Clinical Trials in Arizona - Project HoneyBee
About Project Honey Bee: Recent advances in information technology and explosive growth in sophisticated but inexpensive data capture devices—biosensors—promise to revolutionize our ability to detect, diagnose, and prevent disease. By developing the ability to continuously record physiological parameters, we will pinpoint the transition from health to disease and intervene more effectively for improved health outcomes at a reduced cost. Importantly, our validation process is disease, device, and outcome-agnostic, particularly one that can handle the large variety of devices for clinical settings. We leverage our extensive experience in the careful validation of biomarkers for clinical application with a parallel methodology aimed at the utilization of physiological metrics obtained from wearable biosensors to address key clinical problems. To accomplish this goal, we enlist the considerable multidisciplinary resources of Arizona State University, while partnering with health systems such as the Mayo Clinic and Banner Healthcare in the United States and with Chang Gung University and Hospital system in Taiwan.
Advancing Innovation Thru Public Private Partnerships - Critical Path Institute
Martha Brumfield, PhD – President & CEO
The Critical Path Institute
Public Private Partnerships were envisioned by the FDA 10 years ago in their report “Stagnation and Innovation” and C-Path is one of the few organizations that has successfully implemented parts of this vision. The uniqueness of being a “neutral, third-party” enticed competitive biopharmaceutical companies to join together in sharing expertise and actual data toward the greater benefit for advancing techniques to develop medicines faster and get them to the patients who are waiting. FDA, EMA and PMDA have collaborated in each of C-Path’s 7 global consortia in offering advice toward a formal regulatory acceptance of new tools and methods. The presentation will review successes from two of these consortia which are focused on developing biomarkers and modeling and simulation tools to expedite new treatments for Alzheimer’s disease and Polycystic Kidney disease.
Valley Fever Solutions
Valley Fever Solutions, Inc. (VFS, an Arizona corporation), is developing Nikkomycin Z (NikZ) as a dramatically superior potential cure for Valley Fever. This is a painful and debilitating orphan disease causing over 2,000 serious cases and 150 deaths a year. About 60,000 people are sickened each year, suffering for months. Victims with more serious cases suffer for years.
Clinical Trials in Arizona - Cancer Prevention Pharmaceuticals
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.These studies also may show which medical approaches work best for certain illnesses or groups of people. A critical step in the process from discovery to development to delivery, clinical trials may provide access to qualified participants (patients) prior to final FDA approval and also through the dedication of researchers, innovators, and trial participants we find the answers we need to drive life changing innovation forward.Recently, PhRMA released state by state reports on the status of clinical trials in the bio pharmaceutical industry. From Hope to Cures: Arizona provides a snapshot of the work being done in clinical trails across our state. But how do we measure up.Population is a key comparative measure that can be used to determine our peer group. Since Arizona’s population is just greater than 6.7 million people, we have looked at states that have 5 million to 7 million people to see how we measure up when it comes to clinical trials.(Note: These comparative numbers only reflect bio pharmaceutical clinical trials. Additional trials take place everyday studying medical devices, diagnostics, behavioral health and other life changing healthcare innovations.)
Mind Crowd - Keynote by Dr. Matt Huentelman
Before we can discover new treatments for brain-related diseases, we need to understand healthy brains.
Matthew Huentelman. Ph.D
Associate Professor, Neurogenomics Division and Head of the Neurobehavioral Research Unit
Translational Genomics Research Institute (TGen)
Dr. Huentelman, Ph.D., is an Associate Professor in TGen's Neurogenomics Division, where he oversees research programs focused on sensory disorders, including hearing and vision loss, and on aging and age-related diseases, such as Alzheimer's disease and the genetics of learning and memory - highlighted recently by the launch of TGen's MindCrowd project (MindCrowd.org). Dr. Huentelman also is the Co-Director of TGen's Center for Rare Childhood Disorders, which investigates uncommon neurologic problems among children, often those that are only a collection of symptoms with no diagnosis.
