Xtalks Life Science Podcast

Dr. Lahar Mehta Speaks About New Trial to Evaluate ALS Drug for Progressive Supranuclear Palsy

This episode features an interview with Dr. Lahar Mehta, Head of Global Clinical Development at Amylyx Pharmaceuticals, who spoke to Xtalks about Amylyx’s clinical trial design of ORION, a Phase III Global Study of AMX0035 (Relyvrio) in Progressive Supranuclear Palsy (PSP). The company presented details about the trial at the Neuro2023 PSP and CBD International Research Symposium that took place in London last month in October. The ORION study will evaluate the safety, efficacy, and tolerability of AMX0035 in PSP patients. The drug was approved by the FDA last year for the treatment of ALS.PSP is a rare, progressive, adult-onset neurological disorder that affects body movements, walking and balance, eye movement, swallowing, and speech. There are currently no approved medicines to treat PSP. Hear more about the details of the trial, which is set to begin in December this year.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

FDA Considers Self Administered Nasal Flu Vaccine + Wayne Gretzky Features in GSK RSV Vaccine Ad

In this episode, Ayesha talked about the FDA’s acceptance of AstraZeneca’s supplemental biologics license application (sBLA) for a self-administered option of its nasal influenza vaccine FluMist Quadrivalent. While FluMist has been in the market since 2003, AstraZeneca is now seeking FDA authorization for a self-administered option of the vaccine. By offering a more accessible and flexible self-administered option, the company and experts in the field hope it will help increase uptake of the flu vaccine, especially as flu vaccinations have been on the decline in recent years.Ayesha and the editorial team also talked about a new ad from GSK Canada that features Wayne Gretzky, as well as a younger, AI-generated Gretzky, raising awareness about RSV vaccination among older adults. The ad features young Gretzky reminding his older self to get his RSV vaccine as older adults are at a greater risk of developing complications from RSV infection. Hear more about the ad featuring the Canadian hockey icon.Read the full articles here:FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-AdministrationGSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and OldFor 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

Innovations and Clinical Trial Diversity in Medical Aesthetics: Insights from Dr. Stephanie Manson Brown, VP & Head of Clinical Development at Allerga...

Visit clinicaledge.xtalks.com/issue1 to dive into the first issue of Xtalks Clinical Edge magazine and be a part of the conversation shaping the next era of clinical trials. Xtalks Clinical Edge — "where innovation meets expertise!"This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of Clinical Development & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. Dr. Manson Brown’s Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device. Dr. Brown is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary. Prior to joining industry, Dr. Manson Brown was trained to be a Plastic Surgeon and is a board-certified surgeon (MRCS).Dr. Manson Brown spoke about the innovations in the medical aesthetics space, including breast reconstruction for breast cancer patients. She spoke about clinical trials in the space, including Allergan Aesthetics' commitment to increasing diversity in trials and developing products that do not cater to any one beauty standard.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

Lead Investigator Dr. Genevieve Neal-Perry Discusses New Trial Data for Astellas’ Menopause Drug Fezolinetant (Veozah)

This episode features an interview with Dr. Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat vasomotor symptoms, which include hot flashes and night sweats, associated with menopause. Dr. Neal-Perry spoke about some of the latest trial data for fezolinetant that was presented at the recent Annual Meeting of The Menopause Society. This includes the effect of the drug on moderate-to-severe vasomotor symptoms in subgroups based on hormone therapy history from pooled data from two randomized Phase III studies. It also included safety data over a period of 52 weeks from three randomized Phase III studies (SKYLIGHT 1, 2 and 4). It is estimated that around 60 to 80 percent of women experience vasomotor symptoms during or after the menopausal transition. They can have a significant impact on daily activities and overall quality of life. Tune into the episode to hear from Dr. Neal-Perry about vasomotor symptoms associated with menopause and the new trial data for fezolinetant.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

