A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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Exploring opioid dependence in America from the perspectives of subject matter experts in the field and those who are trying to positively influence this crisis.
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Vocational school is becoming a popular choice among graduates and others looking to pave a new career path, especially with the cost of college climbing. Furthering your education is always a great idea, so if you have your heart set on a particular occupation, check out a trade school first. You may be pleasantly surprised to find you can get your training in the trades or in healthcare faster, for a lot less money and still come out with a job.
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Interviews and Discussions With Fascinating People Who are Creating A Better Tomorrow For All Of Us Host - Ira S. Pastor
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The Regulatory Transparency Project is a nonprofit, nonpartisan effort dedicated to fostering discussion and a better understanding of regulatory policies. On RTP’s Fourth Branch Podcast, leading experts discuss the pros and cons of government regulations and explain how they affect everyday life for Americans.
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In An Hour of our Time Podcast, we choose a new topic each episode. Topics range from sociopolitical, to scientific, to historical. We each perform an hour of research followed by a marginally focused one hour discussion. Featuring: Joe, Dave, and Mark. Fun for anyone who enjoys funny but sometimes frustrating tangents of referential conversation. For mature audiences.
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Learn about all the things that you wish you were taught about the practice of neurology. The podcast will cover types of careers (academics, private practice, locums, concierge neurology, etc.), contracts and worth, promotional development and CV building, continuing medical education and maintenance of certification, visas, billing, challenges on the job, work/life balance, and more. Creator and Executive Producer: Sara Schaefer; Associate editors: Katherine Fu, Sana Aslam, Sagari Bette, P ...
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Blood Advances, a Journal of the American Society of Hematology, provides an open international forum for the publication of original articles describing basic laboratory, translational, and clinical investigations in hematology and related sciences. Music for Blood Advances Talks is preformed by the Art Topilow Trio
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The Cardiovascular CME podcast is a new educational offering from Mayo Clinic, featuring content geared towards physicians, physician assistants, and nurse practitioners who are interested in exploring a multitude of cardiology-related topics. Tune in and subscribe to explore today’s most pressing cardiology topics with your colleagues at Mayo Clinic and gain valuable insights that can be directly applied to your practice. No CME credit offered for podcast episodes at this time.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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Anesthesia Wise Guys aims to host discussions, commentaries, and overall engaging topics bringing out some of the humor most anesthesia providers possess.
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Many medical devices and prescription drugs claim to be the resolution to all your problems, but while they may solve your current issue, it’s possible they may cause another. Medical products are often rushed to market before they’re adequately tested. Clay Hodges wants to educate you on these products and their side effects before they lead to litigation.
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The Federation for American Immigration Reform's podcast bringing you the most important updates about U.S. immigration. Featuring special guests including members of Congress, journalists, and experts in the field.
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The podcast, "Race and Regulation," focuses on the most fundamental responsibility of any society: ensuring equal justice, and dignity and respect, to all people. Listen as leading scholars uncover how government regulations across a wide range of areas—including voting rights, child welfare, banking, land use, and more—have contributed to racial inequities, as well as how regulatory changes could help build a more just society. The podcast features some of today’s foremost experts working o ...
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Vid Desai - Chief Information Officer, Office of Digital Transformation, U.S. Food and Drug Administration - Unlocking Potential, Leading Transformation
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Send us a text Vid Desai is Chief Information Officer, Office of Digital Transformation (ODT), at the U.S. Food And Drug Administration (FDA), where he sets and leads the agency’s Information Technology (IT) strategy, as well as the agency’s enterprise IT, data management, and cybersecurity. (https://www.fda.gov/about-fda/fda-organization/vid-desai…
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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IV Agents to Improve Echo Images, Value, and Safe Administration
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IV Agents to Improve Echo Images, Value, and Safe Administration Guest: Jeremy Thaden, M.D. Guest: Mays Ali, M.D. Hosts: Kyle Klarich, M.D. In this podcast we will review current and evolving indications for UEA use in the clinical and research setting. They will review Mayo Clinic’s practice for UEA administration, commonly encountered UEA side-ef…
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Dr. Francis Collins - Former Director, U.S. National Institutes Of Health (NIH); NIH Distinguished Investigator, Center for Precision Health Research, National Human Genome Research Institute - The Road ...
