Empowered Patient Podcast

Bill Hinshaw is the President and CEO of Axcella Therapeutics, a clinical-stage biotech company founded by Flagship Pioneering, Founder of Moderna. Using their platform to create compositions of endogenous metabolic modulators, EMMs, Axcella has generated two liver programs including 1125 for treating NASH.  Preclinical and clinical data led them to test 1125 for long COVID fatigue in conjunction with Dr. Betty Raman Senior Clinical Research Fellow in the Radcliffe Department of Medicine at the University of Oxford. Bill explains, "So 1125 is a composition of amino acids and their derivatives, which is put together to address specific biologies. And we have tested it all the way into phase 2b in NASH patients. And what we've seen is it has an effect on important energy aspects, so bioenergetics, along with inflammatory redox, and immune and muscle functions." "And what happens, in this case, is that basically, the virus comes in, hijacks the mitochondria to help it reproduce or redirect its efforts towards pr

Dr. Betty Raman is the Senior Clinical Research Fellow in the Radcliffe Department of Medicine at the University of Oxford and has been studying the effects of COVID-19 since the pandemic began to better understand the effects of COVID on multiple organ systems. Betty elaborates, "So, at Oxford, we've led a program when thousands of patients recovering from COVID-19 had volunteered and enrolled in our study. We have undertaken comprehensive assessments on magnetic resonance imaging, as well as cardiopulmonary exercise testing and blood tests. "What has come out from all this work is that number one, a significant proportion of people are recovering from moderate to severe disease. But also, those with mild infections may have ongoing, lingering symptoms of fatigue, pain in various parts of the body, breathlessness, and difficulty breathing when walking, for instance. So, post-exertional breathlessness, post-exertional release." "So, we were quite interested in this new compound that Axcella wanted to test out

Dr. Antonia Chen is the Director of Research for the Division of Adult Reconstruction and a surgeon performing total joint arthroplasty in the Department of Orthopedic Surgery at Brigham and Women's Hospital. In addition to informing surgeons and other healthcare professionals about ways to avoid surgical site infections, Antonia emphasizes there is also a need to educate patients about preoperative actions to optimize them for surgery. Antonia explains, "Surgical site infections unfortunately still plague us today, and they basically are infections that happen after surgery. It can happen in any patient and after any surgery. There are some surgeries that have a higher likelihood of it and some surgeries that don't. What happens is that after we make a cut through the skin due to surgery, the bacteria on your skin that is natural can actually get into your wound and potentially cause a surgical site infection or SSI." "It's really nice to have something inside the wound to prevent the bacteria from growing.

Dan Greenleaf is the President and CEO of Modivcare and is presenting a complete solution for vulnerable patients whose healthcare outcomes are most affected by recognized social determinants of health. Dan elaborates, "But our view is it's not necessarily about the clinical intervention. It's about having access to the healthcare system through transportation. It's about getting a nutritious meal on a daily basis or meals on a daily basis. It's about in the event you need somebody to help you with activities of daily living that we can provide that member a caregiver. Or it's about remote monitoring where we have a way to be in kind of a constant conversation with that patient about whether it be their vitals, whether it be about medications, or whether it be about personal emergency response systems." "We're a one-of-a-kind company doing what we're doing right now. I joined this company two years ago. It was largely a transportation company, but it did have access to 25 million lives at the time. We're 30 m

Kathy Lee-Sepsick is the President, CEO, and Founder of Femasys, and not looking at minor levels of improvement in women's healthcare, but products and technologies that change the standard of care.  With a focus on reproductive health, they are looking at infertility as well as a permanent birth control option for women. Kathy explains, "So one of our major products is called FemVue. And what we did here is another example of what we're trying to do in these other product categories. We have developed a way to move an essential test for infertility diagnosis from radiology back to her GYN, utilizing ultrasound. So FemVue offers a saline and air contrast, or we call it bubbles, where those bubbles enable the evaluation and viewing of her fallopian tubes, which is suspect when a physician is evaluating all potential infertility factors." "And at the same time, we are also advancing through clinical trial work, our FemBloc solution, which is our permanent birth control option for women. And both of those are de

