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Halteres Associates

Halteres Presents

A Life Sciences and Science podcast

#62 in Life Sciences · 🇮🇪 #78 in Life Sciences · 🇸🇬
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About the show

Halteres Presents is an award-winning, brand-agnostic interview podcast designed to unbiasedly highlight the happenings within the diagnostics industry. In each episode, founding partner Mickey Urdea and managing partner Rich Thayer interview an expert who brings their own unique perspective to an industry topic. https://youtu.be/OmbeM2uGkHo Halteres Associates is a leading bioscience consultancy with extensive, long-term, direct operating experience in a broad spectrum of areas of expertise, including diagnostics, medical devices, therapeutics, research reagents, and bioscience tools.

Newest episodes

BONUS: Live from HLTH 2025's "Diagnostics Zone"!

30 min

On this bonus episode of "Halteres Presents", host Mickey Urdea is recording live from the first-ever "Diagnostics Zone" at HLTH 2025 in Las Vegas! Among the many old colleagues and new faces we got to meet up with and learn from, we had the opportunity to chat with two very interesting exhibitors: Molecular Testing Labs and OTO Fertility. From Molecular Testing Labs, Mickey spoke with their Chief Commercial Officer James York about their "tailored solutions for diverse markets" approach, and from OTO Fertility, Mickey spoke with their CEO Caleb Evans about how their wearable device tracks more than fifty biometric markers to help users track their own optimal fertility in harmony with their doctors' care. Please enjoy this bonus episode of "Halteres Presents". James York is a graduate of East Tennessee State University where he majored in Exercise Physiology and prepared for medical school. Even though his interest was always focused on medicine and science, his first career position was a trader of equities and options on the Southwest Securities Trading Floor. Desiring to enter the healthcare sector and return to his roots, he leveraged his experience from the trading floor to start capitalizing, managing, operating, and making markets in various healthcare companies. James was involved in medical devices, intra-operative neuromonitoring, clinical research, networking, pharmacies, and laboratories. He has had many roles within each company including VP of Sales, President, and CEO – for companies both private and public. Caleb Evans is a health-tech entrepreneur and the CEO & Founder of OTO Fertility, a breakthrough biometric wearable and AI platform transforming reproductive care. With a background in biochemistry, digital health, and nonprofit leadership, Caleb has scaled organizations across sectors, from EMR software to fertility clinics. His mission with OTO is to apply elite biometric science to family-building, creating a new standard of care for women...

Ep. 407: "The Value of a Molecular Cancer Signal of Origin" with Dr. Eric Klein

57 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Eric A. Klein, MD, to get his perspective on the value of a molecular cancer signal of origin in guiding targeted diagnostic evaluations based on his real-world experience overseeing GRAIL's clinical development program spanning 9 clinical trials and diverse populations, including those with occupational exposure, and more than 350,000 Galleri tests run. He also opines on what could make multi-cancer early detections tests more widely adopted and how to broaden the definition of clinical utility for reimbursement in MCED testing. Please enjoy this episode of "Halteres Presents". Eric A. Klein, MD is a Distinguished Scientist at GRAIL. Previously he served as the Andrew C. Novick Distinguished Professor and Chair of the Glickman Urological and Kidney Institute and Lerner College of Medicine of the Cleveland Clinic, where he was also a member of the Department of Cancer Biology of the Cleveland Clinic Lerner Research Institute, the Taussig Cancer Institute, and the Genitourinary Malignancies Program in the Case Comprehensive Cancer Center. Dr. Klein was a Fellow in the Distinguished Careers Institute at Stanford University in 2022 and joined GRAIL in 2023. His recent work has focused on the clinical development of multicancer early detection tests. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠. You can also broaden your skills with thei...

