Podcasts about clinical development

As far as healthcare conferences go, the American Society of Clinical Oncology (ASCO) annual meeting is the top of the crop.Every year, thousands descend on Chicago for days worth of oncology-focused presentations, data readouts and industry-shaping news. Ahead of ASCO this weekend, Eisai's Dr. Corina Dutcus speaks with Pharma Editor Lecia Bushak to preview the annual oncology megaconference.Additionally, we dive into some data from the upcoming 2025 MM+M Agency 100 list, namely the representation of women at the C-suite level of leading medical marketing agencies. Also, don't forget to register to attend the 2025 Women of Distinction event on June 3 in New York. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.

Malaikannan Sankarasubbu (Chief Technology & AI Officer, Saama) and Jonathan Shough (Chief Information Officer, Parexel) join this week's episode to discuss how the strategic use of AI technologies is transforming clinical development. They dive deeper into which advancements in generative AI have the potential to improve the clinical trial workflow, the integration of AI and predictive analytics in risk assessment processes, and the importance of strong change management strategies when implementing new AI technologies.

May 20, 2025 ~ A new FDA-approved blood test, the Shield test, is available for colon cancer screening for people 45 and older. Guardian VP of Clinical Development, Dr. Sam Asgarian, talks with Lloyd, Jamie, and Chris about this alternative test to traditional methods and simplifying the screening process.

Send us a textDr. Mirza Rahman, MD, MPH serves as the President of the American College of Preventive Medicine ( ACPM - https://www.acpm.org/about-acpm/governance/executive-officers/mirza-rahman/ ), a professional community, founded in 1954 as a professional community for board-certified physicians to network, share their expertise and advocate for the advancement of prevention. Today, ACPM represents over 2,000 physicians, medical students, non-physicians, and other partners. All believe in the importance of preventive medicine in our society. Dr. Rahman also serves as the Senior Vice President, Patient Safety & Pharmacovigilance at Cybin ( https://cybin.com/our-team/ ), a pharmaceutical company seeking to bring novel, second-generation psychedelics to market. He also and is a Co-Founder and President of the Guyanese Diaspora Charity ( https://www.guyanesediasporacharity.org/ ), a 501(c)(3) non-profit organization focused on helping to improve the lives of Guyanese. In addition, Dr. Rahman is an Adjunct Associate Professor of Epidemiology at Columbia University ( https://www.publichealth.columbia.edu/profile/mirza-i-rahman-md ) and as an Adjunct Associate Professor at the University of Guyana.Most recently, Dr. Rahman was the Vice President & Chief Safety Officer at Organon, a global healthcare company. There, he was responsible for leading and setting the broad strategic direction for pharmacovigilance for this multinational company.Prior to that, Dr. Rahman was the Senior Vice President, Chief Global Pharmacovigilance Officer & European Research & Development Lead at Otsuka Pharmaceuticals, a global Japanese based pharmaceutical company. In 2013, he created the ACPM - Otsuka Pharmacovigilance Physician Program in Global Medical Safety. Dr. Rahman joined Otsuka from Merck Research Laboratories, where he was an Executive Director in the Clinical Risk Management/Global Safety department. Before this, he worked at Johnson & Johnson in a variety of positions, serving as a Worldwide Vice President, Health Economics & Reimbursement at Ortho-Clinical Diagnostics in his last role there.During his 25+ years in the pharmaceutical industry, while Dr. Rahman has worked primarily in Pharmacovigilance, he has also worked in Medical Affairs, Medical Information, Health Economics and Outcomes Research, Quality Management, Clinical Development, Manufacturing, and Regulatory Affairs.Dr. Rahman completed his Public Health & General Preventive Medicine Residency along with his Family Medicine Residency at Stony Brook University. He completed the Advanced Management Program at the Columbia Business School and earned his Master of Public Health degree from the Columbia University School of Public Health. Dr. Rahman earned his Doctor of Medicine degree from the Stony Brook University School of Medicine, and his Bachelor of Science degree from the Sophie Davis School of Biomedical Education at the City College of the City University of New York. #MirzaRahman #AmericanCollegeOfPreventiveMedicine #PatientSafety #Pharmacovigilance #GuyaneseDiasporaCharity #Epidemiology #ColumbiaUniversity #UniversityOfGuyana #MedicalAffairs #HealthEconomics #OutcomesResearch #QualityManagement #ClinicalDevelopment #RegulatoryAffairs #PublicHealth #BrainHealth #DiabetesPrevention #ReducingHypertension #LifestyleMedicine #PopulationHealth #ViolencePrevention #Psychedelics #ProgressPotentialAndPossibilities #IraPastor #Podcast #Podcaster #Podcasting #ViralPodcast #STEM #Innovation #Science #Technology #ResearchSupport the show

Featuring perspectives from Dr Jonathan Goldman and Dr Natasha B Leighl, including the following topics: Introduction (0:00) Current Management of Nonmetastatic and Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) — Prof Leighl (1:42) Promising Novel Agents in Clinical Development; EGFR Exon 20 Mutation-Positive NSCLC — Dr Goldman (37:25) CME information and select publications

This week's newsmaker, Yukti Choudhury, Director of Clinical Development at HistoIndex, joins Roger Green to discuss FibroSIGHT, a new HistoIndex service that allows clinicians to use HistoIndex's Second Harmonic Generation (SHG) technology and analytics to determine specific CRN fibrosis level for patients with inconclusive NIT results.  One reason FibroSIGHT is worthy of attention: This is the first time an in-depth analysis of clinical trial biopsy results is being placed at the service of clinical treatment. Another reason: Yukti states that demand for this technique could equal 163,000 cases this year, rising to one million by 2028. The interview starts with Yukti sharing information on her own academic and commercial background and how she came to this role. She describes FibroSIGHT, a service that will provide a highly accurate CRN fibrosis level for patients whose NIT results suggest no clear or consistent finding. Yukti provides practical cues on ordering the test and its reimbursement. Roger shares his long-standing respect for SHG and the clarity it produces. He notes the economic benefit of determining whether a patient has F2 fibrosis, which is indicated for pharmacotherapy, vs.F1, which is not indicated. He sees clear benefit in this analysis. Roger goes on to express concern that any option requiring more biopsies will reduce the number of patients treated, particularly if having this tool encourages payers to require a biopsy as a prerequisite to treatment. He asks whether, over time, HistoIndex might be able to develop a companion analytic to improve these estimates without requiring biopsy. 

