Welcome to BIOTECH NATION !!! With understandable interviews requiring no background in science, BTN attracts a wide global audience. From everyday people looking for hope in treatments in development, to bioentrepreneurs interested in the experience of their fellow travelers, to venture capitalists looking for possibilities in cutting-edge breakthroughs, to scientists simply interested in the work of others, BioTech Nation is the voice of human endeavor, driving science to new realities for ...
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Formerly known as Intelligence Matters, the NatSec Matters podcast features former senior national security officials Michael Allen, Jeremy Bash, and Andrew Shapiro as they interview top leaders in national security, including intelligence officers, military leaders, and policymakers, on the most critical security challenges of our time. Their interviews offer insights into the world’s most pressing problems and assess the effectiveness of U.S. policy responses. They also explore the biograp ...
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LeaderVoices is a show about leaders, and their infinite ability to change the world. Each episode in LeaderVoices, we dig into stories and sparks from “for-purpose” leaders, coaches, comedians, luminaries, and everyday heroes from around the globe. Tales of impact and failing forward, of aspirations and innovations — and the infinite and inspiring ways that social purpose leaders lead and make the world a better place. This show is brought to you by the American Express Leadership Academy a ...
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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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190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
15:17
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15:17Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why reg…
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Michael Allen talks with former CIA executive and US foreign policy expert Glenn Corn, a regular guest of NatSec Matters. Glenn shares insights from his recent trip to Ukraine and the outlook for US support in its fight against Russia. He also highlights smart moves by President Trump in countering the Kremlin and offers reasons for optimism for Uk…
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PART II: A Regenerative Leap for Epilepsy… Dr. Cory Nicholas, Co-Founder and CEO, Neurona Therapeuitcs
27:03
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27:03This week on BioTech Nation, Dr. Cory Nicholas, CEO of Neurona Therapeutics, returns for part two. With early results now in from Neurona’s first clinical trial, patients with severe epilepsy are seeing dramatic improvements, including seizure reductions of over 90 percent, and even full remission in some cases. This one-time treatment delivers new…
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Michael Allen talks with former senior State Department official Jeffrey Feltman about President Trump's "new approach" to the Middle East following his recent trip to the Gulf. Jeffrey analyzes the President's focus on major investment deals, the evolving US positioning on Iran's nuclear program, the surprising U-turn on Syria, and how Mr. Trump's…
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189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
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17:14Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards…
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PART 1: A Regenerative Leap for Epilepsy…Dr. Cory Nicholas, Co-Founder and CEO, Neurona Therapeutics
24:27
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24:27This week on BioTech Nation, Dr. Cory Nicholas, Co-Founder and CEO of Neurona Therapeutics, discusses their groundbreaking success in treating drug-resistant epilepsy. With a single, targeted delivery of lab-grown brain cells, Neurona is offering not just symptom control but the possibility of long-term seizure relief. This is Part 1 of a two-part …
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188 – Certified Quality Auditor(CQA) and Audits in the Future
15:39
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15:39In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi…
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Michael Allen talks with retired rear admiral and China expert Mike Studeman about the geopolitical implications of President Trump's trade negotiations with China and US policy to counter Chinese influence and threats. Mike, former Commander of the Office of Naval Intelligence, discusses how China might exploit an "America First" orientation, the …
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Episode 22: Nomad on Two Wheels: Living a Story Most People Are Too Afraid to Write
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54:33Episode Summary: What happens when you trade a nine-to-five life for a motorcycle and the open road? Quintin Bynum is living the answer. In this unforgettable conversation, Quintin shares how he left Boston with a bike and a dream — and how that dream turned into a two-year, multi-continent odyssey across mountains, jungles, deserts, and war zones.…
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Fighting Cancer, Easing Pain... Dr. Lorin Johnson, CSO, Glycyx Therapeutics
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17:23This week on BioTech Nation, we explore a new approach to cancer treatment that could help patients manage pain without compromising their care. Dr. Lorin Johnson, CSO of Glycyx Therapeutics explains how a new once-daily pill could help patients manage pain without blocking their treatment.By Moira Gunn
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187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
16:26
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16:26What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products? In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical devi…
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Jeremy Bash explores the biotech battleground with former CIA science and technology chief Dawn Meyerriecks. Dawn, a key voice on the National Security Commission on Emerging Biotechnology, discusses the urgent need for US leadership to address critical vulnerabilities in the country's bio-industrial base. Dawn also makes a case for why powerful go…
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Freezing Out Chronic Pain…Sameer Sabir CEO, Brixton Biosciences
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14:21This week on BioTech Nation, Sameer Sabir, CEO of Brixton Biosciences, shares how their breakthrough injectable cold therapy, Neural Ice, could offer lasting relief for osteoarthritis pain. With a drug-free, nerve-targeting approach currently in clinical trials, this innovation may change how we treat joint pain without pills or repeated steroid in…
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Andrew Shapiro talks with former US Ambassador Dennis Ross, who argues that the country's foreign policy needs a reboot. Amb. Ross explains the principles of "Statecraft 2.0" – why the US must adapt its leadership for a challenging multipolar world, navigating the global influence and interests of China and Russia.…
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186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
12:38
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12:38In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regu…
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Beyond the One-Size-Fits-All Cure... Jeff Liter, Founder & CEO, Luminary Therapeutics
11:21
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11:21This week on BioTech Nation, Luminary Therapeutics CEO Jeff Liter shares how his team is working to make advanced cell therapy easier to access and more affordable. Instead of using each patient’s own cells, they use healthy donor cells that are ready to go. This approach could help more people get treated for cancer and autoimmune diseases like lu…
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185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
25:51
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25:51In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regula…
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Andrew Shapiro talks with former Pentagon Arctic policy head Iris Ferguson about how melting sea ice is ushering in a new era of great power competition, ending decades of 'Arctic exceptionalism.' Iris, the DOD's first Deputy Assistant Secretary for the Arctic, discusses Russia's interests, China’s pursuit of influence as a 'near-Arctic state,' and…
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Beyond Pills and Shots... Sean Ainsworth, CEO, Immusoft
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12:44This week on BioTech Nation, Sean Ainsworth, CEO of ImmuSoft, explains how modifying the body’s own B cells to produce therapeutic proteins could revolutionize drug delivery. From improving treatment for rare diseases like Hurler syndrome to potentially replacing injections for autoimmune and metabolic conditions, this new approach opens the door t…
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184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
30:37
30:37
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30:37In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies. Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharma…
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Michael Allen talks with Craig Singleton, Senior Director for China at the Foundation for Defense of Democracies, about whether President Trump is locked into an inescapable trade war with China's Xi Jinping. Craig discusses the high-stakes gamble each leader is making, convinced the other will fold first. They explore whether 'strategic decoupling…
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Breaking Barriers in Brain Cancer... Dr. Thomas Chen, Founder and CEO, NeOnc Technologies
24:39
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24:39This week on BioTech Nation, Dr. Thomas Chen, Director of Neuro-Oncology at USC and Founder of NeOnc Technologies, shares treating glioblastoma by delivering a drug directly to the brain through nasal inhalation changes the drug delivery game, bypassing the blood-brain barrier. This technique is achieving results in clinical trials.…
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183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
37:11
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37:11Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufa…
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Michael Allen talks with former CIA senior executive Glenn Corn about whether Turkey is a US ally or wildcard. They discuss how Turkey is navigating the conflicts in Syria and Ukraine while managing relationships with both Washington and Moscow. Glenn also explores the fall of Bashar al-Assad, the future of the Kurds, the decline of Hezbollah, and …
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Episode 21: Talent Talks: Recruiting for Pharma and Biotech
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54:26
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54:26Join Dr. Sadhna Bokhiria as she sits down with Jamie Riley, a seasoned veteran in the pharmaceutical recruitment industry and the founder of Pharma Search Partners. With a career spanning over two decades, Jamie shares his transformative journey from a military career to reshaping recruitment in the biotechnology and pharmaceutical sectors. This ep…
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The Future of Synthetic Biology... Dr. John Cumbers, Founder & CEO, SynBioBeta
18:53
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18:53This week on BioTech Nation, I speak with Dr. John Cumbers, founder and CEO of SynBioBeta, the annual synthetic biology conference. We discuss how biology, AI, and technology are transforming industries, covering tracks on human health, planetary health, and hyperscale biology. SynBioBeta 2025 will take place in San Jose, CA, from May 5 to 8.…
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182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
18:42
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18:42In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer …
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Trump, Ukraine, and the Ceasefire Gamble: Peter Rough
45:08
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45:08What does President Trump's plan for peace in Ukraine look like, and what could it cost Kyiv? Michael Allen talks with Peter Rough, a senior fellow at the Hudson Institute, about the high-stakes diplomacy under way right now. Peter unpacks the determined push for a ceasefire, the potential shift to offering Russia more 'carrots' than 'sticks,' and …
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Reimagining Bone Marrow Transplants... Kevin Caldwell, Co-Founder & CEO, Ossium Health
13:29
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13:29This week on BioTech Nation, Ossium Health co-founder and CEO Kevin Caldwell shares how their breakthrough approach is changing bone marrow transplants. By cryobanking marrow from organ donors, Ossium is reducing wait times, improving access, and preparing for future emergencies. With support from BARDA and promising clinical trial results, this ne…
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181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
20:14
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20:14Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of…
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Michael Allen speaks with Eddie Fishman, sanctions expert and author of Chokepoints: American Power in the Age of Economic Warfare. Eddie explains how the U.S. has wielded economic weapons against Russia, Iran, and China, and how sanctions and supply chain dominance are reshaping global power. He also explores the risks of overusing these tools, Ch…
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When Your Immune System Attacks You... Prof. Dr. Niels Riedemann, Co-Founder & CEO, Inflarx
21:52
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21:52This week on BioTech Nation, we explore what happens when your immune system overreacts. Professor Niels Riedemann, CEO of InflaRx, explains how the body’s defense system can sometimes cause more harm than good, leading to serious conditions like rheumatoid arthritis, severe COVID-19, and lung failure. Learn how InflaRx is developing treatments to …
