Volume 11.37 | Sep 27

Cell Therapy News 11.37, September 27, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  |  Unsubscribe

TOP STORY  


Scientists Reveal Gut Stem Cell Secrets
Scientists have discovered that gut stem cells replace each other in a ‘one in, one out’ system, which is completely different to previously accepted theories. [Press release from Cancer Research UK discussing online prepublication in Science]

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SCIENCE NEWS


Mechanism Behind Demethylation Pinpointed in APC Gene Mutants
Researchers demonstrate in the mechanism by which mutation of the APC gene affects a cellular process known as DNA methylation. [Press release from the Huntsman Cancer Institute at the University of Utah discussing online prepublication in Cell]

Inhibiting Cell Signaling Pathway May Improve Bone Marrow Transplant Success Rate
Identification of a molecular communications pathway that influences the mobilization of hematopoietic stem cells could lead to targeted therapies for improving bone marrow transplant success rates. [Press release from Cincinnati Children’s Hospital Medical Center discussing online prepublication in Nature Medicine]

Molecule 968 Binds Glutaminase and Starves Cancer Cells
A molecule – simply called 968 – can starve cancer cells and the tumors they produce, says new research. [Press release from Cornell University discussing online prepublication in Cancer Cell]

Researchers Map Thousands of MAPK Protein Interactions
Investigators have mapped a huge network of protein interactions involving mitogen activated protein kinase (MAPK) pathways. [Press release from the University of California, San Diego discussing online prepublication in Nature Methods]

Researchers Discover New Signaling Pathway That Controls Cell Development and Cancer
Researchers have discovered a new cell signaling pathway that controls cell growth and development, a pathway that when defective helps promote the formation of several major forms of human cancer including lymphoma and leukemia. [Press release from the UCLA Jonsson Comprehensive Cancer Center discussing online prepublication in Molecular Cell]

Study Offers First Explanation of How Cells Rapidly Repair and Maintain Structure
Researchers have discovered that a protein, zyxin, is necessary for the maintenance and repair of the cell’s cytoskeleton, or internal framework, which serves as the muscle and bone of the cell. [Press release from the Huntsman Cancer Institute at the University of Utah discussing online prepublication in Developmental Cell]

Research Suggests Compound Administered During Some Bone Marrow Transplants Elevates Risks
New research may spur debate about the risks associated with administering a specific compound in some forms of bone-marrow transplantation. [Press release from Oregon Health and Science University discussing online prepublication in Cell Host and Microbe]

Mice Engrafted with Human Immune Cells May Provide Clues to Better Prevention and Treatment of Typhoid Fever
Better treatments and prevention for typhoid fever may emerge from a laboratory model that has just been developed for the disease. The model is based on transplanting human immune stem cells from umbilical cord blood into mice that are susceptible to infections. [Press release from University of Washington discussing online prepublication in Proceedings of the National Academy of Sciences USA]

Visionary Stem Cell Technique Offers New Potential to Treat Blindness
Scientists are pioneering a stem cell treatment to replace diseased parts of the retina, which could lead to a future treatment for retinal diseases. [Press release from the Medical Research Council discussing online prepublication in Human Molecular Genetics]

Researchers Find Faster, Less-Intrusive Way to Identify Transplant Recipients' Organ Rejection
A simple, inexpensive blood test could soon help doctors halt organ rejection before it impairs transplanted hearts and kidneys. [Press release from the Stanford University School of Medicine discussing online prepublication in PLoS Computational Biology]

New Therapy Found for Lung and Skin Cancer, Based on Suicide Gene E
Scientists at the University of Granada have developed a new therapy for the treatment of skin and lung cancer. This therapy involves the use of a suicide coliphage-gene (gene E) that can induce death to cells transfected with it. [Press release from ScienceDaily discussing online prepublication in the Journal of Molecular Medicine]
 
'Synthetic Lethality' Strategy Improves Molecularly Targeted Cancer Therapy
Looking for a way to combat the problem of drug resistance, researchers hypothesized that hitting already weakened cancer cells with a second targeted agent could kill them — but only if it was the right second agent. [Press release from the Fox Chase Cancer Center discussing online prepublication in Science Signaling]

Sequencing Tested as Infection Early Warning
Scientists are co-opting the power of cheap, fast DNA sequencing as an environmental sensor for infectious pathogens that can spread through a community. They hope that the approach can provide earlier warning of disease outbreak. [Press release from MIT Technology Review discussing research presented at the 2010 Cold Spring Harbor Laboratory Meeting on Personal Genomes]

