Featured Outsourcing Editorial
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What's Wrong With A Transactional Relationship With Your Contractor?
8/10/2020
A deal between firms is necessarily an alignment of interests, at least over the term of the deal. There should be no expectation that the interests of two firms will be constant over time or that they will always be able to make a deal or collaborate.
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Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering
7/30/2020
Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.
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Incorporating Injection Molded Plastics In Medical Device Design — Initial Considerations
7/29/2020
Even a great component idea can be undermined by gaps in knowledge surrounding plastic materials, from engineering and design considerations to optimal procedures for turning that idea into a reliable plastic part that can be consistently produced, affordably and with high quality.
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The Case For Optimism In The U.S. Biosimilar Market
7/28/2020
In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S.
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Unpacking FDA’s New Guidance On Collecting Patient Experience Data
7/28/2020
The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.
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Critical Thinking In Root Cause Investigations: Are You Asking The Right Questions?
7/27/2020
As we write or review a root cause investigation, it is up to each of us to challenge the information we are given and see if it stands up to having a critical light shined on it.
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Lessons Learned From An Outsourced Validation Project That Came Off The Rails
7/24/2020
I was recently hired by a sponsor company to support initiatives related to computer system, information technology validation, and automation system validation. This article discusses my experiences and perspectives on this engagement, including best practices and lessons learned that other life sciences sponsor companies can apply in their interactions with their consultants.
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Why The Chronic Lower Back Pain Market Vexes Most Medtechs
7/22/2020
The chronic lower back pain market is one of the most difficult to break into, even though an estimated 35 million patients in the U.S. alone seek treatment, and a vast treatment gap remains between the go-to standards of conservative care and surgery.
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4 Skills An Exceptional Project Manager Can’t Survive Without
7/22/2020
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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Searching For Clinical Trials: How Can We Improve The Patient Experience?
7/21/2020
While adherence to ClinicalTrials.gov guidance is not optimal, the bigger issue is the widespread absence of patient focus in most brief titles and brief summaries.