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Nanomedicine – Part 2

§ October 2nd, 2011 § Filed under Nano Medicine Comments Off on Nanomedicine – Part 2

Students Santosh Boddupalli, Sandeep Gandham, Swathi Jokkapur, and Chandana Chintalapani give a presentation on "Nanomedicine" during their Global Technology class. (Group 5 Presentation.) (Part 2 of 2.)

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Nanomedicine - Part 2

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Cell Therapy & Regenerative Medicine Domains Available

§ September 25th, 2011 § Filed under Nano Medicine Comments Off on 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

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Lifeline Skin Care Video: Care For Your Skin with Lifeline Skin Care

§ September 25th, 2011 § Filed under Nano Medicine Comments Off on Lifeline Skin Care Video: Care For Your Skin with Lifeline Skin Care

Stem Cell Skin Care
Born Different.

Lifeline Skin Care® (Lifeline) is a wholly owned subsidiary of International Stem Cell Corporation (OTCBB:ISCO), a publicly traded biotechnology company which has developed a powerful and ethical new stem cell technology called “parthenogenesis”.  ISCO created Lifeline Skin Care® to further develop its discoveries that extracts from human parthenogenetic stem cells had beneficial effects on human skin cells.
International Stem Cell is focused on advancing its human parthenogenetic stem cell technology towards finding treatments for blinding diseases of the eye, liver disease, diseases of the nervous system and diabetes.
Our goal at Lifeline Skin Care® is to help individuals improve the look and feel of their skin by combining the latest discoveries in the fields of stem cell biology, nanotechnology and skin cream formulation technology to create the highest quality, scientifically tested and most effective skin care products.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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NANO Medicine (1-3)

§ September 22nd, 2011 § Filed under Nano Medicine Comments Off on NANO Medicine (1-3)

made by Starx*Media (Andy G.)

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NANO Medicine (1-3)

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Micro and nanotechnologies are revolutionising medicine

§ September 20th, 2011 § Filed under Nano Medicine Comments Off on Micro and nanotechnologies are revolutionising medicine

More information: ec.europa.eu. Micro and nanotechnologies are revolutionising medicine 'Almost invisible' tools are being developed by European researchers to discover diseases earlier and to treat patients better

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Micro and nanotechnologies are revolutionising medicine

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Commercial-stage Cell Therapy Companies and Products

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Commercial-stage Cell Therapy Companies and Products

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.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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§ September 18th, 2011 § Filed under Nano Medicine Comments Off on

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Cell Therapy Group and BioBusiness.TV are pleased to announce they are collaborating to build a "cell therapy" video channel focused on the cell therapy industry.  The initiative is part of BioBusiness.TVs "Best of the Web" initiative intended to bring together publicly available video content that complements their original content.

The Cell Therapy channel will focus on cell-based therapeutic products which are in clinical development by or are commercially available from companies around the world.   We will update this channel frequently.

To view other video content, see Cell Therapy Group’s YouTube channel.

To recommend video content, submit your comments below.

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy

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The FDA recently issued an untitled letter to Parcell Laboratories and its contract manufacturing organization, New England Cryogenic Center (NECC), pertaining to the product PureGen™ Osteoprogenitor Cell Allograft intended for the "repair, replacement, reconstruction of musculoskeletal defects". The letter stated:

"The PureGen™ Osteoprogenitor Cell Allograft is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Act and the PHS Act."

This would appear to be an indicator that the FDA does not intend to relax enforcement of its view of how autologous cell therapies are to be regulated despite its ongoing litigation on this very subject with RSI.

As followers of this blog know, since the battle's inception in 2008 I have followed the case of Regenerative Sciences, Inc and their war with the FDA over their right to provide certain autologous cell therapy treatments to patients in certain circumstances without FDA approval. My first blog entry on the topic was in September 2008 in which I pointed out that the FDA had written a letter to RSI that July taking issue with some of their practices.

My next blog on the subject was February 2009 in which I concluded "I think the FDA is building its case and a showdown is on its way to Denver-town."

At the advice of legal counsel, I pointed out in a March 2010 blog entry that my reference to FDA's July 2008 letter to RSI was not officially a "warning letter" as that is defined and as I had referred to it but rather an "untitled letter". I also commented that FDA's lack of enforcement action against RSI to-date was emboldening medical practitioners into thinking FDA was reconsidering their position on the legality of providing autologous, expanded cells to patients outside of an FDA-cleared IND or BLA.

