ARTICLES BY CHRISTOPHER OHMS
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The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond12/2/2024
These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
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3 Focus Areas To Transition From Clinical To Commercial Readiness11/12/2024
Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.
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Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product's Labeling & Shipment10/14/2021
When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse.
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Design Thinking: A Shared Methodology Between Sponsor And CMO To Benefit Patients9/15/2020
Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.
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4 Skills An Exceptional Project Manager Can't Survive Without7/22/2020
Project manager can mean many different things to many people. To some it means passing a PMI-accredited test and being knighted into project management. To others it means running cross-functional meetings, issuing and following up on minutes and action items, and managing GANTT charts. And to others it means meeting key project milestones and budgets.
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COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain3/26/2020
To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.
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The 5 Pillars Of Clinical Trial Material Management2/25/2020
Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.
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The 4 Most Important Elements Of A Successful Sponsor-CDMO Relationship1/28/2020
When a sponsor contracts with a manufacturing organization, it takes on oversight beyond that within its own organization. These understated considerations play an important role in a successful relationship.