Category

LIFE SCIENCES

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market
LIFE SCIENCES, MEDICAL DEVICES

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

Dina is currently the Vice President of Regulatory Affairs for Terumo Medical Corporation where she oversees both US and global Regulatory Affairs. Prior to joining Terumo in 2008, Dina spent 17 years at the FDA as a reviewer and later a branch chief in the Division of Cardiovascular Devices. She also spent some time as a Sr. RA consultant prior to joining Terumo.

Dina holds a BS in Biomedical Engineering from The Catholic University of America and a Master of Business Administration from the University of Maryland.

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Transforming Supply Chain Quality Processes in the Digital Era
LIFE SCIENCES, MEDICAL DEVICES

Transforming Supply Chain Quality Processes in the Digital Era

Aileen Barreto Rivera is a transformational global leader with extensive experience in Supply Chain and Quality within the Medical Devices and Pharmaceuticals industry. Since joining Johnson & Johnson in 1995, Aileen has held multiple roles of increasing responsibility across various business units including Orthopedics, Vision Care, Diabetes Care and Innovative Medicine with direct accountability of Manufacturing, Lean, Engineering, and Quality functions. Her professional journey spans across key locations, including Puerto Rico, Europe, and the United States.

Throughout her tenure, Aileen has successfully led numerous strategic projects, including operational readiness for key product launches, site start up strategies and significant efficiency improvements within the manufacturing landscape. Her leadership has facilitated remarkable accomplishments, during acquisitions, compliance improvements initiatives, as well as significant contributions to community initiatives, reflecting her passion for people. Aileen’s commitment to excellence is evident in her ability to drive performance and engagement while maintaining high standards of quality and customer satisfaction.

Her academic background includes a Bachelor of Science in Electrical Engineering from the University of Puerto Rico, as well as an alumni of notable leadership programs at J&J.

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From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation
LIFE SCIENCES, MEDICAL DEVICES

From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation

Zillery A. Fortner is a respected professional in the life sciences industry with over 30 years of experience. She has held roles like surgical assistant, quality assurance specialist, regulatory affairs expert, and accreditation professional. Now, she is the Industry Business Development Director, SME at Honeywell, advocating for customers.

Her dedication to innovation is evident in her involvement in professional organizations and her numerous patents. Zillery’s extensive knowledge helps drive digital innovation and ensure regulatory compliance in the industry.

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Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery
LIFE SCIENCES, MEDICAL DEVICES

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Evaluating the effects of new regulations on the medical device sector
Providing guidance on creating and deploying efficient quality management systems
Examining the careful balance between innovation and safety mandates
Sharing approaches for conducting quality risk assessments and taking proactive measures
Charting a future course for the medical device industry with best practices and learned insights

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How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing
LIFE SCIENCES, MEDICAL DEVICES

How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing

In his role, Viju is responsible for global operations, including manufacturing, direct procurement, regulatory affairs, quality assurance, sustainability, integrated business planning, logistics and advanced operations such as additive manufacturing technology development.

Prior to joining us, Viju served as Chief Supply Chain Officer and Senior Vice President at Verizon. Before his work at Verizon, Viju held key leadership roles at Intel in technology, supply chain and manufacturing operations.

Viju earned his doctoral degree from the University of Pennsylvania and dual graduate degrees (MBA, S.M. in electrical engineering) from the Massachusetts Institute of Technology’s Leaders for Global Operations program. He also holds a graduate degree (M.S.E. in computer science engineering) from the University of Michigan and a bachelor’s degree in engineering from the University of Kerala, India.

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The Journey from Quality Remediation to Quality Excellence
LIFE SCIENCES, MEDICAL DEVICES

The Journey from Quality Remediation to Quality Excellence

David Kunz was appointed Senior Vice President, Global Quality and Regulatory Affairs in May 2017. He is responsible for providing strategic and operational direction to achieve Quality and Regulatory Excellence across the organization and he chairs the Company’s Quality Excellence Steering Committee. Mr. Kunz joined the Company (then Zimmer) in 2011 as Vice President, Regulatory Affairs and Quality Assurance for the Spine division. He was appointed Senior Vice President, Global Quality, Clinical and Regulatory Affairs in April 2016. Prior to joining Zimmer, he served as Vice President, Quality Assurance of Ecolab, where he led a supply chain network including nine chemical plants and two equipment plants. Previously, he spent 13 years at Guidant/Boston Scientific Corporation in a variety of leadership positions, most recently as the Director of Supplier Quality Assurance for the CRV Division. He began his career at the Naval Nuclear Propulsion Program Headquarters as a mechanical engineer. Mr. Kunz holds a Bachelor of Science and an MBA from the University of Minnesota. He is a certified Nuclear Engineer and previously was a certified Licensed Professional Mechanical Engineer.

