Shows
ISPE Podcast: Shaping the Future of PharmaEp 13 Recap: Accelerating Technology Adoption: Reflections and PredictionsIn this recap episode recorded after the 2025 ISPE Annual Meeting, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.
2026-02-1719 min
ISPE Podcast: Shaping the Future of PharmaEp 13 Recap: Accelerating Technology Adoption: Reflections and PredictionsIn this recap episode recorded after the 2025 ISPE Annual Meeting, host Bob Chew shares insights on accelerating technology adoption in the pharmaceutical industry. Dive into this discussion to explore the future of pharma innovation, including transitioning from document-centric to data-driven quality systems, leveraging AI and digital twins for enhanced manufacturing processes, and reimagining risk management with statistical tools.
2026-02-1719 min
Pharmacy Made SimpleISPE Glossary of Pharmaceutical and Biotechnology TerminologyA specialized reference for the pharmaceutical, biotechnology, and medical device industries. It provides clear definitions for a vast array of technical terminology, ranging from molecular biology and genetic engineering to manufacturing hardware and chemical processes. The text incorporates standards from influential organizations like the ISPE, FDA, and ISO, ensuring that terms regarding quality control, regulatory compliance, and validation procedures are accurately detailed. Additionally, it lists numerous acronyms and abbreviations used in global clinical and industrial settings. By bridging the gap between scientific research and engineering applications, the document establishes a standardized language for professionals in the field. This resource...
2026-02-1418 min
ISPE Podcast: Shaping the Future of PharmaEp 12 Future ATMPs CompilationThis episode includes highlights from our Future of ATMPs series, featuring speakers from last year's ISPE Europe Annual Conference discussing industrialization of Advanced Therapy Medicinal Products production by replacing manual, high-cost processes with standardized and modular automation.
2026-02-0329 minISPE Podcast: Shaping the Future of PharmaEp 12 Future ATMPs CompilationThis episode includes highlights from our Future of ATMPs series, featuring speakers from last year's ISPE Europe Annual Conference discussing industrialization of Advanced Therapy Medicinal Products production by replacing manual, high-cost processes with standardized and modular automation.
2026-02-0329 min
The Life Science EffectHow Modular Biotech is Changing Everything - Even in Orbit In this episode, host Steve Vinson dives into one of the most futuristic — yet rapidly emerging — trends in life sciences: transportable and point‑of‑care pharmaceutical manufacturing. After discovering a compelling ISPE article, Steve explores how modular clean rooms, distributed manufacturing models, and space‑ready production units are reshaping the future of medicine. From personalized tablet production to on‑demand therapies in extreme environments, these technologies could redefine how and where healthcare happens. Drawing on his 30+ years in manufacturing, Steve connects these innovations to what he's seeing in real project work, including the rise of standardized, copy‑and‑paste biot...
2026-01-3010 min
Facility RockstarsBeyond the Four Walls: Leveraging Networks for Engineering Success | Stephanie WhiteWhat happens when a technically brilliant engineer hits a wall that expertise alone can’t climb? Jay Culbert sits down with Stephanie White, a passionate engineering leader with over 20 years of experience in the pharmaceutical and biotech industries. Stephanie shares her transformation from a "technically strong" engineer working in isolation—often "reinventing the wheel" through exhausting trial and error—to a global leader who champions professional networking and harmonized standards.They dive deep into the importance of active engagement in organizations like ISPE (International Society of Pharmaceutical Engineering). Stephanie explains how mov...
2026-01-2927 min
ISPE Podcast: Shaping the Future of PharmaUnlocking Innovation: Embracing Validation 4.0 for a Digital Pharma FutureIn this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digit...
2026-01-2134 minISPE Podcast: Shaping the Future of PharmaUnlocking Innovation: Embracing Validation 4.0 for a Digital Pharma FutureIn this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digit...
2026-01-2134 min
ISPE Podcast: Shaping the Future of PharmaEp 10 Insights from the 2025 ISPE LATAM SymposiumIn this episode, host Bob Chew is joined by Martin Orcoyen, President of ISPE Argentina Affiliate, Ricardo Miranda, President of the ISPE Brazil Affiliate, and Alejandro Bustamante, President of the ISPE Mexico Affiliate, to discuss the jointly hosted 2025 ISPE LATAM Symposium.
2026-01-0628 minISPE Podcast: Shaping the Future of PharmaEp 10 Insights from the 2025 ISPE LATAM SymposiumIn this episode, host Bob Chew is joined by Martin Orcoyen, President of ISPE Argentina Affiliate, Ricardo Miranda, President of the ISPE Brazil Affiliate, and Alejandro Bustamante, President of the ISPE Mexico Affiliate, to discuss the jointly hosted 2025 ISPE LATAM Symposium.
2026-01-0628 min
The Future of PharmaEpisode 38 - Sanjeev Luther and Patient Life Quality Beyond CuresMy guest in this episode is Sanjeev Luther. Sanjeev is President & CEO of Ernexa Therapeutics. He is a seasoned life sciences leader with decades of experience in oncology, biotechnology innovation, and corporate leadership across global markets. He has guided clinical-stage biopharmaceutical companies through corporate strategy, R&D, licensing, regulatory affairs, and operations, overseeing global Phase 3 trials, major partnerships, and portfolio expansions in multiple therapeutic areas. His career includes senior roles at Cornerstone Pharmaceuticals, BMS, Novartis, Bausch and Lomb, and GE Healthcare, along with contributions to health policy initiatives such as Cures 2.0 and U.S. manufacturing efforts.
2025-12-0133 min
Helical Brew#50 - ISPE Boston at Gillette Stadium –Robots, Enclosures & Boston Energy🎙️ Hosts: Sura Hadi, Mike Ouren🎧 Episode Title: ISPE Boston at Gillette Stadium – Robots, Enclosures & Boston EnergyFrom Rockwell rails to Germfree enclosures (and a field-goal after-party), Sura and Mike unpack what went down at ISPE Boston 2025 — hosted inside Gillette Stadium.This Helical Brew episode brings the perfect mix of automation insights, event chaos, and Boston flavor.🔍 We cover:• ISPE Boston recap from the field-level after-party 🏟️• Vendor tech that mattered: Rockwell MagneMotion, Germfree enclosures & 3D motion pucks• When not to bring a robot arm - reading the room at vendor shows• Zdeno Cha...
2025-11-1133 min
Helical Brew#49 - Class Rings, Metric Fails & Why Women’s Pockets Suck🎙️ Hosts: Sura Hadi, Mike Ouren, Elizabeth Rodziewicz🎧 Episode Title: Unfiltered Brew - Class Rings, Metric Fails & Why Women’s Pockets Still SuckFrom class rings and college debt to metric vs. imperial hardware fails, McMaster wins, and a Theranos throwback — this Unfiltered Brew episode is all chaos, caffeine, and comedy. We even end with the rant of 2025: women’s pockets.🔍 We cover:• College rings, EU free tuition, and student debt• Metric vs. imperial IRL — Lowe’s fail → McMaster saves the day• Space program sidebar: when NASA mixed units• Theranos mini-l...
