Podcasts about Clinical pharmacology

We continue our Project Optimus series with a focus on clinical pharmacology—a foundational element in redefining dose optimization in oncology drug development. Dr. Wael Harb is joined by Pierre-Olivier Tremblay, Vice President of Clinical Pharmacology at Syneos Health, to discuss how model-informed strategies, exposure-response analysis and biomarkers are transforming early phase trials. They examine how tools like PK/PD modeling and tumor dynamics simulations enable a shift from traditional maximum tolerated dose approaches to more patient-centric dosing strategies, and explore how AI, data sharing and regulatory innovation are shaping the future of precision oncology.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.

Guest: Martin Cheatle, PhD A thoughtful, communicative, and compassionate approach to opioid use is essential for responsible patient use. Join Dr. Martin Cheatle as he explains the neuroscience of chronic pain, the psychosocial components often overlooked in these patients, and evidence-based strategies for evaluating risk and treatment response. Dr. Cheatle is the Director of Behavioral Medicine at the Penn Pain Medicine Center as well as an Associate Professor of Psychiatry, Anesthesiology, and Critical Care and the Director of Pain and Chemical Dependency Research at the Center for Studies of Addiction at the University of Pennsylvania. He also presented on this topic at the 2025 Congress of Clinical Rheumatology East conference.

You can text us here with any comments, questions, or thoughts!In this encore episode, Kemi welcomes Dr. Tamorah Lewis, a neonatologist and pediatric clinical pharmacologist, to discuss the intricate dance of motherhood and career. Together, they explore the challenges and triumphs of being high-achieving women of color in academia.   Join Kemi and Dr. Lewis as they candidly reflect on their personal journeys, the evolving definition of success in motherhood, the vital role of supportive partnerships and the intentional steps we can take to empower our children.  Highlights from this episode: Embracing Imperfections in Motherhood The Importance of Self-Worth and Identity Navigating Career and Family Dynamics The Role of Support Systems in Parenting Redefining Success as a Working Mother  Loved this convo? Please go find Dr. Lewis on X (fka Twitter) @TamorahLewisMD and show her some love!  More about Dr. Tamorah Lewis, MD, PhD - Dr. Tamorah is a physician scientist and the Division Head for Clinical Pharmacology and Toxicology at SickKids. In this role, her goal is to advance the hospital-wide vision for Precision Child Health and collaborate with multiple clinical Divisions to research and implement precision therapeutics. She will provide clinical care in the Level IV NICU at SickKids. Prior to this new role, Lewis was at Children's Mercy Kansas City in the Divisions of Neonatology and Pediatric Clinical Pharmacology for seven years. She worked as an attending in the Level IV NICU and led translational / clinical research in neonatal pharmacology.  If you'd like to learn more foundational career navigation concepts for women of color in academic medicine and public health, sign up for our KD Coaching Foundations Series: www.kemidoll.com/foundations.  REMINDER: Your Unapologetic Career Podcast now releases episode every other week! Can't wait that long? Be sure you are signed up for our newsletter (above) where there are NEW issues every month! 

Guest: Andre Harvin, PharmD, MS, MBA Biosimilars have greatly impacted the US healthcare system over the last decade, creating cost savings and increasing access for patients.1,2 However, although some biosimilars have seen significant adoption, not all biosimilars have been able to achieve sustainable market use.1 Learn about the barriers to biosimilar adoption in the US and strategies for overcoming them from Dr. Andre Harvin. Dr. Harvin is the chief pharmacy officer at Cone Health in Greensboro, North Carolina. References: AAM, The U.S. Generic & Biosimilar Medicines Savings Report, September 2023 IQVIA Institute for Human Data Science, Biosimilars in the United States 2023-2027: Competition, Savings, and Sustainability, January 2023 © Fresenius Kabi USA, LLC 2025 03/2025

Den här gången går vi igenom en något invecklad historia som tidigare aldrig beskrivits i detalj, men som innehåller ett exempel på storskalig amerikansk kopiering av östeuropeisk teknologi under kalla kriget, hallucinerande apor, ett mystiskt motgift och en koppling till Israel via CIA.  Vi försöker nysta upp det hela steg för steg och förklara varför det är principiellt intressant samt ta upp en oväntad vinkel av särskild relevans för de med svår allergi än idag. Källorna inkluderar allt från CIA:s arkiv till gamla farmakologiska tidskrifter, en tidigare hemligstämplad tjeckoslovakisk forskningsartikel, och mycket annat (därför blir källförteckningen nedan ett urval snarare än uttömmande).Länk till den öppna föreläsningen på FHS den 7 maj:https://www.fhs.se/arkiv/kalenderhandelser/2025-02-12-hotbilder-fran-genetisk-teknologi.htmlKällor (ett urval):Washington Post-artikeln (1984):https://www.cia.gov/readingroom/docs/CIA-RDP90-00965R000100130039-8.pdf"Assessment of the Weapons and Tactics Used in the October 1973 Middle East War" (1974), Weapons Systems Evaluation Group:https://www.cia.gov/readingroom/docs/LOC-HAK-480-3-1-4.pdf"Chemical Warfare: Progress and Problems in Defensive Capability" (1986). US General Accounting Office, Washington D.C.Kreicer, M. (1967), Nekatorie sposobi rasceta dozirovok dlja celoveka ishodjascih na rezultatov polucennih na podopitnih zivotnih (Rus.). Sbornik Vedeckych Praci, 25, 27-71"Nervgasmotmedel: aktuellt kunskapsläge" (2005), FOI:https://www.foi.se/rest-api/report/FOI-R--1610--SEVojvodic, V. B. & M. Maksimovic (1972). "Absorption and Excretion of Pralidoxime in Man after Intramuscular Injection of PAM-2CL and Various Cholinolytics", European Journal of Clinical Pharmacology 5, 58-61Von Bredow, Jürgen D. et al. (1991). "Effectiveness of Oral Pyridostigmine Pretreatment and Cholinolytic-Oxime Therapy against Soman Intoxication in Nonhuman Primates", Fundamental and Applied Toxicology 17, 761-770

At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics. HostJef Akst, Managing Editor, BioSpaceGuestPrathap Nagaraja Shastri, Scientific Director and Group Leader, Clinical Pharmacology and Pharmacometrics, Johnson and JohnsonBioSpace is a media partner of the National Biotechnology Conference.

What is a Clinical Pharmacologist? Who better to tell us than Professor Lauren Walker, Professor of Clinical Pharmacology & Therapeutics and Honorary Consultant in General Internal Medicine at Liverpool University. Lauren is a leading researcher in multimorbidity and AI-driven healthcare and plays a key role in early-phase clinical trials. We chat about her role in ‘First in Human' trials - what are they, what are the risks and why are they so important? And how does this work reach across to her clinical role which focuses on multimorbidity and polypharmacy. We discuss the role that AI may play in predicting polypharmacy and the development of DynAIRx - an Artificial Intelligence being designed to support medicines optimisation on multimorbid patients. It's a Robotic version of Steve the Chemist!Our micro-discussion continues with the theme of clinical trials. How can we ensure they are representative of the populations they are supposed to be treating. Is it ever ethical to test new drugs on elderly and frail patients? ‘The current status of inclusion of older groups in evaluations of new medications: Gaps and implementation needs to fill them' https://pubmed.ncbi.nlm.nih.gov/38600697/As with all of our guests, Lauren shares with us her Memory Evoking Medicine, a career anthem and book that has influenced her career or life. Fans of pharmacology will not be disappointed. Check out Lauren's impressive full bio here, with further details of all of her research: https://www.liverpool.ac.uk/people/lauren-walkerThis week we also discuss Steve's impressive TV debut where he describes the role of a Clinical Pharmacist to none other than Professor Green on BBC Morning Live. This is a must watch for anyone who wants to understand this role and the impact of polypharmacy. A new career beckons… You can watch it here: https://www.rpharms.com/about-us/news/details/polypharmacy-featured-on-bbcs-morning-live. Our website is https://www.theauralapothecary.com/You can listen to the Aural Apothecary playlist here; https://open.spotify.com/playlist/3OsWj4w8sxsvuwR9zMXgn5?si=tiHXrQI7QsGtSQwPyz1KBg You can view the Aural Apothecary Library here;  https://litalist.com/shelf/view-bookcase?publicId=KN6E3O  To get in touch follow us on Bluesky and X @auralapothecary or email us at auralapothecarypod@gmail.com . Don't forget to rate us and comment wherever you have got this podcast from. 

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology), which aims to educate listeners on clinical pharmacology and related topics. Chapters 00:51 The Changing Landscape of Pharmaceuticals 03:49 Virtual Clinical Trials and Patient Engagement 08:06 Optimizing Drug Dosage in Oncology 10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy 14:26 The Complexities of Cell Therapy 17:33 Navigating Immunocompromised States in Treatment 20:09 Advice to Young Scientists in Biopharma  23:04 Defining Success in Life and Career 24:47 The Purpose and Impact of Nathan's Podcast, Clinical Pharmacology HOW TO REACH US: Nathan Teuscher https://www.linkedin.com/in/nathanteuscher/  Aplos Analytics - https://aplosanalytics.com/  Email: nathan@aplosanalytics.com Nathan Teuscher's Podcast: Clinical Pharmacology Podcast https://teuschersolutions.com/  Collaboration with BioTalk Unzipped (Ep. 40) https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951  Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacology Podcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234 Dr. Chad Briscoe https://www.linkedin.com/in/chadbriscoe/  Celerion - https://www.celerion.com/   Gregory Austin https://www.linkedin.com/in/gregoryaustin1/  ECI - https://eci-rx.com /  Takeaways Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics. Virtual clinical trials can enhance patient engagement and diversity in research. Finding the right dosage is a critical challenge in drug development. Project Optimus aims to redefine oncology drug development practices. AI and data analysis can help identify ideal candidates for clinical trials. Ethical considerations are paramount in the use of patient data for research. The right dose for each patient varies significantly. Understanding individual immune system capacities is crucial in treatment. Collaboration is key to success in the scientific community. Success is measured by the happiness of loved ones. Finding joy in helping others is essential for career fulfillment. Podcasts serve as valuable educational resources. Engaging with diverse disciplines enhances scientific understanding. Sound Bites “If you want to be successful, seek first to understand, then be understood.” “If you're looking to help people and in collaboration, you'll be successful.” “Success in life is the happiness of loved ones around you.” New News Story:  After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast keywords BioTalk, pharmacology, AI in pharma, drug development, Nathan Teuscher, pharmacometrics, virtual clinical trials, clinical research, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