I took some satisfaction in announcing on my blog in August 2010 that the FDA had finally taken action against RSI. My satisfaction was not rooted in a belief that the FDA is right (I've always been agnostic as to which side is right) but in the sense that things had occurred as I had predicted they would.

The action the FDA chose to take against RSI was to seek an injunction against RSI from continuing to provide the "offending" treatment - a version of the Regenexx™ procedure using mesenchymal stem cells (“MSCs”) grown outside the body after harvest for the later infusion back into the donor-patient for the treatment of various orthopedic conditions - which the FDA alleges is a "product" falling under its regulatory authority but for which RSI has never received any FDA clearance to provide to patients.

RSI counterclaimed against the United States, challenging the FDA’s authority to regulate the Regenexx™ Procedure in question and challenging certain FDA regulations. The United States moved to dismiss Defendants’counterclaims and for summary judgment.

I have continued to follow the case relatively closely through a number of source (see this sample media coverage in OthosSpineNews) as it continued to progress. Last month, for example, a blog I follow posted an eloquent case in support of RSI's position with the help of Mary Ann Chirba, J.D., D.Sc., M.P.H. of Boston College Law School.

So it was with much interest that I was recently notified of an order issued by the court which appears to have the potential to take the case in a very unexpected direction with enormous potential ramifications.

The context is that the judge was reviewing the FDA's motion for summary judgment, RSI's response, and FDA's reply when the judge issued this order to show cause.

At its essence the Judge has ordered the FDA to file a brief no later than 26 September showing the court why the term “chemical action” applies to stem cells. It is is a short Order the core of which reads as follows:

The Government finds its definition for a “drug” in the FDCA: “The term ‘drug’means . . . articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(B)&(C).

This definition, at least as to subsection (C), would be broad enough to encompass a boot on a patient’s ankle to hold it secure after ankle surgery. The Court doubts that was Congress’s intent.

Neither party references the definition for “device,” found in the statute at 21 U.S.C. § 321(h). A “device,” is a certain kind of “article” used in diagnosis, cure, mitigation, treatment or prevention of disease, 21 U.S.C. § 321(h)(2), but which, presumably unlike a drug, “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h).

These contrasting definitions immediately raise the question of why the Court should not interpret the meaning of the word “drug” to include not only an article for use in diagnosis, etc., and intended to affect the structure or function of a patient, but also an article that “achieve[s] its primary intended purposes through chemical action” and which is “dependent upon being metabolized for the achievement of its primary intended purposes.” Id.

The United States is ORDERED TO SHOW CAUSE why the Court should not read the definition of “device” at 21 U.S.C. § 321(h) as informing and restricting the definition of “drug” at 21 U.S.C. § 321(g)(1)(B)&(C).

It will be most curious to see how the FDA argues out of the corner that many believe the Judge has painted the agency. The FDA recently defined “chemical action” in its draft "Guidance for Industry and FDA Staff: Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h)of the Federal Food, Drug, and Cosmetic Act". What is curiously absent from the document is any mention of cells or HCT/P’s despite CBER’s approval stamp on the document.

Another line of argument centers around whether cells - notably 'stem' cells - are “metabolized" as that term is defind.

If one extrapolates the ramifications of where the court appears to be currently leaning, the implications of this judgment may have far-reaching implications for biologics in general well beyond cell therapy and certainly well beyond autologous cell therapy.

As some quite logically argue, one potential scenario is that this judge rules all biologics fail to fall within the legislative "drug" definition. The argument goes like this. The drug regulations live under title 21, which has narrow definitions for what constitutes a drug. The FDA’s authority over biologics comes from title 42, which is merely to control communicable disease transmission in transplants, with no authority to take the drug provisions from title 21 and apply them to title 42. So the agency is risking a loss of control over all biologics.

What’s curious here - and perhaps somewhat ironic for RSI at this stage - is that they only ever set out to challenge their ability to regulate autologous cells used by a physician as part of his or her medical practice yet now the FDA's authority to govern all biologics is currently under question.

The fact that I cannot fathom the courts striking FDA's jurisdiction over all biologics when the dust settles on this case does not make the arguments any less compelling and it does leave open the possibility that a lower court Judge such as the one presiding over this case may be inclined to make a ruling which essentially ensures the issues are punted to the appellate courts for a more considered ruling. In such circumstances, even if the FDA were to prevail at the end of the day (perhaps a decade down road) the uncertainty such a ruling would rain down on the sector would be commercially stifling - even if if were just limited to autologous cell therapy let alone if were any broader.

