Volume 11.38 | Oct 4

Cell Therapy News 11.38, October 4, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe


TOP STORY  


Harvard Medical School Researchers Discover New Method of Creating Adult Stem Cells
Harvard Medical School researchers have outlined a more efficient, safer way to reprogram adult stem cells, a development that holds strong implications for the field and patient care. [Press release from Harvard University discussing online prepublication in Cell Stem Cell]

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SCIENCE NEWS

Researchers Create First Molecule Able to Block Key Component of Cancer Genes' On-Off Switch
In the quest to arrest the growth and spread of tumors, there have been many attempts to get cancer genes to ignore their internal instruction manual. In a new study, scientists have created the first molecule able to prevent cancer genes from “hearing” those instructions, stifling the cancer process at its root. [Press release from the Dana-Farber Cancer Institute discussing online prepublication in Nature]

Gene Variations that Alter Key Enzyme Linked to Prostate Cancer
Researchers at the National Institutes of Health have found that variations in a gene for an enzyme involved in cell energy metabolism appear to increase the risk for prostate cancer. [Press release from the National Institutes of Health discussing online prepublication in the Journal of Clinical Endocrinology and Metabolism]

Sodium Plays Key Role in Tissue Regeneration: New Drug Treatment Triggers Sodium Ions to Regrow Nerves and Muscle; Could Extend Treatment Window for Acute Injuries

Biologists have discovered that sodium plays a key role in initiating a regenerative response after severe injury. Scientists have found a way to regenerate injured spinal cord and muscle by using small molecule drugs to trigger an influx of sodium ions into injured cells. [Press release from Tufts University discussing online prepublication in the Journal of Neuroscience]

Jevtana® Improves Survival in Advanced Prostate Cancer Patients
Sanofi-aventis announced that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana® (cabazitaxel) Injection, was published in the October 2 issue of The Lancet in an article titled “Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.” [Press release from Sanofi-aventis discussing online prepublication in The Lancet]

Yale Researchers Find Protein is a Key Tool in Chromosomal Repair Kit
Scientists have discovered how one protein plays a key role in repairing damage to chromosomes that can cause different types of cancer. [Press release from Yale University discussing online prepublication in Nature Structural & Molecular Biology]

Triple-Negative Breast Cancers May Have Unique Therapeutic Target
Patients with triple-negative breast cancer, one of the hardest subtypes to treat, may have a unique biomarker that would enable them to receive more targeted therapy. [Press release from the American Association for Cancer Research (AACR) discussing data presented at the Fourth AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development]

Circulating Tumor Cells Can Provide 'Real-time' Information on Patient's Current Disease State
Circulating tumor cells may be a promising alternative, noninvasive source of tumor materials for biomarker assessment. [Press release from the American Association for Cancer Research (AACR) discussing data presented at the Fourth AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development]

Novel Biomarker May Predict Response to New VEGF Receptor Inhibitor
Researchers believe there may be a way to predict, based on individual tumors, those patients who are more likely to respond to the investigational new drug tivozanib. [Press release from the American Association for Cancer Research (AACR) discussing data presented at the Fourth AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development]

Proteins To Yield New Clues in Fight Against Osteoporosis
A $1.76 million study at Rensselaer Polytechnic Institute seeks to identify new methods of diagnosing osteoporosis and inform the development of next-generation drugs to treat the bone disease. [Rensselaer Polytechnic Institute Press Release]

Technique to Reattach Teeth Using Stem Cells Developed at UIC
A new approach to anchor teeth back in the jaw using stem cells has been developed and successfully tested in the laboratory for the first time by researchers at the University of Illinois at Chicago. [Press release from the University of Illinois at Chicago discussing online prepublication in Tissue Engineering]

MicroRNA Panel Provides a More Precise Lung Cancer Diagnosis
A test based on a panel of microRNAs under development by Rosetta Genomics, Ltd., in Rehovot, Israel, may allow for more precise diagnosis and better targeted therapy for patients with lung cancer. [ScienceDaily Press Release]

Scientists Stack Up New Genes for Height
An international team of researchers has discovered hundreds of genes that influence human height. [Press release from the University of North Carolina at Chapel Hill School of medicine discussing online prepublication in Nature]

Addition of Immunotherapy Boosts Pediatric Cancer Survival in Children With Neuroblastoma
Administering a new form of immunotherapy to children with neuroblastoma increased the percentage of those who were alive and free of disease progression after two years, according to researchers at the University of California, San Diego School of Medicine and fellow institutions. [Press release from ScienceDaily discussing online prepublication in the New England Journal of Medicine]

