...this is a continuation of Part I...
So are Personalized Medicines the Long Tail of the Therapeutics Industry?
In 2006, Chris Anderson, Editor-in-Chief of Wired magazine, released "The Long Tail" – a book describing the Web 2.0-induced business-to-consumer economics (r)evolution enabling businesses to now deliver product at outrageously affordable prices to global micro-markets.[i] The book quickly became one of the most influential business books of the ‘new economy’.
Indeed this flat new world – as Thomas L. Friedman describes it[ii] – is all about micro-trends and micro-markets, empowering small companies and niche products to participate successfully in the marketplace along with Fortune 100 companies and blockbuster products. More than that, this paradigm shift is forcing product and service companies to revolutionize their business and pricing models, the latest and rabidly successful of which is the pricing model of “Free!”. The blockbuster-based business model that depends on the economics of a ‘hit’ (whether it’s a platinum-selling CD or a ‘blockbuster’ drug) is no longer seen to be the only way to make money and, indeed, may not have any future at all.
To date, this internet-driven Long Tail (r)evolution has had its largest impact on – if not been largely restricted to – the retail sector. Business-to-consumer (B2C) companies are now enabled like never before to profitably supply unique global products to meet customer demands. In this respect, the (r)evolution has had a visible impact on the retail side of the pharmaceutical and biotech industries. However the ongoing realization of “personalized products” as the future of medicine for consumers seems a perfect fit for the Long Tail economic model.
But does this apply to therapeutics?
To the extent that the Long Tail economy is less about the mass market and more about businesses succeeding in serving niche markets with unique and/or customized products, the analogy fits.
Certainly, it would appear the sun is setting on the "blockbuster hit" days of the therapeutics industry. In June 2008 Genentech's Susan Desmond-Hellmann, president of product development, when outlining the biotech giant's development strategy to a group at the Goldman Sachs healthcare conference, told the group that the blockbuster drugs of the past may never be duplicated. “Future drugs,” she stated, “will cater to a smaller, better defined group of patients” and “the days of big cholesterol-lowering drugs for millions of people may be behind us.” (link).
In a June 8, 2009 post, authors of the IN VIVO Blog stated that pharma "managers these days are learning to leverage only very modest top-line growth into faster bottom-line growth through cost-savings, bolt-on acquisitions, and rapid introductions of incrementally-improved new products. The traditional, high-risk, high-growth R&D-based model is gone, in case you hadn't noticed."
The second indication that personalized medicine fits with the Long Tail supply-demand model is that therapeutics can now be customized taking advantage of personalizing elements such as HLA-typing and advances in genetic, diagnostic, and discovery testing that will permit us to more effectively both pre-select which medicines are best suited for which patient sub-groups and develop therapies that are better suited to particular genetic groups. On the clinical end of the spectrum, advances in theragnostic tools and surrogate biomarkers (e.g., imaging) are allowing clinicians to much more rapidly assess personal responses to treatment and adjust their therapeutic regimines accordingly before any symptomtic response can be observed.
The ability to match therapeutics to genetic make-up, disease stage/presentation, or predisposition will allow the provision of treatments with more confidence in their expected efficacy, fewer patient-specific adverse reactions, and result in cost savings to the health care industry and a better return to fund the premium for the development of such products.
In a recent interview with Xconomy's Luke Timmerman, Alan Frazier, founder and managing partner of Seattle-based Frazier Healthcare Ventures, one of the world’s biggest life sciences venture capital funds, said,
The trend is toward smart pharmaceuticals that address smaller populations, narrower indications, with better results. It’s based on a better understanding of disease from genomics and proteomics. You’ll see more targeted drug delivery. You’ll have incredibly focused pharmaceuticals, which will take care of some of the safety issues you read about.
Does the model apply to cell therapies?
At the intersection of the personalized and regenerative medicine sectors, lies the therapeutic industry’s response to (or reflection of) both the demand for and the ability to deliver a more personalized therapeutic to the consumer (the patient).
If the tail of the therapeutics market is being stretched longer to include products better targeted to smaller markets, this therapeutics Long Tail will almost certainly include regenerative medicine (regen 2.0) products and many of these will be cell-based therapies.