Ep. 406: "The Future of Non-Instrumented, One-Time-Use Tests" with Patrick Vaughan, PhD

1 hr 2 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Patrick Vaughan, PhD, the Chief Operating Officer of DCN Dx, to discuss the latest advances in lateral flow assays, including innovations in reagents, antibodies, and nucleic acid LFA formats, as well as what it will take for broader adoption of rapid point-of-care testing in rural and underserved settings. Dr. Vaughan also provides valuable industry insight on the regulatory and payment challenges facing developers of new LFA tests. Please enjoy this episode of "Halteres Presents". Patrick Vaughan has over 20 years of experience in the Biotech field. Patrick has served as the Chief Operating Officer at DCN Diagnostics since September 2015. Prior to this, he was the Vice President of R&D at Trinity Biotech plc from 2003 to 2015. Patrick also founded and served as the Chief Scientific Officer of HiberGen Ltd from 1999 to 2003. Before that, he worked as a Senior Research Scientist at Enterprise Ireland & University College Cork, Ireland (UCC) from 1994 to 2000. Patrick started their career as a Post Doctoral Fellow at Institut Jacque Monod from 1992 to 1994 and as a Post Graduate at the Imperial Cancer Research Fund from 1988 to 1992. Patrick Vaughan obtained a Bachelor of Science degree in Biochemistry from the University College Cork from 1984 to 1988. Patrick then pursued further education and completed their PhD in Biochemistry at King's College London from 1988 to 1992. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations....

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All episodes

BONUS: Live from HLTH 2025's "Diagnostics Zone"!

30 min

On this bonus episode of "Halteres Presents", host Mickey Urdea is recording live from the first-ever "Diagnostics Zone" at HLTH 2025 in Las Vegas! Among the many old colleagues and new faces we got to meet up with and learn from, we had the opportunity to chat with two very interesting exhibitors: Molecular Testing Labs and OTO Fertility. From Molecular Testing Labs, Mickey spoke with their Chief Commercial Officer James York about their "tailored solutions for diverse markets" approach, and from OTO Fertility, Mickey spoke with their CEO Caleb Evans about how their wearable device tracks more than fifty biometric markers to help users track their own optimal fertility in harmony with their doctors' care. Please enjoy this bonus episode of "Halteres Presents". James York is a graduate of East Tennessee State University where he majored in Exercise Physiology and prepared for medical school. Even though his interest was always focused on medicine and science, his first career position was a trader of equities and options on the Southwest Securities Trading Floor. Desiring to enter the healthcare sector and return to his roots, he leveraged his experience from the trading floor to start capitalizing, managing, operating, and making markets in various healthcare companies. James was involved in medical devices, intra-operative neuromonitoring, clinical research, networking, pharmacies, and laboratories. He has had many roles within each company including VP of Sales, President, and CEO – for companies both private and public. Caleb Evans is a health-tech entrepreneur and the CEO & Founder of OTO Fertility, a breakthrough biometric wearable and AI platform transforming reproductive care. With a background in biochemistry, digital health, and nonprofit leadership, Caleb has scaled organizations across sectors, from EMR software to fertility clinics. His mission with OTO is to apply elite biometric science to family-building, creating a new standard of care for women...

Ep. 407: "The Value of a Molecular Cancer Signal of Origin" with Dr. Eric Klein

57 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Eric A. Klein, MD, to get his perspective on the value of a molecular cancer signal of origin in guiding targeted diagnostic evaluations based on his real-world experience overseeing GRAIL's clinical development program spanning 9 clinical trials and diverse populations, including those with occupational exposure, and more than 350,000 Galleri tests run. He also opines on what could make multi-cancer early detections tests more widely adopted and how to broaden the definition of clinical utility for reimbursement in MCED testing. Please enjoy this episode of "Halteres Presents". Eric A. Klein, MD is a Distinguished Scientist at GRAIL. Previously he served as the Andrew C. Novick Distinguished Professor and Chair of the Glickman Urological and Kidney Institute and Lerner College of Medicine of the Cleveland Clinic, where he was also a member of the Department of Cancer Biology of the Cleveland Clinic Lerner Research Institute, the Taussig Cancer Institute, and the Genitourinary Malignancies Program in the Case Comprehensive Cancer Center. Dr. Klein was a Fellow in the Distinguished Careers Institute at Stanford University in 2022 and joined GRAIL in 2023. His recent work has focused on the clinical development of multicancer early detection tests. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠. You can also broaden your skills with thei...

