Volume 12.01 | Jan 10

Cell Therapy News 12.01, January 10, 2011.
In this issue:  Science  |  Policy  |  Business  |  NIH  |  CBER  |  Regulatory  |  Events Subscribe  


Patient-Derived Embryonic Stem Cells Help Deliver “Good Genes” in a Model of Inherited Blood Disorder 
Researchers report a gene therapy strategy that improves the condition of a mouse model of an inherited blood disorder, beta thalassemia. The gene correction involves using unfertilized eggs from afflicted mice to produce a batch of embryonic stem cell lines. [Press release from Nationwide Children’s Hospital discussing online prepublication in the Journal of Clinical Investigation]



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Punctuated Evolution in Cancer Genomes
Remarkable new research overthrows the conventional view that cancer always develops in a steady, stepwise progression. It shows that in some cancers, the genome can be shattered into hundreds of fragments in a single cellular catastrophe, wreaking mutation on a massive scale. [Press release from the Wellcome Trust Sanger Institute discussing online prepublication in Cell]

Genetic Abnormalities Identified in Pluripotent Stem Cell Lines
A multinational team of researchers has documented specific genetic abnormalities that occur in human embryonic and induced pluripotent stem cell lines. [Press release from University of California, San Diego discussing online prepublication in Cell Stem Cell]
Stem Cell Discovery Could Lead to Improved Bone Marrow Transplants
Researchers have identified a key molecule for establishing blood stem cells in their niche within the bone marrow. [Press release from the University of California, Santa Cruz discussing online prepublication in Cell Stem Cell]

Researchers Publish Findings That May Have Significant Implications for Brain Repair and Abnormal Brain Development
Researchers have shown for the first time that neural stem cells maintain high levels of reactive oxygen species to help regulate normal self-renewal and differentiation. [Press release from the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research discussing online prepublication in Cell Stem Cell]

Male Pattern Balding May Be Due to Stem Cell Inactivation
In a new study, researchers have found that stem cells play an unexpected role in explaining what happens in bald scalp. [Press release from the University of Pennsylvania School of Medicine discussing online prepublication in the Journal of Clinical Investigation]

Transforming Skin Cells Into Cartilage
Researchers at the Osaka University Graduate School of Medicine used fibroblasts isolated from adult mouse skin and expressed proteins used to induce pluripotency along with a factor that promotes a chondrocyte fate. The resulting cells resembled chondrocytes and produced cartilage when injected into mice. [Press release from EurekAlert! discussing online prepublication in the Journal of Clinical Investigation]
Australian Researchers Identify Gene Mutations That Sabotage Kidney Function
Researchers have identified gene mutations that impair kidney function leading to a rare kidney disorder known as dicarboxylic aminoaciduria. The same gene, which is also crucial for normal brain function, has been connected with obsessive compulsive-disorder. [Press release from the Centenary Institute discussing online prepublication in the Journal of Clinical Investigation]
Cancer Cell Survival Is Not ‘miR-ly’ Dependent on p53
Researchers Massachusetts General Hospital investigated the p53-related proteins p63 and p73 in squamous cell carcinoma (SCC) cells, and discovered a feedback loop between p63, microRNAs (miRs), and p73. In a model of SCC, they found that inhibiting one of these miRs decreased tumor growth and made the cells more sensitive to chemotherapy, highlighting a new potential therapeutic target. [Press release from EurekAlert! discussing online prepublication in the Journal of Clinical Investigation]

Pandemic Flu Strain Could Point Way to Universal Vaccine
Data shows that infection with the 2009 pandemic influenza strain could induce broadly protective antibodies that are only rarely seen after seasonal flu infections or flu shots. These findings show that these types of antibodies can be induced in humans, if the immune system has the right stimulation, and suggest that a pan-influenza vaccine might be feasible. [Press release from Emory University School of Medicine discussing online prepublication in the Journal of Experimental Medicine]
Scientists Now Know Why Some Cancers Become Malignant and Others Don't
Cancer cells reproduce by dividing in two, but a molecule known as PML limits how many times this can happen, according to researchers. The team proved that malignant cancers have problems with this molecule, meaning that in its absence they can continue to grow and eventually spread to other organs. [Press release from the University of Montreal discussing online prepublication in Genes and Development]

