Halteres Presents

In the season one finale episode, Rich Thayer and Mickey Urdea are interviewing Dr. Patty García, the former Minister of Health of Peru, about what diagnostics developers must consider about the who, what, where, when, and how of how tests will be used when creating new diagnostics products, and how accessibility of testing, and of self-testing, are democratizing how patients are able to receive their care worldwide.

Dr. Patty J. García is currently a Professor at, and the former Dean of, the School of Public Health at Cayetano Heredia University (UPCH) in Lima-Peru. She is the former Minister of Health of Peru, Dean of the School of Public Health at UPCH, and former Chief of the Peruvian National Institute of Health (INS). She is recognized as a leader in Global Health, having been a member of the PAHO Foundation Technical Advisory Group (FTAG), board member of the Consortium of Universities in Global Health and President of the Latin American Association Against STDs (ALACITS). She is an affiliate Professor of the Department of Global Health at the University of Washington and of the School of Public Health at Tulane University. She is actively involved in research and training in global health, reproductive health, STI/HIV, HPV ,and medical informatics. She has recently been appointed member of the United States National Academy of Medicine, becoming the first Peruvian professional with such a distinction.

Learn more about WomenLift Health, for which Dr. García sits on the global advisory board, here: https://www.womenlifthealth.org/our-mission/

Have an idea for a guest or a topic you'd like to see discussed in Season 2? Let us know here: https://halteresassociates.com/contact/

On this episode, Rich Thayer and Mickey Urdea are interviewing Mike Richey, the Co-Chair of the Board of Directors for the National AIDS Memorial, about the barriers that exist which prevent patients from receiving the healthcare they need, be they geographical, economic, or the result of stigma or prejudice, and the efforts that are being made to circumvent those obstacles. He also shares details on the National AIDS Memorial's "Change The Pattern" initiative and how it is being used in communities across the southern United States as a teaching tool in the fight against HIV/AIDS.

Mike Richey has more than 30 years of experience in the healthcare field specializing in diagnostics and personalized medicine. His areas of focus include medical and government affairs, product development, operations, market development, marketing, sales, and executive management. Mr. Richey's primary emphasis over the past 15 years has been in the development and execution of business strategies that fostered the successful creation of a new, high value segment of diagnostics (therametrics). This movement was driven by conclusive scientific analysis, resulting in the clinical evidence needed to substantiate the role that new metrics play in directing therapeutic intervention. After working as a clinical microbiologist at Children's Hospital in Oklahoma City, he joined Abbott Laboratories in 1978, initially working in research and development for the Diagnostics Division and then served in project management, and sales and marketing management roles. Joining Chiron in 1990, Mr. Richey served as Vice President of Marketing in the Diagnostics Division with responsibility for worldwide sales, marketing, and market development for the company's novel HCV and HIV viral load tests. Most recently, he was Co-Founder and President of Tethys Bioscience, where he was also responsible for medical and regulatory affairs, product development, and laboratory and commercial operations. As a consultant, Mr. Richey focuses on research and development, licensing, business and marketing strategies for biotechnology, genomics, and diagnostic companies. He received his BS in Laboratory Technology from the University of Oklahoma in Norman.

Learn more about the National AIDS Memorial's "Change The Pattern" quilting project here: https://www.changethepattern.org/

On this episode, Rich Thayer and Mickey Urdea are interviewing Nancy Gagliano, MD, MBA, to discuss her role as an executive leader of the National Institute of Health (NIH)’s RADx Tech, Rapid Acceleration of Diagnostics program. In this unique position, she helped oversee over one billion dollars of sponsored programs to bring millions of new COVID-19 tests to market, and in this exclusive interview, she helps outline exactly how the RADx program came to be, what lessons they learned, and what similar programs the NIH is planning to expand next.

Dr. Gagliano has more than 35 years of experience as a senior healthcare physician executive and practicing physician in internal medicine. Prior to her work for the National Institute of Health, Dr. Gagliano was the Chief Medical Officer of Culbert Healthcare Solutions, providing strategic guidance on healthcare consulting services. Before joining Culbert Healthcare, Dr. Gagliano spent six years with CVS Health holding senior leadership positions including as the Chief Medical Officer of Minute Clinic, and as a Senior Vice President overseeing key programs such as the enterprise smoking cessation program and the development of the company’s telemedicine program. Prior to her leadership roles at CVS Health, Dr. Gagliano was a practicing internal medicine physician and held numerous leadership positions at Massachusetts General Hospital and Massachusetts General Physicians Organization. She also currently serves on the board of directors for OraSure Technologies and is the Managing Director for Granite Healthcare Advisors. Dr. Gagliano holds an M.D. from Harvard Medical School, an MBA from Northeastern University, and a Bachelor’s of Science Degree from Union College in Computer Science and Biology.

Learn more about RADx here: https://www.nih.gov/research-training/medical-research-initiatives/radx

On this followup minisode, Rich Thayer and Mickey Urdea are again interviewing Jennifer Leib, founder of Innovation Policy Solutions, to follow up on several key pieces of legislation related to the diagnostics industry, and where that legislation goes from here. This episode was recorded in the spring of 2023 to touch base on how the new session of Congress has (or hasn't) changed the outlook for some key legislation that will have wide-ranging effects on the diagnostics industry.

Jennifer Leib is a board-certified genetic counselor and experienced government affairs professional with an expertise in genomics and precision medicine policy, having studied at the undergraduate program at University of Michigan and the masters program at Johns Hopkins University.