This month we are joined by Sarah Branson (Coram Chambers) and Professor James Coulson (Professor in Clinical Pharmacology and Toxicology at Cardiff University).  We discuss the concern that over-reliance on the numbers generated in hair testing can lead to miscarriages of justice.  The issue is that the use of a standardised cut-off levels have a racial bias, because the dark melanin in the hair helps to incorporate the drugs in the hair so someone with black hair will have a much higher reading than someone with red or blond hair, even if they have used the same amount of drugs over the same period of time.  Sarah recommends that from now on when hair testing is commissioned that it has to be instructed like other expert evidence – with a letter of instruction, there is a full forensic history.  Sarah has drafted a template LOI and order which you can access on the Coram website: https://www.coramchambers.co.uk/resources/hair-strand-testing-resources/ James makes the point that in other Courts (like to civil, criminal or coroners courts) it is unusual to have an analytical chemist commenting on the wider interpretation of the result.  James agrees that it is very important that evidence is not seen in isolation.  James takes us through the information that he would to see in these instructions in the future.  Sarah reminds us that we should start thinking about this evidence as expert opinion evidence rather than elevating the presumptive weight that should be given to the evidence.  Sarah directs us to the judgment of Lord Peter Jackson in D, Re (Children: Interim Care Order: Hair Strand Testing) [2024] EWCA Civ 498 (10 May 2024)https://www.bailii.org/ew/cases/EWCA/Civ/2024/498.html.  Sarah points out the numbers from a test is the science but what those numbers mean is just someone's opinion like any other expert evidence.  During the discussion, Sarah and James refer to:  The incorporation of drugs into hair: relationship of hair color and melanin concentration to phencyclidine incorporation M H Slawson, D G Wilkins, D E Rollins J Anal Toxicol 1998 Oct 22. The effect of hair color on the incorporation of codeine into human hair. Rollins DE, Wilkins DG, Krueger GG, Augsburger MP, Mizuno A, O'Neal C, Borges CR, Slawson MH.J Anal Toxicol. 2003 Nov-Dec;27(8):545–51. doi: 10.1093/jat/27.8.545. Cuypers E, Flanagan RJ. The interpretation of hair analysis for drugs and drug metabolites. Clin Toxicol (Phila). 2018 Feb;56(2):90-100.  Forensic Science Internation (2018)

In this episode of The Psychedelic Podcast, Paul F. Austin welcomes Stephanie Karzon Abrams, a neuropharmacologist and founding advisor of Beyond Consulting. Find full show notes and links here:  https://thethirdwave.co/podcast/episode-276-stephanie-karzon-abrams With her unique background spanning clinical pharmacology, corporate healthcare, and the music industry, Stephanie shares insights on the intersection of psychedelic science, integrative medicine, and community building. She discusses the transformative potential of psychedelics from a neuropharmacological perspective, her work supporting ketamine clinics and plant medicine brands, as well as her journey from traditional healthcare to pioneering innovative approaches in the psychedelic space. Stephanie Karzon Abrams, a neuropharmacologist with a Masters of Science in Clinical Pharmacology, is the founding advisor of Beyond Consulting, providing science, research, operations, and strategy solutions to organizations in the natural product, plant medicine, and psychedelic sectors. Her career spans from clinical research and Johnson & Johnson to pioneering innovative healthcare approaches. Beyond her scientific work, she co-creates community initiatives including Public Secret music label and Mt. Mushmore educational dinner series. As a prescriber for MDMA and psilocybin therapy through Canada's Special Access Program and scientific advisor for the Microdosing Collective, she champions the integration of cutting-edge therapeutic approaches with traditional healthcare. Her work focuses on bridging scientific expertise with strategic thinking to advance innovative healthcare solutions. Highlights: Origins of Public Secret record label and global groove music collective Rich cultural background and journey from Montreal to California Stephanie breaks down clinical psychopharmacology Mount Mushmore Transition from J&J to psychedelic medicine consulting Stephanie's firm, Beyond Consulting Supporting ketamine clinics and integrative medicine centers Deep dive into neuropharmacology of psychedelics vs traditional medications Microdosing applications for ADHD and anxiety Importance of lifestyle changes alongside psychedelic protocols Managing work-life balance in the psychedelic industry Links: Beyond Consulting Public Secret Music Label Microdosing Collective Episode Sponsors: The Practitioner Certification Program by Third Wave's Psychedelic Coaching Institute.

Bridging science and spirit, Stephanie Karzon Abrams chats with Raghu about integrating psychedelics and soul into the medical community.This time on Mindrolling, Raghu and Stephanie delve into: Out-of-body experiences through musicAddressing identity changes after Traumatic Brain InjuriesUtilizing plants to promote better healthReconnecting to ourselves through psychedelic therapiesTrauma from displacement and immigrationBridging science and spirit by integrating holistic views into medicineThe mental health impact of physical health issuesGetting the medical world to want to heal the mind and soul as well as the physicalThe ways that psychedelic experiences can change usThe importance of having a guide through psychedelic experiencesSitting with discomfort and being open to the lessonsHow music expands our minds and creates a space for connectionAbout Stephanie Karzon Abrams:Stephanie Karzon Abrams, a neuropharmacologist with a Masters of Science in Clinical Pharmacology, is the founding advisor of Beyond The Bench consultancy. The firm provides science, research, operations, and strategy solutions to organizations and clinics in the natural product, plant medicine, and psychedelic sectors. A recognized leader in shaping the future of integrative and innovative healthcare, Stephanie Karzon Abrams champions the exploration of novel therapeutic approaches. Her interests extend beyond neurology, encompassing plant medicines, women's health, and the potential of music to enhance healing. Check out Stephanie's music label, Public Secret.“Anybody who has any kind of health challenge will have their mental health affected. There is an impact. Just treating that illness or symptom is not enough; you need to heal the mind. You need to heal the soul. They're all interconnected. There's no reason why medical science, especially when we talk about psychedelics, can't address all of that. For me, that's the ultimate goal, if I can use research as a tool to achieve this then I've succeeded.” – Stephanie Karzon AbramsSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this episode, Dr Camidge sits down with Jeanne Fourie Zirkelbach, PhD, a clinical pharmacologist in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the FDA.  Drs Camidge and Zirkelbach discuss how Zirkelbach got her start in the pharmacokinetics field; her involvement with Project Optimus, an initiative by the FDA's Oncology Center of Excellence that works to reform dose-optimization and -selection paradigms in oncology drug development; and how her research with patient-reported outcomes emphasizes the importance of keeping patient needs, preferences, and experiences at the forefront of drug development to minimize the effects of cancer treatment on quality of life.

Guidance Recap Podcast | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

What if we could redefine what it means to be healthy by setting new medical standards? What if medicine could go beyond treating symptoms and treat root causes?In this episode, the brilliant Dr. Shai Efrati enlightens us on a revolutionary concept, enhanced medicine, which goes beyond conventional treatments and focuses on the body's natural healing abilities. Dr. Shai Efrati is a renowned Physician and Professor at Tel Aviv University, specializing in Internal Medicine, Nephrology, Clinical Pharmacology, and Hypertension. He is also a pioneer in hyperbaric medicine and the Author of "Beyond Normal: How the New Science of Enhanced Medicine Elevates Peak Performance and Repairs Brain Injuries."Throughout this episode, you'll learn what enhanced medicine is, why it is so revolutionary, and how it can change how we see medical attention, treatments, and self-care. You'll also hear Dr. Efrati's thoughts on the importance of focusing on root causes, personalized approaches to improve patient care, the multiple benefits of hyperbaric chambers, and much more.Tune in to episode 445 of Becoming Your Best and discover why enhanced medicine can change how we think about health and wellness.Some Questions I Ask:Tell us about your book "Beyond Normal" and why you wrote it (2:10)Let's take someone who has been having headaches for a year and hasn't figured out why. Using your approach, what would you do with that individual? (9:50)In This Episode, You Will Learn:Dr. Efrati explains the hyperoxic-hypoxic paradox and hyperbaric chambers (6:40)Why understanding the core biology of symptoms and interdisciplinary approaches is crucial (15:00)Dr. Eftati's golden definition of what it means aging (27:40)Connect with Dr. Shai Efrati:WebsiteLinkedInYouTubeBook: Dr. Shai Efrati - Beyond Normal: How the New Science of Enhanced Medicine Elevates Peak Performance and Repairs Brain InjuriesBecoming Your Best Resources:Becoming Your Best WebsiteBecoming Your Best University WebsiteBecoming Your Best LibraryEmail: support@becomingyourbest.comBook: Becoming Your Best: The 12 Principles of Highly Successful LeadersBook: Conquer Anxiety: How to Overcome Anxiety and Optimize Your PerformanceFacebook Group – Conquer Anxiety Hosted on Acast. See acast.com/privacy for more information.

Our guest's journey with cannabis began as a youthful experiment but transformed into a profound exploration of its medicinal and truth-telling properties. In this episode of Consciously Cannabis, Stephanie Karzon shares her evolution with cannabis, moving from casual use to a deeper appreciation for its potential for mental and physical wellness. From setting up an integrative medicine clinic in LA to understanding the holistic approach to women's health, Stephanie shares insights into combining Western medical practices with alternative therapies. We explore the significance of treating the whole person rather than just symptoms and the potential of psychedelic therapies in neurological and women's health. We also journey through the multifaceted world of psychedelic-assisted therapy, emphasizing the necessity of safe, structured environments. From the rich historical context of psychedelics to their benefits in clinical settings, we explore how these substances can foster acceptance and support, especially among women facing societal pressures. Wrapping up with reflections on gratitude and self-exploration, we discuss how integrating plant-based therapies into daily routines can enhance emotional well-being and personal growth. Join us for an enlightening conversation on harnessing the power of cannabis and psychedelics for holistic health! Guest bio: Stephanie Karzon Abrams, a neuropharmacologist with a Master of Science in Clinical Pharmacology, is the founding advisor of Beyond The Bench consultancy. The firm provides science, research, operations, and strategy solutions to organizations and clinics in the natural product, plant medicine, and psychedelic sectors. A recognized leader in shaping the future of integrative and innovative healthcare, Stephanie Karzon Abrams champions the exploration of novel therapeutic approaches. Her interests extend beyond neurology, encompassing plant medicines, women's health, and the potential of music to enhance healing. Stephanie is a dedicated advocate for public education and strives to redefine the landscape of health and wellness through open-access education and public speaking. Her passions extend to community building, philanthropy, and music, with a particular focus on integrating her passions through unique gatherings and initiatives that foster connection. Stephanie is the co-creator of Public Secret, a music label, management agency, and artist collective; Mt. Mushmore, Higher Elevation, a social and educational dinner series; and The Last 6, a community organization that educates and funds research for the acute childhood illness, Kawasaki disease. Stephanie's career path transcends traditional boundaries, blending her deep scientific expertise with strategic thinking and a passion for exploring innovative healthcare solutions. Her foundation lies in rigorous research, followed by experience at Johnson and Johnson (Biosense Webster) where she honed her operational, strategic planning, and key opinion leader (KOL) engagement skills. Stephanie's current work as a prescriber of MDMA and psilocybin therapy for the Canadian Special Access Program (SAP), and her role as a scientific advisor for the Microdosing Collective, exemplifies her commitment to advancing these emerging fields. Thanks for listening to another episode. Follow, review, and share to help Consciously Clueless grow! Connect with me: https://www.consciouslycarly.com/ Join the Consciously Clueless community on Patreon: https://www.patreon.com/consciouslycarly Connect on Instagram: https://www.instagram.com/consciously.carly/ Connect on Facebook: https://www.facebook.com/consciously.carly.blog Music by Matthew Baxley

Dr. Oren Cohen, President of Clinical Pharmacology and Chief Medical Officer at Fortrea, a global CRO spun-off from Labcorp, discusses the contract research environment and how it continues to change to meet the need for increased productivity in the development and testing of new drugs, devices, and treatments. One key goal is to work in close partnership with clients to include the patient's voice in trial design to increase diversity, drive recruitment, and improve retention.   Oren explains, "I think with all the pressure the industry is under productivity pressure, that's changed massively. It's a very heavy responsibility because we are entrusted with developing very precious intellectual property that represents the next generation of therapeutics for patients affected by all the diseases out there, from rare diseases to cancer to neurodegenerative diseases like Alzheimer's. It's a very exciting time. I think the science is moving very quickly, and we have the good fortune to be working on some very promising and super interesting potential products." "There's lots of innovation in every aspect of clinical trials, from design through process and execution to analysis. So yes, all that is on the table. I would say that our preferred method of engagement is to partner with our clients to get to the best place in terms of what advances science. What is necessary from a regulatory perspective to push a product along toward approval, to show its mettle? What is best for patients and sites responsible for recruiting them?" "It's a natural marriage because our sponsors, the biopharmaceutical companies we serve, obviously have the best expertise for the particular molecule they're studying. They've potentially discovered it, they have it in their portfolio, and they obviously know a lot about it." #Fortrea #ClinicalTrials #DrugDevelopment #PatientVoice #ClinicalTrialDesign #CRO #ContractResearchOrganization fortrea.com Download the transcript here