Dr. Aharona Shuali is the Vice President of Medical Affairs at Nucleix developing a liquid biopsy to detect cancer. It can be a blood test or a urine test that looks at DNA, but it doesn't look at DNA as mutations. Rather, it's looking to detect changes in methylation which are small molecules that are sitting on the DNA and have shown to be much more important than mutations in the early detection of cancer. Aharona explains, "What we do is a unique approach that is actually using enzymes. We have a very good signal-to-noise ratio. So I'll just talk a little bit about the standard. It is usually bisulfite, and bisulfite is a chemical that is very harsh. So it usually degrades, it ruins up to 90% of the DNA, and then it also introduces a lot of noise. So when you find the low amount of DNA in the blood that is coming from the tumor, if you treat it with bisulfite, you actually are going to destroy most of it. Then what is remaining is going to be very hard to tell if this is a real signal or it's actually noi

Nataly Youssef Ph.D. is the Co-Founder of Reclaim Health trained as an industrial engineer, with expertise in operations research, AI, and big data. Nataly explains, "So this is the genesis of Reclaim. Really being able to provide that tool for patients, to be able to be well informed about both their health insurance and then to be able to manage their healthcare bills in the very context of that health insurance, all data-driven basically. This is all personalized to their own claims data, to their own information, and to provide them with these actionable items, actionable recommendations, in the context of their own journey." "We sort of say, most of the people that I ask recommended X, Y, and Z, and that's why I'm going with X, Y, and Z. But imagine AI doing exactly the same, but at a scale of asking millions of people that could look like you. And, as a result, be able to really democratize these insights of all of our experiences and being able to make it available to each one of us. But the importance

Dr. Waqaas Al-Siddiq is the Founder and CEO of Biotricity and a leader in the development of mobile cardiac telemetry, MCT, devices to provide real-time, continuous monitoring of at-risk patients. Waqaas explains, "One of the core areas that we strongly focus on is long-term data collection in this real-time intelligent monitoring. When you talk about our core product, which is Bioflux, which is used for diagnostics, we are talking about a device that has built-in algorithms, that's FDA cleared, as well as the algorithms to collect data from a patient, determine if there is an emergency or an anomaly, and then alert somebody for emergency response. "Most importantly, we have three channels of data. Three channels of data means that we have three different views of the heart. What that does is that it creates more data. More data means better accuracy and a better diagnosis. The standard in the MCT space is actually two channels. With three contact points, two channels. To get three contact points, you need fi

Dr. Jennifer Jones-McMeans is the Divisional Vice President of Global Clinical Affairs at Abbott's Vascular Business. She talks about recently released data from their Beyond Intervention Survey of 1800 stakeholders including 1289 vascular disease patients, 408 healthcare physicians, and 173 healthcare leaders from across 13 countries. The study looked particularly at Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) which revealed these diseases disproportionately affect Black, Latino, and Native Americans. Jennifer reports, "I think what Beyond Intervention allowed us to do is to see what the patient is feeling, experiencing, and how does that differ from what your healthcare provider or your healthcare leader is saying? Because one of the key findings that we found was that patient experience is maybe not as good as the healthcare provider may be thinking it is." "And we know that when you look at these social determinants, and they can be anything from socioeconomic status, availability to

Lauren Walrath is Vice President of Public Affairs in North America, and Susan Thiele is Director of Advocacy and Brand Communications at Kyowa Kirin, a Japan-based global specialty pharmaceutical company known for its cutting-edge scientific discoveries in four therapeutic areas including neurology, nephrology, hematological cancers, and immunology. Lauren explains their approach to patient-centric discovery, "In advocacy, we're really trying to find where the gaps are and how we can best work with partners to make long-term and sustainable improvements for patients. So that can be in the form of starting new research, funding new grants, addressing disparities, working on developing new education programs. Generally, we're looking for meaningful opportunities to help patients and their families on their journey from diagnosis to treatment. We work closely with the advocates, and we bring all of that understanding back to our teams here at Kyowa Kirin so that we really can engage our cross-functional partner

