Getting Innovation to the Finish Line: Regulatory Perspective in the era of 21st Century Cures
insights from our discussion with Arizona based regulatory experts Michelle
Lott of Lean RA/QA Systems and Joni
Creal of Bard
It has been said that “Arizona’s collaborative gene” is a secret to our success. When we all work together, we can and we will achieve great things.In November of 2014, a new organization was born out of collaborations to add to the ecosystem that supports life science innovation and enable individuals and teams to come together as partners to help develop new health innovations and enable Arizona take its place on the global life science stage.D3Bio is a collaboration between the Opportunity Through Entrepreneurship Foundation (OTEF), an Arizona 501c3 corporation, and the Arizona Bioindustry Association, Inc. (AZBio) and will operate as a division under OTEF.
Innovative Applications of Analytics: Use in Veteran’s Health
Abbaszadegan, MD, Chief Medical Information Officer, Phoenix VA Health Care
IGC- Partnerships for Success
Robert Penny, MD, PhD, - Founder and CEOParadigm and International Genomics Consortium (IGC)
Dr. Robert Penny is Founder and CEO of Paradigm, a cutting-edge advanced diagnostics company that will help usher in the age of personalized medicine. Dr. Penny drove the vision and launch of the company, along with Dr. Jay Hess to provide improved cancer treatments based on an individual’s cancer’s unique biology. This is his sixth start up company; the previous five are all successful in the practice of medicine and financially.
Dr. Penny is also the Co-founder and CEO of the International Genomics Consortium (IGC) in Phoenix, Arizona. He created and drove the success of IGC’s national Expression Project for Oncology (expO). Dr. Penny was awarded the Principal Investigator for the Biospecimen Core Resource (BCR) for the founding Pilot Project and the full project for The Cancer Genome Atlas Project (TCGA) and a separate award for TCGA’s founding Tissue Source Site network. He helped create the vision of TCGA through his expO work and helped lead the practice of Oncology to utilize molecular pathways and the drugs that work on those pathways. While at the IGC, he envisioned and founded the Molecular Profiling Institute and served as its CEO and Chairman of the Board. The Molecular Profiling Institute is the first company to commercially introduce gene expression analysis into oncology in the U.S. He developed the successful commercially available test Target Now.
The College of American Pathologists awarded Dr. Penny the national organization’s 2012 Distinguished Patient Care Award for his extensive scientific translational research to accelerate the adoption of molecular pathways and associated therapies. In 2011, the AZ BioIndustry Association honored Dr. Penny with the Jon W. McGarity Leadership Award for his vision in advancing cancer personalized medicine and success in leading the industry. Dr. Penny received his B.S., M.S., Ph.D. (Genetics) and M.D. from the University of Arizona and then went on to receive his pathology training at Harvard’s Brigham & Women’s Hospital in Boston, Massachusetts
Right to Try - Testimony in Colorado
“Right to Try” - Testimonly on Colorado HB14-1281
This video is a reproduction of an audio recording of testimony in the Colorado General Assembly House Health, Insurance & Environment Committee on March 13, 2014.
The recording is an unabridged excerpt from the committee hearing that lasted for over 7 hours on several Bill topics. The "Right to Try" discussion is the only content provided here.
For ease of finding information, the following minute marks are provided:
Bill Sponsor Comments: 00.01.02
Opposition Comments: 00.24.19 (includes Larry Sarner - Fellow at the Institute of Science and Medicine & Maureen Maker (Patient and representing Colorado Citizens for Science and Medicine) & Dr. Bill Marsh Associate Medical Dir, Kaiser & Josh Gordon, Clinical Trials at Kaiser) All Speakers are from Colorado.
For the Bill - 00.48.15 - Includes Lorraine and Philip McCartin from Boston, Steve Walker of the Abigail Alliance from Florida, and Kurt Altman, Esq of the Goldwater Inst. from AZ.
Neutral and expressing serious concerns - 01:26:37 includes Janet Stevens of the Colorado Hospital Assoc with concerns and need for hospitals to be exempted from the bill as they can not implement due to Federal regulation conflict & David Blake, Esq, Deputy Attorney General in Colorado explaining the constitutional conflict, the tort risk to physicians and drug companies in federal court and other issues & written comments with concerns for patients from the hospice association.
Source: Colorado General Assembly Recordings at http://www.leg.state.co.us