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Send us a text Dr. Francis S. Collins, M.D., Ph.D., ( https://www.francisscollins.com/ ) is the former Director of the U.S. National Institutes of Health (NIH), where as the longest serving director of NIH (spanning 12 years and three presidencies) he oversaw the work of the largest supporter of biomedical research in the world, from basic to clini…
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Dr. Benjamin Oakes, Ph.D. - CEO, Scribe Therapeutics - Engineering The Future Of Genetic Medicine
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Send us a text Dr. Benjamin L. Oakes, Ph.D., is Co-Founder, President, and Chief Executive Officer at Scribe Therapeutics ( https://www.scribetx.com/ ), a molecular engineering company focused on creating best-in-class CRISPR-based therapies that permanently treat the underlying cause of disease. Previously, as an Innovative Genomics Institute Entr…
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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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Cardioneural Ablation - A Promising Treatment Strategy for Refractory Vasovagal Syncope
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Cardioneural Ablation - A Promising Treatment Strategy for Refractory Vasovagal Syncope Guest: Guru G. Kowlgi, M.B.B.S. Host: Anthony H. Kashou, M.D. The learners will get an overview of how to diagnose and manage vasovagal syncope. In addition, they will gain an understanding of cardioneural ablation, which is a promising new catheter ablation tre…
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Ben Zimmer - CEO, Priovant Therapeutics - Novel Therapies For Severe Autoimmune Diseases
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Send us a text Ben Zimmer is CEO of Priovant Therapeutics ( https://www.priovanttx.com/ ), a clinical-stage biotechnology company focused on delivering novel therapies for autoimmune diseases associated with the greatest morbidity and mortality. Priovant is developing oral brepocitinib, a potential first-in-class dual inhibitor of TYK2 and JAK1, ac…
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National Delicacies - Part 3 (depression sandwich)
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This week, we continue our series on national delicacies and focus specifically on regional American cuisine.By HOOT Studios
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Rocky Batzel - CEO, SnapSlide - Addressing The Unmet Needs Of Medication Accessibility & Adherence
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Send us a text Rocky Batzel is CEO of SnapSlide ( https://www.snapslide.com/ ), a company that recently introduced to the market the First Child-Resistant Closure with Single-Handed Opening for RX and OTC medication Bottles. This patented solution, of which Mr. Batzell is the inventor, is focused on bringing life-changing potential for over 60 mill…
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Deep Dive 296 - Will the Congressional Review Act Be Revived in 2025?
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Federal regulators were busy in April 2024, with agencies publishing a record-breaking 66 significant new regulations; more than half of which had price tags higher than $200 million. This burst of regulatory activity can be attributed to a once obscure law known as the Congressional Review Act (CRA). If the November election brings Republican cont…
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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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Dr. Angie Burnett, Ph.D. - Program Director, Advanced Research + Invention Agency (ARIA) - Synthetic Plants For A Sustainable Future
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Send us a text Dr. Angie Burnett, Ph.D. is Program Director at the Advanced Research and Invention Agency ( ARIA - https://www.aria.org.uk/ ), a UK organization created by an Act of Parliament, and sponsored by the Department for Science, Innovation, and Technology, to fund projects across a full spectrum of R&D disciplines, approaches, and institu…
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Pre-Pregnancy Risk Assessment for CV Patients
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Pre-Pregnancy Risk Assessment for CV Patients Guest: Katie A. Young, M.D. Hosts: Malcolm R. Bell, M.D. In this podcast we will review the importance of specialized care in Cardiovascular Obstetrics and the role of the Pregnancy Heart Team in pregnancy risk assessment and pre-conception counseling. Topics Discussed: With maternal mortality rates bei…
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Exploring a Career as a Behavioral Health Assistant at InterCoast Colleges
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In this episode, we dive into Behavioral Health with InterCoast Colleges. If you’re passionate about making a difference in people’s lives and considering a rewarding career in Behavioral Health, this episode is for you! We explore InterCoast’s comprehensive and fully online Behavioral Health Assistant Training Program, which is perfect for those n…
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Dr. Deborah Sesok-Pizzini, MD, MBA - Chief Medical Officer & SVP, Labcorp Diagnostics; Global Head of Quality And Discipline Director, Immunohematology - Innovative Diagnostic Solutions To Enhance Patient ...