Innovation Policy Solutions (iPolicy) is a leading government affairs consulting firm that promotes innovation through policy change. The firm actively advises and advocates on behalf of patients, providers, and innovators in laboratory medicine, precision medicine, public health, synthetic biology, gene therapy, neuroscience, rare diseases, and more. Grounded in a foundation of scientific expertise, iPolicy identifies data-driven solutions to health and science policy issues and builds coalitions of support to drive the adoption of clinical advances and enhance patient access to cutting-edge diagnostics and therapeutics. iPolicy is headquartered in Washington and supports clients across the country. For more information, visit www.ipolicysolutions.com.

On this episode, Rich Thayer and Mickey Urdea are interviewing Jennifer Leib, founder of Innovation Policy Solutions, to dissect several key pieces of legislation related to the diagnostics industry. This episode was recorded in the last days of 2022 to capture the hot-off-the-presses developments at the end of the last session of Congress. 

Jennifer Leib is a board-certified genetic counselor and experienced government affairs professional with an expertise in genomics and precision medicine policy, having studied at the undergraduate program at University of Michigan and the masters program at Johns Hopkins University.

Innovation Policy Solutions (iPolicy) is a leading government affairs consulting firm that promotes innovation through policy change. The firm actively advises and advocates on behalf of patients, providers, and innovators in laboratory medicine, precision medicine, public health, synthetic biology, gene therapy, neuroscience, rare diseases, and more. Grounded in a foundation of scientific expertise, iPolicy identifies data-driven solutions to health and science policy issues and builds coalitions of support to drive the adoption of clinical advances and enhance patient access to cutting-edge diagnostics and therapeutics. iPolicy is headquartered in Washington and supports clients across the country. For more information, visit www.ipolicysolutions.com.

In this week’s episode, Rich Thayer and Mickey Urdea are interviewing Dr. Paul Keim, who was recently featured in the noteworthy 2022 Netflix documentary "The Anthrax Attacks", about his essential and pivotal scientific research used in the FBI’s 2001 anthrax letters investigation. While the Netflix series focused on the twists and turns of the nationwide manhunt, here on Halteres Presents Dr. Keim is able to more thoroughly delve into the science behind his laboratory’s analysis of the 2001 anthrax letters, and to explain why there may never be a true “smoking gun” in this infamous case.

Dr. Paul Keim is the executive director of the Pathogen and Microbiome Institute (PMI) at Northern Arizona University (NAU), a joint program between NAU and the Translational Genomics Research Institute (TGen) which uses genomic tools to protect America against dangerous pathogens, in particular Bacillus anthracis (anthrax). A graduate of NAU himself, where after 34 years on the faculty he holds the Cowden Endowed Chair in Microbiology and is a Regents Professor, Dr. Keim was trained as a protein biochemist before moving into molecular microbiological genetics and genomics as a postdoctoral fellow at the University of Utah. Dr. Keim is an elected fellow of both the American Association for the Advancement of Science and the American Academy for Microbiology. The National Institutes of Health appointed him to the National Science Advisory Board for Biosecurity in 2004 and served as its chairman for two years. He has published over 450 scientific research articles that have been cited over 30,000 times.

The Pathogen and Microbiome Institute (PMI): https://joinpmi.com

"The Anthrax Attacks" on Netflix: https://www.netflix.com/title/81213109

In a special 3-part season premiere, Halteres Presents is spotlighting tuberculosis diagnostics worldwide, and where things stand in the field today. In Part Three, Rich Thayer and Mickey Urdea are interviewing Dr. Shibu Vijayan, the Medical Director for Global Health Practice at Qure.ai, a healthtech company that uses artificial intelligence assistance for medical imaging diagnostics. Dr. Vijayan is a senior clinician in Community and Public Health Services with over 25 years of experience in developing, monitoring, and evaluating public health projects, including developing healthcare-related proposals in both private and not-for-profit organizations. He is also an accredited International general Tuberculosis (TB) expert by the TB team hosted by WHO and Stop TB Partnership. Prior to Qure.ai, Dr. Vijayan was at PATH and has also worked with the WHO as Technical Consultant for the TB Control Program in India and was associated with Medicines Sans Frontiers (MSF, Netherlands) as a field Epidemiologist in Ethiopia.

In a special 3-part season premiere, Halteres Presents is spotlighting tuberculosis diagnostics worldwide, and where things stand in the field today. In Part Two, Rich Thayer and Mickey Urdea are interviewing Dr. Peter Small, the Chief Medical Officer at Hyfe.ai, an acoustic epidemiology company which uses machine learning to build acoustic tools for respiratory diagnostics and monitoring. For more than a decade, Dr. Small was responsible for building and running the innovative TB program at the Bill & Melinda Gates Foundation, performing seminal work on clinical, epidemiologic, evolutionary, and genetic aspects of tuberculosis. He has deep expertise in translating cutting-edge science into drugs, diagnostic methods, and vaccines, as well as the business and public health processes to get innovative tools to those in need. Dr. Small holds a BA from Princeton University and a MD from the University of Florida, and he is also the Founding Director of the Stony Brook University Global Health Institute.

In a special 3-part season premiere, Halteres Presents is spotlighting tuberculosis diagnostics worldwide, and where things stand in the field today. In Part One, Rich Thayer and Mickey Urdea are interviewing Dr. Morten Ruhwald, who leads the TB Programme at FIND in Geneva, Switzerland. He trained as a medical doctor at Copenhagen University Hospitals, Denmark and obtained his PhD in TB Immunology at Copenhagen University. Prior to joining FIND, Morten served as CMO and Head of Human Immunology at Statens Serum Institute of Denmark, overseeing the clinical development of the TB and chlamydia vaccine programs. Morten's research interests include molecular and immunoassay development for TB and TBI diagnostics, non-sputum-based diagnostic approaches, biomarkers, digital tools, and personalized medicine in TB.

FIND Tuberculosis Programme: https://www.finddx.org/what-we-do/programmes/tuberculosis/

World Health Organization (WHO) Global Tuberculosis Report, 2022: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022