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CMC Talks

Crediton Milling Company

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Welcome to the CMCTalks podcast. The ramblings of William and Karen joined by farmers, industry professionals and intriguing guests discussing relevant industry topics and enjoying some banter and good chat. This is not a serious or overly-technical podcast by any means but hopefully will provide some light entertainment for our highly valued customers and prospects.
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The VirtualPharm

Despina & Ethan at Enkrisi

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The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate profession ...
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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

David Brühlmann: Biotech Entrepreneur & Cell Culture Technology Innovation Aficionado

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The Go-to Podcast for Biotech Scientists Who Want to Master Bioprocess CMC Development and Manufacturing of Biologics. **TOP 10 LIFE SCIENCES PODCAST** Do you want to simplify bioprocessing so that you can scale with confidence and reduce time to market? Are you sick of feeling overwhelmed by the complexity and guesswork of biologics drug development? Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commerc ...
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing ...
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Manufacturing has its challenges. Digital Transformation has its challenges. Welcome to the DigitalituM Podcast, where we delve into the intersection of manufacturing and digital transformation. Manufacturing, a cornerstone of our global economy, faces various challenges—from optimizing production processes to ensuring quality control and maintaining a skilled workforce. In parallel, the digital transformation journey presents its own set of hurdles. Integrating new technologies, managing da ...
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What every business needs to survive and to grow are new clients. In the B2B world, new clients equal generating highly qualified sweet leads. Well, for BizzBee Solutions, the way to that was via outreach. Dancho Dimkov, MBA, CMC, CEO of BizzBee Solutions, author of "Sweet Leads" and BizzBee's Outreach COO - Natasha Razmoska reveal all their outreach knowledge and experience to this podcast's host Vera Eftimovska, MA, and BizzBee's Content COO. It's a dream team with tons of valuable insight ...
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The Richard Sherman Podcast

