Dr. Omar Sinno, MD, U.S. Medical Lead, Rare Disease at UCB discusses the positive topline results from the Phase 3 RAISE trial evaluating zilucoplan, a self-administered, subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibitor), versus placebo in adults with generalized myasthenia gravis (gMG). Alongside zilucoplan, UCB is also investigating whether rozanolixizumab, an SC-infused monoclonal antibody targeting the neonatal Fc receptor (FcRn), could deliver patient value to people living with gMG. UCB is currently the only company investigating two potential treatments with multiple mechanisms of action in gMG. The safety and efficacy of zilucoplan and rozanolixizumab have not been established and are not approved for use in any indication by any regulatory authority worldwide.
Dr. Joe Flanders, PhD, VP, Psychology at Numinus Wellness Inc, a Canadian-based company at the forefront of advancing safe, effective, and innovative psychedelic-assisted therapies, and assistant instructor with the McGill University Psychology department, discusses the enrollment of the first clinical trial volunteer as part of the next implementation phase in the clinical trial “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX).” The trial is sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC). MAPPUSX is an extension of the parent study MAPP1 by MAPS, which investigated the safety of MDMA-assisted therapy for treating severe PTSD.
Thomas Lendvay, CMO and co-founder of Tend Health, Inc. discusses the recent announcement of the initiation of a clinical trial at Massachusetts General Hospital evaluating the comparability of the company’s Gut Microbiome CAP device to current non-standardized methodologies for the delivery of Fecal Microbiota Transplant (FMT) for patients suffering from Clostridium difficile infection.
Dr. Christopher Ianelli, Co-Founder and CEO of iSpecimen (NASDAQ: ISPC), discusses the company’s proprietary, global Marketplace where researchers can search for and find millions of human biospecimens across its vast network of healthcare providers quickly and compliantly to support their medical research. iSpecimen eliminates the cumbersome and time-consuming process of biomaterial procurement. He talks about the platform’s benefits for researchers, the medical community at large and patients, how the technology works and what’s up next for the company.
Dr. Katherine Iscoe, co-founder and CEO discusses Advanced Human Imaging, a developer of a leading patented, proprietary technology that enables users to take vital signs and detect warning signs for myriad diseases using their smartphone. She has watched the Company grow from its initial conception as “MyFiziq”, a primarily B2C offering, into what it is today – a global, highly scalable, and innovative B2B company that is disrupting multiple verticals, including fitness, virtual health, and insurance. She also shares her strategy for the Company in the future.
Dr. Tobias Barker, Chief Medical Officer at Everside Health, takes a deep dive into value-based and direct primary care (also known as direct to employer), how it compares to fee-for-service clinical environments, and – most significantly – how it benefits patients, providers and employers alike. Dr. Barker explains how this type of advanced primary care can potentially address and mitigate many of the problems in the U.S. healthcare system – from skyrocketing rates of physician burnout to more than 90 million Americans having limited to no healthcare access – and lead to higher quality care and reduced costs.
Dick Simon is co-founder and CEO of Sensorium Therapeutics, a drug discovery platform translating insights from nature and modern neuroscience to develop novel mental health therapeutics. The search for natural compounds with medicinal value is an underexplored area in the advancement of clinical-grade medicines. Dick talks about Sensorium’s proprietary drug discovery platform, which has created better tools to address these unique technical challenges with machine learning and through a significant library of psychoactive plants to pinpoint realistic drug candidates targeting mental health.
Bill Stilley, is CEO and President of Adial Pharma, a company focused on developing therapies for the treatment of addiction and related diseases, specifically Alcohol Use Disorder (AUD). He discusses the company’s lead product AD04, a genetically targeted therapeutic for the treatment of AUD and the promising results from the phase 2b clinical trial in reducing frequency and quantity of drinking. AD04 is now in Phase 3 and has the potential to be an effective and safe treatment option for AUD that does not require abstinence as part of the treatment and does not have the negative side effects of the current drugs on the market.
Anastasia Daifotis, Chief Scientific Officer, Janssen North America Pharmaceuticals discusses disparities in health care, ways to improve the system, and why innovation matters. She also talks about what we can expect to see in our healthcare system in the next 5 – 10 years.
Dr. Mary Mulcare, MD, Chief Medical Officer at Summus, the world’s leader in virtual specialty care, discusses their mission to restore human connection in healthcare. Using proprietary technology, Summus creates a new healthcare model, where members quickly connect with leading doctors to provide personalized, condition-specific support across the continuum of care. For patients, this is providing an elevated virtual specialty care experience that includes the ability to access high-quality specialist doctors across any health question, from anywhere in the world. For physicians, this is working to re-engage their professional satisfaction. She also talks about the launch of Summus Wellbeing, a new program grounded in Lifestyle Medicine.