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Light at the end of the tunnel
Cell Transplantation, Vol. 4, No. 5, p. 437, 1995 Copyright 0 1995 Elsevier Science Inc. Printed in the USA. All rights reserved 0963-6897/95 $9.50 + .@I
Pergamon 0963-6897(95)00031-3
Guest Commentary LIGHT AT THE END OF THE TUNNEL professional standards and quality assurance practices that have evolved in the blood and tissue supply industry. Yet, with the many uncertainties and special nuances involved with newer cell therapy applications, things could get mired quickly in bureaucratic red tape and adversity at the expense of progress. To their credit, however, the emerging cell-based therapy industry and its regulators appear to have found a common basis on which to proceed, an approach based upon science and mutual respect. It is an atmosphere whereby scientists-regulators are treated as partners, collaborating with academic and commercially oriented scientists to jointly develop common sense approaches to the unknown. It is not an atmosphere where regulations rule, but one in which they evolve for scientific reasons by mutual agreement. This is not to imply that everything is perfect or that honest disagreements do not arise, but to underline that they appear to be handled largely in a professional way for the benefit of all. Nurturing of this atmosphere in a world where the desire for absolute certainty and absolute safety all too often prevail will be the key to continued progress. All of this is not to minimize the other hurdles that must be overcome before cell transplantation therapy becomes commonplace in medicine. These include, among others, the infrastructure to deliver and market such therapies, the acceptance of such therapies by the medical community at large, and the issues relating to third party reimbursements. However, we would never have the privilege of overcoming these hurdles were it not for us already addressing the largest one, ourselves.
The rapid advances of the past decade in the field of cell transplantation, the growing number of researchers in this area, and the increasing involvement of biotech companies in this field all point to the long-awaited coming of age of cell-based therapies for a variety of diseases. Skeptics, however, will question whether the apparent light at the end of the tunnel is the aura of commercialization of cell-based therapies, or merely the headlights of an oncoming freight train destined to derail before it gets to its destination. As a relative newcomer to the field of cell transplantation therapy and a chemist by training at that, I confess to still being on the learning curve concerning the many underlying technical and logistical problems that interpose between the laboratory and commercial realization. History, however, teaches that given enough incentives and sufficient resources, scientists have a way of overcoming such problems. The barriers less easily overcome are those we create for ourselves. Having spent 25 yr in the traditional, small molecule oriented pharmaceutical industry, I am well versed on such barriers. Despite occasional examples to the contrary, this industry has enjoyed a uniquely adversarial relationship with regulatory authorities, a barrier that has impeded the timely availability of many useful therapeutics. This relationship is one grounded in mistrust, lack of common understanding, and poor communication on all sides. Based on my assessment of the cell-based therapy scene to date, and especially the relationship between the industry and its regulators, I provisionally and happily conclude that the light at the end of the tunnel is indeed the aura of commercialization of cell-based therapy. It is an aura fueled by an enlightened approach to creating a path to success, rather than barriers. The collegial and common sense regulatory path currently being taken toward the commercialization of cell transplantation therapies was outlined in this Special Symposium. Much of the underlying structural and regulatory basis is wisely being drawn from the
Richard C. Allen President & CEO Theracell, Inc. 1505 O’Brien Drive, Suite B Menlo Park, CA 94025
437
Pergamon 0963-6897(95)00031-3
Guest Commentary LIGHT AT THE END OF THE TUNNEL professional standards and quality assurance practices that have evolved in the blood and tissue supply industry. Yet, with the many uncertainties and special nuances involved with newer cell therapy applications, things could get mired quickly in bureaucratic red tape and adversity at the expense of progress. To their credit, however, the emerging cell-based therapy industry and its regulators appear to have found a common basis on which to proceed, an approach based upon science and mutual respect. It is an atmosphere whereby scientists-regulators are treated as partners, collaborating with academic and commercially oriented scientists to jointly develop common sense approaches to the unknown. It is not an atmosphere where regulations rule, but one in which they evolve for scientific reasons by mutual agreement. This is not to imply that everything is perfect or that honest disagreements do not arise, but to underline that they appear to be handled largely in a professional way for the benefit of all. Nurturing of this atmosphere in a world where the desire for absolute certainty and absolute safety all too often prevail will be the key to continued progress. All of this is not to minimize the other hurdles that must be overcome before cell transplantation therapy becomes commonplace in medicine. These include, among others, the infrastructure to deliver and market such therapies, the acceptance of such therapies by the medical community at large, and the issues relating to third party reimbursements. However, we would never have the privilege of overcoming these hurdles were it not for us already addressing the largest one, ourselves.
The rapid advances of the past decade in the field of cell transplantation, the growing number of researchers in this area, and the increasing involvement of biotech companies in this field all point to the long-awaited coming of age of cell-based therapies for a variety of diseases. Skeptics, however, will question whether the apparent light at the end of the tunnel is the aura of commercialization of cell-based therapies, or merely the headlights of an oncoming freight train destined to derail before it gets to its destination. As a relative newcomer to the field of cell transplantation therapy and a chemist by training at that, I confess to still being on the learning curve concerning the many underlying technical and logistical problems that interpose between the laboratory and commercial realization. History, however, teaches that given enough incentives and sufficient resources, scientists have a way of overcoming such problems. The barriers less easily overcome are those we create for ourselves. Having spent 25 yr in the traditional, small molecule oriented pharmaceutical industry, I am well versed on such barriers. Despite occasional examples to the contrary, this industry has enjoyed a uniquely adversarial relationship with regulatory authorities, a barrier that has impeded the timely availability of many useful therapeutics. This relationship is one grounded in mistrust, lack of common understanding, and poor communication on all sides. Based on my assessment of the cell-based therapy scene to date, and especially the relationship between the industry and its regulators, I provisionally and happily conclude that the light at the end of the tunnel is indeed the aura of commercialization of cell-based therapy. It is an aura fueled by an enlightened approach to creating a path to success, rather than barriers. The collegial and common sense regulatory path currently being taken toward the commercialization of cell transplantation therapies was outlined in this Special Symposium. Much of the underlying structural and regulatory basis is wisely being drawn from the
Richard C. Allen President & CEO Theracell, Inc. 1505 O’Brien Drive, Suite B Menlo Park, CA 94025
437