Cell Therapy Industry- Billion Dollar Global Business With Unlimited Potential

EDITORIAL

265ISSN 1746-075110.2217/RME.11.28 © 2011 Future Medicine Ltd Regen. Med. (2011) 6(3), 265–272

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Chris Mason

David A Brindley

Emily J Culme-‐Seymour

Natasha L Davie

Cell therapy industry: billion dollar global business with unlimited potential

The cell therapy industry (CTI) has undoubt-edly come of age with its international base, billion dollar per year turnover and broad spec-trum of proven therapies ranging from conven-tional organ transplantation to advanced stem cell therapies. Now is, therefore, not the time to have an identity crisis by continuing to pretend that regenerative medicine and cell therapies are one and the same – they are not. Whilst they do overlap, they are definitely two distinct and very different entities. Regenerative medicine uses any method to replace or regenerate cells, tissue or organs in order to restore or establish normal function [1] and therefore draws upon therapies from all four pillars of healthcare: pharmaceuti-cals, biologics, devices and cell therapies [2]. Cell therapy is the therapeutic application of cells regardless of cell type or clinical indication – a platform technology. Regenerative medicine is an approach to treating patients and therefore defi-nitely not a platform technology. It is closest to a hospital specialty, for example, emergency medi-cine, gerontology or palliative medicine, in other words platform technology independent. Its goals are ultimately to cure and therefore a paradigm shift away from conventional symptom control and pain management. Whilst it is true that some cell therapies are regenerative, the majority are not. Just as regenerative medicine is far bigger than regenerative cell therapies alone, cell thera-pies collectively represent a market opportunity many orders of magnitude greater than regen-erative medicine. Equating one with the other is therefore not advantageous but instead does both a major disservice. Overall, the impact of blurring the two is to confuse politicians, funding agencies, investors and most of all the public and patients [101]. So why has it happened and, more importantly, why has it perpetuated?

Regenerative medicine initially became used as a synonym for ‘tissue engineering’ and later popu-larized by William Haseltine (founder of Human

Genome Sciences) [3]. From 2002 onwards, the term was increasingly embraced as political spin to distance the tissue engineering field from the disasters of its past – overambitious claims and wild research programs that resulted in bil-lions of dollars of squandered investment, zero investor confidence, and only a handful of US FDA-approved products [4,5]. Out of the decline of ‘tissue engineering’ rose the term ‘regenerative medicine’ to rescue the field (FIGURE 1). Initially intended to re-badge tissue engineering and other similarly focused cell-based therapies, it quickly became apparent that the term’s depth and breadth unwittingly encompassed pharma, biotech, and device products such as recombi-nant erythropoietin, growth hormone and bone morpho genic protein. Unfortunately, these mul-tibillion dollar drugs and devices totally dwarf the fledgling cell-based industry sector. Confusion has reined ever since and was compounded by President Bush with his federal funding restric-tions on human embryonic stem cells, and the desire of the nonembryonic stem cell community to distance themselves from this political and ethical debate. For example, the pragmatice nam-ing of the industry lobby group, the Alliance for Regenerative Medicine (ARM) [102]. The arrival and increasingly frequent use of the term ‘stem cell tourism’ has also not helped. It goes without saying that no legitimate CTI company wishes to be associated with the unethical use of cell thera-pies. Medical travel is of course a valid activity with a growing global multibillion dollar mar-ket [6,7]; however, the current state of cell product development has resulted in charlatan activities occurring outside of the ethical CTI [8]. Indeed, only by coalescing and acting as a united CTI will it be possible to defeat stem cell tourism and bring genuine cell-based therapies into the legitimate medical travel arena. Just like biotechnology in the early 1990’s needed its own lobby group [103], today the CTI needs its own voice [9].

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EDITORIAL Mason, Brindley, Culme-Seymour & DavieEDITORIAL Mason, Brindley, Culme-Seymour & Davie

Times certainly have changed for the CTI. President Obama together with the NIH has started to reverse the impact of his predecessor on human embryonic stem cell research [10]. In 2011 an important landmark will be reached – the annual revenue for the CTI will pass the billion dollar mark. Furthermore, the CTI’s first block-buster product is not only in routine clinical practice but also being adequately reimbursed by the Centers for Medicare and Medicaid Services (CMS) [104,105]. All other indicators, including the sheer number of clinical trials, industry growth and bespoke infrastructure, look highly promising for a secure future for the CTI. This article discusses a number of these key issues and draws the robust conclusion that the CTI is a distinct healthcare sector that is rapidly devel-oping the capability and capacity to be a highly competitive, sustainable, multibillion dollar 21st century industry.