00:00:00 - Surf's Up: Season 6 Episode 3Surfing the MASH Tsunami continues its coverage of the AASLD Emerging Trends Conference on MASLD, MetALD and ALD. This week, the panelists focus on what studies on bariatric surgery and drugs in development can tell us about future treatment and explore some clinical trial questions. Our newsmaker, HistoIndex Director of Clinical Development Yukti Choudhury, introduces us to FibroSIGHT, which provides clinicians with highly precise biopsy analysis. Finally, our expert, Global Liver Institute Vice President, Liver Programs Jeff McIntyre, discusses the implications of recent US government job cuts on future MASH treatment options and patient care.00:04:35 - IntroductionHost Roger Green briefly describes this episode's three sections and one key lesson from each.00:05:45 - Roundtable: Highlights from the AASLD Emerging Trends Conference, Part 3This portion of our Emerging Trends Conference Roundtable looks at how therapy might evolve over time. Aleksander Krag starts by discussing a presentation on what we can learn from bariatric surgery in terms of fibrosis reduction and why pharmacotherapies work (or not). He envisions a day where we have multiple treatment options and understanding how each works for specific types of patients, leading to robust, cost-effective, patient-specific treatment algorithms.  Alex Lalos describes how presentations on FGF-21s in advanced fibrosis and cirrhosis have whetted his appetite and Jenn Jones asks questions regarding ALD patient trial selection and assignment and clinical endpoints for cirrhosis trials. 00:16:55 - Newsmakers: FibroSIGHT Brings Clinical Trial Analytics to Clinical Practice Use of BiopsyYukti Choudhury, Director of Clinical Development at HistoIndex, joins Roger Green to discuss FibroSIGHT, a new HistoIndex service that allows clinicians to use HistoIndex's Second Harmonic Generation (SHG) technology to determine specific CRN fibrosis level for patients with inconclusive NIT results.  Yukti states that demand for this technique could equal 163,000 cases this year and rising to one million by 2028. She provides practical cues on ordering the test and its reimbursement. Roger shares his long-standing respect for SHG and the clarity it produces. He notes the economic benefit of determining whether a patient has F2 fibrosis, which is indicated for pharmacotherapy, vs.F1, which is not indicated. He sees clear benefit, but expresses concern that any option requiring more biopsies will reduce the number of patients treated.00:41:49 - Patient Advocate and Policy Expert Jeff McIntyre Discusses the Implications of FA/NIH Job Cuts on MASLD Patient CareGlobal Liver Institute Vice President, Liver Programs Jeff McIntyre joins Roger to discuss the April 1 job reductions at the FDA, explore implications for the entire MASLD community, and to ask what patients can and should do. Jeff and Roger note that the job changes will create significant uncertainty and probably reduce the government's ability to respond to future health crises. Jeff notes former FDA Commissioner Rob Califf's comment that the FDA as we know it "is dead," and that we have little idea what the future holds. According to Jeff, patients need to become even more vigilant self-advocates and also seek the guidance and support they need from patient advocacies. Finally, the conversation turns to discuss FibroSIGHT. Jeff describes FibroSIGHT as "exactly where we should be and should not be at the same time," a technology that takes a large step forward in understanding and patient support, but one that ties us to biopsy as a standard for clinical care. Jeff and Roger agree this issue will play out over the coming years. 01:09:18 - Business ReportRoger thanks listeners quoting a letter from one of them, and describes the next round of episodes. 

OKYO Pharma CEO Gary Jacob joined Steve Darling from Proactive to share a significant advancement in the company's ongoing drug development efforts. The company has successfully demonstrated that urcosimod—formerly known as OK-101—remains stable for more than two and a half years in single-use ampoules, which are used for patient administration. This milestone is a crucial step forward in ensuring the long-term viability of the drug as it progresses through clinical trials. Urcosimod is currently being evaluated in a Phase 2b clinical trial, which is a randomized, placebo-controlled, double-masked study involving 48 patients. The trial is focused on assessing the drug's effectiveness in treating neurotrophic keratopathy (NCP), a serious and progressive degenerative eye disease. Jacob emphasized that achieving success in clinical development extends beyond obtaining positive clinical trial data. A crucial aspect of regulatory approval includes meeting the rigorous Chemistry, Manufacturing, and Controls (CMC) requirements set by the U.S. Food and Drug Administration (FDA). By demonstrating long-term stability, OKYO Pharma has strengthened its regulatory submission package, addressing an essential factor in the drug's future approval and commercialization. The company recently completed Good Manufacturing Practice (GMP) stability assay testing of single-use ampoules containing urcosimod in an ophthalmic solution. The results were highly promising—ampoules stored under refrigerated conditions maintained stability for over two and a half years, while initial three-month data from samples stored at room temperature showed potency levels at or above 100%. These findings reinforce confidence in urcosimod's shelf life and its potential for real-world clinical use. As OKYO Pharma continues to advance urcosimod through the regulatory and clinical development process, this stability milestone represents a critical achievement in its journey toward providing an effective treatment for patients suffering from NCP. #proactiveinvestors #okyopharmalimited #nasdaq #okyo

Widex has introduced the Widex Allure, a new hearing aid platform designed to enhance speech clarity and improve awareness in various listening environments. Featuring the W1 chip and 'Precision Hearing Technology', the platform focuses on delivering clearer speech while maintaining natural sound awareness. In this conversation with Shari Eberts, Dana Helmink, Doctor of Audiology and Senior Director of Clinical Development at Widex USA, and Søren Nielsen, President of WSA Wholesale US, offer their insights into the Widex Allure platform. Dana discusses how Widex is streamlining the adoption of new technologies for hearing professionals, while Søren reflects on the company's years of development in hearing technology and the ongoing efforts to refine and improve solutions for users. He also highlights the importance of balancing innovation with practical usability to ensure a seamless experience for both clinicians and patients. They also discussed the role of the Widex Compass Cloud, the first cloud-based fitting software, and how machine learning and features like LE Audio streaming are helping provide users with a more personalized and seamless hearing experience.Be sure to subscribe to our channel for the latest episodes each week and follow This Week in Hearing on LinkedIn and X (formerly Twitter).https://twitter.com/WeekinHearing- https://www.linkedin.com/company/this-week-in-hearing- https://hearinghealthmatters.org/thisweek/