iHeartPodcasts and The Volume

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All-Pro CB Richard Sherman is talking about the NFL all season long, and reacting to the entire NFL slate of games every week alongside his co-host Mitch Eisenstein. During the week, Richard interviews some of the biggest names in football. One of the most unique voices in NFL history brings his one-of-a-kind energy to the podcast world.
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Merideth Bisiker, Certified Money Coach (CMC)® and mentor to entrepreneurs brings you industry experts who inspire you to find success in your business and in life on your own terms. These are powerful conversations that provide you with inspiring stories and strategies to rise above the mediocre and struggle you're facing now so you can finally live a life you love. Merideth and her guests inspire you to feel good about wanting to make money in your business so that you can make a bigger im ...
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Send us a text Are you ready to dive into the cutting-edge world of biomanufacturing? In this episode, strategic consultant James Ryall unveils the staggering potential of bio-based products to revolutionize industries. From cultured meat to human breast milk, discover how cells are becoming the ultimate manufacturing facilities. James shares inval…
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In this podcast, Desi and Ethan discuss the importance of a robust Global CMC regulatory strategy for pharmaceutical companies seeking global market access. It emphasizes the need to understand the regulatory requirements of each target market, harmonize CMC data and documentation across regions, and establish a comprehensive quality system. The ar…
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Richard Sherman reacts to Tua Tagovailoa and the Miami Dolphins taking out the Los Angeles Rams on Monday Night Football in Week 10 of the 2024 NFL season, as well as the Sunday Night Football matchup that saw the Detroit Lions overcoming Jared Goff's five interceptions to win a hard-fought game against C.J. Stroud and the Houston Texans. After, he…
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The podcast discusses the International Council for Harmonisation (ICH) guidelines and their impact on pharmaceutical development. Specifically, the text focuses on the key updates to the ICH guidelines, including Q2(R2)/Q14 for analytical validation, Q5(R2) for viral safety evaluation, and Q9(R1) for quality risk management. The text also examines…
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Send us a text In this eye-opening episode, we explore the intricate landscape of Advanced Therapy Medicinal Products (ATMPs) with Oliver Kraemer, a technical development leader at Flagship Pioneering. Drawing from his extensive experience at industry giants like BMS, Sanofi, and Boehringer Ingelheim, Oliver challenges conventional wisdom about aut…
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Richard Sherman reacts to Week 10 of the 2024 NFL season, including Brock Purdy and the San Francisco 49ers winning Christian McCaffrey's first game back against Baker Mayfield and the Tampa Bay Buccaneers, Cooper Rush and the Dallas Cowboys getting blown out by Jalen Hurts' Philadelphia Eagles in their first game without Dak Prescott, Patrick Maho…
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Richard Sherman interviews New York Jets star cornerback Sauce Gardner. The two-time NFL All-Pro tells Sherm about his journey, from getting snubbed by Michigan State as a three-star recruit to breaking out at Cincinnati and going fourth in the NFL Draft to the Jets. The two also discuss New York's mid-season firing of Robert Saleh and promotion of…
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The International Council for Harmonisation (ICH) has updated its guidelines on quality risk management (QRM) with ICH Q9(R1). This update emphasizes a more proactive and structured approach to risk management in the pharmaceutical industry, emphasizing reducing subjectivity and integrating knowledge into risk-based decision-making. The update enco…
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Send us a text Want to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing. Sigma shares game-changing insights into accelerating biologics development…
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This Podcast is a guide to authoring a successful CMC Quality Module 3 and Quality Overall Summary (QOS) for a New Drug Application (NDA) submission to the Food and Drug Administration (FDA). Ethan and Desi detail the importance of these documents for demonstrating a product's quality, navigating the regulatory review process, and achieving global …
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Richard Sherman reacts to Patrick Mahomes leading the Kansas City Chiefs to an overtime victory over Baker Mayfield and the Tampa Bay Buccaneers in Week 9 of the 2024 NFL season, the Minnesota Vikings eking out a win against the Indianapolis Colts on Sunday Night Football, Christian McCaffrey reportedly returning for the San Francisco 49ers in thei…
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Send us a text In this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development. Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship…
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Richard Sherman reacts to Week 9 of the 2024 NFL season, including Geno Smith getting sacked seven times as the Seattle Seahawks fell to Matthew Stafford and the Los Angeles Rams, Jared Goff and the Detroit Lions continuing their dominant run with a win over Jared Love's Green Bay Packers, the Dallas Cowboys falling to 3-5 on the season as they too…
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Send us a text Discover the captivating journey of Julian Helmle, co-founder of CMC Engineers, as he takes us from the prestigious halls of Porsche and Mercedes-Benz to the cutting-edge realm of virtual reality in manufacturing. Julian's passion for VR is palpable as he recounts his mission to democratize this revolutionary technology, making it ac…
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This podcast covers the common regulatory challenges faced by professionals working in the pharmaceutical and biotechnology industries. The authors provide seven scenarios, ranging from an unexpected clinical hold to difficulty obtaining budget approval for regulatory activities, and present solutions for each. These solutions include strategies fo…
