11.25.09
Recently Gene Express has received recently significant recognition for its technology.
1. Gene Express has received the NIH GO grant, submitted in early June to the National Institute of Health (NIH) has been funded. The amount funded was approximately $1.6 million to fund collection of normal bronchial epithelial cell (NBEC) samples on 700-1075 individuals over age 50 with greater than 20 pack year smoking history and without the prevalence of lung cancer.
The primary study objective is to demonstrate that Gene Express's LungCenturyGX (LCGX) test can be used as a risk prediction test for determining individuals at higher odds for developing lung cancer in the future based on normal bronchial epithelial cells sampled from a non-cancer bronchial site. LCGX is based upon the level of genomic expression of 10 genes in NBEC samples whose expression products protect the airway from carcinogens present in cigarette smoke.
The Mayo Clinic, Case Western, Ohio State University, Henry Ford Hospital, University of Toledo, and Vanderbilt will collect the samples. They will begin in early October to collect from patients willing to participate and sign an IRB approved consent form.
This provides the funds to initiate the clinical trial necessary to prepare for the FDA submission. This study is being conducted through Dr. James Willey (founder and largest shareholder of Gene Express, Inc.) as lead investigator at the University of Toledo. Gene Express is very excited about this news and looking forward to moving this test forward utilizing it proprietary Internal Standards.
2. Dr Jim Willey also received word that grant RCA138397A "Implementation of Innovative RNA sample quality control methods" will be funded. This Gene Express technology is incorporated in a Biotrove grant. If this RNA QC method is successful it can produce another stream of revenues for Gene Express that was not considered in the revenue projections. The market awareness as it relates to Gene Express and its proprietary Internal Standards continues to gain momentum and exposure.
3. The manuscript on our LungCentury (LCGX) test will be published in Cancer Research for your review. This will facilitate getting this test to market through a CLIA laboratory.
12.02.08
BioTrove, Gene Express to Co-Market Novel Standardized Genetic Profiling Test
Novel PCR-Based Platform Simplifies Complex Assay Analysis, Enabling Lung Cancer Risk Evaluation in Standard Diagnostic Laboratories
Woburn, MA and Wilmington, NC, December 2, 2008 – BioTrove Inc. and Gene Express, Inc. today announced an exclusive co-marketing agreement to test market a standardized genetic profiling test for indicators of lung cancer risk. Supported by a two-year National Institutes of Health (NIH) grant, the new profiling test combines BioTrove’s OpenArray® nanofluidic polymerase chain reaction (PCR) technology platform, Gene Express standards for accurate and consistent PCR measurement, and the clinical expertise of the University of Rochester School of Medicine and Dentistry to create the Standardized NanoArray PCR (SNAP) gene expression profiling system – a novel method for consistent and accurate lung cancer risk analysis deployable to diagnostic laboratories or community hospitals.
“Our customers’ need for viable gene expression analysis, in order to better evaluate patient risk, inspired us to bring together proven OpenArray PCR technology with Gene Express standards to control for consistent accurate results,” said David Lester, Chief Technical Officer, Gene Express. “The result, our SNAP gene expression profiling system, simplifies and standardizes laboratory workflow, as well as reduces reagent and sample requirements, making genetic profiling viable and translatable across diagnostic laboratories around the country and potentially around the world. This will be a significant contribution for the delivery of Personalized Medicine.”
Combining several high complexity, multi-gene diagnostic tests into a simple and easy-to-use diagnostic tool, the SNAP system is designed to both accelerate and control PCR analysis of biomarkers for lung cancer risk. The BioTrove OpenArray nanofluidic PCR platform enables large-scale analyses with minimal sample requirements, while the Gene Express Standardized RT PCR (StaRT-PCR) standards method controls for false negatives and false positives, and TaqMan® fluorogenic-labeled probes enable specific detection of PCR products, together providing the same quality and dynamic range of standard real-time quantitative PCR, but with simplified workflow and reduced sample requirements – an important consideration when dealing with limited clinical samples. The OpenArray system allows scientists to conduct up to 3,072 independent PCR analyses simultaneously on up to 144 samples in a plate the size of a microscope slide, while StaRT-PCR standards offer a novel method to control for consistent results.
“Receiving grant support from NIH earlier this year reinforced for both of our companies the importance and promise of our joint effort, and the real opportunity to impact patient care by creating a faster, more efficient and more reliable means to evaluate genetic markers related to lung cancer risk,” said Colin J.H. Brenan, Ph.D., Chief Technology Officer, BioTrove. “Our companies are committed to working together to further develop the SNAP platform for next-generation gene expression-based, multi-gene diagnostics, and we look forward to making this technology available commercially to help bolster the services available at health organizations like local diagnostic laboratories and community hospitals.”
About Gene Express, Inc.