Today's guest is Panos Karelis, Director of Customer Experience and Insights at Intelligencia AI. Intelligencia AI is a life sciences technology company that uses proprietary data, biomedical expertise, and AI-driven algorithms to assess the probability of technical and regulatory success for drug candidates, helping pharmaceutical companies make informed decisions on which drugs to advance or discontinue. Panos joins us on today's show to explore the key challenges and opportunities in AI adoption for drug development. He discusses the “black box” problem in AI and the importance of transparency and explainability in building trust. Panos also highlights the role of high-quality, harmonized data in generating accurate AI-driven insights and the mindset shift required for organizations to integrate AI-assisted decision-making successfully. Additionally, he explains how AI can optimize clinical trial design, enhance portfolio management, and improve business development and licensing decisions. This episode is sponsored by Intelligencia AI. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1.

Liz is joined by Dr. Varun Malhotra on the podcast this month to discuss clinical competency exams for clinical support reps. As both a practicing physician and an industry leader, he shares invaluable perspective on both how a rep should act in the OR and how companies should prepare reps to do so. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Dr. Varun Malhotra is an ophthalmologist with specialized training in glaucoma who has successfully bridged the worlds of clinical practice and biotechnology innovation.Dr. Malhotra completed his undergraduate education at Dartmouth College before earning his medical degree from New York University School of Medicine. He continued at NYU for his ophthalmology residency, gaining comprehensive training in diagnosing and treating various eye conditions. His education was further enhanced with a specialized fellowship in glaucoma at the prestigious Illinois Eye and Ear Infirmary, where he developed expertise in managing this complex eye disease.With additional credentials including an MBA from the University of Chicago Booth School of Business, Dr. Malhotra cultivated a multifaceted career spanning both academic and private practice settings before making a strategic transition to the biotechnology sector with a role at Genentech, where he was the clinical lead for the Port Delivery System Diabetic Macular Edema program. He also served as the global surgical lead for the entire Port Delivery System, where he oversaw the expansion and surgical training for all internal and external stakeholders of ophthalmic clinical trials from the United States to encompass countries in Europe, South America, and Asia.Dr. Malhotra is currently the Vice President of Clinical Development for Ollin Bioscience, an ophthalmic biotech company. He still practices ophthalmology and trains resident physicians in clinical and surgical skills on a weekly basis. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Varun MalhotraCumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality."

Finding the right amount of therapy materials is a struggle for many clinicians. It's hard to find the balance between having enough options, without having so many choices it feels overwhelming.Now that we have access to digital resources, we also have to think about how to use technology responsibly and effectively. That's why I invited Dr. Karen Rose to episode 204 of the De Facto Leaders podcast to discuss how digital platforms can minimize cognitive fatigue and improve communication on multidisciplinary teams. Dr. Karen Rose has over two decades of experience as a pediatric speech and language pathologist, fueling her passion for improving healthcare. As the former Vice President of Research and Clinical Development at Cognishine, she provided clinical and academic guidance and contributed to numerous research projects. She is now engaged in postdoctoral research and continues to work with Cognishine as an external advisor. Her work has been published in numerous internationally renowned journals.In this conversation, we discuss:✅How different clinical disciplines can collaborate with each other, as well as IT professionals to create engaging therapy resources.✅Using technology to enhance (but not replace) interactive in-person experiences.✅Thinking of digital platforms and therapy materials as a communication tool for team collaboration and parent coaching. ✅Leveraging online materials to provide scaffolding for therapists so they don't have to start from scratch; while still allowing room for engagement and creativity. Learn more about Cognishine here: https://www.cognishine.com/Follow Cognishine on LinkedIn here. https://www.linkedin.com/company/cognishine-therapy-and-education-ltd/Explore some of Congishine's Educational Resources and Free Activities here: https://app.cognishine.com/en-us/free-activitiesConnect with Dr. Karen on LinkedIn directly here: https://www.linkedin.com/in/karen-rose-228757327/ In this episode, I mention the School of Clinical Leadership, my program that helps related service providers develop a strategic plan for putting executive functioning support in place in collaboration with their school teams. You can learn more about that program here: https://drkarendudekbrannan.com/clinicalleadership We're thrilled to be sponsored by IXL. IXL's comprehensive teaching and learning platform for math, language arts, science, and social studies is accelerating achievement in 95 of the top 100 U.S. school districts. Loved by teachers and backed by independent research from Johns Hopkins University, IXL can help you do the following and more:Simplify and streamline technologySave teachers' timeReliably meet Tier 1 standardsImprove student performance on state assessments

What separates top-performing medical sales reps from the rest?  It's not just talent; it's elite training. Amy Harrington, VP of Clinical Training, reveals how the right approach to learning can make or break your success in this industry. Inside this episode: How Amy went from surgical tech to nurse to top-tier medical sales leader Why sales training isn't optional—it's the secret weapon for dominating the field The overlooked power of personalized learning in high-stakes industries How startups shaped her ability to adapt, innovate, and build winning teams Whether you aim to break in, level up, or reinvent your career, this episode delivers the insider playbook for thriving in medical sales. Meet the guest:  Amy Harrington is the Vice President of Clinical Training and Practice Development at R2 Technologies, Inc., where she leads the company's clinical education and advancement strategies. With over a decade of experience in the aesthetic and medical technology industries, Amy is known for designing innovative training programs that equip sales teams to sell confidently through science and knowledge. Since joining R2 in 2021, Amy has been a driving force behind the company'scompany's growth and innovation. Her strategic leadership—first as Director of Clinical Development & Education, then as Senior Director of Clinical Development, and now as VP of Practice Development—has been instrumental in establishing the R2 brand within clinical practices. Her contributions reflect a deep commitment to advancing the field of aesthetics through education and collaboration. Before R2, Amy held impactful leadership roles at Syneos Health, Obagi, and Solta Medical, where she developed and implemented transformative clinical and sales training programs. Beginning her career as a Registered Nurse in the operating room, she gained invaluable hands-on experience that continues to inform her practical and patient-centered approach to clinical education. Amy's academic background includes a dual bachelor's Degree in nursing and biology from the University of Maine, as well as an associate's Degree in criminalistics. She further enhanced her expertise in curriculum development with an instructional design certification from the Association of Talent Development. Outside of her professional endeavors, Amy is a wellness enthusiast who enjoys yoga, rowing, and exploring Maine's landscapes. A proud dog mom, she embraces an active outdoor lifestyle while balancing her passion for transforming clinical education with her love for the outdoors.  Connect with her:  LinkedIn Instagram

