Xtalks Life Science Podcast

This episode features an interview with Fady Boctor, MBA, President and Chief Commercial Officer at Petros Pharmaceuticals, a Men’s Health pharmaceutical company that aims to develop complementary therapeutics designed for a man’s journey. The company focuses on therapeutics that promote medication adherence, tolerability and preservation of male organic function.Fady has over 20 years of experience in the pharmaceutical industry, and has worked for companies such as Novartis, Forest Pharmaceuticals, Auxilium Pharmaceuticals, Endo Pharmaceuticals and Adapt Pharmaceuticals (Emergent Biosolutions).In the episode, Fady discussed Petros Pharma’s lead ED therapeutic and its potential to be transitioned to OTC status. He also discussed the overarching challenges in men’s health today and how Petros is positioned to tackle them.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 Wa'el Hashad, CEO of Longeveron.Hashad discussed Longeveron’s mission and the therapeutic areas the company is investigating. He discussed the mechanism of action of the company’s lead program, Lomecel-B.Lomecel-B is an “allogeneic” (donor-derived) cell therapy product. Lomecel-B is a cellular therapy currently under clinical investigation as a potential treatment for various aging-related chronic diseases and life-threatening conditions. These studies are conducted under the approval of the FDA’s Investigational New Drug (IND) Applications.Lomecel-B is under clinical investigation for pediatric hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and aging frailty.Longeveron is based in Miami, Florida, with its corporate headquarters and manufacturing operations situated in the Converge Miami Building.Hashad also shared the next steps for Longeveron’s programs.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 Attorney Temitope (Tope) Leyimu, a toxic exposure attorney at Motley Rice  who is leading a lawsuit over hair relaxing products that contain harmful chemicals. Hair relaxing products are used for straightening/smoothening hair and many contain harmful formaldehyde, formaldehyde-releasing and other toxic chemicals. The FDA recently issued a recommendation for the recall of chemical hair relaxers containing harmful chemicals. While the agency has initiated its rule-making process, a ban hasn’t been implemented yet.The products, which have historically been targeted primarily at black and brown women of African descent, have drawn major concern due to their links with reproductive-related cancers such as ovarian, cervical and uterine cancer. An October 2022 study by the National Institutes of Health, revealed that women using chemical straighteners face a 150 percent increased risk of uterine cancer. Attorneys leading the hair relaxer lawsuit including Leyimu say the FDA proposal is a significant step in advancing public health for women, particularly black and brown women, who are disproportionately impacted by many of these products that are alleged to be harmful.Tune into the episode to learn more about the litigation, including the historic racialized marketing of harmful hair relaxing products to women of African descent in the US.If you or anyone you know may have been affected by these products, you can complete the webform to contact Motley Rice if you would like to talk to someone about the lawsuit.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 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

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

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

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

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

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

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