Biotech TGen Alzheimers Disease Research
The Translational Genomics Research Institute (TGen) is a Phoenix-based nonprofit working with collaborators in the scientific and medical communities to improve the efficiency and effectiveness of gene research, fighting diseases such as cancer, neurological disorders and diabetes. This video features researchers Matthew Huentelman and Travis Dunkley, as well as a few patients.
Iron Horse Diagnostics - 2013 AZBio Fast Lane Honoree
Iron Horse Diagnostics was honored with the 2013 AZBio Fast Lane Award from the Arizona Bioindustry Association for Accelerating the Development of New ALS Diagnostic Tests. Amyotrophic Lateral Sclerosis (also known as ALS or Lou Gehrig’s disease) is a devastating disease that is nearly always fatal within 5 years of onset. Due to similarities in their symptomatic progression is it difficult to differentiate ALS from several other disease mimics (motor neuropathy, progressive muscle atrophy, etc.) until it is too late for intervention to have any real effect. With an earlier diagnosis, and therefore earlier intervention, current clinical care may increase the lifespan of these patients and additional drug therapies that are likely to be introduced to the market could be more rapidly initiated. Not only might life expectancy increase, but patients would be given the chance for a higher quality of life for a longer duration due to more rapid inclusion of the patient into multi-disciplinary care treatment offered at specialized ALS clinics.
Convergence and Personalized Medicine
Greg Yap is Senior Vice President and Lifecycle Leader for Advanced Staining Assays at Ventana Medical Systems. In this role, Greg is responsible for Ventana’s 450 million dollar cancer diagnostic testing business. Ventana’s tests are the market leaders and are used to help guide treatment for over 6 million cancer patients each year worldwide. Previously, Greg was Chief Operating Officer at Cellective Dx, a circulating tumor cell company, and held multiple senior operating roles at Affymetrix.
Arizona Pioneer Thomas M. Grogan, MD
Thomas M. Grogan, M.D., Founder of Ventana and SVP, Medical Affairs of Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, receives the AZBio Pioneer Award for Lifetime Achievement at the 2013 AZBio Awards on October 10, 2013. Dr. Grogan was a pathologist and professor at the University of Arizona when in the mid 1980’s he and a small team set out to challenge the limitations of the then current standards and processes for cancer pathology. What was to become the company’s first digital pathology instrument evolved from Grogan’s notes on a yellow pad into the BenchMark IHC/ISH staining platforms. Under Grogan’s leadership, Ventana was founded in 1987, went public in 1996, and was acquired by Roche for $3.4 billion in 2008. Over the last 25 years, Ventana has grown to become a global leader in developing and manufacturing tissue-based diagnostic instruments and tests focused on the detection of cancer. Ventana employees continue to pursue the same deeply rooted mission of innovating diagnostic testing and enabling personalized healthcare to improve the lives of all patients afflicted with cancer worldwide. Dr. Grogan has made it his personal mission to make life better for the millions of patients who battle cancer each day. His passion and dedication are infectious and has spread across the company that he and his team built. Through their efforts they have revolutionized the field of cancer diagnostics and are pioneering new roads in the field of personalized healthcare.”
2012 Fast Lane Award Winner - the Critical Path Institute
With both drug development costs and healthcare costs at record heights, how can we drive innovation and lifesaving discoveries down the path faster. That is the question the team at the Critical Path Institute (C-Path) asks every day. Critical Path Institute , a healthcare change agent and leading center of excellence for collaborative scientific innovation, was formed with visionary support from the State of Arizona, UA, Science Foundation Arizona, FDA and the community at large. Its mission: to improve human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. There is no other entity in the country that does what C-Path does. C-Path Milestones and “firsts” include: 1st preclinical safety biomarkers (7) qualified by FDA and its counterparts in Europe and Japan – biomarkers used to detect drug-induced kidney injury earlier and more precisely. 1st CDISC (Clinical Data Interchange Standards Consortium) therapeutic area data standard enables aggregating and easier FDA review of Alzheimer’s clinical trial data. 1st and largest open database of CDISC aggregated Alzheimer’s clinical trial data (6,100 patients, 22 clinical trials) enabling scientists to look for means to detect disease earlier and understand disease progression based on age, sex, genotypes. 1st drug-disease trial model and clinical trial simulation tool submitted/under review by FDA – model enables scientists to better design Alzheimer’s clinical trials. 1st imaging biomarker for trial enrichment qualified by EMA – biomarker used to select patients in very early stages of Alzheimer’s for inclusion in clinical trials. C-Path brings together stakeholders to create what no one company, university, or government agency could do alone: 6 global consortia with 1,000 scientists, 41 companies, government agencies, patient groups, and academia to collaborate on “tools” to help drug development and focus on drug safety, drug effectiveness, diseases of the brain, developing new imaging biomarkers, and testing drug combinations. C-Path’s collaborative work is just beginning to translate knowledge of disease and human physiology into safe and effective therapies.
