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.)
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.
2012 State of the Industry: John D. Carroll of FierceBiotech
John D. Carroll is a biotech analyst with 34 years of prize-winning experience in journalism. Appointed editor of FierceBiotech in 2003, he has covered virtually every aspect of the global drug development industry over the past decade. His work includes the popular Fierce 15, which recognizes the most innovative private companies in the business each year. His daily reports keep more than 100,000 subscribers around the world clued in to the latest developments on deals, data and industry trends. Carroll plans to address the biggest influences affecting the fast-changing biopharma industry and what it means to biotech executives in Arizona.
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.
AZBio Public Service Award - Rick Myers
A widely respected and tireless civic leader, Rick Myers is a visionary and a strong advocate for promoting the biosciences in Arizona. Rick serves as the Governor-appointed Chair for the Arizona Board of Regents and advocates for growing the research enterprise and promoting biosciences.
In 2012, Regent Myers was honored with the 2012 AZBio Public Service Award.