BackgroundUntil recently, healthcare has been supported by three main therapeutic pillars (FIGURE 2A). The col-umns stand for individual platform technologies,

the steps up to these pillars represent the essential infrastructure (including scalable manufactur-ing, appropriate regulation, reimbursement and widespread clinical adoption) and the pediment (roof) symbolizes total medical need. Whilst the three pillar structure is highly successful, improving the lives of millions of patients, cre-ating thousands of jobs and generating wealth, there are still unmet medical needs that pres-ently cannot be satisfied. These include cures for diabetes, heart failure, neurodegenerative diseases and major trauma, not to mention the far more serious issue of the inequality of global healthcare [11]. Hence the overhanging pedi-ment resulting in an overall structural imbal-ance – reflecting the unmet medical need both in the developed and developing worlds.

The current main three therapeutic pillars of healthcare therapy (pharmaceuticals, bio-pharmaceuticals and medical devices) are each built upon different platform technologies with unique core competencies: small molecules, biological molecules and devices (TABLE 1). Their different underpinning sciences; chemistry (pharma), molecular biology (biotech), and

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Figure 1. Indicator of frequency of general usage of the terms, ‘tissue engineering’, ‘regenerative medicine’ and ‘cell therapy’ (2004–2011). Data generated by Google Trends, which analyzes a portion of Google web searches to compute how many searches have been requested for a given term relative to the total number of searches requested by Google over time (www.google.com/trends). The terms ‘tissue engineering’, ‘regenerative medicine’ and ‘cell therapy’ were entered in order to generate the above graph. The general observation is that there has been an overall decline in the usage of ‘tissue engineering’, which has been replaced by ‘regenerative medicine’ and, in particular, ‘cell therapy’.

EDITORIAL Mason, Brindley, Culme-Seymour & Davie

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EDITORIAL Mason, Brindley, Culme-Seymour & Davie Cell therapy industry: billion dollar global business with unlimited potential EDITORIAL

physics and engineering (medical devices) define their resultant products and services. Using their respective core technology platforms, Big Pharma, biotech and the medical device industry all individually cover a broad diversity of medi-cal specialities and applications. So too does the CTI, including permanent cell replacement therapies (hematological and nonhematological), tissue engineering (cells plus scaffolds), transient cell therapies that disrupt or reduce natural dis-ease progression, immunomodulatory cell thera-pies, cell therapies that protect cells and tissues at risk, gene therapy (via cell delivery vehicles) and cell cancer vaccines [2].

Cell therapy is a totally different therapeu-tic platform technology to that of the current big three industries. It is certainly a disruptive technology [12]; however, it is not new. The CTI has its origins rooted in blood transfusion, bone marrow and organ transplantation, tissue banking and reproductive in vitro fertilization. Cell-based therapies have progressed from the first recorded human–human blood transfusion by James Blundell (Guy’s Hospital, London, UK) [13] through to the advanced cellular thera-pies of today. A 200 year journey based initially on clinical trial and error, and more recently laboratory science, that has culminated in the necessary critical mass and unique challenges to justify being a distinct industry in its own right. Thus, today cell therapy is the fourth and final therapeutic pillar of global healthcare.

The spectrum of cell therapies is currently highly diverse (BOX 1) but broadly has two major categories: permanent cell therapies such as the replacement of limbal cells for damaged cor-neas [14] and transient cell therapies such as the immunomodulation provided by adult stem cells for the treatment of graft-versus-host disease [106]. The number of different types of cells used for therapies will also rapidly expand in the future with the potential for bespoke designer cells, synthetically engineered cells, cell fragments, cell hybrids, substitute tissues and the gradual emergence of enhancement therapies rather than mere health restoration. The future possibilities for cell-based therapies are boundless, but what of today’s market and the CTI’s likely future 5–10 years from now?

