Shows
Facility RockstarsA Holiday Message of Gratitude: Reflecting on the Facility Rockstars Community, Events, and MissionIn this special holiday episode, Jay Culbert offers a message of gratitude, reflecting on the past year and sharing exciting news about the future of Facility Rockstars. The episode begins by thanking the entire community, from weekly listeners to long-time and new members. Jay emphasizes that the show's growth and vitality are a "real testament" to the engagement, feedback, and shared knowledge within the community. He reinforces the core mission of Facility Rock Stars: "honoring the unsung heroes of our everyday lives," facility professionals, and consistently bringing like-minded people together who are actively willing to share and help one...
2025-12-2309 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
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
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 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
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
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
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
Digitalization Tech TalksEpisode 45, part 2: Midrex Technologies - From Digital Vision to Digital TransformationWhat does it take to create a vision for digital transformation and then bring it to life? That’s exactly what we discuss in this episode of Digitalization Tech Talks! The company that achieved this is Midrex Technologies who specializes in direct reduction ironmaking technology in the steel industry. Join us as we interview Curtis Hughes, Midrex’s Chief Information Officer, about all the factors that went into their digitalization journey. First presented at the Siemens Realize LIVE conference in May 2024, Curtis focuses on completing a “people-centric transformation” and all the benefits associated with it (please reach out to Curti...
2024-10-0315 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
Digitalization Tech TalksEpisode 45, part 1: Midrex Technologies - From Digital Vision to Digital TransformationWhat does it take to create a vision for digital transformation and then bring it to life? That’s exactly what we discuss in this episode of Digitalization Tech Talks! The company that achieved this is Midrex Technologies who specializes in direct reduction ironmaking technology in the steel industry. Join us as we interview Curtis Hughes, Midrex’s Chief Information Officer, about all the factors that went into their digitalization journey. First presented at the Siemens Realize LIVE conference in May 2024, Curtis focuses on completing a “people-centric transformation” and all the benefits associated with it (please reach out to Curti...
2024-09-2616 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
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
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
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 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
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
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
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 min
Modern BioPharma PodcastMBP - Kevin Chronley - A/Z CorpToday on the Modern Biopharma Podcast we sit down to talk with Kevin Chronley, Vice President at A/Z Corp.
Kevin and I have known each other for a number of years now as he is very active in the Boston chapter of ISPE and A/Z Corp is very active in the life sciences industry in New England.
This discussion is getting to know Kevin, who he is, and some of his experiences in the industry.
Here are some of the questions we discussed:
Tell me a little about yourself How did...
2020-07-0619 minModern BioPharma PodcastMBP - Brian Hagopian - Clear Water Consulting - Part 3 Rapid Microbiological MonitoringIn Part 3 of our water series with Brian Hagopian we discuss Rapid Microbiological Monitoring of pure water systems.
This is a technology that continues to get attention as it matures in the Pharma space. With microbiological control being so important to the modern water system in a BioPharm plant, understanding what is going on on the micro level is too important to have to always wait for a multi-day test result.
Here are some of the items we discuss:
What is the reason behind microbiological monitoring in a water system? What are you look...
2020-06-2430 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 minModern BioPharma PodcastMBP - Brian Hagopian - Clear Water Consulting - Part 1 Micro-Electronics Water vs PharmaDid you know that standards for Microelectronics water are FAR more stringent than those for the Pharmaceutical industry? By any measure, the water used in manufacturing semi-conductors is superior to what is used in pharmaceutical manufacturing.
On Part 1 of my discussions with Brian Hagopian from Clear Water Consulting talking water, we discussed some of what makes them different and what we can learn from what they do. Here are some questions we discuss:
Every industry has different “drivers” for how and why certain water quality is needed. What do you see as the main drivers for wat...
2020-06-1539 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 minModern BioPharma PodcastMBP - Rick Pierro - Superior ControlsRick Pierro is an institution in the New England area Biopharma space. He has been leading his company, Superior Controls, for many years and been active in organizations like the ISPE Boston Area Chapter for as long.
It was a pleasure speaking with Rick for this episode of the podcast and hear more about what he sees in the industry in his role at Superior.
He speaks about the role of #BigData in Biopharma, the impact #celltherapyand #genetherapy are having on the world of medicine, and ways he thinks many facilities could improve on their...
2020-04-2927 minModern BioPharma PodcastMBP - Eric FelzLast week I got to sit down with Eric Felz to talk about his experience in the BioPharma industry, how COVID-19 has impacted his work life, and the things he is excited about as our industry marches forward.
Eric currently is a Director at Takeda here in the Boston area, the sitting President of the ISPE Boston Area Chapter, and an all around good guy. Give it a watch/listen!
2020-04-1432 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
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
The Future of PharmaEpisode 0 - Welcome to the Future of Pharma!The introductory episode to launch our Podcast - The Future of Pharma with ISPE Boston. Learn about the podcast, ISPE Boston and the host, Samir Gondalia and why it's a must subscription for a pharma professional.
2018-10-1103 min