My dated and unpolished law degree can only take this analysis so far and anyone interested in some further but delightfully light and practical reading on the potential ramifications of the case could do no better than read a paper published recently by the relevant practice groups at the law firm K&L Gates entitled "Cultured Stem Cells for Autologous Use:Practice of Medicine or FDA Regulated Drug and Biological Product in which they review the case and its potential implications - the latter of which the authors are not guilty of underestimating in the following concluding sentence of their analysis:

The court’s decision will, to a large degree, dictate the types of legal strategies and business models that will be necessary to successfully perform stem cell procedures in the future.

_____________

post-script: The potential stink of commercial uncertainty wafting from this case is even more egregious when combined with the uncertainty around what to expect from the FDA in its much-anticipated and typically overdue guidance on adipose-derived cell therapies.

Rumor has it that the FDA is leaning toward considering most (if not all) means of deriving cell populations from adipose tissue (typically lipoaspirate) to be governed as what we colloquially refer to as a '351' thus taking it out of the purview of the practicing physician and into the hands of companies prepared to follow the traditional "drug development' model for new medicines. The rationale here is that the mechanical and/or enzymatic digestion required to separate the desired cell populations from the stroma take the process beyond "minimal manipulation'.

Watch for this guidance from CBER OCTGT in the weeks to come and/or any relevant rulings by the Tissue Reference Group. This would be a serious blow to those building business models around point-of-care, autologous adipose-derived cell therapy treatments.

What makes this even more interesting is the pace of which US-based medical practitioners (and/or companies supporting them) are adopting and selling autologous cell-based products, services and/or treatments for sundry indications in ways which many would argue are apparently in obvious and flagrant disregard for the FDA's regulatory authority over such treatments. Included for consideration on such a list would be the following:

IntelliCell Biosceinces

eternaMD

Arizona Stem Cell Center

.

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Cancer Stem Cell Chronicle

§ September 18th, 2011 § Filed under Nano Medicine Comments Off on Cancer Stem Cell Chronicle

About 3 months ago, as an experiment, I launched the Cancer Stem Cell Chronicle, an online daily newspaper that's based on excerpts from 3 streams of content: 1) Twitter content tagged #cancerSC, 2) Twitter content that includes the keywords "cancer stem", and, 3) content derived from a PubMed RSS feed for the search term "cancer stem".

The experiment looks promising. The CSC Chronicle is beginning to provide a convenient way to monitor recent research news about cancer stem cells. Archives are available. The section headings in the CSC Chronicle aren't very meaningful, and should be ignored.

The CSC Chronicle is hosted by Paper.li.

Source:
http://cancerstemcellnews.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell to Present at the Rodman & Renshaw Annual Global Investment Conference on September 12

§ September 11th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell to Present at the Rodman & Renshaw Annual Global Investment Conference on September 12

International Stem Cell Corporation (OTCBB: ISCO) announced today that Kenneth Aldrich, Chairman, is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference on Monday, September 12, 2011 at 11:40 a.m. Eastern (8:40 a.m. Pacific). The conference takes place at the Waldorf Astoria Hotel in New York City.
A webcast of the International Stem Cell Corporation presentation can be viewed live at http://www.wsw.com/webcast/rrshq20/isco. The presentation will be archived and available at the same link for 90 days. After the conference, a link to the presentation will also be posted to the ISCO website, http://www.intlstemcell.com.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dmarkley@lhai.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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Video: The Promising Cells Presented by International Stem Cell Corporation

§ September 11th, 2011 § Filed under Nano Medicine Comments Off on Video: The Promising Cells Presented by International Stem Cell Corporation

Ken Aldrich of International Stem Cell Corporation (ISCO.OB) on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body...as well as other applications. Mr. Aldrich also discusses neurological applications focusing on reversing Parkinson's disease.
This corporate video was produced by Big Sky Productions Inc. (BGSI.OB).
Executive Producer: Ellis Martin
Producer and Creative Director, Narrator, Editor: Bob Lange
http://www.ellismartinreport.com  http://www.intlstemcell.com  
contact: bigskymedia@yahoo.com
Video Link - http://www.youtube.com/watch?v=CcXPMHqENys

Source:
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Living Polymerization and nano-medicine

§ September 7th, 2011 § Filed under Nano Medicine Comments Off on Living Polymerization and nano-medicine

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Living Polymerization and nano-medicine