The cell therapy sector now encompasses the convergence of three distinct technologies, i.e. cell transplantation, tissue engineering, and biomaterials. Often also drawn in are elements of gene and molecular (e.g., proteins and antibodies) therapies.
Autologous cell therapies are the ultimate personalized medicine and while such medicines are often not included in definitions of personalized medicine, any approach to regenerative medicine – whether using tissue engineered products, cell-based therapies, small-molecule drugs, scaffolds, nano or biobots, etc – intended to trigger in vivo regeneration or repair... is personal!
Again, to the extent the Long Tail economy is about “selling less of more” then medicines such as cell therapies will certainly be part of the long tail of the therapeutics industry giving access to highly-personalized, tailored products to meet the unique needs of the consumer.
But does the Long Tail economic model apply?
While there may well be blockbuster cell therapies in the future, concern around the scarcity of potential blockbusters in cell therapy are seated in the notion that the blockbuster economy is the only successful model.
Who thought you could make money by giving free access to internet searches and email? There are a lot of ways the analogy breaks down but what the Long Tail economy has shown us is modern corporate ingenuity in finding profitable business models in niche markets despite the long-standing dominance of blockbuster products.
Where the paradigm falls short, in my opinion, is when one realizes that a fundamental pillar to the Long Tail economy is the commoditization of products and production processes as well as the standardization of delivery systems. The Long Tail economic model is enabled by the fact that the cost of goods sold has been brought sufficiently low enough - by new technologies which allow for small batches to be produced and shipped - that the products in question are affordable to most. Highly unique and/or customized goods were always available to those with sufficient ability to pay. The Long Tail brings these kinds of products to micro-market at the same price or lower than their mass-market counterparts.
We are a long way from this kind commoditization of personalized medicines and, in particular, of cell-based therapies. There is little-to-no standardization of production systems at any scale. The next generation of these therapies will still be highly priced goods which many people, insurers, and/or healthcare systems will be pressed to afford.
In once sense, this is not surprising. Even in the world of electronic or digial products, Moore's principle only applies because the cost of goods for new technologies when they first enter the market are prohibiitively expensive. If the model applies in the therapeutics industry, technological advances in production will bring down the cost of goods and therfore the price.
On the other hand, what drives the price of therapeutics has not been so much the cost of goods (production) but the need to recoup massive upfront R&D costs which must be recovered (with a reasonable profit) during the life of a patent.
Will this change with personlized medicines and cell therapies? One could argue it might if personlized medicines and cell therapies can deliver on the promise to have a much higher effective rate among those given the therapies. Pharmaceuticals have a notoriously low effective rate among those prescribed any given drug. New research methodologies employing surrogate biomarkers, imaging, cell-based assays, etc promise the potential to significantly lower R&D costs by (a) getting to a much quicker "go/no-go" decision point in therapeutic development, and (b) identifiying patient sub-groups for which the therapeutic will have a high rate of effectiveness. One the one hand, this has the potential to lower the cost of goods (driven by R&D costs) and simultaneously justify a higher price point because of a high rate of therapeutic success.
However, even if we were able to materially lower upfront R&D costs, this still does not change the fact that cell therapies are costly to produce on a per-unit basis and the opportunity to "scale-up" is limited particlarly with autologous cell therapies which require lot sizes to be an individual batch. While this is a seperate discussion, I am confident technological and/or commercial innovation will find a way to economically bring therapeutics to market that are proven effective. I am not alone. Recenly Howard Liang, MBA, Ph.D., Analyst and Biotechnology Managing Direct at Leerink Swan as quoted as saying that “Autologous manufacturing is not the deal breaker it used to be. If these [cell-based] vaccines work for really difficult-to-treat diseases, the manufacturing issues will be worked out.” ("Special Report: Customized Cancer Vaccines Finally (Maybe) Arrive". GEN News Highlights. 12 June 2009)
There are other reasons the Long Tail business model as it is currently defined does not fit cookie-cutter with the therapeutics industry not the least of which is that the consumer demand does not solely regulate supply. In highly regulated industries, the economies are different. Some would argue this should not be the case particularly if personalized medicines, genomics,theragnostics, etc advance to point where the consumer has an abundance of therapeutic information and options but that is the subject of another discussion.
