Xtalks Life Science Podcast

In conversation with FNIH’s Dr. Courtney Silverthorn, Director of the AMP Bespoke Gene Therapy Consortium, About New Rare Disease Trial Portfolio

This episode features an interview with Dr. Courtney Silverthorn who is an Associate Vice President at the Foundation for the National Institutes of Health (FNIH) and the Director of the Accelerating Medicines Partnership (AMP) program including the Bespoke Gene Therapy Consortium. The FNIH recently announced that the AMP Bespoke Gene Therapy Consortium has selected eight rare diseases for its clinical trial portfolio. Xtalks spoke with Dr. Silverthorm about the consortium’s new rare disease clinical trial portfolio.Hear more about the diseases that were selected and the consortium’s goal of accelerating the path of new therapies for rare diseases to clinical trials.The Bespoke Gene Therapy Consortium was jointly launched by the NIH and US Food and Drug Administration (FDA) in 2021 to help address common issues that gene therapy developers face. It included formulating a standardized therapeutic development model that would help accelerate clinical trial processes for new treatments.Read more at: Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial PortfolioFor 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

AI and ChatGPT for Medical Record Management: Interview with Carm Huntress, CEO and Founder of Credo Health

In this episode, Vera interviews Carm Huntress, CEO and Founder of Credo Health, about the challenges that the US healthcare industry is facing today with medical record management. Carm discusses why medical records should be digitized and the improvements needed for the retrieval and analysis of digital medical records.Vera and Carm also discussed how Credo Health’s new AI platform for medical records, PreDX, works and how it makes the tasks of healthcare providers easier. Carm also shared his thoughts about privacy concerns regarding the use of AI to scan medical records. The episode concluded with Carm sharing what’s next for Credo Health.Read the full article here:Advancing Medical Record Management: The Power of AI/ChatGPTFor 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

First Topical Gene Therapy + Bausch + Lomb’s First Prescription Med for Dry Eye

In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). It’s the first treatment for the rare disease. Hear more about DEB and Vyjuvek in this episode.Ayesha and the team also discussed the FDA approval of Bausch + Lomb’s first prescription drug for the treatment of dry eye disease. The drug, called Miebo, is also the first treatment that targets tear evaporation, which is a leading cause of dry eye disease. Hear more about the drug and its approval in the show.Read the full articles here:Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin DiseaseMiebo Approved as First Dry Eye Disease Treatment to Target Tear EvaporationFor 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

Veozah the New Drug for Menopausal Hot Flashes + SkinVive the New Dermal Filler

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.) during or after the menopausal transition. Importantly, vasomotor symptoms can have a substantial impact on daily activities and overall quality of life. The team discussed Veozah and the benefits of this drug for women’s health.Vera and the team also discussed the recent FDA approval of Allergan Aesthetics’ new hyaluronic acid product, SkinVive by Juvéderm, for achieving skin smoothness. SkinVive will be the first and only intradermal microdroplet injection of hyaluronic acid available in the US, representing a significant milestone in skincare innovation. The team discussed the benefits and novelty of the product, as well as their personal opinions of hyaluronic acid products for skincare and the costs of such treatments.  Read the full articles here:Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot FlashesSkinVive by Juvéderm: The New Dermal Filler Coming to the USSee the related webinars here:Hot Flashes, Brain Fog and the Blues: Frontiers in Menopause TreatmentsInnovations in Skin Care Ingredients: Beauty from Within, Wellness ThroughoutFor 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

Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis

In this episode, Sarah interviews Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis, about the challenges of bring biosimilars to market. Dr. Woollett clears up some common misconceptions about achieving interchangeable status and addresses the issues with differences in global regulatory standards for biologics medicines. Sarah and Dr. Woollett also discuss Samsung Bioepis’ first US Biosimilar Market Report (linked below) and some of its key findings on biosimilar cost savings, uptake and market share. She also shares the way forward to help biosimilars see broader use both in the US and Europe.Read about the publications mentioned in this episode here:Samsung Bioepis’ First US Biosimilar Market ReportA 'Global Reference' Comparator for Biosimilar DevelopmentAn Efficient Development Paradigm for BiosimilarsComparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized RelianceInterchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical OneThe Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right QuestionFor 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/featuredSocial Post:

World’s First RSV Vaccine + First Novel Treatment for ALS

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

Axonics’ Non-Drug Incontinence Therapy + How AI Can Be Used to Study the Side Effects of Drugs

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

Interview with Cody Simmons, CEO of DermaSensor, Maker of a Handheld Skin Cancer Evaluation Tool

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

EPA Proposes Stricter Ethylene Oxide Limits + Johnson and Johnson Offers $8.9 Billion Settlement

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

Interview with Wei-Li Shao, President Virtual Care Company Omada Health

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