In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of Clinical Development at Nektar Therapeutics, a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology. He has more than 15 years of research and teaching experience in Bone Marrow Transplant (BMT)/Cellular Therapies and more than 10 years of industry experience. He was the Program Lead for early-stage assets at Nektar and manages clinical trial programs from Phase I through to Phase III. Dr. Marcondes is a member of multiple professional clinical and translational research organizations, including the American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), American Association for Cancer Research (AACR) and Center for International Blood & Marrow Transplant Research (CIBMTR). Listen to the episode to hear about the current research landscape in autoimmune disorders, including the work Dr. Marcondes is leading at Nektar Therapeutics. 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 this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, engages in an enlightening discussion with Smitha Sivaraman, PhD, MBA, Vice President of Medical Affairs at Verastem Oncology. Their discussion highlights the growing trend of integrating Medical Affairs into the Clinical Development process, and how this integration can streamline development when executed properly. Dr. Sivaraman shares her insights on the expectations for Medical Affairs teams working alongside clinical development, the ideal timing for their involvement, and how their role should progress over time. They also discuss the necessary skills and qualities that Medical Affairs team members need to collaborate effectively with Clinical Development, as well as the additional training that could be advantageous. Lastly, they cover what defines success in this emerging trend.

A few weeks ago, Sernova they announced their cell pouch system of islet cell transplants has seen seven people achieve insulin independence and has kept one person off of insulin injections for four years. What does that really mean going forward? I'm talking to their new CEO Jonathan Rigby and to Frank Shannon, Senior Vice President, Clinical Development and Regulatory Affairs More about Sernova here This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Join us at an upcoming Moms' Night Out event! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

In this episode, Dr. Alexandria Wise celebrates 15 years of innovation at CNS Summit 2024 by sitting down with Kevin Craig, Senior Vice President of Clinical Development at atai Life Sciences. Recorded from the floor of the conference, Kevin shares his journey from research and medicine to leading drug development in mental health, with a focus on the company's pioneering work in psychedelics.This episode delves into the complexities of drug development in the psychedelic space, the importance of global accessibility, and the profound impact of patient involvement in clinical trial design. Kevin also shares his perspective on the future of the life sciences industry, emphasizing the role of big data, biomarkers, and efficient trial models in advancing mental health care.The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Sonal Gupta, MD, PhD, SVP and Head of Clinical Development at Affyimmune Therapeutics talks with host Emily Walsh Martin, PhD, to explore the challenges of cell therapy clinical trials and how to move patients quickly and thoughtfully through the steps required to receive therapy in aggressive solid tumor cancers.  But first, "we've moved straight from pumpkin spice season into ASGCT Annual Meeting registration season," as Dr. Walsh Martin says. So hop online and join ASGCT, then register and take advantage of the incredible member discounts on Annual Meeting registration. We'll see you in New Orleans, May 13-17, 2025! AnnualMeeting.ASGCT.org/register Music by: https://www.steven-obrien.net/--------------------------Bright New Morning - Steven O'Brien (Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

Part 4 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Many of the clinical trial delays and recruitment challenges in today's industry can be attributed to decisions made while designing the protocol and in the outsourcing strategy. Bringing clinical operations experts into the decision-making process can help proactively address some of the biggest challenges facing trials today. In this podcast, Raul Lima, MBA, EVP, Strategic Clinical Operations of inSeption Group, explains the difference between clinical development and clinical operations, misconceptions CMOs have about clinical operations and how to successfully navigate the complexities of clinical trial execution.  For more information about inSeption Group, visit inSeptionGroup.com.  For more information about the annual Chief Medical Officer Summit 360° and its affiliated editorials, podcasts and webcasts, please visit CMO360.org.

Dr. Jared Baeten, Senior Vice President of Clinical Development and Virology Therapeutic Area Head at Gilead Sciences, joins me to discuss the incredible advancements in pre-exposure prophylaxis (PrEP) treatments in honor of World AIDS Day. What if a twice yearly shot could replace a daily pill? Listen now to learn more!

Part 3 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Part 2 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD-PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Part 1 of 4: Jon Chee hosts Barry Ticho, Founder of Verve Therapeutics and Chief Medical Officer at Stoke Therapeutics, a biotech company addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. With an MD-PhD from the University of Chicago and extensive experience across academia and industry, Barry brings over two decades of expertise in clinical development. His journey includes roles as Head of Development at Moderna, Head of External R&D Innovation at Pfizer, and VP of Clinical Development at Biogen, where he's been instrumental in advancing numerous therapeutic programs across multiple disease areas. Barry's unique perspective spanning academic medicine and biotechnology innovation makes his insights invaluable for aspiring leaders in the field.

