Cell Therapy Manufacturing Market

Just to prove I haven't abandoned serious blogging to become a cartoonist, I've got a heavy one for ya. Grab a beverage and a comfy chair - this one’s a little dense for a blog but I excerpted it out of an article I'm submitting for publication and didn't want it to go to waste...

This is my attempt to define the cell therapy manufacturing market. According to my database, there are currently 700+ stakeholder companies[i] in the cell therapy sector. This includes ~250 therapeutic “cell therapy” companies with approximately 344[ii] products in the market or in some stage of clinical or pre-clinical development[iii].

Companies
My data suggests the cell therapy products around the world (both commercially available and in development) can currently be broken down into the following categories:

Table 1
Manufacturing Costs
What follows is a sample analysis of one way to assess the manufacturing sector of the cell therapy market.

For the purposes of this analysis, I have assumed average spending at the various stages of therapeutic product manufacturing to be that shown in the table below. It must be noted that while these numbers are clearly within the range of what a company might spend at each phase they are chosen merely for illustrative purposes and are NOT the result of any researched conclusion that these numbers represent the average or mean amount spent by companies.

Table 2
Using those averages and based on the number of products in each stage as outlined in Table 1, the current global value of cell therapy product manufacturing would be estimated to be as follows:

Table 3
Manufacturing as a % of Global Cell Therapy Market
A $542 million manufacturing expenditure in 2008 would represent 2.2% of an overall market estimation of $25 billion (see my upcoming paper for more analysis of why I believe this is the best available estimate of the 2008 cell therapy market as I define it). This would average out to roughly $1.6 million per product and $2.2 million per company spent on manufacturing[vi].

To help test the accuracy of these calculations, Michael Lysaght graciously provided the data set behind his recent publication in Tissue Engineering[iv]. Lysaght provided the annual expenditures for over 150 therapeutic companies broken down by phase of development (pre-clinical, phase I, II, II, and commercial). The average expenditures per company by phase are shown below:

Table 4
Using the previous estimations of manufacturing costs-per-phase as shown in Table 2, one can estimate what percentage of overall annual expenditures is represented by manufacturing costs in the different phases of development. These are show below:

Table 5
Based on those figures, the overall estimated amount spent on manufacturing by these companies in 2008 would be $160 million. Using Lysaght’s current market estimate of $3.4 billion, $160 million represents 4.7% of the market.

Based on both these calculations, the amount of money spent on manufacturing as a percentage of the overall market would lie somewhere 2.2% and 4.7%.

If one applies these percentages to a broader market definition and the broader market assessment at $25 billion market, the manufacturing subsector would be between $550 million and $1.175 billion.

It should be noted, however, that Lysaght’s “market” does not include all therapeutic companies as I define the sector and also excludes tools, reagents, services, non-clinical research, etc.

It is also worth noting that percentage-of-market is quite different from percentage-of-expenditures. Most organizations developing therapeutics are likely to spend more like 10-20% of their cost of goods on manufacturing but the market is comprised of more than just therapeutic companies’ expenditures thus explaining the lower percentage as expressed as a percentage of the market.


Outsourced Manufacturing Market
Based on information gleaned from public sources and confidential discussions with the primary contract manufactures in the industry[viii], I believe approximately 40 of the total 340+ cell therapy products currently in development or on the market – approximately 12% - are being outsourced to corporate contract manufacturing organizations (CMOs)[ix] for manufacturing.

On another analysis, again based on information gleaned from public sources and confidential discussions with the primary contract manufactures in the industry[x], I believe not more than $60 million is being spent this year for CMO manufacturing services. This represents ~11% of the ~$550 million used in the sample analysis above.

Based on data from more mature predecessor biotechnology sectors, a number of experts believe the rate of manufacturing outsourcing will increases as the cell therapy industry matures.

According to a 2005 survey conducted by BioPlan Associates[xi], 35% of biomanufacturers were at that time outsourcing at least some of their biologics production in mammalian, microbial, yeast, plant, or insect systems. These manufacturers projected this number would increase by 30% by 2008. Overall, nearly half of all biopharmaceutical manufacturers responded that they might contract-out production of biologics by 2008. According to a 2005 Frost & Sullivan report, the global contract manufacturing industry for pharmaceuticals was then projected to grow at a rate of 11% over the next 6 years from $13.6 billion in 2005 to $25 billion in 2011 [xii].