Johnson & Johnson Faces Lawsuit Over Patient Data Breach + Sleepiz’s Sleep Monitoring Device Gets FDA Clearance

In this episode, Ayesha talked about a lawsuit that Johnson & Johnson and IBM are facing over a data breach that occurred at Janssen’s CarePath, Johnson & Johnson’s patient assistance program, the portal for which is run by IBM. The lawsuit was filed with the federal court in the Southern District of New York by a Florida resident who claims the companies failed to adequately protect patients’ personal identity and health information as per the Health Insurance Portability and Accountability Act. Hear more about the data breach and the risk and repercussions of cyberattacks in pharma and healthcare.Ayesha also talked about a new contactless, at home sleep monitoring device that measures vital signs which received clearance from the FDA. The device, developed by Zürich-based med tech startup Sleepiz AG and called Sleepiz One+, offers short- and long-term monitoring of heart rate and respiration during sleep to provide insights into a patient’s physiological status. The company says the device helps monitor disease progression or remission and also helps in the diagnosis of sleep disorders such as sleep apnea. Hear more about the device in this episode.Read the full articles here:Johnson & Johnson and IBM Hit with Class Action Lawsuit Over Patient Data BreachSleepiz’s At Home Sleep Monitoring Device Wins FDA ClearanceFor 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

Advancing CAR T Cell Therapies in Immuno-Oncology – Featuring Dr. Paul Rennert, CEO, CSO, Aleta Biotherapeutics

This episode features an interview with Dr. Paul Rennert, co-founder, CEO and CSO of Aleta Biotherapeutics, an immuno-oncology company focused on multi-antigen targeting solutions designed to enhance the action of CAR T cell therapies in B cell lymphoma, B cell leukemia and multiple myeloma, as well as non-B cell cancers such as acute myeloid leukemia (AML) and solid tumors such as breast cancer, gastric cancer and pediatric brain tumors.Dr. Rennert spoke to Xtalks about CAR T cell engagers that Aleta is developing for both B-cell and non-B cell cancers. The company was recently granted clinical trial authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational biologic CAR T-Cell engager ALETA-001. It will be evaluated in a Phase 1/2 clinical trial for the treatment of patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T-cell therapy.  Dr. Paul Rennert is a noted research scientist and biotechnology executive with extensive strategic and leadership experience. After launching successful new biotech companies from 2012 to 2016, he co-founded Aleta Biotherapeutics. Dr. Rennet’s ability to work broadly across the industry grew from his outstanding early career at Repligen and Biogen, highlighted by multiple successful drug-development campaigns, over 50 patents filed and granted, and approximately 100 peer-reviewed publications. Tune into the episode to hear more about Dr. Rennert’s work in advancing CAR T cell therapies in oncology.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

New HPV Vaccine Data Shows Long-Term Impact – Featuring Dr. Elmar Joura from the Medical University of Vienna

This episode features an interview with Dr. Elmar Joura, Associate Professor of Gynecology in the Department of Obstetrics and Gynecology at the Medical University of Vienna, who spoke to Xtalks about exciting new long-term Gardasil vaccine data from a study he led as principal investigator that showed the long-term impact of HPV vaccination.Merck recently announced new, 10-year long-term follow-up data published in the journal, Pediatrics, for girls and boys who received a three-dose regimen of the HPV vaccine Gardasil 9 at the ages of nine to 15 years old.Immunogenicity data from the study showed sustained HPV-antibody responses ten years after administration of the third dose in both boys and girls. Results also showed no cases of certain HPV-related high-grade disease or certain studied cancers or genital warts. Additionally, no GARDASIL 9-related serious adverse events or deaths were reported.HPV-related cancers and diseases remain a significant public health issue with the CDC estimating that tens of thousands of people were diagnosed with certain HPV-related cancers each year from 2015 to 2019. Hear more about the new long-term HPV vaccine data and the importance of increasing vaccine coverage, particularly in the developing world, in the prevention of HPV-related cancers.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