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Send us a text Dr. Deborah Sesok-Pizzini, MD, MBA, is Chief Medical Officer And Senior Vice President, Labcorp Diagnostics, and Global Head of Quality And Discipline Director, Immunohematology, Labcorp ( https://www.labcorp.com/deborah-sesok-pizzini-md-mba ), where she is involved in furthering the company's initiatives to enhance the patient exper…
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Listener Mail Responses, Alien Eruption, and Other Stories
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***Explicit. Shelly, Mawi, and Tim go through multiple listener emails, and tell stories that are rather unbelievable. Follow the hosts through the journey of clinical medicine.By Shelly Ferrell
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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…
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Cardio-oncology: What is the Big Picture, What Drugs to Use, and What Tests to Follow
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Cardio-oncology: What is the Big Picture, What Drugs to Use, and What Tests to Follow Guest: Chadi Ayoub, M.B.B.S., Ph.D. Hosts: Sharonne N. Hayes, M.D. In this podcast, we will describe more frequent cardiotoxic effects associated with cancer therapies. Identify imaging modalities that can be used to detect and evaluate cardiotoxicity and common a…
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How to Become a Cybersecurity Specialist at InterCoast Colleges
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🔐 Unlock your potential as a Cybersecurity Specialist with InterCoast Colleges! Dive into our detailed video on how to start your career in cybersecurity, exploring everything from academic requirements to key personal skills and technical proficiencies. Whether you're starting from scratch or looking to switch careers, our comprehensive guide will…
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Unlocking the Power of CISSP Certification: A Guide for Cybersecurity Professionals
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🔒 Unlock the Power of CISSP Certification | Cybersecurity Career Guide Are you a cybersecurity professional aiming to elevate your career? Discover the CISSP certification, a globally recognized credential that boosts your expertise and opens up incredible career opportunities and salary prospects. This video breaks down the benefits, eligibility, …
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This week, we discuss the War of Jenkins' Ear - a forgotten 1700s war between England and Spain.By HOOT Studios
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Mass Catch-and-Release Policies, Illegal Alien Criminals and Alternatives to Detention
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Congressman Byron Donalds (R-Fla.), discusses the burdens that illegal immigration is placing on American taxpayers and how Alternatives to Detention can help keep track of the millions of illegal aliens in the country with FAIR's Executive Director, Julie Kirchner. ★ Support this podcast ★By Federation for American Immigration Reform
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Dr. Lily Brown, Ph.D. - Director - Center for the Treatment and Study of Anxiety, Perelman School of Medicine, University of Pennsylvania - World Leading Anxiety Disorder Research
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Send us a text Dr. Lily Brown, Ph.D., is an Assistant Professor of Psychology in Psychiatry and Director at the Center for the Treatment and Study of Anxiety, Perelman School of Medicine, at University of Pennsylvania ( https://www.med.upenn.edu/ctsa/LilyBrownPhD.html ). Dr. Brown received her Bachelors of Science Degree in Psychology at Drexel Uni…
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Prof. Dr. Dan Blumberg Ph.D. - Vice-President for Regional and Industrial Development - Ben-Gurion University of the Negev - Chair, Israel Space Agency - Planetary Science Innovation For All Humanity
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Send us a text Professor Dr. Dan Blumberg, Ph.D. is the Vice-President for Regional and Industrial Development at Ben-Gurion University of the Negev ( BGU - https://www.blumberg.bgu.ac.il/ ), an elected Member of the International Academy of Astronautics, and Chair of the Israel Space Agency ( https://www.space.gov.il/en ), a position he was appoin…
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Deep Dive 294 - West Virginia v. EPA, Two Years Later: Updates on the Major Questions Doctrine
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Experts will examine the major questions doctrine, its role in regulatory litigation, and its place in administrative law in light of recent developments. Please register and join us for a live webinar on August 14, 2024 at 11 am EST. Featuring: Paul Ray, Director, Thomas A. Roe Institute for Economic Policy Studies, The Heritage Foundation Elliot …
