We are pleased to announce that Dr. Ken Washenik has met with representative from HairSite for an in-depth interview on May 30, 2003. 

Ken Washenik, M.D., Ph.D., is the Chief Medical Officer of Bosley Medical Institute and Bosley Medical Group. Dr. Washenik is currently directing Bosley Medical's hair-related research initiative. This research effort will focus on all aspects of hair follicle growth and development, but will have as its primary emphasis the tissue engineering aspects of hair follicle induction and neogenesis.

The entire interview lasted almost three hours at Bosley Medical's Manhattan (NY) office. The final draft of the interview is now under review and we shall publish the full transcripts of the interview within two days. 

Dr. Washenik was very gracious and generous with his time. He addressed all the important questions raised in the Hair Multiplication Forum by our readers and most important of all, Dr. Washenik offered our readers the latest update on the timeframe issue. 

We wish to thank Dr. Washenik and Bosley Medical for accommodating our interview request and we also wish Aderans much success in their research.
  

For your reference, the following was the final list of questions we compiled in the Hair Multiplication forum in November 2002 for the purpose of the interview. Please note that the following was used primarily as a guide to structure the progress of the interview and it was by no means our goal to have each and every single question answered. 

HairSite – Dr. Washenik Interview, November 2002
Interview Questions From HairSite Forum Members
Part 1 of 2 – General Questions

1) It has been almost a year since you joined Bosley Medical. Can you tell us how you feel being the Chief Medical Officer for the largest hair transplantation clinic in the world, what you have accomplished so far and what are your goals for the near future?

2) It appears that Aderans Research Institute (ARI) has multiple divisions (e.g.: Atlanta, Philadelphia) for researching cellular based hair restoration procedures. Please provide us a brief overview of each of these divisions as well as their goals for the near and long-term future?

3) How far along is ARI in each of these research divisions, and do you feel that one particular area of research is more promising than the other? In other words, does one area of research appear to have the potential to beat the other to the market?

4) In the long term, which area of research do you feel will provide the best solution to the average patient with MPB?

5) What is the official term for this new hair restoration technique that ARI is currently researching? Do you refer that as Hair Multiplication, Hair Cloning or something else?

6) Are you aware of any serious competition to what ARI is currently working on? Can you comment on some of them?

7) Do you still stand by your original estimate that this new technique will be available to the mass consumers in about five years? i.e. 3 years for the research to complete and 2 years for FDA review.

8) On several occasions you implied that FDA approval would be sought *after* clinical trials were concluded. Therefore, under such a time frame, if clinical trials took 3 years, and FDA approval took an additional 2 years, the time such a procedure might take to reach the public might take a total of five years! But several people have pointed out that FDA approval of new medical procedures do not always work that way. Often, where a new medical procedure is promising and can potentially help many people, there is industry pressure on the FDA to "expedite" the approval process. Under such an "expedited" approval process, clinical trials might be shorter in duration, and the actual application for approval might begin not after the trials were concluded, but DURING the trial period, so that the FDA is monitoring the trials while they are being done, and can rapidly approve the application as soon as they are satisfied that the procedure is safe and effective. Why add additional years to an approval process?

9) What is the reason for FDA review requirement? Is that because the procedure involves putting a foreign substance or material into the body? It is our understanding that procedures involving simple autologous transplants of unmodified cultured cells do NOT require FDA review. Can you comment on that please?

10) Does ARI, BioAmide or Bosley Medical currently have any applications for review or approval of any procedure pending with the FDA? Have you or anyone from ARI, BioAmide or Bosley Medical discussed any of your proposed procedures with FDA? Has any paperwork been submitted or filed with the FDA in connection with an application for clinical trials, review, or approval of any cell therapy, tissue engineering, or biotechnology-related hair restoration procedure, including the one described in the August 8, 2002 patent?

11) Can you tell us more about this new technique that you predict will be available to the mass consumers in about 5 years? Is it just a basic form of cell therapy procedure or is it a more sophisticated technique that relies primarily on tissue engineering?

12) It has been suggested in our forums that you have made a comment saying that ARI is pursuing both cell therapy and tissue engineering based research. Is there a conscious effort to distinguish the two disciplines? Does it mean that the public can anticipate two separate breakthroughs in hair restoration from ARI? Or perhaps we simply misunderstood your statement and what you meant was that the particular technique currently being researched is based on both cell therapy and tissue engineering?

13) Do you think that extensive training is required in order to perform this new technique? Similarly do you think the eventual results will be heavily dependent on the skills and techniques of the surgeon much like the case with traditional hair transplantation nowadays?

14) It has come to our attention that BioAmide has a new patent dated August 8, 2002 titled "Hair Follicle Neogenesis By Injection Of Follicle Progenitor Cells". Is this patent the core foundation of the eventual treatment/cure that will be available to the public in about 5 years or is it just one of the many techniques that ARI is experimenting?

15) Can we anticipate more patents from ARI / BioAmide in the next 12 - 24 months?

16) This may be premature, but when this new technique becomes available, how much do you think the cost will be to restore a Norwood 6 to a Norwood 1? Do you think it will be as expensive as hair transplantation these days?

