Xtalks Life Science Podcast

Cognitive and Neuropsychiatric Disorders Drug Development, Featuring Dr. Adam Kaplin, Cofounder, President, CSO, MIRA Pharmaceuticals

This episode features an interview with Adam Kaplin, MD, PhD, Cofounder, President and Chief Scientific Officer at MIRA Pharmaceuticals, a preclinical-stage pharmaceutical company focused on the development and commercialization of new molecular synthetic cannabinoid analogs for the treatment of anxiety and cognitive decline typically associated with early-stage dementia. Dr. Kaplin is a neuropsychiatrist whose research focuses on the investigation of the biological basis of immune-mediated depression and cognitive impairment by using multiple sclerosis as the model. Dr. Kaplin transitioned into industry by joining MIRA Pharmaceuticals to help lead drug development in the space.Prior to joining MIRA Pharmaceuticals, Dr. Kaplin served in a number of positions at Johns Hopkins University, including Principal Neuro-Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis Center of Excellence, among others. He also served as Co-Founder of numerous healthcare related startups, including, from 2018 to present, REWARD Pathways, a company devoted to addiction treatment focused on a combined eHealth and medicine approach.Dr. Kaplin’s original research has been published over 70 times in peer-reviewed publications in key areas in neuroscience and immunology, with a particular focus on the intersection of neurology and psychiatry. In this episode, hear about drug development for conditions like dementia, cognitive decline and anxiety, and how MIRA Pharmaceuticals’ synthetic cannabinoid-based drug candidate could serve as a significant treatment advancement for these conditions.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

Pneumococcal Vaccination for Adults: Conversation with Vaccine Scientists Dr. Heather Platt and Dr. Ulrike Buchwald from Merck

This episode features an interview with vaccine scientists and executives from Vaccines Global Clinical Development at Merck, Dr. Heather Platt, MD, Distinguished Scientist and Pneumococcal Vaccine Lead; and Dr. Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head.Over the past ten years, Dr. Platt has worked across both infectious disease and vaccines products in both early- and late-stage clinical research. In her current role at Merck, she leads the product development team for V116, an investigational pneumococcal conjugate vaccine. Dr. Platt completed her training in Internal Medicine at Rutgers/Robert Wood Johnson Medical School, and Infectious Diseases Fellowship at New York Presbyterian/Columbia University Medical Center.Dr. Buchwald applies her experience in public health and basic science research to expand Merck’s pneumococcal vaccine franchise and the development of next generation adult and pediatric pneumococcal conjugate vaccines. Since 2017, Dr. Buchwald has focused on pneumococcal disease prevention in various roles at Merck. Dr. Buchwald received her MD and Dr. med degree from the Freie University in Berlin, Germany, and completed her Internal Medicine residency and Infectious Diseases fellowship at New York University. She continues to see patients at Johns Hopkins University.Merck recently announced results from STRIDE-3, a Phase III trial evaluating the immunogenicity, tolerability and safety of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, which is specifically designed for the protection of adults against pneumococcal infection.In this episode, hear more about V116, pneumococcal infection, Merck’s vaccine development program and the company’s approach to addressing the specific needs of different populations, including infants and children, adults and at-risk subgroups.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

A Focus on Men’s Health — Conversation with Fady Boctor, Petros Pharma President and CCO

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

“Off-the-Shelf” Cellular Therapy: Interview with Longeveron CEO Wa’el Hashad

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

Attorney Tope Leyimu Discusses Proposed FDA ban on Hair Relaxer Products Containing Harmful Chemicals

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

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