Hi Helpmeout, EAS83 and Lucky,
To answer your questions, I have to give some background into the formation of HairClone so bear with me.
The classic approach to developing a new medicinal product or treatment and the one we used at Intercytex and others are using currently is one which I call “scientific innovation”. The basic process of being to
a) Design a hypothetical product/treatment based on the best scientific and pre-clinical information available
b) Raise large amounts of investment either through Venture Capital or from a commercial partner
c) Design a series of clinical trials to test the hypothesis from a) and hope the outcome is sufficient to maintain the interest from the funders to continue the work
d) If all goes well eventually produce after many years a commercial product that then can enter the market and provide a sufficient return on the investment to satisfy those who have invested their risk capital
Importantly, often in order to spread the financial risk, investors will demand a “product pipeline” of other medical products so that if the lead one fails or falters there is a back-up.
I have come to realise that scientific innovation is not best suited to the development of medical products that are surgically applied. Here, success requires the right product to be implanted in the patient in the right way and I have found that you are working with two many unknown variables to get it right the first time. Was the lack of absolute success due to the product or the way it was implanted? Unfortunately, investors rarely have the stamina for a second attempt and they prefer that the company moves on to their back up projects so that they have a chance of a return on their investment within the time horizon of their VC fund which is exactly what happened with Intercytex. It is VERY important however to emphasis that clinical trials are absolutely needed to eventually gain the licenses needed to MARKET a product in a broad international market and we absolutely intend to carry these out but not until we have optimised the treatment itself.
There is another way to develop a medical treatment however and I call this “Medical Innovation”. Its what hair transplant surgeons do all the time. They innovate step by step, learning from their peers, sharing best practice etc and this has resulted in the transition from punch grafts to FUT then FUE and the innovations will continue. I have seen the power of this approach many times and I have been working with regulators to discuss how this could be applied to the use of cells as medical products (Known as either Regenerative Medicine, Cell Therapy or Advanced Therapies).
An international group of us with a huge amount of experience therefore came together about a year ago to combine all these scientific, clinical and financial learnings and we had a series of meetings to develop the business plan of HairClone which at its very simplest is to:
a) Create an exclusive group of Clinicians, patients, scientists and biotechnologists, who will combine the best elements of scientific and medical innovation to bring hair cloning into clinical practice
b) Importantly fund the development of this treatment, not through classic investor routes, but from the interested parties themselves. The intention is that through such a partnership we can better develop the treatment step by step rather than the one-step/one-shot approach that is inherent with scientific innovation where external VC funders control or stop the development process if the perfect solution isn't developed at the first attempt.
We chose the name ‘HairClone” to emphasis to everyone, both the nature of our mission, but also perhaps more importantly, that we have one mission and one only and that we weren’t going to generate a portfolio of products and thereby dilute our efforts.
As you can see from our website, we already have some of the leading hair transplant surgeons as our clinical partners and we will be inviting others to join later in the year. We also have Claire Higgins and Paul Sharpe on our SAB. Both of these highly respected developmental biologists are interested in cell induced organ regeneration and are providing really important input. We have already started clinical implantation work to better understand what we will need to do in the future and we are also developing international research collaborations so that all the various elements that I described above can be combined. Our next step is to begin to involve an exclusive group of interested patients and we are going to do that through crowd-funding which is currently being set up and follicle banking.
As you point out, why bank cells now when a patient could just bank hairs when we are ready to treat. There are several reasons why and I would really like to get your feedback on them. Firstly, all the revenues we raise through banking will be used to develop and thus accelerate the time to the treatment itself. Secondly the banking patients would then be first-in-line for treatment when it is available. Thirdly it has been shown that even DHT insensitive hair follicles age and finally we want to recognise the banking patients' very important contribution to the development of the treatment by providing a significant discount to the treatment that would more than compensate for the cost of the banking.
I am sure that banking now would not be attractive to all people, but all of us involved with HairClone are convinced that the best way to achieve this in the shortest time frame possible and with the greatest chance of success is through an exclusive partnership and deep collaboration. Follicle banking is just one element of this.
We are currently obtaining the regulatory licenses required to set up a cell bank and we expect the cost to be similar to the costs of other banks such as cord blood. The difference between what we are doing and what Cord Blood banks do which is just bank cells as an end in itself is that we will be using the revenues to develop a treatment.
I hope this helps, but I am very happy to discuss more and welcome your feedback