Xtalks Life Science Podcast

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. RSV is a respiratory virus that causes mild to moderate cold and flu-like symptoms, but it can cause complications like lower respiratory tract disease (LRTD) and pneumonia in older adults and young children. Read more about the vaccine, including clinical trial results on its efficacy and safety. Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS. The treatment, an antisense oligonucleotide developed by Biogen, targets abnormal proteins arising from SOD1 mutations, which are associated with the development of ALS in some patients. Even though these mutations only account for two percent of ALS cases worldwide, the treatment is an important milestone that sets the stage for the development of more ALS therapies.Read the full articles here:Arexvy Becomes World’s First RSV VaccineQalsody (Tofersen) Becomes First-of-Its-Kind Treatment for ALSFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment of bladder and bowel dysfunction. The team discussed Axonics Therapy and the occurrence of non-drug (medical device) TV ads.Vera and the team also discussed how two companies, Cerner Enviza and John Snow Labs, are teaming up with the FDA to use AI tools to better understand the side effects of drugs. This project is part of the FDA’s Sentinel Initiative to evaluate the effects of medicines on real-world populations. Hear more about how Cerner Enviza and John Snow Labs will use AI to explore the mental health side effects of a commonly prescribed asthma drug, Singulair (montelukast)Read the full articles here:Axonics Touts Non-Drug Incontinence Therapy in TV AdsHow Cerner Enviza Will Use AI To Study the Mental Health Side Effects of MontelukastFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @XtalksFacebook: https://www.facebook.com/Xtalks.Webinars/LinkedIn: https://www.linkedin.com/company/xtalks-webconferencesYouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers. The skin cancer evaluation tool, also called DermaSensor*, is a point-and-click device that can provide health care practitioners with a skin evaluation in seconds.  As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians and patients. Prior to joining DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening and monitoring startup. He began his career in business development and commercial strategy roles at Genentech.Hear more about the innovative technology and application of DermaSensor in this episode. And view a video excerpt of the device in action here: https://youtu.be/4-NnRcyOFHcRead more at: Clinical Studies Support DermaSensor’s Skin Cancer Detection Device*FDA submission pending review. DermaSensor is currently not for sale in the United States.References1. Merry SP, Croghan I, McCormick B, Chatha K, Leffell D. Clinical Performance of Novel Elastic Scattering Spectroscopy (ESS) in Detection of Skin Cancer: A Blinded, Prospective, Multi-Center Clinical Trial [Initial Results]. Poster Presentation, Innovations in Dermatology Conference, Las Vegas, NV, November 3-5, 2022.2. Carli P, Nardini P, Crocetti E, De Giorgi V, Giannotti B. Frequency and characteristics of melanomas missed at a pigmented lesion clinic: a registry-based study. Melanoma Res 2004;14(5):403-407.3. Soyer H, Argenziano G, Zalaudek I, Corona R, Sera F, Talamini R, et al. Three-point checklist of dermoscopy. A new screening method for early detection of melanoma. Dermatology. 2004;208:27-31.4. Stanganelli I, Serafini M, Bucch L. A cancer-registry-assisted evaluation of the accuracy of digital epiluminescence microscopy associated with clinical examination of pigmented skin lesions. Dermatology. 2000;200(1):11-16.5. Dinnes J, Deeks JJ, Grainge MJ, et al. Visual inspection for diagnosing cutaneous melanoma in adults. Cochrane Database of Systematic Reviews. 2018;12:CD013194.6. Data on File, DermaSensor Inc.7. Seiverling EV, Agresta T, Cyr P, Caines L, Nguyen VL, Chatha K, Siegel DM. Clinical Utility of an Elastic Scattering Spectroscopy Device in Assisting Primary Care Physician’s Detection of Skin Cancers. Poster Presentation, Maui Derm Hawaii Conference, Wailea, HI, January 24-28, 2023. For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about new rules that the US Environmental Protection Agency (EPA is proposing for curbing ethylene oxide emissions from sterilization facilities. The agency says the new guidelines would help reduce emissions by 80 percent, which is particularly important for communities that live near sterilization plants and workers who work at them. Ethylene oxide is a known carcinogenic, with long-term exposure to the odorless, colorless gas being associated with cancers including breast cancer and myeloma among others. The gas is used to sterilize medical equipment as well as spices. Hear about the new proposed rules and industry reactions to them.Ayesha and the team also discussed Johnson & Johnson’s latest offer of $8.9 billion to settle the mountain of talc lawsuits it continues to face. The claimants maintain that the company’s talc-based baby powder had high amounts of asbestos contamination, which the company has known about since the 1970s. One plaintiff group has said Johnson & Johnson’s latest offer is not enough and criticized the company’s strategic bankruptcy plans. A US Court of Appeals rejected the plan earlier this month but Johnson & Johnson said it will take its case to Supreme Court. Hear more about the company’s latest settlement offer in this episode.Read the full articles here:EPA Wants Tougher Restrictions on Ethylene Oxide Emissions from Sterilization FacilitiesJohnson & Johnson Offers $8.9 Billion in Talc Lawsuits But Not Enough Says a Plaintiff GroupFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Wei-Li Shao, President of Omada Health.Omada Health is a provider of virtual care solutions focused on common chronic conditions, including both type 1 and type 2 diabetes, hypertension and musculoskeletal. As a virtual-first chronic care provider, the company helps members make lasting changes to improve health and reduce care costs for organizations.Wei-Li is a global executive leader with over 20 years of experience building and leading biopharmaceutical and diagnostic imaging businesses in the United States, New Zealand, China and Taiwan. He joined Omada Health in 2019 following an 18-year career as an executive at Eli Lilly and Company.Hear more about Omada Health and its commitment to quality virtual care in this episode.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Xtalks’ senior editorial staff discuss how the pharmaceutical industry has changed – and stayed the same – in the last 2 decades. Sarah talks about the global value of the pharmaceutical industry in 2002 versus today and which companies made the top 3 based on revenue.Sarah also shared the top-selling drugs in 2002, 2012 and 2022, and how much the industry as a whole has invested in R&D in those years. The team discusses the number of new drugs and biologics approved by the FDA each year, and debates whether the regulator will be able to keep up with growing submission numbers and the expectation of speedy approval decisions. The team also talked about the role of Xtalks in knowledge dissemination and facilitating meaningful conversations in the pharma industry through webinars, written content, videos and, of course, this podcast!To read more, visit Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History. For a closer look at the stats discussed in this episode, check out this infographic.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Manu Garg, VP, Head of Healthcare Consulting at Definitive Healthcare. Sarah and Manu discussed the transformative role of healthcare commercial intelligence in the industry today, and how machine learning (ML) and artificial intelligence (AI) are changing care delivery for patients. As new drug development is increasingly focused on targeted therapies for rare diseases and other indications with limited patient pools, healthcare commercial intelligence can help companies find their target market and help direct resources. Manu explained how both large and small pharmas, biotechs and medtechs can benefit from Definitive Healthcare’s SaaS-based tools.Manu explained how AI is helping to predict tumor mutations so that cell and gene therapies can be targeted to individual patient’s needs, realizing the true promise of “personalized medicine.” He also discussed why the healthcare sector needs to adopt new ways of using patient-generated device-based health data to bring care to patients when and where they need it.For more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Howard Look, CEO and co-founder of Tidepool, a non-profit organization that has a range of software tools for people with diabetes and the clinics that serve them. Tidepool recently received US Food and Drug Administration (FDA) clearance of Tidepool Loop, an automated insulin dosing app meant for the management of type 1 diabetes in patients who are six years of age and older. Howard spoke about the FDA clearance and discussed how Tidepool Loop addresses an unmet need in the type 1 diabetes space.Howard shared his story about his personal connection to diabetes and what prompted him to start Tidepool. He discussed his strategy for engaging stakeholders — the patients, health care providers, caregivers and payers — to pave the way for individuals with type 1 diabetes to access Tidepool Loop.Hear more about Tidepool Loop and Tidepool’s continuing work in the diabetes management space.Read more here:Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 DiabetesFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

