Halteres Presents

In Part Two of the Season 2 Finale of "Halteres Presents", Rich Thayer and Mickey Urdea continue their discussion with Paul Davis, dissecting the potential improvements to be made to today's lateral flow technologies, the possibilities (and realities) of what is yet to come with LFAs, and the best ways to build a team of inventors out of disparate personalities. Paul paints a detailed portrait of what "imagineering" can do to expand the scope and capabilities of lateral flow technologies, based on his trailblazing experiences in the field. Please enjoy Part Two of our interview with Paul Davis.

Paul Davis has worked in immunology for over 45 years and has founded or co-founded eight bioscience businesses since 2002, with Mologic being the most prominent. As Mologic’s chief scientific officer, Paul led the Centre for Advanced Rapid Diagnostics (CARD), funded by the Bill & Melinda Gates Foundation. Until 2002, he was as a senior scientist at Unilever Research leading applied immunology, and is one of the inventors of the lateral flow immunoassay.

In Part One of the Season 2 Finale of "Halteres Presents", Rich Thayer and Mickey Urdea are interviewing Paul Davis, PhD, on the founding of the consumer diagnostics industry. In celebration of his upcoming retirement, Paul Davis reflects on his involvement in the development of Clearblue, the first one-step home pregnancy test, among many other accomplishments while at Unilever, as well as his next adventures as an entrepreneur, founding multiple life sciences companies, including Mologic with his son Mark. Paul shares much of what he learned along the way, including the challenges for creating tests for untrained users, and how opinions on rapid testing technologies have changed over time.

On Part Two, Paul will further elucidate the technology behind lateral flow assays - what works, what doesn't work, and where the field is going. Enjoy Part One, and stay tuned for Part Two.

Paul Davis has worked in immunology for over 45 years and has founded or co-founded eight bioscience businesses since 2002, with Mologic being the most prominent. As Mologic’s chief scientific officer, Paul led the Centre for Advanced Rapid Diagnostics (CARD), funded by the Bill & Melinda Gates Foundation. Until 2002, he was as a senior scientist at Unilever Research leading applied immunology, and is one of the inventors of the lateral flow immunoassay.

On this week's episode, Rich Thayer and Mickey Urdea are exploring metagenomics with Dr. Rick Nolte, an engaging expert on the subject. Dr. Nolte helps to define what metagenomics is, its diagnostic uses, its advantages, and where the field is going. This is a delightfully in-depth interview about a complicated but important topic that is very much worth your time; please enjoy.

Frederick (Rick) S. Nolte, PhD, is currently a Senior Director/Medical Advisor at Karius, the microbial cell free DNA company, and Professor Emeritus of the Department of Pathology and Laboratory Medicine at the Medical University of South Carolina. He served as Vice-Chair for Laboratory Medicine/Medical Director of Clinical Laboratories and Molecular Pathology. He is a Diplomate of the American Board of Medical Microbiology and a Fellow of the American Academy of Microbiology. Dr. Nolte completed his B.S. degree in Biology at the University of Cincinnati, and his Ph.D. in Medical Microbiology at the Ohio State University. Dr. Nolte completed a postdoctoral fellowship in Public Health and Medical Laboratory Microbiology at the University of Rochester. Prior to coming to MUSC in 2007, he spent 18 years at Emory University School of Medicine where he was a Professor of Pathology and Laboratory Medicine and Director of the Clinical Microbiology, Molecular Diagnostic, and Serology Laboratories at Emory Medical Laboratories. He is active in and held positions of responsibility in the American Society for Microbiology, Association for Molecular Pathology, Clinical and Laboratory Standards Institute, Infectious Diseases Society of America, American Society for Clinical Pathology, College of American Pathology and American Association for Clinical Chemistry. He has authored numerous book chapters, practice guidelines, and peer-reviewed publications in the areas of clinical microbiology and molecular diagnostics.

On this week's episode, Rich Thayer and Mickey Urdea are publicizing public health with the help of Dr. Bela Matyas, the Health Officer and Deputy Director the Department of Public Health of Solano County, California. Dr. Matyas is known for his outspokenness regarding his against-the-grain, fact-based positions on matters of public health, and "Halteres Presents" is very proud to have him on to discuss his findings and his modus operandi for all matters related to public health, particularly in regard to diagnostics. Dr. Matyas is a top-notch interview subject, and a fantastic resource for data-driven public health expertise. Please enjoy his interview.

Bela Matyas, MD, MPH, is currently the Health Officer/Deputy Director for Solano County. His most recent prior posts include various roles with the California Department of Public Health (CDPH), and Medical Director of the Epidemiology Program in the Massachusetts Department of Public Health. Dr. Matyas received his medical degree from the University of California, San Diego School of Medicine and completed a residency in Occupational Medicine/Preventive Medicine at the Harvard School of Public Health, where he also received a Master of Science degree in epidemiology and a Master of Public Health degree.