2025-11-0815 min
The Future of PharmaEpisode 37 - Dr. Dave Miller and the Evolution of Drug Delivery TechnologiesMy Guest in this episode is Dr. Dave Miller. Dave is CSO of AustinPx and leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol™ Technology. Prior to his current position, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller is a co-inventor of the pharmaceutical applications of the KinetiSol technology. He has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He...
2025-10-1647 min
Facility RockstarsFacility Rockstars Go On the Road: Highlights from ISPE 2025In this special edition of Facility Rockstars, we take you inside the recent ISPE event at the iconic Gillette Stadium for a fast-paced compilation of conversations with professionals across biotech, pharma, life sciences, and facilities management. Hosted by the producer of Facility Rockstars, Amanda Goyette, chats with attendees from organizations like CBRE, Moderna, CHA, New England Biolabs, and more, asking each guest a few simple questions in order to create connections. The result is a lively snapshot of how diverse, curious, and connected the facilities world truly is, with plenty of laughs, sports banter, and thoughtful insights about building...
2025-10-0926 minISPE Podcast: Shaping the Future of PharmaEp 8 Unlocking Innovation: Embracing Validation 4.0 for a Digital Pharma FutureIn this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digit...
2025-10-0734 minISPE Podcast: Shaping the Future of PharmaEp 8 Unlocking Innovation: Embracing Validation 4.0 for a Digital Pharma FutureIn this episode, Michelle Vuolo, Head of Quality at Tulip Interfaces and ISPE Good Practice Guide: Validation 4.0 co-lead, along with guide team member, Victor de Oliveira Silva Ferreira, Cruz, Project Manager for PEQMS – Implementation of Electronic Systems for the Quality Management System, Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz, join the podcast share their insights on how Validation 4.0 aims to leverage digital tools to transition from traditional validation methods to more dynamic, real-time processes. Explore how to utilize the principles of Quality by Design and Quality Risk Management to create dynamic, continuous validation practices, powered by digit...
2025-10-0734 min
The Future of PharmaEpisode 36 - Brandon Rice and IND Submission with AIMy guest in this episode is Brandon Rice. Brandon is the CEO and co-founder at Weave Bio, a software company focused on automating regulatory submissions in the pharmaceutical industry using AI where he oversees product development, specifically leading the creation of AutoIND, their AI-powered platform for IND preparation. In this conversation, Brandon discusses his journey to co-founding Weave Bio. He highlights the challenges of regulatory compliance, the potential of AI to streamline processes, and the importance of human oversight in AI-generated content. The discussion also touches on the cultural differences in AI adoption among pharmaceutical c...
2025-09-1734 min
Let's Combinate - Drugs + Devices204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan NeadleIn this episode of Let’s ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection read...
2025-09-0332 minISPE Podcast: Shaping the Future of PharmaWhat to Look Forward to at the 2025 ISPE Annual Meeting and ExpoScott Billman, Senior Vice President, Global Engineering, Technology, and Facilities at Solventum and Immediate Past Chair of the ISPE International Board of Directors, joins the podcast to share more about the upcoming ISPE Annual Meeting and Expo. Explore the featured topics, trends, and pharmaceutical innovations, as well as opportunities for networking and career advancement that you can expect at the event.
2025-09-0225 minISPE Podcast: Shaping the Future of PharmaEp 7 What to Look Forward to at the 2025 ISPE Annual Meeting and ExpoScott Billman, Senior Vice President, Global Engineering, Technology, and Facilities at Solventum and Immediate Past Chair of the ISPE International Board of Directors, joins the podcast to share more about the upcoming ISPE Annual Meeting and Expo. Explore the featured topics, trends, and pharmaceutical innovations, as well as opportunities for networking and career advancement that you can expect at the event.
2025-09-0225 min
The Future of PharmaEpisode 35 - Nikkhil Masurkar and How American Healthcare and Indian Pharma Are ConnectedMy guest in this episode is Nikkhil Masurkar. Nikkhil is the CEO of Entod Pharmaceuticals which is based in India. He is often called India's Eye Drops Man because Entod specializes in ophthalmic, ENT, and dermatological medicines. In this interview, Nikkil and I talked about how closely American and Indian pharma worlds are intertwined - 4 out of 10 prescriptions filled in the U.S. are supplied by Indian companies. They supply almost half of all generic prescriptions. This translates to a significant cost savings for the U.S. healthcare system - over $1.3 trillion in last 10 years al...
2025-08-2736 minISPE Podcast: Shaping the Future of PharmaEp 6 2025 ISPE Annual Meeting and Expo Insights from the Executive Chair (audio)On this episode, Gunter Baumgartner, SVP Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of 2025 ISPE Annual Meeting and Expo, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.
2025-08-1224 minISPE Podcast: Shaping the Future of PharmaEp6: 2025 ISPE Annual Meeting and Expo Insights from the Executive ChairOn this episode, Gunter Baumgartner, SVP Head of Global Engineering at Takeda Pharmaceuticals International AG, and Executive Chair of 2025 ISPE Annual Meeting and Expo, joins the podcast to discuss the upcoming conference and the topics, speakers, and key highlights of what you can expect from the educational content and agenda.
2025-08-1224 min
Making it in ManufacturingHow a Crack in Equipment Taught Abbas Hussain the Value of Planning BuffersIn this episode, we’re joined by Abbas Hussain, an internationally recognised engineering leader and current Projects & Engineering Manager at EUROAPI.He oversees the end-to-end design and delivery of GMP-compliant manufacturing facilities for APIs, peptides, and oligonucleotides, combining technical depth with strategic execution.With over 20 years of experience in pharmaceutical and biotech engineering, Abbas has led major capital projects across global markets.His career includes an extensive tenure at Sanofi, where he held senior roles in process engineering, project delivery, and technology transfer.A regular speaker on the international stage, Abbas most recently represented EUROAPI at...
2025-07-2442 min
Making it in ManufacturingHow Michael Vrijs Defends His Site Against Auditors - Without Saying Too MuchIn this episode, we feature Michael Vrijs, a well-recognised expert in cleaning validation and biopharma manufacturing, known for turning complex compliance into practical strategy:Currently Manager, Manufacturing Technology at Incyte (since 2021), leading cleaning process development and validation at Incyte’s biologics manufacturing site in Switzerland.Brings nearly 20 years of experience in biopharma manufacturing, specialising in cleaning processes, cleaning validation, tech transfer, continuous improvement, and CAPEX in multi‑product environments.Spent over a decade as a consultant - serving as Senior Consultant with GxP Consulting Switzerland, and holding senior C&Q/validation roles at Novartis, MSD, Biog...