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Send us a text Struggling to unravel the complexities of your bioprocess? Prepare for a paradigm shift as we dive into the world of Process Analytical Technology (PAT) with Katharina Dahlmann who is Application and PAT Expert at Hamilton. This eye-opening episode dissects how PAT is redefining biologics manufacturing, balancing its immense potentia…
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Richard Sherman interviews Kansas City Chiefs safety and two-time Super Bowl champion Justin Reid, and the two discuss Kansas City's 7-0 start to the 2024 NFL season, Chiefs defensive coordinator Steve Spagnuolo's masterful game planning, and how Patrick Mahomes, Travis Kelce, and Andy Reid have crafted their Super Bowl-winning culture. Justin brea…
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Richard Sherman reacts to Russell Wilson leading the Pittsburgh Steelers to a victory over Daniel Jones and the New York Giants on Monday Night Football in Week 8 of the NFL season. Russ looked like his old self from the Seattle Seahawks as he sliced up the Giants defense by feeding George Pickens and Calvin Austin III. Are the 6-2 Steelers a conte…
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The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It emphasizes aligning stability protocols with regulatory guidelines from bodies like the FDA and EMA, focusing on key aspects like study…
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Send us a text Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT). Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell be…
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Richard Sherman reacts to Week 8 of the 2024 NFL season, including Brock Purdy leading the San Francisco 49ers come-from-behind victory over Dak Prescott and the Dallas Cowboys on Sunday Night Football, Geno Smith and the Seattle Seahawks taking a frustrating loss to Josh Allen and the Buffalo Bills, Jayden Daniels connecting on an UNREAL Hail Mary…
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Richard Sherman interviews his former Seattle Seahawks teammate Bobby Wagner. The two close friends discuss Bobby's move to the Washington Commanders, rookie QB Jayden Daniels taking the NFL by storm in his first season, and how it feels for Bobby to reunite with former Seattle defensive coordinator Dan Quinn in Washington. Richard also asks Bobby …
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The episode "Strategic Timing for Defining Regulatory Starting Materials (RSMs)" highlights the impact of timing when defining RSMs during Active Pharmaceutical Ingredient (API) development. It examines three stages—Pre-IND, Post-IND but pre-clinical trials, and late development before submission—each with its own advantages and challenges. Early-s…
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Richard Sherman interviews New York Jets cornerback D.J. Reed. Richard asks his former San Francisco 49ers teammate about how the Jets locker room felt when they found out Robert Saleh got fired, how Davante Adams has acclimated to the team after his trade from the Las Vegas Raiders, Jeff Ulbrich's first weeks as the Jets head coach, what Aaron Rod…
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Send us a text Imagine predicting your bioprocess outcomes as easily as checking the weather forecast. Sound impossible? Not anymore. In this insightful episode, we dive deep into the world of digital twins and process models with Fabian Feidl, co-founder and CTO of DataHow. Discover how these cutting-edge tools are reshaping the biotech landscape,…
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The source is a guide to the field of Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) within the pharmaceutical industry. It explains the role of CMC RA in ensuring drug development, manufacturing, and marketing comply with regulatory standards. The source details the key functions of CMC RA, such as regulatory strategy develop…
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Richard Sherman reacts to the Monday Night Football slate for Week 7 of the 2024 NFL season. Lamar Jackson and Derrick Henry's dominance over NFL defenses continued as the Baltimore Ravens took care of Baker Mayfield and the Tampa Bay Buccaneers 41-31. Is Baltimore the biggest threat to Patrick Mahomes and the Kansas City Chiefs in the AFC? In Ariz…
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Send us a text Are you ready to decode the future of bioprocessing? In this eye-opening episode, we dive deep into the world of digital bioprocess development with Fabian Feidl, co-founder and CTO of DataHow. Discover how cutting-edge process models are transforming the biotech industry, bridging the gap between raw data and actionable insights. Ke…
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Richard Sherman reacts to Week 7 of the 2024 NFL season, including Patrick Mahomes and the Kansas City Chiefs moving to 6-0 with a convincing victory over Brock Purdy and the San Francisco 49ers, the Seattle Seahawks seizing control of the NFC West with a road win over the Atlanta Falcons, Jared Goff looking like an MVP leading the Detroit Lions ov…
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This article argues that strategic outsourcing, particularly for Small Molecule APIs, is a key component of successful drug development. It outlines the benefits of outsourcing for pharmaceutical companies, including cost reduction, increased focus on R&D, and faster time-to-market. The article also emphasizes the importance of regulatory strategy …
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Richard Sherman reacts to the Las Vegas Raiders trading star wideout Davante Adams to the New York Jets, reuniting Adams with his former Green Bay Packers quarterback Aaron Rodgers. Richard breaks down the trade and criticizes Jets owner Woody Johnson for saying he’s focused on building a culture after firing head coach Robert Saleh. Richard also r…
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Richard Sherman reacts to the Monday Night Football matchup between the Buffalo Bills and the New York Jets in Week 6 of the 2024 NFL season. Josh Allen accounted for three touchdowns in a 23-20 victory over Aaron Rodgers and the Jets, who were playing their first game after the firing of head coach Robert Saleh. Richard heaps praise on the Bills d…
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Send us a text In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and i…