I believe it is reasonable to assume that the percentage of products in the cell therapy sector being outsourced for manufacturing will increase.

In addition to a growing rate of outsourced manufacturing, it would be fair to assume growth in the overall dollar value of the outsourced manufacturing market based on the assumption that the products currently in commercial or mature stages of the development pipeline are comprised of a higher percentage of simpler and unregulated cell therapy products than is represented in the second wave of cell therapy products now making their way through the development pipeline.

While this may not represent a linear path of growth if the third wave of products are – more proportionately allogeneic and arguably again on the simpler side of the processing-complexity scale – it is reasonable to expect manufacturing costs to be higher for the same number of products over the next five years than they have been for the past 5 years. Depending on the development of embryonic stem cell (ESC) products, one can currently expect they will involve a more complex manufacturing process and therefore again raise manufacturing costs comparatively.

Based on this data and understanding and given an industry CAGR ranging from 13-40%, it would appear conservative to project that the global contract manufacturing business for cell therapy products will grow at a rate of at least 2% per year above the sectors’ CAGR over the next 5 years.


Summary
Based on the assumed manufacturing-expenditures-per-product-phase in Table 1, the total spent on cell therapy product manufacturing is estimated to be around $542 million.

Based on an estimated $25 billion cell therapy market in 2008, this means somewhere between 2.2% and 4.7% of the overall market is spent on manufacturing.

Approximately 11-12% of cell therapy product manufacturing is currently outsourced to private, industry contract manufacturers with this rate expected to grow faster than the market over the next number of years.

The assumed manufacturing-expenditures-per-product-phase in Table 1 are gross estimated averages. Changing these numbers skew the end result considerably. Consequently this is no better than a a rough-order-of-magnitude and sample assessment of the industry's manufacturing costs but I hope it serves to inform further discussion and better analysis.

As always, I welcome your comments and hope a few of you will read this close enough to point out any errors or ways we could improve this analysis ...

--Lee
_________________________________________________________________

[i] Estimates range from ~225 to ~300 therapeutic companies among what I define as ~700 stakeholder companies in the cell therapy industry. Sources: author’s database; Cell Therapy Pages (Connexon Communications); Proteus Venture Partners; Bionest Partners. Cell therapies and tissue engineering. February 2007; Burger SR. 2004. Cell and Gene Therapy - Challenges and Strategies for an Emerging Industry. Cell and Gene Therapy 5:9-14.
[ii] For the purposes of my analysis below I have lowered this to 329 product discounting basic stem cell transplants being done commercially by companies in various countries. Even the larger number (344) does not include pre-licensed “products” being researched or “developed” by academic institutions.
[iii] “Pre-clinical development” is defined to product in development prior to initiation of a phase I trial but not including products in the early research phase.
[iv] This figure is based on calculations from the data used by Michael Lysaght, PhD, Professor and Director of the Center for Biomedical Engineering at Brown University, in publication of Lysaght M, Jaklenec A, Deweerd E: Great Expectations: Private Sector Activity in Tissue Engineering, Regenerative Medicine, and Stem Cell Therapeutics. Tissue Eng 14, 305. 2008. That data indicates that the average annual spending of companies categorized as “commercial” was $30 million. I then assumed that manufacturing represents 10% of annual expenditures based on the calculation that manufacturing represents between 8-15% of annual expenditures cited by Lysaght in the data. Annual expenditure for commercial-stage manufacturing does and will vary wildly depending on the type of product and the volume of production by as much, for example, as $1.5 million and $80 million for production of 20,000 products per year - the difference largely driven by the products being allogeneic versus autologous.
[v] Calculated using 53 companies discounting for at least some of the basic stem cell transplants being done commercially by companies in various countries.
[vi] Calculated using 329 products and 250 companies.
[vii] Average annual expenditure of the 26 company in the Lysaght database with at least one product listed.
[viii] Lonza, Progenitor Cell Therapy, Cognate BioServices, Apptec Laboratories, Angel Biotechnology, Eufets, Cell Therapy Pty, and PharmaCell. We have not included products outsourced to other biotechnology companies using excess capacity to provide contract services not products outsourced to academic centers.
[ix] This excludes manufacturing being done by pharma partners, academic institutions or non-profit organizations.
[x] Lonza, Cognate BioServices, Apptec Laboratories, Angel Biotechnology, Eufets, Cell Therapy Pty, and PharmaCell. I have not included products outsourced to other biotechnology companies using excess capacity to provide contract services not products outsourced to academic centers.
[xi] “Advances in Large Scale Biopharmaceutical Manufacturing and Scale-Up Production, 2005”, a survey by BioPlan Associates, Inc. (2005), as quoted in Broeze RJ: Key Challenges facing Bio Manufacturing, BioProcessing & BioPartnering 1 (2006).
[xii] Frost & Sullivan: Global Pharmaceutical Contract Manufacturing Market 2005.