2025-07-1028 min
The Future of PharmaEpisode 34 - Arielle Smith and How to Get the Most Out of the Pharma ConferencesMy guest in this episode is Arielle Smith. Arielle serves as the President of Life Science at Event Cadence which is an event management platform. She was also one of the founding members of Event Cadence. It enables Life Science companies to efficiently plan and manage both industry conferences and internal meetings. Arielle has worked with pharma companies such as Merck, AstraZeneca, Jazz Pharma, Sanofi, and more. Previously, she has worked with Lampire Biological Laboratories and Jefferson Health, which helped her to provide the Healthcare industry with the best all-in-one industry conference solution. She...
2025-07-0237 min
Making it in ManufacturingHazem Eleskandarani: Engineering Excellence in Global Pharmaceutical QualityIn this episode, we feature Hazem Eleskandarani, P.E., PMP, a distinguished leader in pharmaceutical engineering and quality assurance: Hazem leads the Global Quality Engineering team at CSL Behring, a global biopharmaceutical company specialising in plasma-derived therapies and he holds a Master's degree in Mechanical Engineering from the University of Utah.30+ years of global experience. Hazem has expertise in manufacturing, process engineering, quality engineering, technology management, and project engineering.His career includes significant roles at Fluor Daniel, Jacobs Engineering, Merck, and Johnson & Johnson, where he led global commissioning and qualification initiatives, and is internationally recognised...
2025-06-1945 minISPE Podcast: Shaping the Future of PharmaExploring AI with the Newest ISPE Community of PracticeThis episode, Ben Stevens, Director of CMC Policy and Advocacy with GSK, and Eric Staib, Vice President of Corporate Quality with Syneos, join the podcast to share more about the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities facing the industry, and the work they’re doing on ISPE’s recently established Artificial Intelligence Community of Practice to help support the industry in navigating the rapid proliferation of AI.
2025-06-1730 minISPE Podcast: Shaping the Future of PharmaEp 3 Exploring AI with the Newest ISPE Community of PracticeThis episode, Ben Stevens, Director of CMC Policy and Advocacy with GSK, and Eric Staib, Vice President of Corporate Quality with Syneos, join the podcast to share more about the current state of AI in the pharmaceutical industry, key AI-related challenges and opportunities facing the industry, and the work they’re doing on ISPE’s recently established Artificial Intelligence Community of Practice to help support the industry in navigating the rapid proliferation of AI.
2025-06-1730 min
Making it in ManufacturingHilary Mills-Baker: Championing Quality and Innovation in Life Sciences AutomationIn this episode, we feature Hilary Mills-Baker, a distinguished expert in process automation and computer systems validation within the life sciences sector:Hilary serves as the Chair of the UK GAMP Community of Practice, where she leads initiatives to advance good automated manufacturing practices in the pharmaceutical industry, and was previously the European Quality and Validation Manager at Emerson Automation Solutions.35+ years in process automation engineering and more than 20 years in the life sciences sector, Hilary has extensive experience in computer systems validation and quality assurance, as well as holding a BSc and an MEng...
2025-06-1235 minISPE Podcast: Shaping the Future of PharmaEpisode One: ISPE's Role in Advancing Pharmaceutical ManufacturingMike Martin, President and CEO of ISPE, joins ISPE’s podcast host Robert Chew for this first episode to discuss the current pharmaceutical landscape, how the industry is responding to new challenges and opportunities, where he sees the industry going in the next five years, and more.
2025-05-2032 min
Trend Detection PodcastSetting your organization up for predictive maintenance success - with ISPE and Johnathan BonnerWelcome to the Trend Detection podcast, brought to you by Senseye Predictive Maintenance – the platform which enables predictive maintenance at scale across all of your assets, across all of your plants.This session was originally recorded for ISPE and their Technical Tuesday session.Watch the video here: Technical Tuesday: Boosting Pharmaceutical Efficiency Through Scalable Predictive Maintenance Find out more information here: Homepage | ISPE | International Society for Pharmaceutical Engineering
2025-05-0846 min
The Future of PharmaEpisode 33 - Ray Jordan and Pharmaceutical Industry's Reputation and ImageMy guest in this episode is Ray Jordan. Ray is Principal at Putnam Insights. Ray Jordan is a corporate affairs leader and reputational growth driver in healthcare, technology, biotechnology and consumer industries and has worked with or for companies such as Moderna, Amgen, Johnson & Johnson and Pfizer. Ray has been recognized numerous times by industry sources such as PRWeek, and PRovoke Media. He has helped companies get recognized for high reputational status, including in such rankings by FORTUNE, Axios/Harris, Science Magazine, Dow Jones and others. In this candid interview about the pharmaceutical i...
2025-04-3048 min
The Future of PharmaEpisode 32 - Vinay Patel and the Invisible Factors Impacting Drug Prices at PharmaciesMy guest in this episode is Vinay Patel. Vinay is a pharmacist executive with over 18 years in the field and founder of MakoRx. He has been involved with health management, community pharmacy operations, and creating pharmacy services. Vinay has worked in various pharmacy settings including national retail, local community, hospital pharmacy, academia, and group medical practices. His efforts now focus on scaling clinical pharmacy services within employer on-site clinics and bringing employers innovative Rx savings programs. Usually, I interview leaders from the pharmaceutical world, but this was the first time I talked to someone about w...
2025-04-1742 min
The Future of PharmaEpisode 31 - Rene Marcotte and Leveraging Data in the Life Science IndustryMy guest in this episode is Rene Marcotte. Rene is Senior Vice President Life Sciences at RCM Technologies. Rene has nearly 40 years of experience as a data architect across multiple industries, including Life Sciences for the past 20 years. He has helped to lead and build over 40 data warehouses and analytic solutions, including for some of the largest and smallest pharmaceuticals. In this discussion, Rene and I talk about data aka the digital gold. Some of the topics we discussed are - The evolution of data over last few decades - Change i...
2025-03-2536 min
The Future of PharmaEpisode 30 - Dr. Mohit Jain, Biomarkers, and Precision Guided MedicineMy guest in this episode is Dr. Mohit Jain, founder and CSO of Sapient. Dr. Jain is a physician-scientist with more than 20 years of expertise in physiology, computational biology, and mass spectrometry-based bioanalytics. He formed the Jain Laboratory at UCSD, where he led his team to develop next-generation mass spectrometry systems to probe the non-genetic landscape of disease across large-scale human studies. He founded Sapient in 2021 as a spinout of the Jain Laboratory to expand upon this mission, providing bespoke services multi-omics biomarker discovery. In this wide ranging yet focused interview, we discuss
2025-03-1840 min
The Future of PharmaEpisode 29 - Scott Chetham and the Future of Clinical TrialsMy guest in this episode is Scott Chetham. Scott is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. His role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and...
