Xtalks Life Science Podcast

Discussing Next Generation Chemotherapy Drugs with Processa Pharma’s Dr. David Young

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 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

More US States Take on Eli Lilly in Court Over Proposed Insulin Pricing Settlement + Regeneron’s High Dose Eylea Wins FDA Approval

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 SettlementRegeneron’s High Dose Eylea Gets FDA Nod for Wet AMD and DMEFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

Interview with BriaCell’s CEO Dr. William Williams

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 MediaTwitter: @Xtalks Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

First Oral Tablet for Postpartum Depression + Court Rejects JJ’s Latest Bankruptcy Attempt

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 AttemptFor more life science and medical device content, visit the Xtalks Vitals homepage.Follow Us on Social MediaTwitter: @XtalksInstagram: @XtalksFacebook: https://www.facebook.com/Xtalks.Webinars/LinkedIn: https://www.linkedin.com/company/xtalks-webconferencesYouTube: https://www.youtube.com/c/XtalksWebinars/featured

FDA Clearances for World’s Smallest Insulin Pump + New Cardiac Biomarker Test

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 ClearanceNew Cardiac Biomarker Test Gets 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

In Conversation with Principal Investigator and SME Dr. Lawrence Eichenfield About the FDA Approval of a Drug-Device Combo for Common Skin Infection

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.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

Point-of-Care Testing for Infectious Diseases: Senzo CEO Jeremy Stackawitz Speaks About Company’s New Lateral Flow Technology

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 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

Biosimilars and the Problem with PBMs: Interview with Juliana M. Reed, Executive Director of the Biosimilars Forum

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. 110For 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

Opioid Use Disorder and Brixadi Approval: Interview with Dr. Joshua Cohen, Chief Medical Officer at Braeburn

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 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/featuredSocial Post:

Developing More Affordable Cellular Immunotherapies: Interview with CytoMed Therapeutics

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 InnovationFor 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