Dr. Oren Cohen, President of Clinical Pharmacology and Chief Medical Officer at Fortrea, a global CRO spun-off from Labcorp, discusses the contract research environment and how it continues to change to meet the need for increased productivity in the development and testing of new drugs, devices, and treatments. One key goal is to work in close partnership with clients to include the patient's voice in trial design to increase diversity, drive recruitment, and improve retention.   Oren explains, "I think with all the pressure the industry is under productivity pressure, that's changed massively. It's a very heavy responsibility because we are entrusted with developing very precious intellectual property that represents the next generation of therapeutics for patients affected by all the diseases out there, from rare diseases to cancer to neurodegenerative diseases like Alzheimer's. It's a very exciting time. I think the science is moving very quickly, and we have the good fortune to be working on some very promising and super interesting potential products." "There's lots of innovation in every aspect of clinical trials, from design through process and execution to analysis. So yes, all that is on the table. I would say that our preferred method of engagement is to partner with our clients to get to the best place in terms of what advances science. What is necessary from a regulatory perspective to push a product along toward approval, to show its mettle? What is best for patients and sites responsible for recruiting them?" "It's a natural marriage because our sponsors, the biopharmaceutical companies we serve, obviously have the best expertise for the particular molecule they're studying. They've potentially discovered it, they have it in their portfolio, and they obviously know a lot about it." #Fortrea #ClinicalTrials #DrugDevelopment #PatientVoice #ClinicalTrialDesign #CRO #ContractResearchOrganization fortrea.com Listen to the podcast here

In this week's episode, Danie du Plessis, Executive Vice President, Pharmaceutical Operations, Kyowa Kirin, sits down with the EMJ GOLD team to share the value that patient partnerships can hold in the industry. Danie explores how patient partnerships have evolved over the years, what companies should be doing to get them to their best potential, the value of learning from others and much more. A little more on EMJ GOLD's guest… After completing his medical studies and a Master's Degree in Clinical Pharmacology in South Africa, Danie spent three years working in a primary care setting including his own private practice. He joined the pharmaceutical industry in 1993, worked in medical affairs, marketing and sales, pharmacovigilance and clinical operations. He has held roles such as including Senior Vice President and Head of Worldwide Medical Affairs at GlaxoSmithKline. Danie joined Kyowa Kirin International in August 2019 as head of Medical Affairs and has been Executive Vice President Pharmaceutical Operations since April 2024.  He is also a Director and Chair of the Global non-profit Medical Affairs Professional Society (MAPS) Board, Fellow of the Faculty of Pharmaceutical Medicine in the UK, visiting senior lecturer at King's College, London and an affiliate member of the Association for Professional Executive Coaching and Supervision (APECS). 

On this episode, Susan McCune, MD (VP, Pediatrics & Clinical Pharmacology, The PPD Clinical Research Business of Thermo Fisher Scientific) and Jacqui Whiteway, PhD (Senior Director & Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON plc) join the podcast to discuss what makes pediatric clinical trials unique and how industry can make participation easier for pediatric patients and their families.They dive deeper into the role that compassion plays in designing successful trials, the importance of including pediatric patients and families in trial protocol design, and creative tools to boost patient engagement

Guidance Recap Podcast | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics

Youtube https://youtu.be/2wiIZNf8aT0 https://integral-clinic.com Dr. Torres is a Medical Doctor(MX), a licensed acupuncturist, and has a Master's Degree in Chinese Medicine (TCM). While she has not been in practice for quite 3,000 years, she is one of Chicago's most experienced and respected holistic practitioners. “Let's treat your mind, body, and spirit to achieve a whole new level of well-being. Dr. Cristina Torres has always been interested in solving health problems for people. She received her medical degree from the UNAM Autonomous University of Mexico in Mexico City. Dr. Torres extended her studies at UNAM to earn an additional Diploma in Clinical Pharmacology. Several years of practicing medicine in Mexico were followed by working in the private industry where she was involved in pharmaceutical product development, regulation, and compliance. While conducting clinical trials she participated in initiatives to promote good clinical practices, patient rights, and their protection while participating in clinical trials in Mexico and Latin America. Ms. Torres desired, however, to return to direct contact with patients in a holistic way. While living in the United States she discovered that Traditional Chinese Medicine would offer what she was looking for in terms of practicing medicine and patient treatment. She pursued a Master's degree in Traditional Chinese Medicine at the Pacific College of Oriental Medicine in Chicago and obtained Certification from NCCAOM. She also has board certification as a Hypnotherapist from the American Board of Hypnotherapy. Dr. Torres is considered a holistic practitioner as she applies one or more modalities to support patients healing, she has a private practice in Illinois where she is part of a network of practitioners aimed at the prevention and early management of diseases.

Listen to Dr Charly Annesley (Consultant Learning Disability physician) and Dr Rebecca Kuruvilla (RCP clinical education fellow and Clinical Pharmacology and GIM registrar) discuss health inequalities in the population of patients living with a learning disability and why we need more physicians who are trained in this area of medicine. They also talk to Dr Alex Tyler who is an ST6 registrar in Geriatrics and GIM who is completing a PG certificate in Medical Practice in Adult Learning Disability.Dr Charly Annesley is a consultant learning disability physician. She works at North Middlesex University hospital in London, having set up the first and only post of its kind in the country. She is also an honorary clinical lecturer and course lead for a postgraduate certificate in Learning Disability Medicine that is run with the RCP and Edge hill university.Links: Training Programme to meet the Medical Needs of Adults with a Learning Disability | RCP LondonLearning from Lives and Deaths - people with a learning disability and autistic people (LeDeR) - King's College London (kcl.ac.uk)BTS clinical statement on aspiration pneumonia | Thorax (bmj.com)BTS Clinical Statement on the prevention and management of community-acquired pneumonia in people with learning disability | Thorax (bmj.com)Master LeDeR 2023 (2022 report) (kcl.ac.uk)RCP Toolkit:  Acute medical care for people with a learning disabilityThis podcast has been made with an educational grant from Bristol-Myers Squibb Pharmaceuticals Limited (“BMS”). BMS has had no input or involvement in the design, development or content of the podcast whatsoever. Sound by bensound.com

Join us as we welcome Dr. Emma Magavern to The Genetics Podcast! In addition to being a medical doctor with an English Literature degree, Dr. Magovern is a Clinical Research Fellow at the Centre of Clinical Pharmacology and Precision Medicine at Queen Mary, Barts, and the London School of Medicine and Dentistry. Emma also works closely with East London Genes and Health, a program dedicated to increasing engagement in a community that is underrepresented in research. Most recently, she published a paper looking at pharmacogenomics in a British South Asian population. Tune in to this interesting episode!

Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

Pediatricians, families, and pharmacists are faced with increasing drug costs and a vast array of complex biologic therapies. Up-to-date knowledge on prescribing practice is constantly a need, specifically regarding generics and the availability of biosimilar and interchangeable biosimilar agents. According to a report from the Association for Accessible Medicines, the U.S. healthcare system saved $408 billion from using generic and biosimilar drugs in 2022, a huge jump from the $195 billion in savings accumulated in 2013. In today's episode, we have a rare opportunity to learn critical knowledge about this topic from renowned experts in the field.  We are joined by John Routt Reigart, MD, and Dr. Siu. Dr. Reigart is professor emeritus at the Medical University of South Carolina as well as the chairperson for the American Academy of Pediatrics' (AAP) Committee on Drugs. “I have been recognized in my state, and to some extent nationally, as being an advocate for improved health for children. I feel that it's very important that pediatricians be advocates for effective regulations for their patients,” Dr. Reigart says.  Dr. Siu is a clinical professor, the vice chair for teaching and learning, and the director of faculty mentoring at the Ernest Mario School of Pharmacy at Rutgers University. She is a pediatric pharmacy clinical coordinator and practices at the K. Hovnanian Children's Hospital and Jersey Shore University Medical Center. She has also been appointed to the board of directors of the Board of Pharmacy Specialties and the pediatric pharmacy association liaison for the AAP Section on Clinical Pharmacology and Therapeutics executive committee. “We want to make sure that medications are easily accessible to families and we also want to make sure that they are also cost effective,” Anita Sui, PharmD, says.  This episode was recorded at the 2023 American Academy of Pediatrics National Conference and Exhibition. Some highlights from this episode include:  The difference between biologics and generics  What the orange and purple books are and their roles in the industry  What an interchangeable product is  Patents and exclusivity  What savings could look like with an uptick of biologics and generics    For more information on Children's Colorado, visit: childrenscolorado.org    

CME credits: 0.75 Valid until: 26-01-2025 Claim your CME credit at https://reachmd.com/programs/cme/putting-it-all-together-coordinating-the-multidisciplinary-care-plan-for-the-elderly-patient-with-atrial-fibrillation/17992/ Older patients with atrial fibrillation (AF) are challenging to treat due to concomitant increased risk for both stroke and bleeding and the presence of an increasing number of comorbidities. Data from clinical trials, meta-analyses, and real-world evidence support the relative merits of NOAC therapy compared with conventional anticoagulation in treating elderly patients with AF. This program focuses on the factors and considerations that can drive the choice of anticoagulation therapy for elderly patients with AF, such as comorbidities and associated medications, falling risk, and monitoring and treatment adherence, which may help clinicians optimize the care of their elderly patients with AF.

CME credits: 0.75 Valid until: 26-01-2025 Claim your CME credit at https://reachmd.com/programs/cme/the-case-of-arthur-frank-how-do-we-manage-elderly-patients-with-atrial-fibrillation/17991/ Older patients with atrial fibrillation (AF) are challenging to treat due to concomitant increased risk for both stroke and bleeding and the presence of an increasing number of comorbidities. Data from clinical trials, meta-analyses, and real-world evidence support the relative merits of NOAC therapy compared with conventional anticoagulation in treating elderly patients with AF. This program focuses on the factors and considerations that can drive the choice of anticoagulation therapy for elderly patients with AF, such as comorbidities and associated medications, falling risk, and monitoring and treatment adherence, which may help clinicians optimize the care of their elderly patients with AF.

CME credits: 0.75 Valid until: 26-01-2025 Claim your CME credit at https://reachmd.com/programs/cme/what-anticoagulation-options-are-available-to-optimize-care-in-the-management-of-elderly-patients-with-atrial-fibrillation/17990/ Older patients with atrial fibrillation (AF) are challenging to treat due to concomitant increased risk for both stroke and bleeding and the presence of an increasing number of comorbidities. Data from clinical trials, meta-analyses, and real-world evidence support the relative merits of NOAC therapy compared with conventional anticoagulation in treating elderly patients with AF. This program focuses on the factors and considerations that can drive the choice of anticoagulation therapy for elderly patients with AF, such as comorbidities and associated medications, falling risk, and monitoring and treatment adherence, which may help clinicians optimize the care of their elderly patients with AF.