2025-02-1242 min
The Future of PharmaEpisode 28 - Ron Gutman, New Technology in Healthcare and the Power of SmilingMy guest today is Ron Gutman. Ron is an inventor, an investor, a serial technology and healthcare entrepreneur and a Stanford University adjunct Professor. Ron has built and invested in technology and healthcare companies that have served hundreds of millions of people and saved countless lives worldwide. He's an inventor holding a series of patents in healthcare technology and Artificial Intelligence and won the World Economic Forum Technology Pioneer award. Ron's articles have been published in respected media such as The Harvard Business Review, Forbes, Fortune Magazine, CNN, and TechCrunch. He also wrote a best-selling TE...
2025-01-2348 min
PEP Talks ISPEPPatient Engagment: Driven by empathy, fuelled by business. How ISPEP supports all patient professionalsPep Talks, hosted by Emma Sutcliffe, is a podcast series sponsored by the International Society for Patient Engagement Professionals (ISPEP). In a twist, Emma is interviewed by Alexandra Charge, CEO of ISPE, about her new role as Chief Patient Officer. Emma shares her journey from a medical biochemist to a patient engagement professional, emphasizing the importance of empathy and strategic business practices in the pharmaceutical industry. The discussion highlights the challenges and responsibilities of patient engagement professionals, the need for professionalization, and the evolving role of patient advocacy. Emma envisions a future where new leaders...
2024-12-2024 min
The Future of PharmaEpisode 27 - Nathan Clark and 10% Faster to the Market with DigitalizationMy guest in this episode is Nathan Clark. Nathan is the Co-Founder of Ganymede.bio, one of the fastest-growing software startups in biotech. Ganymede is the modern, data platform for life sciences companies, and its focused on integrating physical lab instruments with digital workflows. Prior to Ganymede, Nathan was the product manager at Benchling for Machine Learning and Insights Analytics. He also has a background in financial technology and trading, and notably launched affirm.com/savings. In this informative talk, Nathan and I talked about - His journey from being a bond trader to a...
2024-11-2141 min
Life Sciences 360ISPE’s Role in Shaping the Future of mRNA and Personalized MedicineIn this episode of Life Sciences 360, we dive into the evolution of pharmaceutical and biotech manufacturing with our guest, Scott, a seasoned expert with nearly 30 years of experience working with industry giants like Novartis, Biogen, Thermo Fisher, and Merck. Scott shares insights on cell culture technology, mRNA vaccines, and the challenges and innovations in scaling biotech facilities. Discover the impact of collaboration and how organizations like the International Society for Pharmaceutical Engineering (ISPE) are transforming the landscape.Chapters :00:00 - Introduction to Vaccine Technologies00:14 - Importance of Collaboration in Pharma Manufacturing00:22 - The Role...
2024-11-0534 min
The Future of PharmaEpisode 26 - Kyle Felmet, Jennifer Lospinoso and the Art of Efficient Commercial Product LaunchI have two guests in today's episode, something I rarely do. My guests are Kyle Felmet and Jennifer Lospinoso. Kyle Felmet serves as the Vice President of Specialty Commercialization at Two Labs, an Envision Pharma Company, where he plays a pivotal role in ensuring that specialty drug manufacturers have the necessary distribution channel strategy infrastructure and pre-launch workstreams in place to facilitate a successful product launch with the appropriate wrap-around patient/prescriber services tailored to each unique product. His expertise spans across key therapeutic areas including oncology, rare diseases, and cell and gene therapies. Over the past d...
2024-10-3035 min
Facility RockstarsChallenging the Status Quo - Mike Temple - Facility Rockstars - Episode # 029In this episode of Facility Rockstars, host Jay Culbert interviews Mike Temple, Director of Facilities and Engineering at Recipharm. With over a decade of experience in biotech and pharma, Mike shares his journey from a young engineer to a thought leader who challenges norms in highly regulated industries. He emphasizes the importance of questioning standard practices, effective time management, and fostering a safety culture.Mike offers valuable insights on handling regulatory audits, utilizing data-driven safety metrics, and integrating new systems into existing operations. The conversation also touches on personal anecdotes about mentorship, networking, and professional growth...
2024-09-2635 min
The Future of PharmaEpisode 25 - Dr. Ben Coverdale and Using AI for Targeted Drug DiscoveryMy guest today is Dr. Ben Coverdale. Ben is an experienced Global Account Director of Patsnap with a demonstrated history of working in the life sciences and innovation intelligence industries. Patsnap is Powered by advanced AI, where they help IP and R&D teams collaborate and accelerate the entire innovation lifecycle. He has a strong research professional background with a Doctor of Philosophy (PhD) focused in Biomedical Materials from The University of Manchester. He developed 3D scaffold fabrication methods for the regeneration of bone tissue, gaining insight in product development and the patent landscape in t...
2024-09-0527 min
Facility RockstarsSafety, Collaboration, and Culture - Jeffrey Kaminski- Facility Rockstars - Episode # 026In this episode of Facility Rockstars, host Jay Culbert interviews Jeff Kaminski, an EH&S expert with 25 years of experience. Jeff shares insights from his career, including roles at Biogen and Sanofi, and his current position as Associate Director and Head of EH&S at EyePoint Pharmaceuticals. He discusses key lessons learned, such as the value of diverse perspectives, effective communication, and collaboration in facility management. Jeff highlights the critical role of EH&S in problem-solving and maintaining safety compliance and offers best practices for regulatory visits and cross-functional team engagement. He also addresses t...
2024-09-0532 min
Facility RockstarsSafety, Collaboration, and Culture - Jeffrey Kaminski - Facility Rockstars - Episode # 026In this episode of Facility Rockstars, host Jay Culbert interviews Jeff Kaminski, an EH&S expert with 25 years of experience. Jeff shares insights from his career, including roles at Biogen and Sanofi, and his current position as Associate Director and Head of EH&S at EyePoint Pharmaceuticals. He discusses key lessons learned, such as the value of diverse perspectives, effective communication, and collaboration in facility management. Jeff highlights the critical role of EH&S in problem-solving and maintaining safety compliance and offers best practices for regulatory visits and cross-functional team engagement. He also addresses t...
2024-09-0531 min
The Future of PharmaEpisode 24 - Dr. Samuel Ewing and the New World of Digital HospitalsMy guest in this episode is Dr. Samuel Ewing. He is the Global Head of Pharmaceutical Partnerships at Doccla. Before joining Doccla, Dr. Ewing led the development of a connected auto-injector system for Roche's Alzheimer's disease program at Capgemini Engineering. He also led the development of Biofourmis's wearable vital sign monitoring platform. At Roche, he managed remote patient monitoring across various diseases, including Parkinson's, Huntington's, Alzheimer's, Multiple Sclerosis, and others. As Chief Neuroscience Officer at NeuroPro, he developed a wearable brain monitoring device for epilepsy. Dr. Ewing's extensive experience in digital health and...
