Volume 11.43 | Nov 8

Cell Therapy News 11.43, November 8, 2010.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  

TOP STORY  


Scientists Turn Skin into Blood 
In an important breakthrough, scientists have discovered how to make human blood from adult human skin. The discovery could mean that in the foreseeable future people needing blood for surgery, cancer treatment or treatment of other blood conditions like anemia will be able to have blood created from a patch of their own skin to provide transfusions. [Press release from McMaster University discussing online prepublication in Nature]
 
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SPECIAL FEATURE


Clinical Development to Commercial Development
With recognition that the International Society for Cellular Therapy (ISCT) is uniquely positioned to serve the global translational regenerative medicine research community as a network hub for scientific standards and policy, the ISCT commissioned the establishment of an Industry Task Force to address current and future roles for industry.[International Society for Cellular Therapy]

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SCIENCE NEWS


Armed Antibody Triggers Remissions for Hodgkin Lymphoma
An antibody loaded with an anti-cancer agent produced complete or partial remissions in 38 percent of patients with relapsed or therapy-resistant Hodgkin lymphoma enrolled in a Phase I clinical trial, investigators report. [Press release from the University of Texas MD Anderson Cancer Center discussing online prepublication in the New England Journal of Medicine]
 
Non-Small Cell Lung Cancer Study Highlights Advances in Targeted Drug Therapy
A multicenter study is testing whether the drug crizotinib effectively slows, stops or reverses growth in advanced non-small cell lung cancer tumors by targeting a genetic mutation that causes uncontrolled tumor growth. Study participants all tested positive for a mutation in the anaplastic lymphoma kinase gene. [Press release from the University of California, Irvine discussing online prepublication in the New England Journal of Medicine]
 
Scientists Find Non-Viral Pathway of Blood Cancer Development
An international team of scientists has found three new regions of DNA linked to the development of Hodgkin lymphoma. [Press release from The Institute of Cancer Research discussing online prepublication in Nature Genetics]
 
Breakthrough in Cancer Vaccine Research
New research reveals that a type of stromal cell found in many cancers which expresses fibroblast activation protein alpha plays a major role in suppressing the immune response in cancerous tumors — thereby restricting the use of vaccines and other therapies which rely on the body's immune system to work. [Press release from the University of Cambridge discussing online prepublication in Science]
 
Small Protein Changes May Make Big Difference in Natural HIV Control
An international research team describes finding that differences in five amino acids in a protein called HLA-B are associated with whether or not HIV-infected individuals can control viral levels with their immune system only. [Press release from Massachusetts General Hospital discussing online prepublication in Science]

Timing Is Everything in Combination Therapy for Osteoporosis
Researchers identified a subset of skeletal stem cells that were recruited to bone remodeling sites in response to bone resorption. Importantly, the authors demonstrated the TGF-beta1 is essential for recruitment of skeletal stem cells during PTH-stimulated bone remodeling. Further, alendronate inhibited release of TGF-beta1 during bone resorption. [Press release from EurekAlert! discussing online prepublication in Cell Stem Cell]
 
New Lymphoma Therapy May Be More Effective with Fewer Side Effects
Researchers have found a combination therapy that is more effective than traditional treatments and is able to kill the cancer cells without harm to surrounding tissues. [Press release from Weill Cornell Medical College discussing online prepublication in the Journal of Clinical Investigation]
 
Fly Stem Cells on Diet: Scientists Discovered How Stem Cells Respond to Nutrient Availability
A study revealed that stem cells can sense a decrease in available nutrients and respond by retaining only a small pool of active stem cells for tissue maintenance. When, or if, favorable conditions return, stem cell numbers multiply to accommodate increased demands on the tissue. [Press release from the Salk Institute for Biological Studies discussing online prepublication in Current Biology]
 
Study Finds NSAIDs Cause Stem Cells to Self-Destruct, Preventing Colon Cancer
Nonsteroidal anti-inflammatory drugs (NSAIDs) prevent colon cancer by triggering diseased stem cells to self-destruct, according to researchers. [Press release from the University of Pittsburgh Medical Center discussing online prepublication in the Proceedings of the National Academy of Sciences USA]
 
Of 50,000 Small Molecules Tested to Fight Cancer, Two Show Promise
A class of compounds that interferes with cell signaling pathways may provide a new approach to cancer treatment. The compounds, called PITs (non-phosphoinositide PIP3 inhibitors), limited tumor growth in mice by inducing cell death. [Press release from Tufts University School of Medicine discussing online prepublication in the Proceedings of the National Academy of Sciences USA]
 
