Succeeding in Quality Consulting with Lisa Helmonds, VP of Operations at MWA Consulting

 


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Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. 

Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.

Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights. 

Show Notes: 

Lisa Helmonds on LinkedIn

MWA Consulting

BioMarin

Genentech

U.S. Food and Drug Administration (FDA)

FDA - Form 483 Warning Letter or Inspection Observation

FDA - Guidance Documents

Application to be on the show: From Lab to Launch

Qualio

Music by keldez

 

Transcript

We seek to transcribe the audio as accurately as possible. Please excuse any minor grammatical or misspellings. 

Robert: Hi everyone. Thanks for tuning in to another episode of From Lab to Launch. Today, we’re excited to chat with Lisa Helmonds. She’s the VP of Quality Services and Operations at MWA Consulting.

Lisa has over 30 years of industrial training in the areas of manufacturing and quality assurance in the pharmaceutical, biotechnology, and medical device industries. She also has extensive GXP knowledge and does work with several startups and large companies to implement or improve quality systems and procedures, so she 100% understands the challenge facing the industry today.

We wanted to bring Lisa onto the show to chat more about life as a quality consultant, the innovations she’s seen in the industry, and her advice to life science innovators and entrepreneurs everywhere, because she has seen it all. You’ll definitely get some useful takeaways from her insights. Hope you enjoy.

Kind of difficult to know where to kick this off because (I think) did we first meet in—it might have been 2016, maybe it was 2017?

Lisa: No, it was 2016 when I first started working with MWA. I can’t believe it’s been five years already.

Robert: Five years. Isn’t that insane?

Lisa: Oh, just because it’s warp speed.

Robert: There are so many things here that (I think) we could [...] into and spend a lot of time. I’m just wondering for yourself, Lisa, think what might be really useful to kick this off for everybody listening is maybe you could give me a better background for some of the work that you and the team at WMA do and how are you helping companies bring life-saving products to market and scale successfully.

Lisa: I’ve been in this industry for 30 years—both for 30 years—and I’ve worked with MWA when it was a young company, when Marion Weinreb first started the company. I worked for her as a consultant for 12 years, so have a lot of experience on the consultant side. Then she sold the company and I was hired by the new CEO, Bill Daniels; you know Bill. We did such great work. 

From where I started with Marion, we’ve been to so many companies and helped companies get their drugs approved. We did the support that the companies really need. We do everything from audits. We do hands-on, writing procedures. We do remediation work. We do a lot of work on quality and regulatory aspects of the companies that we work with. It’s a great company to work with.

Robert: What types of companies do you work with in life sciences?

Lisa: We work with all kinds. We work with medical device. We work with pharmaceutical biotech. Marion is really instrumental in getting BioMarin up and running. There’s been a lot of companies. Genentech. We work with the bigger ones and the smaller ones.

We focus on small- to mid-sized companies right now, and we really like that space, especially startups. It’s great working with startups because they just don’t know what they don’t know and it’s nice for us to be able to go in and kind of guide them, get them efficient systems set up.

Robert: I’m curious over those 30 years and maybe to clear reference still [...] 5 or 10, what are some of the biggest changes that you’ve seen?

Lisa: Definitely the use of technology platforms. In my day, we didn’t have all of this. Everything was paper. Now, the use of technology, when it’s done right, is really, really useful.

Robert: And are you seeing a difference in the actual profile of the client as well? You mentioned the systems your customers and clients use. They have been very much paper-based, but now we’re seeing companies get themselves hire edges and software company.

Lisa: Definitely, the software industry for this, I see a lot of small companies starting up trying to get the software, EDMS, and all kinds of different software out there. I’ve worked on large systems. I’ve worked on smaller systems. I tend to like the simplicity of the smaller systems sometimes, especially for startups. You don’t need all the bells and whistles that Genentech or a bigger company would need.

Robert: At the beginning you mentioned something about helping these companies get to market. They don’t know what they don’t know. Why is this so complex? If you’re making a drug or device—diagnostic or therapeutic agent—why is it so hard for these companies, in your experience, actually to get that humans can now benefit? Or animals, or whatever you’re serving?

Lisa: It’s difficult because our industry is very complex. We have a lot of regulations and I think that’s one of the reasons. We have constraints. We can’t just make a system and just use it. We have to get it validated. We have to make sure it’s the right system. It takes time and money. I think it really is a lot more complex in that regard.

Robert: Yeah. When I speak to people, both company founders who have now scaled successfully and people who helped companies bridge this, ‘The product works, but can we prove its quality? Can we actually get this approved by the FDA and the sister bodies?’ I often hear that, ‘I wish I knew this thing five years ago,’ or typically people in your role will say, ‘I really wished they hired me five years ago because we could have done XYZ differently.’ For anybody listening, we’re going to try shortcuts with that. I’m curious, how do you wish every founder or CEO or early founding executive team knew that would help smooth the path for them when it comes to getting that stamp of approval and that ability to sell?