Dr. Colin Banas is the Chief Medical Officer at DrFirst a health IT company that's been around for over 21 years. Started as an e-prescribing platform and developed expertise in medication management.  Colin explains, "What we as a company are hoping to do is empower patients by connecting the dots to help them get on therapy and stay on therapy. And so, one of the core things that we do as a company is around price transparency." "And when I say price transparency, what I'm really talking about is serving up data to the multiple parties involved in prescribing decisions. When I mention price transparency for a provider, for example, what I'm saying is at the moment of making that decision to write that prescription, ostensibly with the patient in front of me, or the encounter happening, so much of it now is virtual via telehealth. But at the moment of making that prescription decision, I can see what the patient's copay will be, what they're out of pocket will be. And that really lends itself to having a con

Bob Connelly is the CEO of Elicio Therapeutics which has figured out how to deliver immunotherapies from vaccines into the lymph nodes where they are activated to defeat cancer and infectious diseases. Bob says, "Our overall mission is to treat many different types of cancers primarily, but even to bring our technology into other areas like infectious diseases by engaging the lymph nodes, which are really the command center for the immune response in our body." "And to date, they really have not been a part of the cancer immunotherapy revolution that's really started over the last ten years and is very exciting. We're using a technology that initially is focused on KRAS mutation-driven cancers, which comprise 25% of all solid tumors. So we're in a trial right now where we have colorectal cancer patients, we have pancreatic cancer patients, but our lead program can apply in lung cancer, ovarian cancer, bile duct cancer." "In our bodies, albumin is a very large protein that is constantly circulating throughout

Dr. Peter Altman is the President and CEO of BioCardia and emphasizes that heart disease is the leading cause of death in the Western world. BioCardia is developing technologies to treat cardiovascular diseases with cell and cell-derived therapies which allow for precise cell delivery in the heart and technologies associated with optimizing the selection of patients to find those most likely to respond to the therapy.  Peter explains, "In this setting, I think what's unique is there's a technology around that cell processing and around the cell delivery. I think what's most unique is these are autologous cells, as we've said, and because of how we're doing this, we can achieve, in appropriate patients with this point-of-care processing and the efficient delivery, we can deliver and create dosage forms that are not only more significant than others historically but are very inexpensive to provide for the patients. And that means it can have a real boon to the healthcare system." "Most autologous therapies they

Walter Wolf is the author of The Right Rehab: A Guide to Addiction and Mental Illness Recovery When Crisis Hits Your Family and also an interventionist.  He has written this book to highlight options for those with addictions and family members and friends who want to help find an effective treatment. Walter explains, "There are lots of books about addiction, about the clinical aspect of it, but there were no books whatsoever, there were no guides about how you get the right treatment for the right individual. So a few years go by, and ironically I'm now an interventionist and a treatment placement specialist. People come to me not only to intervene with loved ones because they need to go to treatment but also I match people up with the right treatment facility for them." "Until just recently, the conventional wisdom was that if somebody had an addiction, well, that was because that was a choice on that individual's part, and that choice meant that person had very low morals, had very low character. But in fa

Boro Dropulić is the Co-Founder and Executive Director of Caring Cross, a 501 (c)(3) non-profit dedicated to accelerating the development and manufacturing of advanced medicines to improve access to cures for all patients independent of where they live. Boro explains, "One way to reduce the cost is by manufacturing the product locally at, what we call, the clinical place-of-care rather than using a centralized manufacturing model that has traditionally been used for drug distribution. By using automated devices to ensure the consistency of the products while they're being made, for example, CAR-T cell products, they can be produced at a fraction of the cost than when they're made centrally, even a 10th of the cost with current cost and materials." "Once the CAR-T cell product is made, it is then reinfused back to the patient to have its anti-tumor effects. The most effective CAR-T cell products so far are autologous, meaning that they are from the patient's own cells and return back to the patient. There have

