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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
______


In January, the following product was classified as a tissue engineered product - not combined:

• Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions

In April, the following product was classified as a tissue engineered product, combined: 

• Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology

In May, the following product was classified as a somatic cell therapy medicinal product: 

• Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis

In July, the following product was classified as a Tissue Engineered Product, non-combined:

• Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 

In September, the following product was classified as a Tissue Engineered Product, non-combined:

• Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

• Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)

In October, the following product was classified as a somatic cell therapy medicinal product: 

• Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma

In November, the following products were classified as tissue-engineered products:

• Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
• CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI

In December, the following product was classified as somatic cell therapy medicinal product:

• Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.

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INDUSTRY PHASE III or II/III (active or expected to be active in 1H 2012)  

• 52% (12) are autologous
• 33% (7) are allogeneic
• Two are gene-modified allogeneic
• One involves autologous and allogeneic cells

• 24% (5) are for cardiac-related indications
• 33% (7) are for oncology or related indications
• Two are for cartilage repair

• Assistance Publique - Hôpitaux de Paris (France)
• Association of Dutch Burn Centres (Netherlands)
• Barts and The London NHS Trust (UK)
• Erasmus Medical Center (Netherlands)
• European Group for Blood and Marrow Transplantation (Europe)
• Leiden University Medical Center (Netherlands)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Meshalkin Research Institute of Pathology of Circulation (Russia)
• Ministry of Health (Malaysia)
• Royan Institute (Iran)
• Rush University Medical Center, University of Sao Paulo, Uppsala University (US, Brazil, Sweden)
• Third Military Medical University (Chia)
• University of Minnesota, Masonic Cancer Center (US)
• University of Minnesota, Masonic Cancer Center (US)
• University Hospital of North Norway (Norway)
• University of Utah (US)

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Following is a list of cell therapy products approved recently (2010-11):    

•  Dendreon                           Provenge                           US
•  FCB-Pharmicell                 Hearticellgram-AMI           Korea
•  Fibrocell Sciences              Laviv                                  US
•  Living Cell Technologies    DIABECELL                     Russia

 Honorable mention goes to TiGenix' ChondroCelect approved in late 2009 representing the first EMA approval of an ATMP:

• TiGenix                              ChondroCelect                   EU

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When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

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I'm proud to use every available resource at our disposal, including this blog, to highlight the efforts of the charity we support - especially during this holiday season.  


I would be so delighted to have you join me in supporting Sabrina Cohen and her efforts.  You can start by buying next year's calendar!

The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   

--Lee


_________________________________________________________________

On the night of November 12, David Porosoff’s Artrageous Gallery hotspot was converted into something likely never imagined -- a hotbed of stem cell research.  Sabrina Cohen fused the vividly artistic backdrop and venue with gambling, cuban music, great food, and beautiful people all to further her mission of raising money and awareness for stem cell research.

Dr. Sally Temple with Sabrina Cohen

Dubbed the Havana Casino Night, the event had several highlights including the granting of the 2011 Sabrina Cohen Foundation award to stem cell researcher Dr. Sally Temple.  


Representing the 3rd recipient of the annual SCF award, Dr. Sally Temple is studying how neural progenitor cells may be employed to create cell-based therapies for neurodegenerative disorders.  Dr. Temple is the co-Founder and Scientific Director of the Neural Stem Cell Institute located in Rensselaer, NY.  NSCI is the first independent, non-profit stem cell research institute in the USA.


The night, sponsored in part by DMR, Evensky & Katz and Harke Clasby & Bushman, raised $10,000 which will be dedicated toward next year’s SCF Award for Stem Cell Research.  


The event also marked the lauch of the the Foundation’s 2012 CELLebrity Doctors Calendar, this year featuring women in the field of stem cell research.  The calendar features academics, industry executives, physicians, and advocates primarily from the United States but also representing Sweden, Australia and Canadian covergirl, Dr. Fiona Costello.


“In science you don't have to accept anything anyone tells you, you can come up with a hypothesis and test it yourself. And you can be the first one to do it,” says Dr. Costello, whose research focus is on multiple sclerolsis and other impairments of the central nervous system. 


“Stem cell science is often accused of being ‘hyped,” says Cohen, “but that doesn’t necessarily translate into monetary support for or society recognition of the enormous contributions made by stem cell resarchers.  They often toil in anonymity making significant discoveries at great personal sacrifice.  I consider it my job to find a way to financially support their work and bring profile to them as people.”  


The ‘CELLebrity’ Doctors Calendar
The 2012 CELLebrity Doctors calendar is now available for purchase from http://www.CELLebrityDocsCalendar.com.  All proceeds from calendar sales benefit the Sabrina Cohen Foundation for Stem Cell Research, a 501c3 non-profit organization directly funding stem cell clinical research.   