Research on Killer HIV Antibodies Provides Promising New Ideas for Vaccine Design
Rockefeller researchers have made two fundamental new discoveries about the immune defenses of a rare group of HIV patients whose bodies can naturally keep the virus at bay. [Press release from The Rockefeller University discussing online prepublication in Nature]

Rescue Services at the Cellular Level: How Stem Cells Help the Brain to Regain its Functions After a Stroke
A study has now demonstrated, in a long-term animal study on rats, that the positive effect of stem cell injection after a stroke is mainly based on a stimulative effect in the surrounding cell region. [Press release from the Max Planck Institute for Neurological Research in Cologne discussing online prepublication in PLoS ONE]

Scientists Discover Gene that Controls Stem Cells in Central Nervous System   
Scientists at the Medical Research Council have discovered that a gene called Sox9 plays a critical role in how stem cells behave and is crucial in the development of the central nervous system. [Press release from the Medical Research Council discussing online prepublication in Nature Neuroscience]

Arizona Cancer Center-TGen-Mayo Study Finds Gene Associated with Aggressive Skin Cancer
The loss of a gene known as INPP5A could predict the onset and track the progression of an aggressive type of skin cancer, according to a study. [Press release from the Arizona Cancer Center discussing online prepublication in Cancer Prevention Research]

Synosia Presents Data from Clinical Trial of SYN-118 As A New Treatment For Parkinson's Disease
Synosia Therapeutics announced the first clinical study results showing that SYN-118 provides clinically meaningful benefits to Parkinson’s patients, has a good safety profile and is well tolerated. [Synosia Therapeutics Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Anti-GD2 Antibody with GM-CSF, Interleukin-2, and Isotretinoin for Neuroblastoma
Researchers conducted a study to determine whether adding ch14.18, GM-CSF, and interleukin-2 to standard isotretinoin therapy after intensive
multimodal therapy would improve outcomes in high-risk neuroblastoma. [New Engl J Med]

Selective Inhibition of BET Bromodomains
The data establishes proof-of-concept for targeting protein–protein interactions of epigenetic ‘readers’, and provides a versatile chemical
scaffold for the development of chemical probes more broadly throughout the bromodomain family. [Nature]

Hundreds of Variants Clustered in Genomic Loci and Biological Pathways Affect Human Height
Here, using 183,727 individuals, researchers show that hundreds of genetic variants, in at least 180 loci, influence adult height, a highly
heritable and classic polygenic trait. [Nature]

Polyreactivity Increases the Apparent Affinity of Anti-HIV Antibodies by Heteroligation
Here, researchers show that during the human antibody response to HIV, somatic mutations that increase antibody affinity also increase
breadth and neutralizing potency. [Nature]

Prednisone Plus Cabazitaxel or Mitoxantrone for Metastatic Castration-Resistant Prostate Cancer Progressing After Docetaxel Treatment: a Randomised Open-Label Trial
Researchers aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with
metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. [Lancet]

Highly Efficient Reprogramming to Pluripotency and Directed Differentiation of Human Cells with Synthetic Modified mRNA
Here researchers describe a simple, nonintegrating strategy for reprogramming cell fate based on administration of synthetic mRNA modified to
overcome innate antiviral responses. [Cell Stem Cell]

SOX9 Induces and Maintains Neural Stem Cells
Data identifies a functional link between extrinsic and intrinsic mechanisms of neural stem cell specification and maintenance, and establish
a central role for SOX9 in the process. [Nat Neurosci]

Cooperation of Breast Cancer Proteins PALB2 and Piccolo BRCA2 in Stimulating Homologous Recombination
Inherited mutations in human PALB2 are associated with a predisposition to breast and pancreatic cancers. The studies provide the first
biochemical insights into PALB2's function with piccolo BRCA2 as a mediator of homologous recombination in DNA double-strand break repair. [Nat Struct Mol Biol]

Induction of Vertebrate Regeneration by a Transient Sodium Current
Whereas voltage-gated sodium channels play a well known and important role in propagating action potentials in excitable cells, researchers
have identified a novel role in regeneration for the ion transport function mediated by the voltage-gated sodium channel, NaV1.2. [J Neurosci]

Phosphodiesterase 11A (PDE11A) Genetic Variants May Increase Susceptibility to Prostatic Cancer
The data suggest that, like in the adrenal cortex and the testicular germ cells, PDE11A-inactivating genetic alterations may play a role
in susceptibility to prostatic cancer. [J Clin Endocrinol Metab]