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…
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Dr. Parag Mallick, PhD - Co-Founder, Nautilus Biotechnology - Unlocking The Complexity Of The Proteome For A New Era Of Scientific Discovery
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Send us a text Dr. Parag Mallick, Ph.D. is an Associate Professor at Stanford University ( https://profiles.stanford.edu/parag-mallick ) and Co-Founder of Nautilus Biotechnology ( https://www.nautilus.bio/ ), a development stage life sciences company, engaged in creating a platform technology for quantifying and unlocking the complexity of the prot…
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Clinical Quantification of Myocardial Blood Flow Using PET
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Clinical Quantification of Myocardial Blood Flow Using PET Guest: Panithaya Chareonthaitawee, M.D. Hosts: Malcolm R. Bell, M.D. In this podcast, we will describe the clinical applications of PET MBF quantitation and discuss the strengths and limitations of PET MBF quantification. Topics Discussed: Why has PET myocardial perfusion imaging seen such …
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How to Become an Electrical Trainee in California
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Discover how to kickstart your career as an electrician in California by becoming an Electrical Trainee! Our detailed guide outlines the steps to obtain an Electrician Trainee Card, the benefits of this path, and the differences from apprenticeships. At InterCoast Colleges, we offer programs that prepare you for success in the electrical industry, …
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Terror Suspects and Surging Northern Border Encounters
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Congressman Mike Kelly (R-Pa.), Co-Chairman of the Northern Border Security Caucus, discusses surging encounters at the northern border and the rising numbers of potential terrorists encountered with FAIR's Executive Director, Julie Kirchner. ★ Support this podcast ★By Federation for American Immigration Reform
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Gillian Schauer, Jessice Burgess and an Outlook on Hemp from State Regulators
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Jonathan Miller interviews Gillian Schauer, Executive Director of the Cannabis Regulators Association (CANNRA), and Jessica Burgess, Deputy General Counsel of the Massachusetts Department of Agricultural Resources, about hemp policy from the purview of state regulators. If you have questions about the episode or ideas for Hemp related topics, email…
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Ronnie Vasishta - Senior Vice President, Telecom, NVIDIA - Intelligently Connecting Intelligence - Accelerating Development Of 6G Technologies For A Hyper-Intelligent World
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Send us a text Ronnie Vasishta is Senior Vice President, Telecom at NVIDIA ( https://blogs.nvidia.com/blog/author/ronniev/ ), where he leads all aspects of NVIDIA's telecom business from business management to product go-to-market strategy. His organization is responsible for defining and architecting next-generation virtualized, open 5G advanced a…
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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
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On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…
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3D Visualization of the Heart in Immersive Technology Like Mixed Reality
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3D Visualization of the Heart in Immersive Technology Like Mixed Reality Guest: Dr. Klaudia Proniewska Host: Anthony H. Kashou, M.D. The most commonly applied way of teaching students the foundations of human anatomy and physiology involves textbooks and lectures. This method of transmitting knowledge causes difficulties for students, especially in…
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Explainer Episode 73 - Changing Presidential Candidates
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Kathryn Ciano Mauler and Eric Wang join the podcast to discuss the FEC rules behind campaign funds, particularly in the transfer of said funds between candidates. Their discussion breaks down the questions surrounding the recent changes to the 2024 ballot, and how that will affect each campaign's fundraising efforts, especially in a post-Chevron le…
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Food and Drug Administration - Part 2 (age of adulteration)
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This week, it's time for part two of our series on the Food and Drug Administration. Don't get a tummy ache.By HOOT Studios
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Explainer Episode 71 - Regulatory Modernization in Idaho and Virginia: What lessons can be learned?