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Nanomedicine — a Key Ingredient of the Medicine of the Future

§ September 6th, 2011 § Filed under Nano Medicine Comments Off on Nanomedicine — a Key Ingredient of the Medicine of the Future

(11. Juli 2011) Recognizing that the root of disease is often at the nanoscale, the question arises if medical diagnosis and therapy would not also work best at the nanoscale

Read this article:
Nanomedicine -- a Key Ingredient of the Medicine of the Future

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Onemedplace.com Interview – "International Stem Cell Corp Develops Similar Embryonic Stem Cells Without Fertilized Embryos"

§ August 28th, 2011 § Filed under Nano Medicine Comments Off on Onemedplace.com Interview – "International Stem Cell Corp Develops Similar Embryonic Stem Cells Without Fertilized Embryos"

Ken Aldrich, Executive Chairman of International Stem Cell Corporation [OTC:ISCO] was interviewed by OneMedRadio where he discussed the company’s regenerative medicine therapies.
Brett Johnson:  Good day, this is Brett Johnson in New York City with OneMedRadio. Today, I am with Ken Aldrich. He is the co-founder and executive chairman for International Stem Cell, symbol ISCO on the bulletin board. It is a Carlsbad, California company in the stem cell business.  Ken, thanks for joining us today.
Kenneth Aldrich: Thank you. I appreciate the opportunity to speak with you.
BJ: Ken, go ahead and tell us a little bit about the business of International Stem Cell and what you guys are doing that’s unique and distinctive.
KA: I’d be happy to. International Stem Cell is in the regenerative medicine business broadly speaking. We produce and develop therapies that are based on what are called pluripotent stem cells. Pluripotent stem cell simply means a stem cell that can be converted  (the technical word is differentiated) into any cell in the body and theoretically treat any kind of disease that can be treated with cell therapy.
There are today basically only two ways to create a pluripotent stem cell. One is what’s been around for ten years called embryonic stem cells derived from a fertilized human embryo, and the other is parthenogenesis, which is our own creation, our own patent. Our people really developed it from the very beginning.
They function very much the same but we have two unique advantages. One, we take the ethical issue right off the table. We do not use a fertilized egg and we never damage or destroy anything that could become a human being. And second, the DNA that results when we go through that process of using only an unfertilized egg is a much simpler DNA structure. It’s complete, but simpler in its form. It enables us to use a single cell line from a single donor to match very large numbers of people. So it gives us the potential a few years down the road to have a true stem cell bank. And by that I don’t mean the banking of somebody’s own cells, but a bank much like a blood bank in which any patient who needs stem cells can come, get cells that will match their immune system and thereby eliminate or reduce the need for immunosuppressant drugs.
We think ultimately that’s going to be the single defining differentiator for our company because a cell transplant is like a miniature organ transplant. If the body rejects it, there’s no benefit, and we’re working on a way to provide cells that anyone can use at any time for any disease that any scientist is smart enough to figure out a way to treat with cells. It’s a tall order but we think we’re up to it.
To read the full text or listen to the interview, please visit onemedplace -http://www.onemedplace.com/blog/archives/9031

Source:
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International Stem Cell Corporation presents "The Promising Cells" Video

§ August 28th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation presents "The Promising Cells" Video

In this video presentation, see and hear an overview of International Stem Cell Corporation (ISCO.OB). ISCO has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISC a unique leadership role in the field of regenerative cell therapy. You'll hear directly from Executive Chairman, Kenneth Aldrich. Lifeline Cell Technology and Skin Care Products, revenue generating units of ISCO are also reviewed.


This presentation was produced by Big Sky Productions, INC (BGSI.OB), Co-Executive Producers Ellis Martin and Bob Lange. 
contact: bigskymedia@yahoo.com

Unfortunately, this content is currently being updated and will be posted again soon.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell Corporation to Present at the Southern California Investor Conference on Monday, August 29th

§ August 28th, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation to Present at the Southern California Investor Conference on Monday, August 29th

International Stem Cell Corporation (OTCBB: ISCO) announced today that Kenneth Aldrich, Chairman, will be presenting at the 2011 Southern California Investor Conference on Monday, August 29, 2011 at 1:30 p.m. Pacific (4:30 p.m. Eastern). The conference takes place at The Island Hotel in Newport Beach, California.