Cell Therapy Group Session? :)

Pardon the advert - didn't know where else to post my bitstrip fun?

Cell Therapy Market Overview

Below is my snapshot of the cell therapy sector and year-to-date activity - investments, business activity, and market size - that I just posted on docstoc and on my website. It's a very basic status overview of the business side of the industry. There is much more detail behind these summary slides but I can't give away everything now can I? :)


Cell Therapy Business-Market Summary (July 2008)

-- Lee Buckler
the Cell Therapy Group

Does Cell Therapy Demand a Different Investigatory-to-Commercial Paradigm?

I've just finished reading a great post by blogger Sonya Fatah. It's a very balanced and thorough post (click here to read it) on the stem cell medical tourism phenomenon complete with ample anecdotal patient testimonials - including some longer-term follow-up stories - as well as content from interviews of Indian embryonic stem cell transplant [pioneer / capitalist / fraud / savior - depending who you ask] Dr. Geeta Shroff (pictured here). Sonya's post also outlines the reaction of Dr. Stephen Minger et al (including colleagues in India) who tow the more western medicine party line that all this treating patients commercially prior to the rigor of clinical trials, peer review, and regulatory compliance/approval is...well, just wrong.

Word is that ISSCR is busy preparing a public policy statement regarding the stem cell medical tourism industry. It will be curious to see how they balance the various perspectives here given that they are an 'international' society with a clearly 'western' bent. They apparently had a very lively session at their latest conference on this topic.

I'm a firm advocate of regulatory frameworks to protect people from the predators, fraudsters, or even just the sloppy. I'm also an ardent believer in the benefits of peer review, transparency, and accountability. As a product of western inculcation (education) I also believe in the benefits of the clinical trial system and long-term follow-up as a means of vetting therapies before we let them loose on a 'suspeptible' public, regardless how well-meaning or even beneficial the efforts to make such therapies available earlier might be.

Having said all that, even in the West we make certain - albeit regulated - exceptions for no-option patients, etc. And patients - upset they cannot access what are perceived to be relatively safe, low-risk, potentially life -saving/altering stem cell treatments in the US - are voting with their feet and checkbooks traveling to Central America, the Caribbean, India, Asia, and anywhere else they can pay for the privilege to access unproven treatments. It's hard to argue with patients suffering from crippling, painful, and/or terminal ailments that they should be denied the right to choose their treatment.

Would it be better if these treatment providers - most of them companies charging amply for their treatments - would publish their science, conduct clinical trials even whilst they charge patients for treatment, be more transparent with their products/protocols, and/or conduct and publish the results of long-term follow-up? Sure. But this is not as much a part of the culture of eastern medicine. Clinical trials, regulatory approval, peer review...are all hallmarks of western science. Furthermore, different attitudes toward IP protection means transparency and publication are more easily exchanged for trade secret protection.

Has this therapeutics globalization triggered more a clash of cultures than one science and medicine? Could it be said that cell therapies - not unlike herbal remedies, acupuncture, chiropractic regimes or other forms of relatively harmless treatment modalities - do not require as strict a regime of clinical trial and regulatory oversight prior to commercial access? Are they inherently safe enough to allow for a different investigatory pathway or have we just not yet discovered the potentially harmful - if not deadly - side effects presented by predecessor pharmaceuticals, biotechnologies, and even the sister gene therapy which mandate the kind of process we've invented? Would our efforts be better spent on patient education rather than opposing the development and practices of such clinics?

Perhaps only time will tell. I definitely don't have the answers but I can most certainly understand those who - when faced with unbearable alternatives and a perception of very little downside - decide to travel and pay for treatments that cannot be accessed in North America. I am also sure that we in the West must be more than careful in judging or attempting to impose our values or worse - our systems - on those who think differently.