Myostatin Exon Skipping Shows Promise for a Wide Range of Muscle Conditions
Researchers have used exon skipping technology in mice to block the activity of myostatin, a protein that prevents muscles from growing bigger and stronger. Scientists think that by blocking the activity of myostatin, it might be possible to build up muscle size and strength in people with muscle disease. [Press release from the Muscular Dystrophy Campaign discussing online prepublication in Molecular Therapy]
 
MRI Contrast Agents Change Stem Cell Proliferation
When researchers tested three different labeling agents on three different stem cell populations to determine what effect the labeling agents had on stem cell phenotype, biological behavior and migration abilities, they found changes in stem cell proliferation depending on the type of contrast agent used. [Press release from EurekAlert! discussing online prepublication in Cell Transplantation]
 
Researchers Engineer Miniature Human Livers in the Lab
Researchers have reached an early, but important, milestone in the quest to grow replacement livers in the lab. They are the first to use human liver cells to successfully engineer miniature livers that function — at least in a laboratory setting — like human livers. [Press release from Wake Forest University Baptist Medical Center discussing research presented at the 61st Annual Meeting of the American Association for the Study of Liver Diseases]

Scientists Unveil New Method to Create Bioartificial Organs
Spanish scientists presented a new technique to create bioartificial organs for transplant using stem cells which they said will vastly reduce the risk of rejection of the donated organ. The technique involves “stripping” a donated heart, liver or other organ which is deemed unsuitable for donation of their cells, leaving just a “scaffold.” [PhysOrg] 

Potential Breakthrough for TB Treatment
Immune Network Ltd. advises that a clinical trial of V5 Immunitor oral vaccine was published demonstrating an unexpected powerful effect against tuberculosis, including multi-drug-resistant tuberculosis and tuberculosis that is complicated by co-infection with HIV and hepatitis C. [Immune Network Ltd. Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Brentuximab Vedotin (SGN-35) for Relapsed CD30-Positive Lymphomas
To enhance the antitumor activity of CD30-directed therapy for Hodgkin's lymphoma and anaplastic large-cell lymphoma, the antitubulin agent monomethyl auristatin E was attached to a CD30-specific monoclonal antibody by an enzyme-cleavable linker, producing the antibody-drug conjugate brentuximab vedotin. [N Engl J Med]
 
Anaplastic Lymphoma Kinase Inhibition in Non–Small-Cell Lung Cancer
The inhibition of anaplastic lymphoma kinase (ALK) in lung tumors with the ALK rearrangement resulted in tumor shrinkage or stable disease in most patients. [N Engl J Med]
 
Direct Conversion of Human Fibroblasts to Multilineage Blood Progenitors
Researchers demonstrate the ability to generate progenitors and mature cells of the hematopoietic fate directly from human dermal fibroblasts without establishing pluripotency. [Nature]
 
A Genome-Wide Association Study of Hodgkin's Lymphoma Identifies New Susceptibility Loci at 2p16.1 (REL), 8q24.21 and 10p14 (GATA3)
To identify susceptibility loci for classical Hodgkin's lymphoma (cHL), researchers conducted a genome-wide association study of 589 individuals with cHL (cases) and 5,199 controls with validation in four independent samples totaling 2,057 cases and 3,416 controls. They identified three new susceptibility loci at 2p16.1, 8q24.21 and 10p14. [Nat Genet]
 
Suppression of Antitumor Immunity by Stromal Cells Expressing Fibroblast Activation Protein-Alpha
The stromal microenvironment of tumors suppresses immune control of tumor growth. A stromal cell type that was first identified in human cancers expresses fibroblast activation protein-alpha (FAP). Researchers created a transgenic mouse in which FAP-expressing cells can be ablated. [Science]
 
The Major Genetic Determinants of HIV-1 Control Affect HLA Class I Peptide Presentation
Specific amino acids in the HLA-B peptide binding groove, as well as an independent HLA-C effect, explain the SNP associations and reconcile both protective and risk HLA alleles. These results implicate the nature of the HLA-viral peptide interaction as the major factor modulating durable control of HIV infection. [Science]

Inhibition of Sca-1-Positive Skeletal Stem Cell Recruitment by Alendronate Blunts the Anabolic Effects of Parathyroid Hormone on Bone Remodeling
Researchers showed that mouse Sca-1-positive (Sca-1+) bone marrow stromal cells are a skeletal stem cell subset, which are recruited to bone remodeling sites by active TGF-beta1 in response to bone resorption. Alendronate inhibits the release of active TGF-beta1 and the recruitment of Sca-1+ skeletal stem cells for the bone formation. [Cell Stem Cell]
 