Mon, 11 Nov 2024 17:00:00 +0000 https://podcastae8fac.podigee.io/402-new-episode 05d38b65bf0814edbb14803f71b46e04 402 full Interview with Oscar Segurado, MD PhD no Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

Dr. Ahmed is the Director of Research and Operations for METAVOMetavo is a first of its kind high concentration of AvoB, the natural compound found in avocados which restores and promotes true metabolic health.With a doctoral degree in Food Science from the University of Guelph, Dr. Ahmed has emerged as a trailblazer in the field of metabolic health and nutritional biochemistry. He hit the scene with a groundbreaking doctoral thesis titled "Clinical Development of Avocado-Derived Lipids as Modulators of Fatty Acid Oxidation for the Treatment and Management of Metabolic Disorders." This seminal work laid the foundation for the development of innovative solutions that form the core of Metavo's product offerings. Currently serving as the Director of Research at SP Nutraceuticals, Dr. Ahmed has been pivotal in the product development and successful launch of Metavo, the flagship natural health product that leverages the benefits of avocado for metabolic well-being. TNoteworthy is Dr. Ahmed's role as the study director for the first-in-human clinical trial of Metavo and his current role in conducting further clinical research on Metavo.Join Ken and Eric on the GCP as they learn from Dr. Ahmed all bout the natural ways to boost metabolic health with METAVO!https://www.metavo.com/

In this episode you will: Discover how AI can predict the success of clinical trials in terms of efficacy, regulatory approval, operational feasibility, reimbursement attainment and product uptake. Learn why AI can give us deeper insights by analyzing unstructured data for better-informed clinical development decisions. See how an agentic AI approach can speed up what would take months and weeks manually, to days and hours, while looking at even more information for the analysis.   Speaker: Raja Shankar, Vice President of Machine Learning in IQVIA's Research and Development Solutions

What does it take to create an effective clinical development plan? How do our early decisions shape the path of a compound through clinical phases? And how can statisticians actively balance the demands of science, speed, and cost in drug development? In this special 400th episode of The Effective Statistician, I dive into these questions with Carrie Li, a biostatistics expert whose career spans both big pharma and startups. Carrie shares how she builds clinical development plans from scratch, collaborates with cross-functional teams, and uses statistical expertise to create strategies that drive both scientific and commercial success. Join us as we explore the impact statisticians have on the clinical development journey.

Designating something "safe" in this industry means acceptable risk. AI can help us improve acceptable risks if it is used appropriately. However, industry experts must be thoughtful and responsible in their use of AI within clinical trials. In the third episode of our mini series on artificial intelligence, our guests explore the challenges and benefits of integrating technology into the lives of patients. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA ⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow ⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics ⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

"The procedures are not just vascular access and abscess drains and biopsies anymore. You know, the gamut of procedures that are done in pediatric now is ... across the board everything, practically, that is done in adult IR is done in pediatric IR. And I think you'd find that filing that niche and filing that need would make your pediatric specialists and your patients and families extremely satisfied." —James Donaldson, MD, the first president of the Society for Pediatric Interventional RadiologyIn this episode, part of the ongoing celebration of the Society of Interventional Radiology (SIR) 50th anniversary, host Sudhen B. Desai, MD, FSIR, speaks with James Donaldson, MD, the first president of the Society for Pediatric Interventional Radiology, about the early days and growth of the subspecialty, what its future holds and more.Related resources:Society for Pediatric Interventional RadiologySIR Clinical Specialty Council (including Pediatric IR Council)SIR Pediatric ForumSIR 50th Anniversary homepageIR Quarterly pediatric IR supplement, "Tiny patients, big impact"Contact us with your ideas and questions, or read more about about interventional radiology in IR Quarterly magazine or SIR's Patient Center.(c) Society of Interventional Radiology.Support the show

Globalization, return on investment, diverse data sets undiscovered: this episode continues the exploration of AI. As we see the industry level out AI adoption, the future is still exciting and yet uncertain. With quantum around the corner, there are still challenges with AI at every turn. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA ⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow ⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics ⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

HOST: Hildy Grossman, CO-HOST: Jordan Rich GUESTS: Geoff Oxnard, MD, VP Clinical Development, Global Head Thoracic Cancer | Thoracic Oncologist, Boston Medical Center With so many misunderstandings about clinical trials, this podcast aims to clarify what a clinical trial is, how they have changed over time, why it is important to inform patients about them … Continue reading Misunderstandings About Clinical Trials Reflecting On Past Lessons to Future Innovations →

As 2024 closes, it is only right to discuss where we are when it comes to AI and where we will be in the future. As technology continues to evolve and blend into science in 2025 and beyond, a practical approach to what it can and cannot do must be explored. Additionally, how overpromising while underdelivering has affected investors' and the industry's confidence in AI. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA ⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow ⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics ⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

Are you curious about how artificial intelligence is transforming clinical research? Do you want to know how statisticians can use AI to improve healthcare outcomes? In this episode, I explore these questions with Francois Vandenhende, a seasoned expert in the pharmaceutical industry with nearly three decades of experience. Francois shares his journey from using traditional statistical methods to pioneering AI and machine learning in clinical development. We dive into how AI is making a difference in areas like digital twins and the integration of structured and unstructured data. Francois also highlights how statisticians can leverage AI to shape the future of healthcare. Join us as we uncover the exciting opportunities AI offers in clinical research and why it's more than just a trend.

Subscribe to UnitedHealthcare's Community & State newsletter.Health Affairs' Editor-in-Chief Alan Weil interviews Jennifer Kao of the University of California Los Angeles on her recent paper that explores the impact of the Food and Drug Administration's breakthrough therapy designation program on the reduction of late-stage drug development time.Order the July 2024 issue of Health Affairs.Currently, more than 70 percent of our content is freely available - and we'd like to keep it that way. With your support, we can continue to keep our digital publication Forefront and podcasts free for everyone. Subscribe to UnitedHealthcare's Community & State newsletter.