It is easy to accuse companies charging amply for these treatment of being fraudulent or, at the very least, of being motived solely by profit to sell something unproven to those with no options. This is tricky position to take while sitting in a country noted for its free enterprise with its predatory lending practices, legalized gambling, credit card companies charging double-digit interest rates, capitalist institutions more than eager to take advantage of the purchaser's freedom of choice to buy beyond their means, and a health care system with some of the highest costs in the world while allowing a majority of its citizens to go without coverage.

In this world of increasingly globalized medicine there will be medical jurisdiction shopping just like there are havens for taxes, drugs, weapons, etc. We must find ways to work together to a better, harmonized end. The FDA - at least at CBER - is open to accepting data produced outside the US in trials that follow basic strictures. Innovative organizations, academic institutions, and companies should seek ways to collaborate with the companies providing these treatments to attempt to "validate" them to western standards while opening them up to peer review.

Let's keep an open mind and discourse as we seek global solutions to balancing patient protection, choice, education, and access.

We must do everything we can to encourage all involved to conduct clinical trials, perform long-term follow-up, publish their science, and be open to peer review. We should try to better understand what is happening in these jurisdictions rather then simply expecting or demanding they comply with our systems. We should be cautious in our criticism and open in our consideration of whether new treatment modalities open the door for different regulatory pathways that provide safe choices for patients as soon as reasonably possible.

What is regenerative medicine by any other name?

Whether you say potāto or potäto we all know what you mean. But when someone says they're in regenerative medicine is that somehow different than cell therapy? And how does that differ from tissue engineering? And where does the stem cell industry and gene therapy fit into the mix? We do need to settle into a nomenclature paradigm for this industry. It won't just help us in the industry, its bound to help those trying to understand it - perhaps even an investor or two!

In the concluding paragraph of her 2004 book, The Proteus Effect, Ann B. Parson states:

“Some biologists believe that the greatest legacy of stem cells will lie in their therapeutic value. Others say their best gift will be what they can tell us about the miracle of Life, and how a tiny cell has the wherewithal to grow into a thriving form, of whatever nature. Other biologists instead look at a stem cell as the immortal cell that will extend human life indefinitely and reveal aging to be a mere aberration.’

The cell therapy or regenerative medicine industry indeed embraces at least all those views of cell-based research. The industry is a wide-ranging collective of research using a wide variety of technologies to repair, restore, replace, and/or regenerate human biological systems. The wide scope of the field has recently motivated a few forward-thinking individuals in the industry to attempt to define the industry and encourage a consensus of nomenclature.

After reviewing the history of the sector and several approaches to its definition, Mason & Dunhill recently proposed to define the sector simply as follows:

“Regenerative medicine replaces or regenerates human cells, tissue, or organs, to restore or establish normal functions.” [ii]

This definition, and their “regen” abbreviation for the industry, has been adopted by the BSI (British Standards) in its Publicly Available Specification (PAS) 84:2008.[iii]

This kind of formal adoption of definitions and how the primary terms interrelate and overlap will help this incipient industry.

The regen industry has spawned from and is increasingly about the convergence of three distinct technologies: stem cell transplant, tissue engineering, and biomaterials.

There is, of course, entrenched intransigence among the leading orgs representing the field in that ISSCR really sees the world through a stem cells lens, ISCT sees the field as cell therapy, TERMIS sees the world of tissue engineering as more encompassing than most, AABB believe its all very closely related to blood banking, and BIO hasn't really figured how to properly engage or represent the field given its relative unimportance as yet to their overarching mandate.

This does raise the need for an overarching industry org but that will be the subject for an upcoming blog.

While the term ‘regen’ appears to have spawned more directly from the tissue engineering sector which was one of the early names for the sector (see cover of TIME magazine 22 May 2000), "tissue engeering" now seems to be falling into place as a subset of regen – one that focuses on the engineering of tissues often by or in conjunction with physical devices or matrices. Having said that, tissue engineering was recently broadly defined by a multi-agency task force of the US government as “the use of physical, chemical, biological, and engineering processes to control and direct the aggregate behavior of cells”.[iv]

Notwithstanding such efforts to define tissue engineering broadly, the two terms that appear to be emerging as the overarching title for the industry are “cell therapy” and “regenerative medicine” (or its abbreviation “regen”). The former appears to have arisen primarily from the cell transplant community and the latter out the tissue and biomaterials sectors. Some, like Proteus Venture Partners, define cell therapy as a subset of the regenerative medicine industry.¹⁰¹ Others (like myself) have tended – perhaps sloppily – to use the two terms rather synonymously and interchangeably.