CME credits: 0.75 Valid until: 26-01-2025 Claim your CME credit at https://reachmd.com/programs/cme/how-do-i-improve-the-ability-to-screen-interpret-and-diagnose-elderly-patients-with-atrial-fibrillation/17989/ Older patients with atrial fibrillation (AF) are challenging to treat due to concomitant increased risk for both stroke and bleeding and the presence of an increasing number of comorbidities. Data from clinical trials, meta-analyses, and real-world evidence support the relative merits of NOAC therapy compared with conventional anticoagulation in treating elderly patients with AF. This program focuses on the factors and considerations that can drive the choice of anticoagulation therapy for elderly patients with AF, such as comorbidities and associated medications, falling risk, and monitoring and treatment adherence, which may help clinicians optimize the care of their elderly patients with AF.

Today's episode is about cell therapies, including CAR T-cell theraphy for cancer. I give an overview of cell therapy and the challenges of clinical pharmacology in this new area of research. Links discussed in the show: CAR T-cell Therapy Image You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

In this instalment of The G Word, our guests engage in a compelling discussion centred around a recently published paper that supports the integration of whole genome sequencing into standard cancer care.  Our guests shed light on the transformative potential of combining health data with whole genome data. Discover how this innovative approach empowers doctors to deliver more personalised and effective care. Our guests delve into the findings of a landmark national study, unravelling the significance of identifying inherited cancers for patients and their families. The episode explores not only the scientific advancements but also the real-world impact on individuals facing a cancer diagnosis.  Our host Naimah Callachand is joined by Dr Nirupa Murugaesu, a Consultant in medical oncology at Guy's and St Thomas' NHS Foundation Trust, and the Principal Clinician for Cancer Genomics and Clinical Studies at Genomics England.  And by Professor Sir Mark Caulfield, a Professor of Clinical Pharmacology at Queen Mary University of London, and who previously served as Chief Scientist for Genomics England and was instrumental in the delivery of the 100,000 Genomes Project.    "In cancer we were sequencing sections of the tumour and comparing them to DNA inherited from your mum and dad, and that comparison allows us to work out what is driving the cancer, what may be affecting its potential for treatment and how we might choose treatments for patients.  So this is a real opportunity to create precision cancer care."     You can read the transcript below or download it here: https://files.genomicsengland.co.uk/documents/Podcast-transcripts/Whole-genome-sequencing-in-cancer-care.docx   Naimah: Welcome to the G Word.  What does it mean if we can test for inherited genes?    Nirupa: It can influence how their cancer is treated.  So it means that there may be certain types of therapy that are available if they have a specific inherited cancer gene, number one.  It also can impact in terms of preventing further or other cancers related to those genes, and it may impact the type of surgery they have, and also the type of overall cancer treatment.  And then finally, if they have got an inherited cancer, then, as I mentioned before, it may impact in terms of testing and screening for their family members.  Naimah: I'm your host Naimah: Callachand.  Today, I'm delighted to be joined by Dr Nirupa Murugaesu, who's a consultant in medical oncology at Guy's and St Thomas' NHS Foundation Trust, and the principal clinician for cancer genomics and clinical studies here at Genomics England.  And Professor Sir Mark Caufield, who's a Professor of Clinical Pharmacology at Queen Mary University of London, and who previously served as chief scientist for Genomics England and was instrumental in the delivery of the 100,000 genomes project.  Today, Mark and Nirupa are going to discuss key findings from a recent paper that's just been published in Nature.  If you enjoy today's podcast, we'd really love your support.  Please like, share and rate us on wherever you listen to your podcasts.  Now, let's get into the interview.  So first of all, Mark, I wondered if you could give me a bit of background on the 100,000 genomes project?  Mark: So the 100,000 genomes project started in July 2013 following an announcement by the then prime minister, David Cameron, that the UK would be the first health system in the world to sequence 100,000 whole genomes, which is as much as you and I can read of the genetic code.  In the case of cancer, which we focused on here, in cancer we were sequencing sections of the tumour and comparing them to DNA inherited from your mum and dad, and that comparison allows us to work out what is driving the cancer, what may be affecting its potential for treatment and how we might choose treatments for patients.  So this is a real opportunity to create precision cancer care.  Naimah: And Nirupa, can you tell me what the 100,000 genomes project meant for these patients with cancer?   Nirupa: I think, firstly, we're very grateful for all of the participants in the programme, because what it's allowed us to do is to look at the data as a whole, and having all of that sequencing data alongside clinical information has been incredibly valuable, it has also developed the infrastructure for testing.  And really I think for patients with cancer, they participated in this programme as a research project, and unusually for a research project these results were returned back to treating clinicians to clinical teams, if there may have been a result that would impact or change their management.  But I think, importantly, what it enabled is the implementation of standardised cancer testing in the NHS, and really enabling that for a wider range of patients, not just those that participated in the project.  And because of patients participating, this then allowed all of the data to be stored in a single place, and this has been incredibly valuable for clinical academics and researchers.    Naimah: And can I ask what specific types of cancer that were looked at in 100,000 genomes project?   Nirupa: Again, the project was set up such that we allowed a number of different types of cancers to be sequenced and, therefore, very permissible, because we also wanted to ensure that some of the less common and rarer cancers were also sequenced and, as you would expect, more of the common cancers as well.  In addition, I think the opportunity to sequence paediatric cancers, as well as haematological malignancies, or blood cancers, was also key as part of the cancer programme.  Here, we focus on the solid cancers, but obviously there was a much wider range of cancers that were sequenced.    Naimah: And next, can we move on to talk about the findings of the study?  Nirupa: I think, firstly, by undertaking sort of a pan-cancer analysis, it really gave us an overview of the number of target and genes that were found to be actionable.  And what I mean by that is that they have a, well, clinically relevant, and we can see that in certain cancer types, such as in brain cancers, in colon cancers, lung cancers, there were within the genome sequence more than 50% of these cancers had something that was what we would call actionable.  So there was a mutation in a gene for which this would influence treatment.  And as we started to look more across the entire cohort of patients, you can really get an idea of the fact that the more that we sequence, and the more comprehensive the testing is, the number of different types of mutations that we were able to discover.     Naimah: And when you mentioned that these findings were actionable, what does that mean?  Nirupa: So what that means is that has an impact in how the patient will be managed and treated.  It may influence, firstly, the type of surgery they have, it may influence the type of cancer treatment that they receive.  And all of this, I suppose, comes back to the point that Mark mentioned, of precision oncology, so we more precisely treat patients based on their individual cancers.     Naimah: And could you give me some examples of maybe some of these genes that were found in the study that were actionable?  Nirupa: Yes, so the types of genes also matter, or the type of mutations.  So some of them were in known cancer genes, and if you have, for example, a mutation in lung cancer, in a gene called the EGFR gene, we know that there are cancer therapies that can be provided that target specifically this mutation.  So that's one example, and this is quite well characterised and understood in oncology care.  But what we were also able to do with whole genome sequencing, is identify different types of mutations that are harder to characterise routinely.  And these are often included things that we call pan-genomic markers, where we can see what the mutational landscape is of the cancer, the different patterns of mutations can be gleaned from this, and often this can then give you an idea of the underlying biology of the cancer.  But importantly, in certain types of cancers, such as high grade serious ovarian cancer, it highlights which patients may have a particular marker that means they may or may not benefit from a particular type of therapy.  So in this particular case, the class of therapy is called PARP inhibitors.  Naimah: And how did the study compare to other similar stuff studies in the genomics area?  Nirupa: That's a really good question, and I think we looked at this from other large sequencing endeavours, such as the ICGC, TCGA, so these are big studies where have been whole genomes sequencing.  Also within the Hartwig Institute in the Netherlands, they've also undertaken whole genome sequencing for cancer patients.  And what we were able to identify is that the patterns of mutations were as expected, we found, you know, a lot of similarities.  I think the difference, the main difference is not just identifying the type of mutations across the different cancers.  But the fact that we were then able to look at the longitudinal outcome, and correlate some of these genomic markers with outcomes related to both therapies, as well as survival impact of having certain mutations in terms of prognosis.    Naimah: Mark, do you have something you'd like to add there as well?  Mark: Yeah.  So one of the things that we did in the 100,000 genomes project, was to evaluate the best way of measuring the whole of your or my genetic code.  And we discovered that very early on that if you expose the tumour to a preservative, which is called formalin which keeps the tumour preserved, that actually you could get quite a number of misleading findings.  And so to address that, the distinctiveness from former programmes, such as Nirupa mentioned, like the Cancer Genome Atlas, is that all of the tumours that we studied in this paper were actually produced under fresh tissue conditions, and have not been exposed to a preservative.  And that means that what we have is a really accurate reflection of the variation within the tumours.  And the other thing about this particular resource is it's the biggest resource.  We were able to look at 13,000 people with solid tumours, but we also had blood cancers and other cancers which also feature of this paper.    And a further remarkable thing about this is early on, Nirupa and the team and I decided that we would longitudinally life-course follow the patients and by accruing data from multiple sources in the health system.  So, every attendance at the hospital, what chemotherapy was had, we've been able in this paper to recapitulate signatures that clearly show that certain mutations are harmful.  And many of the findings that we've made are absolutely, if you look at the survival of patients particularly, you can see almost identical patterns to those in clinical trials.  What this means is that by the really rich data set which is now many billions of clinical data points on these patients, we can actually look for long-term signals of benefit and harm that perhaps would not be detected by a clinical trial that might last for six months or a year.  So this is a really valuable resource, and the really great thing is we can use what's called real-world data, which is where we take routine health data, and we can recapitulate the findings from tightly controlled clinical trials.  And I think that's quite an important finding.    Naimah: That kind of brings me onto the next question, Mark, where I want to talk about the value and benefit of genomics sequencing for cancer patients.  I wondered if you could expand?  Mark: Well, what we know from one of the genomics medicine centres which were regional hubs, is that they use the information that we return, that Nirupa outlined earlier in a report, for 25% of their patients.  Which means that they concluded having evaluated that as the clinical team locally, that there was something the patients could benefit from.  Now, what we think is this makes the case for certain cancers being part of the national genomics test directory whole genome sequencing, but it's still the case that the majority of testing for cancer is now very large focused panels that are focused on specific gene features.  But in some measure, this work is also able to reassure us that those gene features are the right ones to focus on, so this work has been very useful in that respect, even where the NHS today cannot make the financial or clinical case for using whole genomes in specific cancers.  So I think the programme's made a massive difference.    The biggest thing it's done for patients, which Nirupa was very actively involved in, is it's allowed us to create a national genomics test directory.  So when we started this, cancer genomic testing was completely random and would vary from one postcode to another, one hospital to another.  And what Nirupa and the cancer team created is a national cancer genomic test directory, which now means that standard of care, that's the basis for reimbursement, and it's available across the landscape of 56 million people.  And given that one in two of us will have cancer, this is a massive advance.    Naimah: Yeah, you've really highlighted the impact of having access to such a large database.  And I just wanted to ask as well, what are the challenges associated with implementing routine whole genome sequencing into clinical care?  Nirupa: I think as with all of these things when implementing something new within a healthcare system, it requires a level of education, upskilling and also, as Mark has touched on, how we handle the tumour tissue, so that it's handled in a genomic-friendly way to enable the best results if you like, because we want to ensure that their DNA is not damaged so that we can get accurate read-outs on the results.  So there are challenges and there is also cost implications in weighing up the pros and cons.  And I think what we were able to show, and by undertaking this sort of pan-cancer analysis, is where there are those cancer type where there is a real need for whole genome sequencing, or where it can be justified, because there are a number of different types of mutations both within the tumour.  And also from a blood sample that is also taken, so this is your constitutional DNA, so this is if there is a risk of an inherited cancer.  So we are able to pull together all of this information, and obviously that's important, not just for the patient, and their management, but also for family members.  So I think really what this shows is that where you have to identify many of these different types of mutations, whole genome sequencing enables that through a single test.   Naimah: Mark, would you like to add something else there?  Mark: One thing I think which Nirupa's very much part of, is the distinctiveness of the Genomics England approach has been to involve the NHS at every stage.  Now, what that means is we estimate that at the peak of the 100,000 genomes project, 5,000 frontline NHS staff touched the project at some point in their working week.  