Gene Express, Inc. accelerates and enables drug and molecular diagnostic development by providing standardized genomic data. The Company's proprietary and patented StaRT-PCR™ (Standardized Reverse Transcription Polymerase Chain Reaction) platform technology for measuring gene expression levels in cells, clinical biopsies and blood is being used by numerous pharmaceutical concerns, as well as leading academic centers. The Company's $3 billion focus market for licensing and contract services includes the drug development, academic and molecular diagnostics segments. Additional information is available on the Company's website at www.geneexpressinc.com.
About BioTrove, Inc.
BioTrove, Inc. offers two innovative technology platforms: OpenArray®, which advances genomic research in a wide range of life science fields, including agriculture, disease research, and public health, and RapidFire®, which enables the acceleration of drug discovery and pipeline decisions. With 11 of the 15 largest biopharmaceutical companies based on global sales as clients, and partnerships with prestigious research and public health centers around the world, BioTrove's products and services ensure that an industry committed to accuracy and speed can meet business goals.
The OpenArray® Platform enables genomics researchers to generate SNP and real time qPCR data in the hundreds of thousands of data points per day, significantly increasing the number of samples analyzed while significantly decreasing the time and cost required. The flexible format and nanoliter scale of the OpenArray system allows for easy adjustment of sample and assay numbers, achieving economical, high-throughput genomics.
RapidFire® Mass Spectrometry (RF-MS) feeds samples directly to the mass spectrometer at six to eight seconds per sample, eliminating the bottleneck created by traditional mass spectrometry throughput. RF-MS is routinely used in many applications including the high-throughput screening of previously intractable drug targets, ADME assays and directed evolution studies.
Contacts:
Dr. Albert A. Luderer, President and CEO
BioTrove, Inc.
781-721-3600
info@biotrove.com
Dr. David Lester, Chief Technology Officer
Gene Express Inc.
973-223-5739
dlester@geneexpressinc.com
Jennifer Seelin
Makovsky + Company
212-508-9610
jseelin@makovsky.com
10.06.08
Gene Express Announces Strategic Alliance With AbaStar MDx
Gene Express Licenses Technology for Development and Commercialization
WILMINGTON, NC--(Marketwire - October 6, 2008) - Gene Express, Inc. today announced that it has signed a definitive agreement with AbaStar MDx Inc. to license Gene Express, Inc.'s SEM Center and StaRT-PCR Technology. AbaStar MDx will utilize Gene Express' proprietary technology in the development and commercialization of genetic biomarkers for the accurate diagnoses of neurological and psychological disorders.
Current methods for diagnosing neurodegenerative and psychological disorders predominantly involve physician observations and patient reports. In the early stages of these diseases, symptoms can present similarly, which results in many months to years until the disorder is effectively diagnosed. There are no clinical lab tests that can accurately diagnose psychiatric disorders and neurodegenerative diseases. This represents a large unmet clinical need. The combination of Gene Express, Inc.'s StaRT-PCR technology with AbaStar MDx's RNA biomarker signature will lead to the development of diagnostic tests, run from a simple blood sample, that will provide results in a day.
Dr. Terry Osborn, President and CEO of AbaStar MDx, stated, "AbaStar MDx arranged a strategic alliance with Gene Express for the accuracy of its technology. StaRT-PCR has several advantages over existing methodologies. Specifically, StaRT-PCR uses known quantities of Internal Standard (IS) for each gene to provide quantitative results and standardized PCR gene expression data. Thus during the product development process the diseased patient and normal subject gene expression data can be put into a standardized database that can be leveraged for use with future clinical trials to refine the molecular signatures and for future products. Additionally, the day-to-day, run-to-run variability are greatly eliminated with the Gene Express technology. This facilitates the incorporation of the molecular signatures into commercial diagnostic kits that can be performed with less labor cost."
Jonathan D. Rowe, Ph.D., Chief Operating Officer for Gene Express, stated, "The alliance between AbaStar MDx and Gene Express, Inc. is an important leap in identifying molecular diagnostic tests for the diagnosis of psychiatric disorders. The combination of AbaStar's research with Gene Express' technology will lead to high quality, specific, sensitive and comparable tests that can be used to bring the right care to the right patients."
Over the next several years, Gene Express and AbaStar MDx will be undertaking activities to develop these genetic tests and bring them to market. Such activities will include the creation of several hundred gene standards, screening of gene expression profiles and the creation of validated standardized mixtures of internal standards for clinical trial use. Once the StaRT-PCR signatures are validated AbaStar MDx will introduce these diagnostics to the market. The overall value of the transaction could potentially exceed $100 million.
About AbaStar MDx, Inc.