If we define regen as Mason & Dunhill do above, cell therapy is clearly a subset of regenerative medicine. Cell therapy is always about the ‘replacement or regeneration of human cells, tissue, or organs, to restore or establish normal function’. Regenerative medicine, however, may or may not use cells as the vehicle for doing so[v]. Regenerative medicine may use small molecule activators, non-cell-based gene therapy, and/or non-cellularized biomaterials.

Notwithstanding the utility of such definitions, distinctions are increasingly blurring because of the interdisciplinary mechanisms now being employed in many advanced regenerative medicines like cellularized matrices, cell-based gene therapies, cell therapies accompanying small-molecule activator therapies, small-molecule regimens supporting accompanying cell therapies, etc.

All the more need for an overarching nomenclature. Let me know your thoughts...

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[i] Parson AB: The Proteus effect: stem cells and their promise for medicine. Joseph Henry Press (2004).

[ii] Mason C, Dunnhill P: A brief definition of regenerative medicine. Regen. Med. 3, 1-5 (2008).

[iii] Publicly Available Specification (PAS) 84:2008: Regenerative medicine – Glossary. British Standards (BSi) (April 2008).

[iv] Advancing Tissue Science and Engineering: A Muliti-Agency Strategic Plan. Mulit-Agency Tissue Engineering Sciences (MATES) Interagency Working Group (IWG) under the National Science and Technology Council of the Committee on Science of the Subcommitee on Biotechnology. June 2007.

[v] BSi’s PAS 84:2008 defines “cell therapy” as ‘administration of cells to the body to the benefit of the recipient” and defines “cell based medicinal product (CBMP)” as a “medicinal product containing cells” noting that “these products may be combined with non-cellular components and may include genetically modified human cells” which it states is “derived from the European Medicines Agency’s Guideline on Human Cell-Based Medicinal Products [EUROPEAN MEDICINES AGENCY (EMEA). Committee for medicinal products for human use (CHMP). Guideline on Human Cell-Based Medicinal Products. Consultation draft issued 25 January 2007. London: EMEA, January 2007.]

The Perfect M&A Storm is Brewing.

I'm not going to write only about the financial side of cell therapy sector but I'm on a roll here so I'll continue on the theme for at least on more post.

I've been privy to a lot of conversations recently in which M&A is on the tip of everyone's tongue. I'm likely not going out on too much of a limb - and certainly won't be the only one on it - when I make the prediction that the next 12-24 months is going to see a spike in M&A activity at all levels in the cell therapy industry.

I don't think I need a hard data set to convince you that we've seen an increase in M&A activity over the past 6 months.

This I know:

• There is a fair amount of M&A activity right now in the sector.
• The M&A pendulum has now swung back to the "sexy" side after falling out of favor for some time.
  
• A high percentage of companies in the sector are expressing interest in some level of merger or acquisition.
  
• There are a lot of M&A discussions currently being explored.

Certainly we're seeing this in the larger biotech sector with Roche's offer for Genentech, MacroGenics' acquisition of Raven Biotechnologies, Lonza's purchase of Amaxa Biosystems, and Invitrogen's merger with Applied Biosystems as prime examples just in the past few weeks alone.

There is a perfect storm of factors brewing up the ideal climate for a spike in M&A. VCs are increasingly tightfisted and conservative about life sciences for now, capital markets are tough with predictions it won't get better for some time (see today's IN VIVO blog), and - to round out the trifecta - the sector's maturation translates into increasingly larger burn rates for a higher number of cell therapy companies in later stage trials.

I'm not in the business of spilling confidential information or spreading rumor so any companies mentioned below are used simply by way of example. Don't assume I know something you don't know about any of the companies referenced below.

So what might this potential M&A dustup look like?

It will certainly involve many smaller companies - think Onyvax, KeraCure, Aastrom, Memgen, ReNeuron, HemoGenix, Novocell, Opexa, IRX, BioLife Solutions, BioSafe, Cellerant, Eufets, Progenitor Cell Therapy, Angel Biotech, Epiontis, ISCO, Lifeblood Biological Services, Stem Cell Sciences, Thermogenesis, TiGenix - some of which will look to M&A to solve their fundraising needs and others will be M&A targets because of their revenue stream.

Larger companies are not likely to be immune from this swing of the M&A pendulum - say (for example!) Dendreon, Neurotech or even - might it be possible - Osiris? The newly improved, profitable, and growing Organogenesis might be a target for its revenue and Stem Cells Inc has been none-too-shy about its M&A intentions for some time. It may involve some bigger companies in the sector - say like Genzyme or Caridian BCT (formerly GambroBCT) which we know is almost certainly being positioned for a resale by the private group that bought it to maximize its value for resale.