The Southern California Investor Conference is the only conference focused exclusively on the wealth of exciting growth companies from Southern California. The annual one-day conference features more than 35 companies from the region presenting to attendees from throughout the nation. The conference is open to the public and investors can find a list of 2011 presenting companies and registration information at http://www.CaliforniaStocks.com


A webcast of the International Stem Cell Corporation presentation will be accessible online at http://events.powerstream.net/002/00271/20110829_SCIC_T2/ or from the link on the Company's web site at http://www.internationalstemcell.com. An archived version will be available for 30 days.


About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.


To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.


International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com

or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dmarkley@lhai.com

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell’s Q2 Revenues Nearly Triple by Deborah Sterescu

§ August 21st, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell’s Q2 Revenues Nearly Triple by Deborah Sterescu

International Stem Cell Corporation (ISCO) (OTCBB:ISCO) reported Wednesday that second quarter sales more than doubled to almost triple, while year-to-date sales jumped a whopping 271%, as the company's operating subsidiaries continue to generate more revenue.
In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that have reflected revenue growth in the meantime, including Lifeline Cell Technology, which sells its cell-culture products to researchers to grow human cells for pre-clinical research, and Lifeline Skin Care, which sells skin care products based on its parent's stem cell technology.
For the three months ending June 30, International Stem Cell saw revenues rise to $1.1 million, from $0.44 million a year earlier.
Year-to-date revenues totaled $2.6 million, versus $0.7 million for the same period in 2010, helped by a $1.7 million contribution from Lifeline Skin Care, and a $0.9 million addition from Lifeline Cell.
In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy ISCO plans to continue.
Meanwhile, the company's skin care business is coming off a highly successful launch at the end of last year, exceeding its plans to sell 1,000 products, with 7,000 products sold initially. Lifeline Skin plans to aggressively kick start major marketing initiatives again in September.
While these two subsidiaries are busy chalking up revenues, ISCO, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.
Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.
The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos. Like embryonic stem cells, they also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.
Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.
These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells. It has also started pre-clinical animal trials to create neuronal cells in the brain, to potentially cure Parkinson's disease.
Unsurprisingly, all this work to progress the company's technology has increased expenses, contributing to a $2.5 million loss in the second quarter, or a 3 cent loss per share.
Research and development costs grew on account of greater scientific projects, while general and administrative costs leapt on increased headcount as the company bulks up its management team.
International Stem Cell, with $3.6 million in the bank at the end of the quarter, said that it has not ruled out future capital raising, but it already has a facility that allows it to draw equity as necessary to secure its planned growth.

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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International Stem Cell Corporation Announces Second Quarter 2011 Financial Results and Corporate Events

§ August 21st, 2011 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation Announces Second Quarter 2011 Financial Results and Corporate Events


International Stem Cell Corporation (OTCBB: ISCO), a biotechnology company that developed a powerful new stem cell technology called "parthenogenesis" which promises to significantly advance the field of regenerative medicine, today announced financial results for the quarter ended June 30, 2011 and for the first six months of the fiscal year and provided an update on corporate events.

ISCO reported year-to-date revenues of $2.6 million compared to $0.7 million for the same time period in 2010, representing an increase of 271%. The increase in our revenues relates to sales generated by ISCO's wholly-owned subsidiaries Lifeline Skin Care (LSC) which contributed $1.7 million and Lifeline Cell Technology (LCT) which contributed $0.9 million of revenues.

Total year-to-date expenses, excluding cost of sales increased $2.0 million or 38%, compared to the first six months of the previous year. The most significant reasons for the increase in total expenses related to increases in R&D and G&A. Research & Development expenses increased primarily due to increased activity on our scientific projects. General & Administrative expenses increased primarily due to increased headcount, non-cash stock-based compensation and increased expenses related to business development activity and general corporate expenses.
Our cash balance at June 30, 2011 was $3.6 million. Net cash used in operating activities for the six months ended June 30, 2011 was $3.0 million.

Second Quarter 2011 Highlights:
-- The first U.S.-based donor was enrolled in ISCO's program to establish a bank of clinical-grade human parthenogenetic stem cells (hpSCs) capable of being immune-matched to millions of patients.

-- We strengthened our senior management team to assist in the continued development of the Company. Kurt May was appointed Senior Vice President responsible for mergers and acquisitions and development of new international collaborations. Donna Queen was added to the management team as Vice President of LSC, where she is responsible for marketing and business development.