2012 AZBio Fast Lane Award Winner - Ulthera
Beauty and Growth – Ulthera, Inc Ulthera’s mission is to work with physicians to provide therapeutic ultrasound to improve the appearance and health of patients worldwide. The company is not only defined by its proprietary technology, but also its people. Ulthera’s team consists of experts in their respective fields who are aligned by the strength of the company’s mission and its leadership. Ulthera was founded in 2004 to leverage seven years of prior scientific research in therapeutic ultrasound for aesthetic and medical applications. In 2009, the Ulthera® System received FDA approval in the United States and is the first and only energy-based device to receive FDA clearance for a non-invasive aesthetic lift indication. The first application for Ultherapy® – the procedure enabled by the System – is a non-invasive treatment of the face to achieve a brow lift. Ulthera’s robust scientific foundation and relentless pursuit of superior clinical outcomes have resulted in the rapid global uptake of the Ulthera platform. As Ulthera continues to develop and provide more applications for its platform, the company also remains committed to bringing value to physicians and their patients. In 2006, Matt Likens was hired as President and CEO of Ulthera by founder and owner Michael Slayton, Ph. D, with the expectation of obtaining FDA approval for Ulthera’s product and service (known as Ultherapy) within three months. Less than two years into his tenure at Ulthera, Matt found himself navigating this venture capital backed start-up though the worst economic downtown since the Great Depression. The Company also found itself facing an increasing skeptical and less commercially friendly US Food and Drug Administration (FDA) regime. With both of these risks significantly threatening the Company’s viability, Matt decided to change the Company’s regulatory pathway and focus by obtaining CE Mark from the European Union prior to obtaining FDA clearance. If this bet paid off, Ulthera’s regulatory runway would be significantly reduced and the Company would be able to generate sales in the European market. These revenues would also allow the Company to lessen the need to obtain additional venture capital financing thus reducing additional dilution to the Company’s current shareholders. While risky, the core of this decision was based on the multinational experience Likens attained at Baxter and his general entrepreneurial nature. The bet ultimately paid off. Today, Ulthera is a global, growth-stage medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology. More than 1,000 Ulthera Systems have been sold globally while treatments performed using the System have surpassed 100,000.
Raymond L. Woosley, MD, PhD - 2012 AZBio Pioneer
Raymond L. Woosley earned a Ph.D. in Pharmacology from the University of Louisville and an M.D. from the University of Miami. He began his career as the first scientist in the US operations for Glaxo, now known as GlaxoSmithKline. Dr. Woosley specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University where he rose to the rank of Professor of Medicine. At Georgetown University he served as Chairman of the Department of Pharmacology and in 2000 was appointed Associate Dean for Clinical Research. In 2001 he became Vice President for Health Sciences at the University of Arizona and Dean of the College of Medicine. In January of 2005 he assumed the position of President of The Critical Path Institute (C-Path), a non-profit corporation formed by the Food and Drug Administration, SRI, International and the University of Arizona to accelerate the development of safe innovative medicines. Since 1999, he has directed one of seven federally-funded (Agency for Healthcare Research and Quality) Centers for Education and Research on Therapeutics (CERT).Under Dr. Woosley’s leadership, C-Path (the Critical Path Institute) orchestrated the acceleration of medical product development through a unique collaborative process among industry, academia, and the FDA. Our collaborations among 6 global consortia, 1000+scientists, and 41 companies has already produced these notable successes: First preclinical safety biomarkers (7) qualified by the FDA, EMA, and PMDA (the Japanese counterpart) First CDISC (Clinical Data Interchange Standards Consortium) therapeutic area data standard First and largest open database of CDISC aggregated clinical trial data for Alzheimer’s disease (6,100 patients and 22 clinical trials) Read more First drug-disease trial model & clinical trial simulation tool submitted and under review by the FDA First imaging biomarker for trial enrichment qualified by the EMA Dr. Woosley’s research has investigated the basic and clinical pharmacology of drugs for the treatment of arrhythmias and the cardiac toxicity of drugs, and has been published in over 260 publications. His research discovered the mechanism of the toxicity of the antihistamine Seldane®. He is the recipient of the Rawls-Palmer Award from the American Society of Clinical Pharmacology and Therapeutics for his contributions to medicine and the FDA Commissioner’s Special Citation for his work to advise the agency on the toxicity of dietary supplements containing ephedra. Dr. Woosley is a Past-President of the Association for Medical School Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. He has served on numerous boards including the US Pharmacopeia. He is a member of the Biodesign Institute at Arizona State University. As a member of the University of Arizona’s Sarver Heart Center and Bio5 Institute, he conducts research on the prevention of adverse drug interactions.