2024-07-3136 min
The Future of PharmaEpisode 23 - Greg Kunst and Corneal Endothelial Therapy for Partial or Full Vision LossMy guest in this episode is Greg Kunst, CEO of Aurion Biotech. At Aurion, Greg and his colleagues are working on a regenerative treatment (corneal endothelial cell therapy) for millions of people who have partial or complete vision loss. Greg joined Aurion Biotech with deep and varied experience in ophthalmic medical devices, drug delivery systems, diagnostics, biotechnology, and pharmaceutical products. His expertise spans global corporate development, strategy, health policy, marketing, commercialization, business development, market access and medical affairs. Before Aurion Biotech, Greg spent 6 years at Glaukos Corporation (NYSE: GKOS) in numerous roles of...
2024-06-0535 min
The Future of PharmaEpisode 22 - Nikhil Bhojwani and Using Generative AI in Pharmaceutical Industry without Irrational FearMy guest in this episode of The Future of Pharma is Nikhil Bhojwani. Nikhil is an entrepreneur, investor, strategist, and TedTalk speaker. He is a Managing Partner at Recon Strategy, a boutique consulting firm that he founded in 2010. At Recon Strategy, Nikhil works with executives and boards on strategy at the portfolio and business-unit levels for payers, hospitals, life science, and digital health companies. Nikhil stays close to the startup community as an investor, board member, and advisor to several companies. These have included CIC Health, a national leader in COVID testing and vaccinations, which wa...
2024-05-0731 min
The Future of PharmaEpisode 21. Dr. Harsha Rajasimha and the Challenges and Complexities of Clinical TrialsMy guest in this episode is Dr. Harsha Rajasimha, CEO/founder of Jeeva Clinical Trials. We talked about the pharmaceutical industry's blackbox - clinical trials. Personal tragedy inspired him to dedicate his life to make technology more efficient for healthcare solutions including AI and generative AI. We discussed the complexities of clinical trials, its patient recruitment, and data unavailability challenges, and why we must make them more efficient He is also the founder of a non-profit, IndoUSRare, which as the name implies bridges the rare disease treatment and awareness gap between...
2024-03-2549 min
Let's Combinate - Drugs + Devices119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David SimoensOn this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.
David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex one
and the ISO 14644 standard, for learning more about sterile processing and clean room requirements.
01:01 Experiences in Clean Room
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2024-01-1826 min
Life Science SuccessTom Hartman - President & CEO - International Society of Pharmaceutical Engineering (ISPE)Send us a textIn this episode of Life Science Success, my guest is Tom Hartman. Tom is the President and CEO of the International Society of Pharmaceutical Engineering (ISPE), Tom leads a global network of 20,000+ professionals spanning the complete pharmaceutical lifecycle. In this edition of Life Science Success, Don Davis interviews Tom Hartman, the president and CEO of the International Society of Pharmaceutical Engineering (ISPE). They discuss Hartman's career journey and the role of the ISPE in the life sciences industry. Hartman discusses the critical role of the society's volunteer network and em...
2024-01-1141 min
Remote LeadershipLeadership Techniques To Strengthen Your Hybrid Team with Laura Moody | S2E005Laura Moody and Debra Dinnocenzo discuss how distance leaders can strengthen their hybrid teams through effective communication techniques. Scheduling regular check-in remote meetings and utilizing multiple communication methods are critical to building trust and developing a connected team. Laura shares her views on the importance of having cameras on during video meetings and the value of nurturing a learning culture for geographically dispersed organizations.Learn more about the Remote Leadership Mastery program by scheduling a call with Debra by CLICKING HERE. About the Guest:Dr. Laura Moody is the Director of Product Management Pharm...
2023-12-2030 min
The Art of Engineering028 - Zen Zen YenDenise visits with Zen Zen Yen, Head of Engineering at Bayer Supply Center in Germany. Denise caught up with Zen Zen at the ISPE Annual Meeting and had a chance to discuss what it was like growing up in Germany, switching from studying medicine to engineering, and the importance of finding a community of peers like ISPE.
2023-12-0617 min
The Future of PharmaEpisode 20 - Hon. Prof. Tom Chittenden and the Potential and Challenges of AI in the Pharmaceutical IndustryMy guest today is Hon. Prof. Dr. Tom Chittenden, but he prefers to go by Tom. He is the Chief Scientific Officer and President of R&D at BioAI Company and leads scientific research operations and ongoing development and implementation of the BioAI Health PREDICT-X Drug Discovery and Development platform. Tom Chittenden is an Honorary Professor of AI in Biomedicine at Queen Mary University of London. His research has been published in top-tier scientific journals, including Nature and Science. Tom is regarded as one of the world's leading authorities on causal AI in the biomedical...
2023-11-0936 min
The Future of PharmaEpisode 19 - Alpesh and Jigisha Gandhi and The Global Supply Chain for the Pharma IndustryMy guests today are the dynamic husband-wife duo of Alpesh and Jigisha Gandhi who jointly run Ami Polymer Pvt. Ltd. which is a leading manufacturer of silicon tubing something we use a lot in the life science industry. Starting with Alpesh and later with Jigisha, Ami Polymer is a leading silicon tubing manufacturing company in India and played an important role in COVID vaccine manufacturing. Alpesh Gandhi did his engineering in Rubber Technology from L. D. College of Engineering, Ahmedabad, India. The same college where I did my Chemical Engineering. Then he did his MBA from Jamnalal...
2023-09-2638 min
Let's Combinate - Drugs + Devices093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan NeadleOn this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
Supplier Management for Combination Products
Drug & Device Analytical Testing
Considerations for Biologics
Connected/Digital Health
Changing Regulatory Landscape for Combination Products
Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X...
2023-07-1225 min
Let's Combinate - Drugs + Devices091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan NeadleOn this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation
Subhi's questions on each chapter
What she learned from authoring and coordinating of the book
Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.
Her leadership, innovation...
2023-06-2840 min
Modern BioPharma PodcastSeason 4 - Andrew Lamore - ASME BPEToday's episode is with Andrew Lamore from Burkert USA Corp and ASME BPE Chair for Multi and Single-use Process Instrumentation.
As this show airs at the same time as the 30th Annual ISPE CASA Life Science Technology Showon Feb 28 2023, we thought it would be great to discuss some of the ways these two industry groups (ISPE and ASME) compliment each other to build a safer and more effective pharmaceutical manufacturing industry. In case you were wondering...they work "hand in glove". While you certainly could have one without the other...you wouldn't want to.
Listen in...
2023-02-2834 min
Risk RevolutionDisrupting the ParadigmThis episode originally aired on September 14th, 2021
This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.
Resources from this episode:
One Voice of Quality Website - https://prst.ie/1vq/
One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-part-2-podcast-episode
One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ... - https://www...
2022-11-1356 minRisk RevolutionFacilitator - Friend or Foe?This episode was orginally aired on June 15th, 2021
In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.
Resources in this episode:
Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein
The Surprising Power of Questions HBR
Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT
Bias, Heuristics & Risk (Pt. 2) on Risk...