What is not clear is who might be the buyers. Potential companies that pop to mind include BD , Celgene, and J&J. Might Amgen make a play? What about Shire, Schering, or any of a number of other pharma looking to diversify their sagging pipelines and bolster their lackluster innovation initiatives. There will likely be other players external to the field who use M&A as an entree into the sector - think Reliance Life Sciences

We know Hospira is making a play in the cell therapy space with several investments they won't yet disclose. They hiring key and experienced executives (e.g., K. Gunter from ViaCell some time ago and recent D. Perritt from J&J). It would appear they are positioning to make a significant play in the market and it would not be surprising to see it in the services side of the sector.

It is likely to be an interesting year or two for cell therapy. On the other side of it, the industry will likely look much different, be more robust, held by a much wider diversity of parent companies, investors, and shareholders, and likely somewhat more integrated with other biotech/pharma.

So...make sure your boat is tied up, get a good window seat (if you're a watcher) or a kite sail (if you're want to participate), and let's have fun. Let's make sure smart deals get done that get good technologies in the hands of companies that will make them work - as therapies, as the base of sold companies, and rewarding to investors with the cojones & foresight to put cell therapies in their portfolio.

Drug Companies Ready for Cell Therapies?

Ok I won't title every blog in the form of a questions but this one seems a fitting follow-up to my last blog re: VCs.

Today Pfizer announced an investment in an early-stage (pre-clinical) cell therapy company. Forbes' commetary on the deal begins: "Big drug companies have largely stayed away from testing exotic stem-cell treatments. But now Pfizer is betting that a radical new adult stem-cell treatment may be able to stave off diabetes-induced retina damage, a leading cause of blindness. In an unusual deal, the big drug maker is funding the creation of a biotech company in San Diego called EyeCyte, which will develop stem-cell treatments for eye diseases." (click here for full Forbes article).

The press release states "The financing will fund the company into 2010 [the target date for phase I] and will be primarily used to drive product development of the company’s initial clinical target, diabetic retinopathy."

Friedlander and El-Kalay have a fascinating technology and it looks very promising in mouse models. It is, I believe, now being tested in primates. The approach is unique in that it encourages vascularization in a disease states often marked by overvascularization on the premise (borne out in very nice pre-clinical data) that using a highly purified progenitor cell population isolated from the patient’s own bone marrow using proprietary reagents and processes then injected to support healthy vascularization, prevents ineffective vascular proliferation.

In a conference this spring they also spoke of their efforts in looking at not only their scientific methodology but also already working on scale-up (bioreactor me-thinks?) technologies and closed production systems. This is uncharacteristically forward thinking (and admirable) for a company in early development stage.

There have been some encouraging signs recently regarding Pharma's involvement (or potential involvement) in the field.

As Langreth alludes in the Forbes article, J&J is indeed more involved than any other pharma peer. In fact, by my account they are by far the largest cell therapy company in the world if you add up their diverse projects around the globe. They have wisely diversified their investments to internal and external, therapuetic and tools, early and later-stage companies.

There were some, of late, who even presiently opined (or at least wondered aloud) about Pfizer's potential interest in cell therapy (see fellow-blogger J. Rowley's Dec 2007 post at http://tinyurl.com/3kj93m) given the creation of a new Bioinnovation Center "to focus on discovering and developing new medicines". Then in April Pfizer announced the creation of Pfizer Regenerative Medicine "a new research unit focused on stem cells and modulators of regenerative processes".

For the most part, pharma's interest in the sector to-date has been largely focused on the use of stem cells for discovery or testing. Understandable.

Pfizer's investment is modest: $3 million - with rights of first refusal to buy it outright. Hopefully with Pfizer on the board, the team finds a way to ensure that the fact EyeCyte can now leverage Pfizer's "prowess" is a positive influence on prudent development rather than a drag on momentum.

This is an encouraging notch on the bed post of cell therapy. Particularly autologous cell therapy at a time when many are - rather prematurely in my opinion - writing autologous therapies off in favor of allogeneic models. The venture might be a one-off and it might fail, but to me, this is just another small checkmark in the 'reasons-to-be-positive-about-cell-therapy-going-forward' column.

Stay tuned...