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.

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.

2012 Financing Recap: Cell Therapy and Cell-Based Regenerative Medicine Companies

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In October we posted a teaser saying that we had at that time tracked the infusion of over $1 billion dollars into cell therapy and cell-based regenerative medicine companies in 2012.  We promised details.  Here they are:

For the first half of the year, see our post "Monthly recap of funds raised by cell therapy & regenerative medicine companies" dated July 31 and updated August 8.

Since that post, we back-filled the following deals which we missed earlier:

• In February, Stemgent raised $6.3M from eight private investors
• In April, BioRestorative Therapies raised $2.1M from undisclosed private parties
• In July, Immusoft received a $300,000 grant from NIH-SITR.

August saw the following financings:

• Cell Cure Neurosciences was awarded $1.3M from Israel's Office of the Chief Scientist
• Stemgent collected another $11.3M from eight private backers
• Neuralstem brought in $2.76M in a public offering
• Fate Therapeutics received $9.2M from undisclosed investors

September was a busy month with the following deals and grants:

• Cellerant benefits from a further BARDA grant tranche with the potential to hit upwards of $36.4M
• StemCells Inc saw the second of its CIRM-funded boats come in to the tune of $20M
• Argos Therapeutics collected $16M from 24 different unnamed investors
• Neuralstem succeeded in bringing in another $7M in a direct public offering
• Pluristem rode its well-orchestrated fame to a $34M underwritten public offering
• Advanced Cell Technology brought in $35M via ATM
• Cellerant collected $2.09M from private investors
• Cytori was awarded a BARDA grant with potential to hit up to $106M
• Vital Therapies closed the first $16M from a multistage commitment to invest $76M by existing private investors. The investment is intended to fund three  Phase III trials of the company’s bioartificial liver therapy, ELAD, for two types of acute liver failure. One trial in the US (not yet recruiting) in acute alcoholic hepatitis involving 200 patients; the other two trial in EU and Australia/New Zealand for acute alcoholic hepatitis patients who fail steroid therapy and in subjects with fulminant hepatic failure
• Avita Media rounded out the month with a modest $880,000 grant from AFIRM

So after seeing $172M come into the sector in Quarter One and $252M in Quarter Two, the Third Quarter saw companies in the sector glean commitments of up to $408M from various sources. 

The Fourth Quarter saw $288M infused into the sector broken down as follows:

    October

• Capricor gleaned a $19.8M from CIRM
• China Cord Blood Corp secrured $50M in a convertible note financing from Golden Meditech Holding Limited
• Cellerant kept the grant machine rolling with a $1.7M phase 1 SBIR grant from NCI
• Tengion secured $15M in senior secured convertible notes from Celgene Corporation, RA Capital Management,  Deerfield Management Company, Bay City Capital and HealthCap
• Viacyte saw a $10M grant from CIRM
• Massachusetts-based Bluebird Bio finagled $9.36M from California's CIRM
• Fibrocell Sciences did a $45M PIPE
• Avita Medical gleaned $10M from a secondary public offering

    November

• Athersys closed a $23M secondary offering priced at $1.00
• Tissue Regeneration Therapeutics eked out a $100,000 grant from Ontario Genomics Intitute
• Quy Biosciences (formerly MedCell) raised $2.7M in a private placement
• Kiadis Pharma managed a $12.8M financing round lead by LSP (Life Sciences Partners) and supported by a large investment from DFJ-Esprit. Other investors included Alta Partners, Quest for Growth and NOM.  The round will be used to do a late-stage phase 2 trial which they hope will position them for a solid pivotal with partner, Hospira.
• NeoStem received a $1.2M grant from NIH
• French biotech, TxCell raised €12.4M from existing shareholders to support an internationa ph 2b trial of Ovasave for the treatment of Crohn’s disease in patients who are refractory to current treatments.
• In a Biotech Showcase presentation, Adaptimmune COO reported they were given 9.6M British Pounds by 'high-net-worth investors' in November to move forward their clinical pipeline

    December

• Northwest Biotherapeutics brought in $13.8M in a secondary public offering
• Organovo secured $7.7M in a tender offer to warrant holders
• Cytori closed a $23M secondary public offering (including the shoe)

Unfortunately neither Cell Therapy Group, nor any of our industry organizations, have any comprehensive financing data from year's past to know for certain whether broaching this $1,000,000,000 threshold is indeed a first-ever accomplishment.  We tracked $390M of investment into the sector in 2008 and then did not track this data for 2009-11 inclusive.

Based on everything we know, we believe this is almost certainly the first time the sector has raised over one billion dollars. 

Hope that helps.

--Lee

2013 Biotech Showcase Cell Therapy and Regenerative Medicine Presentations #BTS13

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While the Alliance of Regenerative Medicine has published a list of presentations by its members, this is not inclusive of all sector-related presentations so we've made our own list.  In case it is useful, here is our schedule of the 2013 EBD Biotech Showcase cell therapy and regenerative medicine presentations.

Downloadable versions:
    http://bit.ly/Z4sYeO (Excel)    http://bit.ly/VIVW2s (PDF)

Text version:

Monday, January 7, 2013
  Room Hearst - Track A
  10:00  Adaptimmune

  Mission Room II - Track C
  09:30  International Stem Cell

  Powell Room - Track D
  09:00  Cryoport

Tuesday, January 8, 2013
  Hearst Room - Track A
  15:00  TissueGene

  Mission I Room - Track B
  09:15  DC Prime
  10:00  MaxCyte
  10:15  Capricor
  10:30  Juventas Therapeutics
  11:00  PharmaCell
  11:15  DiscGenics
  11:30  SanBio
  11:45  Histogenics
  13:45  RhinoCyte

  Mission Room II – Track C
  10:00  Avita Medical 
  16:30  ViaCyte

  Powell Room - Track D
  10:00  Advanced Cell Technology
  10:30  ReNeuron Group
  11:00  Q Therapeutics
  11:30  Cytori Therapeutics
  13:45  Organovo
  14:15  Shire Regenerative Medicine
  14:45  Tigenix
  15:15  Athersys, Inc.
  15:45  Neuralstem
  16:15  Amorcyte

Wednesday, January 9, 2013
  Hearst Room - Track A
  10:30  TVAX Biomedical
  15:45  Aderans Research

  Mission Room I - Track B
  15:00  America Stem Cell
  15:15  Auxocell Laboratories

  Powell Room - Track D
  10:30  InVivo Therapeutics
  16:15  Medistem

I hope to see you there.

--Lee

Cell Therapy Blog welcomes 2013

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Happy new year to all our readers.  We look forward to our interactions throughout 2013. This month watch for:

• a post summarizing some of the things we think are watch-worthy in the cell therapy industry in 2013, 
• our recap of the money cell therapy and cell-based regenerative medicine companies raised in 2012, and
• us to formalize our position statement on non-compliant cell therapies as discussed in following previous blog posts:
• A proposed 6-step platform for the cell therapy industry to consider in combating non-compliant cell therapy treatments
• Six steps to fighting non-compliant cell therapy treatments. --- The stuff of grey shades, spades, ivory towers and (ahem) balls

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 

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 Doses. BioProcess 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. www.incell.com

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.