Researchers Show How Thymosin Beta 4 Protects Human Stem Cells
RegeneRx Biopharmaceuticals, Inc. reported that a team of cardiovascular researchers in China have shown that thymosin beta 4 can protect endothelial progenitor cells derived from the blood of healthy human volunteers. [Press release from RegeneRx Biopharmaceuticals, Inc. discussing online prepublication in the Journal of Cellular Physiology]

Extracting Cellular 'Engines' May Aid in Understanding Mitochondrial Diseases
Medical researchers who crave a means of exploring the genetic culprits behind a host of neuromuscular disorders may have just had their wish granted: a team of scientists have performed surgery on single cells to extract and examine their mitochondria. [Press release from the National Institute of Standards and Technology discussing online prepublication in PLoS One]
Faster, Scalable Method for Producing AAV-Based Gene Transfer Vectors Described
A new, simplified method for producing large amounts of viral vector cassettes capable of shuttling genes into host cells will help advance the promising field of gene therapy as applications move into large animal studies and human clinical trials. [Press release from Mary Ann Liebert, Inc. Publishers discussing online prepublication in Human Gene Therapy]

Nanocarriers Come Through
A new nanodelivery system is able to sneak cancer treatments past the defenses of drug-resistant tumor cells — offering hope to many cancer patients who benefit little from existing drug treatments. [Press release from MIT Technology Review discussing online prepublication in Science Translational Medicine]
Interim Results from Mesoblast's Phase II Heart Failure Trial Shows “Off-the-Shelf” Proprietary Adult Stem Cell Product Revascor™ Reduces Cardiac Events, Mortality, and Hospitalization
Cephalon, Inc. and Mesoblast Limited announced positive interim results from Mesoblast's ongoing multi-center Phase II trial of its “off-the-shelf” proprietary adult stem cell product Revascor™ for patients with congestive heart failure [Mesoblast Limited Press Release]

Bioheart Reports Positive Results for Adipose Derived Stem Cells in Critical Limb Ischemia
Bioheart, Inc. announced positive efficacy data has been reported from the registry study of bone marrow and adipose derived stem cells for the treatment of end stage critical limb ischemia with wounds. [Bioheart, Inc. Press Release]
Generex and RXi Pharmaceuticals Announce Positive Research Data Using RNAi Technology in the Development of Therapeutic Vaccines for Cancer
Generex Biotechnology Corporation, together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, Inc., and RXi Pharmaceuticals Corporation announced that they have obtained positive early research data from their collaboration to explore the use of RXi's RNAi technology to develop proprietary vaccine formulations for active immunotherapy. [RXi Pharmaceuticals Corporation Press Release]

CURRENT PUBLICATIONS (Ranked by Impact Factor of the Journal)

Massive Genomic Rearrangement Acquired in a Single Catastrophic Event During Cancer Development
Using next-generation sequencing, researchers characterize a phenomenon, which they term chromothripsis, whereby tens to hundreds of genomic rearrangements occur in a one-off cellular crisis. [Cell]

Dynamic Changes in the Copy Number of Pluripotency and Cell Proliferation Genes in Human ESCs and iPSCs During Reprogramming and Time in Culture
Results illustrate the dynamic nature of genomic abnormalities in pluripotent stem cells and the need for frequent genomic monitoring to assure phenotypic stability and clinical safety. [Cell Stem Cell]

Robo4 Cooperates with Cxcr4 to Specify Hematopoietic Stem Cell Localization to Bone Marrow Niches
Researchers demonstrate that the guidance molecule Robo4 functions to specifically anchor hematopoietic stem cells to bone marrow niches. [Cell Stem Cell]

