this velocity once you get to human experiments. Also, as Dr. Kemp points out, the problem is not simply with the research itself. Many other factors are involved, one of which is satisfying investors. Of course, if we try to release it in the US, we have the FDA to contend with and many other potential hurdles.
I love Terskykh’s method. However, it’s safety has not been proven, it’s not been shown to work in humans, it has zero funding, it’s unknown whether it’s subject to the future ravages of DHT, and Terskykh will probably try to take it through the FDA. This research is comparatively at about the same level of maturity as McKelwee’s research in 2003. Although a different product, It still has a long way to go from here to market.
Dr. Kemp’s research will draw-from, piggyback, and enhance upon other research. Thus, let’s say, in 2018, you go to Japan and get Shiseido’s treatment and get 10% regrowth. Then you go back in 2020 and get another treatment but simply break even due to the taper-effect and your own continual loss of hair. But by 2023, HairClone has developed it’s procedure using fast-track agile techniques. So you get it and wind up with a 35% pop in your density. Another Shiseido patient who was a zero% responder goes to hairclone and gets a 40% increase. I go to HairClone and get a 10% increase. So I go to Shiseido and get a 35% increase.
It’s important to keep in mind, human beings are biochemically unique. What works for you, might not work for me. Therefore, it’s important during the early market stage of these treatments that we have a variety of techniques to choose from. This also drives down the cost to the patient.
In order to succeed, HairClone will have to satisfy investors, much the same as Replicel. But it must satisfy it’s investors in a different way. It will need to concentrate on a single treatment area (hair), and it will need to deliver results early and often. Dr. Kemp must become the Craig Venter of hair, where results matter far more than fitting into the neighborhood.