Learn the business and management skills you need by enrolling in the University of Tennessee Physician Executive MBA program at nonclinicalphysicians.com/physicianmba. Get the FREE GUIDE to 10 Nonclinical Careers at nonclinicalphysicians.com/freeguide. Get a list of 70 nontraditional jobs at nonclinicalphysicians.com/70jobs. =============== One of the first interviews devoted to the pharma industry featured Dr. Laura McKain in September 2021. Dr. McKain received her medical degree from Georgetown University in Washington, DC, and completed her training in obstetrics and gynecology at Virginia Commonwealth University in Richmond, Virginia. She was in private practice for over twelve years where her clinical interests included wellwomen care, contraception, HPV, menopause management, as well as general and high-risk obstetrics. In 2008 she transitioned her career to the pharmaceutical industry where she was involved in clinical development projects encompassing a broad range of therapeutic areas. She was involved in bringing two new therapeutics to market. She recently retired from full-time work and is now focused on helping other physicians find new nonclinical careers. She is a career coach and resumé expert at mckainconsulting.com. Laura is the founder of the Physician Nonclinical Career Hunters Facebook Group. With almost 30,000 members, it is the premier group where physicians connect with other physicians, share advice, find job openings, and obtain valuable advice and mentorship about nonclinical careers. In today's interview, Laura and I will be talking about strategies for finding a pharma job in the area of Clinical Development. You will find all of the links mentioned in the episode at https://nonclinicalphysicians.com/land-a-pharma-clinical-development-job/

Dr. Mollie Leoni, Executive Vice President for Clinical Development of Kura Oncology, discusses the company's ziftomenib program, a menin inhibitor for acute myeloid leukemia (AML). The company initially allowed all AML patients to participate in the clinical study, but later found that specific subtypes, such as those with NPM1 mutation or KMT2A rearrangement, were more likely to respond to the menin inhibitor. They also discovered other subtypes that were responsive, expanding the potential patient population. Understanding the role of menin and menin inhibitors in addressing abnormal gene expression and promoting healthy cell development opens the door to potential combination therapy, where menin inhibitors could be layered onto existing treatments for various cancers related to menin independence. Mollie explains, "In oncology, we have gotten good at treating the end state, but cancer has many, many causes with a common final endpoint to the way the cells look. So, it's many, many different diseases all at once. We've learned and are learning that with better technology and a better understanding of cancer in general we can identify not just how to stop the end state but how to stop it from starting." "That's where ziftomenib comes in. Ziftomenib addresses key mutations that when they occur, are what cause the development of cancer. So you're able to shut down the development and force the cells to develop normally rather than waiting until they're already diseased and killing them with chemotherapy or some other cytotoxic agent." "There is a protein complex that we refer to as the menin MLL complex, which goes rogue when something unusual happens in the cell. For example, that could be an NPM1 mutation. That could be a KMT2A rearrangement. Those are two things that are well-known to happen within AML diseases. It could also be a SETD2 RUNX1 mutation. So many types of mutations could happen that could cause this machinery to go rogue within the cell. And that complex causes genes to become active at levels and at times that are abnormal." #KuraOncology #Ziftomenib #MeninInhibitors #PrecisionMedicine #BTD #AML KuraOncology.com Listen to the podcast here

Dr. Mollie Leoni, Executive Vice President for Clinical Development of Kura Oncology, discusses the company's ziftomenib program, a menin inhibitor for acute myeloid leukemia (AML). The company initially allowed all AML patients to participate in the clinical study, but later found that specific subtypes, such as those with NPM1 mutation or KMT2A rearrangement, were more likely to respond to the menin inhibitor. They also discovered other subtypes that were responsive, expanding the potential patient population. Understanding the role of menin and menin inhibitors in addressing abnormal gene expression and promoting healthy cell development opens the door to potential combination therapy, where menin inhibitors could be layered onto existing treatments for various cancers related to menin independence. Mollie explains, "In oncology, we have gotten good at treating the end state, but cancer has many, many causes with a common final endpoint to the way the cells look. So, it's many, many different diseases all at once. We've learned and are learning that with better technology and a better understanding of cancer in general we can identify not just how to stop the end state but how to stop it from starting." "That's where ziftomenib comes in. Ziftomenib addresses key mutations that when they occur, are what cause the development of cancer. So you're able to shut down the development and force the cells to develop normally rather than waiting until they're already diseased and killing them with chemotherapy or some other cytotoxic agent." "There is a protein complex that we refer to as the menin MLL complex, which goes rogue when something unusual happens in the cell. For example, that could be an NPM1 mutation. That could be a KMT2A rearrangement. Those are two things that are well-known to happen within AML diseases. It could also be a SETD2 RUNX1 mutation. So many types of mutations could happen that could cause this machinery to go rogue within the cell. And that complex causes genes to become active at levels and at times that are abnormal." #KuraOncology #Ziftomenib #MeninInhibitors #PrecisionMedicine #BTD #AML KuraOncology.com Download the transcript here

XTMAB-16, a drug now in clinical trials has been developed by Xentria.  In this episode of the FSR Sarc Fighter podcast, Noopur Singh, Vice President of marketing & Patient Affairs, and Tom Matthews, Vice President for Clinical Development join me to explain how XTMAB-16 works in the body as a "referee" to control our body's immune responses.  Listen in as we learn more about one of the most promising reasons for hope in the fight against Sarcoidosis.         Show notes: More about Xentria: https://xentria.com/who-we-are More about XTMAB-16: https://xentria.com/clinical/xtmab16 Join the Clinical Trial: https://xentria.com/clinical/xtmab16-phase-2 Help FSR further its mission by becoming an Alliance Volunteer:  www.stopsarcoidosis.org/gsca-leaders/ Become a community outreach leader: https://www.stopsarcoidosis.org/gsca-leaders/   MORE FROM JOHN: Cycling with Sarcoidosis http://carlinthecyclist.com/category/cycling-with-sarcoidosis/ Do you like the official song for the Sarc Fighter podcast?  It's also an FSR fundraiser!If you would like to donate in honor of Mark Steier and the song, Zombie, Here is a link to his KISS account.  (Kick In to Stop Sarcoidosis)  100-percent of the money goes to the Foundation.  https://stopsarcoidosis.rallybound.org/MarkSteier The Foundation for Sarcoidosis Research https://www.stopsarcoidosis.org/ Donate to my KISS (Kick In to Stop Sarcoidosis) fund for FSR  https://stopsarcoidosis.rallybound.org/JohnCarlinVsSarcoidosis?fbclid=IwAR1g2ap1i1NCp6bQOYEFwOELdNEeclFmmLLcQQOQX_Awub1oe9bcEjK9P1E My story on Television https://www.stopsarcoidosis.org/news-anchor-sarcoidosis/ email me  carlinagency@gmail.com                    