-- We started a series of preclinical animal studies of neuronal cells derived from hpSCs. The studies will evaluate the in vivo safety and tumorigenicity of neuronal cells as well as their ability to develop into functioning dopaminergic neuron–like cells to treat Parkinson's disease.

-- We successfully completed the first series of preclinical testing of hepatocytes derived from hpSCs. In the transplantation mouse model, inoculated cells were capable of engrafting and surviving in specific niches within the liver, and were further developing into cells with essential hepatocyte-like features.

About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

International Stem Cell Corporation and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Statements of Financial Condition
June 30,
2011
December 31,
2010
(Restated)(1)
(Unaudited)
Assets
Cash and cash equivalents
$
3,581,933
$
5,782,027
Accounts receivable
341,666
738,506
Inventory
1,329,433
856,083
Prepaid expenses and other current assets
290,196
228,338
Total current assets
5,543,228
7,604,954
Property and equipment, net
1,495,916
1,295,328
Patent licenses, net
1,056,562
986,714
Deposits and other assets
16,279
39,812
Total assets
$
8,111,985
$
9,926,808
Liabilities and Stockholders' Equity
Accounts payable
$
1,032,531
$
582,824
Accrued expenses
855,315
545,781
Deferred revenue
137,834
759,667
Advances
250,000
250,000
Warrants to purchase common stock
1,027,171
2,399,605
Total current liabilities
3,302,851
4,537,877
Commitments and contingencies
Stockholders' Equity
Common stock, $.001 par value, 200,000,000 shares authorized, 76,599,928 shares and 74,771,107 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
76,600
74,771
Convertible preferred stock, $.001 par value, 20,000,000 shares authorized, 2,800,043 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
2,800
2,800
Subscription receivable on common stock
-
(4,875
)
Additional paid-in capital
59,780,363
56,170,006
Deficit accumulated during the development stage
(55,050,629
)
(50,853,771
)
Total stockholders' equity
4,809,134
5,388,931
Total liabilities and stockholders' equity
$
8,111,985
$
9,926,808

(1)
The Company restated its financial statements for the year ended December 31, 2010, and the quarter ended March 31, 2011.
International Stem Cell Corporation and Subsidiaries
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
Inception
(August 2001)
through
June 30,
2011
(Restated)(1)
2011
2010
(Restated)(1)
2011
(Restated)(1)
2010
(Restated)(1)
Revenues
Product sales
$
1,114,309
$
441,118
$
2,629,225
$
713,744
$
5,728,390
Royalties and license
-
-
-
-
135,000
Total revenue
$
1,114,309
$
441,118
$
2,629,225
$
713,744
$
5,863,390
Development expenses
Cost of sales
362,131
214,330
791,125
360,706
2,506,597
Research and development
1,128,869
754,000
2,132,279
1,338,069
15,992,557
Marketing
345,800
291,576
664,006
424,994
3,063,155
General and administrative
2,135,732
2,033,615
4,368,470
3,408,821
27,692,292
Total development expenses
3,972,532
3,293,521
7,955,880
5,532,590
49,254,601
Loss from development activities
(2,858,223
)
(2,852,403
)
(5,326,655
)
(4,818,846
)
(43,391,211
)
Other income (expense)
Settlement with related company
-
-
-
-
(92,613
)
Miscellaneous expense
(12,040
)
(256
)
(11,140
)
(20,649
)
(28,652
)
Dividend income
-
350
-
25,999
92,875
Interest expense
-
(6,805
)
-
(14,079
)
(2,225,074
)
Sublease income
2,450
2,125
4,650
3,525
303,083
Change in market value of warrants
478,669
7,083,365
1,349,518
(1,347,960
)
(2,380,664
)
Total other income (expense)
469,079
7,078,779
1,343,028
(1,353,164
)
(4,331,045
)
Income (loss) before income taxes
(2,389,144
)
4,226,376
(3,983,627
)
(6,172,010
)
(47,722,256
)
Provision for income taxes
-
-
-
-
6,800
Net income (loss)
$
(2,389,144
)
$
4,226,376
$
(3,983,627
)
$
(6,172,010
)
$
(47,729,056
)
Dividends on preferred stock
$
(107,203
)
$
-
$
(213,231
)
$
(1,238,067
)
$
(7,751,380
)
Net income (loss) attributable to common stockholders
$
(2,496,347
)
$
4,226,376
$
(4,196,858
)
$
(7,410,077
)
$
(55,480,436
)
Basic earnings per common share
$
(0.03
)
$
0.06
$
(0.06
)
$
(0.11
)
Diluted earnings per common share
$
(0.03
)
$
0.04
$
(0.06
)
$
(0.11
)
Share used in per share calculations:
Weighted average shares outstanding
76,340,016
68,676,504
75,842,071
64,789,250
Weighted average shares outstanding on a Fully Diluted Basis
76,340,016
114,797,830
75,842,071
64,789,250
(1)
The Company restated its financial statements for the year ended December 31, 2010, and the quarter ended March 31, 2011.
http://cts.businesswire.com/ct/CT?id=bwnews&sty=20110817005393r1&sid=14230&distro=ftp
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com

