Explorez tous les épisodes du podcast Xtalks Life Science Podcast

In this episode, Ayesha spoke with Joshua Cohen and Justin Klee, co-CEOs and co-founders of Amylyx Pharmaceuticals, a company developing therapeutics for neurodegenerative diseases like amyotrophic lateral sclerosis (ALS).

Josh and Justin co-founded Amylyx Pharmaceuticals in 2013. Josh co-invented the oral, fixed-dose combination AMX0035 (known commercially as Albrioza in Canada and Relyvrio in the US), which is being explored for the potential treatment of neurodegenerative diseases. With a background in biomedical engineering, Josh is passionate about improving outcomes where there is a significant unmet need by pursuing research into novel drug candidates for ALS and other neurodegenerative diseases.

Justin previously conducted research in neural systems in the Moore lab at Brown University and in neurophysiology and Alzheimer’s disease under Dr. Rudolph Tanzi, founding member of Amylyx’ Scientific Advisory Board, at Harvard Medical School to explore new approaches to treating relentlessly progressive neurodegenerative diseases.

In 2020, Josh and Justin were named to Business Insider’s 30 Under 40 in Healthcare list and PM360’s ELITE in the Drug Researchers and Developers category among the many other awards they have won throughout their careers thus far.

Josh and Justin have overseen the growth of Amylyx from its start as a concept dreamed up in a dorm room at Brown University to a global, commercial stage and publicly traded pharmaceutical company hundreds of employees and headquarters in the US, Canada and the Netherlands to support Amylyx’s global operations.

Josh and Justin led the global regulatory approvals of AMX0035 for the treatment of ALS in Canada and the US. In April, Amylyx decided to remove the drug from the US and Canadian markets based on data from a confirmatory trial.

Tune into the episode to learn more about Amylyx’s plans for AMX0035, which include investigations in progressive supranuclear palsy (PSP) and Wolfram syndrome.

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In this episode, Ayesha spoke with Howard McLeod, PharmD, Director of the Center for Precision Medicine and Functional Genomics, Professor of Pharmacy and Medicine at Utah Tech University and Precision Medicine Advisor at the Geriatric Oncology Consortium; and Sharmeen Roy, PharmD, Chief Strategy and Science Officer at DoseMe, which is the world’s first and largest Bayesian dosing platform designed for clinical practice.

Precision dosing, also known as personalized dosing, aims to tailor drug dosages to the individual characteristics of each patient to achieve optimal therapeutic outcomes while minimizing adverse effects. It leverages various patient-specific factors, including genetics, age, weight, organ function and even lifestyle, to determine the most appropriate dosage for each individual. 

Dr. McLeod is an internationally recognized expert in precision medicine, who has made novel contributions at the discovery, translation, implementation and policy levels. Dr. McLeod received his Doctorate in Pharmacy from the Philadelphia College of Pharmacy and Science and completed his Post-Doctoral Training at St Jude Children’s Research Hospital and the University of Glasgow. 

Dr. Roy is passionate about leveraging technology to amplify the impact of the pharmacist. Her career spans pediatric clinical pharmacy, clinical research and pharmacogenomics with leadership roles at University of Chicago Medical Center and PipelineRx. She received her Doctor of Pharmacy degree from the University of Illinois at Chicago, is a Board-Certified Pharmacotherapy Specialist and completed a Pediatric Specialty Pharmacotherapy Residency at Texas Children’s Hospital.

Tune into the episode to learn more about the current landscape of precision dosing, including the latest technologies and tools designed to help optimize drug dosages.

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In this episode, Ayesha spoke with Brian Atwood, Chairman and CEO of CERo Therapeutics, a company pioneering a new generation of autologous T-cell-based therapies for both hematologic and solid tumor cancers. 

Prior to joining CERo, Brian Atwood served as Chairman of the board of directors of Phoenix Biotech Acquisition Corp., which merged with CERo Therapeutics to form CERo Therapeutics Holdings, Inc. Mr. Atwood has founded and co-founded several biotechnology and healthcare-focused companies throughout his career, including Cell Design Labs Inc. where he served as President and Chief Executive Officer until 2018 when it was acquired by Gilead Sciences. He has also served as chairman on the board of directors of numerous biotech companies, including Immune Design Corp. (which was acquired by Merck in 2019), Veracyte and Five Prime Therapeutics among others. Mr. Atwood holds a BS in Biological Sciences from the University of California, Irvine, a MS in Ecology from the University of California, Davis and an MBA from Harvard Business School.