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Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise
LIFE SCIENCES, MEDICAL DEVICES

Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise

In his role as Head of Supply Chain & Operations for Philips Image Guided Therapy Devices, Cory is responsible to lead a world-class supply chain organization and to drive operational excellence in support of the business goals, which are fully focused on providing patient-focused and market-leading solutions. His passion for building a high-performing team of supply chain and operational leaders is rooted in his belief that there is always a better, more efficient way to serve our customers. Prior to entering the diagnostic / therapeutic medical devices industry, Cory spent over 20 years in development and leadership roles in the medical device and automotive industries.

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The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare
LIFE SCIENCES, MEDICAL DEVICES

The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare

Premier Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,350 U.S. hospitals and health systems and approximately  325,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, NC, Premier is passionate about transforming American healthcare.

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Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor
LIFE SCIENCES, MEDICAL DEVICES

Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor

Mark MewsVice President, Global Supply Chain & Operations LeaderW. L. Gore & Associates Mark Mews leads the operations and supply chain for the Peripheral Business Group and has been at W.L. Gore and Associates, Inc. for over 16 years spending a majority of that time leading cross-functionally in various operations & supply chain leadership roles across both new product development and commercial life cycles. Mark is an advocate for continuous improvement, creating a lean culture, and focusing teams and organizations on delivering targets that improve both top and bottom-line growth.

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Building a Quality Culture and Continuous Improvement
LIFE SCIENCES, MEDICAL DEVICES

Building a Quality Culture and Continuous Improvement

Ensuring safety, compliance and innovation – How to build a strong quality culture and implementing continuous improvement practices

Successful implementation of quality culture & continuous improvement

Overcoming challenges in building a quality culture

Embrace quality at every level of the organization and adopt continuous improvement as a core value to stay competitive, compliant, and trusted in the marketplace

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Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?
LIFE SCIENCES, MEDICAL DEVICES

Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Innovation and R&D: Fueling our industry, R&D drives groundbreaking solutions. We will explore strategies to stay ahead in technology and product development

Manufacturing Processes and the Future: Optimizing processes for agility and sustainability is key. We adapt to innovations to lead the industry forward

Quality in the Age of AI/ML: Exploring the future of medical device manufacturing and how automation will reshape operations while maintaining quality standards and leveraging technologies for risk mitigation and improvement

Regulatory Compliance: Employing effective strategies for clearance and ongoing compliance

Supply Chain Resilience and Sustainability: Enhancing supply chain resilience and sustainability through strategies that leverage digitization and AI to bolster efficiency, traceability and fortify against unforeseen challenges

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How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better

In the run-up to the 2025 edition of the Medical Device Manufacturing Excellence Summit series we spoke with Shawn McCarthy, Jessica Swanson, and Peggy Hansen of Regenity Biosciences about exciting developments in the Medical Device space, with a particular emphasis on both the power of collaboration and the importance of a regulatory strategy. Regenity is an industry-leading CDMO working with 120 different industry partners and offering special expertise in regenerative devices. In this wide-ranging conversation we talk about industry trends, how medical device manufacturers are evolving to continue to meet the needs of patients, and also about some of the big ideas Regenity wants to share with the executives attending MDMES25. For all this and more, give this episode a listen!

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The Speaker Roundtable from BMWS24 — A Conversation About Biopharmaceutical Manufacturing Issues and Ideas
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST, ROUNDTABLES

The Speaker Roundtable from BMWS24 — A Conversation About Biopharmaceutical Manufacturing Issues and Ideas

For this special episode of Executive Platforms’ bluEPrint Podcast series we had some of the most senior speakers and delegates from the 2024 edition of the long-running Biomanufacturing World Summit series sit down and speak to the challenges and opportunities submitted by attendees of the event as they filled out their delegate profiles, weighted by popularity.