What that does mean is that Nirupa and the cancer team could realign the cancer tissue handling pathways.  But it also meant that we were able to upskill the frontline workforce, such that at the end of the programme, when we produced a genomic test directory, they were really up for it because they did not want all the hard work they'd put in to stop.  And so what we've done is produce the national test directory within five years of starting, that wasn't a deliverable for the project, but it was nonetheless obvious to all of us working in it, including NHS England, that there needed to be service transformation, and we've managed to effect it.    Now, if you look at other settings where perhaps Nirupa and I might have a research team, we might do it some distance from the health system, it would be in the health system, but not with the health system, then it takes between nine and 16 years to get these things into clinical practice.  And that was achieved here in five years.  So there is a lesson from this, the cancer programme particularly, because the cancer programme testing was very limited when we started, but you can take an entire workforce on a journey and leave them with the legacy of an entirely transformed system for patients.  And thankfully because we got, Nirupa and I, the NHS to agree to reimburse for the testing directory being used, we have eliminated a lot of randomness that was in the system previously.  So it's quite an important advance in that respect, and it really does show in the beautiful work that Nirupa was describing exactly how you can use this information to change an entire system.  And the NHS is not the easiest system to change in the world.  Naimah: Nirupa, you mentioned the findings show that there was potentially inherited genes.  Can you tell me what does that really mean for patients, if we're able to diagnose these inherited genes sooner in life?  Nirupa: It can influence how their cancer is treated, so it means that there may be certain types of therapy that are available if they have a specific inherited cancer gene, number one.  It also, can impact in terms of preventing further or other cancers related to those genes, and it may impact the type of surgery they have, and also the type of overall cancer treatment.  And then, finally, if they have got an inherited cancer, then, as I mentioned before, it may impact in terms of testing and screening for their family members.  And that's really key as well, because this means that their cancer can be diagnosed, if they do develop a cancer, because they're being monitored, because it's much more targeted, their approach in terms of screening for a particular type of cancer, they can potentially have their cancer treated much earlier.  Or even better, before it becomes what we call an invasive cancer but at the pre-cancerous stage.  So this has huge implications, and what we're finding actually with more and more testing – and this is not just... our study was consistent with other studies that have been published – is that when you undertake more routine testing, then you are able to identify this.  It is not common amongst the population, but in those patients where it is relevant, it really can impact their care.  Naimah: Mark, do you have something to add there?  Mark: Well, I think Nirupa's just highlighted a really important point.  So to bring that into a little bit more ways of which people listening to this can relate to it, we have a family where there was a women who had no family history of breast cancer, she developed breast cancer, and in the tumour we found that she had a BRCA 2 mutation.  We also found that she'd probably acquired that or inherited it, we don't know.  That for her meant that she could enter the Olympia trial, which was running at the time, which Nirupa alluded to earlier, was a study of PARP inhibitors.  But without that genetic makeup she'd never have got into that trial, and she probably wouldn't have been tested for BRCA at that time in the NHS because she had no family history, I think that's probably right, Nirupa.    And then there was a family-wide consequence for that, because she had a brother and son, and she also had a daughter, and the daughter was under 30 at the time and underwent BRCA testing and was BRCA 2 positive.  But she has the opportunity now to enter intensive breast screening from the age of 30, and that's what's happened.  And her brother, and this is the lady who had the breast cancer, her brother and her son may be at risk of prostate cancer, so they can consider testing.  So Nirupa makes a really important point, that when people have inherited a previous disposition to cancer, that can have a family-wide impact.  And one test in one family member can open the doors to opportunity for others to understand their risk and to be screened more actively and intensively, hopefully with meaning that if they do develop cancer it will be detected very early, or maybe we can just prevent it altogether.     Naimah: Thanks, Mark, a really good example of the impact that this testing has had.  I just wanted to touch back on your point, Mark, that you'd made about real-world data.  And I wondered actually, Nirupa, if you could kind of explain to me why it's important to link real-world data to the genomic data?  Nirupa: Yeah.  So I think the work we've done here really does emphasise this, because when we refer to real-world data, we're talking about different types of healthcare data across the population.  And we had the opportunity to link the genomic data to a number of key data sets that are curated by the cancer registry, the national cancer registry database.  And this includes things like all of the population base systemic anti-cancer therapy, so we know that for each of the participants the type of cancer therapy they receive, and also, as Mark has mentioned previously, the hospital episode.  So when patients needed to be... we can see their data in terms of admissions, investigations, and so on.  And these are really valuable data points, because you get an indication of when patients may have had to then have further testing, or if there is a risk of recurrence and importantly survival data, because a lot of this has been, in terms of a lot of the cancer genes have been well characterised and tested.    But what we were able to do here at a pan-cancer level on a large cohort of patients over a period of time, is to look at if you had a particular mutation, what is the impact of that in terms of outcome for a particular cancer type, and even more broadly, on a pan-cancer level?  And actually, as this type of data accumulates, I think the real value, and if you've got a larger number, you know, what is the value for patients who've participated in this programme going forwards, is that as that data accumulates and the numbers go up, we are able to then ask more detailed questions.  What is the impact of a particular type of mutation, or a particular type of variant within a gene?  And, importantly, what happens when you get a different sequence or a combination of genes?  And how does that impact?  And this, I feel, is the way that we are going to move more towards precision oncology, because we are beginning to understand the cancer in more detail, how it is going to behave, and then try and tailor therapies accordingly.   Naimah: And Nirupa, I wondered if you could tell me as well if the findings from this study have benefited directly those patients that were involved in the 100,000 genome project?  Nirupa: It has benefited some of the patients because, as Mark has mentioned, there are findings that we weren't expecting in terms of potentially inherited cancers and, therefore, this has had implications.  The way that the project was set up from the outset, is that we were obtaining tumour samples from patients who had not received any previous cancer therapy.  And what this meant is that this was predominantly in patients, so they were treatment naïve with early stage disease that were having surgery to treat their cancers.  And as such, what we know is that fortunately most of those patients did not require further therapy, because their cancers were treated successfully with surgery.  But what it did tell us, and what it's really highlighted, is the number of important genes that were identified.  And so whilst it may not have impacted patients directly, it's enabled us to study the biology of the different types of cancers, how they behave, along with the longitudinal clinical data.    But what it is doing now, is through the national test directory through the genomic medicine service, is enabling testing for patients that unfortunately now have more advanced cancers, but where these genomic findings are more likely to impact directly in terms of therapy.  So, for instance, as we've mentioned, the ability to have whole genome sequencing for patients with high grade serious ovarian cancers, means that this will impact the type of treatment they have.  And this also was the tumour type where we found the highest number of patients with BRCA mutations, so we have a potential inherited risk of a cancer as well.  So now what we have learnt and the infrastructure that we have developed has enabled this to have a real impact, not just for patients in the project now, but wider within the NHS.  Naimah: Mark, would you like to add something else there?  Mark: I think Nirupa's encapsulated it very well.  There were a range of benefits, so I mentioned earlier that in one centre 25% we have evidence got a benefit for their treatment for their cancer in some way shape or form.  So an example to what there might be is that some people got a medicine they wouldn't have received from routine care, and that might have been licensed for the treatment of that tumour, but it wouldn't have been the first line treatment choice.  Some people got medicines that they wouldn't have got because we don't normally associate using that medicine with that cancer, but they had a signature that showed that they were very likely to benefit.  Quite high numbers got an opportunity to get into a clinical trial, which is really important because if you look, over 50% of global oncology trials now have some kind of biomarker or diagnostic, or something like this alongside, what better than to have a comprehensive inventory of the variants and the cancer, and to be able over time to use that library to understand better the treatment course of that patient.  And that's what I think a whole genome adds, rather than the single, look at a single part of the genetic makeup.   And then finally, some had lots of mutations, really high rates of mutations, and maybe they should receive specific advance therapies, like immunotherapies.  Or alternatively, they had a feature in their genetic makeup which it looks like they inherited, as Nirupa absolutely correctly said earlier, these people need to be followed-up and they need more intensive screening, because this is how you detect cancer at an earlier stage.  And the final way people benefited is we could detect genetic changes in  their DNA that meant that if they were exposed to certain medicines, they were likely to suffer harm. And there's a particular, two medicines, 5-fluorouracil capecitabine, where possibly about 5% of people will need either a reduced dose or a completely different medicine, because it will be very harmful.  And so this is about getting the right medicine to the right patient first time, and getting the right outcome for that patient downstream.    And I think, you know, Nirupa's encapsulated it perfectly, there's a whole range of benefits that the patients can accrue from this.  And I think we should probably, Nirupa, say that people were quite cynical when we started, about what it would be that you would get over and above, for example, the cancer genome map that's at the international cancer genome consortium.  And, you know, I'd had leading cancer scientists in Britain say, "Oh well, we've discovered it all, there's nothing to find here."  And I think what this paper shows is that's not entirely true.    Nirupa: I would agree with that Mark, but I would also probably add that it highlights the value of having a large data set alongside that clinical information.  And what we were also able to do,  is whilst we very much talked about what were the gene targets that had a direct impact or genomic markers that impact care now, for which there is an approved therapy.  What we've also been able to do through this analysis, is actually highlight the number of mutations that have been identified for which there is a licence therapy in another cancer type, but not in that particular cancer type.  And what that means, is that specially now, as we have more and more biomarker-driven therapies, I mean, if we look at that compared to when the project started and now, that has increased dramatically.  And what that means is then there are sort of licensed medications that actually can be used in non-licensed indications via a clinical trial, via these very, you know, these basket studies which are across cancer types and are actually based on different types of molecular markers.  And really, we're able to show this at a pan-cancer level across the 13,000 tumours through the results from whole genome sequencing.  Naimah: You've both kind of touched on this throughout and, you know, we've talked about the development of personalised medicine.  And where do you see the future of cancer treatment in the next five years?  Maybe, Nirupa, we can go to you first?  Nirupa: That's a very good question.  I think and what I hope is that with more comprehensive and equitable and standardised testing for patients, especially within the NHS, that this will enable more personalised and targeted therapy alongside, you know, systemic chemotherapy.  And as well as that, better selection of patients that are likely to benefit from the newer immunotherapies.  And also where sequencing is very exciting, is that once we begin to understand more about the individual tumours, you know, going forwards there are a number of cancer vaccine trials, and the aim of those are to have specific vaccines that are going to target an individual's tumour.  So I think in the next five years, this is I think a very exciting space, I hope so, because we need to keep doing more in the space for our patients to try and improve therapy and precision oncology for them.  Naimah: And Mark, do you have anything to add to that point?  Mark: I think Nirupa's right, that there are new therapy extractions coming on, vaccination's one way.  But I think that what will become clear is whether we can use any molecular mechanisms for early detection of cancer.  The battleground here is that we all too often detect cancer late, when it's already outside of the organ it originated in and may be spread in other parts of the body.  It's very hard to effect a cure, almost impossible in that setting.  But what if we could detect cancer earlier?  And then what if we could place a whole genome or detailed molecular characterisation alongside that?  And then, as Nirupa suggested, give someone a vaccine tailored to their tumour that would eliminate it.  The real problem is all too often we detect cancer late, so maybe some of these new molecular diagnostics, such as cell-free tumour DNA will usher in an era of early detection.    And one of the things, and particularly before we did this project but also up until the beginning of the last decade, there were very few good biomarkers of cancer that were usable in the health system.  So we have for the first time opened the vista of having early detection, if we combine early detection with detailed molecular characterisation, possibly a whole genome, possibly another test, then I think we really can usher in the era of precision medicine.  And so I think Nirupa's absolutely right, there will be new treatments, there always will be, but what we have to do is to get detection at an earlier stage.  Naimah: We'll wrap up there.  Thank you to our guests, Dr Nirupa Murugaesu and Professor Sir Mark Caulfield for joining me today.  If you'd like to hear more about this, please subscribe to the G Word on your favourite podcast app.  Thank you for listening.   