AbaStar MDx™ Inc. develops blood-based gene expression, molecular diagnostic tests for the accurate diagnosis of mental disorders and neurodegenerative diseases. AbaStar's focus diseases for product tests include schizophrenia, bipolar disorder, depression, Alzheimer's disease and Parkinson's disease. From a simple blood sample, the Company's gene expression products detect and measure the unique disease-specific gene profile or molecular signature. Determining the molecular signature of a disease from a sample of blood revolutionizes diagnostic technology. For brain disorders, this breakthrough technology enables accurate diagnosis with a laboratory test for the first time. The resultant early detection, patient monitoring, disease progression and effective treatment of these diseases will eliminate medical expenditure waste due to misdiagnoses and expensive trial and error medication treatments. Additional information is available on the Company's website at www.AbaStarMDx.com.
About Gene Express, Inc.
Gene Express, Inc. is a molecular diagnostic company that integrates personalized medicine into clinical care by enabling the generation of standardized, comparable and quality controlled data for molecular diagnostic testing. The Company's proprietary and patented StaRT-PCR™ (Standardized Reverse Transcription Polymerase Chain Reaction) platform technology for measuring gene expression levels in cells, clinical biopsies and blood is being used to develop proprietary molecular diagnostics and to develop the molecular diagnostics capabilities of other companies. The Company's $3 billion focus market for licensing and contract services includes the drug development, academic and molecular diagnostics segments. Additional information is available on the Company's website at www.geneexpressinc.com.
Any forecasts, plans, projections and other information contained in this press release describing events or results that may occur in the future are "forward-looking statements" as defined in the United States Private Securities litigation Reform Act of 1995. Forward-looking statements are subject to risks, uncertainties and important factors that are beyond the control of the Company that could cause actual results and events to differ materially from the results presently anticipated or projected. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to this cautionary statement. All forward-looking statements contained herein speak only as of the date of this release and are based on current expectations. The Company disclaims any obligation to update or revise any forward-looking statements.
Contact:
Gene Express, Inc.
Jonathan Rowe PhD, MS, MA, COO
Email Contact
860 819 3762
08.11.08
Gene Express Announces Licensing Agreement With NeoGenomics Laboratories
Companies Establish Key Partnership for Validation and Commercialization Purposes
WILMINGTON, NC, Aug 11, 2008 (MARKET WIRE via COMTEX) -- Gene Express, Inc. today announced that it has signed three definitive agreements with NeoGenomics Laboratories to license the SEM Center and StaRT-PCR(TM) (Standardized Reverse Transcription Polymerase Chain Reaction) Technology. NeoGenomics will support Gene Express in its FDA validation of its Lung Cancer Risk Prediction and BCR/ABL tests. The agreements will also allow NeoGenomics to commercialize Gene Express diagnostic tests, validate future Gene Express technology to fulfill FDA requirements, and utilize StaRT-PCR for their own commercial activities. These agreements succeed in establishing a key validation and commercialization partnership between Gene Express and NeoGenomics.
Jonathan D. Rowe, Ph.D., Senior Vice President of Strategy and Clinical Innovation for Gene Express, stated, "NeoGenomics provides significant experience and insight in the field of clinical molecular diagnostics as well as new assay validation, clinical trials and FDA submissions which are of great value to Gene Express. This partnership allows Gene Express to fully develop and execute its innovative pipeline with a skilled partner that is able to provide comprehensive support from validation through commercialization of our products."
Robert Gasparini, President and Chief Scientific Officer for NeoGenomics, stated, "Gene Express has developed advanced and innovative technologies to support the diagnosis, prognosis and therapeutic response monitoring of disease. NeoGenomics, through its Clinical Trials Services division is excited to provide our expert assay validation, development and FDA submission services to Gene Express for their Lung Cancer Risk Prediction, BCR/ABL and pipeline products. This collaboration also reaffirms NeoGenomics' commitment to providing cutting edge diagnostic testing services to the medical pathology and oncology communities."
Over the next year, Gene Express will be undertaking activities to develop these genetic tests and bring them to market. Such activities will include: clinical trials to validate the lung cancer risk prediction test, submission of the data to the FDA, manufacturing of a regulatory compliant standard mixture of internal standards(SMIS) for the testing of BCR/ABL gene expression, clinical trials to validate the SMIS, and clinical trials to support a regulatory approved molecular diagnostic with internal standards for BCR/ABL.
Gene Express intends to complete the clinical validation and submission for FDA approval of the Lung Cancer Risk Prediction test in 4Q 2008, and will begin clinical trials to support an FDA approved BCR/ABL test by 1Q 2009.
About NeoGenomics Laboratories
NeoGenomics Laboratories is a high-complexity CLIA-certified clinical reference laboratory specializing in providing cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry, to the Medical, Pharmaceutical and Diagnostic development industries. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, morphology studies, anatomic pathology and molecular genetics. With business headquarters and their East Coast laboratory in Fort Myers, FL, and Clinical Trials Services and Research and Development departments operating out of their West Coast laboratory in Irvine, CA, NeoGenomics services the needs of pathologists, oncologists, urologists, hospitals, pharmaceutical and biotech companies, and Clinical Research Organizations throughout the United States. For additional information about NeoGenomics, visit
www.neogenomics.org.
