Are You Ready For A Grant-funding QA Audit?

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

Read Part 1 of this four-part series - What Is the Role VCs Play In Partnering With Small Biotech?

Peter Young, a 35-year industry veteran and executive-in-residence with AM Pappas & Associates began planning his presentation for this year’s BIO International Convention about 10 months ago. He wanted to create a session that included academia, industry, and finance participants and was worthy of your time. I believe he’s done so with his session Inventing Your Own Hub: Evolving Institutional Models for Translational Medicine, (June 16, 3:30 PM – 4:45 PM, Room 105AB). Below, he shares with me some additional insights (that aren’t part of his session) on how to prepare for a QA grant-funding audit — all from a lesson learned the hard way.

Life Science Leader: What is your advice for preparing for a QA grant-funding audit?

Peter Young: Experience is a hard but very effective teacher. For example, I was working with a company where I had a research team that was working on a very complicated technology. They all had academic backgrounds, and they were very confident on the science but very inexperienced on the development. This was a partially funded NIH program. For a completely unrelated reason to this company or the technology, the NIH division in question wanted to do systematic quality audits of all of its funded clinical-stage programs. So, they sent an independent quality team into the company — one of many that it did this with — for a QA audit. This was an intentionally rough and challenging experience. Within the first five minutes, you could almost see the blood drain out of the faces of the research team sitting around the table. During the three concentrated, painful days, they “got religion” when it came to downstream development and regulatory criteria they would have previously tended to dismiss. Sometimes, you don’t get to recover from those lessons, and that is an even harder and more bitter lesson.

The point of a good VC is to bring expertise to help you avoid making these types of mistakes. My management style relies on sharing a lot of stories of good and bad past experiences to inform and instruct. The virtue of the story is if you’ve got your ears and mind open, you can learn from somebody else’s experience as opposed to having to replicate it yourself. Go to school on what everybody else has already learned, instead of feeling you have to rewrite your own chapter in the biotech textbook.

Let’s say you’ve just found out that in two weeks you are going to be audited. How do you get ready? The reality is, if you haven’t taken a long-view approach to being prepared for an audit 365/24/7 then you’re probably in trouble already. Being ready for a QA audit starts by ensuring you have a QA function. If you’re making a product for use in clinical trials or further downstream, you need to have somebody who not only understands the manufacturing flow diagram and synthetic process, cell culture, or whatever process you’re using, but you need the QA expertise to help you design and integrate your quality system. What I find really fascinating about this as an organizational process is it’s dynamic. You’ve got something that, by definition, is moving across the threshold from research to development. That’s a process that is cumulative over years. It requires pretty very intimate collaboration. Sometimes it’s the same people on the R&D side of that threshold, and yet, it’s continually evolving, and has got to stay embedded in a consistent quality and regulatory matrix in order for the data ultimately to be useful and valuable.

Watch for part three of this four-part series of interviews with Young — “What Are Areas Often Overlooked By Academics Turned Biotech Entrepreneurs?”