Amir Raza is the Vice President, Strategic Services at Encora and is working with technology-enabled companies to design and support patient engagement, telehealth, remote patient monitoring, digital clinical trials, and connected care solutions. Amir explains, "So, if you peel back the onion on the statement, we are a product engineering services company. I think what it unveils is four core capabilities that support that assertion. The first is the ability to build underlying digital platforms. The second is having mastery of data because data is increasingly crucial and critical, certainly within the empowered patient, consumer engagement, patient engagement space. I mean, data is the oil of that industry. So, all things data." "Then, of course, I think the other key capability that comes into play when you're designing these kinds of platforms is CX, or what is known in the industry as CX/UX, which is consumer experience and user experience. How do you design delightful, intuitive products? Finally, I thi

Khalid Al-Maskari is the CEO of Health Information Management Systems (HiMS) and a thought leader in healthcare informatics. Behavioral healthcare is an area that Khalid has identified as ripe for innovation and where integration of systems needs to be better focused on transparency and the coordination of the care of patients. Khalid says, "So in behavioral healthcare, a lot of the communication is between care coordinators and case managers. And most of it traditionally has been on the side of the healthcare providers having a lot of information, and then patients communicate with them. But the communication typically is long-term communication. It's not instantaneous. A lot of times, the patients have to request that information rather than them having access to it directly. So it's a longer process, unlike going to a PCP for a specific issue, behavioral health typically is a long-term process." "One of the things that COVID made clear is that behavioral health patients are ready to be more active and part

Dr. Paul Peter Tak is the President and CEO of Candel Therapeutics which is focused on educating the immune system to recognize and kill tumor cells in patients with a solid tumor. Candel is developing immunotherapies using engineered oncolytic viruses for prostate cancer, brain cancer, lung cancer, pancreatic cancer, and eye cancer. Paul Peter explains, "Viruses probably got a bad reputation during the pandemic, but you can actually use them to do something beneficial to a patient, and that's what we are doing. So, using molecular engineering, we change the viruses in such a way that they infect the tumor cells and that they induce cell death. They kill the tumor cells in a way that activates the patient's own immune system, which is basically a very natural way to fight cancer." "So, at the same time, we change the so-called tumor microenvironment from a cold tumor, a tumor that is not very active in terms of immune activity, into a hot tumor where we activate a whole variety of immune cells. And that's an

Bronwyn Spira is the CEO of Force Therapeutics which is supplying tools to manage procedure-based care. CMS  created CMMI, the Centers for Medicare and Medicaid Innovation to evaluate new alternate payment models and service delivery models that were designed to reward high-value, high-quality care while also reducing payments. They would reduce the payments to clinicians who were not meeting the performance standards but preferentially reimburse high-quality and high-value providers. And these were called alternate payment models or APMs.  Bronwyn explains, "I think the important key here is that in order to reward quality, you first have to be able to measure quality and collect quality measures. So this is where patient-reported outcome measures and performance measures become so key. You actually now need those measures to submit for reimbursement based upon the services you're providing." "And this has changed provided behavior in a big way because before these APMS were implemented, a lot of providers a

Matt Walz is the CEO of Trialbee which is empowering patients through a more inclusive trial process. The Trialbee Honey product provides three user experiences on top of one common data architecture linking the patient, the test sites, and the sponsors providing real-time information about enrollment and how a study is performing. The Trialbee Hive product uses real-world data to model outreach to a hyper-targeted audience. Matt explains, "In terms of remote participation for studies, COVID brought to light the fact that there are tools and methods that have been available to allow patients to participate more and collect data more during clinical research without having to have frequent visits to a site. Not in all cases, but in a number of cases. And that also accelerated timelines to get to the point where you can seek a regulatory authority approval." "One of the things we've done in some of our studies, and this really comes down to how you do outreach for recruitment, is we've started to look at rare d