Data-Driven Distribution:
Thermal Modeling and the Future of Cold Chain Compliance with Karen Greene

Episode Summary

In this episode of Measuring Up, Thinking Out Loud, host Bill White sits down with Karen Greene, Vice President of Client Solutions at Network Partners Group and Principal Consultant at Canyon Labs, to discuss the critical intersection of packaging engineering and temperature control. With over 40 years of experience in the life sciences industry, Karen explores the complexities of cold chain applications and the necessity of protecting temperature-sensitive products as they move from point A to point B.

The conversation delves into the vital work of the International Safe Transit Association (ISTA), where Karen serves on the Board of Directors. She explains how ISTA sets the standards for distribution packaging and how its Pharmaceutical Committee provides the industry with the thought leadership and test profiles needed to safely ship sensitive medical devices and biotech products.

About the Guest

Karen Greene is Partner and VP, Client Solutions – Packaging Engineering at Network Partners Group and Principal Consultant at Canyon Labs. She is a seasoned life sciences packaging engineering professional with more than 40 years of industry experience. Karen is an IoPP Certified Packaging Professional (lifetime CPP), a global board member of ISTA, the International Transit Association, and a board member of the ISTA Pharma committee. Additionally, she is a member of ASTM F02 Flexible Barrier Packaging Committee and an ISTA 7E-certified auditor.

Karen’s expertise spans packaging testing, compliance, quality systems, design, and validation across medical device and pharmaceutical product portfolios. In her dual roles at Network Partners Group and Canyon Labs, she leverages this deep technical and regulatory background to help clients bring safe, effective, and compliant products to patients.

She holds a bachelor’s degree from Holy Cross College in Worcester, MA, and a certificate in engineering management from the University of California, San Diego.

Cold Chain Excellence:
Navigating the Four Quadrants of Risk with Jim Bacon

Episode Summary

In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down again with Jim Bacon, founder of Stay Cool Logistics, to break down the complexities of risk management in pharmaceutical logistics. 

Jim comes back to his "Four Quadrants of Risk" (financial, hazard, strategic, and operational) concept to explain how understanding these categories allows organizations to better protect product integrity and patient safety. The conversation explores the critical shift from a silo mentality to a total cost calculation, where procurement, quality, and finance work together to decrease risk tolerance. 

Jim also shares a real-world example of how a robust cold chain process can lead to innovative self-insurance strategies, such as stock-throughput coverage. Finally, the duo discusses the evolving role of technology, emphasizing that human instinct remains the bedrock of successful risk mitigation.

About the Guest

Jim Bacon is a cold chain logistics expert with decades of experience across manufacturing, operations, sales, and technical consulting in the pharmaceutical and biotech industries. His work has focused on advancing best practices, implementing robust monitoring systems, and improving industry-wide cold chain acumen.

Commissioning, Qualification, and Validation:
The History and Evolution of Validation with Sean Merrill

Episode Summary

In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down with Sean Merrill, a Validation Engineer at Testo with over 11 years of experience in commissioning, qualification, and validation. They explore the critical history of the regulatory landscape and how modern risk-based approaches are streamlining safety protocols in the pharmaceutical and industrial sectors.

The conversation traces the reason behind modern regulations to contextualize the current integrated approach that prioritizes innovation and efficiency. Sean explains how companies can leverage documentation and third-party expertise to turn validation from a necessary evil into a value-added asset for patient safety and product quality.

About the Guest

Sean Merrill is a Validation Engineer at Testo. With more than a decade of experience in commissioning, qualification, and validation, he specializes in helping organizations navigate complex regulatory environments and operational nuances. Sean is an expert in implementing risk-based strategies for pharmaceutical manufacturing, logistics, and distribution centers, ensuring that facilities and equipment consistently meet the highest standards for their intended use.

Partners Over Vendors:
Instilling Ownership in Pharmaceutical Logistics with Jim Bacon

Episode Summary

In this episode of Measuring Up: Thinking Out Loud, host Bill White sits down again with Jim Bacon, whose decades of pharmaceutical logistics experience spans domestic and international cold chain operations. In this episode, Bill and Jim take a deep dive into ensuring the integrity of the pharmaceutical cold chain. Jim shares how the industry’s most successful logistics programs are built not on transactions, but on strategic partnerships that are rooted in trust, communication, and shared responsibility.

