Empowered Patient Podcast

Dr. Jacob Donoghue is the CEO and Co-Founder of Beacon Biosignals, a computational neurobiomarker discovery and deployment platform taking EEG readings and applying their algorithms to identify novel neurobiomarkers that might be related to a disease that can be modulated by a new therapy.  Jacob drills down, "We anchor these biomarkers that we are able to identify off the world's largest annotated EEG database, which we have at Beacon, to be able to really put things into context. When we make a discovery, we can really see, even in a small cohort of patients, how does that relate to both other patients with that related disease or also healthy normal patients? "Beacon was born by looking at the massive opportunity and unmet need in patients with neurological and psychiatric diseases and to take in all these long data sets of electrical brain activity, EEG data, to be able to provide the same types of tools that were transforming digital pathology, radiology, and GI to better characterize diseases of the bra

Dr. Jennifer Jones-McMeans is a Divisional Vice President of Global Clinical Affairs at Abbott Vascular Business and she sheds light on the FDA guidance to encourage sponsors of clinical trials to include all genders, ethnicities, and under-represented patients to participate. New guidelines are more organized and provide better guidance for what sponsors of clinical trials should consider during their submissions to the FDA. Jennifer explains, "If you think about where clinical trials sit, clinical trials are part of the overall healthcare ecosystem. And if we consider that the healthcare ecosystem is to be inclusive, it is to make sure that there are appropriate treatments for women and different ethnic groups. Also understanding that possibly there could be differences in maybe therapeutic responses, or even considering access too. Clinical trials have to then move forward as the medical ecosystem is moving forward to ensure that there's treatment available for all patients. And so this is where again, thi

Kathleen Aller is the Director of Market Strategy for Healthcare at InterSystems, a software company that focuses on high-volume data management and mobile applications to manage healthcare data. By taking advantage of the InterSystems capabilities on the AWS platform, young startup companies can use its technology to help them cost-effectively build interoperable applications or data-intensive applications and scale up as needed. Kathleen explains, "In fact, there are more than a billion records managed in our technology. One of the groups we've been working with a lot in the last few years are payer organizations who are responding to government regulation that says you have to make the information you hold about patients available to them. You need to do it using a standard called FHIR, Fast Health Interoperability Resources. They have to be able, then, to import that data into applications so that they can do things with it." "We've been involved in digital health practically since its inception. Some of

Keith Palmer is the Worldwide Vice President for Hip Reconstruction at DePuy Synthes, which is the orthopedic company of Johnson & Johnson. DePuy Synthes is focused on adapting their technology, techniques, and implants to provide stability, flexibility, and durability to an ever more active patient population. Keith reports, "When we think about our surgeons and our patients and keep them in mind, we have solutions that address unmet needs in patients that lead to improved outcomes. So, through our anterior advantage, our portfolio solutions, in particular, patients benefit from shorter hospital stays, quicker recovery times, and reduced use of pain medication when they're surgeon implants or comprehensive systems for hip replacement surgeries." "Our patients today are highly educated on different surgical technique offerings. They even think about what's best in terms of meeting their needs, the quicker recovery, and even going to outpatient surgery centers and ensuring that the time is reduced to help

Javier Szwarcberg, CEO of Spruce Biosciences, is developing a compound to address the needs of patients with classic congenital adrenal hyperplasia, CAH, a rare disease first diagnosed at birth. Only recently have companies started to explore innovative therapies to improve the standard of care discovered in the early 1960s. Currently, patients manage their conditions with glucocorticoids but often suffer from steroid-related complications. Javier explains, "What we're trying to do with our drug is to treat the disease. The compound is a small molecule that binds to a receptor in the pituitary and blocks the release of a hormone called ACTH or adrenal corticotropin hormone. By blocking that hormone, you reduce the amount, the stimulation on the adrenals, and the buildup of precursors that are going to lead to a hyperandrogenic state. So our drug treats the disease. Patients, of course, will still need to get steroids daily to supplement the missing cortisol. But the CAH piece of the disease will be well manag