Ep. 406: "The Future of Non-Instrumented, One-Time-Use Tests" with Patrick Vaughan, PhD

1 hr 2 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Patrick Vaughan, PhD, the Chief Operating Officer of DCN Dx, to discuss the latest advances in lateral flow assays, including innovations in reagents, antibodies, and nucleic acid LFA formats, as well as what it will take for broader adoption of rapid point-of-care testing in rural and underserved settings. Dr. Vaughan also provides valuable industry insight on the regulatory and payment challenges facing developers of new LFA tests. Please enjoy this episode of "Halteres Presents". Patrick Vaughan has over 20 years of experience in the Biotech field. Patrick has served as the Chief Operating Officer at DCN Diagnostics since September 2015. Prior to this, he was the Vice President of R&D at Trinity Biotech plc from 2003 to 2015. Patrick also founded and served as the Chief Scientific Officer of HiberGen Ltd from 1999 to 2003. Before that, he worked as a Senior Research Scientist at Enterprise Ireland & University College Cork, Ireland (UCC) from 1994 to 2000. Patrick started their career as a Post Doctoral Fellow at Institut Jacque Monod from 1992 to 1994 and as a Post Graduate at the Imperial Cancer Research Fund from 1988 to 1992. Patrick Vaughan obtained a Bachelor of Science degree in Biochemistry from the University College Cork from 1984 to 1988. Patrick then pursued further education and completed their PhD in Biochemistry at King's College London from 1988 to 1992. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations....

Ep. 405: "Think Of The Laboratory As Your End User" with Dr. Beth Marlowe

57 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Dr. Beth Marlowe, Executive Scientific Director and Head of R&D for Quest Diagnostics Infectious Diseases, for an in-depth discussion on how “Home to Lab” remote specimen collection and other at-home testing options have shifted the patient journey, what is needed to support the changing paradigm, and how to reduce barriers for diagnostic testing. Please enjoy this episode of "Halteres Presents". Dr. Elizabeth (Beth) Marlowe is the Executive Scientific Director and heads R&D for Quest Diagnostics Infectious Diseases and Immunology. Dr Marlowe joined Quest in June of 2019.  Beginning January of 2020, her team played a key role in the COVID-19 response and in 2022 the Mpox response. Previously she worked as the global director of medical affairs for microbiology at Roche Molecular Systems, provided laboratory leadership for over a decade within the Kaiser Permanente Regional Laboratories and worked on assay development for Gen-Probe (now Hologic). She is a diplomat of the American Board of Medical Microbiology, past-president for the So Cal branch of the American Society for Microbiology (ASM), served as an editor for the Clinical Microbiology Newsletter as well as the Journal of Clinical Virology. She has served as an elected member to the Council on Microbial Sciences for ASM, an appointed member of CLIAC, the federal advisory committee for CLIA to the United Stated Health and Human Services Secretary and an elected member of the Board of Directors for ASM. Her research areas of interest are focused on the translation of new infectious disease diagnostics for use in evidence-based research for clinical and public health microbiology practice. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vit...

Ep. 404: "The Promise, The Potential, and the Pressing Questions Facing Multi-Cancer Early Detection (MCED) Testing" - Tom Beer, M.D.