Tune into the episode to learn about CERo’s next-gen T-cell technology and its lead therapeutic candidate, a CER T cell product that contains a phagocyte receptor component. Hear about how it is being employed for AML, a blood cancer that remains among the most challenging cancers to treat. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/   Follow Us on Social Media

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In this episode, Ayesha spoke with Sam Lee, PhD, Co-Chief Executive Officer and President of Cocrystal Pharma, a company developing novel antiviral therapeutics against COVID-19 and other coronaviruses, influenza viruses and noroviruses.

Cocrystal Pharma leverages a unique structure-based drug discovery platform, complemented by Nobel Prize-winning expertise, to develop leading-edge antiviral drugs that are both first-in-class and best-in-class. Their antivirals specifically target the viral replication process and are designed for safety, broad-spectrum effectiveness, resistance management and ease of administration.

Dr. Lee brings over 25 years of experience in anti-infective drug discovery research to his role. Before joining Cocrystal, he spent eight years overseeing anti-infective drug discovery initiatives at Icos Corporation. During his tenure at Icos, Dr. Lee integrated protein crystallography and structural screening technologies into the company's research programs and was instrumental in the development of phosphoinositide 3-kinase (PI3K) delta inhibitors, leading to an FDA-approved product. 

Dr. Lee earned his PhD in Biological Sciences from the University of Notre Dame and completed his postdoctoral training in viral biochemistry at Stanford University. While at Stanford, he also established Viral Assays in Cupertino, CA, where he served as CEO.

Tune in to the episode to learn about Cocrystal Pharma’s structure-based drug discovery approach to developing next-gen antiviral treatments.

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In this episode, Ayesha spoke with John Finn, PhD, Chief Scientific Officer at Tome Biosciences, a company developing programmable gene insertion (PGI) technology.

PGI is a cutting-edge gene editing technology that allows for the insertion of large sequences of DNA with site-specific precision. PGI is a revolutionary approach for the development of potentially curative cell and integrative gene therapies. The technology underlies Tome’s investigational candidate therapeutics for autoimmune diseases and the rare metabolic disorder phenylketonuria (PKU) among other conditions.

Dr. Finn has over 20 years of experience in the gene therapy space with a focus on genome editing and delivery technologies. He was most recently Vice President of Discovery Research at Codiak Biosciences, where he led the development of a new class of therapeutics based on engineered exosomes. Prior to Codiak, Dr. Finn was Executive Director of Platform Biology and Liver Discovery at Intellia Therapeutics, where he was responsible for the development of viral and non-viral delivery systems and demonstrated the first in vivo systemic administration of CRISPR-based therapeutics. He has served as an American Society of Gene and Cell Therapy (ASGCT) Committee Member for multiple committees. Dr. Finn trained with Pieter Cullis and Ian MacLachlan and received his PhD in Biochemistry and Molecular Biology from the University of British Columbia.

Tune in to the episode to learn about Tome Biosciences’ innovative gene editing technology and lead therapeutic assets.

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In this episode, Ayesha spoke with Jeremy Levin, D. Phil, MB BChir, CEO and Chairman of Ovid Therapeutics Inc., and Meg Alexander, Chief Strategy Officer at Ovid.

Ovid Therapeutics is a biopharmaceutical company focused on the development of medicines for epilepsies and seizure-related neurological disorders.

Prior to founding Ovid, Dr. Levin was president and CEO of Teva Pharmaceutical Industries and a member of the executive committee at Bristol-Myers Squibb (BMS) Company where he was the architect, lead and implementer of the String of Pearls Strategy, which transformed BMS and facilitated the initiation and massive growth of the immuno-oncology revolution in the biopharmaceutical industry. 

Dr. Levin also serves on the board and executive committee of the Biotechnology Innovation Organization (BIO) as the immediate past chairman. Dr. Levin was voted as one of the 25 most influential biotechnology leaders by Fierce Biotech, one of the top three biotechnology CEOs by The Healthcare Technology Report and one of the PharmaVoice100 CEOs in 2020 and 2021. He was selected by Endpoints in 2021 as one of the 60 living pioneers of the industry, and has received several awards throughout his career. Dr. Levin has practiced medicine at university hospitals in England, South Africa and Switzerland. 

Meg Alexander serves as Ovid’s chief strategy officer, a role in which she oversees and supports the company’s corporate strategy and planning, performance measurement and risk mitigation. She also oversees the company’s corporate affairs function with a focus on engaging Ovid’s stakeholders across patient and caregiver communities, policymakers, press and investors.

Ms. Alexander has worked in the biopharmaceutical industry for two decades and has played a key role in launching more than 25 new medicines for many conditions including rare epilepsies, ALS, HIV, multiple sclerosis, Batten’s disease, cardiovascular disease and cancer. She has advised and led campaigns for large healthcare organizations, including Pfizer, Novartis, Amgen, Eli Lilly, Nestle and Coca-Cola among many others. Prior to Ovid, she founded and led the Reputation & Risk Management Group, a consultancy within Syneos Health, one of the world’s largest clinical research organizations. Ms. Alexander was named a “Disruptor” and a “Rising Star” in her industry by PM360 and the Healthcare Business Women’s Association, respectively.

