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Gain insights from leaders as they discuss their experiences guiding the organizations that make Medical Alley the epicenter of health innovation and care. Join us for conversations with top healthcare CEOs, startup entrepreneurs, and other experts in healthcare community who are doing innovative work right here in Medical Alley.
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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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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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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences ...
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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This Food Industry 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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The Project Medtech podcast is interview-style podcast on the Medtech Industry where guests share stories, advice, pitfalls, trends and innovations produced by Project Medtech.
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BioTalk with Rich Bendis

BioHealth Innovation, Inc. (BHI)

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BioHealth Innovation, Inc. (BHI) Founder, President & CEO, Rich Bendis, hosts BioTalk — conversations with some of the most accomplished and exciting business, academic, and government leaders in the biohealth industry. BioTalk enables you to learn from these leaders about issues which can help you grow your business. What are the current trends? Where are industry sectors headed? How do we increase access to capital in our region? Rich and his guests dive deep into these topics and much mor ...
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The Luxury of Choice podcast is a sales skills and knowledge podcast brought to you by the training team of george james ltd. Each month Jonathan Cooper, Pru Layton and Steve Vaughan discuss various aspects of technical sales methodologies and skills. The mid month show features a guest interview with a subject matter expert in a relevant field. George james ltd is a specialist training, executive recruitment and consulting business operating in the life science, laboratory equipment, medica ...
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As someone looking to make a real difference in the lives of patients suffering from disease , there is a lot you can do beyond publishing papers. It takes an average of 17 years to go from research finding to clinical implementation. This means that ground-breaking discoveries will not matter much if no one picks up the mantle to carry those discoveries forward. It’s hard to become the kind of leader who drives research findings forward into clinical application. It used to be that through ...
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EUAudio

EU Automation

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EUAudio provides automation professionals with a seamless way to listen in on the biggest manufacturing trends, anytime, anywhere. Covering the industry’s most relevant topics from environmental issues to predictive maintenance, cyber security to supply chain management, each series is carefully curated allowing listeners to develop their knowledge and skill set along the way. Your journey to becoming an automation expert starts here.
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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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Welcome to On The Line! Joe Mullings is hoping to provide insight to those looking to really drive his personal careers with advice rooted in 3 decades of career development and coaching. Joe has helped build hundreds of companies working closely with CEO’s and entrepreneurs in the high-tech world. He founded the top search firm in the medical device industry and has built other businesses including The Armory which had world class UFC fighters and World Champion Brazilian Jiu Jitsu professi ...
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In this episode, Rebecca McManus at Amethyst Care and Duane Mancini discusses the technology she is working on out of Trinity College of Dublin, their next 18 months, the innovation scene in Dublin, Ireland, her interest in Northeast Ohio, Adapt Research Center, lessons learned so far, how she overcame the anxiety of how long everything takes in Me…
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In this episode of the Medical Alley Podcast, host Ben Wagner talks to Technical Manger Jason Longhorn of Element Materials Technology. The conversation runs the gamut from the role Element plays in the medical testing market, COVID-19 and the ongoing recovery of the industry, the use of Ethylene oxide (EtO) in sterilization (and potential alternat…
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In this episode of the Luxury of Choice podcast, host Steve Vaughan, along with fellow sales trainer Jonathan Cooper and Debbie Airey, delve into the complexities of the "player manager" role in sales. In other words, both managing a sales team, whilst maintaining personal sales responsibility such as a territory, key account, product line, etc. Th…
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On this episode of the Medical Alley Podcast, we're coming to you live (at least at the time of recording) from the floor of MD&M Minneapolis, a premier medtech and medical manufacturing convention. In a series of short interviews, host Ben Wagner talks with guests about what conversations were happening between major companies, how each company is…
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In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. The…
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In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, aiming to transform the industry by 2030. Hanger shares her career journey, from her roles at PatientsLikeMe and Memori…
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In this episode of BioTalk, Rich Bendis speaks with Dr. Frank Gupton, Co-Founder of Phlow and CEO of the Medicines for All Institute, about his pioneering efforts to improve pharmaceutical manufacturing and global access to essential medications. Dr. Gupton shares how Phlow is addressing vulnerabilities in the U.S. pharmaceutical supply chain by pr…