In the end, it is certainly clear to me that the emerging technologies are enabling new therapeutic paradigms that will introduce elements of the Long Tail business model into the therapeutics industry.
How much Impact will Cell Therapies Have on New Therapeutic Paradigms and Systems?
Despite the exponential escalation of cell therapy innovation, is cell therapy ready to be a viable business that will make any material impact on the therapeutic industry? For reasons which I will continue to explore in this blog in the months to come, I believe the answer is 'yes'.
The cell therapy industry has more products in late-stage development than many believe. While the existing commercial products are far from blockbusters and questions remain regarding the business models and potential margins for cell therapy products, ground-breaking research and market enthusiasm is driving a renewed interest among an early second-round of investors including participation by mature industry players making cautious plays in the sector. Regulatory issues in the primary markets of the US and EU are rapidly becoming less problematic though harmonization remains a significant challenge.
In blogs to come I will outline the commercial developments I see transpiring that make me believe the primary issues around the 'business models' question are being addressed. Regenerative and personalized medicines are enough of a force that creative business people will (a) invent ways to lower the cost of goods and (b) figure out how to price and reimburse appropriately to ensure effective therapies get to people that need them and incentivize doctors to prescribe them.
Most indicia point to this sector being poised for a phase that will start demonstrating real answers to those challenges which have to-date prevented many from participating in a sector that they believe presents too many unanswered risks.
Conclusion
As with so many of the paradigm-shifting economic revolutions in the past, once the underlying technologies exist, business and economic models radically adjust to reflect and accommodate that change. The latest of these is the Long Tail economy (r)evolution with it ability to deliver niche (if not personalized) products to niche markets. Pesonalized medicines - regenerative medicine and cell therapies in particular – are the therapeutic industry’s answer for the demand for personalized products. For a host of reasons, however, the economic model is not yet one which makes for profitable delivery of such products to niche markets.
Nonetheless, while questions about the viability of the business and economic models for these paradigm-shifting therapies are reasonable, the next 5 years will show that today’s questions about the business models for cell therapy were rooted in limited imagination about the potential for technological and commercial innovation as well as outdated concepts of the therapeutics industry and its economies.
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[i] Anderson C: The Long Tail: Why the Future of Business is Selling Less of More. Hyperion (2006).
[ii] Friedman TL: The World is Flat. A Brief History of the Twenty-First Century. Farrar, Straus and Giroux (2005).
Showing posts with label personalized medicine. Show all posts
Showing posts with label personalized medicine. Show all posts
Tuesday, June 23, 2009
Wednesday, March 25, 2009
Cell Therapy Industry HiLites 2009-03-25
I am more intrigued every day by the potential for identifying opportunities in the convergence of cell therapies, diagnostics, personalized medicines, theragnostics, regenerative medicine, and more traditional biotechnologies and pharmaceuticals.
I wonder to what extent we will look back on these primitive days of ex vivo cell therapy and chuckle at its ephemeral but educational existence much like betavision or pervasive therapeutic bloodletting. I suspect many of these therapies will have a role in future medicine but I'm starting to believe more and more that the future of cell therapy will be more about in vivo manipulations than ex vivo manufacturing.
In an attempt to catch up from my brief hiatus and to have more frequent and less tome-like posts, I bring you this mid-week edition of Cell Therapy Industry HiLites.
___________________________________________________________________
Contact Lee [at] celltherapygroup [dot] com
____________________________________________________________________
FINANCIAL
Given the continued extraordinary market conditions, NASDAQ has further suspended enforcement of the rules requiring a minimum $1.00 per share. closing bid price and a minimum market value of publicly held shares until Monday, July 20, 2009. Good new for many including Aastrom Biosciences, Inc. (Nasdaq:ASTM) which now has until September 18, 2009 to regain compliance with the $1.00 minimum closing bid price rule in order to remain listed on the Nasdaq Capital Market.
