The ROI on pant-wearing and other social media tips

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With many things in life, there is a payoff for doing them.  Do the dishes and the kitchen is cleaner, your household is more functional, and hopefully one or more family members notice and appreciate you for it.



For other things, however,  the people around you have such high expectations you’ll do them that you only lose points if you don’t but gain very little if you do.  For you, this may be true of the dishes.  Certainly I’ve always maintained this is true for Valentine’s Day.  Get flowers and you simply maintain the relationship’s status quo; fail to do anything and you lose big points fast.  


Similarly, at some point certain things become so ubiquitous that they are expected as a baseline.  This is true of putting on your pants.

The global head of social media for Ford Motor Company, Scott Monty, once asked, “What’s the ROI* of putting your pants on in the morning?“.   The truth is that there is very little benefit to putting on your pants other than to avoid the significant cost of not doing so.

Certainly this is true now of having a website or an email address for your company.  Unlike a couple decades ago, no company gets kudos for having a website or email addresses but it would certainly raise eyebrows of criticism if your company failed to have them.

Arguably social media participation is not quite there yet but it is, I submit, fast approaching.  Someday in the not-too-distant future you will receive the cringe of shame if your company is not active in the leading social media platforms of the day.  Today – for companies – these are LinkedIn, Twitter, and Facebook.  This will be true irrespective of whether yours is a B2B or B2C company.
Recently I was invited to write an article for Future Medicine’s special issue for the World Stem Cell Report.  I was asked to make the case for why and how participating in social media stood to benefit the scientists, companies, executives, employees, academics, activists, and other stakeholders in the cell therapy industry.  

The result is “Why the stem cell sector must engage with social media“.  What I attempted to succinctly outline are the ways social media primarily benefit one’s career and organization or company.


“I can tell you without the slightest hesitation of conviction – having experienced it myself and seen it repeated countless times – is that active and successful social media engagement translates into:
  • Unparalleled learning: accessing more information relevant to your discipline, specialty and company than you otherwise will. 
  • Enhanced profile: higher profile within your industry, profession, specialty and community. Social media is not the only way to build a profile but it can be very effective.
  • Wider network: more touch points and meaningful relationships with people than you otherwise will accomplish by any other means combined.”
The measurable impacts and benefits are real and certainly include:
  • Traffic: “For companies, increased traffic equals increased opportunity to call readers/viewers to your intended action – interaction, citation, linking, investing, buying or engaging in some other action you solicit. For individual professionals, increased viewers translate into more chances for collaboration, citation, engagement, etc.”
  • Collaboration: “There is an intrinsic correlation between one’s profile and the opportunities one has for collaboration. For companies this means finding the right partnerships, joint ventures, strategic alliances, collaborators, employees, management and so on. For individual professionals, this means more and/or better quality invites to speak, write or collaborate in other ways. It also means finding quality grad students, faculty, employees and interns
  • Revenue/Income: This is about translating a broader knowledge base and a wider network over which you have some level of influence (if only just that they are listening) into more money for your company, organization and yourself. For companies, this means finding the right partners, investors, customers and so on. For organizations this means finding the right donors, impressing the right grant reviewers and/or recruiting the right rain-maker faculty. For individual professionals this translates into promotions or job offers.”

As I conclude my article I will conclude here:

    “In order to create the kinds of perceptions and solicit the kinds of actions we want from the world around us, we must engage the world around us. The world around us is engaging online. 

    For all kinds of selfish and selfless reasons you, your company or organization and your career will benefit from you engaging there too.”

    and this prediction:

    “…in less than the blink it took for the commercial world to accept websites and email, it will seem similarly ridiculous for professionals, academics and companies to operate and succeed without actively using social media.”

    ____________


    If this topic is of interest to you, here are some great resources particularly focused on the value of social media to those in life sciences.


    Canaday, M. Is Life Science Social Media Worth It Yet? Three Tenets Behind Its Relevance To Your Business. Comprendia. 6 December 2012. 


    Bersenev A. Scientific blogging as a model for professional networking online. Cellular Therapy and Transplantation. 2010;2(7). 10.3205/ctt-2010-en-000084.01. 


    Bersenev, A. Scientific blogging as a model for professional networking online. 4 August 2010. StemCellAssays.com 


    Bersenev, A. Who’s Who in the Stem Cell Blogosophere.  27 June 2011. StemCellAssays.com 


    Bishop, D.  How to bury your academic writing. Bishop’s Blog. 26 August 2012. 