Proliferative Neural Stem Cells Have High Endogenous ROS Levels That Regulate Self-Renewal and Neurogenesis in a PI3K/Akt-Dependant Manner
Researchers investigated reactive oxygen species (ROS) function in primary brain-derived neural progenitors. Somewhat surprisingly, they found that proliferative, self-renewing multipotent neural progenitors with the phenotypic characteristics of neural stem cells maintained a high ROS status and were highly responsive to ROS stimulation. [Cell Stem Cell]
Gene Therapy by Allele Selection in a Mouse Model of Beta-Thalassemia
Researchers present proof of principle that, for diseases associated with dominant alleles (gain-of-function or haploinsufficient loss-of-function), disease allele-free embryonic stem cells can be derived from afflicted individuals without genome manipulation. [J Clin Invest]
Bald Scalp in Men with Androgenetic Alopecia Retains Hair Follicle Stem Cells but Lacks CD200-Rich and CD34-Positive Hair Follicle Progenitor Cells
Findings support the notion that a defect in conversion of hair follicle stem cells to progenitor cells plays a role in the pathogenesis of androgenetic alopecia. [J Clin Invest]
Generation of Hyaline Cartilaginous Tissue from Mouse Adult Dermal Fibroblast Culture by Defined Factors
Researchers show that retroviral expression of two reprogramming factors (c-Myc and Klf4) and one chondrogenic factor (SOX9) induces polygonal chondrogenic cells directly from adult dermal fibroblast cultures. [J Clin Invest]
Loss-of-Function Mutations in the Glutamate Transporter SLC1A1 Cause Human Dicarboxylic Aminoaciduria
Researchers report that SLC1A1 mutations leading to substitution of arginine to tryptophan at position 445 and deletion of isoleucine at position 395 cause human dicarboxylic aminoaciduria, an autosomal recessive disorder of urinary glutamate and aspartate transport that can be associated with mental retardation. [J Clin Invest]
A MicroRNA-Dependent Program Controls p53-Independent Survival and Chemosensitivity in Human and Murine Squamous Cell Carcinoma
Researchers have identified a direct, microRNA-dependent regulatory circuit mediating inducible chemoresistance, whose inhibition may provide a new therapeutic opportunity in p53-deficient tumors. [J Clin Invest]
Broadly Cross-Reactive Antibodies Dominate the Human B Cell Response Against 2009 Pandemic H1N1 Influenza Virus Infection
Researchers report a detailed analysis of plasmablast and monoclonal antibody responses induced by pandemic H1N1 infection in humans. Unlike antibodies elicited by annual influenza vaccinations, most neutralizing antibodies induced by pandemic H1N1 infection were broadly cross-reactive against epitopes in the hemagglutinin stalk and head domain of multiple influenza strains. [J Exp Med]
Detection of Heteroplasmic Mitochondrial DNA in Single Mitochondria
This work describes a method for isolating individual mitochondria from single cells and performing molecular analysis on that single mitochondrion's DNA. [PLoS One]
Improving Drug Potency and Efficacy by Nanocarrier-Mediated Subcellular Targeting
Researchers investigated the real-time subcellular fate of polymeric micelles incorporating (1,2-diaminocyclohexane) platinum(II) (DACHPt/m), the parent complex of oxaliplatin, in tumor tissues by fluorescence-based assessment of their kinetic stability. [Sci Transl Med]



How New COMPETES Science Law Broadens NSF Education Programs
Only one of the seven directorates at the National Science Foundation (NSF) has “education” in its title. But the reauthorization of the America COMPETES Act spells out program changes meant to ensure that every component of the $7 billion agency is involved in training the next generation of researchers and improving public scientific literacy. [National Science Foundation, United States]
ESF Moves Toward Rebirth, But Change Worries Some
2011 will likely see the end of the European Science Foundation (ESF), at least in its current form. After 37 years of funding researchers, organizing collaborations, and convening meetings across the continent, ESF is expected to transform into a lobbying and strategy organization. [European Science Foundation, European Union]

Judicial Watch Sues Health and Human Services to Obtain Documents Regarding Medicare/Medicaid Review of Cancer Treatment Provenge
Judicial Watch announced that it filed a lawsuit on January 3, 2011, against the Obama Department of Health and Human Services regarding a controversial decision by the Centers for Medicare and Medicaid Services to undertake a one-year review of the prostate cancer treatment Provenge to determine if the treatment is “reasonable and necessary” and should therefore be reimbursed. [Judicial Watch Press Release]



