Halteres Presents

On the finale episode of season 3 of "Halteres Presents", Rich Thayer and Mickey Urdea are honored to sit down with their longtime colleague Nobel Laureate Sir Michael Houghton. Sir Michael Houghton is a British-born virologist known for his contributions to the discovery of hepatitis C virus (HCV). The identification of HCV facilitated the development of improved blood screening tests and diagnostic methods for the detection of hepatitis caused specifically by HCV. For his breakthrough, Houghton was awarded the 2020 Nobel Prize in Physiology or Medicine, shared with American virologists Harvey J. Alter and Charles M. Rice. Dr. Houghton was born into a working-class family; his father was a truck driver. After successfully passing exams, Houghton was admitted to a private high school. He later won a scholarship to study at the University of East Anglia, where he completed a degree in biological sciences in 1972. He then attended King’s College London for graduate studies. His research focused on elucidating the human beta interferon gene; interferons produced by the body’s cells are a key defense response against viruses. In 1977 Houghton graduated from King’s College, earning a doctoral degree in biochemistry. Dr. Houghton subsequently moved to the United States. After a short period at the pharmaceutical manufacturer G.D. Searle & Company (later G.D. Searle, LLC, a subsidiary of Pfizer), he joined the California-based biotechnology firm Chiron Corporation. At Chiron, Houghton worked closely on investigations of non-A, non-B hepatitis with fellow Chiron scientists George Ching-Hung Kuo and Qui-Lim Choo and American virologist Daniel W. Bradley, who was based at the U.S. Centers for Disease Control and Prevention. Using a complementary DNA library developed from blood plasma containing a non-A, non-B hepatitis virus, the researchers successfully identified a DNA clone derived from the HCV RNA genome. Houghton and colleagues subsequently developed an assay to screen for HCV in blood samples. The breakthrough facilitated the development of highly effective blood screening tests to prevent the transmission of HCV via blood transfusion. While at Chiron, Houghton also contributed to the discovery of the hepatitis D virus genome. In 2007 he left Chiron to join Epiphany Biosciences, where he was the chief scientific officer. Two years later he moved to Canada, having accepted the position of Li Ka Shing Professor of Virology at the University of Alberta. His later research focused on the development of an HCV vaccine. Dr. Houghton received various honors and awards during his career, including the Robert Koch Prize (1993) and the Albert Lasker Clinical Medical Research Award (2000, shared with Alter). He declined the Canada Gairdner International Award (2013) because of its exclusion of his colleagues who helped identify HCV. In 2021 Sir Houghton was made a knight. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

On this solo episode of "Halteres Presents", Rich Thayer and Mickey Urdea are highlighting the potential market applications for wearable diagnostic devices. The recent increased interest in the wearables space has been ignited by significant technological improvements in microfluidics and microelectronics, as well as the use of smart phone apps and AI-driven algorithms that help to enrich the data stream and the actionability of the diagnostic results. Rich and Micky cover new detection technologies, improved biomarkers and biofluid collection capabilities, the unique value of continuous monitoring for assessing women's health, and applications beyond human health, such as for companion, herd, and wild animals. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  UC San Diego Extended Studies In Vitro Diagnostics Product Development Course Use code: HALTERES10 at checkout! This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

On this week's episode of "Halteres Presents", Rich Thayer and Mickey Urdea are discussing with David Engelthaler, the director of the Pathogen and Microbiome Division at TGenNorth, the status of today's most cutting-edge genomics tools and how they're being utilized for clinical medicine, public medicine, and the One Health space. These next-gen genomic tools are more useful, flexible, accurate, and affordable than ever before, but they are only as intelligent as the hands they're in, so Dave is here to help uncover the best applications for these tools and the most applicable data to mine for the most useful and expansive possible inferences. Tune in to raise the level of your own pathogenic intelligence with David Engelthaler. Dave Engelthaler, Ph.D., is a professor and the director of the Pathogen and Microbiome Division (aka TGen North). His research team at TGen North has a specific mission to advance human health through the application of pathogen genomic sciences and next generation technologies.  He is also director of the TGen North Clinical Laboratory, and Co-Director of the TGen Integrated Microbiomics Center.Dave was formerly the State Epidemiologist for Arizona and a biologist for the Centers for Disease Control and Prevention. He has over 160 peer-reviewed publications and over two dozen patented inventions. Dave's team at TGen North led TGen's emergency response operations to COVID, providing direct support to the residents of Arizona, especially for tribal nations and rural communities. Post-pandemic, his translational research is heavily focused on detecting and tracking outbreaks, characterizing and monitoring drug resistance in tuberculosis patients, and studying disease emergence and pathogen evolution.Dave received a Ph.D. in Biology from Northern Arizona University with a focus on genomic epidemiology, and a Master’s Degree in Microbiology from Colorado State University, where he studied host-vector-pathogen dynamics. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