Dr. Daniel Stone speaks with Drs. Mario Mietzsch and Robert McKenna from the University of Florida to discuss a recent article published in the Biomanufacturing in Gene and Cell Therapy special issue of Molecular Therapy Methods & Clinical Development by Drs. Mietzsch, McKenna, and colleagues titled Production and characterization of an AAV1-VP3-only capsid: An analytical benchmark standard. If you enjoy today's conversation, you'll also enjoy the upcoming ASGCT Policy Summit in Washington, DC, September 23-24.  This can't-miss event brings together policymakers and gene and cell therapy experts, including FDA leaders Julie Tierney and Dr. Nicole Verdun, to discuss the latest policies impacting this rapidly evolving field.  Register now at https://www.asgct.org/PolicySummit for invaluable insights on navigating the regulatory landscape.  In This Episode: Dr. Daniel StoneAssociate Editor-in-Chief of Molecular Therapy Methods & Clinical Development and Senior Staff Scientist, Infectious Disease Sciences, Vaccine and Infectious Disease Division at Fred Hutch Cancer Center Dr. Mario MietzschAssistant Scientist, Department of Biochemistry and Molecular Biology, University of Florida Dr. Robert McKennaProfessor and Director of the Center for Structural Biology, Department of Biochemistry and Molecular Biology, University of Florida 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0.www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

Mohamed Abou-el-Enein, MD, PhD, MSPH, the new editor-in-chief of Molecular Therapy Methods & Clinical Development (MTMCD), sits down with Scientific Editor Rory Bricker-Anthony, PhD, to discuss his vision for the journal. If you enjoy today's conversation, you'll also enjoy the upcoming ASGCT Policy Summit in Washington, DC, on September 23 and 24. This can't-miss event brings together policymakers and gene and cell therapy experts, including FDA leaders Julie Tierney and Nicole Verdun, PhD, to discuss the latest policies impacting this rapidly evolving field. Register now at ASGCT.org/PolicySummit for invaluable insights on navigating the regulatory landscape. Virtual attendance options are also available. Dr. Abou-el-Enein has served as MTMCD's associate editor-in-chief for the past two years, which will allow him to make a smooth transition in leadership. His vision for MTMCD is consistent innovation, evolution, and growth. Dr. Abou-el-Enein firmly believes that MTMCD has the potential to become a leading voice in the gene and cell therapy landscape. He is eager to leverage his experience and expertise to expand the journal's reach and impact.  Dr. Abou-el-Enein is an associate professor of clinical medicine (oncology), pediatrics, and stem cell biology and regenerative medicine at USC Keck School of Medicine as well as executive director of the USC/CHLA cell therapy program. He is an internationally recognized expert in planning and executing clinical development programs, designing and operating academic GMP facilities, and translating cell and gene therapy products from preclinical research to clinical applications. His research laboratory is dedicated to pioneering advancements in CAR T-cell therapies, including optimizing engineering techniques and devising novel strategies for allogeneic applications and genetic delivery tools to increase accessibility and scalability. 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0.www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

In this episode, Dr. Geoff Oxnard, a thoracic oncologist, discusses his career journey into oncology and shares insights from his experience treating lung cancer patients and conducting research. He emphasizes the increasing role of precision medicine and genomic and biomarker testing in guiding treatment decisions, providing examples of how identifying specific mutations can lead to dramatically better outcomes with targeted therapies. Dr. Oxnard also highlights the changing narrative surrounding lung cancer, with emerging stories of remarkable responses and newfound optimism as treatments improve. He provides perspective on navigating clinical trials, especially for rare genomic subtypes, and shares his motivations for transitioning from academia to the pharmaceutical industry, driven by a desire to have a larger impact on drug development and patient care. Key Highlights: 1. The increasing role of precision medicine and genomic testing in guiding lung cancer treatment decisions. 2. The changing narrative and renewed optimism surrounding lung cancer, as treatments improve and stories of remarkable responses emerge. 3. Dr. Oxnard's transition from academia to the pharmaceutical industry, driven by a desire to have a larger impact on drug development and patient care. About our guest: Geoff Oxnard, M.D., is the Vice President, Clinical Development, Global Head, Thoracic Cancer at Loxo@Lilly. Previously, Dr. Oxnard served as a thoracic oncologist and clinical-translational researcher at Dana Farber Cancer Institute and was also an Associate Professor of Medicine at Harvard Medical School. Dr. Oxnard received his BA in chemistry from Harvard University and his MD from the University of Chicago-Pritzker School of Medicine. He completed his residency in internal medicine at Massachusetts General Hospital and completed his fellowship in medical oncology at Memorial Sloan-Kettering Cancer Center. As an experienced oncologist, Dr. Oxnard is passionate about raising awareness of thoracic cancer and helping to make an impact on cancer care. Key Moment: 8 minutes: “It starts with precision therapy, if I may, right? Once you have defined a specific molecular subtype, you've tried to sort of sift through the randomness of cancer care to find a group of patients who are going to behave in a similar way. Let's go into that for a moment, if I may, OK? EGFR mutations. If you give an EGFR inhibitor in the original studies to a bunch of patients on average with lung cancer, they live a couple months longer, but 10 % of those patients have fantastical responses that can last for a year or two or more. And so when you are a lung cancer patient, which are you looking for, by the way, to live on average two months longer or to have a fantastical response that can work for years? And of course, people are looking to be that outlier.” Visit the Manta Cares website  Disclaimer: This podcast is for general informational purposes only and does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice, and no doctor/patient relationship is formed. The use of information on this podcast or materials linked from this podcast is at the user's own risk. The content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard, or delay in obtaining, medical advice for any medical condition they may have, and should seek the assistance of their health care professionals for any such conditions. --- Support this podcast: https://podcasters.spotify.com/pod/show/manta-cares/support

In this episode of Medical Affairs Unscripted, Peg Crowley-Nowick, PhD, MBA, President of Medical Affairs Consulting at Lumanity, and Jodi Smith, PhD, the Global Medical Strategy Lead in Thoracic Oncology at Pfizer, discuss the value of Medical Affairs. While they agree that there's a cost associated with bringing Medical Affairs into the early development of a drug, they see a clear and measurable benefit, from accelerated enrollment to having a solid foundation for commercialization. Through their many years in different roles within Medical Affairs, they know that to achieve these benefits, organizations need to have the right team members in the right roles with the agility to work in an ever-changing landscape as well as provide strategic thinking, a diversity of audience, and continuity throughout the product lifecycle - from clinical development through commercialization and beyond.