This year, OVID is expecting several CNS data readouts, including one for its lead product candidate soticlestat, which is currently in Phase III trials for the treatment of refractory seizures in Lennox-Gastaut syndrome and Dravet syndrome, a rare epilepsy with high unmet need.

Tune in to the episode to learn more about Ovid Therapeutics’ developmental pipeline featuring treatments for epilepsies and seizures associated with rare brain conditions. 

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In this episode, Ayesha spoke with William Schaffner, MD, Professor of Preventive Medicine Health Policy and Professor in the Division of Infectious Diseases at Vanderbilt University; and Kelly Moore, MD, MPH, President and CEO at Immunize.org and Associate Professor of Health Policy at Vanderbilt University.

Dr. Schaffner and Dr. Moore discussed the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation of a trivalent influenza vaccine strain selection, as opposed to a typical quadrivalent vaccine, with the 2024/2025 influenza season reflecting the removal of the B/Yamagata strain. 

A renowned infectious disease expert, having appeared on numerous media outlets including CNN particularly during the COVID-19 pandemic, Dr. Schaffner’s primary interest has been the prevention of infectious diseases domestically and globally in both pediatric and adult populations. After residency training and a fellowship in infectious diseases at Vanderbilt University, Dr. Schaffner served in the US Public Health Service as an epidemic intelligence service officer with the Centers for Disease Control and Prevention (CDC) in Atlanta. After that tour of duty, Dr. Schaffner joined the faculty at Vanderbilt, establishing a long collaboration with the Tennessee Department of Health. Dr. Schaffner has been a member of numerous expert advisory committees that established national vaccine policy. Dr. Schaffner is also the current medical director and past president of the National Foundation for Infectious Diseases and has served on the executive board for the Infectious Diseases Society of America. 

Prominent infectious disease expert Dr. Moore served for 14 years as the director of the Tennessee Immunization Program and later founded her own consulting company, The Vaccine Advisor, to advise public health and industry before her current role as president and CEO of immunize.org, a leading nonprofit organization focused on national and global vaccine policy and immunization program implementation. Dr. Moore has served in a variety of immunization policy advisory roles with the World Health Organization (WHO) since 2016, including as chair of its Immunization Practices Advisory Committee. Dr. Moore is a graduate of the Vanderbilt School of Medicine and the Harvard School of Public Health. She completed her public health leadership training as an epidemic intelligence service and preventive me

In this episode, Ayesha spoke with Robert Barrow, CEO and Board Director at MindMed, a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. 

The company is developing innovative psychedelic-based product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.

Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. After joining MindMed as Chief Development Officer in January 2021, he was named CEO in June 2021. Mr. Barrow has a Masters degree in Pharmacology from The Ohio State University and a Bachelor of Science degree from Wake Forest University, where he graduated summa cum laude and is a CFA charterholder.

Last month, MindMed received FDA Breakthrough Therapy Designation for its MM120 (lysergide d-tartrate) program for the treatment of generalized anxiety disorder (GAD).

The company also announced that a Phase IIb study of MM120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity.

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In this episode, Ayesha spoke with John K. Celebi, MBA, President & Chief Executive Officer, Sensei Bio, a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients. Sensei Biotherapeutics specializes in creating conditionally active antibodies. These are engineered to operate specifically within the tumor microenvironment, enhancing the immune system's ability to combat cancer. John Celebi, MBA, has over 25 years of experience building innovative entrepreneurial biotechnology companies. Mr. Celebi currently serves on the Board of Directors of Egle Therapeutics SAS, a biotechnology company developing first-in-class immunotherapies targeting immune suppressor regulatory T cells (Tregs) for oncology and autoimmune diseases. Mr. Celebi received an MBA from Carnegie Mellon University and a BS in biophysics from the University of California, San Diego. Tune into the episode to learn more about Sensei Bio’s mission and therapeutic approach.    For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/   Follow Us on Social Media

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In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics, a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. 

Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business. His experience offers him a unique combination of business acumen and scientific credibility with the ability to assess, quantify and bridge both disciplines.

Dr. Berman gained corporate experience with increasing responsibilities and positions as a Medical Science Liaison at AbbVie where he spent 7.5 years launching Venetoclax in CLL and later, supporting numerous solid tumor assets. He also served in leadership roles at Novartis Pharmaceuticals and Eli Lilly.

