Critical Path Institute - Data Collaboration with Global Impact
Presented by Debra Hanna, PhD
- Executive Director, Critical Path to TB Regimens (CPTR), Critical Path
Institute, and Richard Liwski – Program Director, Data Collaboration Center,
Critical Path Institute
DNA Sequencing and Disease Diagnosis
Northern Arizona University's Paul Keim describes how automated technology and robotics are used to analyze thousands of samples of DNA at one time. He explains the human genome and the information contained in DNA. Keim believes researching the DNA of disease causing organisms will advance disease treatment. Northern Arizona University is home to one of the largest pathogen related genomics research centers in the world. Read the article Genomic Research>>
AZBio Expo Welcome by Mayor Jim Lane
Mayor W. J. “Jim” Lane served for four years on the Scottsdale City Council beginning in June 2004, and began his first term as Mayor in January 2009. He was re-elected to the Mayor’s Office in 2012 and began his second term in January of 2013. Mayor Lane serves as a member of the Arizona Bioscience Roadmap Steering Committee and has been a lead driver in the development of Scottsdale’s Cure Corridor.
Recorded Live at the AZBio Expo on June 19, 2014 in Scottsdale, Arizona
Industrial Biotech in Arizona
Where is Industrial Biotech in Arizona Today?Glen Galster, co-founder of Algae Biosciences and AZBio Chairman of the Board moderates this panel discussion from the AZBio Expo 2012 featuring:
Leif P. Christoffersen, Director of Biomass Integration, Yulex Corporation.
Ben Cloud, President and CEO, Phyco Biosciences, Inc.,
Josh Hottenstein, Cleantech Open
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.
Michael Kozlowski OD, PHD, Chief Science Officer
Kalos Therapeutics, Inc dedicated to treating patients not just their diseases. Kalos is a peptide therapeutic company treating virulent cancers and the related comorbidities. The Kalos solution focuses in putting tumor cells into a prolonged non dividing state, also treating the ascites and edema that lead to pain and death. Kalos drugs engage known pathway receptors in the MAPK pathway and it does so more efficiently without the side effects associated with chemotherapeutic compounds. As confirmed in an Investigator IND our clinical effects of increased natriuresis and diuresis will treat the related comorbidities of cancer reducing ascites, and edema, as well as shrinking the tumor.
Clinical Trials - Engaging Patients in the Process
Clinical Trialsin Arizona - Engaging Patients in the Process (Panel)
- Greg Vigdor - Moderator (President & CEO, Arizona Hospital and Healthcare Association)
- Brian Browne (Director - Education & Outreach, Banner Research)
- Barbara Kavanaugh (Arizona Myeloma Network )
- Marcia K. Horn, JD (International Cancer Advocacy Network)