Welcome to our 100th episode! This week we talked to the renowned Dr. David T. Rubin! Dr. Rubin is the Joseph B. Kirsner Professor of Medicine and a Professor of Pathology, Chief of the Section of Gastroenterology, Hepatology & Nutrition and the Co-Director of the Digestive Diseases Center at The University of Chicago Medicine. He also currently serves as an associate faculty member at the MacLean Center for Clinical Medical Ethics, an associate investigator at the University of Chicago Comprehensive Cancer Center and is a member of the University of Chicago Committee on Clinical Pharmacology and Pharmacogenomics. He is the chair of the National Scientific Advisory Committee of the Crohn's & Colitis Foundation, where he also serves as a Board of Trustees member. He is the deputy chair of the Executive Committee of the International Organization for the Study of Inflammatory Bowel Disease.  In 2018, Dr. Rubin completed the Harvard T.H. Chan School of Public Health Leadership Development Course for Physicians.Dr. Rubin is a Fellow of the American Gastroenterological Association (AGA), the American College of Gastroenterology (ACG), the American Society for Gastrointestinal Endoscopy (ASGE), the American College of Physicians (ACP), and the Royal College of Physicians (Edinburgh). He is on the Board of Trustees for the ACG. Among numerous awards and honors, Dr. Rubin was chosen by his peers as a member of Best Doctors (recognized for superior clinical ability) and America's Top Physicians (gastroenterology). Additionally, he twice received the ACG's Governor's Award of Excellence in Clinical Research (2003 and 2013), and the UChicago Postgraduate Teaching Award in recognition of significant contributions for fellowship education (2006). In 2012, he received the Crohn's & Colitis Foundation's Rosenthal Award, a national leadership award bestowed upon a volunteer who has contributed in an indisputable way to the quality of life of patients and families. He is an Associate Editor of the journal Gastroenterology and Editor-in-Chief of the ACG On-Line Education Universe. In 2020, Dr. Rubin received the Sherman Prize for Excellence in Crohn's and Colitis.Dr. Rubin is an editor of a best-selling book Curbside Consultation in IBD which is now in its 3rd edition and an author or coauthor of over 500 articles on treatment and management of IBD, cancer in IBD and novel paradigms, as well as the first author of the 2019 ACG Guidelines for ulcerative colitis. His current research is in the area of novel approaches to monitoring of IBD (wearables and point of care intestinal ultrasound), prevention of progressive complications from uncontrolled inflammation, and a variety of collaborative and translational studies related to the causes of IBD and its complications. Episodes from some of Dr. Rubin's UChicago's team: Dr. Alysse Bedell- Gastro PsychologistMichele Rubin, APN- JPouch surgical nurse extraordinaireMarita Kametas- Ostomy Specialist! Dr. David Choi- IBD PharmacistPlease keep in mind that the views and opinions expressed in this program are those of the speakers and should not be considered medical or legal advice. Please consult with your healthcare team on any changes to your disease, diet, or treatment.Let's get social!!Follow us on Instagram!Follow us on Facebook!Follow us on Twitter!

In 2011, a paper was published in Pharmacogenomics and Personalized Medicine examining the relationship of antidepressants and akathisia side effects in those with genetic mutations in the metabolizing genes of the CYP450 family. In the study, eight of the subjects had committed homicide and many more became extremely violent while on antidepressants. On today's podcast we welcome one of the co-authors, Christopher Crotty, and subject, David Carmichael, to share their stories.Note: This podcast episode is designed solely for informational and educational purposes, without endorsing or promoting any specific medical treatments. We strongly advise consulting with a qualified healthcare professional before making any medical decisions or taking any actions.*If you are in crisis or believe you have an emergency, please contact your doctor or dial 911. If you are contemplating suicide, call 1-800-273-TALK to speak with a trained and skilled counselor.RADICALLY GENUINE PODCASTDr. Roger McFillin / Radically Genuine WebsiteYouTube @RadicallyGenuineDr. Roger McFillin (@DrMcFillin) / X (Twitter)Substack | Radically Genuine | Dr. Roger McFillinInstagram @radicallygenuineContact Radically Genuine—-----------FREE DOWNLOAD! DISTRESS TOLERANCE SKILLS—----------ADDITIONAL RESOURCESLucire, & Crotty, C. (2011). Antidepressant-induced akathisia-related homicides associated with diminishing mutations in metabolizing genes of the CYP450 family. Pharmacogenomics and Personalized Medicine, 65. https://doi.org/10.2147/pgpm.s17445 16:00 Zhou, Y., Ingelman-Sundberg, M., & Lauschke, V. (2017). Worldwide Distribution of Cytochrome P450 Alleles: A Meta-analysis of Population-scale Sequencing Projects. Clinical Pharmacology & Therapeutics, 102(4), 688–700. https://doi.org/10.1002/cpt.69030:00 - Know Your Drugs39:30 - David Carmichael v. GlaxoSmithKline Inc.40:00 - Carmichael, D. Calm, organized, homicidal behaviour – my connection to school shooters. Mad In America.46:15 - RxISK Prescription Drug Side Effects

Kerri Weingard is a founding partner and global chief operating officer at Verified Clinical Trials (VCT). VCT is the largest global research subject database to reduce dual enrollment and prevent protocol violations. Ms. Weingard is also the CEO and founder of Study Scavenger and Clinical Hero. Both companies are dedicated to clinical trial recruitment and education. Ms. Weingard, who is a nurse practitioner, holds a master's degree in science from Stony Brook University. She, before creating VCT and Study Scavenger, has conducted over 500 clinical trials as a research administrator and sub-investigator. She has more than two decades of experience in the field and is a member of a number of professional organizations, including the American Society for Clinical Pharmacology and Therapeutics, the Drug Information Association and the Association of Clinical Research Professionals.  

This episode I talk about finding a job in Clinical Pharmacology or Pharmacometrics. I share a few thoughts from my experience followed by an interview with TJ Elder, the president of STEM Sourcing Recruiting and Staffing. TJ shares his insights and best practices on securing a new job in Clinical Pharmacology or Pharmacometrics. Links discussed in the show: • Connect with TJ Elder on LinkedIn • You can connect with me on LinkedIn and send me a message • Send me a message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

In this episode In this illuminating episode, we dive deep into the world of proton pump inhibitors (PPIs), commonly prescribed medications for heartburn and acid reflux. While these drugs have brought relief to millions worldwide, recent studies have begun to uncover potential links between PPI use and an increased risk of dementia. We explore the mechanisms that might underlie this association, the clinical implications for patients, and the broader question of how seemingly unrelated conditions might be connected at a molecular level. Whether you're a healthcare professional, a patient on PPIs, or simply someone curious about the intricate web of human health, this episode promises to offer fresh insights into a hotly debated area of medicine. References: Main papers disucssed in this episode: - Northuis, Carin, et al. "Cumulative Use of Proton Pump Inhibitors and Risk of Dementia: The Atherosclerosis Risk in Communities Study." Neurology (2023). https://n.neurology.org/content/early/2023/08/09/WNL.0000000000207747?utm_source=twitter&utm_medium=organic - Gomm, Willy, et al. "Association of proton pump inhibitors with risk of dementia: a pharmacoepidemiological claims data analysis." JAMA neurology 73.4 (2016): 410-416. https://jamanetwork.com/journals/jamaneurology/article-abstract/2487379 - Li, Min, et al. "Proton pump inhibitor use and risk of dementia: systematic review and meta-analysis." Medicine 98.7 (2019). - Ortiz-Guerrero, Gloria, et al. "Proton pump inhibitors and dementia: physiopathological mechanisms and clinical consequences." Neural plasticity 2018 (2018). - Wijarnpreecha, Karn, et al. "Proton pump inhibitors and risk of dementia." Annals of translational medicine 4.12 (2016). - Haenisch, Britta, et al. "Risk of dementia in elderly patients with the use of proton pump inhibitors." European archives of psychiatry and clinical neuroscience 265 (2015): 419-428. - Batchelor, Riley, et al. "Dementia, cognitive impairment and proton pump inhibitor therapy: a systematic review." Journal of gastroenterology and hepatology 32.8 (2017): 1426-1435. - Gray, Shelly L., et al. "Proton pump inhibitor use and dementia risk: Prospective population‐based study." Journal of the American Geriatrics Society 66.2 (2018): 247-253. - Ahn, Nayeon, et al. "Do proton pump inhibitors increase the risk of dementia? A systematic review, meta‐analysis and bias analysis." British Journal of Clinical Pharmacology 89.2 (2023): 602-616. Follow us: Join the NEURO Academy: NEUROacademy.com Follow us on social media: Instagram: The Brain Docs @thebraindocs Facebook: The Brain Docs TikTok: @thebraindocs Website: TheBrainDocs.com  

This episode is all about the intersection of motherhood and ambition, particularly for high-achieving Black women!We are so excited to welcome Dr. Tamorah Lewis to the podcast! Dr. Lewis is a physician-scientist (MD PhD), Division Head for Clinical Pharmacology and Toxicology at SickKids in Toronto, Canada and is a proud mother of three children, Quinton (13), Lydia (10), and Elijah (6).  Listen in as Kemi and Tamorah discuss the intricacies of balancing ambition and motherhood. They emphasize the importance of nurturing emotional intelligence, self-worth, and character in their children while recognizing the value of building a supportive village to help them thrive. Highlights from this episode:Redefining success as a working motherChallenges and triumphs of motherhoodThe power of representing Black cultureThe evolving parent-child relationshipRejecting the "Either/Or" narrative and embracing multidimensional roles as working mothersIf you enjoyed this conversation with Tamorah as much as we do, head over to Twitter @TamorahLewisMD and show her some love!And if you'd like to learn more foundational career navigation concepts for women of color in academic medicine and public health, sign up for our KD Coaching Foundations Series: www.kemidoll.com/foundations.

In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to get in touch with me, and give the reason why I started this podcast. Links discussed in the show: You can connect with me on LinkedIn and send me a message Send me a messsage Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Go online to PeerView.com/TNQ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. How much do you know about non-factor therapies in the prophylactic management of hemophilia? Test your knowledge and earn credit, as you get the latest evidence and expert guidance on integrating these therapies into individualized management plans for adult and pediatric patients with hemophilia. Upon completion of this activity, participants should be better able to: Discuss current unmet needs and barriers to optimal prophylaxis of hemophilia; Summarize the MOAs and latest safety/efficacy evidence supporting the use of novel and emerging antibody and siRNA therapies for the prophylaxis of HA and HB; Develop personalized prophylactic regimens with novel and emerging antibody and siRNA therapies, including in the context of clinical trials, for the management of HA and HB; and Manage practical aspects of care when using novel non-factor agents, including dosing/scheduling, patient education, adherence, monitoring, and adverse events.