BCL6 Repression of EP300 in Human Diffuse Large B Cell Lymphoma Cells Provides a Basis for Rational Combinatorial Therapy
Researchers show that retro-inverted BCL6 peptide inhibitor induces a particular gene expression signature in human diffuse large B cell lymphoma cell lines that included genes associated with the actions of histone deacetylase and Hsp90 inhibitors. [J Clin Invest]
 
Stem Cell Dynamics in Response to Nutrient Availability
Data indicate that stem cells can directly sense changes in the systemic environment to coordinate their behavior with the nutritional status of the animal, providing a paradigm for maintaining tissue homeostasis under metabolic stress. [Curr Biol]

Chemoprevention by Nonsteroidal Anti-Inflammatory Drugs Eliminates Oncogenic Intestinal Stem Cells via SMAC-Dependent Apoptosis
Results suggest that effective chemoprevention of colon cancer by nonsteroidal anti-inflammatory drugs lies in the elimination of stem cells that are inappropriately activated by oncogenic events through induction of apoptosis. [Proc Natl Acad Sci U S A]

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POLICY


Last Brief Filed in Stem Cell Lawsuit
The documents are all in for the government's appeal of a 23 August preliminary injunction that briefly shut down stem cell research. [Court of Appeals, United States]
 
Scientists to Congress: Pass the Stem Cell Law … While You Still Can
In a letter sent to the leadership of the House of Representatives and the Senate, the deans of American medical schools, chief executives of U.S. hospitals and heads of organizations with names like the American Society for Biochemistry and Molecular Biology and the American Society of Human Genetics said that federal funding for human embryonic stem cell research “is essential” if scientists are to succeed in turning the cells into usable treatments. [Congress, United States]
 
Court Sets Date for Oral Arguments in Stem Cell Appeal
An appeals court in Washington, D.C. has set December 6th as the date it will hear oral arguments on whether U.S. government funding of human embryonic stem cell research should remain legal. [Court of Appeals, United States]
 
Korean Supreme Court Rules Stem Cells as Medicine
The Supreme Court has ruled that stem cells used to treat illnesses should be regarded as medicine that requires approval from the drug administration for use. [Supreme Court, Korea]

Agency Information Collection Request. 30-Day Public Comment Request (FR Doc. 2010-27842) [Department of Health and Human Services, United States]

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BUSINESS


Alnylam, Medtronic, and CHDI Foundation Form Collaboration to Advance RNAi Therapeutics for the Treatment of Huntington's Disease
Alnylam Pharmaceuticals, Inc., Medtronic Inc., and CHDI Foundation, Inc., announced that they have formed a collaboration to advance ALN-HTT, a novel drug-device combination for the treatment of Huntington's disease. [Alnylam Pharmaceuticals, Inc. Press Release]
 
Dako and Quintiles Form Alliance to Speed Development of Personalized Medicine
Dako and Quintiles announced a strategic alliance to advance personalized medicine by collaborating on the co-development of targeted therapies and companion diagnostics. [Quintiles Press Release]
 
Fibrocell Science, Inc. Establishes Joint Venture to Market Its Technology Platform in Asia
Fibrocell Science, Inc. announced that it has signed an agreement to establish a joint venture with Hefei Meifu Bio-Tech Limited Co. for developing and marketing autologous fibroblast therapies in Asia, excluding Japan. The joint venture will be called Fibrocell Science Asia Co. Ltd. [Fibrocell Science, Inc. Press Release]

ThermoGenesis Signs Major Bone Marrow Product Distribution Agreement in China
ThermoGenesis Corporation said it has signed a distribution agreement covering China and Hong Kong for its products used to prepare cell concentrates, including stem cells, from bone marrow, at the point-of-care and in the laboratory. [ThermoGenesis Corporation Press Release]

Secretaries Geithner, Sebelius, NIH Director Collins Announce Recipients of Affordable Care Act Grants to Support Groundbreaking Biomedical Research
Secretary of the Treasury Tim Geithner and Secretary of Health and Human Services Kathleen Sebelius joined with NIH Director Dr. Francis Collins to announce the recipients of the $1 billion in new therapeutic discovery project credits and grants created by the Affordable Care Act. [Department of Health and Human Services Press Release]

Helmsley Charitable Trust Awards More than $15 Million to Salk Institute-Columbia University Collaborative Stem Cell Research Effort
The Salk Institute for Biological Studies and Columbia University Medical Center have been awarded a $15 million grant by The Leona M. and Harry B. Helmsley Charitable Trust, establishing a collaborative program to fast-track the use of induced pluripotent stem cells to gain new insight into disease mechanisms and screen for novel therapeutic drugs. [Salk Institute for Biological Studies Press Release]
 
