David S Alberts AZBio Pioneer
David S. Alberts, MD. Throughout his career, Dr. Alberts has focused on translational cancer prevention and treatment research. The emphasis of his laboratory-based and clinical research has been on the chemoprevention and treatment of such pervasive and potentially deadly diseases as cancers of the breast, colon, ovary, and skin. He has been the UA Cancer Center’s director since 2005. Under Dr. Alberts’ leadership the extensive research portfolio of The University of Arizona Cancer Center includes more than $60 million in annual research funding, including four large NCI interdisciplinary programs, and two Special Programs of Research Excellence, one in gastrointestinal cancers and one in lymphoma. Clinically, Dr. Alberts pioneered new treatments for advanced ovarian cancers, including in vitro tumor cell chemosensitivity testing for personalized medicine strategies, intraperitoneal chemotherapy , and maintenance chemotherapy. Presently, Dr. Alberts helps to coordinate Phase I and II and pharmacokinetic drug studies at The University of Arizona Cancer Center for molecularly-targeted chemopreventive agents. His laboratory research is concentrated on the evaluation of new surrogate endpoint biomarkers for cancer prevention trials with a special focus on precursor lesions for bladder, breast, colon, cervical, endometrial, ovarian, prostate, and skin cancers, using quantitative histopathology (i.e. karyometric) approaches. His NCI funded drug and diagnostics research has resulted in more than two dozen patents and the co-founding of five Arizona pharmaceutical and biotechnology companies.
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.
Partnering with the FDA
Michelle Ann Wells, RAC works in Regulatory Affairs at WL GORE and has spent her career navigating the maze known as the FDA. Her 20 year career includes working on the regulatory teams of Schein (Steris/Watson), Zila, The Tech Group, Bard (Impra), Medicis, and Regulatory Compliance Consulting Services. Outside of Arizona, Michelle has worked with Proctor & Gamble, Dey (Mylan), Inale (Nektar), and Pfizer.
Linda Hunt of Dignity Health Arizona, 2013 Arizona Bioscience Leader of the Year
The Jon W. McGarity Arizona Bioscience Leader of the Year Award honors the person in Arizona who provided the most outstanding leadership that contributed significantly to development of the State’s bioindustry and/or recognition of the advancement of bioscience in Arizona. Recognizing that collaboration builds a stronger community, Linda Hunt has taken a leadership role to advance healthcare and the biosciences for the people of Arizona. Hunt has worked diligently with legislators, business leaders, educators, scientists and community organizations in order to identify, formulate, and support policies that will give Arizonans better healthcare and raise the bar of knowledge.Hunt has served as the head of Dignity Health in Arizona since 2012. Dignity Health includes three major hospitals in the Valley, St. Joseph’s Hospital and Medical Center and Chandler Regional and Mercy Gilbert Medical Centers. A fourth hospital, St. Joseph’s Westgate, is under construction.
Arizona Bioscience Overview
Arizona is home to one of the fastest growing bioscience industries in the U.S. Watch the video to see how a statewide collaboration built the research infrastructure and attracted a growing talent base of thought leaders committed to making Arizona a leading bioscience state.
Cancer Genomics: the future of personalized medicine
2012 Bioscience Leader of the Year, Robert Penny, MD, PhD shares the history of the Cancer Genome Atlas Project and a look forward at the future of personalized medicine.