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.
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.
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.
Lightworks Algae Energy ASU Research
The Arizona Center for Algae Technology and Innovation (AzCATI) at Arizona State University and the Algae Testbed Public-Private Partnership (ATP3) are working with Health Enhancement Products, Inc (HEPI) to advance the science behind algae-based health and wellness products like vitamins and food chemicals.
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.
Keeping People Healthy...at a cost we can afford (Full Presentation)
Michael Birt, director of the Center for Sustainable Health at the Biodesign Institute at Arizona State University. In Birt’s address, “Sustaining Health: How Do We Prevent and Detect Disease Early Enough to Keep People Healthy … at a Cost We Can Afford?” he calls for a shift in our health system to reward cost-effective prevention, early detection and intervention. Such a shift and the technology that it would require has the potential to spur growth among bioscience organizations, reduce patient suffering, and lowering health care costs.