Karyopharm Therapeutics Inc. Closes $20 Million Series A Financing to Advance Pipeline of Novel Nuclear Transport Modulators for Cancer, Inflammation and Other Disorders
Karyopharm Therapeutics Inc. has completed a $20 million Series A financing. Karyopharm is focused on the discovery and development of novel selective inhibitors of nuclear export (SINE) for the treatment of cancer, autoimmune diseases and HIV. [PR Newswire]
 
NIH Renews Georgia Tech-Led Nanomedicine Center For $16.1 Million
The Georgia Tech-led Nanomedicine Center for Nucleoprotein Machines has received an award of $16.1 million for five years as part of its renewal by the National Institutes of Health (NIH). The eight-institution research team plans to pursue development of a clinically viable gene correction technology for single-gene disorders and demonstrate the technology's efficacy with sickle cell disease. [Georgia Institute of Technology Press Release]
 
Texas Center for Cancer Nanomedicine Targets Two Tough Cancers
A $16-million, five-year grant by the National Cancer Institute's nanomedicine initiative blends the expertise of five research institutions to focus an array of innovative nanotechnologies on improving the outcome of patients with ovarian or pancreatic cancers. [University of Texas MD Anderson Cancer Center Press Release]
 
Roche Reports Promising Phase II Results with New Targeted Approach in Advanced Melanoma
Roche announced results from a Phase II clinical study of RG7204 (PLX4032), an investigational first-in-class molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in approximately half of metastatic melanoma tumors. [Roche Press Release]
 
Local Chinese Government Authorities Approve Pricing and Reimbursement for NeoStem's Licensed Adult Stem Cell Treatments for Orthopedic Applications in China
NeoStem, Inc. announced that Weihai Municipal Price Bureau, the local authority in charge of pricing for public medical services in China, approved the pricing for single side and bilateral arthroscopic orthopedic autologous adult stem cell based treatment being administered at Wendeng Orthopedic Hospital. [NeoStem, Inc. Press Release]


NIH
 

Issues Persist with NIH Genetic Testing Registry
Dozens of geneticists showed up at a 1-day public meeting and voiced their concerns about a planned registry of genetic tests run by the National Institutes of Health (NIH). The gathering highlighted ongoing worries about how the registry will work and whether it will leave consumers thinking that the tests listed there are all scientifically solid.
 
Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-27743)

Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2010-27575)
 
National Cancer Institute; Notice of Closed Meeting (FR Doc. 2010-27626)
 
National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2010-27562)
 
Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-28072)

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CBER


2010 Meeting Materials, Cellular, Tissue and Gene Therapies Advisory Committee 

Agenda: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule


REGULATORY


FOOD AND DRUG ADMINISTRATION (United States)

Agency Information Collection Activities: Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension [Docket No. FDA-2010-N-0536]

Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability [Docket No. FDA-2009-D-0132]
 
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Review of Medicines Legislation: Informal Consultation on the Provisions for Patient Group Directions (PGDs) and Other Matters
As part of the Agency’s review of medicines legislation, they are looking at the provisions for PGDs in the National Health Service and private sector. 

Information Sent to Healthcare Professionals in October About the Safety of Medicines

THERAPEUTIC GOODS ADMINISTRATION (Australia)

TGA Approved Terminology for Medicines
The Therapeutic Goods Administration (TGA) has developed and maintains lists of Australian approved terminology, to ensure accuracy and consistency in the information compiled in the Australian Register of Therapeutic Goods.
 
European Union Guidelines – Newly Published



EVENTS (Listed by Date)

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

Select Biosciences 2nd International Forum on Stem Cells
November 12-13, 2010
Tianjin, China

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

The 16th International Conference of the International Society of Differentiation: From Stem Cells to Organisms
November 15-18, 2010
Nara, Japan

3rd Annual Workshop on Genome Engineering
November 16, 2010
Seattle, United States

22nd European Organization for Research and Treatment of Cancer (EORTC)-National Cancer Institute (NCI)-American Association for Cancer Research (AACR) Symposium: Molecular Targets and Cancer Therapeutics
November 16-19, 2010
Berlin, Germany

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

Translational Excellence in Regenerative Medicine (TeRM) – Biophysical Stimuli and Mass Transport for Tissue Development
November 18-19, 2010
Lattrop, The Netherlands

4th Annual Conference of the Korea Society of Gene Therapy (KSGT)
November 19, 2010
Seoul, Korea

Stem Cell Network's 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

American Association for Cancer Research (AACR) Tumor Immunology – Basic and Clinical Advances
November 30-December 3, 2010
Miami, United States