Interview with Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics

In this episode, Vera interviews Dr. Kristin Yarema, President of Cell Therapy at Poseida Therapeutics, about Poseida’s cell therapy approach and technologies.In April 2023, Dr. Yarema became the President of Cell Therapy at Poseida. She brings a wealth of knowledge from the biopharmaceutical realm, with expertise in oncology and allogeneic T-cell immunotherapy.Poseida is a clinical-stage biopharmaceutical firm that utilizes its unique non-viral gene engineering methods to develop innovative cell and gene therapies. With their extensive genetic engineering capabilities, they are paving the way for potentially better and safer treatments for conditions including blood cancers such as multiple myeloma, solid tumors like breast and ovarian cancer, and rare genetic liver diseases.In this episode, Dr. Yarema talks about the advantages of “off the shelf” or allogeneic CAR-T cell therapy vs. autologous cell therapy — and what makes Poseida’s approach unique.Dr. Yarema discusses Poseida’s two Phase I programs in collaboration with Roche, highlighting the strategic partnership's significance for Poseida.She shares what Poseida is looking forward to with the Investigational New Drug (IND) clearance for the first dual CAR program targeting CD19 and CD20 for the treatment of B-cell malignancies. Dr. Yarema also discusses how the recent $50 million strategic investment from Astellas Pharma in Poseida signifies a notable endorsement and potential growth trajectory for the company.The episode concludes with Dr. Yarema sharing her thoughts about the promise of allogeneic CAR-T cell therapy for patients.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

Advancements in Blood-Based Biomarker Tests for NASH — Interview with Dr. Tania Kamphaus and Tony Villiotti

This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH).The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.The research, published in Nature Medicine, presents results from a study that evaluated blood-based biomarker tests for the diagnosis of NASH.The study’s co-author, Dr. Tania Kamphaus, Director of Translational Science, Metabolic Disorders, as well as Director of Patient Engagement, at the Foundation for the National Institutes of Health (FNIH), shared results from the study in this podcast episode. She discussed the potential of non-invasive tests to become the standard of care for liver disease diagnosis and the ongoing work her group is doing in this area.Tony Villiotti is the founder of the nonprofit, NASH Knowledge, and a patient whose NASH led to liver cancer and subsequent liver transplant. He spoke about the impact this research will have on the patient community. Tony believes that his liver cancer could have been prevented had a non-invasive test for NASH been available to him.Hear more about Dr. Kamphaus' group’s research in liver disease and Tony’s patient advocacy work to help improve awareness around NASH and help bring new diagnostics and treatments to light.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

Insights into New Alzheimer’s Treatments: Treating Agitation and First THC-Based Therapeutic in Trials — Interview with IGC’s Ram Mukunda and Claudia ...

This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma, a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s. The drug is the only natural THC-based investigational drug undergoing FDA trials. Ram and Claudia spoke about the compound, including clinical data from the ongoing trials evaluating it.Ram Mukunda is the founder and CEO of IGC Pharma. Previously, he served as Chairman and CEO of Startec Global Communications Corp., Council Member at Harvard Kennedy School of Government and Council Member at Belfer Center for Science & International Affairs. Ram Mukunda has an undergraduate and a graduate degree in biomedical engineering from the University of Maryland.Claudia Grimaldi is currently Vice President, Principal Finance Officer, and Chief Compliance Officer at IGC. She has been with the company for almost 12 years with increasing responsibilities including managing SEC and NYSE filings, regulatory compliance and disclosures. She is also the Managing Director of IGC Pharma Columbia, a director of the company’s subsidiary in India and a director of the board at IGC. Ms. Grimaldi is a psychologist by training, is certified as a public director by the NACD and has an MBA from Meredith College in North Carolina.Tune into this episode to hear from the team at IGC about the company’s commitment to discovering new treatments for Alzheimer’s to help improve the lives of patients and their caregivers.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