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Category Archives: Regenerative Medicine

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/

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2013 Annual Regenerative Medicine Industry Report

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The Alliance for Regenerative Medicine announced today the release of the 2013 annual regenerative medicine industry report.  Here is the announcement in the Wall Street Journal online.

I'm proud to have been a part of putting it together and hope people find it useful.  It is available for download on the ARM website here.  


In addition to the complete download, ARM will make many of the figures, charts,  tables and sections available for members to download and use in their own publications and presentations. Watch for these resources to be announced soon.


























Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/yFBYKblnudk/2013-annual-regenerative-medicine.html

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Cell Therapy Blog welcomes 2013


Happy new year to all our readers.  We look forward to our interactions throughout 2013. This month watch for:
We look forward to seeing you on the 2013 conference circuit.  For a complete and current list of 2013 cell therapy industry conferences, click here.

We will be in San Francisco next week during EBD Biotech Showcase and JP Morgan as well as at the Phacilitate Cell and Gene Therapy Forum in Washington, DC at the end of the month.

As always we welcome your comments, feedback, criticisms, and questions.

Thank you for all for everything to contributed to and did to support this blog and our efforts this past year.  Let's have a great 2013!


p.s.  Don't forget to follow Cell Therapy Blog on Twitter @celltherapyblog 

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/ABphTtPOrwo/cell-therapy-blog-welcomes-2013.html

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The Accuracy of Adipose Stem Cell Doses

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In August we published a blog post, "Are some cell counts too good to be true? Why some companies' product data may mislead", pointing people to a white paper released by INCELL Corporation.  That white paper appears now to have been pulled from their website (we are working to get a copy to make available again) but now they have published a paper providing more detailed data on aspects of their comparative cell count study.


The paper is introduced by the following abstract:

"Cell therapy products derived from adipose tissue have some unique processing issues with regard to obtaining accurate cell counts. This is because processing methods may not only show us the nucleated stromal vascular fraction (SVF) cells but also the micellular and microvesicle particles. This is true for both veterinary and human clinical products, and poses special concerns for in-clinic processing where the cell therapy dose is correlated with cell numbers and other QC data is not especially useful.

In this study, multiple cell counting methods were compared for SVF cell reparation that were derived from canine adipose tissue using commercially-available rocessing kits. The data clearly showed that many non-nucleated particles appear cell-like by size and shape, and can lead to counting errors with automated counters. In addition, certain reagents important to processing can have properties wherein the reagents alone (e.g., lecithin) may be counted as cells. The most accurate cell numbers were from hemocytometer-counting of cells stained with 4´,6-diamidino-2-phenylindole (DAPI) which shows the nuclei in concert with a viability stain such as trypan blue. The data clearly showed that care must be taken when counting cells used as a therapeutic dose."

This is an important issue particularly as it pertains to autologous cell-based treatments produced by point-of-care devices and/or kits.  I encourage you to read the paper.   

Morrison DG, Hunt DA, Garza I, Johnson RA, Moyer MP*. Counting and Processing Methods Impact Accuracy of Adipose Stem Cell DosesBioProcess J, 2012; 11(4): 4-17.

* Dr. Moyer is CEO and Chief Science Officer for INCELL Corporation, 12734 Cimarron Path, San Antonio, Texas 78249 USA. http://www.incell.com

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/z30UCNTkzIQ/the-accuracy-of-adipose-stem-cell-doses.html

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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, FACTAABB  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/

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The ROI on pant-wearing and other social media tips

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/IncomeThis 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/

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