Dr. Berman received a Bachelor in Biology from the University of Michigan and a Masters and PhD in Neuroscience and Pharmacology from Weill Cornell Medical School.

Tune into the episode to learn more about Coya Therapeutics and its Treg-targeted therapies program. The company’s current pipeline includes its lead candidate product COYA 302, which is currently being evaluated in a clinical study for the treatment of amyotrophic lateral sclerosis (ALS).

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In this episode, Ayesha spoke with Margaret Froh, President of the Métis Nation of Ontario (MNO). Margaret is also a lawyer by training.    The Métis are a distinct Indigenous people recognized in s.35 of Canada’s Constitution. Métis communities have their own shared customs, traditions and collective identities that are rooted in kinship, their special aboriginal relationship to the land and a distinctive Indigenous culture and way of life that persists to the present day.    Cancer is a significant concern among Métis people in Ontario and across the Métis Nation Homeland, including women, as they experience higher cancer rates and lower cancer screening uptake than the non-Indigenous population.    Cancer Prevention Action Week, which took place during the third week of February, focuses on supporting and empowering people to make changes to their lifestyle and promoting routine cancer screening to reduce the risk of preventable cancers.    To help uncover and address cancer disparities among the Métis, Margaret has helped lead Métis-specific health research in collaboration with organizations like Ontario Health (formerly Cancer Care Ontario) and the Sunnybrook Research Institute.    Margaret is also a recent breast cancer survivor and by sharing her personal cancer story, is helping raise awareness about the importance of routine cancer screening among the Métis.    Tune into the episode to learn about the disproportionate impact of cancer on Métis communities and how Margaret’s leadership at the MNO is helping to drive changes to help improve cancer screening rates and better health outcomes.    For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/   Follow Us on Social Media