Stem Cell Mediation of Functional Recovery after Stroke in the Rat
In order to address the underlying mechanisms of stem cell mediated functional improvement, this functional improvement after stroke in the
rat was investigated for six months after stroke by use of fMRI, somatosensory evoked potentials by electrophysiology, and sensorimotor behavior testing. [PLoS ONE]

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POLICY

Appeals Court Says Stem Cell Funding Can Continue
An appeals court decided to allow federal funding for human embryonic stem cell (hESC) research to continue while the court considers legal arguments that halted hESC research last month. [Court of Appeals, United States]

Lawmakers Introduce Bipartisan Legislation to Create Jobs and Promote Investment in Life Sciences
U.S. Representatives introduced bipartisan legislation that will provide tax incentives for small and mid-sized businesses to invest in life sciences research and development on a targeted basis. The Life Sciences Jobs and Investment Act of 2010 provides an opportunity to enhance medical innovation, life sciences education and job creation in the United States. [House of Representatives, United States]

NIH and FDA Announce Awards to Advance Regulatory Science
The National Institutes of Health will award $9.4 million over three years to support four research projects in regulatory science. This research is conducted in partnership with the U.S. Food and Drug Administration, which will contribute approximately $950,000. [National Institutes of Health and Food and Drug Administration, United States]

Clarification of the Submission Date for Applications for Program Projects for Collaborative Research on the Basic Biology of Pluripotency and Reprogramming (P01) (RFA-GM-11-005) (NOT-GM-10-109) [National Institute of General Medical Sciences, United States]

Tumor Microenvironment Network (TMEN) (U54) (RFA-CA-10-021) [Department of Health and Human Services, United States]

Resource Related Research Projects for Development of Animal Models and Related Materials (R24) (PAR-10-289) [National Center for Research Resources, United States]

Animal and Biological Material Resource Centers (P40) (PAR-11-001) [National Center for Research Resources, United States]

NHLBI Translational Research Implementation Program (TRIP) – Limited Competition – (P50) (RFA-HL-12-003) [National Heart, Lung, and Blood Institute, United States]

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BUSINESS

Subra Suresh Confirmed as NSF Director
The U.S. Senate has confirmed Subra Suresh, President Barack Obama's nominee for director of the National Science Foundation (NSF), for a six-year term. [National Science Foundation Press Release]

Teva and OncoGenex Announce Initiation of Second Phase 3 Trial of Custirsen in Men with Metastatic Prostate Cancer
Teva Pharmaceuticals Industries Ltd. and OncoGenex Pharmaceuticals, Inc. announced the initiation of SYNERGY, a global Phase 3 trial evaluating custirsen (also known as OGX-011/TV-1011) as first line therapy for the treatment of castrate-resistant prostate cancer. [Teva Pharmaceuticals Industries Ltd. Press Release]

Neupro® (Rotigotine) Provided Clinically Relevant Improvements in Health-Related Quality of Life for People with Parkinson's Disease
People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms. [PR Newswire]

Covance and Sanofi-Aventis Sign Definitive Agreements for 10-Year Strategic R&D Alliance
Covance Inc. announced the signing of definitive agreements with Sanofi-aventis for Covance to become Sanofi-aventis' R&D partner. [Covance Inc. Press Release]

Warburg Pincus Agrees to Invest Up to $35 Million in Protox
Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins for the treatment of diseases of the prostate and cancer, and Warburg Pincus, a leading global private equity firm, jointly announced that they have entered into an Investment Agreement. [Protox Therapeutics Inc. Press Release]

Rigel Earns Milestone Payments From AstraZeneca
Rigel Pharmaceuticals, Inc. announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. [Rigel Pharmaceuticals, Inc. Press Release]

Sanofi's GLP-1 Drug Hits Promising Marks in PhIII Diabetes Trial
Sanofi-Aventis' GLP-1 diabetes drug lixisenatide impressed analysts with a solid set of top-line results demonstrating its effectiveness–in combination with the bestselling Lantus–for controlling blood sugar. [Fierce Biotech]

Tobira Therapeutics Inc. Raises $31 Million in Series B Financing
Tobira Therapeutics Inc., a biopharmaceutical company focused on developing and commercializing innovative antiviral compounds to treat HIV disease, announced the completion of a $31 million Series B financing. [Tobira Therapeutics Inc. Press Release]