Cell therapy market size & valueIt was estimated for 2009 that the potential mar-ket for all cell-based therapies in the USA alone was well in excess of 100 million patients [15]. The main targets include heart disease, diabetes, neuro-degenerative diseases, musculoskeletal disorders,

spinal cord injury, stroke, autoimmune diseases and major trauma. The CTI alone (as opposed to regenerative medicine, which includes small and large molecules, devices and cells) had global sales of $410 million in 2008, and is predicted

Figure 2. Cell therapy: the fourth and final therapeutic pillar of healthcare. (A) The columns stand for individual platform technologies, the steps represent the essential infrastructure (i.e., scalable manufacturing, appropriate regulation, reimbursement and widespread clinical adoption) and the pediment (roof) symbolizes total medical need. Whilst the established three pillar structure is highly successful, improving the lives of millions of patients and creating thousands of jobs and generating wealth, there is still unmet medical need that presently cannot be satisfied – hence the overhanging pediment. (B) Today, the fourth pillar, cell therapy, is being built. However, the necessary infrastructure is not yet in place – depicted by the lack of steps. (C) The final goal for the cell therapy industry with all four pillars working together for the benefit of patients.

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to grow to $2.7 billion by 2012 and $5.1 billion by 2014 [15], with even greater growth expected to follow. This 2008 figure agrees well with the independently generated data for regenerative cell therapies alone of $100–200 million for the year 2009–2010 [16]. Currently, there are eight FDA/European Medicines Agency (EMA)-approved cell therapies [16] including Provenge® (Dendreon, Seattle, WA, USA) [104,105], a cell-based prostate cancer vaccine with reimbursement in the USA set at $93,000 per treatment [17]. Through Medicare reimbursement alone, Provenge is expected to generate sales of $1.75 billion per annum by 2014 [104] – the first CTI blockbuster product. Moreover, the overall market predictions above are considered conservative [15] given the existing clinical demand and the volume of cell therapy clinical trials that are currently underway. For example, in 2009 it was estimated that 2,500,000 patients in the USA could have benefited from the existing cell-based therapies of the day. However, due to the limitations of early market penetra-tion, only 6000 patients actually received these advanced therapies [15]. Around the world cell therapy research is progressing at a rapid pace. Globally, over the past 10 years more than 2500

trials involving cell-based therapies (hematologi-cal and non hematological) have commenced, with the majority still either enrolling patients or gathering clinical data. More significantly, over 50% of these trials are at Phase II and III, the stages that begin to examine a therapeutic’s clini-cal effectiveness [D!"#$ NL, C%&'$-S$(')%* EJ, B*#+,&$(

DA, M!-)+.C, U+/%0&#-1$, D!2!]. Therefore, using a pessimistic overall 1–2% success rates (currently biotech is running at a 5.3% compounded prob-ability success rate going from Phase II to mar-ket authorization [107]), the number of regulatory approved cell therapies 5–10 years from now could be well over a hundred. Encouragingly, to date cell therapy clinical trial success rates have fared far better than their biotech and pharma counter-parts. In part this is due to both their mode of action plus the FDA allowing Phase I studies to be conducted in patients (compared with healthy volunteers), thus presenting the opportunity to demonstrate efficacy as a secondary end point. In general, failures are far more likely to result from lack of finance (e.g., abandoned or hurried clinical trials that result in both the deployment of too many and often inappropriate clinical trials centers and poor patient selection) than from a failure due to the underpinning science.

In 2011 the CTI will have its first billion dol-lar revenue year. Just taking the big hitters alone, Advanced BioHealing (Westport, CT, USA), Dendreon and Organogenesis (Canton, OH, USA) plus cord blood banking, this figure can easily be justified. Advanced BioHealing had rev-enues last year of $146 million for Dermagraft® (fibroblast-derived dermal substitute) [108] and are currently preparing to become a publicly traded company on the NASDAQ Stock Market [108]. The company’s growth in revenues has gone from $44 million (2008) to $85 million (2009) to this year’s $146 million, with even more impressive gross profits of $28, $65 and $115 million for each respective year [108]. Likewise Dendreon is also rapidly gaining momentum following FDA approval of their first product Provenge (sipuleu-cel-T) on 29 April 2010. Provenge is an autologous cellular immunotherapy for the treatment of met-astatic prostate cancer. The commercial sale of the product commenced in May 2010 and resulted in revenues of $48 million for 2009–2010 [109]. Currently, Dendreon is predicting sales revenues for Provenge in the range of $350–400 million for 2011 [105]. Other potential blockbusters are well advanced, including laViv™ (azficel-T) from Fibrocell Science, Inc. (Exton, PA, USA), which is awaiting the outcome of its FDA Biologics Licence Application (BLA) [110]. The industry

Table 1. Therapeutics and core competencies for the industries that make up the four pillars of healthcare.