44 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Dr. Tom Beer, Vice President and Chief Medical Officer of Multi-Cancer Early Detection at Exact Sciences, to discuss all things MCEDs - the most impactful attributes of a successful MCED test, the consumer education efforts made by Exact Sciences, and what it was like to see Woody Harrelson lampoon the Cologuard test on SNL. Please enjoy this episode of "Halteres Presents". Tomasz (Tom) Beer, M.D. earned his bachelor’s degree in biomedical engineering and his M.D. degree from Johns Hopkins University. He completed his post-graduate training in internal medicine, hematology, and medical oncology at Oregon Health & Science University. Dr. Beer has served as the vice president and chief medical officer, for multi-cancer early detection at Exact Sciences since 2022. Prior to joining Exact Sciences, Dr. Beer was the Grover C. Bagby Endowed Chair for Prostate Cancer Research at the OHSU Knight Cancer Institute, where he led the Prostate Cancer Research Program. Dr. Beer also served as deputy director of the OHSU Knight Cancer Institute and the National Cancer Institute designated Comprehensive Cancer Center. He was previously the chief medical officer for the Center for Early Detection Advanced Research (CEDAR), where he led clinical trials of multi-omic blood-based cancer early detection tests. Dr. Beer continues to serve as adjunct professor of medicine at the OHSU Knight Cancer Institute, where he treats men with prostate cancer. He has authored or co- authored more than 280 peer-reviewed articles, including investigations of multi-cancer early detection, as well as targeted therapies and immunotherapies in prostate cancer. Dr. Beer’s research served as the basis for a global change in the standard of care for advanced prostate cancer. This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for pro...

Ep. 403: "What Useful Insights Can Be Gleaned From The Gut Microbiome?" - Dr. Daniel van der Lelie

1 hr 4 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Dr. Daniel (Niels) van der Lelie, the CEO & CSO for Gusto Global, the Microbiome Ecology Company™, to cover the work that's being done to decipher the complex relationship between the gut microbiome and the human host, the methods being utilized to manipulate the composition of the gut microbiome, and the microbiome-based technologies which may allow for early detection of cancerous tumors. It's a fascinating new field of study which could potentially yield massive returns on human health outcomes. Please enjoy this episode of "Halteres Presents". Dr. Daniel van der Lelie has worked for the last ten years in a senior management role in pharma-oriented biotechnology, agriculture, environmental sciences and on the interphase between biological sciences and nanotechnology. At Brookhaven National Laboratory he was the founder of the microbiology group, and the co-founder of the group for bioinspired assembly of nanomaterials. In 2011 he founded the Center for Agriculture and Environmental Biotechnology at Research Triangle Institute, and built an asset portfolio that led to the Center’s acquisition in 2013 by FMC Corporation, where he assumed the role of Global Director of Ag BioSolutions R&D. After leaving FMC in June 2016, he cofounded and became the Chief Scientific Officer of Gusto Global, a startup company that is developing microbiome-based next-generation immune therapeutics for modulation of the immune system. As Gusto’s Chief Scientific Office, Dr. van der Lelie focused the company’s efforts on two major programs driven by insights in the gut microbiome: immune oncology and inflammation. Since becoming Gusto’s Chief Scientific Officer, he has played a critical role in defining Gusto’s strategic vision, and to translate this into an action plan that is successfully being implemented to develop Gusto’s core facilities and technology platforms, create strategic partne...

Ep. 402: "Is America Ready To Defend Against A Biological Attack?" - Jennifer Nuzzo, DrPH

1 hr 14 min

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Dr. Jennifer Nuzzo, the Director of the Pandemic Center and Professor of Epidemiology at the Brown University School of Public Health, to comb through the lessons learned from the COVID-19 pandemic and to assess America's readiness for pathogens both natural and from a bioterrorism weapon. This at times sobering conversation covering surveillance methods to curtail disease outbreaks, how to combat health-related misinformation, and improving American prosperity through global health security initiatives can hopefully kickstart the precautions necessary to prevent the worst case scenarios. Please enjoy this episode of "Halteres Presents". Jennifer Nuzzo is a nationally and globally recognized leader on global health security, public health preparedness and response, and health systems resilience. Together with colleagues from the Nuclear Threat Initiative and Economist Impact, she co-leads the development of the first-ever Global Health Security Index, which benchmarks 195 countries’ public health and healthcare capacities and capabilities, their commitment to international norms and global health security financing, and socioeconomic, political, and environmental risk environments. In addition to her scholarly work, Nuzzo regularly advises national governments and for-profit and nonprofit organizations on pandemic preparedness and response, including during the COVID-19 pandemic. She is a pandemic advisor for Impact Assets’ Stop the Spread Campaign. She is currently a member of the National Academies of Sciences, Engineering and Medicine’s (NASEM) Standing Committee for the Centers for Disease Control and Prevention (CDC) Center for Preparedness and Response. Her articles have appeared in The New York Times, The Washington Post, USA Today, Fox News, Politico, The Hill, and The Boston Globe. She was featured in Debunking Borat, a television series on Amazon Prime Video, a...