Cell Medica Signs an Exclusive License Agreement and Strengthens Collaboration with the Center for Cell and Gene Therapy, Baylor College of Medicine
Cell Medica announced an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy, Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus. [Cell Medica Limited Press Release]

AVI BioPharma and Leading Researchers at Karolinska Institutet Form Collaboration to Identify RNA-Based Therapeutic Candidates for Treatment of Extensively Drug-Resistant Tuberculosis (XDR-TB)
AVI BioPharma, Inc. announced the formation of a collaboration with leading scientists at the Swedish medical university Karolinska Institutet to identify RNA-based therapeutic candidates for the treatment of Extensively Drug-Resistant Tuberculosis. [AVI BioPharma, Inc. Press Release]

Horizon and University of Washington Announce Collaboration to Apply rAAV Gene Editing in iPS Cells
Horizon Discovery a leading provider of research tools to support the development of personalized medicines, and the University of Washington announced that they have entered into a two-year research collaboration aimed at generating a process for gene editing in inducible human pluripotent stem (iPS) cells. [Horizon Discovery Limited Press Release]

ReproCELL to Enter Collaborative R&D on Human iPS Cell Derived Hepatocytes
ReproCELL, Inc. announced that the company will enter a collaborative R&D agreement with the National Institute of Biomedical Innovation, which could offer new hepatocyte derived from human iPS (induced pluripotent stem) cells used for an effective in vitro drug screening for hepatic toxicity and liver metabolism. [PR Newswire]

Santaris Pharma A/S Announces Expanded Worldwide Strategic Alliance with Pfizer Inc. Directed to Development of RNA-Targeted Medicines
Santaris Pharma A/S and Pfizer Inc. announced that the companies have expanded their collaboration directed to the development and commercialization of RNA-targeted medicines using Santaris Pharma A/S Locked Nucleic Acid Drug Platform. [Santaris Pharma A/S Press Release]

Seattle Genetics Announces Antibody-Drug Conjugate Collaboration with Pfizer
Seattle Genetics, Inc. announced that it has entered into a collaboration agreement with Pfizer Inc. under which Pfizer will pay an upfront fee of $8 million for rights to utilize Seattle Genetics' antibody-drug conjugate technology with antibodies to a single oncology target. [Seattle Genetics, Inc. Press Release]

Transposagen and Cellular Dynamics International Cross-License Technologies for Induced Pluripotent Stem Cells
Transposagen Biopharmaceuticals, Inc. announced that it has entered into a non-exclusive license agreement with Cellular Dynamics International, the world’s largest producer of human induced pluripotent stem cell lines and tissue cells, for drug discovery and safety. [Transposagen Biopharmaceuticals, Inc. Press Release]

AMT to Supply cGMP Manufacturing to Consortium Led by Institut Pasteur for Clinical Development of Gene Therapy for Rare Genetic Disorder in Children
Amsterdam Molecular Therapeutics (AMT) announced that it has entered into an agreement with Institut Pasteur, Paris, France, and a group of French research institutes to support clinical development of a novel gene therapy to treat Sanfilippo B. [Amsterdam Molecular Therapeutics Press Release]

ZIOPHARM Oncology and Intrexon Announce Worldwide Partnership for Synthetic Biology DNA-Based Oncology Therapeutics
ZIOPHARM Oncology, Inc. and Intrexon Corporation announced a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector® Technology. [ZIOPHARM Oncology, Inc. Press Release]

Epizyme Announces Strategic Alliance to Develop Epigenetic Therapeutics
Epizyme announced a worldwide strategic alliance with GlaxoSmithKline to discover, develop, and market novel small molecule therapeutics targeting histone methyltransferases, an important class of epigenetic enzymes, for the treatment of cancer and other diseases. [Epizyme, Inc. Press Release]