On this week's episode, Rich Thayer and Mickey Urdea are hosting Jennifer Leib and Elliot Cowan for their first-ever roundtable discussion in order to parse through the ramifications of the FDA's recent final rule on laboratory-developed tests (LDTs), which amends FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. This new LDT regulation has massive implications for test developers, patient care, and the FDA itself, so having Jennifer and Elliot, who possess very different experiences and opinions on the FDA's final rule, on the podcast together for this special roundtable discussion was critical for putting the new rule and its fallout in the proper context. This unique, frank conversation is a one-of-a-kind opportunity to see the whole picture of this complicated subject matter; please enjoy. 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. She is the founder of Innovation Policy Solutions (iPolicy), 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. Elliot Cowan is the founder and principal of Partners in Diagnostics after 20 years of service at the US Food and Drug Administration (FDA). As Chief of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases at FDA’s Center for Biologics Evaluation and Research, he was responsible for the regulatory oversight of all blood donor screening tests and retroviral diagnostics, covering every facet of the regulatory review process. He served as chair or supervised the review of numerous IVD applications, as well as acting as the product expert for manufacturing facility inspections. He played key roles in the development of policy, coordinating decisions on issues such as the approval and use of the first of rapid HIV tests and the first over-the-counter HIV test system. He served as the Chair of the HIV Diagnostics Subcommittee of the Laboratory Technical Working Group in the President’s Emergency Plan for AIDS Relief (PEPFAR), and assisted the World Health Organization in the development of its Prequalification of Diagnostics Programme. Elliot received a BA from Williams College and a PhD in biology and biomedical sciences from Washington University in St. Louis. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

On this episode of "Halteres Presents", Rich Thayer and Mickey Urdea are chatting about decentralized diagnostic testing with Dr. Donna Wolk, division director of Molecular and Microbial Diagnostics and Development at Geisinger Medical Laboratories. Dr. Wolk helps to put into perspective the market explosion of decentralized diagnostic tests designed for point-of-care, near-patient, at-home, over-the-counter, and pharmacy-based use, and the patient-driven factors to weigh when considering which tests to offer in which decentralized venues. Dr. Donna Wolk is the division chief, Molecular and Microbial Diagnostics and Development, at Geisinger Medical Laboratories and director of the Infectious Disease Research Laboratory at the Weis Research Center. She is a diplomate of the American Board of Medical Microbiology, a board-certified medical laboratory scientist, and a professor at the Geisinger Commonwealth School of Medicine. Dr. Wolk also serves on the faculty of the Geisinger Pathology Residency Program.  Dr. Wolk received her master’s in health administration at Wilkes University and her Ph.D. at the University of Arizona in Tucson. She completed a postdoctoral fellowship in clinical and molecular microbiology at the Mayo School of Graduate Medical Education in Rochester, Minnesota. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

On this episode of "Halteres Presents", Rich and Mickey are sitting down with David Persing, the Executive Vice President, Chief Medical and Scientific Officer for Cepheid, to reflect upon his experiences at the dawn of molecular diagnostics, the effectiveness of surveilling animal reservoirs to monitor for disease outbreaks, and just how nervous we should be about the spread of H5N1 (and when we should really start to worry). David Persing, MD, Ph.D., has spent most of his 30-year career in biomarker discovery, translational medicine, and innovation in the diagnostics space. Dave joined Cepheid in 2005 and has focused on the enablement of molecular diagnostic technology to meet global needs in infectious diseases and oncology. He conducted his scientific and medical training with Don Ganem and Nobel laureate Harold Varmus at the University of California, San Francisco. After residency training in Clinical Pathology at Yale University, he held leadership roles in academia and industry starting in the early 1990s with the design, implementation, and operation of the first PCR reference laboratory at the Mayo Clinic. His interest in the democratization of molecular diagnostic methods has been longstanding, starting in 1993 with his publication of the first of five widely adopted textbooks to include PCR protocols and guidelines for laboratory operations. He has published over 300 peer-reviewed articles and reviews, including multiple articles in the New England Journal of Medicine, Science, and PNAS. In 2020, he was named to the Fierce Pharma list of the 22 most influential scientists in the fight against COVID-19. To maintain a connection with the latest trends in translational medicine, Dave also serves as Consulting Professor of Pathology at Stanford University School of Medicine. He obtained his MD and Ph.D. degrees from UCSF in 1988. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