The Sabrina Cohen Foundation
The Sabrina Cohen Foundation for Stem Cell Research (SCF) is an internationally recognized nonprofit organization dedicated to building a global network of top scientists and clinicians in the field of Regenerative Medicine, while simultaneously funding cutting edge research and innovative therapies that will reverse spinal cord injury and effectively treat other impairments of the Central Nervous System.


Sabrina Cohen is the Executive Director and President of the foundation. She graduated from the University of Miami with a degree in Communications, double majoring in Advertising and Psychology, and holds a post-graduate degree in Copywriting from the Miami Ad School.  She is a C5 Quadriplegic, as the result of a spinal cord injury from a car accident in 1992. In 2006, she established SCF to raise funds for research because she believes the field of Regenerative Medicine will lead to the greatest advances of our time. Sabrina is a Motivational Speaker & Spokesperson continuously speaking in schools, universities and community centers. She has spoken at scientific conferences around the country, including the "World Stem Cell Summit" at the University of Wisconsin, Harvard University, Stanford University, Baylor College of Medicine at the University of Texas, and at the United Nations. Sabrina believes her wheelchair is a vehicle to promote change.  


Sabrina Cohen was recognized by WebMD Magazine as a 2009 "American Health Hero”.  Sabrina is currently available for interviews highlighting the 2012 “CELLebrity” Doctors Calendar.

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Below is sample list of companies with cell therapy products* on the market in Europe, USA, or Japan.

Company                                                    Product              
Advanced BioHealing (now part of Shire)       Dermagraft
Aliktra                                                       MySkin
Avita Medical                                             ReCell® Spray-On Skin
Bio-Tissue                                                 Prokera
Bio-Tissue                                                 AmioGraft
BioTissue Technologies                              BioSeed-C
BioTissue Technologies                              chondrotissue
Cytori                                                        Celution System
euroderm                                                   Epidex
euroderm                                                   EpiGraft
Fidia Farmaceuitici                                     Hyalograft 3D
Fidia Farmaceuitici                                     Laserskin
Fidia Farmaceuitici                                     Hyalograft C
J-TEC Epidermis                                       Japan Tissue Engineering Co.
J-TEC Cartilage                                         Japan Tissue Engineering Co.
J-TEC Corneal Epithelium                          Japan Tissue Engineering Co.
Nuvasive                                                    Osteocel Plus
Provenge                                                    Dendreon
Sanofi (previously Genzyme)                       Epicel
Sanofi (previously Genzyme)                       Carticel
TiGenix                                                      ChrondroCelect
Therakos                                                    Therakos Photopheresis

* This list does not purport to be exhaustive of all cell therapy products legally sold in these regions.  This list  does not include approved products in other highly-regulated jurisdictions, such as Australia, New Zealand, or Korea, for example.  This list also excludes those cell-based treatments provided as a hospital or clinic-based service such as stem cell transplantation (hospital) or Regenexx (Regeneration Sciences, Inc.).

For the purposes of this list, “cell therapy” is defined loosely as any product which has in it live cells when administered to the patient including tissue transplants and devices.

Note that some of these products may be subject to emerging regulatory restrictions under the EMA ATMP regulations which may result in them having to be pulled from the market by the end 2012 at the latest.

If you would like to suggest any revisions or additions to this list, please do so in the comment section below.

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Please pardon the crass commercial nature of this post.  I try to keep self-promotion to a minimum here but I'm looking to unload a number of domains I have the related to cell therapy and regenerative medicine and thought this might be the easiest way to get the word out.  Let me know if you are interested in any of the following: 


anticyte.com*
biocellutions.com***
.
cardiacregenerativemedicine.com* 
cardiacregenmed.com* 
cardiactissuerepair.com* 
.
cellexpertsolutions.com**
.
celltherapyalliance.com* 
celltherapyassays.com*** 
celltherapycellutions.com**** 
celltherapycompany.com**** 
celltherapyconsortium.com* 
celltherapydevelopment.com***
celltherapymanufacturing.com**** 
celltherapymarketing.com* 
celltherapypartner.com* 
celltherapypatents.com**** 
celltherapysolution.com*** 
celltherapystrategies.com*** 
celltherapysupport.com* 
celltheraytech.com** 
celltherapytechnologies.com*** 
celltherapyventures.com*** 
celltherapyworks.com***
.
cellutionstrategies.com*** 
.
commerciaizingcelltherapy.com** 
commercialisingcelltherapy.com* 
commercializingcelltherapies.com** 
commercialisingcelltherapies.com* 
.
cordbloodshipper.com*** 
cordbloodshipping.com*** 
.
developingcelltherapies.com* 
.
diagnostacell.com* 
diagnostacells.com* 
diagnosticstemcells.com** 
.
discoverystemcells.com** 
.
expertcellutions.com***
.
integratedcelltherapycellutions.com** 
integratedcelltherapysolutions.com**
.
ipsbiologics.com** 
ipsbiomedical.com**
ipsbioscience.com**
ipsbiosystems.com**
ipsbiotechnologies.com** 
ipslifesciences.com**
.
longtailbiomedical.com***
longtailtherapeutics.com*** 
longtailtherapies.com*** 
.
personalizedcelltherapy.com*** 
.
regenerativecellutions.com*** 
regenerativemedicinepatents.com****
.
stemostics.com** 
stemomics.com** 
stemonics.com*** 
.
stemcellcollect.com*** 
.
strategiccellutions.com** 
strategicell.com*** 
.
thecelltherapycompany.com****
.
totalcelltherapysolution.com***
totalcelltherapysolutions.com*** 