Researchers Engineer Adult Stem Cells That Do Not Age, Overcoming a Major Barrier to Progress in Regenerative Medicine
Biomedical researchers have engineered adult stem cells that scientists can grow continuously in culture. Scientists created the new cell lines — named “MSC Universal” — by genetically altering mesenchymal stem cells. [University at Buffalo Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

DNA Demethylase Activity Maintains Intestinal Cells in an Undifferentiated State Following Loss of APC
Loss of the APC tumor suppressor gene causes upregulation of a DNA demethylase system and the concomitant hypomethylation of key intestinal cell fating genes. [Cell]

Pharmacological Inhibition of EGFR Signaling Enhances Granulocyte Colony-Stimulating Factor-Induced Hematopoietic Stem Cell Mobilization
Findings reveal a previously unknown signaling pathway regulating stem cell mobilization and provide a new pharmacological approach for improving hematopoietic stem and progenitor cell mobilization and thereby transplantation outcomes. [Nat Med]

Intestinal Stem Cell Replacement Follows a Pattern of Neutral Drift
Combined with long-term clonal fate data, researchers show that the rate of stem cell replacement is comparable to the cell division rate, implying that neutral drift and symmetrical cell divisions are central to stem cell homeostasis. [Science]

Targeting Mitochondrial Glutaminase Activity Inhibits Oncogenic Transformation
Researchers describe a small molecule inhibitor that blocks oncogenic transformation induced by various Rho GTPases in fibroblasts, and the growth of human breast cancer and B lymphoma cells, without affecting normal cells. [Cancer Cell]

A Human MAP Kinase Interactome
Researchers applied a systematic experimental and computational approach to map 2,269 interactions between human mitogen-activated protein (MAP) kinase-related proteins and other cellular machinery and to assemble these data into functional modules. [Nat Methods]

AID-Induced Genotoxic Stress Promotes B Cell Differentiation in the Germinal Center via ATM and LKB1 Signaling
Data show that CRTC2 inactivation, via physiologic DNA damage response signaling, promotes B cell differentiation in response to genotoxic stress. [Mol Cell]

A Zyxin-Mediated Mechanism for Actin Stress Fiber Maintenance and Repair
Findings demonstrate a mechanism for rapid repair and maintenance of the structural integrity of the actin cytoskeleton. [Dev Cell]

Granulocyte-Colony Stimulating Factor Reactivates Human Cytomegalovirus in a Latently Infected Humanized Mouse Model
In addition to establishing a humanized mouse model for systemic and latent human cytomegalovirus (HCMV) infection, the results suggest that the use of granulocyte-colony stimulating factor mobilized blood products from seropositive donors pose an elevated risk for HCMV transmission to recipients. [Cell Host Microbe]

Humanized Nonobese Diabetic-scid IL2r(gamma)null Mice Are Susceptible to Lethal Salmonella Typhi Infection
Researchers show that S. Typhi can replicate in vivo in nonobese diabetic-scid IL2r(gamma)null mice engrafted with human hematopoietic stem cells to cause a lethal infection with pathological and inflammatory cytokine responses resembling human typhoid. [Proc Natl Acad Sci U S A]

Cone and Rod Photoreceptor Transplantation in Models of the Childhood Retinopathy Leber Congenital Amaurosis Using Flow-Sorted Crx-Positive Donor Cells
Researchers conclude that flow-sorted embryonic-stage Crx-positive donor cells have the potential to replace lost cones, as well as rods, an important requirement for retinal disease therapy. [Hum Mol Genet]

Synthetic Lethal Screen of an EGFR-Centered Network to Improve Targeted Therapies
Researchers developed a protein network centered on the epidermal growth factor receptor (EGFR), which is a validated cancer therapeutic target, and used small interfering RNA screening to comparatively probe this network for proteins that regulate the effectiveness of both EGFR-targeted agents and nonspecific cytotoxic agents. [Sci Signal]

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POLICY


Parties in Stem Cell Lawsuit Want to Keep University of California Out
The two sides in the court battle over whether federally funded research on human embryonic stem cells is legal both registered their opposition to the University of California's request to become a party to the suit, the first university to do so. [Court of Appeals, United States]

Government Asks Appeals Court to Keep Stem Cell Research Going
Government lawyers sallied forth on another legal maneuver today in an effort to defend U.S.-funded research on stem cells: they asked an appeals court to grant a longer stay to allow research on human embryonic stem cells to continue while the court considers a lower court's ruling that it is illegal. [Department of Justice, United States]

New Legislation Introduced to Form First U.S. National Strategy for Regenerative Medicine, with Commendation from the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine announced the introduction of the bi-partisan Regenerative Medicine Promotion Act of 2010 in the U.S. House of Representatives. [House of Representatives, United States]