Welcome to Season 3 of "Halteres Presents", the award-winning, brand-agnostic interview podcast designed to unbiasedly highlight the happenings within the diagnostics industry.  Our first guest of Season 3 is Holden Thorp, the editor-in-chief of Science Magazine and family of journals. Holden brings his unique perspective to the subject of science communications, discussing his thoughts the quandary of fostering public trust in science, how to improve the way science is taught in schools, and just what made the greatest scientific communicators so great. Holden Thorp became Editor-in-Chief of the Science family of journals on 28 October 2019. He came to Science from Washington University, where he was provost from 2013 to 2019 and professor from 2013 to 2023.  He is currently a professor at George Washington University and on leave to serve as the Editor-in-Chief at Science. Thorp joined Washington University after spending three decades at the University of North Carolina at Chapel Hill (UNC), where he served as the 10th chancellor from 2008 through 2013. Thorp earned a bachelor of science degree from UNC, a doctorate in chemistry from the California Institute of Technology, and completed postdoctoral work at Yale University. He holds honorary degrees from Hofstra University and North Carolina Wesleyan College and is a fellow of the American Academy of Arts and Sciences, the National Academy of Inventors, and the American Association for the Advancement of Science.   Thorp cofounded Viamet Pharmaceuticals, which developed VIVJOA (oteseconazole), now approved by the FDA and marketed by Mycovia Pharmaceuticals. Thorp is a venture partner at Hatteras Venture Partners, a consultant to Ancora and Urban Impact Advisors, and is on the board of directors of PBS, the College Advising Corps, and Saint Louis University.  He serves on the scientific advisory boards of the Yale School of Medicine and the Underwriters’ Laboratories Research Institutes.  In 2023, STAT named Thorp to its STATUS list of top leaders in the life sciences. Thorp is the coauthor, with Buck Goldstein, of two books on higher education: Engines of Innovation: The Entrepreneurial University in the Twenty-First Century and Our Higher Calling: Rebuilding the Partnership Between America and its Colleges and Universities, both from UNC Press. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

"Halteres Presents" is back with Season 3 beginning Tuesday June 11th! Seasons 1 and 2 of "Halteres Presents" had a very rewarding awards season, having been honored with: a Gold 2024 American Business Award, a Silver 2023 Davey Award, a Gold 2024 Muse Creative Award, a Gold 2023 Titan Health Award, and an Award of Distinction from the 2024 Communicator Awards. Thank you all so much for your dedicated listening. This season's guests include Holden Thorp the editor-in-chief of Science Magazine and their family of journals, and 2020 Nobel Laureate Sir Michael Houghton, the co-discoverer of Hepatitis C, as well as many others to cover a wide variety of topics including infectious disease outbreaks being unleashed by global climate change, new FDA guidance on laboratory developed diagnostic tests, and the latest information on the spread of H5N1 avian flu. Follow us on Apple or Spotify, and enjoy season three of "Halteres Presents" beginning Tuesday June 11th!

In honor of World TB Day 2024, we're re-releasing our three-part series from last year on the status of tuberculosis diagnostics worldwide. For World TB Day 2024, the World Health Organization updated their new ⁠⁠recommendations⁠⁠ and their ⁠⁠TB sequencing portal⁠⁠. Our guest Morten Ruhwald also wrote this ⁠⁠press release⁠⁠ on behalf of FIND. These episodes originally premiered on March 3rd, 2023. 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 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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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 This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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). This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

*Special 20th Anniversary Episode!* At Halteres Associates, we are celebrating our 20th Anniversary, and we want to acknowledge and thank our many constituents around the world for their support and allowing us to assist them with their innovations.  When we started Halteres Associates, we had no idea where it would take us, and the last twenty years have been an exciting and fulfilling journey.  We would like to take some time now to reflect on where we have been as a company, the changes we have seen in the global healthcare community, and where we believe things are headed for diagnostics and devices. There has been quite a bit of change in our industry in the last twenty years, especially regarding the level of sophistication used to define and evaluate the entire diagnostic ecosystem, including how new technologies may best address market and product needs and opportunities. We have seen these changes develop across the board with our industry and academic partners, NGOs and global health partners (including with funding and policymakers), ministries of health, and other key stakeholders. While arguments can always be made to develop new technologies, it is now more widely understood that it is equally important to demonstrate and deliver positive impacts. We believe that this is a good time to take stock of what we have learned and how we can use that knowledge to anticipate what’s ahead. We look forward to what the next 20 years will bring, and to making new connections in this ever-evolving global health industry.  Thank you for your support, and we hope you enjoy this reflection on the first 20 years of Halteres Associates.  Watch the video version here: https://youtu.be/Xlio02VtsPU This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

In honor of World TB Day 2024, we're re-releasing our three-part series from last year on the status of tuberculosis diagnostics worldwide. For World TB Day 2024, the World Health Organization updated their new ⁠recommendations⁠ and their ⁠TB sequencing portal⁠. Our guest Morten Ruhwald also wrote this ⁠press release⁠ on behalf of FIND. These episodes originally premiered on March 3rd, 2023. n 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. This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

In honor of World TB Day 2024, we're re-releasing our three-part series from last year on the status of tuberculosis diagnostics worldwide. For World TB Day 2024, the World Health Organization updated their new ⁠⁠recommendations⁠⁠ and their ⁠⁠TB sequencing portal⁠⁠. Our guest Morten Ruhwald also wrote this ⁠⁠press release⁠⁠ on behalf of FIND. These episodes originally premiered on March 3rd, 2023. 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/ This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Development course, a unique live-online program designed for managers, entrepreneurs, investors, and scientists. Enroll today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.  ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.