Richard Hague is the CEO and President of PolarityTE, creating a paste-like substance containing multicellular skin segments that can be spread on the patient's wound bed and engrafts into the wound. This stimulates healing from the inside out with wounds created by diabetic foot ulcer and venous leg ulcer. Richard elaborates, "We're very excited about our SkinTE platform. It's a very unique and novel approach for treating wounds. The goal here is to use the patient's own cells so that there's no risk of rejection of any kind, no introduction of anything foreign to the body." "The first thing that happens is a physician takes a very small, full thickness harvest from the patient's body, usually somewhere in the proximal calf area. So this is healthy tissue. It's a small harvest that's easily stitched up and closed. And that tissue is sent back to our facility in Salt Lake City. We have a proprietary process for processing that skin that allows us to utilize all aspects of that harvest. So we're using all laye

Greg Sturmer is the Co-Founder and CEO of Elysium Therapeutics and rethinking how to overcome the challenges of opioid abuse and addiction by reformulating the drug itself. Blending an understanding of chemistry and human behavior, Elysium questions why it takes 70 years for an opioid to lose half its potency and what would discourage patients from taking more opioids than their prescribed treatment plan. Greg explains, "When you look at Elysium's mission, just to step back briefly, it's all about relieving suffering from acute pain, from opioid use disorder, and from an opioid overdose. And our objective is to save thousands of lives each year and reduce the next generation of opioid use disorder sufferers while still providing patients with highly effective, proven pain relief." "O2P, again, which stands for Oral Overdose Protection, is expected to be the first-in-class immediate-release opioid that eliminates that incentive to take more. And it protects against fatal overdose, not only orally but also via

Dr. Alice Martin is the Co-Founder of Dermanostic, the largest teledermatology resource in Europe. Their vision is to give access to a dermatologist to everyone worldwide with a rapid diagnosis and suggested therapy, including prescriptions. While many skin conditions are not life-threatening and are often seen as unimportant by physicians, they impact the quality of life and are treatable. Alice explains, "We have a lot of patients with skin cancer, white and also black skin cancer melanoma, for example, and it's so easy to just make the pictures because we can see the criteria for malignancy. The patients don't want to go to the appointment because they don't have any symptoms. It's just skin, the area that is growing, and by having such easy access, they are sending the pictures. They are getting the diagnosis before it's starting to make any metastases." "So the application is available, for example, on the Apple Play Store or Google Play Store, and you can download it in your language. It's also availabl

Patty Hayward is the Vice President of Industry Strategy for Healthcare and Life Sciences at Talkdesk which is working with payer and provider organizations, life sciences companies, and other clients in the healthcare and life sciences areas.  Its mission is to synchronize data streams so that there is a convenient way for care providers and patients to receive healthcare information and services using their channel of choice. Patty elaborates, "People are really looking for that kind of convenience, and I think that's a radical shift from where we've been in the provider space, where it's really, you hang a sign outside and people came to you. You didn't do as much of the big outreach and marketing unless you were in really congested marketplaces. Even then it was very traditional in how you went about marketing." "I think today that's really shifted. A lot of folks that we're talking to are really looking to digitize their contact centers, digitize their patient experience, and trying to look at things in

Terry Weber is the CEO of BioTE and is on a mission to educate medical professionals about the need to address the hormone levels in patients as they age. With a personalized approach, BioTE focuses on providing hormone therapy to help patients maintain their quality of life and not just be dismissed as getting old when they report discomfort, sexual dysfunction, and loss of muscle mass.   Terry explains, "At BioTE we don't just do hormone treatment. We try to optimize the individual's hormones, and that would be estrogen and testosterone, both for men and women. Testosterone's very important for women. Also, looking at the thyroid and adrenals. What we look to see is how do we balance those hormones in the individuals so that they really feel their absolute best. We take blood tests, and we have very in-depth questionnaires because everyone's reaction to hormone levels is very personal." "BioTE's history has been to focus on putting a light on testosterone for women because it's such a critical hormone. Most