    Buckler, L. If You’re Breathing, You’re in PR. Cell Therapy Blog. 11 June 2010.  

    Buckler, L. Don’t feel the pain of ignoring social media? Just wait a minute…. CellTherapyBlog.com 22 October 2008.    

    Jewell, T. Survey: How our scientists use social media. AZHealthConnections.com. 12 February 2012. 


    Knoepfer, P. Top ten tips for blogging for scientists. 2 August 2012. IPScell.com   


    Shipman, M. Why Scientists Should Publicize Their Findings – for Purely Selfish Reasons. Scientific America. Blog. 18 June 2012. 
         
    Shipman, M. A gentle introduction to Twitter for the apprehensive academic. Scientific America. Blog.  14 June 2011.  


    Small, G. Time to Tweet. Nature 2011. 479 141 2 November 2011 


    Wilcox, C. Social Media for Scientists Part 1: It’s Our Job. Scientific American Blog. 27 September 2011.  


    Wilcox, C. Social Media for Scientists Part 2: You Do Have time. Scientific American Blog. 29 September 2011.  


    Wilcox, C. Social Media for Scientists Part 3: Win-Win. Scientific American Blog. 10 October 2011.  

    Wilcox, C. Guest Editorial: It’s time to e-Volve. Taking Responsibility for Science Communication in a Digital Age. Biol Bull. 22285-87. (April 2012)  

    The Rules of Social Media.  Fast Company.  8 August 2012. 


    Source:
    http://feedproxy.google.com/~r/CellTherapyBlog/~3/k7ANTnLXNjc/the-roi-on-pant-wearing-and-other.html

    Source:
    http://www.longevitymedicine.tv/the-roi-on-pant-wearing-and-other-social-media-tips/

    Commercialization of Regenerative Medicine: Learning from Spin-Outs

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    The meeting “Commercialization of Your Regenerative Medicine Research: Lessons from Spin Out Successes” was hosted by the Oxbridge Biotech Roundtable (OBR) (Oxford, UK) at the University of Oxford in February, 2013, and attracted a multi-stakeholder audience spanning academia and industry. 


    The event featured case studies from Gregg Sando, CEO, Cell Medica (London, UK), John Sinden, CSO, Reneuron (Guilford, UK), and Paul Kemp, CEO and CSO, Intercytex (Manchester, UK). 


    OBR is a student-led initiative with over 7000 members across eight different UK and US locations with a mission to foster a conversation about the healthcare and life sciences industry. 


    Anna French and David A. Brindley, along with some of my assistance, captured and have now published the main themes of the meeting and the major questions facing the regenerative medicine industry and its rapidly emerging subsets of cellular and gene therapies. 


    Notably, we discuss the compatibility of regenerative therapies to the existing healthcare infrastructure, biomanufacturing challenges (including scalability and comparability), and the amenability of regenerative therapies to existing reimbursement and investment models. Furthermore, we reiterate key words of advice from seasoned industry leaders intended to accelerate the translation path from lab bench to the marketplace.


    To read the review see: Commercialization of Regenerative Medicine: Learning from Spin-Outs


    Anna French, R. Lee Buckler, and David A. Brindley. Rejuvenation Research. April 2013, 16(2): 164-170. doi:10.1089/rej.2013.1423.

    Source:
    http://feedproxy.google.com/~r/CellTherapyBlog/~3/4Uv2o54_hWQ/commercialization-of-regenerative.html

    Source:
    http://www.longevitymedicine.tv/commercialization-of-regenerative-medicine-learning-from-spin-outs/

    A proposed 6-step platform for the cell therapy industry to consider in combating non-compliant cell therapy treatments

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    Further to my recent post, “Six steps to fighting non-compliant cell therapy treatments. The stuff of grey shades, spades, ivory towers and (ahem) balls.“, I have crafted a 6-point platform that I propose to submit (with potential edits based on preliminary feedback) to several of the leading  industry and professional organizations for their consideration including ARM, ISCT, ISSCR, FACT, AABB  ICMS, and perhaps, in due course, to patient groups, physician groups, disease-specific professional organizations (e.g, cardiology, oncology, neurology, cosmetic, etc).



    I welcome comments and feedback. 


    1. In addition to helping patients distinguish between compliant and non-compliant treatments (and providers) we must do more to help patients distinguish between non-compliant cell therapy treatments (and providers) which are more or less risky. 


