Let's Talk Quality17 Maalis

Lessons from Building Quality in Start-Up Cell Therapy, with Rex Ready

If you are the first quality hire in a startup, your job is not to build everything at once.

Your job is to build the right things first.

That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality.

A few practical points he shared stood out:

· Follow the path of the product

· Understand the patient experience

· Focus first on what directly affects patient safety

· Build procedures around processes that already work

· Prioritise quality investment based on stage, modality, and risk

In early-phase environments, it is easy to create a long list of things you would like to have.

An EQMS.

A fuller audit programme.

More formal vendor oversight.

A bigger team.

All of that matters.

But not all of it matters equally on day one.

Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.

That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.

A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.

Timestamps:

(00:00) Introduction

(02:30) From Funeral Director to Biotech: A Unique Path

(05:47) Early Experiences in Quality Control

(07:26) Leadership in Quality: Building Relationships

(09:57) Vision for the Future: Drug Development and Quality

(15:04) Building Effective Relationships in Quality

(17:59) Prioritizing Quality in a Lean Team

(22:58) Planning for Future Growth in Quality

(28:01) Reflections on Cell and Gene Therapy

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