Halteres Presents Halteres Associates

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.

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.

Houghton subsequently moved to the United States. After a short period at the pharmaceutical manufacturer G.D. Searle & Company (later G.D. Searle, LLC, a subsidiary of Pfizer), he joined the California-based biotechnology firm Chiron Corporation. At Chiron, Houghton worked closely on investigations of non-A, non-B hepatitis with fellow Chiron scientists George Ching-Hung Kuo and Qui-Lim Choo and American virologist Daniel W. Bradley, who was based at the U.S. Centers for Disease Control and Prevention. Using a complementary DNA library developed from blood plasma containing a non-A, non-B hepatitis virus, the researchers successfully identified a DNA clone derived from the HCV RNA genome. Houghton and colleagues subsequently developed an assay to screen for HCV in blood samples. The breakthrough facilitated the development of highly effective blood screening tests to prevent the transmission of HCV via blood transfusion. While at Chiron, Houghton also contributed to the discovery of the hepatitis D virus genome.

In 2007 Houghton left Chiron to join Epiphany Biosciences, where he was the chief scientific officer. Two years later he moved to Canada, having accepted the position of Li Ka Shing Professor of Virology at the University of Alberta. His later research focused on the development of an HCV vaccine.

Houghton received various honours and awards during his career, including the Robert Koch Prize (1993) and the Albert Lasker Clinical Medical Research Award (2000, shared with Alter). He declined the Canada Gairdner International Award (2013) because of its exclusion of his colleagues who helped identify HCV. In 2021 Houghton was made a knight.





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

⁠UC San Diego Extended Studies In Vitro Diagnostics Product Development Course⁠

Use code: HALTERES10 at checkout!


Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

On this solo episode of "Halteres Presents", Rich Thayer and Mickey Urdea are highlighting the potential market applications for wearable diagnostic devices. The recent increased interest in the wearables space has been ignited by significant technological improvements in microfluidics and microelectronics, as well as the use of smart phone apps and AI-driven algorithms that help to enrich the data stream and the actionability of the diagnostic results. Rich and Micky cover new detection technologies, improved biomarkers and biofluid collection capabilities, the unique value of continuous monitoring for assessing women's health, and applications beyond human health, such as for companion, herd, and wild animals.



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

UC San Diego Extended Studies In Vitro Diagnostics Product Development Course

Use code: HALTERES10 at checkout!




Learn more about Halteres Associates ⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠.

On this week's episode of "Halteres Presents", Rich Thayer and Mickey Urdea are discussing with David Engelthaler, the director of the Pathogen and Microbiome Division at TGenNorth, the status of today's most cutting-edge genomics tools and how they're being utilized for clinical medicine, public medicine, and the One Health space. These next-gen genomic tools are more useful, flexible, accurate, and affordable than ever before, but they are only as intelligent as the hands they're in, so Dave is here to help uncover the best applications for these tools and the most applicable data to mine for the most useful and expansive possible inferences. Tune in to raise the level of your own pathogenic intelligence with David Engelthaler.



Dave Engelthaler, Ph.D., is a professor and the director of the Pathogen and Microbiome Division (aka TGen North). His research team at TGen North has a specific mission to advance human health through the application of pathogen genomic sciences and next generation technologies.  He is also director of the TGen North Clinical Laboratory, and Co-Director of the TGen Integrated Microbiomics Center.Dave was formerly the State Epidemiologist for Arizona and a biologist for the Centers for Disease Control and Prevention. He has over 160 peer-reviewed publications and over two dozen patented inventions. Dave's team at TGen North led TGen's emergency response operations to COVID, providing direct support to the residents of Arizona, especially for tribal nations and rural communities. Post-pandemic, his translational research is heavily focused on detecting and tracking outbreaks, characterizing and monitoring drug resistance in tuberculosis patients, and studying disease emergence and pathogen evolution.Dave received a Ph.D. in Biology from Northern Arizona University with a focus on genomic epidemiology, and a Master’s Degree in Microbiology from Colorado State University, where he studied host-vector-pathogen dynamics.



Learn more about Halteres Associates ⁠⁠⁠⁠HERE⁠⁠⁠⁠.

On this week's episode, Rich Thayer and Mickey Urdea are hosting Jennifer Leib and Elliot Cowan for their first-ever roundtable discussion in order to parse through the ramifications of the FDA's recent final rule on laboratory-developed tests (LDTs), which amends FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. This new LDT regulation has massive implications for test developers, patient care, and the FDA itself, so having Jennifer and Elliot, who possess very different experiences and opinions on the FDA's final rule, on the podcast together for this special roundtable discussion was critical for putting the new rule and its fallout in the proper context. This unique, frank conversation is a one-of-a-kind opportunity to see the whole picture of this complicated subject matter; please enjoy.