Lisa: I think the first thing in some of the companies that I’ve worked with is that the CEOs come from different backgrounds. They might have a biology or biotech background, but they’re really focused on the financial aspects in some regards. I wish that they don’t know everything. There are people out there who’ve been there, done that, really can make their lives easier, and get them on the right path sooner than later. I find that they don’t start early enough on the quality side.

I worked for two startups in the 2010–2011 timeframe, and I was paper-based. It was crazy for me. I was focusing on moving the paper and getting things done versus the true quality systems and equality aspects that needed to be paid attention to.

Robert: I like the words defining for people listening, Lisa. Can you talk about these paper-based systems you’re actually talking about? These binders full of paper in most cases being dropped to desk, [...] to desk to desks [...] be together. Worth pointing that out because a lot of people find it hard to believe that in the 21st century, that was how this is being handled. How this critical documentation proves these things are safe and effective.

Lisa: It was really hard because even back then it was a virtual company. I had batch records from India, my company was from Singapore so I had all of this. I still had to utilize email. It was email and I got the printout. It was awful. It was a nightmare for me and I can’t believe that anybody in this day and age, in 2021 would want to use a paper system. I just can’t. There are so many solutions out there. 

Qualio was a great, simple solution to help manage all of that. Just even the follow-up, the training, and all of that stuff where you have it automatically done for you. You don’t even have to think about it. To me that’s great. [...] getting documents approved, it’s really…

Robert: Maybe let’s talk about the consulting business for a bit. You’ve been in this [...] for quite a while. How long have you been in the quality consulting arena?

Lisa: I was originally manufacturing for about the first seven years of my career when I got out of college. I started in quality in 1990. It’s been awhile and I liked being in quality. We do a lot of good. It’s a hard place to be. You’re always fighting fires, you always kind of make people understand how critical it is to do things in a certain way, especially with young companies who have a lot of development people. 

It’s great they need to be free and creative, but as we get into the regulated part of the industry, you have to do things a certain way. A lot of people resist that and it’s hard. It’s a lot of educating people that you have to follow, you have to stay within the lines.

Robert: And for people who have some expertise in quality and have worked in a couple of companies that might be interested in going out on their own to the big, bad world and helping other companies do better here, what are some lessons learned from your time consulting that you might be able to share for people who might want to get started on that path but hopefully avoid some of the initial mistakes that are all too common?

Lisa: Consulting is really there’s so much you can do and it’s a great place to learn because you have to like to do different things. You go from company to company and you learn so much, but I think what I would do early on is really commit to your area of focus, so build your reputation. Get out there, work with a few companies, and do a really good job so that you are called back. That’s key. Your reputation is what you have as a consultant. If you do a really good job, you will be successful in getting work.

Robert: Why do you think are some areas of focus right now that are particularly interesting?

Lisa: Definitely with the whole COVID thing, the vaccine area is really, really interesting. Integrity has been a hot button item for the FDA in the last few years, so before COVID. But keeping things moving in a company, advising them so that they can get to where they want to be faster. 

What I found in my career is that when you think you’re doing things faster, sometimes you have to slow down. What I find is that when people rush around, then they jump in, and they do things too quickly, they make more mistakes. It takes longer because then you have to fix the mistakes. You have deviations, [...], and investigations. That all takes a lot of QA time that, if you just slow down in the beginning and gotten the right resources, the appropriate resources at the beginning, you could have avoided all of that.

What’s funny is I just saw in LinkedIn this week a visual and the amount of money that’s budgeted for QA. I don’t know if you’ve seen it, but it had the pennies on the bottom of the jar. Then it showed the visual of after you get a warning letter or a 483 observation how big the budget becomes. If we could just swap that, do things right at the beginning, put the money where it’s needed to be, and do a phase-appropriate implementation, companies will be better off. It will be a lot cheaper in the long run to do things in a phase-appropriate manner.

Robert: I like what you said, a phase-appropriate manner. What do you mean by that?

Lisa: You don’t need all of the quality system elements when you’re doing a phase one clinical trial. There’s a guidance document. You definitely need the basics. You need documentation, you need training, you need oversight of your suppliers, but the depth is not as deep as if you’re going to phase two, three, and if you’re going to be in commercial. 

It goes in layers. You put in the basics at the beginning, then you look at how you need to implement the system for the next phase, and what things that are more relevant now that you didn’t need to do. It’s an iterative process. 

Robert: I’ve heard that a lot, actually, where people try to build their systems because if they’re to be regulated the need to have this figured out, but it’s three years before they will actually do it. And they might not actually ever even need it in the way they think because they’re so early on in what they’re doing. I think it’s a really interesting example of when it comes to some of these complex projects, we forget the basics. It’s the first thing we forget as humans; I’m not sure what it is.