Dr. Diem Nguyen is the CEO of Xalud Therapeutics, a DNA delivery gene therapy company striving to develop and deliver medicines for large, broad-based disease indications like chronic inflammatory diseases, particularly musculoskeletal diseases like osteoarthritis of the knee and as well as neurodegenerative diseases like MS and ALS. Earlier in her career, Diem was the global President of Pfizer, covering multiple therapeutic areas, and has joined Xalud because of their ground-breaking DNA delivery platform. Diem explains, "Gene therapy means a lot of things to a lot of people. And the first, I would say, is most people, when they think about gene therapies, think about viral AAV gene therapy. And a lot of promise is associated with that type of platform because you're seeing this potential, particularly in rare diseases. The challenges associated with AAV sometimes are the safety profile associated with that product. Our particular gene therapy is DNA gene therapy, so we do not have the challenges with genom

Sabrina Johnson is the Founder, President, and CEO of Daré Bioscience. Sabrina points out that there are several unmet needs in women's health and that many of the indications or conditions that women are dealing with are not life-threatening but affect their quality of life. Applying technologies created by smaller companies and academic institutions, Daré aims to become a pipeline for companies that have a global commitment to improving women's health. Sabrina explains, "Our business model is to really be that innovation accelerator that starts with finding and identifying that persistent unmet need. And that's where we start. What is that condition that is not adequately addressed today for her? Developing a target product profile, what would the product look like that might be best suited to address that condition for her? We then go out and look for a technology that has a proof of concept that it should address that and hit that target product profile. We bring that into Daré into our portfolio. We adva

Dr. Kimberly Kilby is the Vice-President and Medical Director of Health and Wellbeing at MVP Health Care. Trained as a family and preventive physician, Kimberly is focused on the patient journey and expanding the options for virtual care. MVP collaborates with virtual care providers and other digital health solutions, supporting virtual primary care, urgent care, chronic care management, and specialty care. Kimberly explains, "We want to be sure that patients are finding options for virtual care that are actually high-quality medicine but also thoughtfully integrated into the rest of their care continuum. That's part of the professional reason why a physician is dedicated to that key customer experience as you expand options in the virtual care space." "A lot of the data is showing that patient and consumer preferences within healthcare have obviously changed dramatically, and patients are looking for more convenience and availability. And I'm really charged with determining which of the innovative options pe

Mai-Britt Zocca is the Founder, CEO, and President of IO Biotech, a clinical stage biopharmaceutical company headquartered in Denmark. They are developing immune modeling cancer therapies based on their T-win technology. Using these cancer vaccines, pre-existing T-cells are being directed in patients to attack and eliminate solid tumors. Mai-Britt explains, "Currently, we have a leading program that is in Phase 3. So, this is in first-line advanced melanoma. We have a breakthrough therapy designation granted by the FDA, based on the earlier data that we have seen in melanoma. Our targets also are able to be used in other cancer indications. We are not melanoma per se. We are already running trials in first-line solid tumors where we are including also lung, head, neck, and bladder cancer." "What we do is vaccinate, as I mentioned before, and the vaccination process is a combination of first a booster program, where we give vaccination or injections several times. Then we have a maintenance phase after that. T

Dr. Hernan Bazan is the CEO and Co-Founder of South Rampart Pharma and focuses on finding a new way to treat acute and chronic pain with a drug that has no expectation for abuse and is not toxic to the liver, kidneys, or cardiovascular system. Hernan explains, "This is a tremendous unmet need in that there really has been no innovation in the pain space for over 50 years. Tylenol itself, acetaminophen, Tylenol was born in the '40s and the early '50s and worked by actually someone that was at the NIH that came to visit us a few times, a very well renowned neuroscientist. And he really discovered it incidentally, looking for another pathway, but we won't go into that. And that was adopted by McNeil Laboratories, and then eventually Johnson & Johnson." "And then, in the '60s and '70s, non-steroidals, non NSAIDs, were marketed as Advil and ibuprofen, and a bunch of NSAIDs were derived. And these are very good medicines for preventing inflammation and treating pain in the short term. The challenge with both of