Tengion Presents New Data Demonstrating Functional Regeneration in a Diabetic Chronic Kidney Failure Model at the International Society for Cellular Therapy
Tengion, Inc. presented new research data in a podium presentation at the 2nd Annual Symposium on Stem Cell Translation of the International Society for Cellular Therapy (ISCT) in San Francisco. [Tengion, Inc. Press Release]

McLean Researchers Awarded $1.9 Million Grant for Stem Cell, Blood Research
Researchers at Harvard-Affiliated McLean Hospital have been awarded a $1.9 million National Institutes of Health Director's Opportunity Award to continue their research into creating human induced pluripotent stem cells using a method aimed at eliminating the risk of cancer and other problems associated with other options such as genome-integrating viral methods. [McLean Hospital Press Release]

Einstein Receives $30 Million to Study Protein Form and Function
The National Institute of General Medical Sciences has awarded Albert Einstein College of Medicine of Yeshiva University a five-year, $30 million grant to study the structure and function of thousands of biomedically important proteins. [Albert Einstein College of Medicine of Yeshiva University Press Release]

Manu Platt Wins $1.5M NIH Director's New Innovator Award

A researcher from the biomedical engineering department operated by Georgia Tech and Emory University has received a $1.5 million NIH Director's New Innovator Award to support a project aimed at reducing the incidence of stroke in children with sickle cell disease. [Georgia Institute of Technology Press Release]

Cardium Gains Exclusive Access to Novel Polymer-Based Nitric Oxide Technology for Expansion of Wound Healing Product Portfolio

Cardium Therapeutics announced that it has gained exclusive access to commercial development rights for certain novel supramacromolecular polymer complexes enabling regulatable and localized topical delivery of nitric oxide for prolonged periods of one to three weeks, to broaden and expand the Company's wound healing and tissue regeneration portfolio. [Cardium Therapeutics Press Release]




NIH
 

NIH Transformative Research Project Awards Hasten Innovation
The National Institutes of Health will award up to $64 million over five years to encourage exploration of exceptionally innovative and original research ideas that have the potential for extraordinary impact.

NHLBI Renews Programs for Nanotechnology Research
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is awarding $65 million to renew its Programs for Nanotechnology Research to help researchers develop tools based on materials designed at the molecular level to detect and deliver treatments for heart, lung, and blood diseases.

NIH Awards Muscular Dystrophy Cooperative Research Center Grants
Three grants totaling more than $4.5 million, from agencies of the National Institutes of Health, will be used to explore novel treatment strategies for muscular dystrophy.

NCBI Launches the Database of Genomic Structural Variations
The National Institutes of Health announces the launch of a new resource, called the Database of Genomic Structural Variation, or dbVar, to help scientists understand how differences in DNA contribute to human health and disease.

NIH Grants Will Advance Studies of the Form and Function of Proteins
The National Institutes of Health has awarded 23 grants for structural biology research totaling up to $290 million over five years. The projects will focus on determining the shapes and functions of proteins important in biology and medicine.

NINDS Awards New Udall Centers for Parkinson's Disease Research
The National Institute of Neurological Disorders and Stroke (NINDS), a component of the National Institutes of Health, has established two new sites as part of the Morris K. Udall Centers of Excellence in Parkinson’s Disease Research. The NINDS grants will provide a five-year investment totaling more than $16 million for Emory University in Atlanta and the Feinstein Institute for Medical Research in Manhasset, N.Y.

Notice of Pre-application Meeting and Correction for Request for Applications (RFA-RM-10-011, RFA-RM-10-012, and RFA-RM-10-013) for the Knockout Mouse Phenotyping (U54), Project Database (U54), and Production and Cryopreservation (U42) (NOT-RM-10-015)

Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-24548)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-24680)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-24549)

Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-24550)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-24556)

National Human Genome Research Institute; Notice of Meeting (FR Doc. 2010-24555)

National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-24408)

National Cancer Institute; Notice of Meeting (FR Doc. 2010-24413)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2010-24414)

Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-24405)

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CBER

November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee Meeting Announcement




REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

FDA Issues Final Rule on Safety Information During Clinical Trials
The U.S. Food and Drug Administration (FDA) issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic Priorities Document; Request for Comments (FR Doc. 2010-24603)

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans [Docket No. FDA-2000-N-0108] (Formerly Docket No. 00N-1484)




EVENTS (Listed by Date)

9th Annual BIO Investor Forum
October 5-6, 2010
San Francisco, United States

5th World Congress on Preventive & Regenerative Medicine (WCRM)
October 5-7, 2010
Hannover, Germany

17th Annual Meeting German Society for Gene Therapy (DG-GT e.V.)
October 6-9, 2010
Munich, Germany