2nd European Association for Cardio-Thoracic Surgery (EACTS) Meeting on Cardiac and Pulmonary Regeneration
December 3-4, 2010
Vienna, Austria

3rd Annual BioPartnering China
December 5-7, 2010
Shanghai, China

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

5th Annual Stem Cell Meeting on the Mesa
December 7, 2010
La Jolla, United States

Genesis 2010
December 9, 2010
London, United Kingdom

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

Pharmacology in Stem Cells Research and Regenerative Medicine
December 17, 2010
London, United Kingdom

Functional Consequences of Structural Variation in the Genome
January 8-13, 2011
Steamboat Springs, United States

COGEM Symposium: GM Viruses as Medicine: Panacea or Pandora's Box?
January 20, 2011
Amsterdam, The Netherlands

Extracellular Matrix and Cardiovascular Remodeling
January 23-28, 2011
Tahoe City, United States

5th Annual Stem Cells and 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, D.C., United States

Phacilitate 9th Annual North American Vaccine Forum
January 24-26, 2011
Washington, D.C., United States

IQPC’s 4th Biobanking Conference
January 24-26, 2011
Philadelphia, United States

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

16th Proteomics Symposium
February 3-6, 2011
Lorne, Australia

36th Lorne Conference on Protein Structure and Function
February 6-10, 2011
Lorne, Australia

CMC Workshop: Translating Science into Successful Regulatory Submissions
February 7-9, 2011
Washington, D.C., United States

23rd Lorne Cancer Conference
February 10-12, 2011
Lorne, Australia

32nd Lorne Genome Conference
February 13-15, 2011
Lorne, Victoria

BMT Tandem Meetings (ASBMT/CIBMTR)
February 17-21, 2011
Honolulu, Hawaii

1st Annual Clinical Meeting of the Cell Society
February 18-19, 2011
La Jolla, United States

Molecular Medicine Tri-Conference: Stem Cells – Revolutionizing Regenerative Medicine and Personalized Therapy 2011
February 23-25, 2011
San Francisco, United States

Molecular Medicine Tri-Conference: Inaugural Circulating Tumor Cells for Cancer Detection, Diagnosis, Prognosis and Treatment
February 23-25, 2011
San Francisco, United States

American Association for Cancer Research (AACR) Targeting PI3K/mTOR Signaling in Cancer
February 24-27, 2011
San Francisco, United States

9th Annual BioPartnering North America
February 27-March 1, 2011
Vancouver, Canada

18th Conference on Retroviruses and Opportunistic Infections (CROI 2011)
February 27-March 2, 2011
Boston, United States

NEW 6th Annual Stem Cell Summit
March 1, 2011
New York, United States

American Association for Cancer Research (AACR) Stem Cells, Development, and Cancer
March 3-6, 2011
Vancouver, Canada

Stem Cells, Cancer and Metastasis (C4)
March 6-11, 2011
Dillon, United States

BIO-Europe Spring 2011
March 14-16, 2011
Milan, Italy

The 6th International Conference on Oncolytic Viruses as Cancer Therapeutics
March 16-19, 2011
Las Vegas, United States

HIV Evolution, Genomics and Pathogenesis
March 20-25, 2011
Whistler, Canada

United Kingdom National Stem Cell Network 2011 Annual Scientific Conference
March 30-April 1, 2011
York, United Kingdom

10th Annual New England Science Symposium
April 1, 2011
Boston, United States

American Association for Cancer Research (AACR) 102nd Annual Meeting 2011
April 2-6, 2011
Orlando, United States

5th RNAi & miRNA World Congress
April 26-27, 2011
Boston, United States

3rd Epigenetics World Congress
April 26-27, 2011
Boston, United States

Inaugural Next-Gen Sequencing Congress
April 26-27, 2011
Boston, United States

GTCbio 2nd International Conference on Cancer Immunotherapy & Immunomonitoring
May 2-5, 2011
Budapest, Hungary

Australasian Gene Therapy Society (AGTS) 7th Meeting
May 4-6, 2011
Melbourne, Australia

BioPartnering India
May 4-6, 2011
Bangalore, India

Inaugural Theranostics for Personalised Medicine
May 18-19, 2011
London, United Kingdom

International Society for Cellular Therapy (ISCT) 17th Annual Meeting
May 18-21, 2011
Rotterdam, The Netherlands

American Society of Gene and Cell Therapy (ASGCT) 14th Annual Meeting
May 18-21, 2011
Seattle, United States

13th Annual C21 BioVentures
May 24-26, 2011
Napa, United States

Gordon Research Conference: Viruses & Cells
May 29-June 3, 2011
Lucca (Barga), Italy

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

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