About Gene Express, Inc.
Gene Express, Inc. integrates personalized medicine into clinical care by enabling the generation of standardized, comparable and quality controlled data for molecular diagnostic testing. The Company's proprietary and patented StaRT-PCR(TM) (Standardized Reverse Transcription
Polymerase Chain Reaction) platform technology for measuring gene expression levels in cells, clinical biopsies and blood is being used by numerous pharmaceutical concerns, as well as leading academic centers. The Company's $3 billion focus market for licensing and contract services includes the drug development, academic and molecular diagnostics segments. Additional information is available on the Company's website at www.geneexpressinc.com.
Any forecasts, plans, projections and other information contained in this press release describing events or results that may occur in the future are "forward-looking statements" as defined in the United States Private Securities litigation Reform Act of 1995. Forward-looking statements are subjec to risks, uncertainties and important factors that are beyond the control of the Company that could cause actual results and events to differ materially from the results presently anticipated or projected. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to this cautionary statement. All forward-looking statements contained herein speak only as of the date of this release and are based on current expectations. The Company disclaims any obligation to update or revise any forward-looking statements.
MULTIMEDIA AVAILABLE: http://www.marketwatch.com
Contact: Leslie Wolf-Creutzfeldt
The Global Consulting Group
Tel: 646-284-9472
Email: lwolf-creutzfeldt@hfgcg.com
07.01.08
BioTrove, Gene Express Awarded NIH Grant to Develop Novel Standardized Genetic Profiling Test
Tuesday July 1, 9:30 am ET
Companies to Combine PCR Platform, PCR Standards with Mount Sinai School of Medicine Sample Library to Explore Quantitative Multigene Diagnostic Test for Indicators of Lung Cancer Risk
WOBURN, Mass. & WILMINGTON, N.C.--(BUSINESS WIRE)--BioTrove, Inc. and Gene Express, Inc. today announced their receipt of a two-year National Institutes of Health (NIH) grant, awarded in support of their proposed novel research of genetic biomarkers for lung cancer. Part of the NIH competitive grant program “Innovative Technologies for Molecular Analysis of Cancer,” the project will combine for the first time BioTrove’s OpenArray™ nanofluidic polymerase chain reaction (PCR) technology platform, Gene Express standards for accurate and consistent PCR measurement, and the clinical expertise of the Mount Sinai School of Medicine, with the goal of creating a standardized genetic profiling test for indicators of lung cancer risk. The exciting thing about this project is that we are combining proven PCR technologies and existing genetic knowledge to create a new tool with the potential to significantly impact patient care and treatment options for this deadly disease,” said Professor Tony Godfrey, Ph.D., principal investigator and Associate Professor of Pathology and Cardiothoracic Surgery at the Mount Sinai School of Medicine. “Because a successful outcome would mean simplified workflow and reduced reagent and sample requirements, the NIH review committee recognized the high significance and potential impact of this project.”
To produce the novel Standardized NanoArray PCR (SNAP) gene expression profiling system, the collaboration will combine the Gene Express Standardized RT PCR (StaRT-PCR) standards method to control for false negatives and false positives, the BioTrove OpenArray nanofluidic PCR platform to enable large-scale analyses with minimal sample requirements, and TaqMan® fluorogenic-labeled probes to enable specific detection of PCR products. The resulting SNAP system will provide the same quality and dynamic range of standard real-time quantitative PCR, but with simplified workflow and reduced sample requirements – an important consideration when dealing with limited clinical samples.
“A real need exists for point-of-care gene expression analysis, but without standardized measurements for expression patterns, current technology cannot produce reliable results – analysis can vary from lab to lab,” said David Lester, Ph.D., Executive Vice President, Corporate Development, Gene Express. “By combining our StaRT-PCR standards with OpenArray technology, we hope to provide a faster, more efficient and more reliable means to evaluate genetic markers related to lung cancer risk, helping doctors provide better care to their patients.”
The SNAP system is designed to both accelerate and control PRC analysis of biomarkers for lung cancer risk. The OpenArray system allows scientists to conduct up to 3,072 independent PCR analyses simultaneously on up to 144 samples in a plate the size of a microscope slide, while StaRT-PCR standards offer a novel method to control for consistent results. Once developed, the tool will be evaluated independently at the Harvard School of Dental Medicine and the Stanford University Genome Technology Center.
“NIH support for this effort speaks to the real viability, and need, for a reliable, convenient SNAP system to evaluate lung cancer risk,” said Colin J.H. Brenan, Ph.D., Chief Technology Officer, BioTrove. “Combining three proven technologies, and the expertise of Dr. Godfrey, is an exciting opportunity for BioTrove to apply our OpenArray technology toward enabling a viable screening aid for physicians to help improve patient care.”
About Gene Express, Inc.