Go online to PeerView.com/TNQ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. How much do you know about non-factor therapies in the prophylactic management of hemophilia? Test your knowledge and earn credit, as you get the latest evidence and expert guidance on integrating these therapies into individualized management plans for adult and pediatric patients with hemophilia. Upon completion of this activity, participants should be better able to: Discuss current unmet needs and barriers to optimal prophylaxis of hemophilia; Summarize the MOAs and latest safety/efficacy evidence supporting the use of novel and emerging antibody and siRNA therapies for the prophylaxis of HA and HB; Develop personalized prophylactic regimens with novel and emerging antibody and siRNA therapies, including in the context of clinical trials, for the management of HA and HB; and Manage practical aspects of care when using novel non-factor agents, including dosing/scheduling, patient education, adherence, monitoring, and adverse events.

Go online to PeerView.com/TNQ860 to view the activity, download slides and practice aids, and complete the post-test to earn credit. How much do you know about non-factor therapies in the prophylactic management of hemophilia? Test your knowledge and earn credit, as you get the latest evidence and expert guidance on integrating these therapies into individualized management plans for adult and pediatric patients with hemophilia. Upon completion of this activity, participants should be better able to: Discuss current unmet needs and barriers to optimal prophylaxis of hemophilia; Summarize the MOAs and latest safety/efficacy evidence supporting the use of novel and emerging antibody and siRNA therapies for the prophylaxis of HA and HB; Develop personalized prophylactic regimens with novel and emerging antibody and siRNA therapies, including in the context of clinical trials, for the management of HA and HB; and Manage practical aspects of care when using novel non-factor agents, including dosing/scheduling, patient education, adherence, monitoring, and adverse events.

Dr. Dave Kisor, a professor and director of pharmacogenomics at Manchester University. He graduated from The Ohio State University College of Pharmacy in 1986 and completed a two-year fellowship in therapeutic drug monitoring/pharmacokinetics at OSU. Before he joined Manchester, Dave was professor of pharmaceutical sciences at Ohio Northern University after being a research scientist at Burroughs Wellcome Co/GlaxoWellcome. Dave has over 80 peer-reviewed publications including being the lead author on two pharmacogenomics textbooks. He is a past chair of the American Association of Colleges of Pharmacy (AACP) Pharmacogenomics Special Interest Group. Dave was named a Fellow of the American College of Clinical Pharmacology in 2017, and in 2021, along with Dr. Tom Smith, he received an AACP Innovations in PGx Teaching Award. His current research is related to PGx and opioid use disorder. Dave currently serves as co-chair of the Pharmacogenomics Global Research Network (PGRN) Education Committee and is Editor-In-Chief of Pharmacogenomics: Foundations, Competencies, and the Pharmacists' Patient Care Process.

Dr. Dave Kisor, a professor and director of pharmacogenomics at Manchester University. He graduated from The Ohio State University College of Pharmacy in 1986 and completed a two-year fellowship in therapeutic drug monitoring/pharmacokinetics at OSU. Before he joined Manchester, Dave was professor of pharmaceutical sciences at Ohio Northern University after being a research scientist at Burroughs Wellcome Co/GlaxoWellcome. Dave has over 80 peer-reviewed publications including being the lead author on two pharmacogenomics textbooks. He is a past chair of the American Association of Colleges of Pharmacy (AACP) Pharmacogenomics Special Interest Group. Dave was named a Fellow of the American College of Clinical Pharmacology in 2017, and in 2021, along with Dr. Tom Smith, he received an AACP Innovations in PGx Teaching Award. His current research is related to PGx and opioid use disorder. Dave currently serves as co-chair of the Pharmacogenomics Global Research Network (PGRN) Education Committee and is Editor-In-Chief of Pharmacogenomics: Foundations, Competencies, and the Pharmacists' Patient Care Process.   Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.

This Episode Covers the Following Topics & More:The Most Common Food AllergiesWhat Parents Can Do to Prevent the Development of Certain AllergiesDifferent Ways Food Allergies are Tested & Diagnosed: IgE vs IgG TestsA Refresh on the Atopic March (Season 1, Episode 15)Factors of Outgrowing Food AllergiesTreatments for Food AllergiesAdministering an Epipen (epinephrine injection) About Dr. Jonathan Malka:Jonathan Malka, MD, FAAAI is currently the director of Allergy & Immunology at one the largest pediatric groups in the country. Prior to starting the allergy division at Pediatric Associated Dr. Malka was an Assistant Professor of Pediatrics, at National Jewish Health Division of Allergy/Immunology and Rheumatology at the University of Colorado Health Sciences Center. He also served in the Division of Immunopharmacology Laboratory, Division of Clinical Pharmacology, at National Jewish Health in Denver, Colorado.Dr. Malka earned a doctor of medicine degree from “La Universidad Central de Venezuela” in Caracas, Venezuela. After completing his medical education Dr. Malka joined the International Center for Interdisciplinary Studies of Immunology at Georgetown University where he received the International Fellow Distinguished Award in Allergy & Immunology and a Research Achievement Award for Outstanding Research on “Susceptibility Test-Adverse Effects of Smallpox Vaccine”. Dr. Malka completed his pediatric training at Children's Hospital at Montefiore Medical Center at Albert Einstein College of Medicine in the Bronx, NY. Dr. Malka went on to National Jewish Health in Denver, CO were he completed his fellowship in Allergy and Immunology.Dr. Malka is currently a Fellow of the American Academy and American College of Asthma, Allergy and Immunology. Dr. Malka has published more than 20 review articles in prestigious journals both in the USA and Venezuela. Dr. Malka has earned prestigious awards including Favorite Pediatric Specialist award given by Broward Family Favorites on both 2013 and 2014.Dr. Malka's research interest includes food allergies, understanding and managing severe asthma and biomarkers in the diagnosis and management of asthma. He also served in the Division of Immunopharmacology Laboratory, Division of Clinical Pharmacology, at National Jewish Health in Denver, Colorado.

Allopurinol hypersensitivity syndrome (AHS) affects approximately 1 in 1,000 patients prescribed allopurinol, with reported mortality rates between 20% and 25%. The risk of AHS is nearly 100 times higher in carriers of the HLA-B*58:01 allele than in noncarriers. Populations with a high allele frequency include Han Chinese (6%-8%), Korean (12%), and Thai (6%-8%) people.In this episode, Drs. Wid Yaseen and Jonathan Zipursky discuss their paper published in CMAJ, titled "Five things to know about…allopurinol hypersensitivity syndrome". Dr. Jonathan Zipursky is a general internist, clinical pharmacologist, and clinician scientist at Sunnybrook Health Sciences Centre. Dr. Yaseen is a second-year internal medicine resident physician at the University of Toronto. They argue that the syndrome's frequency is often underestimated and emphasize the importance of genetic testing in susceptible populations.Next, Dr. David Juurlink broadens the discussion beyond allopurinol to describe other common medications whose effectiveness and safety are significantly influenced by genetic predispositions. Dr. Juurlnk is a staff internist and head of division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto. He is also a medical toxicologist at the Ontario Poison Centre.  He explores the need for expanded genetic testing to protect patients and ensure proper dosing.Join us as we explore medical solutions that address the urgent need to change healthcare. Reach out to us about this or any episode you hear. Or tell us about something you'd like to hear on the leading Canadian medical podcast.You can find Blair and Mojola on Twitter @BlairBigham and @DrmojolaomoleCMAJTwitter (in English): @CMAJ Twitter (en français): @JAMC FacebookInstagram: @CMAJ.ca The CMAJ Podcast is produced by PodCraft Productions

Today you'll have an opportunity to learn from a cardiologist, pharmacologist, and author, who has brought his expertise into the world of expert witnesses. Dr. Michael Zema shares what he has learned to sharpen his expert witness abilities. Dr. Zema has a routine of breaking up case analysis with research, which not only relieves the tedium of endless pages of documentation but gives him new insights into the case. He describes some of the pitfalls in electronic medical records with a warning that the copy-and-paste function can propagate a medical error for years. As an example, he describes meeting a patient whose chart incorrectly stated that he'd recently had bypass surgery. When Dr. Zema discovered this error, he found that the man's medical records had perpetuated it for two years. Because of the frequency of pharmaceutical errors, Dr. Zema urges expert witnesses to familiarize themselves as much as possible with pharmacology. He describes a case of Stevens-Johnson Syndrome in which an incorrectly prescribed drug played a big role. Of special value to expert witnesses and attorneys is his approach to cross-examination. He always tries to think like the opposing attorney, an approach he also uses in analyzing the medical information. Be prepared for some top-level information and guidance in this podcast. Join me in this episode of Decoding Medical Records - Tips and Techniques for Expert Witnesses - Dr. Michael Zema What's a good way to effectively navigate through volumes of electronic records? Why can copying and pasting electronic records create problems? How does the copy-and-paste repetition of an error in diagnosis inhibit correct perpetuate continued misdiagnosis and incorrect treatment? How does a strong knowledge of pharmacology assist an expert witness? Why is it essential to refer to the standard of care and other documentation extant at the time of an alleged malpractice incident? How can you, under cross-examination, anticipate and derail an attorney's line of questioning? Listen to our podcasts or watch them using our app, Expert.edu, available at legalnursebusiness.com/expertedu. https://youtu.be/jFTS9USMMI4 You can still order the recordings for our 7th Virtual Conference! LNC Success™ is a Virtual Conference 3-day event designed for legal nurse consultants just like you! Pat Iyer and Barbara Levin put together THE first Legal Nurse Consulting Virtual Conference in July 2020. They are back with their 7th all-new conference based on what attendees said they'd find most valuable. This new implementation and networking event is designed for LNCs at any stage in their career. Build your expertise, attract higher-paying attorney clients, and take your business to the next level. After the LNC Success™ Virtual Conference, you will leave with clarity, confidence, and an effective step-by-step action plan that you can immediately implement in your business. Your Presenter of Decoding Medical Records - Tips and Techniques for Expert Witnesses - Dr. Michael Zema Dr. Zema received his Medical Degree from Cornell University Medical College. He completed his post-graduate Internal Medicine training at the North Shore University Hospital in Manhasset, Long Island, with subsequent Fellowships in Cardiology there and at the New York Hospital Cornell Medical Center. He is a distinguished Fellow in the American College of Physicians, American College of Cardiology, American College of Chest Physicians and the American College of Clinical Pharmacology among others. Dr. Zema is a Certified Physician Executive of the American Association of Physician Leadership and a Six Sigma Green Belt in Healthcare. Dr. Zema has penned numerous publications in professional medical journals and most recently has authored the book "Modern Healthcare Delivery, Deliverance or Debacle - A Glimpse From the Inside Out." Connect with Micheal http://www.

