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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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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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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Venture Europe: Entrepreneurship | Technology | Venture Capital | Eu/Acc
Calin Fabri | Entrepreneur | Founder Coach
personal conversations with the entrepreneurs and investors creating a future worth getting excited about
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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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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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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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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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156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
33:01
33:01
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On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
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Interventional Management of Acute Pulmonary Embolism
12:59
12:59
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12:59
Interventional Management of Acute Pulmonary Embolism Guest: Arashk Motiei, M.D. Hosts: Sharonne Hayes, M.D. We will discuss the can temporary interventional management of patients with massive acute pulmonary embolism and intermediate high-risk acute pulmonary embolism. Topics Discussed: Who are the patients with pulmonary embolism who need to be …
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Space Rocks (meteor-wrongs)
1:25:35
1:25:35
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1:25:35
This week, we discuss space rocks - asteroids, meteors, comets, and the like.Kirjoittanut HOOT Studios
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Lukas Saari - AI copilot for healthcare practitioners, Raising $10M seed round in 8 months, The administrative burden and the future of Healthcare
35:09
35:09
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35:09
Lukas Saari - CEO and Co-founder of Tandem Health. Tandem is building an AI co-pilot for healthcare practitioners. Their first product is an ambient scribe that listens during the patient-doctor consultation, transcribes the conversation and generates the draft of the medical note. They were founded only 1 year ago, and recently closed a ~$10M seed…
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155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
25:25
25:25
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25:25
On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
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Cardiac Amyloidosis: No Longer Rare and Untreatable!
23:48
23:48
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23:48
Cardiac Amyloidosis: No Longer Rare and Untreatable! Guest: Omar F. Abou Ezzeddine, M.D., M.S. Hosts: Malcolm R. Bell, M.D. Transthyretin amyloid cardiomyopathy (ATTR-CM), once considered rare, is more prevalent than previously thought. Diagnosing ATTR-CM is particularly important because there are now highly effective, specific therapies for ATTR-…
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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
37:31
37:31
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37:31
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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Florian Brand - MDMA and DMT trials, Raising $400M from Peter Thiel and other investors, Difficulties of bringing a drug to market, The journey of increasing self-awareness
28:41
28:41
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28:41
Florian Brand co-founder and Co-CEO of ATAI Life Sciences. ATAI was founded in 2018 and is a global, listed, biopharma company with the vision to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. They were one of the pioneers to use psilocybin in treating mental health and they have raised around $400M equity…
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IV Agents to Improve Echo Images, Value, and Safe Administration
24:45
24:45
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24:45
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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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
21:56
21:56
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21:56
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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Michael Lazarenko - 350 meetings to raise pre-seed round, The effects of the war in Ukraine, Gearing to raise Seed, The importance of Storytelling, The $140B electronics R&D market
22:49
22:49
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22:49
Michael Lazarenko, founder and CEO of Embedd. With Embedd they provide a unified framework so that all the components coming from tens of different manufacturers can communicate with each other on the circuit board. They raised $1.2M Eur pre-seed round led by Cocoa in May last year and now they are ready and gearing up to raise their seed round. Du…
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Cardioneural Ablation - A Promising Treatment Strategy for Refractory Vasovagal Syncope
11:54
11:54
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11:54
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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National Delicacies - Part 3 (depression sandwich)
1:15:09
1:15:09
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1:15:09
This week, we continue our series on national delicacies and focus specifically on regional American cuisine.Kirjoittanut HOOT Studios
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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
40:48
40:48
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40:48
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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Pre-Pregnancy Risk Assessment for CV Patients
15:20
15:20
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15:20
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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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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Listener Mail Responses, Alien Eruption, and Other Stories
1:01:20
1:01:20
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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.Kirjoittanut 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
33:38
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33:38
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
27:47
27:47
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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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🔒 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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🔐 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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War of Jenkins' Ears (brass balls)
1:16:21
1:16:21
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1:16:21
This week, we discuss the War of Jenkins' Ear - a forgotten 1700s war between England and Spain.Kirjoittanut HOOT Studios
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Mass Catch-and-Release Policies, Illegal Alien Criminals and Alternatives to Detention
29:45
29:45
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29:45
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 ★Kirjoittanut Federation for American Immigration Reform
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Deep Dive 294 - West Virginia v. EPA, Two Years Later: Updates on the Major Questions Doctrine
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52:43
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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Alexandre Momeni - Investing in founders with a sense of urgency, The future of brain machine interface, Paris VS London, Product Market Fit as a spectrum, Opportunities in healthcare in Europe
30:03
30:03
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30:03
Alexandre Momeni - Partner at General Catalyst. Alex specialises in healthcare and AI and has been instrumental in bringing some of Europe’s biggest AI deals to General Catlayst’s door. For background General Catalyst, has $28bn assets under management and is one of the world’s best known VC firms. They backed some of greatest businesses that you p…
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
38:58
38:58
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38:58
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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Clinical Quantification of Myocardial Blood Flow Using PET
21:03
21:03
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21:03
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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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
31:08
31:08
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31:08
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 ★Kirjoittanut 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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25:16
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25:16
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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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
33:11
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33:11
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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Robert Jäckle - Finding and investing in talent, The path to €600M AuM in 5 years, The correlation between risk and success, Surrounding yourself with driven and ambitious people
34:15
34:15
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34:15
Robert Jäkle is a Partner at Visionaries Club. Visionaries is a leading European early-stage VC fund with offices in London and Berlin. The fund is backed by over 30 unicorn founders - such as the founders of UiPath, Flixbus, Miro and Skype - as well as leading European family business entrepreneurs. Bobby joined the fund on day one and has helped …
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3D Visualization of the Heart in Immersive Technology Like Mixed Reality
17:47
17:47
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17:47
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
26:50
26:50
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26:50
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)
1:16:03
1:16:03
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1:16:03
This week, it's time for part two of our series on the Food and Drug Administration. Don't get a tummy ache.Kirjoittanut HOOT Studios
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Explainer Episode 71 - Regulatory Modernization in Idaho and Virginia: What lessons can be learned?
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35:28
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35:28
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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48:03
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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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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26:33
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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Aleksander Larsen - $1.3B revenue, North Korean hack, From the hottest company in web3 to being called a scam, Building digital nations, Competing with Visa
32:55
32:55
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32:55
Aleksander Larsen is the Co-Founder, Chairman, and COO of Sky Mavis, the company behind the popular crypto game Axie Infinity and the Ronin Network. SkyMavis is the breakout company at the intersection of gaming and blockchain, they’ve raised around 300 million dollars according to Dealroom and Crunchbase from top investors like a16z, Accel and Par…
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148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
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26:20
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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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
16:22
16:22
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16:22
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
18:12
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18:12
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
19:41
19:41
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19:41
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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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
23:15
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23:15
On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…
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Food and Drug Administration - Part 1 (poison squad)
1:05:53
1:05:53
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1:05:53
This week, we start a two-part series on the U.S. Food and Drug Administration. Spoiler alert, a lot of food used to be spoiled. Stop drinking raw milk.Kirjoittanut HOOT Studios
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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
35:58
35:58
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35:58
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…
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Deep Dive 292 - Utah v. Su: Are DOL (and SEC) regulations that encourage ESG investing lawful?
1:01:48
1:01:48
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1:01:48
The panelists will discuss Biden Administration policies and regulations at the DOL and SEC addressing investing based on environmental, social, and governance (or “ESG”) factors; whether they are consistent with statutory law; and whether the agencies followed appropriate administrative processes in promulgating these ever-evolving policies. Moder…
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