Gene Express, Inc. accelerates and enables drug and molecular diagnostic development by providing standardized genomic data. The Company's proprietary and patented StaRT-PCR™> (Standardized Reverse Transcription Polymerase Chain Reaction) platform technology for measuring gene expression levels in cells, clinical biopsies and blood is being used by numerous pharmaceutical concerns, as well as leading academic centers. The Company's $3 billion focus marketfor licensing and contract services includes the drug development, academic and molecular diagnostics segments. Additional information is available on the Company's website at www.geneexpressinc.com.
About BioTrove, Inc.
BioTrove, Inc. offers two innovative technology platforms: OpenArray™, which advances genomic research in a wide range of life science fields, including agriculture, disease research, and public health, and RapidFire™, which enables the acceleration of drug discovery and pipeline decisions. With 11 of the 15 largest biopharmaceutical companies based on global sales as clients, and partnerships with prestigious research and public health centers around the world, BioTrove's products and services ensure that an industry committed to accuracy and speed can meet business goals.
The OpenArray™ Platform enables genomics researchers to generate SNP and real time qPCR data in the hundreds of thousands of data points per day, significantly increasing the number of samples analyzed while significantly decreasing the time and cost required. The flexible format and nanoliter scale of the OpenArray™ system allows for easy adjustment of sample and assay numbers, achieving economical, high-throughput genomics.
RapidFire™ Mass Spectrometry (RFMS) feeds samples directly to the mass spectrometer at six to eight seconds per sample, eliminating the bottleneck created by traditional mass spectrometry throughput. RFMS is routinely used in many applications including the high-throughput screening of previously intractable drug targets, ADME assays and directed evolution studies.
TaqMan® is a registered trademark of Roche Molecular Systems, Inc.
MULTIMEDIA AVAILABLE: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5721543
Contact:
BioTrove, Inc.
Dr. Albert A. Luderer,
781-721-3600
President and CEO
info@biotrove.com
or
Makovsky + Company
Arielle Bernstein,
212-508-9643
abernstein@makovsky.com
04.21.08
Gene Express, Inc. today announced that it has signed an agreement with the Division of Patents & Licensing Research Office at the University of South Florida (USF) to license some of their gene expression technology necessary to develop prognostic tests for cisplatin and irinotecan chemoresistance.
The ability to assess patients for resistance to chemotherapeutics prior to chemotherapy would offer physicians an important tool in providing appropriate chemotherapy to patients afflicted with cancers of the lung and colon. Mechanisms of chemoresistance likely involve multiple gene products involved in DNA repair, drug uptake and other unspecified processes.
Some of the specific technology licensed includes the ERCC1 and RRM1 genes. Researchers at the University of South Florida have now discovered a correlation between expression of ERCC1 (excision repair cross-complementing-1) and the survival of patients with NSCLC. In addition, USF scientists have determined that ERCC1 activity is a significant and independent predictor of survival in patients with NSCLC. Researchers at Florida have also shown that RRM1 is a clinically important determinant of malignant behavior in NSCLC. They have determined that knowing the level of expression of this gene adds significant information to management decisions independent of the currently used outcome predictors of tumor stage, performance status, and weight loss.
Jonathan D. Rowe, Ph.D., Senior Vice President of Strategy and Clinical Innovation for Gene Express, stated, "By adding these genes to our growing collection of gene standards, we will be able to develop the most accurate, sensitive and reproducible molecular diagnostic tests for identifying tumors that are resistant to specific chemotherapeutics. The results obtained from such tests will be used by physicians to make appropriate treatment decisions. Ultimately, our goal is to facilitate the implementation of personalized medicine as a standard of practice in healthcare. In this instance, personalized therapy can be provided to cancer patients."
Over the next two years, Gene Express will be undertaking activities to develop this prognostic test and bring it to market. Such activities will include: manufacturing of a regulatory compliant standard mixture of internal standards (SMIS) for genes of interest for testing of cisplatin chemoresistance; development and approval of an Institutional Review Board (IRB) clinical protocol to collect patient samples from normal patients and patients with NSCLC in the absence and presence of treatment with cisplatin; and analytical method validation of cisplatin chemoresistant predictive genes by Standardized Reverse Transcription PCR (STaRT-PCR using SMIS).
Gene Express intends to complete clinical validation for correlation of gene expression versus chemoresistance for cisplatin treatment by April 2009, and submit a 510K class II prognostic test for cisplatin resistance to the FDA by May 2009. The Company would then anticipate receiving FDA approval of the 510K medical prognostic test in August 2009 and commercial application completed by December 2009.