------------------Support the channel------------ Patreon: https://www.patreon.com/thedissenter PayPal: paypal.me/thedissenter PayPal Subscription 1 Dollar: https://tinyurl.com/yb3acuuy PayPal Subscription 3 Dollars: https://tinyurl.com/ybn6bg9l PayPal Subscription 5 Dollars: https://tinyurl.com/ycmr9gpz PayPal Subscription 10 Dollars: https://tinyurl.com/y9r3fc9m PayPal Subscription 20 Dollars: https://tinyurl.com/y95uvkao This show is sponsored by Enlites, Learning & Development done differently. Check the website here: http://enlites.com/ Dr. Jordi Camí is Professor of Pharmacology (specialist in Clinical Pharmacology) at Pompeu Fabra University, General Director of the Barcelona Biomedical Research Park (PRBB), and Director of the Pasqual Maragall Foundation. Dr. Luis Miguel Martínez is Head of the Laboratory of Visual Analogy at the Neuroscience Institute of Alicante. They are both authors of The Illusionist Brain: The Neuroscience of Magic. In this episode, we focus on The Illusionist Brain. We talk about magic from the perspective of neuroscience, and explore aspects of human cognition like the visual system, memory, attention, change blindness, decision-making, and the cultural context. We discuss if people in industrialized societies are less susceptible to magic, how technology influences the development of magic, and if magicians are scientists. Finally, we talk about why magic is an ecologically valid way of studying human cognition. -- A HUGE THANK YOU TO MY PATRONS/SUPPORTERS: PER HELGE LARSEN, JERRY MULLER, HANS FREDRIK SUNDE, BERNARDO SEIXAS, OLAF ALEX, JONATHAN VISSER, ADAM KESSEL, MATTHEW WHITINGBIRD, ARNAUD WOLFF, TIM HOLLOSY, HENRIK AHLENIUS, JOHN CONNORS, FILIP FORS CONNOLLY, DAN DEMETRIOU, ROBERT WINDHAGER, RUI INACIO, ZOOP, MARCO NEVES, COLIN HOLBROOK, SIMON COLUMBUS, PHIL KAVANAGH, MIKKEL STORMYR, SAMUEL ANDREEFF, FRANCIS FORDE, TIAGO NUNES, ALEXANDER DANNBAUER, FERGAL CUSSEN, HAL HERZOG, NUNO MACHADO, JONATHAN LEIBRANT, JOÃO LINHARES, STANTON T, SAMUEL CORREA, ERIK HAINES, MARK SMITH, JOÃO EIRA, TOM HUMMEL, SARDUS FRANCE, DAVID SLOAN WILSON, YACILA DEZA-ARAUJO, ROMAIN ROCH, DIEGO LONDOÑO CORREA, YANICK PUNTER, ADANER USMANI, CHARLOTTE BLEASE, NICOLE BARBARO, ADAM HUNT, PAWEL OSTASZEWSKI, NELLEKE BAK, GUY MADISON, GARY G HELLMANN, SAIMA AFZAL, ADRIAN JAEGGI, NICK GOLDEN, PAULO TOLENTINO, JOÃO BARBOSA, JULIAN PRICE, EDWARD HALL, HEDIN BRØNNER, DOUGLAS FRY, FRANCA BORTOLOTTI, GABRIEL PONS CORTÈS, URSULA LITZCKE, SCOTT, ZACHARY FISH, TIM DUFFY, SUNNY SMITH, JON WISMAN, MORTEN EIKELAND, DR BYRD, DANIEL FRIEDMAN, WILLIAM BUCKNER, MAU MARIA, PAUL-GEORGE ARNAUD, LUKE GLOWACKI, GEORGIOS THEOPHANOUS, CHRIS WILLIAMSON, PETER WOLOSZYN, DAVID WILLIAMS, ROOFTOWEL, DIOGO COSTA, ANTON ERIKSSON, CHARLES MOREY, ALEX CHAU, AMAURI MARTÍNEZ, CORALIE CHEVALLIER, PEDRO BONILLA, BANGALORE ATHEISTS, LARRY D. LEE JR., OLD HERRINGBONE, STARRY, MICHAEL BAILEY, DAN SPERBER, ROBERT GRESSIS, TOM ROTH, THERPMD, IGOR N, JEFF MCMAHAN, JAKE ZUEHL, BARNABAS RADICS, MARK CAMPBELL, RICHARD BOWEN, TOMAS DAUBNER, LUKE NISSEN, CHRIS STORY, AND MANUEL OLIVEIRA! A SPECIAL THANKS TO MY PRODUCERS, YZAR WEHBE, JIM FRANK, ŁUKASZ STAFINIAK, TOM VANEGDOM, BERNARD HUGUENEY, CURTIS DIXON, BENEDIKT MUELLER, VEGA GIDEY, THOMAS TRUMBLE, KATHRINE AND PATRICK TOBIN, JONCARLO MONTENEGRO, ROBERT LEWIS, AND AL NICK ORTIZ! AND TO MY EXECUTIVE PRODUCERS, MATTHEW LAVENDER, SERGIU CODREANU, AND BOGDAN KANIVETS!

Sleep is never more important than when you aren't getting any. And there's a large range of night time teas, herbal tablets and relaxing oils and sprays that promise to help you get some. But can they really deliver? Listener Corrine got in touch after struggling with her sleep post menopause, wanting to know if there was any evidence to back up the claims of various natural sleep aids. Can they give her the restful night's sleep she craves – or is it just a waste of money? She sets Greg Foot the job of finding out, by speaking to an Expert Sleep Physiologist, as well as a Professor in Clinical Pharmacology, Therapeutics and Toxicology. This series we're testing and investigating your suggested wonder-products. If you've seen an ad, trend or fad, and wonder if there's any evidence to back up a claim, drop us an email to sliced.bread@bbc.co.uk or you can send us a voice note to our WhatsApp number: 07543 306807. PRESENTER: Greg Foot PRODUCER: Kate Holdsworth

Dr. Annet Kirabo is an Associate Professor of Medicine, Clinical Pharmacology at Vanderbilt University Medical Center, as well as in the Dept. of Molecular Physiology and Biophysics. In this episode, she explains how time-restricted feeding impacts the microbiota. Dr. Kirabo also discusses how meal timing affects vital physiological systems. Follow Dr. Kirabo on Twitter Get the Ultimate Sleep Cheat Sheet _____________________________________________________________ ABOUT THE BLUEPRINT PODCAST: The BluePrint Podcast is for busy professionals and Household CEOs who care deeply about their families, career, and health. Host Dr. Erik Korem distills cutting edge-science, leadership, and life skills into simple tactics optimized for your busy lifestyle and goals.   Dr. Korem interviews scientists, coaches, elite athletes, entrepreneurs, entertainers, and exceptional people to discuss science and practical skills you can implement in your life to become the most healthy, resilient, and impactful version of yourself.   On a mission to equip people to pursue audacious goals, thrive in uncertainty, and live a healthy and fulfilled life, Dr. Erik Korem is a High Performance pioneer. He introduced sports science and athlete tracking technologies to collegiate and professional (NFL) football over a decade ago and has worked with the National Football League, Power-5 NCAA programs, gold-medal Olympians, Nike, and the United States Department of Defense.   Erik is an expert in sleep and stress resilience. He is the Founder and CEO of AIM7, a health and fitness app that unlocks the power of wearables by providing you with daily personalized recommendations to enhance your mind, body, and recovery. SUPPORT & CONNECT   Instagram - https://www.instagram.com/erikkorem/ Twitter - https://twitter.com/ErikKorem LinkedIn - https://www.linkedin.com/in/erik-korem-phd-19991734/ Facebook - https://www.facebook.com/erikkorem Website - https://www.erikkorem.com/ Newsletter - https://erikkoremhpcoach.activehosted.com/f/  ______________________________________________________________ QUOTES   “The key is using stress and adapting to it and improving. That's what high performance is to me, the ability to adapt rapidly so you can achieve your potential. There are five key pillars to creating the conditions for adaptability: sleep, exercise, mental resilience, nutrition, and community/relationships.” - Dr. Erik Korem   "Stress is your brain and body preparing you to do something effortful." Dr. Alex Auerbach “I maybe have a different concept on leadership. To me, leading is a verb. If you're leading, you're a leader. If you're swimming, you're a swimmer, if you're driving, you're a driver. If you're leading, you're by definition, a leader. I define leading as being looked to in a particular moment to decide or perform an action based on your unique gifts and abilities. So by that definition, everybody is a leader. All rank and role really describe is how many people are hoping you get it right when it's your turn to wear the weight.” - Clint Bruce "Attention is the currency of performance." - Dr. Peter Haberl “That's what I've discovered in the lives of brilliant, prolific, healthy creatives, is that they have networks of people they leverage in the course of their work. That they learn from, that they were challenged by, that they gave great insight and purview into their own life and work, in such a way that they were able to receive feedback that helped them get better at what they do.” - Todd Henry "Restful and fulfilling sleep enables you to grow, adapt, and thrive. It creates the conditions for adaptation, so you can pursue audacious goals and thrive in uncertainty." - Dr. Erik Korem "Most exercise programs fail, not because the reps and sets are poorly designed, but because the program doesn't adjust for how much stress your body can adapt to that day! That's why Dr. Chris Morris' research and practical application of fluid periodization is the key for unlocking your performance potential." - Dr. Erik KoremSee omnystudio.com/listener for privacy information.

Dr. Annet Kirabo is an Associate Professor of Medicine, Clinical Pharmacology at Vanderbilt University Medical Center, as well as in the Dept. of Molecular Physiology and Biophysics. In this episode, she explains the difference between the microbiome and microbiota, and how to foster a healthy gut. In addition, she explains the difference between probiotics and prebiotics, how high salt diets can harm the microbiota, and much more. Follow Dr. Kirabo on Twitter Get the Ultimate Sleep Cheat Sheet _____________________________________________________________ ABOUT THE BLUEPRINT PODCAST: The BluePrint Podcast is for busy professionals and Household CEOs who care deeply about their families, career, and health. Host Dr. Erik Korem distills cutting edge-science, leadership, and life skills into simple tactics optimized for your busy lifestyle and goals.   Dr. Korem interviews scientists, coaches, elite athletes, entrepreneurs, entertainers, and exceptional people to discuss science and practical skills you can implement in your life to become the most healthy, resilient, and impactful version of yourself.   On a mission to equip people to pursue audacious goals, thrive in uncertainty, and live a healthy and fulfilled life, Dr. Erik Korem is a High Performance pioneer. He introduced sports science and athlete tracking technologies to collegiate and professional (NFL) football over a decade ago and has worked with the National Football League, Power-5 NCAA programs, gold-medal Olympians, Nike, and the United States Department of Defense.   Erik is an expert in sleep and stress resilience. He is the Founder and CEO of AIM7, a health and fitness app that unlocks the power of wearables by providing you with daily personalized recommendations to enhance your mind, body, and recovery. SUPPORT & CONNECT   Instagram - https://www.instagram.com/erikkorem/ Twitter - https://twitter.com/ErikKorem LinkedIn - https://www.linkedin.com/in/erik-korem-phd-19991734/ Facebook - https://www.facebook.com/erikkorem Website - https://www.erikkorem.com/ Newsletter - https://erikkoremhpcoach.activehosted.com/f/  ______________________________________________________________ QUOTES   “The key is using stress and adapting to it and improving. That's what high performance is to me, the ability to adapt rapidly so you can achieve your potential. There are five key pillars to creating the conditions for adaptability: sleep, exercise, mental resilience, nutrition, and community/relationships.” - Dr. Erik Korem   "Stress is your brain and body preparing you to do something effortful." Dr. Alex Auerbach “I maybe have a different concept on leadership. To me, leading is a verb. If you're leading, you're a leader. If you're swimming, you're a swimmer, if you're driving, you're a driver. If you're leading, you're by definition, a leader. I define leading as being looked to in a particular moment to decide or perform an action based on your unique gifts and abilities. So by that definition, everybody is a leader. All rank and role really describe is how many people are hoping you get it right when it's your turn to wear the weight.” - Clint Bruce "Attention is the currency of performance." - Dr. Peter Haberl “That's what I've discovered in the lives of brilliant, prolific, healthy creatives, is that they have networks of people they leverage in the course of their work. That they learn from, that they were challenged by, that they gave great insight and purview into their own life and work, in such a way that they were able to receive feedback that helped them get better at what they do.” - Todd Henry "Restful and fulfilling sleep enables you to grow, adapt, and thrive. It creates the conditions for adaptation, so you can pursue audacious goals and thrive in uncertainty." - Dr. Erik Korem "Most exercise programs fail, not because the reps and sets are poorly designed, but because the program doesn't adjust for how much stress your body can adapt to that day! That's why Dr. Chris Morris' research and practical application of fluid periodization is the key for unlocking your performance potential." - Dr. Erik KoremSee omnystudio.com/listener for privacy information.