    2. Whatever we do in response to this issue should be done with an eye to being practical and helpful to patients in the real-life context of their decision about whether or not to buy a non-complaint cell therapy.


    3. Our response to this issue should be based on a risk-based approach recognizing that not all non-compliance is created equal.  We should create a framework for risk-based analysis (both for us and our audiences) and focus initiatives around those which present the highest risk.


    4. We recognize the problem of non-compliant cell therapies is not just a problem that exists in jurisdictions with little, no, or poor regulation but that is a growing problem even in the most highly regulated jurisdictions meaning the solution cannot be regulated it depends on education and enforcement.


    5. We recognize regulatory agencies cannot enforce non-compliance on their own.  We as an industry need to complement their efforts through our own standards and enforcement.


    6. Stakeholder groups should support the formation of a multi-organizational  initiative to, based on a risk-based assessment, spotlight the categories or signs of highest-risk offenders for use by patients and/or their physicians in identifying  whether or not treatments (and providers) they may be considering fall into the that category associated with the highest level of risk.


    What do you think?

    Source:
    http://feedproxy.google.com/~r/CellTherapyBlog/~3/wkSMxAV9938/a-proposed-6-step-platform-for-cell.html

    Source:
    http://www.longevitymedicine.tv/a-proposed-6-step-platform-for-the-cell-therapy-industry-to-consider-in-combating-non-compliant-cell-therapy-treatments/

    FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)

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    As followers of this blog will know I've been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

    I've watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

    Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

    Consequently I read with interest yesterday's federal court ruling upholding the FDA's injunction against RSI and the immediate commentary from the New Scientist, Stanford's Scope Blog and Knopfler's multiple posts (here and here). As a long-term follower of this case, I've been asked to comment.  Here is my brief reaction:

    This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA's favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

    This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government's motion for summary judgement.  In granting the injunction the court  agreed with the government's position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

    The court chose, in its wisdom, not to address the bulk of the RSI's legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

    In my opinion, other than chalking one up in the government's win column there is little to be gleaned from this ruling in terms of how RSI's arguments will be received in appellate court.  The interesting day is yet to come.

    In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

    Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


     For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


    In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they've recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

    In my opinion yesterday's ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I'm not sure it's the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

    Just my two cents....

    --Lee

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    Another > $100M month for companies in the cell therapy space

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    Last month we reported here on this blog that March was more than a $100M month for companies in the stem cell and cell-based regenerative medicine space in terms of monies raised.  

    What we missed was a $15M grant from Cancer Prevention and Research Institute of Texas (CPRIT) for UK-based CellMedica.  This pumps last month's total to just under $140M.

    This month, according to our sources, betters even March's better numbers by coming in at just over $170M though that is largely on the back of one large deal in Asia.  Here's how the numbers break down.

    Allocure kicked off the month with a decent $25M Series B round from new syndicate member Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S.  Allocure is headed into phase 2 for acute kidney injury with an allogeneic mesenchymal stem cell therapeutic they currently call AC607.  


    Little-known Canadian-based, Sernova then announced a $3.6M PIPE to fund continued development of its proprietary Cell Pouch System(TM), and, in particular, to fund the upcoming first-in-man clinical trial for patients with diabetes receiving an islet transplant.  The application to proceed with this trial is currently under review by Health Canada.


    Next up was NeoStem closing a $6.8M public offering for "expanding" their contract manufacturing business, Progenitor Cell Therapy, and "enrolling the PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack".  


    The biggest deal of the month was a $65M convertible debt financing of China Cord Blood by none other than global powerhouse Kohlberg Kravis Roberts (KKR) through it KKR China Growth Fund L.P., a China-focused investment fund managed by KKR.  We believe this is deal is certainly an investment in the future of China's healthcare market potential but that it is bigger than that.  We believe a significant driver for this deal may likely have been the opportunity to consolidate this sector globally - to use a significant operation and 'war chest' to fund mergers and acquisitions on both the public and private cord blood banking sector worldwide.


    The only classic first-round venture raise this month was a milestone-based $5M Series A by Bay City Capital into Phil Coelho's new company, SynGen, to fund his latest iteration of stem cell processing devices.


    Forbion Capital then announced that it was leading a series D round, joined by fellow existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group, and Aurora Funds, of $25M into Argos Therapeutics in order to kick them into their phase 3.  The hope here is that with some early phase 3 data they may be able to attract the elusive partner they couldn't land with a mere bucket of phase 2 data.