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This episode features an interview with Bruce Culleton, MD, CEO, ProKidney, a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for chronic kidney disease. Prior to joining ProKidney in 2023, Dr. Culleton served as Vice President and General Manager at CVS Kidney Care and also worked in leadership roles at Becton Dickinson and Baxter healthcare. Before beginning his career in industry in 2007, Dr. Culleton was a Clinical Associate Professor in the Department of Medicine at the University of Calgary. ProKidney’s lead product candidate, REACT, is an investigational cell therapy designed to stabilize or improve kidney function in patients with chronic kidney disease with diabetes as the primary cause. The candidate is currently being evaluated in Phase II and Phase III clinical trials. To hear more about ProKidney’s cell therapy for chronic kidney disease, including developmental, manufacturing and regulatory considerations, tune into the episode. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/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 marking National Kidney Month, this episode features an interview with Robert Perkins, MD, Vice President, US Medical Affairs (Renal) at Bayer who spoke about kidney health and diabetes-inflicted chronic kidney disease. National Kidney Month is observed every March in the US to raise awareness about kidney health and promote preventive action. It aims to educate the public about the importance of kidneys to overall health and the risk factors for kidney disease, a major one being diabetes. At Bayer, Dr. Perkins is the strategic lead for a team of 8 HQ-based medical directors and a 40-member field medical team. He is responsible for evidence portfolio across two therapeutic indications, chronic kidney disease and heart failure, encompassing seven active trials and studies and more than 3,000 US patients. Dr. Perkins has also led the development and implementation of innovative digital educational outreach campaigns for primary care physicians. In previous roles, Dr. Perkins helped build and develop medical teams at Novartis and AstraZeneca. Last year, the American Diabetes Association (ADA) updated their standards of care guidelines for 2024, which outline strategies for diagnosing and treating diabetes (both type 1 and type 2) and outline methods of preventing and delaying type 2 diabetes as well as associated comorbidities like cardiovascular disease and chronic kidney disease. Tune into the episode to hear Dr. Perkins’ insights about current advancements and challenges in tackling chronic kidney disease, the updated ADA guidelines and how a comprehensive approach to treating diabetes is necessary for reducing the risk of kidney complications. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 featured episode of Xtalks People in Life Sciences, Ayesha spoke with Ashish Jain, Senior Director of Clinical Safety and Pharmacovigilance (PV) at Curis, a pioneering biotech company specializing in cutting-edge cancer therapies. Jain shared his journey into clinical safety and PV, highlighting key milestones along the way. Delving into his daily routine at Curis, he revealed his strategies for prioritizing tasks and staying informed of the latest developments in PV. Throughout the interview, Jain offered invaluable insights into career advancement in clinical safety and PV. He emphasized the indispensable skills and competencies vital for success in the field. Jain also discussed common challenges faced by PV professionals and suggested practical solutions. Aspiring professionals seeking to kickstart their careers in clinical safety and PV will find Jain’s insights informative. He provides actionable recommendations for gaining hands-on experience and navigating the PV landscape. Furthermore, Jain shares his expertise in establishing a PV department, particularly for emerging biotech firms. He outlines critical considerations for setting up an efficient PV system, especially in resource-limited environments. Listeners can also hear Jain’s thoughts on emerging trends in PV and his insights on how PV professionals can proactively prepare for the future. Tune in to this episode for a glimpse into the field of clinical safety and PV with Ashish Jain. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 spoke with Jordyn Playne, President of the Métis Nation of Ontario Youth Council, a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level. Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention. Jordyn has a Master’s degree in social work and licenses/certifications in cognitive behavioral therapy. To mark Cancer Prevention Action Week, which took place during the third week of February, Jordyn also shared a personal story to help raise awareness about the importance of cancer prevention, particularly among Indigenous communities like the Métis. Cancer is a significant concern among Métis people, including women, as they face higher cancer rates than the non-Indigenous population. Jordyn describes herself as a cancer “previvor,” as she took preventative action to reduce her risk of breast cancer. Tune into the episode to learn more about Jordyn’s story and her work in helping to improve health awareness and health outcomes among Métis youth and the greater Métis Nation. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 spoke with H. B. Pierre Simon Jr., MBA, Vice President, Global Head of Marketing, Sight Sciences, about the evolving field of eye care. Sight Sciences is focused on developing and commercializing innovative solutions for eye diseases like glaucoma and dry eye disease to transform care and improve patients’ lives. Among some of Sight Sciences devices and technologies include the OMNI® Surgical System, a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The company’s other notable product is the TearCare® System, which has FDA clearance for localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), the leading cause of dry eye disease. Pierre has been in the eye care industry for almost two decades. Prior to Sight Sciences, he was at Alcon for 15 years in roles with increasing responsibility, including Senior Product Manager, Global Franchise. Pierre is also a life influencer and two-time best-selling author. His latest book is entitled ‘Down Thru Love,’ a story about the journey of a young man born with Down syndrome. In the episode, Pierre discusses some important considerations in the development of innovative new treatments for eye conditions like glaucoma and dry eye, such as working with patients and doctors and having an awareness of both current and future needs. Hear more about Pierre’s work at Sight Sciences and also as an author and speaker. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Rare Disease Day 2024, a global movement held on the last day of February each year that focuses on raising awareness about rare diseases including their impact on patients’ lives. This year, Rare Disease Day falls on February 29, the rarest day in a leap year, making it even more special. Ayesha spoke about how the Rare Disease Day campaign helps increase awareness about rare diseases, promotes research and development, supports advocacy for policies supporting patients and their families and brings together a global rare disease community. Advancements in rare disease research are leading to innovative new treatments for various rare conditions, including genetic disorders, which make up just over 70 percent of all rare diseases. Hear more about new rare disease drugs approved by the FDA in the past couple of years. Also hear about some of the latest trends in rare disease research, including innovative trial designs, patient-centric approaches, the use of cutting-edge technologies like AI and international collaborations. Read the full articles here: Rare Disease Day 2024: Highlighting Statistics and Patient Stories New Rare Disease Drugs and Research Advancements For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Amir Reichman, CEO of Scinai Immunotherapeutics, a biopharma company focused on developing, manufacturing and commercializing cutting-edge biological treatments within the inflammation and immunology (I&I) sector, with a primary focus on addressing autoimmune and infectious diseases. Scinai Immunotherapeutics is working on developing nanosized antibodies from alpacas, known as VHH-antibodies or NanoAbs, which show promise as improved biological therapies for various illnesses. These NanoAbs are being tailored to treat conditions with significant unmet medical requirements and promising market prospects, including psoriasis and asthma. Prior to being appointed as Scinai’s CEO in 2021, Mr. Reichman recently held the position of Head of Global Vaccines Engineering Core Technologies and Asset Management at the GSK Vaccines headquarters in Belgium. Before that, he was the Senior Director of the Global GSK Vaccines Supply Chain. He became part of GSK in 2015 following its acquisition of Novartis Vaccines, where he had various leadership positions with growing responsibilities within the Global Vaccines Supply Chain Management team, based in Holly Springs, NC, USA. Tune into the episode to hear more about the development of new, cutting-edge inflammation and immunology therapies. Mr. Reichman also shares insights into the most significant trends currently shaping the inflammation and immunology sector. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, chief financial officer at OncoC4, a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4. OncoC4 is a spinout of OncoImmune, which was acquired by Merck in December 2020. OncoImmune was founded in 2000 based on the scientific discoveries of the company’s founders who moved their lead product from a basic concept into clinical trials for multiple indications. Dr. Liu is recognized internationally for his research on immune recognition of cancer and activation of lymphocytes. He has received several academic and research awards including the Snyder Award for Cancer Research in 2015, and was elected to the rank of fellow at the American Association for Advancement of Science (AAAS) in 2004 for his pioneering contribution to innate immunity, T cell costimulation and cancer immunology. Prior to serving full-time as OncoC4’s CEO, Dr. Liu was a faculty member at multiple academic institutions, including New York University and the Ohio State University. Abid Ansari is a finance executive with a more 20-year track record in the life sciences industry encompassing corporate finance, fundraising, business development and investor relations experiences for public and private life science companies. Previously, he served as CFO of Artios, a UK-based DNA damage response company where he led the company’s $153 million Series C fundraising. Earlier in his career, Abid held positions at GlaxoSmithKline (GSK) in deal finance and portfolio management. Tune into the episode to hear more about the development of new, cutting-edge cancer treatments, including current challenges in oncology and immunotherapies. Also hear about OncoC4’s collaborations including a co-development commercialization partnership with BioNTech on its lead product and a collaboration with Merck. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Carlos Doti, MD, Vice President, US Medical Affairs Oncology, AstraZeneca, about new breast cancer treatments. Dr. Doti is a hematologist by training and is passionate about developing treatments that have a real impact for people living with cancer across every aspect of their disease. Dr. Doti has worked in industry for the last 14 years, including seven years at AstraZeneca in various roles, and in small markets like Argentina as well as larger global markets. Since 2022, Dr. Doti has been focusing on the US market in hematology and oncology, working in breast, lung, GI and gynecological cancers among others.