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Earlier this year, Thermo Fisher Scientific opened its first clinical trial Innovation Lab in Center Valley, Pa., designed to foster a culture of collaboration by providing a dedicated space for industry partners to come together, share ideas and co-create solutions for the industry’s biggest challenges. The global clinical trial market was valued …
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In this episode, Crystal Weber at Group 31 and Duane Mancini discuss her second career as a marketing expert, how her first career as a nurse prepared her for this role, the importance of tailoring messaging to investors, how to position your product in the healthcare system, and so much more. Crystal Weber LinkedIn Group 31 Communications LinkedIn…
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In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution.00:00 Welcome and Podcast Jo…
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In this episode, Vera spoke with Dr. Sam Lee, Co-Chief Executive Officer and President of Cocrystal Pharma, a clinical-stage biotech company focusing on antiviral drug development with a unique structure-based drug discovery platform. With over 25 years of experience in anti-infective drug discovery, Dr. Lee brings a wealth of knowledge to the disc…
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In this episode of The Factor, Ryan Doxey (Senior Director of Technical Services at Kymanox) and David Harrell (CEO of Helixomer) discuss the innovative potential of RNA Origami in transforming drug development and precision medicine, and the challenges faced by startups in this complex landscape. So what exactly is RNA Origami? About the Factor: T…
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In this episode, Todd Ponsky at Cincinnati Children's and Duane Mancini discuss his background as a pediatric surgeon, his startup company that he launched around education, the changes to the innovation and venture arm of Cincinnati Children's, the importance of having a supportive hospital leadership team for the innovation department, and so muc…
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In this episode of the Luxury of Choice podcast, host Steve Vaughan, fellow sales trainer Jane Green and new colleague Debbie Airey discuss the challenges of facing rejection in sales, particularly the word 'no.' They explore the emotional impact of rejection, the different types of 'no' responses, and the importance of asking open questions to und…
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In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spendin…
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Navigating the complexities of groundbreaking treatments can create headwinds. With innovations like Pulsed Field Ablation (PFA) at the forefront, challenges such as financial uncertainties, regulatory shifts, and global adoption become paramount. Join us for an insightful discussion on how global partners address these challenges, focusing on safe…
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In this episode, Vera spoke with Tim Culp, PhD, Vice President of Research and Development at Interius BioTherapeutics, a Philadelphia-based biotech company. Their lead program focuses on an intravenous CAR therapy for B cell lymphomas. Additionally, the company is advancing a second program aimed at treating autoimmune diseases. Dr. Culp joined In…
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Today we welcome Kerry Love, the co-founder of Massachusetts-based (and wonderfully named) Sunflower Therapeutics. Established in 2018, Sunflower is dedicated to advancing biologic medicines and enhancing global vaccine accessibility through cutting-edge protein manufacturing technologies. As a women-owned organization, Sunflower has a stellar team…
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In this episode, Dylan Horvath at Cortex Design and Duane Mancini discusses how he founded his company, features vs. innovations, lessons learned, common mistakes, and so much more. Dylan Horvath LinkedIn Cortex Design LinkedIn Cortex Design Website Duane Mancini LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠ ⁠⁠⁠⁠Project Medtech Website ⁠ ⁠Mittal Co…
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In this episode of the Medical Alley Podcast, host Ben Wagner looks into the future of 3D-printed healthcare with Amy Alexander, Unit Head, Mechanical Development & Applied Computational Engineering at Mayo Clinic. From custom prosthetics and implants to sharpening the accuracy of medical devices, 3D-printed technology is (literally) reshaping the …
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In this episode, Ayesha spoke with James E. Brown, DVM, co-founder, President and CEO of DURECT. DURECT is pioneering a therapeutic strategy by leveraging the potential of epigenetic modulation to alter the trajectory of severe and life-threatening conditions like acute organ injury and cancer. The company is specifically focused on the development…
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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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In this podcast episode, we're thrilled to introduce you to Julie Conway, a master glass artist and lighting designer who has been manufacturing molten glass products for over 26 years. Get ready to be inspired by Julie's remarkable journey, her commitment to sustainability, and her passion for mentoring the next generation of glass artists.…
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In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the glob…
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In this episode, Steve Vaughan is joined by fellow sales trainers Christian Walter and Pascal le Floche. The team discuss the challenges of transitioning from a sales role to a sales management position, particularly when promoted from within the team. They share insights on: -Recognizing the shift in skills required, from being an individual contr…