Lisa: Yeah, it’s just human nature. But it is true. I found in my experience that the more complex you make everything, the more mistakes that are going to be made. Simplicity is really key. Make your documents simple, make things simple to understand. The more surplus information that you put into documents… 

People just need to know what they need to do and when they need to do it. I’ve seen some messed-up piece where they’re trying to train somebody in the procedure and that’s not really the place. You have guidance documents for that. You don’t need a ton of procedures. Again, keeping everything very simple and easy to understand for folks to do their job. Everybody’s busy, but if you have a clear procedure, it makes things much simpler and your likelihood of making mistakes is much less.

Robert: I guess this is all along the topic of what are things that companies and startups can do to help turn this perceived burden and something that actually helps to move the right foot forward. What else should people be thinking about as they’re getting started, to make sure that they hopefully don’t waste cycles going down the wrong path?

Lisa: I think just making sure you have the right resources and enough of those resources. We can put in quality systems. We can have all the greatest of ease. Actually, we’ve  seen it doing audits with a lot of our clients, their  CROs or CMOs. I just lost my thought. Can you repeat the question?

Robert: Absolutely. We were talking about some ways for people to do better. For example, like phased implementations, and why that helps you not make mistakes. You’re building air quality programs to get you to the marketplace. The question was, what else could entrepreneurs, startups, younger companies could do to help turn quality into something that’s actually an advantage for them rather than a hindrance as they try and grow?

Lisa: Definitely (again) stay away from paper. I’m amazed at how many clients still come to us that they’re on paper.

Robert: We’ve got to fix that, Lisa. We’ve got to fix that.

Lisa: Oh I tell you, I just don’t believe it in the 21st century. If I had had a system like Qualio 10 years ago when I was at the startups, I could have done so much more of the true quality work instead of chasing paper. Again, get the right resources. Get enough of those resources. You don’t need a lot, but you keep in mind that when you write all of these procedures, it’s not just having the SOP. You have to follow it.

That’s where people I don’t think sometimes get it. It’s like, okay yeah. We have all these procedures, but now we have to follow it, and that takes time. That takes a body to do that. That’s one of the things I think that really needs focus on, making sure that you get the right tools in place that help you keep things simple, and then you get the right people in place to make sure that you’re doing it right.

Robert: Speaking of people, how would you recommend people figure out when they need to bring in some external quality resources or quality expertise into the business? How do they decide between, let’s hire somebody versus let’s work with a firm like NWA Consulting?

Lisa: A lot of young companies use consulting firms. That’s pretty standard because, again, you don’t know if you have a product. A lot of these companies don’t have a huge budget to be able to throw money at it and get people at it. You get guidance. At a certain point, the sooner you get quality in, even just as an ad hoc ‘at what point do I do this?’ they can help you so that you’re not stuck at phase three saying, oh my God, I don’t have any quality systems in place.

And that happens, which is amazing to me is, oh my God, you’re at phase three and you don’t have any quality systems? That’s what I meant in the beginning when I said a lot of the CEOs don’t know what they don’t know. Starting off sooner with the basics and then growing those systems as you need to reach phase definitely will make it a lot cheaper in the long run. 

Robert: That’s super helpful. You’ve been in the industry for 30 years. You’ve been consulting for many of those. You’ve watched a lot of trends come and go. When you look at the next 5–10 years, how do you folks see the industry evolve and how are you thinking about that as a business?

Lisa: The industry is ever-changing. COVID has changed a lot of how we work. I think I do see more remote work and definitely getting products to market quicker. This whole COVID vaccine development was an amazing feat to have something get out there so quickly, have that vaccine. I do see that we can learn from this and apply what we’ve learned and what works to other areas of our industry.

Robert: I think that’s super valuable. Lisa, anything else you’d like to share for anybody listening, who’s thinking about following your footsteps and becoming a consultant into life sciences?

Lisa: If you really like to learn technologies, if you like working with people, it’s a great way to go. I’ve enjoyed consulting. I will continue. As I retire from actually full-time work, I will go back to consulting, taking projects here and there. It’s rewarding. Like you said, you meet so many nice people in this industry. Majority of the people want to do the right thing, so it’s a really rewarding place to be. You’re making an impact on everything you do. Yeah, I’ve enjoyed my career.

Robert: Awesome. For anybody who might want some help and is interested in reaching out to MWA Consulting, we’re going to add the website down below. Any other ways to recommend that people might get in touch?

Lisa: You can go directly to our website and submit your CV to us. Let us know what you’re interested in and what you want to consult on. We have a process to get you onboarded into our network. It’s right there on the website. Or you can just email me directly.

Robert: Awesome. Lisa, thank you very much for taking some time out of your busy schedule, working with all the clients you’re doing, [...] MWA to chat with us today. As always, it’s been a pleasure knowing you and the team for the last few years. I’m excited about what’s next and the word is lots of things coming down the pipeline. Thank you, again, for joining the show today. 

Lisa: Thank you. It’s really nice speaking with you again. You guys take care.

Robert: Absolutely.

Lisa. All right. Bye-bye.