17) How will ARI/Bosley balance the release of the new technique while maintaining the integrity of the hair transplantation business model? When the new technique is closer to release will Bosley Medical advise potential clients to hold off traditional hair transplantation procedures until this new technique can be done? How will those interim periods when the new technique is close and hair transplantation is still performed be treated from a business perspective?"

18) When do you think official human trials will begin? Does ARI plan to make public announcement about official human trials? How can someone apply to become a test subject?

  
20) We are aware that Bosley Medical has the domain www.hairmultiplication.info reserved. Can you tell us when the website will be launched and what it will be used for?

21) Can you tell us approximately how much has ARI earmarked for R&D purposes? It has been disclosed in Aderans’ website that the current capital is only $400,000 and we are aware that the amount is just the initial capital and probably has nothing to do with specific funding for R&D.

22) Any plans for the immediate future that you can share with us?

Part 2 of 2 –Questions Pertaining To BioAmide’s August 8, 2002 Patent
 “Hair Follicle Neogenesis By Injection Of Follicle Progenitor Cells”  

1) Is the procedure described in the patent currently being tested on clinical trials patients? If not, when do you estimate clinical trials will commence? 

2) Does the procedure in the patent really work as stated, or is the patent just a projection of a future procedure, based on various experiments done by ARI, BioAmide and Bosley Medical?

3) The patent claims that the procedure is a cure for baldness. Any acceptable cure for baldness would have to replace a sufficient amount of hair on the bald or balding areas of the scalp, and the new hair would have to be healthy and have the capacity to cycle. Does this procedure patented by BioAmide meet those requirements? Regarding the current state of your work with this patented procedure, is the hair produced healthy and does it cycle?

4) Are you able to discuss current technical stumbling blocks which prevent Aderans/Bosley from making the patented procedure available to the public now? Are there remaining technical or scientific problems, or do the only remaining problems relate to formal testing and securing FDA approval?

5) Has it been demonstrated that the new follicles created by the patented procedure do not die shortly after implantation? Do the newly created hairs cycle normally? If the answer to this question about cycling has not yet been determined, how much more research, and how much more time, will be required, to provide an answer?

6) The patent seems to suggest that it is a fairly labor intensive and crafty procedure that require particular attention to details and skills when it comes to the implantation of the cell clusters. Do you agree? Would you say that based on what is described in the patent, the procedure can be somewhat invasive with a fairly large margin of error especially when performed on a large scale on a patient?

7) Certain experiments performed by Dr. Jahoda seem to indicate that when new follicles are grown, they emerge from the skin in varying directions. The BioAmide patent outlines a scheme with a knotted wire that is left protruding from the skin which helps the hair emerge from the skin in the proper direction. How closely can the injections of cell clumps be placed in a single session and since these wires might need to be taped down to the head for awhile, how does that interfere with closely spacing the cellular implants? Basically we would like to know whether the follicles can be packed densely together in one session or do they have to be spaced a certain distance apart in order to execute the bleb technique??

8) The patent seems to suggest that a certain "wire" is involved in administering the cell clusters to the balding area. Does it mean that a patient will have numerous wires sticking to his head simultaneously under this procedure? Is the procedure as invasive as we picture it?

9) According to some studies, one problem cited with hair follicle / dermal papilla culturing is that the cells may lose their phenotype with multiple passages, thus limiting how many cells you can culture from one sample and still get follicular differentiation. Is this true? Has this issued been solved?

10) Since we are creating new follicles with this technique, does it mean that theoretically we can have more density than we were ever born with?

11) The patent mentioned that the donor follicles may be obtained from another individual. Has ARI or BioAmide started testing results using donor follicles or donor cells from other individuals yet?

12) Will the option to use donor cells from other individuals definitely be available with this procedure?

13) Does it matter whether the donor cells from other individuals are male or female?

14) Will there be a test to determine whether the "donors" are a good match for the patient if they are derived from other individuals?

15) Do you think if this technique will be effective in creating a totally natural and undetectable hairline or will hair transplantation be necessary to complement the results?

16) The patent said the invention provides a means for curing male pattern baldness and "other conditions involving hair loss". Can you comment on what these "other conditions" could possibly include and whether experiments have been conducted on patients with conditions other than male pattern baldness?

17) Any reasons why the patent does not make references to female pattern baldness? Does it mean that the procedure will not be effective on patients with diffuse thinning? Will the procedure be effective for women with androgenetic alopecia?

18) Do you think that extensive training is required in order to perform this procedure well? Similarly do you think the eventual results will be heavily dependent on the skills and techniques of the surgeon much like the case with traditional hair transplantation nowadays?

19) Who will make good candidates for this procedure? What kind of screening do you think will be necessary before someone is accepted as a patient?

20) Can you comment on healing time using this technique? How intrusive is this procedure and what would the healing and recovering process entail?

21) Will this technique be effective in scar tissue, say the typical linear scars from traditional hair transplantation surgery? Are there plans to experiment on scar tissues?

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