Jim introduces the critical "core team" concept, which emerged early in his career. This approach emphasizes a strong internal team that collaborates with a robust network of external partner suppliers to navigate the complexity of cold chain processes successfully. He explains why treating suppliers as vendors undermines accountability and why true partners must be integrated into your processes.

The conversation explores supplier qualification, regulatory expectations, mock shipment trials, AI, and the lessons learned from the COVID-19 vaccine rollout. Through it all, Jim returns to one central principle: ownership is everyone’s job, and when partners understand their role in protecting critical therapies, patients ultimately benefit.

About the Guest

Jim Bacon is a cold chain logistics expert with decades of experience across manufacturing, operations, sales, and technical consulting in the pharmaceutical and biotech industries. His work has focused on advancing best practices, implementing robust monitoring systems, and improving industry-wide cold chain acumen. He is the President and Founder of Stay Cool Logistical Consulting, LLC. 

Protecting Pharmaceuticals:
The Logistics of Saving Lives with Patrick Girten

Episode Summary

In this episode of Measuring Up: Thinking Out Loud, host Bill White speaks with Patrick Girten, a pharmaceutical logistics expert whose career journey spans aviation, firefighting, and pharmaceutical operations. Patrick shares how the discipline and accountability from his early experiences translate into protecting life-saving therapies during transport.

From the evolving complexities of cold chain management to the human element that drives vendor compliance, Patrick highlights why logistics is never just about moving packages; it’s about safeguarding patients. He recalls a powerful Christmas Eve shipment that reached a young cancer patient in Canada, a moment that reshaped his entire perspective on logistics and leadership.

The conversation explores regulation, vendor relationships, technology, and the balance between metrics and mission with one central theme: remembering the patient in every package.

About the Guest

Patrick Girten is a pharmaceutical logistics expert with nearly two decades of experience ensuring therapies reach patients safely and on time. He began his career in aviation and firefighting before transitioning into the pharmaceutical industry, where he worked across various areas, including manufacturing, quality compliance, distribution, and logistics. Patrick is known for connecting the technical side of cold chain operations with the human responsibility behind every shipment.

Cold Chain Excellence:
Lessons from Operation Warp Speed with Major General (Ret.) Chris Sharpsten

Episode Summary

In this episode, host Bill White speaks with retired U.S. Army Major General Chris Sharpsten, who played a leading role in Operation Warp Speed. Sharpsten shares insights from coordinating the distribution of COVID-19 vaccines during one of the most complex logistical challenges in modern history. The conversation explores cold chain accountability, lessons learned about teamwork and data transparency, and what the pharmaceutical industry can apply today to reduce the fear of equipment failure and prepare for future crises.

About the Guest

Major General Chris Sharpsten (Ret.) served more than 30 years in the U.S. Army as a logistics leader, directing global supply operations in the Middle East, Europe, Africa, and the U.S. During the COVID-19 pandemic, he was called to the White House to help lead Operation Warp Speed, ensuring the safe and efficient distribution of critical vaccines. Today, he continues to advise on cold chain logistics, resilience, and the reshoring of vital medical capabilities.

Cold Chain Excellence:
Safeguarding Pharmaceuticals with Jim Bacon

Episode Summary

In this episode, host Bill White speaks with Jim Bacon, an industry veteran with over 35 years of experience in the pharmaceutical supply chain, with 25 of those focused on cold chain logistics. Jim shares his unique perspective on safeguarding product integrity, drawing from both professional expertise and personal experience as a parent of children with type 1 diabetes. They discuss the evolution of monitoring technology, best practices in compliance and training, the role of predictive analytics and AI, and how these measures ultimately protect patient safety.

About the Guest

Jim Bacon is a cold chain logistics expert with decades of experience across manufacturing, operations, sales, and technical consulting in the pharmaceutical and biotech industries. His work has focused on advancing best practices, implementing robust monitoring systems, and improving industry-wide cold chain acumen.