Therapeutic product Core technologies IndustrySmall molecule drug Chemistry Pharmaceutical IndustryMacromolecule drug Genetic engineering

Monoclonal antibodyBiotech

Medical device PhysicsEngineering

Medical Device Industry

Cell therapy CellsTissue engineering

Cell Therapy Industry

Box 1. Cell therapy industry activities.

Permanent cell replacement therapies Tissue engineering Transient cell therapies to halt/slow disease

progression Cell therapies that protect tissues at risk Immunomodulatory cell therapies Cosmesis/bioaesthetic cell-based treatments Cells as delivery vehicles, including gene

therapy Cell cancer vaccines Cord blood banking – public and private Combination products Xenografts Advanced human reproductive techniques Animal cloning Transgenic animals Conventional cell, tissue and organ

transplantation




flagship, Organogenesis, likewise has an impres-sive track record of achievement with revenues that are almost entirely generated from Apligraf® (living, bilayered skin substitute) of $79.5 mil-lion in 2009 and that grew to $102.2 million in 2010. Organogenesis fully expects to maintain its current strong growth [M!3K!( G, P$*-. C)''.]. Genzyme BioSurgery (Cambridge, MA, USA) with Epicel® (cultured epidermal autografts), Carticel® (autologous chondrocytes) and matrix-assisted autologous chondrocyte implantation, and TiGenix (Leuven, Belgium) with their autolo-gous chondrocyte product, ChondroCelect®, also contribute significantly to the overall CTI rev-enue. Likewise, the multimillion dollar revenue for Osteocel® Plus (NuVasive®) matrix-containing mesenchymal stem cells must be included [16]. Other notable CTI companies include Cytori Therapeutics (San Diego, CA, USA) with Celution™ – a device that automates and stan-dardizes the extraction, washing and concentra-tion of autologous adipose-derived cells, which can then be reimplanted back into the same patient in a single surgical procedure. Thus, when the predicted $330 million annual revenue from the cord blood banking sector [15] is also taken into account, the billion dollar per year milestone will be more than exceeded by 31 December 2011.

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CTI structureThe CTI is conventionally broken down into its two major components: autologous patient-specific therapies (the majority are produced by service orientated good manufacturing practice (GMP) facilities embedded in existing health-care organizations similar to in vitro fertilization units); and allogeneic universal cell therapies more suited to the ‘cells as pills’ analogy promoted by Tom Okarma (former CEO, Geron). These two approaches are totally complimentary in the same way that biotech embraces both recombi-nant human proteins and monoclonal antibodies. However, there is also an important third category relating to autologous cell therapy – point-of-care devices that minimally manipulate a patient’s cells for immediate use, for example Celution (Cytori

Therapeutics). These FDA 510(k) approved (and/or CE mark in the EU) processing devices thus provide another route for cell therapy-based companies to supply the market. The three afore-mentioned CTI approaches: service, product and point-of-care device, despite having differing busi-ness models, all have delivering cells as therapies as their core technology.

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Today the fourth pillar of global healthcare, cell therapy, is being built (FIGURE 2B). However, the necessary infrastructure, including appro-priate regulation, reimbursement regimes, scal-able manufacturing, robust business models and clinical outlets, are not yet in place (depicted by a lack of steps in FIGURE 2B). Thus, even if the under pinning science was totally resolved today, cell-based products could not yet reach their true potential of widespread clinical adoption. The major challenge is to get from the discovery step through to proof-of-concept clinical trials (to cross the more colloquially branded ‘Valley of Death’) [18]. The general mood of the sector can be summed up by a recent Irv Weissman (cofounder of Systemix, StemCells and Cellerant) comment, “I wouldn’t start a company now unless I had a pretty high degree of control and, much more importantly, had progressed in the university through at least Phase I/II trials” [19]. Solutions are now starting to emerge to cross this translation gap, including the announce-ment by the UK Government of an $80 mil-lion Cell Therapy Technology and Innovation Centre [111] to enable the UK’s world-class stem cell science to be translated into safe, efficacious cell-based therapies that are capable of being manufactured at scale in a cost-effective manner. The goal is a new, internationally competitive, multibillion pound UK healthcare sector. Other countries and US states have similar initiatives albeit based on regenerative cell therapies rather than cell therapies in general (e.g., CIRM and their highly successful Disease Team program of funding awards).