European Medicines Agency Welcomes Adoption of New Pharmacovigilance Legislation by European Parliament
The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament. This is a major step towards the legislation coming into force, currently expected for mid-2012. [European Medicines Agency, European Union]

European Medicines Agency Publishes First Review of Orphan Designation
The European Medicines Agency has published the first of its ‘review of orphan designation’ documents. [European Medicines Agency, European Union]

U.K. Research Leaders Makes Final Stand Against Science Cuts
Top officials from six U.K. universities joined Martin Rees, president of the Royal Society, in London today in a last-ditch attempt to avert the government's expected cuts in science funding, which will be detailed in its forthcoming comprehensive spending review, scheduled for release on 20 October. [Royal Society, United Kingdom]

Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues (FR Doc. 2010-23517) [Department of Health and Human Services, United States]

Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010 [European Medicines Agency, European Union]

European Medicines Agency Recommends Suspension of Octagam in All EU Member States [European Medicines Agency, European Union]

European Medicines Agency Confirms Positive Benefit-Risk Balance of RotaTeq [European Medicines Agency, European Union]

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BUSINESS


NeoStem and Progenitor Cell Therapy Announce Entry Into Merger Agreement
NeoStem, Inc. and Progenitor Cell Therapy, LLC jointly announced the signing of a  definitive merger agreement whereby NeoStem will  acquire Progenitor Cell Therapy. [NeoStem, Inc. Press Release]

Boehringer Ingelheim and Eurofins Medigenomix GmbH Cooperate in the Areas of DNA Banking and Pharmacogenetics/Pharmacogenomics
Boehringer Ingelheim Pharma GmbH & Co. KG and Eurofins Medigenomix GmbH concluded a long-term service agreement in the area of DNA banking, as well as a master service agreement for pharmacogenetic and pharmacogenomic services. [Eurofins Medigenomix GmbH Press Release]

OncoMethylome Sciences Signs Agreement for the Potential Use of Its Technology Platform in GlaxoSmithKline Biologicals Immunotherapy Development Program
OncoMethylome Sciences announced that it has entered into an agreement with GlaxoSmithKline Biologicals S.A. (GSK) for the potential use of one of its DNA methylation specific PCR biomarkers in GSKs immunotherapy development program. [OncoMethylome Sciences Press Release]

RXi Pharmaceuticals and EyeGate Pharma Announce Collaboration Focused on Non-Invasive Ocular Delivery of RNAi Therapeutics
RXi Pharmaceuticals Corporation and EyeGate Pharma announced that they will collaborate on the ocular delivery of RNAi therapeutics. [RXi Pharmaceuticals Corporation Press Release]

Acquisition of U.S. Company Ratified by Mesoblast Shareholders
Shareholders of Australian regenerative medicine company, Mesoblast Limited, overwhelmingly approved the acquisition of its United States associate company, Angioblast Systems Inc. [Mesoblast Limited Press Release]

Masonic Cancer Center Receives $26 Million to Lead National Blood and Bone Marrow Cancer Research
Two of the University of Minnesota Masonic Cancer Center's leading physician-scientists on research and treatment of cancers of the blood and bone marrow, Philip McGlave, M.D., and Jeffrey Miller, M.D., have received renewed five-year program project research grants totaling almost $26 million from the National Cancer Institute. [University of Minnesota Masonic Cancer Center Press Release]

CytomX Therapeutics Completes $30 Million Series B Financing
CytomX Therapeutics announced it has completed a $30 million Series B financing. [CytomX Therapeutics Press Release]

Scientists Seek Donations on Innovative Micro-Philanthropy Site
A creative new Web site connects funding proposals by scientists with contributors who want to support the work out of the goodness of their hearts. [ScienceInsider]

The Rehabilitation Institute of Chicago/Northwestern First Site Open for Spinal Cord Stem Cell Trial
Northwestern Medicine is the first site open for enrollment in a national clinical research trial of a human embryonic stem cell-based therapy for participants with a subacute thoracic spinal cord injury. [Rehabilitation Institute of Chicago Press Release]

Athersys Receives Orphan Drug Designation for MultiStem® in Graft Versus Host Disease
Athersys, Inc. announced that MultiStem®, Athersys' multipotent adult progenitor stem cell therapy, has been granted orphan drug designation by the U.S. Food and Drug Administration for the prevention of graft versus host disease. [Athersys, Inc. Press Release]

AMT Receives Orphan Drug Designation From the U.S. Food and Drug Administration Duchenne Muscular Dystrophy Gene Therapy
Amsterdam Molecular Therapeutics (AMT) Holding N.V. announced that the U.S. Food and Drug Administration has designated AMT-080, a gene therapy for Duchenne muscular dystrophy as an orphan drug. [PR Newswire]