03.17.08
Gene Express, Inc. today announced that it has appointed James L. Mulshine, M.D. to its Scientific Advisory Board. Dr. Mulshine will be joining David Johnston, Ph.D., Dr. David Sidransky, M.D. and Michael N. Liebman, Ph.D., as previously announced on December 19 and November 29, further adding to this esteemed group of internationally recognized experts.Gerald Vardzel, CEO of Gene Express, commented, 'We are honored to have Dr. Mulshine join our Scientific Advisory Board. His research focused on biomarkers of lung cancer, and his groundbreaking work in developing innovative technological approaches to cellular diagnostics, fall perfectly in line with Gene Express' strategy to accelerate drug and molecular diagnostic development to enable the development of targeted therapies for specific disease processes, while enhancing safety and providing a standard measurement system.'
James L. Mulshine M. D., noted oncologist at the National Cancer Institute (NCI) for twenty-five years, is now the Associate Provost for Research at Rush University Medical Center in Chicago. He was previously Head of the Intervention Section, Cell and Cancer Biology Department, Division of Clinical Sciences for the NCI in Maryland. After graduating from the Loyola Stritch School of Medicine in 1977, he completed a Fellowship in Internal Medicine and was a Medical Resident at the Cleveland Clinic Foundation. He completed his training in medical oncology and spent a total of nine years in the NCI - Navy Medical Oncology Branch. In 1990, he moved to the Division of Cancer Prevention and Control to start an Intramural Translation Research Group that was moved back to the Division of Clinical Sciences in 1996.
Dr. Mulshine is a Fellow in the American College of Physicians, as well as a member of the American Society of Clinical Oncology, American Association of Cancer Research, International Association for the Study of Lung Cancer, and the American Federation of Clinical Research.
His numerous honors include the NCI Technology Transfer Award (1996), and the National Institute of Health Director's Award in 1998.
His interest in lung cancer research emerged from an opportunity to join the lung cancer biology group of Dr. John Minna in the early eighties. The group at the NCI-Navy included a number of talented investigators that established a footprint for translational research for lung cancer. During a decade of work with the development of new approaches to control advanced lung cancer, Dr. Mulshine evolved into a committed prevention researcher. Much of his current research centers on the chemoprevention, biomarkers, and early detection of lung cancer. He has been a pioneer in developing new technological approaches to cellular diagnostics for early lung cancer detection, as well as drug delivery to address the airway-confined phase of early lung cancer. His focus has been to develop robust, cost effective integrated approaches to the comprehensive management of pre-invasive lung cancer in a population-based setting.
Dr. Mulshine stated, 'It is a vibrant time for scientific and technological innovation in developing molecular diagnostics. The team at Gene Express embraces those innovations but understands that the demands of assay validation and tailored regulatory strategy are just as vital to ultimate success in bringing new tools into meaningful clinical application.'
01.07.08
Gene Express, Inc. today announced the appointment of Jonathan D. Rowe, PhD to Senior Vice President of Strategy and Clinical Innovation.
Gerald Vardzel, CEO of Gene Express, commented, "We are excited to have Jonathan join our team with over 10 years of developing, managing and supporting strategic initiatives in the fields of pharmaceutical sciences, clinical research, as well as pre and post marketing of drug candidates. His main responsibility is to provide strategic medical and business development input to the clinical and commercial development of Gene Express's products, and Jonathan's extensive experience perfectly complements this role."
Prior to joining Gene Express, Dr. Rowe held numerous integral positions at Pfizer Inc. dating back to 1998. Most recently, he served as Senior Director of Worldwide Pharmaceutical Sciences in Pfizer’s Global R&D Group. In this role, Jonathan was accountable for aligning strategy, developing business metrics and delivering on process and performance improvements for the Pharmaceutical Sciences division. This division consists of over 2700 colleagues, and is responsible for bringing newly discovered molecules to clinical trials, and product enhancements to existing products and candidates. Dr. Rowe's previous positions at Pfizer Inc. included: Director of Intellectual Property Strategy Management where he was responsible for developing and leading intellectual property lifecycle initiatives to increase the value and productivity of product franchises from candidates to post-marketing; and as Clinical Director of the Cardiovascular Risk Factors Group, Dr. Rowe designed, developed and managed phase IIIB and IV clinical studies, and lead the strategic medical input into the marketing and commercial development of Lipitor.
Prior to joining Pfizer Inc., Dr. Rowe was a scientific advisor for the law firm of Kaye, Scholer where he provided scientific support for IP litigation in the biotechnology and pharmaceutical industry.
Dr. Rowe's PhD is from the Department of Biochemistry at the Albert Einstein College of Medicine (AECOM), where he researched the expression of genes and their associated proteins involved in drug detoxification. Dr. Rowe has an MS with a focus on molecular biology (AECOM) and an MA in reproductive endocrinology from the State University of New York at Binghamton. Dr. Rowe has published a number of articles in peer-reviewed journals, has served as a consultant on the topics of Innovation and Strategy Implementation, and currently serves as an expert panel member for The Innovator, a publication supported by www.innovationtools.com and the Monitor Group's Innovation Practice.