Funky ones: 
 cellenterprise.com* 
 cellsforce.com* 
 cellsinnovations.com* 
 cellsmarket.com* 
 cellspitch.com*
 cellsrep.com* 
 cellstech.com* 
 cellsventure.com*
 iregener8.com** 


I have others - some of which are variations of ones listed above (such as with "the" in front) and would be available - some of which I'm still wanting to hold.
 _____________________________ 


 * ~$1,500 
** ~$5,000 
*** ~$10,000
**** ~$20,000

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As some of you may know, much of my recent social media energy has been spent on LinkedIn rather than blogging. This was not a conscious decision but I will admit to finding the immediacy and interconnectivity of the LinkedIn/Twitter combo to be more seductive of my limited time than the more laborious and seemingly more unidirectional facets of blogging. I'm still working on a return to more diligent and regular blogging - we'll see how that goes.

In any event, today's blog entry is ironically about the very thing which has replaced my blogging in many ways for the interim: the LinkedIn Cell Therapy Industry Group which I founded in July 2008 (about the same time as I launched this blog).

Primarily due to the outstanding participation of great members, the group has turned out to be what I had hoped would be and I believe has become a fairly valuable resource for those in or interested in the cell therapy industry.

The group grew exponentially throughout 2010 and we are proud today to announce our 1,000th member. Without his knowledge, Luc Gervais today became the 1,000th member of the LinkedIn Cell Therapy Industry Group.

Luc Gervais lists himself on LinkedIn as a "Technologist Entrepreneur" but is also a Researcher at IBM Research, Zurich Research Laboratory in addition to being a researcher at the University Hospital Basel.

He was recently involved in the development of IBM's novel, microfluidic "lab on a chip" technology that uses capillary action to create a potential one-step diagnostic tool, and which could ultimately test for a wide range of diseases and viruses. The chip requires only a small drop of blood, which it draws through tiny channels within the device. The blood reacts with different disease markers to provide accurate diagnoses in about 15 minutes.

Luc represents what I believe is one of the most exciting signs of development in and maturation of the cell therapy industry. Luc's career has included being a Game Developer at Unlikely Games, a Computational Chemistry Developer at Boehringer Ingelheim Pharmaceuticals, and a Quality Assurance Specialist at Steltor. On LinkedIn, he lists "regenerative medicine" as one of his interests.

People with the kind of experience Luc possesses are bringing a world of scientific, technical, and commercial expertise to regenerative medicine and cell therapy from outside the sector. This promises to revolutionize the way we think about, develop, and apply our technologies.

Luc and others like him who are exploding into the regenerative medicine and cell therapy field bring with them the potential for interdisciplinary exploration, the opportunity to draw from lessons already learned in other sectors, and the chance to view our field not just in terms of the incredible potential for new therapeutics which cell therapy represents but how that fits into the broader world in which cell therapy is growing up. A world that includes phenomenal advancements in personalized medicine, diagnostics, theranostics, biomarkers, bioinformatics, the ability to access and interpret personal genomics data, etc.

I have yet to speak to Luc (this was all posted from publicly available information) but I'm hoping to bring you an interview of him shortly not because being the 1,000th member of the LinkedIn Cell Therapy Industry Group is deserving of any particular attention (and certainly will not rank in his list of accomplishments I'm sure) but because I'm curious about what Luc represents.

Stay tuned....

--Lee

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Over the past six months I have been honored and pleased to have seen and been part of an increasing focus and attention being paid to the unique manufacturing and bioproduction issues related to cell therapy.

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While the US government prints money to shore up failing and broken business models which no one likes but are considered simply too big (not too important or significant or even useful) to fail, Google is making money and investing it in start ups who expect nothing less than to create "disruptive, even world-changing technologies".

No suggestion here that GOOG is being altruistic, just that this is the way the new entrepreneur and investor class thinks. Opportunity and money are to be found in technologies that improve the way we live, work, play, eat, and think... and perhaps even improve the world.