Jennifer Leib is a board-certified genetic counselor and experienced government affairs professional with an expertise in genomics and precision medicine policy, having studied at the undergraduate program at University of Michigan and the masters program at Johns Hopkins University. She is the founder of Innovation Policy Solutions (iPolicy), a leading government affairs consulting firm that promotes innovation through policy change. The firm actively advises and advocates on behalf of patients, providers, and innovators in laboratory medicine, precision medicine, public health, synthetic biology, gene therapy, neuroscience, rare diseases, and more. Grounded in a foundation of scientific expertise, iPolicy identifies data-driven solutions to health and science policy issues and builds coalitions of support to drive the adoption of clinical advances and enhance patient access to cutting-edge diagnostics and therapeutics. iPolicy is headquartered in Washington and supports clients across the country.



Elliot Cowan is the founder and principal of Partners in Diagnostics after 20 years of service at the US Food and Drug Administration (FDA). As Chief of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases at FDA’s Center for Biologics Evaluation and Research, he was responsible for the regulatory oversight of all blood donor screening tests and retroviral diagnostics, covering every facet of the regulatory review process. He served as chair or supervised the review of numerous IVD applications, as well as acting as the product expert for manufacturing facility inspections. He played key roles in the development of policy, coordinating decisions on issues such as the approval and use of the first of rapid HIV tests and the first over-the-counter HIV test system. He served as the Chair of the HIV Diagnostics Subcommittee of the Laboratory Technical Working Group in the President’s Emergency Plan for AIDS Relief (PEPFAR), and assisted the World Health Organization in the development of its Prequalification of Diagnostics Programme. Elliot received a BA from Williams College and a PhD in biology and biomedical sciences from Washington University in St. Louis.



Learn more about Halteres Associates ⁠⁠⁠HERE⁠⁠⁠.

On this episode of "Halteres Presents", Rich Thayer and Mickey Urdea are chatting about decentralized diagnostic testing with Dr. Donna Wolk, division director of Molecular and Microbial Diagnostics and Development at Geisinger Medical Laboratories. Dr. Wolk helps to put into perspective the market explosion of decentralized diagnostic tests designed for point-of-care, near-patient, at-home, over-the-counter, and pharmacy-based use, and the patient-driven factors to weigh when considering which tests to offer in which decentralized venues.



Dr. Donna Wolk is the division chief, Molecular and Microbial Diagnostics and Development, at Geisinger Medical Laboratories and director of the Infectious Disease Research Laboratory at the Weis Research Center. She is a diplomate of the American Board of Medical Microbiology, a board-certified medical laboratory scientist, and a professor at the Geisinger Commonwealth School of Medicine. Dr. Wolk also serves on the faculty of the Geisinger Pathology Residency Program. 

Dr. Wolk received her master’s in health administration at Wilkes University and her Ph.D. at the University of Arizona in Tucson. She completed a postdoctoral fellowship in clinical and molecular microbiology at the Mayo School of Graduate Medical Education in Rochester, Minnesota.



Learn more about Halteres Associates ⁠⁠HERE⁠⁠.

On this episode of "Halteres Presents", Rich and Mickey are sitting down with David Persing, the Executive Vice President, Chief Medical and Scientific Officer for Cepheid, to reflect upon his experiences at the dawn of molecular diagnostics, the effectiveness of surveilling animal reservoirs to monitor for disease outbreaks, and just how nervous we should be about the
spread of H5N1 (and when we should really start to worry).




David Persing, MD, Ph.D., has spent most of his 30-year career in biomarker discovery, translational medicine, and innovation in the diagnostics space. Dave joined Cepheid in 2005 and has focused on the enablement of molecular diagnostic technology to meet global needs in infectious diseases and oncology. He conducted his scientific and medical training with Don Ganem and Nobel laureate Harold Varmus at the University of California, San Francisco. After residency training in Clinical Pathology at Yale University, he held leadership roles in academia and industry starting in the early 1990s with the design, implementation, and operation of the first PCR reference laboratory at the Mayo Clinic.

His interest in the democratization of molecular diagnostic methods has been longstanding, starting in 1993 with his publication of the first of five widely adopted textbooks to include PCR protocols and guidelines for laboratory operations. He has published over 300 peer-reviewed articles and reviews, including multiple articles in the New England Journal of Medicine, Science, and PNAS. In 2020, he was named to the Fierce Pharma list of the 22 most influential scientists in the fight against COVID-19. To maintain a connection with the latest trends in translational medicine, Dave also serves as Consulting Professor of Pathology at Stanford University School of Medicine. He obtained his MD and Ph.D. degrees from UCSF in 1988.





Learn more about Halteres Associates ⁠HERE⁠.