2022-11-1357 minRisk RevolutionBecoming Risk CuriousThis episode was originally aired on January 19th, 2021
The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
In this episode, our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around the risk curious concept and expand into the why’s and why not and the views of this practice under PICs. The group al...
2022-11-1246 minRisk RevolutionDefining Risk CultureThis episode was originally aired on December 15th, 2020
On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from her time as...
2022-11-1032 min
Domus Search - The European BioTech, Pharma & MedTech C-Suite Leadership PodcastEpisode 14 - Thomas Carganico - Marketing & Commications Director & Senior Associate Partner / Chair / Co - Founder - PQE Group / ISPE Italy Affiliate / Resilia ServiceThomas Carganico, Co-Founder of Resilia Service, Board Member & Chair of ISPE Italy Affiliate and is Marketing & Communications Director & Senior Associate Partner of PQE Group.
The Domus Search - Leadership Podcast offers a glimpse into the world of industry leaders through interactive conversations with CEO's, C-Suite Executives and Executive Leadership Teams across European BioPharma and MedTech sectors. Domus Search is THE ONLY BioPharma and MedTech Executive Search Firm with over 97% coverage of C-Suite Candidates in 45 European Countries (at any given time), and we are committed to sharing leadership insight with our European BioPharma and Medtech network.
A...
2022-09-2237 min
The Industry 4.0 Podcast with GrantekChristian Wölbeling of ISPE and Korber Pharma - The Industry 4.0 Podcast with GrantekChristian Wölbeling is an experienced Senior Director with Korber Pharma. He was nominated as a “Pharma Industry Leader” by The International Society for Pharmaceutical Engineering (ISPE) Pharmaceutical Engineering Magazine in 2020, and has been a keynote speaker at many international pharmaceutical engineering conferences. He has a demonstrated history of working for the pharmaceutical industry with over 30 years in the field of Manufacturing IT. As a leader with ISPE, Christian is also focused on supporting the industry with new thinking in the direction of the ISPE Pharma 4.0™ Operating Model.
The Industry 4.0 Podcast with Grantek delivers a look in...
2022-06-2930 min
The Industry 4.0 Podcast with GrantekChristian Wölbeling of ISPE and Korber Pharma - The Industry 4.0 Podcast with GrantekChristian Wölbeling is an experienced Senior Director with Korber Pharma. He was nominated as a “Pharma Industry Leader” by The International Society for Pharmaceutical Engineering (ISPE) Pharmaceutical Engineering Magazine in 2020, and has been a keynote speaker at many international pharmaceutical engineering conferences. He has a demonstrated history of working for the pharmaceutical industry with over 30 years in the field of Manufacturing IT. As a leader with ISPE, Christian is also focused on supporting the industry with new thinking in the direction of the ISPE Pharma 4.0™ Operating Model.
The Industry 4.0 Podcast with Grantek delivers a look in...
2022-06-2930 min
The Art of Engineering020 - ISPE Roundtable | The Art of EngineeringDenise visits with Lindsey Daniel and Jen Clark at the most recent ISPE conference in Boston. In this episode, you’ll learn how each of these women came to be a part of the organization, and how ISPE and Women in Pharma have greatly improved the careers of women throughout the industry.Guests: Lindsey Daniel, Product Operations Program Manager at TakedaJen Clark, VP of Sales and Account Relation Management at CAI
2022-06-0926 minThe Industry 4.0 Podcast with GrantekBryon Hayes of Grantek - The Industry 4.0 Podcast with GrantekBryon Hayes is the Director of Smart Manufacturing Solutions at Grantek. He has 20 years of experience working within in the life sciences industry. At Grantek, he is responsible for translating current trends in the life sciences landscape into actionable technical partnership opportunities, training plans, and growth strategies. Bryon is a member of ISPE and ISA. He is on the ISPE Pharma 4.0 Special Interest Group and sits on the Impact & Maturity sub-committee.
The Industry 4.0 Podcast with Grantek delivers a look into the world of manufacturing, with a focus on stories and trends that lead to better solutions.
2022-05-1719 minThe Industry 4.0 Podcast with GrantekBryon Hayes of Grantek - The Industry 4.0 Podcast with GrantekBryon Hayes is the Director of Smart Manufacturing Solutions at Grantek. He has 20 years of experience working within in the life sciences industry. At Grantek, he is responsible for translating current trends in the life sciences landscape into actionable technical partnership opportunities, training plans, and growth strategies. Bryon is a member of ISPE and ISA. He is on the ISPE Pharma 4.0 Special Interest Group and sits on the Impact & Maturity sub-committee.
The Industry 4.0 Podcast with Grantek delivers a look into the world of manufacturing, with a focus on stories and trends that lead to better solutions.
2022-05-1719 min
The Future of PharmaEpisode 18 - Gareth Shaw and Connecting Doctors and Patients in the 21st CenturyMy guest in this episode is Gareth Shaw. Gareth Shaw is the President, the UK & Europe of Doceree, the first global network of physician-only platforms for programmatic messaging. Prior to joining Doceree, Gareth was the General Manager, Global Programmatic, of PulsePoint where he led the programmatic and operations divisions. Previously, he has held roles at Yahoo! and Experian. Throughout his career, Gareth has gained vast experience in sales and operations across the digital media and advertising technology sectors. He has a well-regarded background in building high-performance teams and implementing strategic plans to facilitate the growth o...
2022-05-0953 min
The Future of PharmaEpisode 17 - Lyndsee Manna on Deriving Actionable Intelligence from DataMy guest in this episode is Lyndsee Manna. Lyndsee is an EVP at Arria NLG, where along with her colleagues, she helps businesses derive actionable intelligence from data to make better decisions. That's the simplistic version and we go into a lot more details. In this wide-ranging episode, we talk about math, words, language, writing, technology, data analytics, success, failure, and personal choices. A standout quote from her is, "There are no failures. There are only lessons." I had a great time talking to Lyndsee, discussing the future possibilities, and learning...
2022-03-3153 min
Transformation in TrialsJakob Juul Rasmussen: Zero cost technology - transforming how smaller companies oversee their assetsSend us a textSam and Ivanna speak to Jakob Juul Rasmussen about the stubborn prevalence of paper in clinical trials, especially in small pharmaceutical and biotech companies. Paying money up front, covering the implementation and license costs and building up internal IT functions can be prohibitive for small pharmaceutical and biotech companies. This leads many companies to outsource their entire IT landscape to CROs. As a result, control over assets becomes complicated and cumbersome, as your clinical data risks being stored in different applications with multiple data models applied. Standard configuration is helping bridge the gap, b...
2022-03-3144 min
Let's Combinate - Drugs + Devices022 - "What Chapter are you in?" with Susan NeadleOn this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss:
Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals
Design to Value, Design Excellence and Process Excellence
The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed.
Creating future plans using tools like the Merlin Exercise, and Future/Back
Vocabulary in Combination Products
AAMI TIR 48 and TIR 105
Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS
Prioritization, Passion and...