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In this episode of the Medical Alley Podcast, host Ben Wagner sits down with Jessica Sylvester, founder and CEO of Humla Health, to explore how her innovative platform is transforming nurse staffing in the healthcare industry. Jessica shares her deeply personal journey from working as a nurse to creating a tech-driven solution that empowers nurses …
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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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In this episode, Vera spoke with Carsten Rudolph, PhD, CEO of Ethris. Ethris was founded by Dr. Rudolph and Professor Christian Plank with the goal of establishing messenger RNA (mRNA) as a novel drug modality for lung diseases such as asthma and rare pulmonary conditions like primary ciliary dyskinesia (PCD) and pulmonary alveolar proteinosis. Eth…
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Carna Health is focused on applying technology to revolutionize kidney care by unlocking the early detection and management of chronic kidney disease (CKD). They provide clinical-grade software as medical devices that deliver instant health metrics, such as creatinine, eGFR, and uACR levels, from small patient samples. Their platform integrates wit…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier …
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Medical device companies often lag behind other industries in adopting advanced technologies, such as artificial intelligence (AI), to digitally transform their organizations throughout the total product life cycle. In this episode of the Medical Alley Podcast, experts from MDIC, FDA, and more, share their insights on the current landscape of digit…
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The landscape of publicly traded food companies is constantly evolving, with consumer preferences, technological advancement and global challenges all playing a role in shaping the industry. In 2024, these factors have culminated in a diverse and competitive market where the largest publicly traded food companies dominate. In this episode of the Xt…
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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In this episode, Ayesha spoke with Kirk Brown, PhD, Vice President of Research at Alnylam Pharmaceuticals. Alnylam is focused on developing RNAi medicines to transform the way diseases like cardiovascular and neurological diseases are treated. Dr. Brown’s preclinical work combining stable siRNA designs with alternative conjugation strategies has en…
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The podcast episode features an interview with Wayne Woodard, the founder and CEO of Argonaut Manufacturing Services, a contract manufacturing company that serves the life sciences industry. Wayne shares the story of starting Argonaut after a long career in operations and supply chain management.De către Ryan Cote
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In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more. Omar Khateeb LinkedIn Khateeb & Co. Website State of Medtech Podcast ⁠Duane Mancini LinkedIn⁠⁠ ⁠⁠…
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In this episode of The Factor, host Nick Schill, Senior Director of Product Development, sits down with Duane Mancini, CEO of Project MedTech, to discuss the importance of agility, strategic planning, and value creation for life science startups. Duane shares his insights on effective fundraising, the vital role of treating consultants as team memb…
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After the summer break, the george james team are back with season 2 of the podcast. In this episode, Steve, Pru and Jayne discuss the topic of ghosting in sales. They define ghosting as when a customer or prospect stops responding to calls, emails, or other forms of communication. The hosts explore the reasons why ghosting happens, such as misalig…
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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Dr. Jonathan Hill, VP of Science and Technology and co-founder of Wasatch Biolabs joins the podcast today to talk about the future of genetic testing technology. Dr. Hill shares his journey in genetics, starting from his undergraduate days to co-founding multiple biotech companies. They discuss the cutting-edge genomic and bioinformatic methods bei…
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In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneur…
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September is Atrial Fibrillation Awareness Month. Patients living with Atrial Fibrillation, or AFib, are at greater risk for stoke, heart failure and dementia. Research suggests cases of AFib are likely to grow across the United States. In this episode of the Medical Alley Podcast, host Ben Wagner talks with Dr. Christopher Piorkowski, chief medica…
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Coca-Cola and OREO have joined forces in a new partnership that’s sure to excite fans of both brands. For a limited time, the Coca-Cola and OREO collab introduces two unique products: Oreo Coca-Cola Sandwich Cookies and Coca-Cola OREO Zero Sugar Limited Edition soda. In this episode of the Xtalks Food Podcast, Sydney talks about the new collab, dub…
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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In this episode, Ayesha spoke with Jennifer Gudeman, Pharm D, Senior Vice President, Medical and Clinical Affairs, Avadel Pharmaceuticals plc, a biopharmaceutical company working on innovative solutions to the development of medications that disrupt treatment paradigms and address unmet needs. The company is currently focused on developing treatmen…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpos…
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In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., sits down with Peter Ronco, Chief Executive Officer of Emmes, a global full-service Clinical Research Organization (CRO). Peter discusses his transition from leading roles at Janssen R&D and Bristol Myers Squibb to guiding Emmes' strategic direction and operat…
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