Or
Ray Wood, CFO
760-940-6383
rwood@intlstemcell.com

Source:
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Part 3: The Ellis Martin Report with Ken Aldrich of Int Stem Cell Corp (ISCO.OB)

§ August 21st, 2011 § Filed under Nano Medicine Comments Off on Part 3: The Ellis Martin Report with Ken Aldrich of Int Stem Cell Corp (ISCO.OB)


Ellis Martin of The Ellis Martin Report interviews Ken Aldrich of International Stem Cell Corporation (ISCO.OB) on the latest research involving stem cell technology utilizing unfertilized eggs, as a basis for cell generation with a goal toward organ transplants which are immune to rejection by the body...as well as other applications. Mr. Aldrich also discusses neurological applications focusing on reversing Parkinson's disease. Preventing and reversing blindness is another topic covered. 

Chttp://www.ellismartinreport.com  http://www.intstemcell.com 
contact:martinrepots@gmail.com

International Stem cell Corporation is a paid sponsor of The Ellis Martin Report

Source:
http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

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Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

§ August 14th, 2011 § Filed under Nano Medicine Comments Off on Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success.

(though perhaps not before certain current management finds themselves polishing their CVs or retiring to spend their time alternating between their yachts and the courtroom defending their questionable stock trading antics)

I received the following message this morning by email. I don't include it here to promote or endorse or even comment on NWBT, DCVax, Linda Powers, or Toucan Capital in any way -- or in a way that is blind to all the things right or wrong about any of them -- but simply to illustrate the 3 points I want to make below the email.
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX® IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS

Northwest Biotherapeutics' (OTC.BB: NWBO)... DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.

The investor concerns in the news relate to the pricing and reimbursement of Provenge for late stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).

NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments. In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax® added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial, although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing processes and product costs have already been determined.
...
...

The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch manufacturing process together with its cryopreservation technology for frozen storage of the finished vaccine. NWBT has spent a decade developing and improving its manufacturing and cryopreservation processes. The manufacturing of personalized, living cell products is expensive. But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells and many other factors).

NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of personalized DCVax® product for 3 years of treatments are much less costly than separate manufacturing runs for each treatment. The technology for freezing the master immune cells (dendritic cells) which comprise DCVax® enables these
cells to remain frozen for years and, when needed, to be thawed and “come back to life” with full potency.

This approach makes DCVax® an "off the shelf” product [for that patient] for several years of treatments after just one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved, which limits its shelf life to at most a few weeks.

Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.

The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting a portion of the prostate cancer market that is 4 times the size of the market segment that Dendreon’s Provenge is currently targeting....