Sheila Frame is the President for the Americas at Amryt Pharma, founded on the belief that rare and ultra-rare diseases were an opportunity to support underserved patients differently than the big pharmaceutical companies could. With the acquisition of Mycapssa, Amryt is changing the treatment for the rare disease acromegaly from painful injections to the first and only twice-daily oral medication. Shelia explains, "We're currently commercially, at least, in three different areas. So lipodystrophy is a pretty significant leptin deficiency for people who suffer from that. It's a fairly rare disease, with about 300 patients roughly in the US. The second one is in homozygous familial hypercholesterolemia, and again, a very rare genetic disease, probably even fewer patients than what we see in lipodystrophy. And then the third area, of course, is acromegaly with Mycapssa, where we actually have products in the market." "I think what's interesting about not only the technology that we have with Mycapssa but also t

Allison London Brown is the CEO of LUMINELLE, inventors of an advanced endoscopic system with a camera and biopsy device that allows physicians to perform gynecological procedures in their offices more safely, more efficiently, and with better reimbursement. Being able to look inside the uterus and bladder and perform operations that in the past would have required a hospital outpatient visit means that women and their doctors are more likely to identify problems sooner and get a prompt diagnosis of cancerous tissues. Allison elaborates, "If you have problems, it can also help with things like drug delivery for overactive bladder. And it can be used for fertility, both treatments, as well as trying to prevent pregnancy. So it's a pretty versatile system. It's very low cost, and it's really so that women can have procedures done in the comfort of their physician's office with less anesthesia and certainly less cost." "And for the payers, if you're catching things sooner, you're not incurring all these costs th

Dr. Emily Hamilton is the Senior Vice President of Clinical Research at PeriGen, which is applying artificial intelligence and machine learning to early warning and clinical decision support in healthcare.  With a focus on labor and delivery, PeriGen is providing real-time information to clinicians to drive down the likelihood of birth-related brain injury. Emily explains, "So, what we have developed is an AI machine learning-based way of looking at the tracing to identify contractions, to notify nurses and doctors that there are excessive contractions, and that's gone on for a while. We've also used that to recognize patterns in the fetal heart rate, which indicate that the baby's not responding well to labor and to notify them of that so that they can intervene and prevent the adverse outcome." "Likewise, we can look at the labor, and we can compare a patient's labor to a group of similar women who are having the same frequency of contractions, a number of other variables, and indicate whether or not this l

Arjan Haverhals is the CEO and President of Milestone Scientific, which is exploring how to modernize hypodermic syringe use. One application of their injection technology is for women during labor and delivery to inject the epidural needle more accurately and control the pain. Milestone is also looking at dentistry, chronic pain, neuro-surgery, and cosmetic medicine as additional opportunities to deliver more efficient, precise, and safer injections. Arjan provides a historical perspective, "Just to give you some background information from a study from last year. It was found that even when male and female patients expressed the same amount of pain, female patients' pain is often seen as less intense and more likely to benefit from psychotherapy versus medication as compared to men's pain. And I do believe that this gender gap in healthcare could lead to bias diagnoses related to chronic pain for women and may also explain why very little has changed in the field of epidural delivery. And any way we can aid

Daniel Teper is the CEO and Founder of Cytovia Therapeutics and talks about using natural killer, NK, cells as an alternative to T-cells in immuno-oncology. He shares insights about the development of induced pluripotent stem cells, IPSC-derived NK cells, iNK cells, used by themselves or using their Flex-NK cell Engagers or in combination to address the challenges cancer patients face. Daniel elaborates, "That's also where the NK cells may have advantages over T-cells, in that it hasn't been reported that they cause CRS, GBHD, or other side effects that would require the patients to be kept in the hospital. Now, if we say the first iteration was derived from the patient's own blood, the second iteration is donor, the third generation, which we are one of a handful of companies to pursue and master, is the production of immune cells, including NK cells, from induced pluripotent stem cells." "We see also that you can direct the cells in two ways. You can direct the cells by inserting what's called a CAR, or chi