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
October 7, 2010
Amsterdam, The Netherlands

Induced Pluripotent Stem Cells: Production and Utility in Regenerative Medicine
October 7, 2010
Hertfordshire, United Kingdom

Functional Stem Cell and Regeneration
October 9-10, 2010
Kansas City, United States

American Association of Blood Banks (AABB) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010
October 9-12, 2010
Baltimore, United States

18th Annual BioPartnering Europe
October 10-12, 2010
London, United Kingdom

3rd Biobridge “Generation Regeneration” Conference
October 11, 2010
Geneva, Switzerland

New York Stem Cell Foundation 5th Annual Translational Stem Cell Research Meeting
October 12-13, 2010
New York, United States

4th International Symposium: Stem Cells, Development and Regulation
October 12-14, 2010
Amsterdam, Netherlands

Translational Cancer Research for Basic Scientists
October 17-22, 2010
Boston, United States

2010 NanoMedicine Summit
October 18-19, 2010
Cleveland, United States

BIO Intellectual Property Counsels Committee Fall Conference and Committee Meeting
October 18-20, 2010
Boston, United States

Stem Cells and Regenerative Medicine – New Solutions to Old Problems
October 18-20, 2010
San Antonio, United States

6th Modern Drug Discovery & Development Summit (M3D)
October 20-22, 2010
San Francisco, United States

European Society of Gene and Cell Therapy (ESGCT) 18th Annual Congress
October 22-25, 2010
Milan, Italy

3rd Annual Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM)
October 26-27, 2010
Dubai, United Arab Emirates

International Consensus Conference on Risk-Based Decision Making for Blood Safety
October 26-28, 2010
Toronto, Canada

World Stem Cells & Regenerative Medicine Congress Asia 2010
October 26-29, 2010
Singapore City, Singapore

Select Biosciences 3rd Annual Molecular Diagnostics World Congress
October 28-29, 2010
San Diego, United States

Fraunhofer Life Science Symposium 2010
October 29-30, 2010
Leipzig, Germany

Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations
November 2, 2010
Bethesda, United States

Stem Cell Society Singapore Symposium 2010: Translating Science to Therapy
November 2-3, 2010
Singapore

BioMalaysia 2010 Conference and Exhibition
November 2-4, 2010
Kuala Lumpur, Malaysia


World Cord Blood Congress
November 4-7, 2010
Marseille, France

Select Biosciences 5th Annual European Biomarkers Summit
November 9-10, 2010
Florence, Italy

Select Biosciences International Forum on Stem Cells
November 12-13, 2010
Tianjin, China

Select Biosciences 2nd Annual RNAi Asia Conference
November 15-16, 2010
Singapore City, Singapore

BIO-Europe International Partnering Conference
November 15-17, 2010
Munich, Germany

The 16th International Conference of the ISD (International Society of Differentiation)
November 15-18, 2010
Nara, Japan

9th Annual Gene Therapy Symposium for Heart, Lung, and Blood Diseases
November 17-19, 2010
Sonoma, United States

8th Annual Commercial Translation of Regenerative Medicine Conference
November 18-19, 2010
London, United Kingdom

Stem Cell Network 10th Annual Scientific Meeting
November 22-24, 2010
Calgary, Canada

HealthTech and Medicines Knowledge Transfer Network 7th Annual BioProcessUK Conference
November 24-25, 2010
Manchester, United Kingdom

Berlin-Brandenburg School for Regenerative Therapies (BSRT) PhD Symposium: Stem Cells — Hopes, Fears and Realities
December 1-3, 2010
Berlin, Germany

2nd European Association for Cardio-Thoracic Surgery (EACTS) Meeting on Cardiac and Pulmonary Regeneration
December 2-3, 2010
Vienna, Austria

Tissue Engineering & Regenerative Medicine International Society (TERMIS) – North America 2010
December 5-8, 2010
Orlando, United States

American Society for Cell Biology 50th Anniversary Annual Meeting
December 11-15, 2010
Philadelphia, United States

Select Biosciences 5th Annual Stem Cells & Regenerative Medicine World Congress
January 24-25, 2011
San Diego, United States

BIO Asia International Partnering Conference
January 24-25, 2011
Tokyo, Japan

Phacilitate 7th Annual Cell & Gene Therapy Forum 2011
January 24-26, 2011
Washington DC, United States

Keystone Symposia-Stem Cells in Development, Tissue Homeostasis and Disease
January 30-February 4, 2011
Santa Fe, United States

Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.


 

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