Now this is NWBT clearly blowing their horn - nothing wrong with that - in an attempt to woo back frightened investors. I'm agnostic as to whether any of it is true but it does serve to draw out several points of distinction between what some companies might do to optimize their products for commercial success versus what others might do in an overriding belief that clinical benefit is the only precursor to the happiness of investors, the physician community, patients, and partners.
What I say below is not a commentary, in criticism or praise, on any particular company including NWBT or Dendreon. Many others - Luke Timmerman among the best of them - have provided outstanding and in-depth analysis of the Dendreon story along the way.
I'm only interested in what we as an industry might learn from recent experiences or trends and to perhaps facilitate a useful discussion based on 3 simple observations from someone who has swum in this cell therapy pond for now just over a decade:
1. There is a tendency among some to believe that what we are making (cell-based therapies) are so revolutionary and compelling that the products should almost sell themselves - to investors, partners, regulators, insurers, physicians, and patients.
Of course we know it's not true but sometime we act like it is.
Appligraf and Dermagraft didn't sell themselves to physicians even after regulatory approval. Neither is Provenge apparently-- though they did a good job of selling it to very vocal patient groups. Organogenesis and Advanced Biohealing had to work very long and hard to get profitable reimbursement and market penetration. Dendreon will too.
Investing early in understanding potential clinical adoption hurdles, reimbursement issues, and how the product is and will be perceived not by its champions but by its critics and most importantly, the average agnostic practitioner, is not easy to do because it means spending precious resources long before there is a product to sell but it may mean the difference between a product which eventually sells and one which doesn't.
2. There is a tendency to de-emphasize what I call the "ancillary sciences" around a product -- like lowering the cost of goods, optimizing fresh or frozen storage, cell delivery (e.g., injection/application science) mechanisms, in vivo cell tracking, onsite clinical handling, etc.
Product development science is a science. The science that turns good data into something commercially viable. Not everyone is good at it and certainly this is where a lot of companies fail. PD is not the 'second cousin' in the room of esteemed basic and clinical science.
Take these examples when considering the cellular immunotherapy sector:
Several prominent immunotherapy investigators I have spoken with strongly believe cell-based immunotherapies will require long-term administration to be meaningfully effective -- certainly longer than 3 doses in 3 months. Did Dendreon lock into their clinical protocol too early?
Other immunotherapy companies - like Opexa Therapeutics for instance - create multiple doses for a patient from a single patient collection thus saving considerable expense and creating a better patient experience. Did Dendreon lock into their manufacturing protocol too early?
Other companies are investing heavily in finding ways to extend viable shelf-life of their fresh products or to create cryopreserved versions of their product to optimize its commercial viability.
Imagine a Dendreon that only had to build one manufacturing facility (with a backup CMO) to serve the US market rather than 3 facilities. With a cryopreserved version of the product or a version that had longer than its current limited shelf-life (~72 hours I believe?) that might have been possible.
At every point in clinical development there must be concurrent R&D towards the product's:
  1. science (e.g., MOA, characterization, etc),
  2. clinical effect, and
  3. how to optimize its commercial viability - a big part of which is what we think of as 'product development'.
This is the 3-legged footstool of a commercialization strategy geared for success (credit to Bob Preti of Progenitor Cell Therapy for this analogy).
But 'product development' is also not always about the product strictly speaking and even an expansive definition of product development is only part of a good commercialization strategy.
There is significant component of it that is about studying ways to lower the cost of goods, improving manufacturability and scalability, how hard/easy it is to handle, the patient treatment experience, the physician experience, how it impacts patient's QOL (quality of life), not just what side effects it generates but what side effects it prevents (resulting from other treatments or no treatment) and the cost-savings that generates, etc.
Other cell therapy companies have been more proactive in terms of engaging not only KOLs but average practitioners in a meaningful way that might impact their product and clinical design as well as reimbursement and clinical delivery issues.
3. There is an understandable, largely VC-driven, desire to race forward to the next trial phase when a phase-repeat to optimize or better understand different aspects of the product might be the better way to go.

What's worse? Facing the prospect of not being able to get funding or a partner on the terms one wants for a 2nd phase II or burning through a bunch more money in phase III in an attempt to bring a product to market that isn't market ready? I understand its a tough choice -I'm not saying it's an easy one - but one is certainly more strategic and, as pharma says, is certainly a "de-risking" pathway.
Consider the ratio of products we've seen thus far in the cell therapy industry's short life-span that have been raced to phase III or (worse yet) market only to seriously stumble if not fail when they get there. I can think of 8-10 off the top of my head and there are less than 20 cell or tissue based therapies on the market in US/EU that have received any kind of formal regulatory approval.
Some would argue that this is a prime example of why spinning companies out of academia too early is not beneficial because companies want to minimize exploratory science and lock into a "product" too early. I would argue that this may be true if the problem is understanding the product characterization or mechanism of action but not if your problem is related to how best to develop/optimize the product for commercial viability. Few academics are geared to think this way.
Summary
I certainly don't believe Dendreon failed to identify or consider each and every one of the things they might have done better along the way. I'm sure they did and sure they made calculated judgement-calls about how to approach each one.
Since I'm not a shareholder I don't have to worry myself about being critical of their decisions but rather simply to do what I can to ensure that we as an industry do our best to learn from what - with the benefit of retrospect - may be apparent they did right and wrong.
What are your thoughts? To what extent are the problems that Dendreon has experienced along the way with PROVENGE a predicable result of it being a first-generation product or the result of insufficient focus on critical investigation into the less sexy "ancillary sciences" of product and commercial optimization?
(comment below and/or in the LinkedIn Cell Therapy Industry Group)



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