As promised, International Stem Cell Corporation (OTCBB:ISCO) has received the third $1 million tranche of an anticipated private equity financing of up to $5 million the remainder of which is says will be funded over the next several months.
Now that Cell Genesys, Inc. (NASDAQ:CEGE) has no products to develop things are looking up for it! The company reported financial results for the fourth quarter and full year ended December 31, 2008. The company reported a net loss of $13.3 million ($0.15 per fully diluted share), for the fourth quarter of 2008, compared to a net loss of $33.4 million ($0.43 per fully diluted share) for the corresponding period in 2007. The net loss for the year ended December 31, 2008 was $47.0 million ($0.56 per fully diluted share), compared to a net loss of $99.3 million ($1.39 per fully diluted share) for the year ended December 31, 2007. As of December 31, 2008, the Company had $86.1 million in cash, cash equivalents and short-term investments. The Company currently expects to have approximately $73 million and $69 million in cash, cash equivalents and short-term investments at March 31, 2009 and June 30, 2009, respectively. The Company continues to explore strategic alternatives, including merger with or acquisition by another company, further restructuring, allocation of its resources toward other biopharmaceutical product areas, and sale of the Company’s assets and liquidation of the Company.
CLINICAL
As a result of ongoing and active discussions in our LinkedIn Cell Therapy Industry Group, it has come to my attention thatprivately-held Harvest Technologies Corp - a company known for its bone marrow and platelet concentrate devices - has entered into the therapeutics business. It recently obtained an Investigational Device Exemption (IDE) from the FDA to conduct a randomized, controlled, double-blind, multicenter clinical trial using the Company’s BMAC System to prepare a composition of bone marrow stemcells to treat patients with Critical Limb Ischemia (CLI). This “feasibility trial” will enroll a total of 48 subjects. Subjects who enroll in this study will have to have exhausted all surgical and procedural options and are at extreme risk for major amputation. The BMAC System is a point-of-care device for concentrating a patient’s own (autologous) bone marrow stem cells in approximately 15 minutes at the bedside. The clinical study design provides for injecting these cells into the affected limb to reduce the potential for limb amputation. It also will offer data with respect to the safety of this procedure.
What's even more interesting is that reportedly the company has submitted an investigation device exemption for a double-blind placebo cardiac safety study—to inject BMAC cells into the myocardium during bypass surgery in patients with severely compromised heart function.
This presents an interesting regulatory pathway for a couple of business models both in providing point-of-care devices and providing therapeutic service employing such devices. More on that in an upcoming blog (and in our LinkedIn discussions).
The Indian Council of Medical Research and the Drug Controller General of India is said to have now approved protocols Bangalore-based firm Stempeutics Research for multi-center phase I/II double blind randomized clinical trials of bone marrow derived ex vivo cultured adult mesenchymal stem cells for Elevated Acute Myocardial Infarction and Critical Limb Ischemia. The cells are to be administered by injection.
COMMERCIAL
MultiCell Technologies, Inc. (OTC Bulletin Board: MCET - News) announced it has entered into a cooperative research and development agreement with Maxim Biotech, Inc. to develop products for the study of liver stem cells and liver cancer. The cooperative research and development agreement with Maxim Biotech, Inc. will initially focus on the development of a family of life science research reagent tool kits which can be used to isolate liver stem cells, and help to elucidate liver stem cell gene function and their encoded proteins. MultiCell plans to further leverage this research effort involving liver stem cells to identify therapeutic targets, and diagnostic and prognostic markers of liver cancer. MultiCell will also seek to develop and patent therapeutic product opportunities specifically targeting the treatment of primary liver cancer and intrahepatic bile duct cancer.
Kosdaq-listed RNL Bio (famous for dog cloning) faces a KFDA ban on its cosmetic containing human-derived stem cells.