2022-03-021h 23
The Future of PharmaEpisode 16 - Mark Sitcoske on Building a Company and Impact of COVID-19 on the Global Supply ChainMy guest today is Mark Sitcoske. Mark is the Founder & CEO of High Purity New England (HPNE), based in Northern Rhode Island, just forty-five minutes south of Boston. HPNE has grown rapidly over the last few years, expanding significantly from a small team of fewer than ten employees to a firm that anticipates reaching approximately 350 employees in 2022. Mark and his growing team of deeply-experienced professionals at HPNE are committed to supplying the biotech and biopharma industries with a variety of innovative, single-use solutions. Currently, HPNE is one of many companies supporting the global efforts of...
2022-01-1928 min
Software Quality TodayA Wrap-Up from the ISPE Annual Meeting & Expo, with Dori Gonzalez-Acevedo and Jason SecolaIn this quick episode following our attendance at the ISPE Annual Meeting and Expo, I sat down with our host, Dori Gonzalez-Acevedo, to do a bit of a post-conference wrap-up episode. We discuss some of the highlights of the conference relating to software quality, common themes we heard, issues that our industry needs to address, and the overall takeaways from the event.Tune in to hear Dori's thoughts and don't forget to rate and subscribe where you get your podcasts!
*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor...
2021-11-0721 min
Modern BioPharma PodcastWomen in Pharma - An Interview with Jennifer Lauria ClarkDiversity gives you access to a greater range of talent, not just the talent that belongs to a particular world-view or ethnicity or some other restricting definition. It helps provide insight into the needs and motivations of all of your client or customer base, rather than just a small part of it.
One way this is being addressed in the Pharmaceutical industry is with a group called Women in Pharma (WIP) in ISPE.
On today’s episode, I am joined by Jennifer Lauria Clark from CAI. Jenn has worked on the WIP committee both locally in t...
2021-11-0327 min
Field Sales UnscriptedKilling it as a Woman in Sales Leadership with Jennifer Lauria ClarkGet FREE Sales Leadership Resources at go.transformedsales.com/podIn this episode of The Science of Selling STEM, I’ll be sitting down with Jennifer Lauria Clark, CPIP. Jennifer is the Vice-President of Sales and Account Relationship Management for CAI, where she is responsible for business development project engineering, commissioning and qualification planning, protocol development and execution, project startup, and coordination, among other duties. She has 18 years of experience in the regulated industry. She held positions as a consultant, where she provided services for MERCK, GSK, Biogen, and others.Previously, she held positions at Yo...
2021-10-0633 min
The Future of PharmaEpisode 15: Dr. Paul Peter Tak on Doing Everything With Patients in MindMy guest today is Dr. Paul Peter Tak. Dr. Tak received his medical degree cum laude from the Free University in Amsterdam and was trained as an internist, rheumatologist, and immunologist at Leiden University Medical Center, where he also received his PhD. He has been a Clinical Associate Professor of Medicine at the University of California San Diego. Next, he served as Professor of Medicine and founding Chair of the Department of Clinical Immunology and Rheumatology at the Academic Medical Centre/University of Amsterdam (AMC). During this time, he founded Arthrogen b.v., a biotech company focused on gene...
2021-08-111h 16
The Future of PharmaEpisode 14 - Amr Raafat, Virtual Design Construction and ShakespeareMy guest today is Amr Raafat. Amr has over 17 years of experience combining architectural, construction, and engineering expertise and is an industry-leading technology expert. As Vice President of Virtual Design Construction & Technology at Windover Construction, he leverages the most cutting-edge technologies such as BIM, laser scanning, drone mapping, virtual and mixed reality, digital fabrication, and 3D printing to streamline the construction process for our clients and project teams. Amr has published multiple articles on construction innovation and is a regular presenter at technology conferences throughout the country. He holds a Master's of Architecture degree from...
2021-02-0342 min
The Future of PharmaEpisode 13 - Francesca McBride, Cell Therapy and Global RegulationsMy guest today is Francesca McBride. Francesca completed a Bachelor of Science Degree at the University of Delaware in 1985, majoring in Pre-Veterinary Science. As a pharmaceutical/ biotechnology regulatory compliance specialist Francesca works with international companies to support the design, start-up, licensing and operation of clinical and commercial product manufacturing facilities. She has been with Jacobs (Pharmaceuticals and Biotechnology) for 25+ years and currently in her capacity as a Director, Regulatory Compliance is involved in the support of client and design teams to ensure the design meets the applicable international cGMP / cGTP requirements. During her tenure at...
2021-01-1351 min
The Future of PharmaBrian Hagopian, Water Purity and Rapid Bacteria DetectionMy guest today is Brian Hagopian who's known as or at least I call him "the Kevin Bacon of the Boston life sciences industry", either you know him or you know someone who knows him. He is currently the President of Clear Water Consulting, Inc.,and received his chemistry degree from Colgate University. He has over 35 years of design, manufacturing, and operational experience and is currently a highly sought after high purity water subject matter expert. Brian is an instructor at Worcester Polytechnic Institute and is also a Massachusetts certified instructor offering licensing courses for industrial wastewater operators. Brian...
2021-01-051h 05
The Future of PharmaEpisode 11 - Dr. Andrea Adamo and the Out of This World Flow TechnologiesMy guest today is Dr. Andrea Adamo who is the Founder and CEO of Zaiput Flow Technologies. He also serves as the Innovation Advisor at Snapdragon Chemistry. Dr. Adamo holds a Master of Science in Engineering from the University of Palermo, Italy and a Ph.D. in Fluid Mechanics from the University Federico II of Naples, Italy in addition to a Master of Science from the Massachusetts Institute of Technology. He was also awarded the Fulbright Scholarship. After completing his graduate studies, Dr Adamo joined the laboratory of Professor Klavs Jensen, Director of the MIT Chemical Engineering Department and...
2020-12-1436 min
The Future of PharmaEpisode 10 - Dr. Arindam Bose and the Evolution of the BiopharmaceuticalsMy guest today is Dr. Arindam Bose. Arindam is currently an Independent Consultant in biologics process development and manufacturing following a 35-year career in bioprocess development, clinical supply manufacturing, external partnering, corporate biotechnology strategy and advocacy for science-based regulations for biologics at Pfizer Worldwide R&D from where he retired as a Vice President. He served as the Technical Lead of the Team that developed and executed Pfizer's strategy for entry into the field of biosimilar medicines. Dr. Bose is a Member of the US National Academy of Engineering. Additionally, he was elected Fellow of AIChE, American...
2020-07-1432 minModern BioPharma PodcastMBP - Brian Hagopian - Clear Water Consulting - Part 2 Sampling & MonitoringIn part 2 of our water series with Brian Hagopian we discuss sampling and monitoring of pure water systems. Understanding what is and isn't in your pure water system is critical to ensuring the safety and efficacy of your product. Brian has been a part of defining many of these rules over the decades. He was a member of the team that wrote the ISPE Good Practice Guide: Sampling Pharma Water, Steam, and Gas Processes.