    Innovacell landed the only European deal by announcing an 8.3M Euro (~$11M) investment by Buschier, Fides, HYBAG, and Uni Venture.  This will be used for the continued clinical development of its cell-therapy (ICES13) for the treatment of stress-urinary incontinence currently in a ph 3 study in several European countries.


    ReNeuron announced a private placement also open to existing shareholders that brought in just under $10M (£6.1M) to support their phase 1 trial in stroke and other pre-clinical, clinical, and regulatory milestones. 


    Finally, the Bio-Matrix Scientific Group, in an apparent ongoing quest to continuously reinvent itself, announced at month's end that they had formed a new subsidiary named Regen BioPharma and that they had raised $20M in a financing commitment from Southridge Partners II to purchase its common stock as required over the term of the agreement at a price set by an agreed formula.  This money is said to be dedicated to the acquisition of discovery-stage intellectual property and driving it through to phase 2 trials in an exercise of maximum value creation over a period they claim to be as short as 18-24 months.


    ..


    So in the end, the month saw companies in the space raise just over $170M and even if you back out the stem cell banking deal its still over $100M for cell therapy companies.  


    Over the 2 months, then, we've seen just over $311M raised through a variety of means by companies at every stage of maturity and for intended purposes ranging from acquisition, consolidation, early stage clinical development, and phase 3 testing.


    --Lee


    p.s. If you are aware of other deals in the sector this month, let us know and we'll update this accordingly.


    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing

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    A short and sweet note to point you to a great article on bioreactor technologies related to cell therapy bioprocessing by CTG consultant and Director of Stem Cell-based Drug Discovery, John E. Hambor, who you can now follow on Twitter @StemCellonDrugs.


    "Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing" was published in the June issue of BioProcess International.  


    The BPI team has made a real and meaningful commitment to representing cell therapy bioprocessing and we applaud them for their contribution to this emerging discipline.




    If this is a topic of interest to you, I recommend you also check out a conference being held this Fall by BPI's sister company, IBC LifeSciences, entitled "Cell Therapy BioProcessing" to be held September 11-12 in Arlington, Virginia.





    Source:
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    Inactive and recently failed or terminated phase III or II/III cell therapy trials

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    In the two previous posts I have outlined what I believe to be the active phase III and II/III cell therapy trials, as well as the cell therapy products to have 'recently' obtained formal regulatory market approval in some jurisdiction.


    In the course of doing that work, I came across the following industry-sponsored phase III cell therapy trials which appear to be inactive and those which failed or were terminated.


    INACTIVE INDUSTRY PHASE III    

    •     Aastrom              BRCs
    •     Aldagen              ALD-101
    •     Arblast               AMT-301
    •     Avax                  Mvax
    •     HepaLife Tech      HepaMate
    •     KeraCure             KeraPac
    •     t2cure                BMCs
    •     TVAX                 TV-Brain
    •     TVAX                 TV-Kidney-1

       
    RECENTLY FAILED /TERMINATED INDUSTRY PHASE III   

    •     ABH (now Shire)        Dermgraft
    •     Cellerix                    Cx401

    I don't imagine this is an exhaustive list but as I have encouraged in previous posts, I welcome feedback as to errors, corrections, or omissions.   I'm using the 2009-11 time-frame here.  I'll update the post accordingly.

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    2011 EMA Committee for Advanced Therapies (CAT) classification record. What can be learned?

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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.

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Recently approved cell therapy products

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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

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Active phase III or II/III cell therapy trials

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    I know that the moment I publish anything that purports to be comprehensive there will be errors and omissions.  At the very least it will almost imminently be out-of-date in a fast-moving sector like cell therapy.
    Nonetheless, because there is no other reliable repository of this information, I am daring to put this out there and hope you will feel obligated to assist me in ensuring its accuracy rather than critical of the effort.
    What follows is what I currently believe to an current and relatively comprehensive list of phase III or II/III cell therapy trials around the world.  I am more confident of the industry list than the academic one.  More confident of its completeness and accuracy for North American and Europe than of Asia (particularly China). 
    There is a spreadsheet behind this that includes more data fields like therapeutic category, cell/tissue source, cell type, expansion, indication, expected completion date, clinical trial site locations, etc.  If you want a copy of it, just email me (I'm not hard to find) or comment below.