This episode features an interview with Diarmuid Flavin, Chief Operating Officer (COO) of Neuromod, a Dublin-based medical device company specializing in the treatment of tinnitus, a condition known as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide.The company recently received De Novo approval from the FDA for its tinnitus treatment Lenire. Lenire is the first of its kind, non-invasive, bimodal neuromodulation device that stimulates nerves to treat tinnitus. Diarmuid spoke about the approval and how Lenire helps address a significant unmet need in the tinnitus space. Diarmuid brings more than 25 years of global leadership experience in a range of medical device, technology, and pharmaceutical companies to Neuromod, where he assumes responsibility for the company’s strategic operational execution, Regulatory Affairs, Engineering & Technology, Manufacturing Operations and Supply Chain teams. Hear more about Lenire and Neuromod’s continuing work in biomodal neuromodulation technologies.Read more here:Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical TrialFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

In this episode, Ayesha talked about the FDA approval of Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy, a leading cause of blindness. The condition is an advanced form of dry age-related macular degeneration (AMD) for which there have been no treatment options up until this recent approval. Hear more about the drug, including some questions about its clinical benefit.Ayesha also talked about the FDA’s emergency use authorization (EUA) of Lucira Health’s over-the-counter (OTC) combination COVID-19 and flu diagnostic that can be administered at-home. The molecular PCR test is the first at-home combination test that can differentiate and detect the Influenza A, B and SARS-CoV-2 viruses in 30 minutes or less. The editorial team discussed the utility of the test, including settings in which they may be useful in and whether they may even be needed at all.Read the full articles here:Apellis’ Syfovre Approved as First Treatment for Geographic Atrophy Despite Uncertain Clinical BenefitFDA Authorizes First At-Home Combination COVID and Flu TestFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured