The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more
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Pharma Manufacturing Podcasts
This Life Science focused podcast brings together Xtalks editorial staff to share insights into the latest B2B industry news. Xtalks connects professionals in the life science, medical device, and food industries with useful content like webinars, job opening, articles and virtual meetings.
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Contract Pharma is the premier media outlet linking contract service providers and their pharma/biopharma sponsors. Rooted in our legacy print publication—issued 9 times per year—the Contract Pharma brand continues to evolve across its digital media platforms through ContractPharma.com, Contract Pharma Direct eNewsletters, and social media channels.
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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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Hogan Lovells is always thinking about how to conquer and foresee the most significant industry issues facing our clients. If you’ve been following us for the past two years, you’ve heard first-hand from our lawyers around the world on significant developments in the Life Sciences & Health Care sector and why they are so passionate about the industry. In season 3, we’ll unpack new and exciting industry trends and bring you more outside perspectives to keep you ahead of the curve.
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Hey Guys!!! Start digging here for industrial knowledge. Industrial process knowledge. Sytem knowledge. Department and their responsibility.
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Discoveries in technology, medicine, and nutrition are emerging with accelerating speed and improving our health and quality of life. Brought to you by Lonza, “A View On” podcast is a series of short conversations with industry leaders. Join us to discuss new trends that are impacting scientific research, drug discovery and business. The series of monthly conversations with pharma, biotech and nutrition leaders from across industry and academia covers a wide range of topics from 3D bioprinti ...
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Valisure founder CEO David Light explores the world of brand, generic and OTC medications. How they come to market, how they are manufactured and some of the challenges facing the pharmaceutical industry.
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Each episode of the Specialty Pharmacy Podcast is meant to serve as a resource for the latest specialty pharmacy trends, tips, and strategies to help listeners grow their specialty pharmacy business - be it in pharma, health systems, independents or anything in between. Tune in for valuable content, insights and actionable strategies from our rotating panel of industry experts as they share real-world examples and wisdom you can’t hear anywhere else.
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BatchMaster Software Pvt. Ltd. is a leading vendor of ERP solutions in all the 7 continents. With over 30 years of presence in the ERP market & 1500+ customers situated all over the globe, BatchMaster is a mature organization of 200 plus employees.
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Welcome to AI Uncovered, a podcast for technology enthusiasts that explores the intersection of generative AI, machine learning, and innovation across regulated industries. With the AI software market projected to reach $14 trillion by 2030, each episode features compelling conversations with an innovator exploring the impact of generative AI, LLMs, and other rapidly evolving technologies across their organization. Hosted by Executive VP of Product at Yseop, Tim Martin leads a global team an ...
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Knowledge is power. Join us and let's learn from experts! The American Business Podcast for the Next Generation (ABP) is an American International business podcast to share educational business content with the current and next generation business leaders, business professionals, executives and the workforce. The American Business Podcast for the Next Generation (ABP) streams live from the center of the global business, New York, every Friday afternoon. We invite real business leaders, busin ...
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The War Room Show is a fast paced, hard hitting news transmission for the afternoon drive. Featuring roundtable discussions with guests from around the world. Hosted by Infowars reporters Owen Shroyer LIVE M-F 3pm-6pm CT at https://infowars.com/show
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[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation
18:15
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18:15Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes. To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse…
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A cure worse than the disease? Using tariffs to bolster U.S. pharma manufacturing
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27:54In this episode of Talking the Cure, Phil Katz talks with Cybil Roehrenbeck, Josh Gelula, and Kelly Zhang about the announced and seemingly ever-changing plans for tariffs on imported goods – and pharmaceutical products in particular – may effect the industry, as well as the availability and cost of drugs. The discussion unpacks the law, the politi…
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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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Episode 5: A View On Smart Capsule Technology
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20:00A Swallow Instead of a Jab? A Capsule That Delivers Like an Injection In this episode, we’re joined by Karsten Lindhardt, Founder and CEO of Biograil, to explore how a spring-loaded oral capsule could revolutionize drug delivery—offering patients a needle-free alternative with the same therapeutic impact as subcutaneous injections. From insulin to …
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Radiopharmaceuticals and the Future of Nuclear Medicine with RadioMedix CEO Dr. Ebrahim Delpassand
37:35
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37:35In this episode, Ayesha speaks with Ebrahim S. Delpassand, MD, Founder and CEO of RadioMedix, a company developing innovative radiopharmaceuticals for cancer diagnosis, monitoring and treatment. With a focus on both PET imaging and therapeutic radiopharmaceuticals labeled with alpha and beta emitters, RadioMedix is helping to shape the future of pr…
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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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Building the Future of Brain Health: Neuroscience Drug Development with Novartis’ Dr. Norman Putzki
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27:30In this episode, Ayesha speaks with Norman Putzki, MD, Senior Vice President and Global Development Head of Neuroscience and Gene Therapy at Novartis, about the complexities and real-world challenges of bringing new therapies to patients with neurological diseases. Dr. Putzki discusses the challenges and opportunities in developing treatments for c…
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188 – Certified Quality Auditor(CQA) and Audits in the Future
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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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Episode #23: A Special discussion with business educators. How should employers engage with the next generation workforce?
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35:39Send us a text Episode #23: A Special discussion with business educators. How should employers engage with the next generation workforce? International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. Let's learn from experts. The American Business Podcast For The Ne…
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Episode #24: A Young Entrepreneur's Insights about Family-Owned Businesses, AI and Real Estate
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29:54Send us a text Episode #24: A Young Entrepreneur's Insights about Family-Owned Businesses, AI and Real Estate The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. Let's learn from e…
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Episode #22: How will be the economy and impact of AI?
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42:54Send us a text Episode #22: How will be the economy and impact of AI? The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. Let's learn from experts. The American Business Podcast Fo…
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Rare Disease Innovation in an Evolving Industry with Amgen’s Dr. Sumita Bhatta
32:03
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32:03In this episode, Ayesha speaks with Sumita Bhatta, MD, Vice President and Global Development Therapeutic Head of Rare Disease at Amgen. In the conversation, Dr. Bhatta shares insights on how large pharmaceutical companies like Amgen are approaching innovation and patient-centricity in the rare disease space. She also discusses the unique challenges…
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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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Episode #21: How should family-owned businesses operate?
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47:27Send us a text Episode #21: How should family-owned businesses operate? The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. Let's learn from experts. The American Business Podcast …
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Episode #20: Best Practices of Small Business Funding and Capital Management
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26:53Send us a text Episode #20: Best Practices of Small Business Funding and Capital Management with John Kozey of Onshore Funding The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. L…
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Episode #19: Will AI Replace Lawyers? PART2
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44:06Send us a text Episode #19: Will AI Replace Lawyers? PART2 with Attorney Will Newman. The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is power. Let's learn from experts. The American Bus…
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Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs
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4:26The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.By Pharma Manufacturing
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186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
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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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Advancing Novel Immunotherapy Approaches for Osteosarcoma and Beyond with Paul Romness, CEO of OS Therapies
43:23
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43:23In this episode, Ayesha spoke with Paul Romness, MHP, chair and CEO of OS Therapies, a company developing novel immunotherapies for cancers like osteosarcoma and other solid tumors. Paul shares insights into OS Therapies’ lead program, the scientific rationale behind the company’s innovative immunotherapy approach and how the company is addressing …
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Episode #18: Let's learn about American work safety requirements in workplaces
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51:28Send us a text Episode #18: Let's learn about American work safety requirements in workplaces with Kristen Panella from 2Safe Consulting The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge i…
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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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Targeting the Cell’s Powerhouse: Dr. Shaharyar Khan on Rivus Pharma’s Mitochondrial Approach to Cardiometabolic Diseases
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41:55In this episode, Ayesha spoke with Dr. Shaharyar Khan, co-founder and chief scientific officer at Rivus Pharmaceuticals. Rivus is developing a new class of investigational medicines called controlled metabolic accelerators (CMAs) for cardiometabolic diseases like diabetes, heart disease, heart failure and MASH by targeting obesity. Dr. Khan is an e…
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Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly]
4:13
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4:13The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat loomsBy Pharma Manufacturing
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Episode #17: U.S. Automotive Industry and Automotive Quality Management System IATF 16949
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37:45Send us a text Episode 17: U.S. Automotive Industry and Automotive Quality Management System IATF 16949 with John Feridun from Prufmeister Quality Consulting The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and…
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Episode #16: How to Improve Business Reporting In This Digital Age
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23:15Send us a text Episode#16: How to Improve Business Reporting In This Digital Age with Jillian Edwards from Revamp Your Reporting LLC The American Business Podcast For The Next Generation (ABP) is an American, International, educational business podcast for current and next generation workforce, professionals, executives and leaders. Knowledge is po…
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Episode #15: The State of American Nonprofit Industry and Career Path in Nonprofit Industry
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40:30Send us a text Episode#15: The State of American Nonprofit Industry and Career Path in Nonprofit Industry with Tommy DiMisa from Nonprofit Connector Nonprofit connector Tommy DiMisa shares his insights about American Nonprofit Industry, challenges and opportunities. Tommy also shares his professional career story and his wisdom with the next genera…
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Episode #14: The State of The American Manufacturing and Impact of Tariffs on Manufacturing PART 2
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28:36Send us a text Episode#14: The State of The American Manufacturing and Impact of Tariffs on Manufacturing PART 2 with Mike Eischer from One World Supply Chain Consulting Due to high demand and repeated requests from our audience, we are presenting you The State of American Manufacturing and Impact of Tariffs PART 2. Supply Chain Guru Mike Eischer s…
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Inside the Latest in Targeted Radiotherapeutics with Plus Therapeutics CEO Dr. Marc Hedrick
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46:36In this episode, Ayesha spoke with Marc Hedrick, MD, MBA, president and CEO of Plus Therapeutics, a company focused on developing a novel class of targeted radiotherapeutics. Prior to heading Plus Therapeutics, Dr. Hedrick served in a number of executive leadership roles including president, CEO and director at Cytori Therapeutics, and president an…
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184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
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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Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly]
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4:10Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites The bad — U.S. urged to invest $15B to counter China’s biotech rise The ugly — Trump signals ‘major’ tariffs on pharm…
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Episode #13: The State of The American Manufacturing and Impact of Tariffs on Manufacturing
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39:10Send us a text Episode #13: The State of The American Manufacturing and Impact of Tariffs on Manufacturing with Eric Ciampoli from ECIC Industrial Consulting Due to high demand and repeated requests from our audience, we are presenting you The State of American Manufacturing and Impact of Tariffs PART 2. Manufacturing Guru Eric Ciampoli shares his …
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Episode #12: Let's Talk About AI and Education. How will AI change the education?
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36:06Send us a text Episode #12: Let's Talk About AI and Education. How will AI change the education? Previously featured in The Wall Street Journal, New York Times and Newsday, in this episode the Principal of Harrow International School New York Matthew Sipple is sharing his insights about the state of education, and AI. Matthew also shares his profes…
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From Lab to Launch: Commercializing Gene Therapies for Rare Diseases with Rocket Pharma’s Carlos Martin
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33:54In this episode, Ayesha spoke with Carlos Martin, MBA, chief commercial operations and revenue officer at Rocket Pharmaceuticals, a company developing gene therapy cures for rare diseases through innovative science and platforms. Carlos joined Rocket in April 2021 and established the company’s early commercial strategy and infrastructure as Chief C…
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183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products
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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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Episode #11: The Story of An Unexpected Entrepreneur. Let's Talk About Employee Engagement, Leadership and Entrepreneurship. How are businesses evolving in the age of AI?
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29:37Send us a text Episode #11: The Story of An Unexpected Entrepreneur. Let's Talk About Employee Engagement, Leadership and Entrepreneurship. How are businesses evolving in the age of AI? In this episode, CEO of SpotCorp Events, Jesse Pudles is sharing his insights about the importance of employee engagements, leadership and entrepreneurship. Jesse P…
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Episode #9: Let's Talk About U.S. Manufacturing, Navy, Workforce Development and Job Training
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34:53Send us a text Episode #9: Let's Talk About U.S. Manufacturing, Navy, Workforce Development and Job Training. How is U.S. Manufacturing changing? In this episode the Workforce Development Administrator of Nassau BOCES, Dr. Peter Dalton, is sharing his insights about the state of U.S. Manufacturing, workforce development and Navy's job program. Dr. …
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Episode #10: Let's Talk About AI, Entrepreneurship, and Technology
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18:24Send us a text Episode #10: Let's Talk About AI, Entrepreneurship, and Technology How are businesses evolving with AI? In this episode, Founder and CEO of ClearSet.AI, Yasmine Gardiner, is sharing her insights about the state of AI industry, advantages of AI technology and impact of AI on the job market. Yasmine Gardiner also shares her professiona…
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Combating Autoimmunity: Vera Therapeutics CEO Dr. Marshall Fordyce Discusses Advancing IgAN Treatments
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44:45In this episode, Ayesha spoke with Marshall Fordyce, MD, founder and CEO of Vera Therapeutics, a company focused on developing treatments for autoimmune diseases. Dr. Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a succes…
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182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma
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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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Oeystein Kjoersvik - Auditing AI: Quality, Compliance & the Role of GenAI in Pharma
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32:51We’re excited to welcome Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments. In this episode, Tim and Oeystein delve into the challenges…
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Episode #8: Let's Talk About Quality Management. How will AI Change the Quality Management Practices in the Future?
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31:53Send us a text Episode #8: Let's Talk About Quality Management. How will AI Change the Quality Management in the Future? The Best Practices of Quality Management in Manufacturing and Business in General. In this episode the President of Amrus Consulting, Alex Kwartiroff, is sharing his insights about best quality management practices, impacts of AI…
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Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly]
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3:18Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Cellares, Cabaletta validate automated CAR T production The bad — FDA warns Aspen over sterility issues The ugly — FDA rejects Hengrui, Elevar cancer combo again…
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181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
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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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Targeting Pressing Unmet Needs in Kidney Diseases with Unicycive Therapeutics CEO Dr. Shalabh Gupta
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40:04In this episode, Ayesha spoke with Shalabh Gupta, MD, founder, chairman and CEO of Unicycive Therapeutics, a company focused on addressing unmet medical needs in renal diseases. Kidney diseases are a major global health concern. In the US, chronic kidney disease (CKD) affects more than one in seven individuals, and one in three adults with diabetes…
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Episode #7: Let's Talk About Best Cybersecurity Practices, AI, Role Models and The Next Generation Workforce
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28:24Send us a text How is the future of AI. What are the best practices of Cybersecurity? How should next generation prepare for their career path? In this episode the CEO of Long Island Tech Advisors Company, Anthony Buonaspina, is sharing the story of his career, his insights about best cybersecurity practices, the future of AI and role models. In th…
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180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
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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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Innovating Treg Therapies for ALS and Alzheimer’s with Coya Therapeutics CEO Dr. Arun Swaminathan
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39:10Join us as we celebrate a major milestone — the 200th episode of the Xtalks Life Science Podcast! From groundbreaking biotech innovations to exclusive interviews with life science industry innovators and leaders, we've covered it all. Thank you for tuning in each week! We look forward to continuing to bring the latest and greatest across the pharma…
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Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]
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3:44Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand. The bad — Merck KGaA’s CDMO business reports a decline The ugly — The FDA issues a warning letter …
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Episode #6: How are The Apprenticeship Programs Helping Businesses and Manufacturers?
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29:56Send us a text How are The Apprenticeship Programs Helping Businesses and Manufacturers? In this episode the CEO of Apprenticeship Connections Company, Michael Todisco, is sharing his insights about How apprenticeship programs are creating jobs for businesses and manufacturers, his professional career path, his insights about the future of AI and h…
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Episode #5: Business Efficiency and The State of Manufacturing
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24:37Send us a text Business Efficiency and The State of Manufacturing In this episode a Partner of EKC Strategic Business Alliance, Philip Mortell, is sharing the story of his professional career path, his insights about the future of AI and his wisdom with the next generation on How to choose the right career path. The American Business Podcast For Th…
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