To Google Ventures this has already meant wind farms, carbon emission reduction systems, green vehicles, and medical cures. To former Microsoft chief scientist Nathan Myhrvold and his high-level think tank, Intellectual Ventures, this means creating TerraPower - a company intending to revolutionize the nuclear power by developing reactors run on waste uranium - and also actively looking at regenerative medicine technologies.

Having formed the fund a little over a year ago, Google is only now starting to make a splash with the fund. Officially the fund has no specific industry focus saying on the Google Ventures website FAQ:

We are interested in a wide range of industries, including (but not limited to) consumer Internet, software, hardware, clean-tech, biotech, health care and others. First and foremost, we're looking for entrepreneurs who are tackling problems in creative and innovative ways, with the potential for significant financial return.

Unofficially and yet not so quietly, Google has named a few broad areas of interest. An article in Monday's New York Times quoted Google Ventures' managing partner, Bill Maris as saying that while they were not going to name particular investment themes, a few broad ares of interest include:

regenerative medicine, bioinformatics, cloud storage, companies that use large data sets, online monetization and mobile.

There it is. Regenerative medicine right there front and center.

In typical Google tradition, Maris, who looks all of 30 years old on the website, has a successfull and multidisciplinary track record. He was involved in founding Web hosting pioneer Burlee.com (now part of Web.com), where he built much of the key computing, network and technological infrastructure.Prior to that, Bill was a biotechnology and healthcare portfolio manager for Stockholm, Sweden-based Investor AB. Bill’s background also includes research at the Duke University Medical Center, Department of Neurobiology.

Google Ventures is said to be aiming at investing about $100 million a year. Any portion of that for regenerative medicine is more than welcome.

While traditional VC money remains reticent to back RM in any signifant way, Google's move confirms a trend we've been seeing and talking about at the Cell Therapy Group for the past 12 months or so. The multinational lifescience, biopharmaceutical, and healthcare companies along with strategic investors all now have regenerative medicine on their radar. They are all quietly and not-so quietly developing internal and external regenerative medicine strategies.

Please join us in welcoming regenerative medicine to the radar screen. It's bound to be an exciting ride ahead.

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Stewart Lyman of Lyman BioPharma Consulting posted a great article in today's Xconomy summarizing some key points and links to more information about the rules governing the Therapeutic Discovery Project Credit which have now been released by the US Treasury Department. Today, a detailed fact sheet was released about the tax credit program and it seems almost perfectly designed for most cell therapy companies.

Lyman points out a few important details about the application schedule including:

1. The Formal IRS applications (Form 8942) will not be available until June 21st or thereabouts.

2. The application period opens on June 21 and ends on July 21. The postmark on the application is deemed to be the date of delivery. Preliminary review of the applications is to be completed by Sept. 30; this is to ensure that applicants are eligible taxpayers and that their applications are complete. Applicants will receive determinations as to whether or not they qualify for credits and/or grants, and how much they will receive, by Oct. 29.

By way of a little more background, the following is excerpted from a March Forbes.com article by Dean Zerbe:

What does the credit cover?

The credit/grant covers research in tax years beginning in 2009 and 2010. The taxpayer is provided a 50% credit/grant for qualified investments in "qualifying therapeutic discovery projects." What expenses count as qualified investments? The aggregate amount of costs paid or incurred in the taxable year for expenses necessary for and directly related to the conduct of a qualifying discovery project. What doesn't count? The pay of employees covered by 162(m)(3) of the tax code--think CEOs--doesn't count. Other excluded items: interest expenses; facility maintenance expenses (e.g. mortgage or rent payments, insurance, utility and maintenance and costs of employment of maintenance personnel); and certain indirect costs (basically general and administrative costs) as defined in the Treasury Regulations at 1.263A-1(e)(4).

What is a qualifying therapeutic discovery project?

According to the legislation, it's a project designed to do one of three things:

--Treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials and clinical studies, or carrying out research protocols for the purpose of securing federal government approval by the FDA.

--Diagnose diseases or conditions or to determine molecular factors related to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions.

--Develop a product, process or technology to further the delivery or administration of therapeutics.

Finally, to qualify, a venture may not have more than 250 employees in all businesses of the taxpayer--meaning a small biotech project at a big company wouldn't qualify.

Which biotech companies might benefit?

Those that are investing significant resources in pre-clinical or clinical studies, which may take years to come to fruition to ultimately satisfy FDA requirements, could now recoup a significant portion of their expenses. Additionally, biotech start-ups focusing on the development of diagnostic assays or applications to advance therapeutics and treatments can also benefit. Finally, companies currently engaged in basic or applied research which may ultimately contribute to curing caner within the next 30 years may also be excellent candidates. Along these lines, companies studying signal transduction pathways, gene therapy and stem cell research seem like prime candidates.

The Cell Therapy Group will be collecting more information about the tax credit and service providers who might be recommended to assist in the application if needed. Contact CTG for more details or watch here for more information.

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