Funding Pathways for Innovators
Panel Discussion: Funding Pathways for InnovatorsModerated by Joan Koerber-Walker
Kelly Slone, Vice President, Life Science Policy at the National Venture Capital Association
Kelly Slone serves as Vice President, Life Science Policy at the National Venture Capital Association (NVCA) NVCA is the national trade association for the venture capital industry; its mission is to foster understanding of the importance of venture capital to the vitality of the U.S. and global economies.Slone is responsible for raising the visibility of NVCA’s life science members to congressional, administrative, and regulatory leaders with regard to the important role venture capital plays in the creation and development of disruptive medical therapies and technologies. She is also the lead lobbyist on public policy issues that affect life science investors and their portfolio companies, including healthcare reform, FDA reform, CMS reimbursement, patent reform, and small-business issues such as those related to SBA’s SBIR grant program. She also partners with other health-related trade associations and patient advocacy groups to coordinate and leverage key policies and messages important to the advancement of U.S. medical innovation.In 2010, Slone directed the launch of NVCA’s Medical Innovation and Competitiveness Coalition (MedIC), a coalition of the top U.S. venture capital firms, their portfolio companies, and entrepreneurs dedicated to developing policies to advance U.S. leadership in medical innovation. She is a member of MedIC’s steering committee, and also represents NVCA as a partner of the Council for American Medical Innovation (CAMI).Prior to joining NVCA, Slone spent 11 years as senior director of legislative and international trade affairs for Baxter Health Corp., a Fortune 50 healthcare company. In this capacity she lobbied, developed, and implemented strategies on a wide range of issues, including FDA reform, the development of FDA user fees, product liability, and various corporate tax issues. She also managed the company’s political action committee.
MaryAnn Guerra, BioAccel
MaryAnn Guerra is currently Chairman of the Board, Chief Executive Officer, and co-founder of BioAccel™. Ms. Guerra is well known for creating novel programs to accelerate the transfer of technology from the lab into useful products and new business opportunities. Ms. Guerra has spent her career operating successful and progressive health, science and technology businesses. She is an expert at business development and strategic planning initiatives that create organizations poised to deliver commercial outcomes. Since the launch of BioAccel in April 2009, 10 companies have been successfully launched with products close to commercial availability. Additional new technologies and companies are under development. Additionally BioAccel partnered with the City of Peoria to create the first medical device accelerator, embedding the BioAccel philanthrocapitalism model into its operations. In May 2013 BioAccel received the City of Peoria’s, City Manager’s Award for Outstanding Partnership in Economic Development. Prior to founding BioAccel, Ms. Guerra served as President of TGen Accelerators, LLC and Chief Operating Officer at the Translational Genomics Research Institute (TGen). While at TGen she facilitated the start-up of 6 companies and was involved in the sale of 3 of those that yielded significant profits for the organization. As TGen’s former COO she grew the organization from $30M to over $60M in less than 3 years.
Paul Jackson, Worthworm and Integrus Capital
Paul Jackson is an entrepreneur, angel investor, and aerospace engineer. His engineering expertise and entrepreneurial spirit are driving forces behind his founding of Integrus Capital, and co-founding its flagship offerings, Worthworm and D-Strut LLC. After a successful career as a dynamics engineer for Orbital Sciences and a commercial space development consultant in Washington D.C., Mr. Jackson founded Dynamic Labs, a recognized leader in environmental testing dedicated to testing and evaluating products in the early stages of development for commercial and military applications. Dynamic Labs served approximately 80% of the high-tech industry in the American Southwest, including defense primes such as Boeing, Lockheed, Raytheon and Honeywell.
Intro to The Clinical Trials Process with Dr. Mark Slater
Mark Slater, PhD, Vice President, Research HonorHealth and Chief Executive HonorHealth Research Institute
The HonorHealth Research Institute is where world-class care and groundbreaking research meet to benefit patients.Here, leading researchers, physicians and clinical teams work together to develop new therapies, as well as provide innovative care and treatments close to home. Focused on improving patients’ health and quality of life, they provide hope today and advancements for tomorrow. Having established partnerships with Harvard, Duke, Johns Hopkins, Columbia, University of Pennsylvania, Salk Institute, TGen, University of Arizona, Arizona State University as well as with many pharmaceutical and biotechnology companies, HonorHealth Research Institute is “an institute without walls.” We strive to remain nimble so we can move quickly to provide the most advanced therapeutic options for our patients.While working on new treatments today, the HonorHealth Research Institute is also ensuring that vital research continues tomorrow. Numerous clinical trials are always underway at HonorHealth Research Institute in areas such as oncology, cardiovascular, bariatrics, trauma and orthopedics/neurology.