Halteres Presents

Halteres Associates

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.

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

    13 JANV.

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

    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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

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

    6 JANV.

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

    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. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠. You can also broaden your skills with their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

    1 h 3 min
  3. Ep. 405: "Think Of The Laboratory As Your End User" with Dr. Beth Marlowe

    16/12/2025

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

    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 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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠HERE⁠⁠⁠⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

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

    09/12/2025

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

    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 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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠HERE⁠⁠⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

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

    02/12/2025

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

    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 partnerships with academic and commercial entities, define and license technologies, build an IP portfolio, and to obtain startup funding from VC and strategic investors. His research has resulted in more than 150 publications in peer reviewed journals, including PLoS ONE, PLoS Genetics, Nature, Nature Chemistry, Nature Nanotechnology and Nature Biotechnology, and 27 patents / patent applications, including seven recent ones assigned to Gusto Global that describe the design and use of microbiome-based LBPs to improve treatment options and clinical outcomes for patients. He has also become an invited speaker to present Gusto’s vision and breakthrough research in the microbiome space at leading international conferences. 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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠HERE⁠⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠.

    1 h 4 min
  6. Ep. 402: "Is America Ready To Defend Against A Biological Attack?" - Jennifer Nuzzo, DrPH

    25/11/2025

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

    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, and her work was featured on Last Week Tonight with John Oliver. She served as COVID Advisor for the Borat Subsequent Moviefilm. 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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠HERE⁠. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠.

    1 h 14 min
  7. Ep. 401: “How Concerned Should We Be About H5N1?” - Dave Engelthaler, Ph.D.

    18/11/2025

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

    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, where he conducted research on highly infectious diseases like plague and tularemia. Dave has over 170 peer-reviewed publications, garnering over 10,000 citations and has over two dozen patented inventions. 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 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 their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course HERE. Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here. Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

    47 min
  8. BANDE-ANNONCE SAISON 4

    “Halteres Presents” Season 4 Arrives 11/18!

    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 complaint handling. Ready to get started? Enroll HERE today and use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment. Accelerate your in vitro diagnostics career with the UC San Diego Extended Studies program – your future in biotech starts here. ⁠⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠⁠ Use code: HALTERES10 at checkout! Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠.

    2 min

Bande-annonce

À propos

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.

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