Ep. 401: “How Concerned Should We Be About H5N1?” - Dave Engelthaler, Ph.D.

47 min

On the Season 4 premiere of Halteres Presents, hosts Mickey Urdea and Rich Thayer are talking all about H5N1 with Dr. Dave Engelthaler, the Director and Professor at TGen North and Executive Director of the Health Observatory at Arizona State University. Dr. Engelthaler returns to the podcast to cover the origins of this strain of avian flu, its devastating effects particularly on dairy farms, what our level of concern for human transmission should be heading into 2026, and even some purr-plexing disease vectors that may be going overlooked. Please enjoy this episode of Halteres Presents. David Engelthaler is the Director and Professor at TGen North, and is a Director of TGen’s Division of Immunology and Microbial Genomics. TGen North focuses on pathogen genomics with a specific mission to advance clinical medicine, public health, and biodefense. Dave is also co-appointed as the Executive Director of the Health Observatory at ASU. During the recent pandemic, Dave oversaw the rapid development of TGen’s FDA-allowed COVID-19 diagnostic test, the creation of a federally-licensed diagnostic laboratory, and the institution of the AZ COVID sequencing reference laboratory—all in support of Arizona’s public health and healthcare response. Prior to joining TGen, Dave was the State Epidemiologist for Arizona where he was responsible for coordinating outbreak investigations and disease research activities statewide. From 2000 to 2005, Dave was also the Arizona Biodefense Coordinator, responsible for coordinating all state-wide activities regarding public health emergency preparedness and response, including response activities to suspect biothreat events, such as the suspicious powders that were seen following the anthrax letter attacks. He also served as statewide coordinator for Pandemic Influenza and other public health emergency response activities. Prior to 2000, Dave was a biologist for the Federal Centers for Disease Control and Prevention, in Fort Collins, Colorado, w...

“Halteres Presents” Season 4 Arrives 11/18!

1 min

Season 4 of our award-winning podcast Halteres Presents begins on Tuesday November 18th! Season 4 of our award-winning podcast Halteres Presents begins on Tuesday November 18th! This season we are honored to interview many more experts across the field of diagnostics to monitor the heartbeat of the community, detect areas of focused effort, and prognosticate where the next waves of innovation may lie. Topics of interest this season include what to expect from H5N1 in the coming year, the potential for multi-cancer early detection, deciphering the human microbiome, advances in home specimen collection and shipment, the future of non-instrumented one-time use tests, and much more! Season 3 of Halteres Presents was recently named a finalist for “Best Podcast” at the 2025 Fierce Pharma Marketing Awards, the inaugural Zenith Awards by CommsWeek, and the 2025 CineHealth film festival. Past seasons of Halteres Presents have also been recognized with a gold Titan Health Award, a silver Davey Award, a gold Stevie Award at the American Business Awards, and an Award of Distinction from the Communicator Awards. Learn more about why we started the podcast here. Season 4 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. This team-taught course by award-winning industry experts covers everything there is to know about the requirements for moving an IVD product from concept to regulatory approval and market launch. Explore real-world product development cases to help you plan for success by covering topics such as setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and composition of the product development team, risk analysis, and IVD clinical and regulatory issues such as compliance and complai...

Ep. 307: Nobel Laureate Michael Houghton on His Legacy Working on Hepatitis C

46 min

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 scre...

