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04.21.08
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.
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.
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-PCR™ 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 |