For more information about the Solano County Department of Public Health, visit their website: https://www.solanocounty.com/depts/ph/about.asp

On this week's episode, Rich Thayer and Mickey Urdea are delving into diagnostics regulations with David Kern, detailing the myriad changes in the regulatory landscape since the pandemic in the United States as well as the implications of the new IVDR regulations in Europe. There are few people who can make regulatory as downright enjoyable as Dave Kern; please enjoy his delightful interview.

David Kern is the founder of K2 Regulatory Consulting. With 30+ years of experience in the IVD medical device industry, he has held positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs at Illumina, where he built a global regulatory organization, with offices in China, Australia, and the UK.

Dave has a B.S degree in Biochemistry from San Francisco State University, an MBA from San Jose State University, and holds a RAC from the Regulatory Affairs Professional Society (RAPS). He is also an instructor at UC Santa Cruz Extension.

On this week's episode, Rich Thayer and Mickey Urdea are interviewing Dr. Alan Rudolph, who has had an active career in translating interdisciplinary life sciences into useful applications for biotechnology development in academia, government laboratories, and the nonprofit and private sectors. Dr. Rudolph spearheads a wide-ranging discussion on innovations in disease surveillance in agriculture, the viability of developing veterinary diagnostics tests, what "One Health" represents for whole ecosystem health, and the values of longitudinal sampling, among many other interesting topics. Sit down and tune into this electric discussion with Dr. Alan Rudolph.

Dr. Alan Rudolph is the former Vice President for Research at Colorado State University, and a former member of the Senior Executive Service, having served as the Director for Chemical and Biological Technologies Directorate, Research and Development Enterprise, Defense Threat Reduction Agency (DTRA) as part of the Defense Advanced Research Projects Agency (DARPA).

On this week's episode, Rich Thayer and Mickey Urdea are interviewing Mohammed Majam, the Director for Medical Technologies at Ezintsha in Johannesberg, South Africa, whose portfolio encompasses Diagnostics, Implementation, and mHealth innovation projects. Mohammed helps lead a deep-dive discussion on what Ezintsha at Wits University brings to the global health space, how usability trials are conducted for diagnostic tests, and where the fields of self- and home-based diagnostic tests are headed in the post-pandemic era. Mohammed Majam is as skilled and savvy as any expert in his field, so please enjoy his thorough analysis in this interview.

Mohammed is a lifelong “Witsie” having not left the Wits University family from his first day back in 2002. He holds a Bachelor of Science with Honours degree in Biochemistry and Genetics, as well as completing an MBA (cum laude) from the institution in 2016. Mohammed has a passion for operational efficiencies which led him to obtain his Six Sigma Black Belt qualification.

Rich Thayer and Mickey Urdea are honored to welcome one of their absolute favorite authors David Quammen as their first guest of season 2 of Halteres Presents. David stops by to discuss just how he predicted a global zoonotic viral pandemic in his book "Spillover" all the way back in 2012, the lessons we've learned (or not learned) about pandemic preparedness in the aftermath of COVID-19/SARS-CoV-2, why bats are such notable reservoir hosts, and much more, including his new page-turner "The Heartbeat of the Wild" about his years of globetrotting the very wildest places on the planet Earth while reporting for National Geographic Magazine. Please enjoy this swashbuckling thriller of an episode with David Quammen.

Three-time winner of the National Magazine Award (the Ellie) and author of 17 previous books, David Quammen is one of the world’s top science writers. His 2012 book "Spillover", which predicted a worldwide pandemic, was shortlisted for eight national and international book awards, and won three, including the Premio Letterario Merck, in Rome. That book, and his 2022 book "Breathless: The Scientific Race to Defeat a Deadly Virus", have made him one of the most sought-after commentators on the coronavirus.

His newest book, 2023's "The Heartbeat of the Wild: Dispatches from Landscapes of Wonder, Peril & Hope" (National Geographic Books), is his inspiring collection of essays from some of the planet’s wildest locales, imparting how keeping remote regions alive and well—even as human activities encroach upon them—is essential to our future. Throughout 21 tales, from two decades of his assignments with National Geographic, Quammen takes readers to places where civilization meets raw nature and explores the challenge of balancing the needs of both. Each piece has been revised to reflect current observations and linked with an awareness of the bigger conservation story that together they tell.

David is a regular contributor of features and Op Eds to National Geographic, The New Yorker, The New York Times, and other journals. He lives in Bozeman, Montana.

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