Ep. 306: How Wearable Diagnostic Devices May Revolutionize Personalized Healthcare

32 min

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.

Ep. 305: The Genomics Tools That Are Helping To Avoid the Next Outbreak - David Engelthaler, Ph.D.

1 hr 12 min

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 "Hal...

Ep. 304: Roundtable Discussion on FDA's Final Rule on Laboratory-Developed Tests - Jennifer Leib and Elliot Cowan

1 hr 6 min

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 fou...

Ep. 303: The Critical Patient-Driven Factors to Consider in Decentralized Diagnostic Testing - Dr. Donna Wolk

1 hr 7 min

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.

Ep. 302: The 411 on H5N1, and Looking Back on the Dawn of Molecular Diagnostics - David Persing

40 min

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 Developm...

Ep. 301: "Science Is A Self-Correcting Body of Knowledge": Lessons Learned On How To Talk About Science - Holden Thorp

45 min

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...

Season 3 Begins June 11th!

1 min

"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!

(World TB Day Re-Release) Ep. 103: Global TB Diagnostics, Part 3 – Dr. Shibu Vijayan

48 min

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.

(World TB Day Re-Release) Ep. 102: Global TB Diagnostics, Part 2 – Dr. Peter Small

38 min

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.

(World TB Day Re-Release) Ep. 101: Global TB Diagnostics, Part 1 – Dr. Morten Ruhwald

38 min

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.

Ep. 208.5: Part Two, Lateral Flow Technologies of Today and Tomorrow - Paul Davis

55 min

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.

Ep. 208: Part One, A Reflection on the Founding of the Consumer Diagnostics Industry - Paul Davis

36 min

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.

Ep. 207: The Ins and Outs of Metagenomics in Diagnostics - Dr. Rick Nolte

56 min

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 Stu...

Ep. 206: The Role of Public Health, and Why To Trust the Experts - Dr. Bela Matyas

56 min

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.

Ep. 205: Navigating the Regulatory Process for Diagnostic Devices in the Post-Pandemic Landscape - David Kern

1 hr 1 min

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.

Ep. 204: "One Health", and Innovations in Agricultural Disease Surveillance - Dr. Alan Rudolph

54 min

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.

Ep. 203: Conducting Usability Trials and Troubleshooting Self-Testing Challenges - Mohammed Majam

50 min

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.

Ep. 202: Predicting The "Spillover" of Zoonotic Diseases - Author David Quammen

1 hr 7 min

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 Geog...

Ep. 201: Celebrating 20 Years of Halteres Associates - A Celebration, A Retrospective, And What’s Next

30 min

*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 dis...

Ep. 108: Democratizing Diagnostics and Considering the Whole Ecosystem for New Diagnostic Products - Dr. Patty García

55 min

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/ 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 HAL...

Ep. 107: Stigma, Community Engagement, and Barriers to Healthcare Access - Mike Richey

37 min

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...

Ep. 106: An Insider's Background on the NIH's RADx Program - Nancy Gagliano, MD, MBA

1 hr 2 min

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 This episode of "Halteres Presents" is brought to you by the UC San Diego Extended Studies In Vitro Diagnostics Product Develop...

Ep. 105.5: A Followup Minisode on Diagnostics-Related Congressional Legislation - Jennifer Leib

21 min

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. 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 c...

Ep. 105: A Primer on Diagnostics-Related Congressional Legislation - Jennifer Leib

48 min

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. 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.

Ep. 104: The Science Behind Netflix’s “The Anthrax Attacks” – Dr. Paul Keim

1 hr 7 min

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 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 toda...

Ep. 103: Global TB Diagnostics, Part 3 – Dr. Shibu Vijayan

48 min

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. 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.

Ep. 102: Global TB Diagnostics, Part 2 – Dr. Peter Small

38 min

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. 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.

Ep. 101: Global TB Diagnostics, Part 1 – Dr. Morten Ruhwald

38 min

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  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.

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