Dr. Doti has previously served in medical affairs roles at Novo Nordisk A/S and Pfizer. His work is supported by more than 70 congress presentations and several peer-reviewed publications. He has also served as an investigator in more than 25 clinical trials in hemostasis, onco-hematology and infectious disease.

Recently, AstraZeneca won approval for the company’s AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN). The approval of Truqap was the first-in-class approval for AstraZeneca. Tune into the episode to hear more about the milestone approval of the new combination breast cancer treatment, which has been a much-needed treatment option for the nearly 50 percent of patients with advanced HR-positive breast cancer who have PIK3CA and AKT1 mutations or PTEN alterations, and experience resistance to first-line treatments such as endocrine therapies and CDK 4/6 inhibitors. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Punit Dhillon, Chairman & CEO of Skye Bioscience, a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development. Punit brings two decades of experience as a leader and investor within the life sciences sector. During the interview, he shared his journey leading up to his role at Skye Bioscience and how his previous experiences have shaped his vision for the company. During the interview, Punit discussed Skye Bioscience’s mission and therapeutic approach. The company is aiming to unlock the medicinal possibilities of the endocannabinoid system for addressing diseases that lack adequate treatments for patients globally. At the end of the interview, Punit shared some advice for those looking to venture into the biotech and pharmaceutical industry. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 some of the trends in the life sciences to watch out for in 2024. From the increasing integration of artificial intelligence (AI) and machine learning (ML) tools in drug development to medically accurate health wearables, hear about the trends and innovations that will be shaping the life sciences this year. Ayesha spoke to industry experts and innovators in the pharmaceutical, biotechnology and medical device spaces to learn more about these trends and more. Hear about the latest technologies and approaches that will help drive innovations in drug discovery, clinical research and medical device design this year. Read the full article here: Life Science Trends to Look Out for in 2024 For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics, a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. Ben is an engineer by training and prior to joining Monogram, he served as the Director of Business Development at Pro-Dex, an OEM manufacturer of Orthopedic Robotic End-Effectors. At Pro-Dex, Ben was responsible for the development, management and launch of a proprietary product solution, helping to negate a distribution agreement with a major strategic partner. Monogram is working to develop tailored orthopedic solutions that can help reduce complications associated with orthopedic procedures such as knee replacement surgery. In this episode, hear about Monogram Orthopedics’ customized implants, which facilitate minimal processing and coordination time for orthopedic joint replacements, and how the company is going up against big industry names like Stryker and its market-leading Mako robot as well as Zimmer Biomet. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 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 Media Twitter: @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 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 Media Twitter: @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 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 Media Twitter: @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 Media Twitter: @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 Media Twitter: @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 Media Twitter: @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-Administration GSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and Old For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Media Twitter: @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 Media Twitter: @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 Breach Sleepiz’s At Home Sleep Monitoring Device Wins FDA Clearance For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Media Twitter: @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 Media Twitter: @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 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 Media Twitter: @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. 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 Media Twitter: @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 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 Media Twitter: @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. David Young, founder and President R&D at Processa Pharmaceuticals, a clinical-stage pharmaceutical company developing personalized approaches to cancer treatments with a focus on next generation chemotherapy drugs with improved safety and efficacy. Processa recently released an update on its clinical cancer program, which Dr. Young discussed with Xtalks in this podcast episode. Dr. Young is Processa’s initial founder, President of R&D and former President and CEO. He has over 30 years of pharmaceutical research, drug development and corporate experience. He served on the Board of Directors and as Chief Scientific Officer of Questcor Pharmaceuticals from 2009 to 2014. He has also served on FDA Advisory Committees and has been a key team member on more than 30 NDA/supplemental NDA approvals. Dr. Young received his Pharm D-PhD with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California. Tune into this episode to hear from Dr. Young about Processa’s developmental pipeline and the promise of personalized, next generation chemotherapies. Learn about Processa’s regulatory science approach to drug development and the changing landscape of cancer treatment. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 how three more US states have filed a lawsuit against Eli Lilly over its proposed $13.5 million insulin pricing settlement. The states join six others who have been fighting Eli Lilly in court since 2017, claiming that the company hiked prices of its insulin product Humalog. The states say the $13.5 million settlement offer from Eli Lilly doesn’t come close to the $1 billion worth of claims the company is facing. Hear more about the insulin pricing controversy in this episode. Ayesha also talked about the FDA approval of Regeneron’s high dose Eylea (HD Eylea) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Hear about how high dose Eylea offers less frequent dosing regiments, and how it will be facing Roche’s blockbuster eye injection Vabysmo. Read the full articles here: More US States Take on Eli Lilly in Court Over Proposed $13.5 Million Insulin Pricing Settlement Regeneron’s High Dose Eylea Gets FDA Nod for Wet AMD and DME For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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. William Williams, CEO of Briacell Therapeutics, a biotech company based in Philadelphia that is dedicated to developing novel immunotherapies to fight cancer and improve patient lives. Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies like Incyte Corporation and GlaxoSmithKline. Dr. Williams has facilitated the entry of over 20 compounds into the clinic, including approvals for ruxolitinib (Jakafi) and baricitinib (Olumiant). BriaCell is developing cell therapies for the treatment of advanced breast cancer and has promising compounds, including Bria-IMT, that are currently being evaluated in clinical trials. BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer. Tune into this episode to hear from Dr. Williams about BriaCell’s novel cell therapies for cancer and what the future of immunotherapy and personalized treatments may look like. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 Zurzuvae (zuranolone) the first oral tablet for the treatment of postpartum depression (PPD). While the approval is a major win in PPD, as current treatments involve administration by infusion or use of general antidepressants, Zurzuvae developers Biogen and Sage Biotech were banking on getting approval for it in major depressive disorder (MDD). However, the FDA rejected it in MDD and only handed the approval in PPD. Hear more about the drug and the approval/rejection in this episode. Ayesha also talked about Johnson & Johnson’s latest bankruptcy attempt related to its talc baby powder cases that was shot down by a US Bankruptcy Court. The company said it will appeal the decision as it continues to offer talc claimants a $8.9 billion settlement, which it says is the best way to resolve the cases in a timely and financially equitable manner. This is the company’s second bankruptcy attempt, both of which have been turned down so far. Listen to the full episode to learn more about Johnson & Johnson’s ongoing legal saga. Read the full articles here: Zurzuvae Earns Win for Postpartum Depression, Faces Challenges in MDDTalc Litigation Saga Continues: Court Rejects J&J’s Latest Bankruptcy Attempt For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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 clearance of the world’s smallest insulin pump from Tandem Diabetes Care. The insulin pump, called the Tandem Mobi, features an automated insulin delivery system with options for manual delivery as well. The device is small enough to fit into the coin pocket of a pair of jeans and offers several wearable options. It can be operated through an app and also features technology compatible with continuous glucose monitoring systems. 

Ayesha and the team also discussed the FDA clearance of the first FDA cleared NMR-based test from Numares Health. The company’s AXINON test system measures levels of low density lipoprotein particle (LDL-p), which the company touts as being a more robust biomarker than LDL-cholesterol (LDL-c) for evaluating cardiovascular disease risk. Hear more about the test, including some of its other disease applications, in this episode.  

Read the full articles here:

Tandem Mobi Becomes World’s Smallest Insulin Pump with FDA Clearance

New Cardiac Biomarker Test Gets FDA Clearance

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Dr. Lawrence Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego, and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine. 

Dr. Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children. Dr. Eichenfield was also the principal investigator on clinical trials evaluating YCANTH.

Verrica Pharmaceuticals is a dermatology therapeutics company developing medications for skin diseases that require medical interventions. 