RegeneRx Biopharmaceuticals Receives $1.45 Million and Secures Additional $11 Million in Committed Funding
RegeneRx Biopharmaceuticals, Inc. announced that affiliates of the Company's largest stockholder, Sigma-Tau Group, have purchased $950,000 of the Company's common stock, and a new institutional investor, Lincoln Park Capital Fund, LLC, has purchased $500,000 of the Company's common stock. [RegeneRx Biopharmaceuticals, Inc. Press Release]

Multiple Myeloma Research Foundation Invests $3 Million in Development of Next-Generation Treatments
The Multiple Myeloma Research Foundation announced that it has awarded $1 million to each of three Boston-area biotech companies through its 2010 Biotech Investment Awards program: Constellation Pharmaceuticals, Inc., Epizyme, Inc. and Karyopharm Therapeutics, Inc. [Multiple Myeloma Research Foundation Press Release]

Dendreon Announces Plans to Seek Marketing Authorization for PROVENGE in Europe
Dendreon Corporation announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline. [Dendreon Corporation Press Release]
Aldagen Announces FDA Clearance of IND to Begin Phase II Study in Ischemic Stroke with Regenerative Cell Therapy
Aldagen, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to conduct a clinical trial using Aldagen's ALD-401, a unique stem cell population, for the treatment of stroke patients. [MarketWire]
MolMed Receives IND Clearance by the FDA to Conduct a Phase III Trial of TK for High-Risk Leukemia in the United States
MolMed S.p.A. announced that it received clearance from the U.S. Food and Drug Administration (FDA) for an IND filed to conduct a Phase III clinical trial of TK, its investigational cell-based therapy for the treatment of high-risk leukemia. [MolMed S.p.A. Press Release]
CEL-SCI Corporation Receives Russian Government Approval to Commence Phase III Clinical Trial of Multikine in Head and Neck Cancer
CEL-SCI Corporation announced it has received governmental approval from the Ministry of Health Care and Social Development of the Russian Federation to begin enrollment of subjects for a Phase III clinical trial of Multikine® in Russia. [CEL-SCI Corporation Press Release]

UTHealth Studies Cord Blood Stem Cells for Pediatric Traumatic Brain Injury
The University of Texas Health Science Center at Houston (UTHealth) has begun enrollment for the first Phase I safety study approved by the Food and Drug Administration to investigate the use of a child’s own umbilical cord blood stem cells for traumatic brain injury in children. [University of Texas Health Science Center at Houston Press Release]
The Power of “Convergence”
A new model for scientific research known as “convergence” offers the potential for revolutionary advances in biomedicine and other areas of science, according to a white paper issued today by 12 leading Massachusetts Institute of Technology researchers. [Massachusetts Institute of Technology Press Release]


Amid Legal Uncertainties, NIH Approves More Embryonic Stem Cells
The legal battle over whether taxpayer dollars can go toward human embryonic stem cells research continues to drag on, but the US National Institutes of Health (NIH) is not waiting for a final court decision before adding new cell lines to its list of those eligible for financial backing.

Despite Dire Budget Outlook, Panel Tells NIH to Train More Scientists
Despite the grim employment picture for would-be academic researchers, the National Institutes of Health (NIH) should maintain or even increase the number of graduate students and postdocs it supports.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting (FR Doc. 2010-33325)
National Cancer Institute; Notice of Meeting (FR Doc. 2010-33321)
National Cancer Institute; Notice of Meeting (FR Doc. 2010-33291)
National Cancer Institute; Notice of Closed Meeting (FR Doc. 2011-253)
National Heart, Lung, and Blood Institute; Notice of Meeting (FR Doc. 2011-254)
Center for Scientific Review; Amended Notice of Meeting (FR Doc. 2011-255)
Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-257)
Center for Scientific Review; Notice of Closed Meetings (FR Doc. 2011-256)



December 14, 2010: Blood Products Advisory Committee Meeting Transcript

December 15, 2010: Blood Products Advisory Committee Meeting Transcript

2010 Biological License Application Supplement Noteworthy Approvals 

2010 Biological Device Application Approvals  

Roster of the Cellular, Tissue and Gene Therapies Advisory Committee 

7341.002A – Inspection of Tissue Establishments

Engerix-B: Approval Letter and Package Insert




FDA Launches Website to Help Regulated Industries Save Time, Resources
The U.S. Food and Drug Administration introduced a new web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency.