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Richard Sherman reacts to Week 6 of the 2024 NFL season, including Jared Goff leading the Detroit Lions to a resounding 47-9 blowout of Dak Prescott and the Dallas Cowboys, Lamar Jackson and Derrick Henry continuing their stellar play in a 30-23 Baltimore Ravens win over Jayden Daniels and the Washington Commanders, Caleb Williams throwing four tou…
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Richard Sherman reacts to the highly-anticipated Thursday Night Football matchup between his two former teams, as the San Francisco 49ers went on the road and handed Geno Smith and the Seattle Seahawks their third-straight loss. Did Brock Purdy, Deebo Samuel, and George Kittle ease concerns around the offense underperforming without Christian McCaf…
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This excerpt from "Robust CMC Process for Small Molecules" is a guide to designing robust manufacturing processes in the pharmaceutical industry. It highlights the importance of comprehensive planning, rigorous design, and continuous improvement in the development of small molecules, biologics, and dosage forms. The author stresses that a robust pr…
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Richard Sherman interviews Green Bay Packers safety Xavier McKinney. Richard talks to the former University of Alabama standout about his relationship with legendary Crimson Tide coach Nick Saban, falling to the New York Giants in the second round of the 2020 NFL Draft, signing a four-year, $67 million contract with the Packers this offseason, and …
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Send us a text Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma. Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's …
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Richard Sherman interviews University of Colorado star and consensus top NFL Draft prospect Travis Hunter. Richard made headlines discussing Hunter's two-way skillset on Detroit Lions wide receiver Amon-Ra St. Brown's podcast, and the two clear the air about what Sherm was trying to say about Hunter. The two go on to discuss the Heisman favorite's …
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Richard Sherman reacts to the primetime matchups to conclude Week 5 of the 2024 NFL season. Patrick Mahomes and the Kansas City Chiefs kept rolling on Monday Night Football as they made easy work of Derek Carr and the New Orleans Saints, winning 26-13 at home to move to 5-0 on the season. Should Mahomes be the early favorite for NFL MVP? The Sunday…
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Podcast Description: In this episode, we explore the essential components of a robust Chemistry, Manufacturing, and Controls (CMC) due diligence framework, with a special focus on drug substance evaluation. Join us as we break down the comprehensive steps involved in conducting due diligence during pharmaceutical acquisitions or in-licensing. From …
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Send us a text Is AI the secret weapon biotech scientists have been waiting for? In this eye-opening episode, we dive deep into the world of AI-driven bioprocess development with Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode. Discover how AI is transforming the biotech landscape, from reducing downtime by 50% to unlocking…
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Richard Sherman reacts to Week 5 of the 2024 NFL season, including the San Francisco 49ers blowing a 23-10 halftime lead in an "unacceptable" upset loss to Kyler Murray and the Arizona Cardinals, Geno Smith getting sacked 7 times as the Seattle Seahawks took an "inexplicable" loss to Daniel Jones and the New York Giants, Lamar Jackson out-lasting J…
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Welcome to "Accelerating the Path to Approval", hosted by Ethan and Despina from Enkrisi. In this podcast, we explore the critical steps in developing a robust Regulatory Chemistry, Manufacturing, and Controls (CMC) strategy that can make or break a successful New Drug Application (NDA) or Biologics License Application (BLA) submission. Today, we’l…
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Send us a text In this electrifying episode, we dive deep into the future of biotech with biotech influencer Benjamin McLeod. From quantum AI mapping cellular interactions to the game-changing potential of process analytical technology, Ben, who is also a Cell & Gene Therapy Segment Lead at NanoMosaic, unveils how artificial intelligence is set to …
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Richard Sherman interviews New England Patriots cornerback Christian Gonzalez. Richard asks the former University of Oregon standout about getting drafted in the first round of the NFL Draft by Bill Belichick, Jerod Mayo's intricate playbook, getting his first career interception against the Miami Dolphins last season matching up with Tyreek Hill, …
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In this insightful episode, hosts Ethan and Desi take you on a deep dive into the drug approval process, emphasizing the critical role of Chemistry, Manufacturing, and Controls (CMC) documentation. With a focus on what sponsors often miss, the discussion highlights how inadequate preparation in key areas like stability studies, process validation, …
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In this episode of CMC Talks, we dive into a comprehensive market update with our CMC Director and welcome two distinguished guests who bring a unique blend of expertise, experience, and engaging conversation. Featured Guests: Guest 1: Mark Gulley, Director of Crediton Milling Company Mark Gulley kicks off the episode with a thorough analysis of th…
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Richard Sherman reacts to the Monday Night Football matchup between the Seattle Seahawks and Detroit Lions in Week 4 of the 2024 NFL season. Geno Smith and Kenneth Walker III had big games on the offensive side of the ball, but the Seahawks defense got carved up by Jared Goff's historically perfect performance. Will Seattle's defense hold the team …
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Send us a text Discover how a failed optometry dream led Benjamin McLeod to become a leading voice in cell and gene therapy. In this eye-opening episode, Ben, who is a Cell & Gene Therapy Segment Lead at NanoMosaic, shares his unconventional path from lab work to LinkedIn stardom, revealing how he bridges the gap between R&D and marketing in biotec…
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