Dr. Rowe stated, "I have been advocating the need for tailored or personalized medicine for years. The value of medicine greatly increases when a medical professional can confidently answer the questions; what class of drug, at what starting dose, for how long, is the best option to treat my unique patient? Gene Express is positioned to deliver on this goal, and I am honored to be part of this great leadership team."
12.19.07
Gene Express, Inc. today announced that it has appointed David Johnston, Ph.D. to its Scientific Advisory Board. Dr. Johnston will be joining Dr. David Sidransky, M.D. and Michael N. Liebman, Ph.D., as previously announced on November 29, to form this prestigious team of internationally recognized experts.
Gerald Vardzel, CEO of Gene Express, commented, "With the addition of Dr. Johnston, and the continued contribution of Drs. Sidransky and Liebman, we have secured the involvement of distinguished advisors who bring a broad understanding of molecular diagnostics as well as deep experience advising biotechnology and pharmaceutical companies at various stages of growth. We are privileged to have this accomplished group of scientific and clinical thought leaders join our Scientific Advisory Board."
David M. Johnston, Ph.D., is Vice President and the Chief Scientific Officer for Esoterix Clinical Trials Services (Esoterix), the clinical trials division of LabCorp. Esoterix provides specialized and routine laboratory analyses for pharmaceutical and diagnostic product development worldwide. Dr. Johnston earned his Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill School of Medicine and has been involved in clinical research for more than 15 years. Dr. Johnston studied gene regulation and surface virulence determinants in the pathogenic Neisseriae. He later studied drug resistance in HIV and worked on the first clinical diagnostic assays to detect HIV drug resistance mutations. Previously, Dr. Johnston held leadership positions in Research and Development and clinical trials Quality Assurance at LabCorp. Dr. Johnston participated in the DIA workshops on pharmacogenomics data submissions and served on the AACC Advisory Committee on pharmacogenomic assay validation. Dr. Johnston is an adjunct professor in the clinical research department of the Campbell University School of Pharmacy, and serves on the scientific advisory board for Kylin Therapeutics. He is a member of the American Association for the Advancement of Science, the Drug Information Association, American Association for Clinical Chemistry, and American Society for Microbiology.
Dr. Johnston stated, "I am pleased to join Gene Express' Scientific Advisory Board. I look forward to contributing to strategies that accelerate drug discovery and biomarker development to further precision medicine."
11.29.07
Gene Express, Inc. today announced that it has appointed the first two members of its Scientific Advisory Board to include Dr. David Sidransky, M.D. and Michael N. Liebman, Ph.D.
Gerald Vardzel, CEO of Gene Express, stated, "We are honored to have recruited such an outstanding team of internationally recognized experts in the study of cancer, genetics and molecular medicine. The wealth of experience and expertise of this board will be invaluable to ensure a solid development plan is in place for Gene Expres's StaRT-PCR technology. From a strategic point of view, this group provides us with strong clinical research and practice perspectives, both for our current and future products intended for enhancing and accelerating the delivery of molecular diagnostics."
David Sidransky, M.D., renowned oncologist and a consultant to a number of leading biotechnology companies, is the Director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine. In addition, he is Professor of Oncology, Otolaryngology, Cellular Molecular Medicine, Urology, Genetics, and Pathology at John Hopkins University and Hospital. He has served as a director of ImClone since January 2004. Dr. Sidransky is a founder of numerous biotechnology companies, and holds a number of biotechnology patents. He is serving and has served on scientific advisory boards of many private and public companies, including MedImmune, Roche, Amgen and Veridex, LLC (a Johnson & Johnson diagnostic company). Dr. Sidransky is Vice Chairman of Alfacell Inc., and serves as Director of the American Association of Cancer Research (AACR). He has over 300 peer-reviewed publications, and has contributed more than 40 cancer reviews and chapters. He is the recipient of many awards and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner Award Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda and Richard Rosenthal Award from the AACR.
Michael N. Liebman, Ph.D. is the Managing Director of Strategic Medicine, Inc and is also a Senior Institute Fellow at the Windber Research Institute after serving as its Executive Director since November, 2003. Previously, he was Director of Computational Biology and Biomedical Informatics at the Abramson Family Cancer Research Institute of the University of Pennsylvania Cancer Center. He served as Global Head of Computational Genomics at Roche Pharmaceuticals, and Director of Bioinformatics and Pharmacogenomics at Wyeth Pharmaceuticals. In addition, he was Director of Genomics for Vysis, Inc. and Director of Bioinformatics at the Amoco Technology Company. He has served on the faculty of Mount Sinai School of Medicine in Pharmacology and Physiology/Biophysics. He serves on 12 international scientific advisory boards, consults for 5 pharma/biotech companies and has been on the economic development programs in the Philadelphia Life Sciences Sector and the State of Illinois Biotechnology Commission. He is an Invited Professor at the Shanghai Center for Bioinformatics Technology and is currently Chair of the Healthcare Task Force for the SMART program, and is on the Human Health and Medicinal Chemistry Commission of the IUPAC. His research focuses on computational models of disease progression stressing risk detection, disease process modeling and analysis of lifestyle interactions.
