I’d like to respectfully suggest the CEO should be responsible for an additional element beyond bringing science, people, and capital together.
Since most CGT companies ultimately have to develop and make drug products, even if via a CDMO, the CEO is also ultimately responsible for the strengths and weaknesses of the quality management system (QMS).
Why is a thorough understanding of the QMS worth the CEO’s time? Because a poorly constructed and overly prescriptive QMS:
1. Neutralizes good people by creating unnecessary rules that limit productivity and sometimes even company progress
2. Wastes time and makes inefficient use of precious capital
3. Ultimately runs the clock out on the opportunity to exploit good science.
A QMS can ultimately make or break a company. Through years of industry interactions via Wilson Wolf and ScaleReady, often viewed through the lens of my former career as a Quality Assurance Engineer at Honeywell, as the primary author of Wilson Wolf’s QMS, and now through my current lens as VP of Quality at CellReady, it’s clear that the CGT field has plenty of work to do to improve the efficiency and effectiveness of our Quality Management Systems.
But it need not be challenging.
We can jumpstart that effort by coopting the best QMS ideas of the medical device industry. The regulatory requirements are quite similar to those in CGT and the medical device industry is far more mature in creating and using a QMS that allows highly efficient product development and manufacture, while simultaneously attaining a very high level of patient safety. Therefore, a good strategy for CGT companies should be to extend their Quality unit hiring net to the medical device field.
In parallel, to help address this problem, we are developing a highly efficient QMS for use in CGT that utilizes medical device insights. When finalized, we’d like to give this QMS away to anyone that wants it at no cost. Our hope is that it can start a trend of evolution in QMS efficiency that allows CGT companies to maximize their science, people and capital and increase their probability of success.
LinkedIn is a marketplace of ideas, so it would be great to hear from others.
Building a strong team, in turn, builds a strong company. Tune's Co-Founder, President, and CFO Akira Matsuno recently shared his perspective at the STAT 2024 Breakthrough West Summit on the three crucial components of building a successful biotech startup.
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Start-up Founder | COO | Business Leader | Medical Device Industry | Changing the future of Intracranial Hypertension Diagnosis
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