Here are some of the things we covered in this episode:
What has sampling and monitoring looked like in p...
2020-06-1832 min
The Future of PharmaEpisode 9 - Prof Charles Cooney, the History and Future of Biotech and Boston BalletMy guest today is Prof Charles Cooney. Prof Cooney received his B.S. in chemical engineering from the University of Pennsylvania in 1966, and the S.M. (1967) and Ph.D. (1970) in biochemical engineering from MIT. He joined the MIT faculty as an assistant professor in 1970, becoming full professor in 1982. Prof Cooney's honors include the 1989 Gold Medal of the Institute of Biotechnological Studies (London); the Food, Pharmaceutical, and Bioengineering Award from the American Institute of Chemical Engineers; the James Van Lanen Distinguished Service Award from the American Chemical Society's Division of Microbial and Biochemical Technology; and election to the...
2020-06-0959 min
D'Cast09. Economic Pandemic, Indonesia Panic part.1Gimana sih Dampak Perekonomian Indonesia terhadap Pandemi Covid-19??? With @galihsmahardhika as Presidium Alumni ISPE (Indef School Of Political Economy).
2020-04-2126 min
The Future of PharmaEpisode 8 - David Sullivan on New Modalities, Price, Patients and the Pharma LandscapeMy guest today is David Sullivan, Sr. Director and Global Lead of Vaccines and Biologics MSAT at Pfizer. He did his Bachelor's in Biotechnology from Worcester Polytechnic Institute and Master's in Engineering Management from Tufts University. Over the years, he's worked in process development, pilot plant, next generation technology, vaccines and biologocs MSAT. I have known Dave for over 15 years and have always been impressed with the width of his knowledge and have never had a boring conversation about anything with him. In this episode, we talk about new modalities, the current changes happening in the pharma industry landscape...
2020-04-0829 min
The Future of PharmaEpisode 7 - Salvatore Mascia and Continuous ManufacturingMy guest today is Salvatore Mascia. Sal is the Co-Founder & CEO of CONTINUUS Pharmaceuticals based in Woburn, MA. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. For his efforts, he was recognized with the "Leadership Award". He co-founded "Professionisti Italiani a Boston" in 2009, and served as President of the "Cambridge University Technology and Enterprise Club" in 2006/07. He also ran a pharmacy business for 2 years and as you'll notice from the interview, has the ability to make a mundane seeming...
2020-03-3040 min
The Future of PharmaEpisode 6 - Matt Roberge and the Global Pharma ForcesMy guest today is Matt Roberge. He got his Mechanical engg degree from Villanova Uni. He currently works for Pfizer and serves as a senior director of Global technology network and Emerging market. He has a truly global organization with teams in the USA, china, russia, argentina, brazil, india and i'm sure i'm forgetting a couple. I had the pleasure of working under Matt's leadership when Pfizer built the first Asian Biologics Development Center in Hangzhou, China few years back. We had a great time recording this interview. Hope you enjoy it too. Here's Matt Roberge from Pfizer.
2020-03-0353 min
AWS re:Invent 2019MFG203: Modernizing pharmaceutical manufacturing with IoT and AI/MLIn this session, learn how to use AWS IoT, AI/ML, and data analytics services to build a connected, intelligent biopharmaceutical manufacturing and supply chain environment. Hear from Moderna Therapeutics, a "born in the cloud" pharma company that constructed a 200,000-square-foot Good Manufacturing Practices (GMP)-compliant manufacturing facility utilizing SAP S/4HANA and AWS services to facilitate a "batch of one"; it recently won the ISPE Facility of the Future Award. Learn how to incorporate AWS IoT and AWS AI/ML while maintaining the automated guardrails necessary for the creation and maintenance of regulated workloads following GMP and other industry...
2019-12-0800 min
The Future of PharmaEpisode 5 - Blockchain and Fake Drugs with Dr. Hariawala, Prof Vaishnav and Mr. MankodiDr. Mukesh Hariawala is a world-renowned heart surgeon, a highly sought after keynote speaker and Chairman of American Healthcare International (AHI). Prof Chintan Vaishnav is a professor at Sloan School of Management at MIT and Director of MIT Tata Center for Technology and Design. Mr. Jayesh Mankodi is an IT industry veteran with expertise in Infrastructure Architecture and Cloud Computing. Chintan and Jayesh are advisors to AHI. Using blockchain technology and cloud computing, Mukesh, Chintan and Jayesh at AHI are working to solve the problem of fake drugs in the market.
2019-06-0428 min
The Future of PharmaEpisode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt TroutEpisode 4 - Continuous Manufacturing and Rare Events with Prof Bernhardt Trout Professor Trout directs the Molecular Engineering Laboratory and Novartis-MIT Center for Continuous Manufacturing at Massachusetts Institute of Technology, Cambridge, MA. He is considered one of the pioneers to pave the way for the continuous manufacturing in the highly complex and regulated field of the pharmaceutical manufacturing. Find out his thoughts on how continuous manufacturing and rare events will affect the future of the pharmaceutical industry in this chat with Samir Gondalia.
2019-03-1126 min
The Future of PharmaEpisode 3 - ISPE Boston and Individualized Medicine with Jack CampionVisit ispeboston.org for complete show notes of every Podcast episode. Jack Campion is Principal at the Hart Companies. He is the immediate past president of the ISPE Boston area chapter. Jack and the show host Samir have known and worked with each other for many years in their capacity as the ISPE Boston board of directors and as volunteers on other committees. Let's hear Jack's thoughts on the new and emerging developments in our industry and what it means for the future of pharma.
2018-11-2820 min
The Future of PharmaEpisode 2 - E. Coli Outbreak and Bacteria Detection with Dr. Monika WeberVisit ispeboston.org for complete show notes of every Podcast episode. Dr. Monika Weber is the Founder and CEO of Fluid Screen, a startup in Boston, MA with a revolutionary chip-on-a-technology to detect and identify bacteria in water, food and process fluids. She was inspired due to the catastrophic foodborne illness in Europe in 2011 due to the E. Coli contamination which resulted in human deaths and hundreds of millions of dollars losses. Using electric forces to control bacteria motion in water, Dr. Weber discovered a method of concentrating and identifying bacteria in fluid samples. Her technology captures...
2018-11-2825 min
The Future of PharmaEpisode 1: Nanoparticles and the future of implants with Prof. Tom WebsterVisit ispeboston.org for complete show notes of every Podcast episode. Professor Webster directs the Webster Nanomedicine Laboratory at Northeastern University, Boston which designs, synthesizes, and evaluates nanomaterials for various implant applications. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. Some of these patents led to the formation of 9 companies. Find out his thoughts on how nanoparticles will affect the future of the pharmaceutical industry in this chat with Samir Gondalia.
2018-11-1028 min