How Community-Based Clinical Trials Can Transform Patient Access and Participation with Ro Wickramasinghe Pi Health
Release Date: 01/20/2026
Empowered Patient Podcast
Ryan Clarke, Co-Founder and CTO of Syntax Bio, is focused on solving manufacturing challenges in producing stem cell-derived therapies, specifically the process of stem cell differentiation. The Cellgorithm platform was designed to make differentiation an engineering problem by using a modified form of CRISPR to turn genes on and off in a specific, controlled sequence, reducing processing time from months to days and resulting in cost savings. One goal is to use AI and machine learning to build models capable of predicting optimal gene regulation sequences accelerating the discovery of...
info_outlineEmpowered Patient Podcast
Ryan Clarke, Co-Founder and CTO of Syntax Bio, is focused on solving manufacturing challenges in producing stem cell-derived therapies, specifically the process of stem cell differentiation. The Cellgorithm platform was designed to make differentiation an engineering problem by using a modified form of CRISPR to turn genes on and off in a specific, controlled sequence, reducing processing time from months to days and resulting in cost savings. One goal is to use AI and machine learning to build models capable of predicting optimal gene regulation sequences accelerating the discovery of...
info_outlineEmpowered Patient Podcast
Dr. Daniel Sodickson is Chief Medical Scientist at Function Health and author of the new book, The Future of Seeing: How Imaging Is Changing Our World. Building on the drive to improve medical imaging, AI and neural networks are now reshaping image interpretation and how and what data are collected. This approach produces high-quality results with minimal additional data and is inspiring innovative scanning techniques and equipment design. The future of medical imaging is the everywhere scanner, enhancing a single-shot session with a large hospital machine with continuous health...
info_outlineEmpowered Patient Podcast
Dr. Daniel Sodickson is Chief Medical Scientist at Function Health and author of the new book, The Future of Seeing: How Imaging Is Changing Our World. Building on the drive to improve medical imaging, AI and neural networks are now reshaping image interpretation and how and what data are collected. This approach produces high-quality results with minimal additional data and is inspiring innovative scanning techniques and equipment design. The future of medical imaging is the everywhere scanner, enhancing a single-shot session with a large hospital machine with continuous health...
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Dr. Howard Federoff, Scientific Co-Founder, Chief Medical Officer, and Executive Vice President of Corporate Medicine and Science at Kenai Therapeutics, is developing a cell therapy for Parkinson's disease that involves transplanting IPSCs into the brain to replace lost dopamine neurons. The goal is not to cure the underlying cause of the disease, but to restore motor function and reverse the disease's progression. Initial clinical focus was on patients with moderate to moderate-severe idiopathic Parkinson's, showing efficacy and safety, leading to expanding the study to include...
info_outlineEmpowered Patient Podcast
Dr. Howard Federoff, Scientific Co-Founder, Chief Medical Officer, and Executive Vice President of Corporate Medicine and Science at Kenai Therapeutics, is developing a cell therapy for Parkinson's disease that involves transplanting IPSCs into the brain to replace lost dopamine neurons. The goal is not to cure the underlying cause of the disease, but to restore motor function and reverse the disease's progression. Initial clinical focus was on patients with moderate to moderate-severe idiopathic Parkinson's, showing efficacy and safety, leading to expanding the study to include...
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Brent Ness, CEO and President of Aclarion, highlights the challenges of diagnosing and treating chronic lower back pain, a leading driver of healthcare costs and opioid addiction. Traditional MRI and CT imaging do not reveal the biochemical source of pain within spinal discs, leading to misdiagnosis and unsuccessful treatment. The Aclarion technology uses MR spectroscopy to measure pain-causing biomarkers and, through a cloud-based, AI-powered SaaS model, analyzes the raw data and sends the physician a report within minutes. Brent explains, "The diagnosis and accurate treatment planning...
info_outlineEmpowered Patient Podcast
Brent Ness, CEO and President of Aclarion, highlights the challenges of diagnosing and treating chronic lower back pain, a leading driver of healthcare costs and opioid addiction. Traditional MRI and CT imaging do not reveal the biochemical source of pain within spinal discs, leading to misdiagnosis and unsuccessful treatment. The Aclarion technology uses MR spectroscopy to measure pain-causing biomarkers and, through a cloud-based, AI-powered SaaS model, analyzes the raw data and sends the physician a report within minutes. Brent explains, "The diagnosis and accurate treatment planning...
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Dr. Alanna Morris-Simon, Senior Medical Director for US Medical Affairs at Bayer, describes the symptoms and diagnostics used to classify heart failure and the key at-risk populations for this condition. The rapidly evolving landscape of heart failure treatments now includes the Bayer drug KERENDIA, a non-steroidal MRA approved to reduce cardiovascular death and heart failure in adults with an ejection fraction of 40% or more. This drug is part of an emerging trend to treat multiple related conditions simultaneously and could prevent the onset of heart failure and treat established...
info_outlineEmpowered Patient Podcast
Dr. Alanna Morris-Simon, Senior Medical Director for US Medical Affairs at Bayer, describes the symptoms and diagnostics used to classify heart failure and the key at-risk populations for this condition. The rapidly evolving landscape of heart failure treatments now includes the Bayer drug KERENDIA, a non-steroidal MRA approved to reduce cardiovascular death and heart failure in adults with an ejection fraction of 40% or more. This drug is part of an emerging trend to treat multiple related conditions simultaneously and could prevent the onset of heart failure and treat established...
info_outlineRo Wickramasinghe, Vice President and Head of Global Business at Pi Health, identifies fundamental problems plaguing clinical trials, including operational inefficiencies and limited access to trials. Pi Health is addressing these challenges by developing an integrated software platform for clinical trial sponsors, sites, and patients and partnering with community-based cancer treatment centers worldwide. The company has built a hospital in India to serve as a living laboratory to test and refine its model to democratize access and increase the ethnic diversity of trial participants.
Ro explains, "I think the challenge has always been, from a pharma-biotech perspective, is to find patients, but, from the other perspective, its patients participating in trials and being able to find clinical trials. So a lot of stats get bandied around, but despite many eligible patients, the percentage of eligible patients who actually end up in a clinical trial is really small. It's like 5% to 8%, so not a huge amount. I think that's kind of one problem."
"So we have it in chicken and egg scenario where we as a company develop clinical trial software, but when ultimately the vision for us is for that to really become the standard of care and really make trials more efficient for the clinicians that treat the patients and run the trials for these pharma companies and biotech companies that develop the drugs and sponsor the study."
"But having said that, I think to run lots of studies, what we decided to do was to build our own cancer hospital in India. And the beauty of that is that it is fully vertically integrated at the point of care. So the data gets captured on those patients in FICS, which is the software we've developed and then we can run trials. We have run trials for pharma and biotech at that site using our software. So it was, I guess, one of the quicker ways to test the software in a real-world environment and also getting lots of data on FICS and how it can benefit patients from the point of care to being on trials."
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