Dr. Liebman commented, It's exciting to join Gene Express's Scientific Advisory Board and be part of new approaches to problems that have existed for a long time, but have yet to be solved. This is critical to making a difference at the research level, as well as the care for patients in the future of medicine."
11.16.07
Gene Express, Inc. today announced the appointment of Larissa Karnaoukhova, Ph.D. to Director of Strategic Partnerships.
Gerald Vardzel, CEO of Gene Express, commented, "Larissa brings to the Company over 9 years of product development, program management and strategy development within the biotechnology industry. She will be responsible for building relationships with key partners, and managing business development on the West coast. Her extensive experience includes complete sales cycle management of bio-pharmaceutical and diagnostic services, as well as full-cycle product development from feasibility to product launch and technical support. All of this will play an integral role in furthering Gene Express's commercial development."
Prior to joining Gene Express, Dr. Karnaoukhova served as the Biosciences Sales Manager at VWR International, a leading product supplier to the global research laboratory industry. In this role, she was responsible for promoting and selling drug discovery and development services from a broad range of contract research organizations (CROs) to biotech, pharmaceutical and medical device companies in Southern California and Arizona. At VWR International, she succeeded in identifying customer needs, in turn presenting solutions through a diverse portfolio of services in genomics, proteomics, pre-clinical development, scale-up manufacturing, imaging, lab automation instrumentation, and clinical trials. Ultimately, this enabled Ms. Karnaoukhova to design strategies to broaden the customer base.
Over the previous nine years, Dr. Karnaoukhova developed her scientific career at Invitrogen Corporation, where she took on positions of increasing responsibility. She developed innovative products and services in gene identification and cloning, and served most recently as a Senior Scientist, facilitating program management in cloning and protein expression. She has authored several academic and scientific publications, highlighting her expertise in gene isolation, cloning, and gene expression. Dr. Karnaoukhova is currently working towards receiving an MBA from UCSD, RADY School of Management. She received her Ph.D. in Molecular Biology from the University of Victoria, Victoria, British Columbia in 1998, and an M.Sc. in Physics/Biophysics from Moscow State University, Moscow, Russia in 1992.
Dr. Karnaoukhova stated, "I am pleased to join such a prestigious team of professionals at Gene Express. Gene Express's StaRT-PCRâ„¢ technology offers a recognized platform for standardizing genomic expression data, which is essential in personalized medicine. I look forward to establishing and growing strategic partnerships in the drug development space in order for our products to gain sustained recognition and ultimate success."
10.16.07
Gene Express, Inc. today announced the appointment of Hannah Monds to Director of Business Development. Gerald Vardzel, CEO of Gene Express, commented, "Hannah brings over 12 years of operational, business and consulting experience in pharmaceutical drug development to the Company. She will be responsible for licensing our StaRT-PCR technology and managing customer relations among our various business partners. Her vast network of contacts within pharmaceutical and clinical research organizations will assist in Gene Express's commercial development."
Prior to joining Gene Express, Ms. Monds spent more than 10 years with AAIPharma, a global provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. She began her career at AAIPharma performing laboratory analyses of pharmaceuticals. Ms. Monds then served as Manager of AAIPharma's Stability Management Services division. Here she developed the department's operations and drove the growth of the business unit through customer development and management.
Over the past seven years, Ms. Monds has also performed operational audits and provided consulting services for various pharmaceutical organizations, presented at several conferences regarding the stability of pharmaceuticals throughout the drug development process, and contributed to technical publications. In 2006, Ms. Monds received an M.B.A from the University of North Carolina at Wilmington.
Ms. Monds stated, "It is an honor to join the Gene Express team, and to work amongst a group of highly experienced professionals in both drug and diagnostic development. I look forward to further developing and managing customer relations, and executing the Company's business strategy."
10.8.07
David S. Lester publishes "Biomarker Editorial: The Many Lives of the Biomarker"
10.2.07
Gene Express appoints David Lester Senior Vice President of Strategy and Corporate Development
9.24.07
CEBPG regulates ERCC5/XPG expression in Human Bronchial Epithelial Cells and this regulation is modified by E2F1/YY1 interactions
8.29.07
Gene Express, Inc. has hired David S. Lester, Ph.D. as its Senior Vice President of Strategy and Corporate Development. Dr. Lester brings with him a wealth of experience in all facets of clinical technology, global R&D and regulatory board advisory. Dr. Lester will be working with GEI management to advance current and future endeavors with the Gene Express platform. Please find his professional biography listed in the management portion of the GEI website.
12.07.06
StaRT-PCR used in Endometriosis Study
4.27.06
Gene Express Technology Highlighted in Nature