J&J's Therakos, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the THERAKOS™ CELLEX™ Photopheresis System for the palliative (reducing the severity of symptoms) treatment of the skin manifestations (appearance) of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment. The THERAKOS™ CELLEX™ Photopheresis System is a system that uses extracorporeal (outside the body) photopheresis (ECP) cell therapy to relieve the symptoms of CTCL. The system also has been cleared recently in Canada and Europe. The new THERAKOS™ CELLEX™ Photopheresis System is said to feature several improvements over but retain the primary benefits of the predecessor THERAKOS™ UVAR™ XTS™ Photopheresis System. The improvementa are said to open up this treatment option to patients for whom it was previously unfeasible including lower weight patients.
Stem Cell Therapy International, Inc. (OTCBB: SCII) decided it was worthwhile to announce that they are in "strategic meetings" with unnamed "global stem cell representatives" and they are "not wasting any time...with the merger of Stem Cell Therapy International, Inc. and Histostem, Ltd. of South Korea" to create the newly name company, AmStem International. Now that's great news.
StemCelDigest.net outlined the single-digit degrees of similarity between companies (STEM, ISCO, ACT) pursuing stem cell solutions for diseases of the retina. Other companies in this space include the Pfizer-backed EyeCyte and UK's ReNeuron.
RESOURCES & EVENTS
Watch for an announcement from ISCT announcing a call for late-breaking abstracts.
Jon Rowley (Lonza) reports that there is more stem cell content - from science to manufacturing - at BIO2009 this year. Dare we think it's not a bubble this time?
Sign-off
A proposal to change the name of the American Society of Gene Therapy (ASGT) to the American Society of Gene and Cell Therapy (ASGCT) has been nanimously approved by the Board of Directors and the proposal is now being forwarded to the general membership of the Society for a final vote in April of 2009. In an editorial in December issue of Molecular Therapy, Membership Committee Chair and Past ASGT President, Savio LC Woo, stated that the Membership Committee has recommended that the following concrete steps,among others, be implemented to maximize its positive impact.
I understand ASGT's desire to ensure its mandate stays relevant and inclusive of all aspects of therapies employing genes. I also believe the increasing overlap between organizations representing "cell therapy" is not in the best interests of the sector. While ISCT remains the only organization with cell therapy of all types at the core of its mission, AABB has encroached into the cell therapy space from the blood banking side, ISSCR from the basic stem cell research end of the spectrum, ASBMT from the clinical stem cell transplant side, TERMIS from the tissue enginering, and now ASGT (following the precedent set by ESGT-ESGCT) from the gene therapy end.
As C. Mason & P. Dunhill wrote last year in Regenerative Medicine, what the industry needs is a strong voice generated by a powerful industry association. As long as we continue to create more silos of representation, we will continue to stray farther away from what's needed. While I have strong ties to ISCT and continue to serve that organization in several capacities, I am increasingly frustrated by the dilution of this nascent industry's time, money, and efforts spread over too many organizations and conferences without creating the voice for industry that is needed.
I'm not sure where this frustration will take me but my increasing conviction is that the companies in the cell therapy sector are ill-represented in any organization and spattering attempts at representation throughout all of them (including BIO which has to-date all but ignored the sector) is increasingly insufficient.
Am I off base here? Is this a real need or am I making something out of nothing? What do you think?
I wonder to what extent we will look back on these primitive days of ex vivo cell therapy and chuckle at its ephemeral but educational existence much like betavision or pervasive therapeutic bloodletting. I suspect many of these therapies will have a role in future medicine but I'm starting to believe more and more that the future of cell therapy will be more about in vivo manipulations than ex vivo manufacturing.
In an attempt to catch up from my brief hiatus and to have more frequent and less tome-like posts, I bring you this mid-week edition of Cell Therapy Industry HiLites.
___________________________________________________________________
Contact Lee [at] celltherapygroup [dot] com
FINANCIAL
Given the continued extraordinary market conditions, NASDAQ has further suspended enforcement of the rules requiring a minimum $1.00 per share. closing bid price and a minimum market value of publicly held shares until Monday, July 20, 2009. Good new for many including Aastrom Biosciences, Inc. (Nasdaq:ASTM) which now has until September 18, 2009 to regain compliance with the $1.00 minimum closing bid price rule in order to remain listed on the Nasdaq Capital Market.