FDA's Number Two Official Leaving for Maryland
Joshua Sharfstein, the number two official at the U.S. Food and Drug Administration (FDA), is leaving next week to head health services for the State of Maryland, according to news reports. The 41-year-old pediatrician has been a key player with FDA Commissioner Margaret Hamburg in reforming the agency over the past 2 years.

Hamburg Names John Taylor as Acting FDA Deputy
U.S. Food and Drug Administration (FDA) commissioner Dr. Margaret Hamburg named her office's top lawyer, John Taylor III, to be the temporary replacement for outgoing deputy commissioner Dr. Joshua Sharfstein.
FDA Transparency Initiative: Improving Transparency to Regulated Industry [Docket No. FDA-2009-N-0247]
Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability [Docket No. FDA-2010-D-0643]


TGA Prescription Medicine Streamlined Submission Process – Questions And Answers (Updated)
Therapeutic Goods Committee (Updated Meeting Dates) 


NEW Keystone Symposia : Genomic Instability and DNA Repair
January 30-February 4, 2012
Keystone, United States

NEW 7th Annual Conference on Biotechnology (STEM 2011)
January 31-February 1, 2011
Gurgaon, India

NEW 7th Annual Swiss Stem Cell Network Meeting
February 4, 2011
Lausanne, Switzerland

 Keystone Symposia : Antibodies as Drugs
February 6-11, 2012
Keystone, United States

 Keystone Symposia: Cancer Control by Tumor Suppressors and Immune Effectors
February 12-17, 2010
Santa Fe, United States

NEW Keystone Symposia: Dendritic Cells and the Initiation of Adaptive Immunity
February 12-17, 2011
Santa Fe, United States

NEW Gordon Research Conference: Stem Cells & Cancer
February 20-25, 2011
Ventura, United States

NEW Human Genomics: The Next 10 Years
February 22-23, 2011
La Jolla, United States

NEW Keystone Symposia: Mechanisms of Cardiac Growth, Death and Regeneration
February 22-27, 2011
Keystone, United States

NEW Student Biotechnology Network : Biotech Expo and Conference
March 1, 2011
Vancouver, Canada

NEW BioPharma Asia
March 28-31, 2011
Marina Bay Sands, Singapore

NEW Human Pluripotent Stem Cell Training Course
April 1-2, 2011
Vancouver, Canada

NEW Stem Cell Network North Rhine Westphalia 6th International Meeting
April 5-6, 2011
Essen, Germany

NEW 7th Annual BioProcess International Europe
April 6-7, 2011
Nice, France

NEW 10th Meeting of the International Hand and Composite Tissue Allotransplantation Society
April 7-9, 2011
Atlanta, United States

NEW Experimental Biology 2011
April 9-13, 2011
Washington, DC, United States

NEW Annual International Conference on Stem Cell Research (SCR 2011)
April 25-26, 2011
Penang, Malaysia

NEW 7th Annual Protein Engineering Summit (PEGS)
May 9-13, 2011
Boston, United States

NEW 22nd European Society of Animal Cell Technology (ESACT) Meeting 2011
May 15-18, 2011
Vienna, Austria

NEW 2011 In Vitro Biology Meeting
June 4-8, 2011
Raleigh, United States

NEW International Society for Stem Cell Research (ISSCR) 9th Annual Meeting
June 15-18, 2011
Toronto, Canada

NEW 5th Annual Lab-on-a-Chip European Congress
June 30-July 1, 2011
Hamburg, Germany

NEW 4th Annual Advances in Biodetection & Biosensors Conference and Exhibition
June 30-July 1, 2011
Hamburg, Germany

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


Lab Technologist – Cell Separation (STEMCELL Technologies)

Lab Technologist – Human Embryonic and Induced Pluripotent Stem Cells (STEMCELL Technologies)

Lab Technologist – Tissue Culture (STEMCELL Technologies)

Assistant Professor (University of Pittsburgh School of Medicine, Center for Cellular and Molecular Engineering)

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