In this episode, Rachel Haines from Rinri Therapeutics joins us to discuss the possibilities of cell therapy for hearing loss. Our conversation with Rachel goes beyond just scientific innovation; we also explore the potential impact of Rinri's upcoming human trials, which are based on Professor Marcelo Rivolta's groundbreaking work. By delving into the challenges and excitement of pioneering clinical trials in uncharted territory, we envision a future where natural hearing restoration could become a reality.First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder. Episodes launch weekly on Tuesdays. To view the full transcript of this episode, click here.Interested in being featured as a guest on First In Human? Please reach out to owen@vial.com.

Welcome to this month's episode of Let's Talk Rare: The Life Science Podcast brought to you by Partners4Access. Host Georgie records this episode at the World EPA Conference in Amsterdam. She holds a panel discussion with Juliette Sinclair-Spence, Sandrine Ruiz,  Neil Grubert, and Seema Sondhi, and together we shared our experiences at the EPA conference.  We also shared our excitement for AI and patient experience topics, as well as the importance of sustainability and finding new pricing approaches in healthcare. Gain insights on inclusivity and involving patients in drug development. Get ready for a meaningful, engaging conversation that will leave you inspired. Take a deep dive into the benefits of tiered pricing, the challenges and concerns of companies and HTA agencies in joint HTA assessments, the importance of inclusivity, and the importance of involving and educating others. Juliette Sinclair-Spence: Bio and Quote LinkedIn Juliette is the Funder and Chairman of the AK Eye Foundation and is a committed

This month we feature three representatives from Neuren Pharmaceuticals to answer frequently asked questions about the recent Phase 2 clinical trial, and plans for a Phase 3. Larry Glass, Neuren's Chief Science Officer provides an insightful breakdown of NNZ-2591, the drug that was being tested. Additionally, Liza Squires, Chief Medical Officer, and Nancy Jones, VP of Clinical Development, offer an overview of the safety, tolerability, and efficacy results. Important links: Phase 2 top line results: https://pmsf.org/document/neuren-phase-2-trial-investor-presentation/?fbclid=IwAR2ytXd7HXVfjJ9hFxwUVlVgJvI_KkczBTpGJCNUOMLTzgUAI6lPy1ZZO9g Phase 2 inclusion and exclusion criteria https://clinicaltrials.gov/study/NCT05025241?cond=Phelan-mcdermid%20syndrome&term=NNZ-2591&rank=1#participation-criteria

In this month's episode of the Scope of Things, host Deborah Borfitz catches listeners up with the latest news of the clinical trials and research industry, starting with SCOPE 2024, where a record-breaking 4,000 attendees arrived to learn and discuss about new products, technology, and ideas. Other hot topics in this episode include convergence of clinical research and clinical care, patient centricity, protocol complexity, the growing use of AI, and an update on decentralized clinical trials. She also interviews CliniSpan Health founder and CEO Dezbee McDaniel, winner of the pitch contest at SCOPE, about his company's novel social media influencer relationship management platform for improving clinical research diversity. LINKS Summit for Clinical Ops Executives (SCOPE) Conference website Convergence of clinical research and clinical care Story in Clinical Research News [link to come, story runs 2/27?] Oliver Patch Project Website   Conference themes Savvy Cooperative's #AskPatients website Barnett International's GCP reference guide ProofPilot integrates Magnol.AI Press release  TransCelerate's Participant Data Return initiative Resource pack Impact of protocol design on trial performance Study in Therapeutic Innovation & Regulatory Science Use of AI in clinical development FDA-issued discussion paper 

October is National Depression and Mental Health Screening Month, with October 10th specifically recognized as World Mental Health Day. A recent study co-led by Harvard Medical School and the University of Queensland established that one out of every two people in the world will develop a mental health disorder in their lifetime. This staggering number underscores the critical need to reduce the stigma of mental health, and to make sure that people who are suffering understand the diverse help and treatment options that are available to them.Dr. Alexandria Wise, Global Head of Therapeutic Strategy and Innovation and Andy Moniz, VP, Therapeutic Strategy and Innovation at Syneos Health, join the podcast to help raise mental health awareness, discussing the evolution in mental health treatment over the past 30 years and where it stands today; the challenges of mental healthcare access for certain patient groups and what is being done to ease this; and the unique aspects of psychedelics in mental health clinical trials and their potential for promising results.For more content on neuroscience topics, check out these insights:Understanding the Role of the Placebo Response in Clinical TrialsDigital Flexibility and the Digital Divide: Meeting Patients Where They're At With Mental Health ServicesWEBINAR | Psychedelics 3.0: Drug Development Challenges and Opportunities in a Rapidly Evolving FieldThe views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at insightshub.health. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.

Cancer survival exceeds 90% when detected during Stage I. Novel technologies are making early detection easier, especially for cancers that usually aren't diagnosed until after metastasis has occurred. Tune in to discover: The important distinction between multi-cancer early detection and liquid biopsy The benefits provided by looking for molecular signs of cancer rather than anatomical, such as by mammogram or colonoscopy How stage I cancer is defined Eric Fung, MD, PhD, is Vice President of Clinical Development at Grail, a company with a mission to detect cancer early, before it has spread to other parts of the body. Unfortunately, as it currently stands, only a fraction of cancers are detected at Stage I, especially when it comes to cancers for which there are no screening guidelines. Over the past 50 years, the primary focus in cancer research has been on therapeutics. But many FDA-approved therapeutics have very little impact on survival rates, because when it comes down to it, the best way to reduce cancer mortality is to detect cancers early, when they can still be cured. Fung explains how a new multi-cancer early detection (MCED) test called the Galleri test can detect the presence of 50 Stage I cancers, and with only a single blood draw. He also discusses the studies supporting the validity of this test, namely the Circulating Cell-free Genome Atlas (CCGA) study and prospective clinical study called PATHFINDER.  The Galleri test is now available to patients by prescription. Press play to hear the full conversation and learn more at grail. https://www.galleri.com/. Episode also available on Apple Podcasts: apple.co/30PvU9C