With topics ranging from leadership and culture, to talent attraction, development and retention, to supply chain issues, to commercializing CGTs and other ATMPs, change and disruption throughout the business landscape, and how to serve patients better now and in the future, this wide-ranging conversation sees five senior executives from five very different companies speaking to the issues, ideas, innovations, and inspirations that matter to all of them as guided by a moderator who knows the industry inside and out. It is a fantastic deep dive into what is most relevant to biopharma technical operations leaders today. Give it a listen!

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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

Sanat Chattopadhyay is responsible for the company’s (approx. $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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FUTURE READY: Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, Data & (High) Yields
LIFE SCIENCES, VIDEO, LIFE SCIENCES

FUTURE READY: Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, Data & (High) Yields

Jerry Murry, is Senior Vice President of Process Development at Amgen. Jerry started his career at Amgen in 2006 as Executive Director, Process Development within the Translational Sciences organization in R&D, and was promoted to Vice President, Process Development in 2010. In 2012, Jerry joined the Amgen Full Potential Transformation team as lead of the initiative “Transforming Process Development at Amgen”(AFP3).

In 2014, as part of the integration and reorganization of a new single, global process development team, Jerry was named the head of CMC Lifecycle management with responsibility for Operations Commercialization activities including regulatory filings and launches.

In 2016, Jerry became head of Drug Product Technologies with responsibility for all formulation and product and process development.
In 2018, Jerry was promoted to Senior Vice President Process Development at Amgen with responsibilities for all global Process Development activities.

Prior to joining Amgen, Jerry spent 8 years at Pfizer Central Research and 6 years at Merck Research Laboratories in Process Development.

Jerry earned BA/BS in Biology and Chemistry at Texas Lutheran University, a PhD in Chemistry from University of Utah and was an NIGMS NIH Fellow at Harvard University.

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Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Tongtong joined Genentech in 2018 as the head of Pharmaceutical Technical Development for US Biologics, and was named global head of Pharma Technical Development in April 2021. Prior to her role at Genentech, Tongtong held several scientific, managerial and strategic roles at Eli Lilly, with increasing responsibilities in the Bioproduct Research and Development organisation. Tongtong also worked at Corixa Corporation, a biotech company, where she gained valuable experiences both as a discovery scientist and as a CMC leader in support of therapeutic antibody and cancer vaccine platforms.

Tongtong received her B. Sc. in Molecular Biology from University of Science and Technology of China, a doctorate in Biology from Syracuse University, and completed her postdoctoral training in cell biology and yeast genetics at Cornell University.

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Authentic Leadership
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Authentic Leadership

As Chief Global Supply Officer, Executive Vice President, Mike McDermott leads Pfizer’s internal and external manufacturing and supply chain activities.

Mike and the Pfizer Global Supply (PGS) team work to ensure uninterrupted supply for Pfizer’s entire product portfolio. This includes hundreds of medicines and vaccines provided to more than 185 countries worldwide. The PGS network, which includes more than 30 global manufacturing sites and approximately 31,000 colleagues, also works with more than 300 contract manufacturers to produce 50 billion doses of medicines and vaccines each year.

Mike has more than 30 years of industry experience, having joined Pfizer in 1989, by way of Wyeth, after starting as a Project Engineer in Pearl River, New York. He has held many roles, including Plant Manager and Operational Vice President of multiple divisions, including Consumer Healthcare, Biotechnology and Supply Chain, as well as roles in Finance and Marketing.

He was named President of PGS in 2018 and assumed his current role in January 2022.

A passionate advocate for Diversity, Equity and Inclusion, Mike has enacted impactful changes to increase diversity within PGS and was recently named Executive Sponsor of Pfizer’s Women’s Resource Group, the company’s largest Colleague Resource Group.

In addition to ambitious goals related to product supply at launch and manufacturing cycle times, Mike and PGS support Pfizer’s Net Zero strategy, which includes delivering Greenhouse Gas reductions.

Mike, his wife Katie and their five daughters – of whom he is incredibly proud – are committed to community engagement and social action. An active volunteer himself, Mike was a Board Member for People to People, a non-profit organization which helps under-served communities, for 10 years.

Mike holds Bachelor of Science and Master of Science degrees in Industrial Engineering from the New Jersey Institute of Technology (NJIT), where he has been an adjunct professor. He was named an NJIT Distinguished Alumnus and is the recipient of the 2023 Newark College of Engineering Outstanding Alumnus Award.

Mike serves on the Executive Committee of the National Association of Manufacturers and is a member of the Pharmaceutical Manufacturers Forum.

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