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180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
25:18
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25:18🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.In this e…
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Jeremy Bash speaks with former Air Force Secretary LTC (Ret.) Frank Kendall about the future of U.S. air and space dominance amid rising threats from China and Russia. Mr. Kendall describes the Pentagon’s toughest modernization decisions, from next-generation fighter jets to autonomous combat aircraft. He also discusses the evolving role of the Spa…
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Designing Healthcare for People... Dr. Daniel Kraft, Tech Nation Health Chief Correspondent
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7:59This week on BioTech Nation, Dr. Daniel Kraft explores how smarter design can make healthcare easier, less stressful, and more effective. From hospitals built for patient comfort to medical apps that adapt to your needs, the way we experience healthcare is evolving. Learn how design thinking and empathy are shaping the future of medicine.…
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179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
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9:27In this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The …
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Michael Allen speaks with Arnold Sinisalu, former chief of Estonia’s Internal Security Service, about Estonia’s frontline role in countering Russian espionage and subversion. Arnold describes how Estonia tracks and disrupts Russian intelligence operations, from spy arrests to cyber defense. He also discusses Russia’s evolving sabotage tactics acros…
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Episode 20: Jailhouse Jitters: Lockdown, Leadership, and the National Guard - Inside the New York Prison Strike
1:29:19
1:29:19
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1:29:19Join Dr. Sadhna Bokhiria on this inspiring episode of LeaderVoices as she dives deep with Adam Ramirez, a retired Deputy Superintendent for Security with over 34 years of experience in the New York State Department of Corrections. Adam shares insights into leading in one of the most challenging environments—maximum-security prisons. He sheds light …
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Why One Drug Isn't Always Enough... Rich Daly, President & CEO, Catalyst Pharmaceuticals
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19:01This week on BioTech Nation, Catalyst Pharmaceuticals CEO Rich Daly discusses the complexities of treating epilepsy and rare diseases. From the challenges of polypharmacy—where patients need multiple drugs to manage a single condition—to the hurdles of diagnosing and treating ultra-rare diseases.By Moira Gunn
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178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know
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31:22In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory context…
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Michael Allen speaks with Nico Lange, senior fellow at the Center for European Policy Analysis, about Germany’s political future and the major shifts in transatlantic security. They discuss the recent German elections, Germany’s evolving defense strategy, and Europe’s response to a changing U.S. foreign policy under President Trump. Nico also offer…
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A Second Chance for an ALS Drug... Dr. Ari Azhir, Founder & CEO, Neuvivo
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17:47This week on Biotech Nation, Dr. Ari Azhir, Founder and CEO of Neuvivo, shares the incredible journey of an ALS drug that was once abandoned, but is now making its way toward FDA approval. After two failed phase two trials, the drug was left behind until Dr. Azhir and her team discovered a crucial mistake in the trial data. Now with new insights an…
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177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED
10:58
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10:58🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com 🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. This ep…
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Michael Allen speaks with The Wall Street Journal‘s Chief European Political Correspondent, Bojan Pancevski, about his recent article on Russia’s new ‘Department of Special Tasks.’ Panchevski reveals the unit’s clandestine operations in Europe, its motives behind acts of sabotage, and the broader geopolitical implications. He also discusses his inv…
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Episode 19: The Human Side of Science: Innovation in Neurodegenerative Research
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40:26In this episode of LeaderVoices, host Dr. Sadhna Bokhiria sits down with Dr. Winnie Pak, Head of Strategy at Elevated Clinical, to dive deep into the world of clinical trials, neurodegenerative diseases, and the power of purpose-driven science. Dr. Pak shares her personal journey into neuroscience, the urgent need for early detection in Alzheimer’s…
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The Mystery of "Dark" Proteins... Dr. Daniel Kraft, Tech Nation Health Chief Correspondent
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9:29This week on BioTech Nation, Dr. Daniel Kraft explores the discovery of "dark" proteins, thousands of previously unknown proteins in the human body. Scientists believe these hidden proteins could be the key to detecting diseases earlier and developing new treatments.By Moira Gunn
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176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski
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26:20In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as c…
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Michael Allen speaks with retired Rear Adm. Mark Montgomery, Senior Director of the Center on Cyber and Technology Innovation at the Foundation for Defense of Democracies. He shares insights on the Ukraine war, examining Russia’s tactical advantage, the challenges Ukraine faces amid inconsistent aid, and the vital role of international alliances. H…
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9 Million Samples: A New Era of Medicine... Dr. Lincoln Nadauld, President & CEO, Culmination Bio
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18:27This week on Biotech Nation, Dr. Lincoln Nadauld shares how Culmination Bio is using 9 million preserved tissue samples and decades of patient data to improve how we understand and treat diseases. From discovering patterns in cancer treatments to exploring breakthroughs in heart and autoimmune diseases, this unique approach is changing medicine.…
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175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
39:49
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39:49🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this…
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