As promised, International Stem Cell Corporation (OTCBB:ISCO) has received the third $1 million tranche of an anticipated private equity financing of up to $5 million the remainder of which is says will be funded over the next several months.
Now that Cell Genesys, Inc. (NASDAQ:CEGE) has no products to develop things are looking up for it! The company reported financial results for the fourth quarter and full year ended December 31, 2008. The company reported a net loss of $13.3 million ($0.15 per fully diluted share), for the fourth quarter of 2008, compared to a net loss of $33.4 million ($0.43 per fully diluted share) for the corresponding period in 2007. The net loss for the year ended December 31, 2008 was $47.0 million ($0.56 per fully diluted share), compared to a net loss of $99.3 million ($1.39 per fully diluted share) for the year ended December 31, 2007. As of December 31, 2008, the Company had $86.1 million in cash, cash equivalents and short-term investments. The Company currently expects to have approximately $73 million and $69 million in cash, cash equivalents and short-term investments at March 31, 2009 and June 30, 2009, respectively. The Company continues to explore strategic alternatives, including merger with or acquisition by another company, further restructuring, allocation of its resources toward other biopharmaceutical product areas, and sale of the Company’s assets and liquidation of the Company.
CLINICAL
As a result of ongoing and active discussions in our LinkedIn Cell Therapy Industry Group, it has come to my attention thatprivately-held Harvest Technologies Corp - a company known for its bone marrow and platelet concentrate devices - has entered into the therapeutics business. It recently obtained an Investigational Device Exemption (IDE) from the FDA to conduct a randomized, controlled, double-blind, multicenter clinical trial using the Company’s BMAC System to prepare a composition of bone marrow stemcells to treat patients with Critical Limb Ischemia (CLI). This “feasibility trial” will enroll a total of 48 subjects. Subjects who enroll in this study will have to have exhausted all surgical and procedural options and are at extreme risk for major amputation. The BMAC System is a point-of-care device for concentrating a patient’s own (autologous) bone marrow stem cells in approximately 15 minutes at the bedside. The clinical study design provides for injecting these cells into the affected limb to reduce the potential for limb amputation. It also will offer data with respect to the safety of this procedure.
What's even more interesting is that reportedly the company has submitted an investigation device exemption for a double-blind placebo cardiac safety study—to inject BMAC cells into the myocardium during bypass surgery in patients with severely compromised heart function.
This presents an interesting regulatory pathway for a couple of business models both in providing point-of-care devices and providing therapeutic service employing such devices. More on that in an upcoming blog (and in our LinkedIn discussions).
The Indian Council of Medical Research and the Drug Controller General of India is said to have now approved protocols Bangalore-based firm Stempeutics Research for multi-center phase I/II double blind randomized clinical trials of bone marrow derived ex vivo cultured adult mesenchymal stem cells for Elevated Acute Myocardial Infarction and Critical Limb Ischemia. The cells are to be administered by injection.
COMMERCIAL
MultiCell Technologies, Inc. (OTC Bulletin Board: MCET - News) announced it has entered into a cooperative research and development agreement with Maxim Biotech, Inc. to develop products for the study of liver stem cells and liver cancer. The cooperative research and development agreement with Maxim Biotech, Inc. will initially focus on the development of a family of life science research reagent tool kits which can be used to isolate liver stem cells, and help to elucidate liver stem cell gene function and their encoded proteins. MultiCell plans to further leverage this research effort involving liver stem cells to identify therapeutic targets, and diagnostic and prognostic markers of liver cancer. MultiCell will also seek to develop and patent therapeutic product opportunities specifically targeting the treatment of primary liver cancer and intrahepatic bile duct cancer.
Kosdaq-listed RNL Bio (famous for dog cloning) faces a KFDA ban on its cosmetic containing human-derived stem cells.