Angiotech Pharmaceuticals and Partner Athersys Announce Updated Results from Phase I Study of Multistem® in Heart Attack Patients
Angiotech Pharmaceuticals, Inc. and partner Athersys, Inc. announced updated results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction [Angiotech Pharmaceuticals, Inc. Press Release]

Clinical Update on TAMARIS Phase III Trial for NV1FGF
Sanofi-aventis announced that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint. [Sanofi-aventis Press Release]

Regulus Therapeutics Secures Additional Patents on microRNA Therapeutics for the Treatment of Hepatitis C Virus Infection
Regulus Therapeutics Inc. announced that the European Patent Office and United States Patent and Trademark Office have recently granted claims for microRNA-122 therapy in hepatitis C viral infections. [Regulus Therapeutics Inc. Press Release]

Patent is Filed on Shrink Nanotechnologies’ CellAlign Advanced Tissue Engineering Platform Technology
Shrink Nanotechnologies, Inc. announced that certain patent applications related to its advanced tissue engineering technology platform, CellAlign™, have been filed. [Shrink Nanotechnologies, Inc. Press Release]

Progenika Receives CE Mark for First DNA Chip to Detect Mutations in Lipoprotein Lipase Gene
Progenika Biopharma S.A. announced that it has obtained the CE Mark allowing the sale in Europe of its LPLchip®, the first DNA chip to detect mutations in the lipoprotein lipase gene. [PR Newswire]

Stem Cells That Save Big Pharma a Bundle
Researchers hope they can use human tissue created from stem cells to help identify potentially dangerous side-effects from drugs under development before human trials. [BusinessWeek]

University of South Florida Stem Cell Scientists Call for Research Ethics Consortium
Two University of South Florida stem cell researchers propose creating an independent national “Stem Cell Research Ethics Consortium” to provide better guidance on stem cell issues for regulatory agencies, law makers and policy makers. [University of South Florida Press Release]


NIH
 

NIH Releases Biennial Report of the Director
Dr. Francis S. Collins, M.D., Ph.D, director of the National Institutes of Health, announced the release of the Biennial Report of the Director, NIH, for fiscal years 2008 and 2009. The report provides an integrated portrait of NIH research activities, making it easy for Congress, advocates and patient groups and the general public to understand the many activities of the agency.

First NIDA Avant-Garde Awards for Medications Development Research
The recipients of the first-ever Avant-Garde Awards for Innovative Medication Development Research by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, will receive $500,000 per year for five years to support their research.

The NCI Cancer Immunotherapy Trials Network (CITN) Seeks Member Clinical Sites (NOT-CA-10-034)

Clinical and Data Coordinating Center(s) for Parkinson’s Disease Biomarkers Identification Network (PD-BIN) (U01) (RFA-NS-11-005)

Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (SBIR [U43/U44]) (PAR-10-286)

Office of Biotechnology Activities, Office of Science Policy, Office of the Director; Notice of Meeting (FR Doc. 2010-23947)
 
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting (FR Doc. 2010-23867)
 
National Center for Research Resources; Notice of Closed Meeting (FR Doc. 2010-23852)

Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2010-23847)

Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-23849)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-23860)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-23952)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2010-23543)

National Cancer Institute; Notice of Closed Meetings (FR Doc. 2010-23545)

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CBER


Warning Letters Regarding Advertising and Promotional Labeling (Biologics)

2010 Biological License Application Supplement Noteworthy Approvals 

2010 Biological Device Application Approvals  

Complete List of Currently Approved NDA and ANDA Application Submissions

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REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

FDA Calls for Hearing on Biosimilars Legislation
The Food and Drug Administration will hold a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products, according to a draft document circulating among healthcare lobbyists. [Food and Drug Administration, United States]

Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori [FDA-2010-D-0459]

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

New Study Launched for Pharmacists to Report Adverse Drug Reactions Electronically
The Medicines and Healthcare products Regulatory Agency is working in partnership with the UK Medicines Information service to make Yellow Card reporting easier for pharmacists.


EVENTS (Listed by Date)

Select Biosciences 6th Annual Ion Channel Targets Conference
September 28-29, 2010
Washington, DC, United States

5th Annual Meeting of the German Society for Stem Cell Research
September 30-October 2, 2010
Lubeck, Germany

Cytokines 2010: Cytokines in Infectious Diseases, Autoimmune Disorders and Cancer
October 3-7, 2010
Chicago, United States

2010 World Stem Cell Summit
October 4-6, 2010
Detroit, United States

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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