FDA

This week I am talking to Connor Landgraf (@connorlandgraf) Co-founder and CEO at Eko (@Eko_Health) – a company rethinking the iconic stethoscope augmenting the capability with innovation Connor founded Eko while studying bioengineering at the University of California, Berkeley, with the goal of improving cardiovascular and pulmonary disease monitoring through machine learning and non-invasive sensors. […]

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Moving Quickly and Safely in Pharma and BioTech This week I am talking to Robert Fenton (@robpfenton), the CEO and founder of Qualio (@Qualiohq). Robert is a pharmacist by training. He was born and raised in Ireland and worked with a range of pharmaceutical companies working in quality and drug development roles. It was this early work focused […]

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This week I am talking to Branislav Vajdic, CEO and Founder of HeartBeam (@HeartBeami) which has developed a credit card-sized medical-grade heart attack detector that anyone can use anywhere. Branislav shares his personal story that includes his place in history in developing the Solid State technology that we all use and depend on for our storage […]

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This week I am talking to Laura Fernandes, PhD, Senior Statistical Director COTA (@cotahealthcare) who provide real-world data and analytics to help health systems expedite cancer research and standardize cancer patient care, and empowers life sciences companies to accelerate drug development and regulatory approvals for life-saving cancer drugs and treatments. Laura comes from an international […]

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The Regulatory Whisperer This week I am talking to Michael Hufford the CEO and Co-Founder of Lygensis a company that is breaking the mold of organ replacement and enabling organ regeneration. They recently received FDA 2A clearance and additional funding and will be starting their first human trials shortly. Michaels background has helped him master the […]

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Neuromodulation Treatment for COVID19 This week I am talking to Peter Staats, MD, MPH,  CMO for electroCore, CMO for National Spine and Pain Center, and President-Elect of the World Institute of Pain. Peter started his career as an anesthesiologist and founder of the division of Pain Medicine in the Department of Anesthesiology and Critical Care Medicine […]

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This week I am talking to Amy Abernethy, MD, Ph.D. (@DrAbernethyFDA) the Principal Deputy Commissioner & Acting CIO for the FDA (@US_FDA). We had talked in January at CES about the forthcoming meeting focused on the FDA’s Technology Modernization Action Plan (outline here) but as a result of the COVID19 pandemic, the meeting was postponed to Jun 30 (details […]

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Navigating Mental Health This week I am talking to Ekaterina Malievskaia MD MScPH, Chief Innovation Officer and Co-Founder of COMPASS Pathways (Navigating Mental Health Pathways). Ekaterina is an entrepreneur dedicated to bringing about positive change in society with a particular focus on health and wellbeing and driven to address the challenge of access to brain health […]

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Staying Relevant In 2009 we watched and were entertained by The Repair of the Hubble Space Telescope We were still knee-deep in the Financial Crisis that began in 2007 The Icelandic banking system collapsed taking the government with it Michael Jackson died The NY Yankees won the World Series (Go Nats!) Mobile Phone Technology use […]

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Hollywood Future Predictions Spoiler Alert – for anyone who has not watched the Showtime series “Homeland” or not got past Season 2 In the episode titled “Broken Heart” (December 2, 2012) we watch a hacker gain remote unauthorized access to the Vice Presidents Pacemaker and induces a tachycardia (increase in the heart rate) causing him to […]

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