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Alex J. Adams, Director of Idaho's Department of Health and Welfare is joined by Reeve T. Bull, Director of the Virginia Office of Regulatory Management. Director Adams and Director Bull detail the importance of regulatory reform efforts in Idaho and Virginia, respectively, and discuss the impact that regulatory reform can have on employment opport…
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Explainer Episode 72 - Parental Rights & Student Privacy in Education
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Legal experts Jonathan Butcher and Jon Riches discuss the debate between parental rights and children’s privacy in education under the Family Educational Rights and Privacy Act (“FERPA”). Moderated by Luke Wake, their discussion examines the debates over the role of student privacy, parental rights, and the role that the governmen…
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Prof. Dr. Alan Widgerow - Division Chief, Center for Tissue Engineering, University of California, Irvine - Chief Scientific Officer, Galderma - Innovation At The Frontiers Of Aesthetic And Regenerative ...
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Send us a text Prof. Dr. Alan Widgerow, MBBCh, FCS, MMed, FACS, is Division Chief, Research, Center for Tissue Engineering ( https://sites.uci.edu/ctelab/team/ ) and Adjunct Professor Plastic Surgery, Dept of Plastic Surgery, University of California, Irvine ( https://faculty.uci.edu/profile/?facultyId=6048 ) and Chief Scientific Officer and Head o…
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Career Development: Involvement in Professional Societies
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Katherine Fu speaks with Dr. Maisha Robinson, who has deep involvement with the American Academy of Neurology, and Dr. Shilpa Chitnis, who has served in many roles within the American Academy of Neurology and the International Parkinson and Movement Disorder Society. They discuss motivations to get involved, ways to break in and move up in an organ…
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Dr. Ryan Potts, Ph.D. - VP and Head, Induced Proximity Platform, Amgen - Leading The Next Wave Of Innovation In Drug Discovery, To Modulate Any Target, Every Time
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Send us a text Dr. Ryan Potts, Ph.D. is Vice President and Head, Induced Proximity Platform at Amgen ( https://www.amgen.com/science/research-and-development-strategy/multispecifics-and-other-modalities ) which is focused on novel ways to bring two or more molecules in close proximity to each other to tackle drug targets that are currently consider…
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Explainer Episode 70 - Litigation Update III: The Supreme Court takes the Vape case--Food and Drug Administration v. Wages and White Lion
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On July 2, 2024, the US Supreme Court granted certiorari in the case, Food and Drug Administration v. Wages and White Lion Investments, LLC. In Explainer Episode 70, expert Jeff Stier discusses the FDA's regulatory action prohibiting specific vape flavors from being sold by these two companies, and the legal issues that the Supreme Court will revie…
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148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …
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Dr. Ashwin Vasan, MD, PhD - Commissioner - NYC Dept. of Health & Mental Hygiene - Strengthening Public Health Systems For Heathier And Longer Lives
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Send us a text Dr. Ashwin Vasan, MD, PhD is the Commissioner of the New York City Department of Health and Mental Hygiene ( https://www.nyc.gov/site/doh/about/about-doh/the-commissioner.page ). Dr. Vasan is a primary care physician, epidemiologist and public health expert with nearly 20 years of experience working to improve physical and mental hea…
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Marfan Surgery Guest: Alberto Pochettino, M.D. Hosts: Paul A. Friedman, M.D. Marfan syndrome is a genetic abnormality where the fibrillin protein is abnormal. That affects all collagen structures within a given individual. Phenotypic features involve ocular abnormalities such as lens dislocation and a higher risk of retinal detachment, as well as d…
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Robert Hoban and the "War" Between Hemp and Marijuana
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Jonathan Miller interviews Robert Hoban, a leading national attorney in the hemp and cannabis space, about the brewing policy conflict emerging between the hemp industry and its cousins in the cannabis industry. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questi…
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How Drug and Device Companies Can Tackle Internet Misinformation
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On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices …
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Hypertensive Disorders of Pregnancy and CV Risk
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Hypertensive Disorders of Pregnancy and CV Risk Guest: Thais D. Coutinho, M.D. Hosts: Paul A. Friedman, M.D. Hypertensive disorders of pregnancy are common and are associated with a significant increase in the risk of future cardiovascular diseases. Despite the well-established statistics, this increase in risk is not well recognized by patients or…
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