J&J's Therakos, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the THERAKOS™ CELLEX™ Photopheresis System for the palliative (reducing the severity of symptoms) treatment of the skin manifestations (appearance) of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment. The THERAKOS™ CELLEX™ Photopheresis System is a system that uses extracorporeal (outside the body) photopheresis (ECP) cell therapy to relieve the symptoms of CTCL. The system also has been cleared recently in Canada and Europe. The new THERAKOS™ CELLEX™ Photopheresis System is said to feature several improvements over but retain the primary benefits of the predecessor THERAKOS™ UVAR™ XTS™ Photopheresis System. The improvementa are said to open up this treatment option to patients for whom it was previously unfeasible including lower weight patients.
Stem Cell Therapy International, Inc. (OTCBB: SCII) decided it was worthwhile to announce that they are in "strategic meetings" with unnamed "global stem cell representatives" and they are "not wasting any time...with the merger of Stem Cell Therapy International, Inc. and Histostem, Ltd. of South Korea" to create the newly name company, AmStem International. Now that's great news.
StemCelDigest.net outlined the single-digit degrees of similarity between companies (STEM, ISCO, ACT) pursuing stem cell solutions for diseases of the retina. Other companies in this space include the Pfizer-backed EyeCyte and UK's ReNeuron.
RESOURCES & EVENTS
Watch for an announcement from ISCT announcing a call for late-breaking abstracts.
Jon Rowley (Lonza) reports that there is more stem cell content - from science to manufacturing - at BIO2009 this year. Dare we think it's not a bubble this time?
Sign-off
A proposal to change the name of the American Society of Gene Therapy (ASGT) to the American Society of Gene and Cell Therapy (ASGCT) has been nanimously approved by the Board of Directors and the proposal is now being forwarded to the general membership of the Society for a final vote in April of 2009. In an editorial in December issue of Molecular Therapy, Membership Committee Chair and Past ASGT President, Savio LC Woo, stated that the Membership Committee has recommended that the following concrete steps,among others, be implemented to maximize its positive impact.
- First, the term “cell therapy” must be included in the Society’s mission statement.
- Second, the Society’s leadership should contact the leadership of the International Society for Cellular Therapy (ISCT) to assure them that our name change represents an opportunity for both societies to collaborate and advance our common interests and to initiate a dialogue with them onthe needs and interests of cell therapists so as to better recruit these researchers into our society.
- Third, the Society leadership should reach out to leading investigators and the research communities in adult and ES cell biology as well as iPS cell biology.
- Fourth, the Program Committee should ensure that cell therapy is richly represented in the symposium programs of the Society’s annual meetings.
- Fifth, the Nominating Committee will need to make a concerted effort to identify and nominate prominent cell therapists into the Society’s leadership positions.
- Finally, the editorial team of Molecular Therapy—the Society’s official journal—is encouraged to increase even further the important efforts they have made over the past few years to recruit Editorial Board members with expertise in cell therapy and stem cell engineering, in additionto continuing their successful solicitation of outstanding articles in these areas.
I understand ASGT's desire to ensure its mandate stays relevant and inclusive of all aspects of therapies employing genes. I also believe the increasing overlap between organizations representing "cell therapy" is not in the best interests of the sector. While ISCT remains the only organization with cell therapy of all types at the core of its mission, AABB has encroached into the cell therapy space from the blood banking side, ISSCR from the basic stem cell research end of the spectrum, ASBMT from the clinical stem cell transplant side, TERMIS from the tissue enginering, and now ASGT (following the precedent set by ESGT-ESGCT) from the gene therapy end.
As C. Mason & P. Dunhill wrote last year in Regenerative Medicine, what the industry needs is a strong voice generated by a powerful industry association. As long as we continue to create more silos of representation, we will continue to stray farther away from what's needed. While I have strong ties to ISCT and continue to serve that organization in several capacities, I am increasingly frustrated by the dilution of this nascent industry's time, money, and efforts spread over too many organizations and conferences without creating the voice for industry that is needed.
I'm not sure where this frustration will take me but my increasing conviction is that the companies in the cell therapy sector are ill-represented in any organization and spattering attempts at representation throughout all of them (including BIO which has to-date all but ignored the sector) is increasingly insufficient.
Am I off base here? Is this a real need or am I making something out of nothing? What do you think?
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