Tune into this episode to learn more about YCANTH and its approval, as well as the changing landscape of dermatology, from Dr. Eichenfield.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Jeremy Stackawitz, CEO at Senzo, a London-based MedTech company that has developed a new lateral flow technology for infectious diseases with the same accuracy as central labs testing. Jeremy, who was formerly at companies like Quotient and Johnson & Johnson, discussed how the development of this technology can unlock new models of care such as personalized, preventative and remote healthcare. Senzo’s products and systems bring testing to the patient, allowing for the generation of results that are as accurate as traditional central-lab testing, but faster and at the point-of-care. Senzo says it has started off by targeting diseases with some of the highest global impacts, such as TB, HIV, Flu, Covid, Hep-C and C. diff and plans to move to other viruses and biomarkers. Hear more about how Senzo is working towards its goal to make lab testing accuracy readily available at the point-of-care, real-time, accessible and affordable. Insights generated at the point-of-care will allow patients and healthcare professionals to make better and faster decisions, improving treatment outcomes and saving lives. For more life science and medical device content, visit the Xtalks Vitals homepage. Follow Us on Social Media Twitter: @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

Uptake of biosimilars is lagging in the US, but why? In this episode, Sarah interviews Juliana M. Reed, Executive Director of the Biosimilars Forum, to find out the real barriers to widespread access to biosimilars, and how these problems could be addressed.

Julie discusses the role of pharmacy benefit managers (PBMs) and the incentives that keep them from listing most biosimilars on their formularies. She applauds the recent launch of multiple new biosimilars for the blockbuster biologic Humira and explains why this moment is pivotal for the biosimilars industry and the US healthcare system as a whole. 

Mentioned during this episode:

Interview with Dr. Gillian Woollett, VP, Head of Regulatory Strategy and Policy at Samsung Bioepis – Xtalks Life Science Podcast Ep. 110

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In this episode, Sarah interviews Dr. Joshua Cohen, Chief Medical Officer at Braeburn, who talks about the stigma associated with opioid use disorder (OUD), and how our treatment of this condition is changing.

Dr. Cohen talks about the recent FDA approval of Brixadi, the first long-acting buprenorphine treatment for opioid use disorder that has both weekly and monthly dosing options, and explains the technology behind its extended-release formula.

Read the full article here:

Brixadi Is a New Long-Acting Buprenorphine Treatment Against OUD 

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In this episode, Vera interviews two experts from CytoMed Therapeutics: Mr. Choo Chee Kong, Chairman and Director; and Dr. Tan Wee Kiat, PhD, Chief Operating Officer.

Established in 2018, CytoMed is a biotechnology firm that originated from the Agency for Science, Technology and Research (A*STAR), Singapore's premier public sector research and development agency. The goal of CytoMed is to develop efficient and cost-effective cellular immunotherapy solutions for solid tumors and hematologic cancers.

On April 14, 2023, CytoMed’s shares began trading on the Nasdaq Capital Market under the ticker symbol "GDTC".

In this episode, Mr. Choo and Dr. Tan share insights about how CytoMed Therapeutics is aiming to engineer more affordable cellular cancer therapies. Dr. Tan discusses the advantages of “off-the-shelf” cell-based cancer immunotherapies. Mr. Choo describes the cellular therapies that are currently in CytoMed’s pipeline. 

The episode concludes with Mr. Choo and Dr. Tan sharing their thoughts about how the company’s initial public offering (IPO) will help them in their mission of developing off-the-shelf cell-based cancer immunotherapies.

Read the full article that mentions CytoMed Therapeutics here:

Biotech IPOs in 2023: Shaping the Future of Innovation

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This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. 

Hormone replacement therapy (HRT) has been the conventional treatment for menopause-associated vasomotor symptoms, otherwise known as hot flashes and night sweats; however, not all women can receive hormone therapies. Apart from HRT, treatment options have been limited for the vasomotor symptoms of menopause and therefore, the approval of Veozah addresses a significant unmet need in the space. 

Hear more about Veozah, including its mechanism of action and the pathways to its approval.

Read more at: Veozah (Fezolinetant) Is a New Type of Drug for Menopausal Hot Flashes

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In this episode, Vera interviews Dr. Grayson Zulauf, CEO and Co-Founder of Resonant Link, about the state of wireless charging for medical device implants today. Dr. Zulauf shares why improvements are needed for faster wireless charging.  

Dr. Zulauf also shared insights into Resonant Link’s latest and the world’s fastest charger for titanium can-based medical device implants. He discussed the impact of this charger on patient care and quality of life. In addition, Vera and Dr. Zulauf discussed the work Resonant Link is doing in other industries, such as electric vehicles and consumer electronics. The episode concluded with Dr. Lulauf sharing what’s next for Resonant Link.

Read the full article here:

Resonant Link Develops Fastest Wireless Charger for Implantable Devices

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