The CTI is complementary to pharma, biotech & the medical device industryFor an architectural building to properly func-tion, the roof must be fully supported. The walls and the foundations work together to achieve



this simple goal. So too, the four therapeutic pillars of healthcare must work together to pro-vide the best possible treatments for all patients, globally. For example, today vascular disease is treated by combinations of small molecule drugs (aspirin and ADP receptor inhibitors), biologics (glycoprotein IIB/IIIA inhibitors) and devices (synthetic bypass grafts, angioplasty and stents) depending upon the site and severity of the atherosclerotic plaques. In the future, if cell therapy approaches, such as Aldagen’s ALD-301 (Durham, NC, USA) or Pluristem’s PLX-PAD (Haifa, Israel), are successful in improving peripheral blood flow, the addition of cells to the above combinations could further improve the patient’s quality of life, reduce the burden on caregivers and overall reduce healthcare costs while improving economic opportunities (con-tinued employment, fewer sick days and avoid-ing premature deaths). It cannot be too strongly stressed that cell-based therapies will in many instances be used in combination with existing products from pharma, biotech and the devices industry or new combinations (e.g., cell ther-apy-friendly immunosuppressant medication for allogeneic therapies, bespoke biopsy and cell delivery devices and diagnostic biomarkers to allow appropriate early intervention – stratified medicine for cell therapies). Whilst cell therapies undergo the inevitable gradual emergence of effi-cacy as they evolve ultimately into cures, it will not simply be a matter of ‘cell therapy in’ and ‘old drug/biologic/device out’ as is often the case today when a new drug, biologic or device arrives on the market. Some cell therapies, however, will indeed be direct replacements, for example insu-lin replacement for type I diabetes will be his-tory once a definitive -islet cell therapy arrives. Whilst the ultimate cell products evolve, there will also be a real opportunity for the other non-cell-based technologies to be deployed in combination with cell therapies. For example, Diabecell® (Living Cell Technologies, Australia) [20] is initially proving to help normalize unstable Type 1 diabetes, by reducing or eliminating life-threatening episodes of currently uncontrollable and sudden hypoglycemia. Thus, an intermedi-ate new market may emerge for special insulins and delivery devices to complete the overall therapy for the patient whilst the unpredictable hypoglycemic episodes are eliminated by the cell implants. Thus, overall cell therapy is not a demolisher of the other three pillars but rather an equal partner in the provision of advanced healthcare. The future success of the other three pillars relies upon all four pillars supporting one

another and working together to deliver out-standing healthcare therapies for the benefit of patients, their caregivers and society in general.

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Big Pharma: moving from exploration to exploitation of cell therapy?There is no doubt that there has been a steady increase in the interest in the cell therapy sector from Big Pharma as well as the larger biotech and medical device companies [21,22]. For exam-ple, Neucentis’ (previously Pfizer Regenerative Medicine, Cambridge, UK) recent partner-ing program (December 2010) with Athersys (Cleveland, OH, USA) [23] includes conducting a Phase II trial to evaluate the administration of MultiStem® (adult stem cells) for inflamma-tory bowel disease. This is despite the inevitable set backs of pharma-backed CTI ventures, the most high profile being the Genzyme–Osiris Therapeutics partnership [24]. However, the defin-ing event for the CTI came with the long awaited success of Dendreon and its potential blockbuster cell therapy product with agreed reimburse-ment by CMS at $93,000 [105]. It is all the more remarkable being that the therapy is autologous and not a more easily scalable allogeneic therapy. This success has certainly made both potential investors and strategic partners reassess their posi-tions on cell therapies. Recent activity includes the $1.7 billion deal by Cephalon (Frazer, PA, USA) with an up-front payment of $130 million to Mesoblast (Melbourne, Australia) to develop and commercialize adult stem cell therapies for a range of medical disorders. Cephalon also paid $220 million for a 19.99% equity stake and a seat on the board of Mesoblast [25]. Venture capitalist, Daphne Zohar of PureTech Ventures (Boston, MA, USA) best sums up the general CTI view of this deal by saying that “The up-front payment is higher than most we’re seeing. Most recent deals are structured as earnouts that are more back-loaded, but Cephalon must have thought it was worth it”[25].