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

           
        Aastrom                         Ixmyelocel-T
        Baxter                            ACT34-CMI
        Bioheart                         Myocell
        Cardio3 Biosciences         C-CURE
        Cardio3 Biosciences         C-CURE
        Cell Medica                     adoptive cellular therapy
        Cook Myosite                  AMDC
        Cytori                            ADRCs
        GamidaCell - Teva           StemEx
        Genzyme                        MACI
        Harvest Technologies       SmartPReP 2 BMAC
        Innovaell                        IES13 (Urocell?)
        Kiaidis Pharma                ATIR
        Miltenyi                         CliniMACS CD34 Selection System
        Medipost                       Cartistem
        MolMed                         TK
        Newlink Genetics            HyperAcute Pancreas
        NovaRx                         Lucanix
        Osiris                           Prochymal
        Osiris                           Prochymal
        Pervasis                        Vasugel
    The 21 active or imminently active cell therapy industry-sponsored trials listed above break down as follows:
      • 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

     
    * ACADEMIC PHASE III or II/III
    • 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)
    * Active trials only - excludes trials which appear inactive, abandoned, and/or are stem cell transplant in oncology.  Primary source is CinicalTrials.gov.
    ___________________________________
    I will try to keep this list updated at least once-per-quarter and indicate the date of the last update at the top of the post.
    I eagerly encourage all readers to comment below or email direct with any errors and/or omissions.

    Source:
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    Commercializing Cell-based Regenerative Medicines

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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.

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Sabrina Cohen Foundation Thanks Stem Cell Researchers

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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.



    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Cell Therapy & Regenerative Medicine Domains Available

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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

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    Commercial-stage Cell Therapy Companies and Products

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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.

    Source:
    http://feeds.feedburner.com/CellTherapyBlog

    FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

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    For those of you who follow this blog, you'll imagine my surprise to wake up the morning to the following announcement from the FDA:
    _____________________________________________________________
    FDA NEWS RELEASE
    For Immediate Release: August 6, 2010
    Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
    Consumer Inquiries: 888-INFO-FDA
    FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
    Violations of current good manufacturing practice and labeling requirements cited
    The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
    The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
    Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
    “FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
    The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
    Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
    The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.

    The LinkedIn Cell Therapy Industry Group – 1,000 members strong

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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

    Cell Therapies: Commercializing a New Class of Biopharmaceuticals

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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.


    Certainly it is the Cell Therapy Group's view, that this is both timely and much-needed as more cell therapies reach later-stage. Issues related to larger scale production and lowering the costs associated with it will be critical to successful commercialization of these products. It is encouraging to see both content-providers and and companies involved in potentially bringing solutions to these issues now bringing their focused energies to this sector.

    This focus has come from a number of different sources including conferences focused solely on the topic, companies engaging stakeholders in identifying potential bottlenecks they might be positioned to solve, more conference sessions dedicated to these issues, and now a commitment by one of the leading publications in bioprocessing to engage both the cell therapy industry and the traditional bioprocessing community in stepping up the level of two-way education, dialog, and problem-solving that will be critical to commercializing these products.

    In March/April 2011, watch for a special issue of BioProcess International entitled "Cell Therapies: Commercializing a New Class of Biopharmaceuticals".

    BioProcess International is a publishing leader of cutting edge technologies, improved processes and breakthrough sciences. With this cell therapy focused issue, in partnership with ISCT and others, BPI is launching what we hope will be a regular supplement and increased focus on the unique bioproduction issues related to cell-based therapies.

    BioProcess International aims to accomplish three main objectives with this supplement:
    • Educate the bioprocess and cell therapy market (suppliers and end-users) on the similarities and differences between the two processes;
    • Educate and encourage the investor community to keep increasing their interest and investment;
    • Expedite the commercialization process.

    Distribution will include:

    • BPI's 30,010 qualified readers;
    • Delegates attending ISCT's 2011 Annual Meeting (included in all delegate bags)
    • Delegates attending ESACT 2011 (Chair drop at the Cell Therapy Plenary Session)
    • INTERPHEX 2011 Cell Therapy Roundtable (VIP Invitations, 200 attendees, produced by BPI)
    • BIO 2011 International Convention (BioProcess Theatre - Cell Therapy track)

    If you are interested in advertising, click here for more info.

    While the content for this issue is now being finalized, it you are interested in contributing something to BPI, we are looking for more cell therapy related content. As the cell therapy representative on BPI's advisory board I would be happy to champion it through submission.

    Cheers.

    --Lee

    Google to Invest in Regenerative Medicine

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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.

    Biotech tax credit appears perfectly designed for cell therapy companies to recoup research dollars spent in 2009-10

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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.