Unfortunately, whilst not a week goes by with-out news on the demise of Big Pharma, even the pace of biotech is starting to falter. In 2009–2010, “sales from biologics slowed from their historical high double-digit rate to mid-single digits” [26].




Aggarwal writing for Nature Biotechnology sug-gested this slowdown is due to a combination of factors including: safety issues, manufacturing lapses, saturation of approved indications, crowd-ing and the ongoing US recession [26] – a list that pretty much everyone would agree with. When compared with the substantial growth rate of the CTI, it is not hard to appreciate the significant renewed interest in the cell therapy sector by private equity houses, institutional investors and governments. In less than a decade, the CTI has progressed from annual revenues of a few mil-lion dollars to over a billion dollars today and is conservatively expected to rise to $5.1 billion by 2014 [15] with even greater growth expected to follow (FIGURE 3). The unavoidable truth is that cell therapy is now starting to emerge as a major therapeutic force across a wide range of medical indications. In 2011, with its first billion dol-lar turnover year, thousands of clinical trials in progress and strong patient support, the CTI has finally come of age. Therefore, there is simply no need to hide behind the term ‘regenerative medi-cine’ any longer. Regenerative medicine replaces

or regenerates cells, tissue or organs in order to restore or establish normal function regardless of the approach [1]: this journal is proud to bear the name, Regenerative Medicine. Likewise, the CTI should also be proud of its name. “What’s in a name?” [Romeo and Juliet: Act II, Scene II] – in this one short line, Shakespeare captured the cen-tral struggle and tragedy of Romeo and Juliet. With cell therapies, as with star-crossed lovers, it turns out that a name means a lot. Therefore next time the question arises, “What do you do?”, please carefully consider before answering and first ask yourself, “Am I truly in regenera-tive medicine, cell therapy or perhaps both?” Is it really so bad to be identified as being part of the fastest growing sector of healthcare therapy? The emerging CTI, with its living cell-based products and services, has its own unique set of require-ments and challenges that are totally different to those of pharma, biotech and the medical device industry. However, once these obstacles are cleared, all the indicators point to a sustain-able multibillion pound healthcare sector. The only question that remains is, “Where?”

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Figure 3. Cell therapy industry market (2008–2014). Graph showing the estimated CTI revenues from 2008–2014†, together with the value of the regenerative cell therapy market estimated for 2009–2010, based on actual sales of US FDA/EMA approved products‡.CTI: Cell therapy industry. †Data taken from [15].‡Data taken from [16].



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Websites101 House of Commons,

Bioengineering – Science and Technology Committee Contents: Memorandum submitted by Professor Chris Mason (Bio 31) www.parliament.the-stationery-office.co.uk/pa/cm200910/cmselect/cmsctech/220/10010606.htm

102 Alliance for Regenerative Medicine: Membership www.alliancerm.org/members.html

103 Biotechnology Industry Organisation: About BIO: Partner to a dynamic industry coming of age www.bio.org/aboutbio/history.asp

104 Bloomberg Businessweek. Dendreon’s Provenge extends survival, U.S. Panel says Larkin C www.businessweek.com/news/2010–2011–17/dendreon-s-provenge-extends-survival-u-s-panel-says.html

105 Larkin C, Waters R: Bloomberg Dendreon says Provenge may generate $400 million, reports expansion plans www.bloomberg.com/news/2011–2001–07/dendreon-reports-projected-provenge-sales-of-400-million-expansion-plans.html

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108 United States Securities and Exchange Commission (Washington, DC): February 25, 2011. Registration Number 333 – Form S-1 Registration Statement under the Securities Act 1993 – Advanced BioHealing Inc. http://ipo.nasdaq.com/ViewFiling_frames.asp?filename=0001193125%2D11%2D046975%2Etxt&filepath=%5C2011%5C02%5C25%5C

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Financial & competing interests disclosureC Mason is a Principle Investigator and DA Brindley, EJ Culme-Seymour and NL Davie are all full /part-time researchers on the British Regen Industry Tool Set (BRITS) project funded by the Technology Strategy Board under their Regenerative Medicine Program: Value Systems and Business Modeling. The authors have

no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materi-al s discussed in the manuscript apart f rom those disclosed.

No writing assistance was utilized in the production of this manuscript.

Cell Therapy Industry- Billion Dollar Global Business With Unlimited Potential

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