In this blog posting we share with you a recent conversation we had with Lenore Coyle, the President of Eurofins | CRL, Inc., recently acquired by Eurofins. CRL (Clinical Research Laboratories) came onto our radar as a result of their recent interaction with ClinicalBid, and given their unique clinical research areas, we couldn’t help but want to know more.
When we say “unique”, we mean it, however we don’t want to spoil the surprise, so enjoy this conversation with Lenore and be prepared for a couple of interesting twists!
|ClinicalBid:||Good afternoon Lenore. I hope all is well there in Piscataway, NJ. I thought we would start off by asking you to share a little bit of history about CRL, to give us all some perspective.|
|Lenore:||Certainly, CRL was born in 1992. Basically, we had two principal owners at that time. They were consultants in the cosmetics and personal care testing industry. They would work with the bigger companies in the area to outsource some of the testing that those companies needed for safety and efficacy testing of their products. During their consultancies, they found that a lot of the third-party laboratories had some shortcomings and decided that they were going to start their own lab to address these needs. They started very small with basic patch testing, just to look at safety like irritation and sensitization on the skin, for topical products. From there they built a portfolio of different types of testing that are core to the services we offer today. Everything from basic safety testing to more advanced evaluations like efficacy testing for claims substantiation.
Products you see on the market that claim anti-wrinkle properties or have an SPF value listed on the label, Eurofins | CRL, Inc. provides that type of testing for products in the personal care and cosmetics industry. In September of last year Eurofins, which is mostly a European-based company, heavily in food and environment testing, was looking for a way to break into the cosmetics and personal care testing market in the US. After considerable time vetting various options, CRL came up at the cream of the crop so they acquired us. We are Eurofin’s first clinical testing laboratory for the cosmetics and personal care industries in the US. We are really excited to be part of the company and are coming up on our one-year anniversary.
|ClinicalBid:||Your planning a party, right?|
|Lenore:||I really haven't had time to think about it. It just dawned on me that it's almost a year. A year just goes by so fast.|
|ClinicalBid:||I’m sure. A year can go by pretty fast. In researching CRL, you clearly have expertise in a number of areas; safety, microbiology, photobiology, cosmetology just to name a few. In terms of workload, what are the top three areas CRL tends to focus on?|
|Lenore:||Most of our testing is split 50/50 between safety and efficacy testing. A lot of times when we bring a client in, we will start with the safety projects, which are really, you know, the first hurdles. We need to make sure the product is safe and that it can be used on consumers without issue. Then once they have that safety profile built for their products, we move on to talk a little bit about special things that they can put on the packaging and be supported through clinical testing. Like what's going to draw people's eyes. For example, if a product is about anti-aging, if they're moisturizing, if they firmed the skin and things like that. We really do work with some clients from beginning to end.
It's really exciting because we get to see a line from start to finish and sometimes even get to know what it's going to be called when it's on the market. When the product hits the market, we can look for it and say, “Hey, that label claim is from the testing that we did. Isn't that neat?” Or that percent increase in firmness was from that study that we did. It's exciting for us to be able to look at products and say that we were a part of it.
|ClinicalBid:||Interesting. We all see those commercials on TV. They talk about getting rid of this wrinkle and getting rid of that wrinkle etc. It makes you wonder how much efficacy testing they really do. So you're one of those companies that really makes sure that they're not making false claims and doing false advertising. Not only are you protecting the consumer, but you're protecting the company because they're not going to have the someone sue them for false advertising.|
|Lenore:||Right. That Is a large part of the service we provide. You can't just go out and say whatever you want about a product. When I first entered this industry over 20 years ago, I understood on the drug side, but on the cosmetic and personal care side, you would just hear some of these claims and thought, “Wow, that can't even be possible! How do you even test that?” Coming into this arena, it's interesting to see that there are instruments and methods to test, and there are ways to question your panel to see if they're really getting the benefits the label claims.
These companies have to have solid data to back up those claims. They can't just make broad stroke claims about products and expect that information be out there in the public and no one to challenge them on it, including not just the consumer but other competitors. Companies will challenge other companies and say, “Well, you know, I'm not sure that I believe that claim. I would like to see the data on that.” That’s a whole other realm of who can challenge who, and what comes out on a product label as far as claims.
|ClinicalBid:||I can just imagine what the women's moisturizing market must be like in terms of competitiveness. It must be insane.|
|Lenore:||Absolutely. And it's creative marketing, but you know, it all has to be based on science and/or consumer perception or testing.|
|ClinicalBid:||Creative marketing. Nicely said. So you've got your traditional line. What's the most recent line of services that you brought on?|
|Lenore:||The newest trend we're seeing coming out of the industry are cannabinoid-based products. It's interesting to see the transition into the consumer care realm because obviously going from recreational use to medicinal and being legalized in some states versus others, makes it very tricky. Companies have definitely wanted to capitalize on some of the skin benefits of having these products infused into their topical products. We, as a product testing service, are asked to test these products but there is a legal limit, in terms of the dosage. We are definitely dedicated to making sure that the products we test are within those legal limits. The products are tested to make sure that the ingredient levels are where they should be. We do this to protect our panelists and our clients. That's really where we see the industry going. Almost every blog that I see has someone looking for someone to manufacture, make, sell, take cannabinoid product and, and infuse it into something.|
|ClinicalBid:||Roughly when did you start to see the cannabinoid requests start?|
|Lenore:||Probably, I would say at least a year ago. The next biggest thing is the skin microbiome, which has been around a little bit longer. Looking at how the products I apply to my skin impact the microorganisms that live on and in our bodies. That's something that a lot of companies want to really wrap their heads around and are speaking heavily to the consumers about.|
|ClinicalBid:||It must be very hard to do since a participant’s microbiome is potentially affected by their daily habits.|
|Lenore:||Certainly. We try to address this with a large sample size so that we make sure that we're getting a good cross section of the population, different ethnicities, different ages, and environments. I think just even having a good benchmark of what the skin microbiome looks like in general and mapping that out, it would be like mapping out the DNA sequence. It's a very big project. I know the industry wants to go there and I see a lot of discussion about it.|
|ClinicalBid:||Interesting. I do recall reading about certain types of skin diseases be attributed to changes or deterioration of the skin microbiome. The thought of trying to get such a trial right sounds daunting.|
|Lenore:||Right. And adverse factors can be so transient. It could be just the environment that you're in for X amount of time. It's really a hard thing to get a baseline read on. Those are the big questions on our industry that impact formulating products. Simply knowing what that condition to begin with and what different facets contribute to a range of conditions like acne to skin aging to photo damage and the like.|
|ClinicalBid:||Wow, that’s amazing to think about. I’m curious, you’ve been at this for over 15 years. Care to share with us some of the more interesting projects you have worked on.|
|Lenore:||Yeah, some of the ones that always pique the interest of the lab staff are definitely the one-off projects that involve odor of any sort. We do underarm odor studies and foot odor studies. Our staff are very professional but understandably, they are not their happiest days at the lab. Those are definitely studies that are interesting. We make people sweat and make them smelly and then see if the products actually protect them from that odor.
I remember when I first started here, we tested a female condom, so that was interesting. I don't think I've seen many of those on the market, so I don't know how well that took off. That was something I was involved in as a lab technician and I found very interesting. So those are a couple areas that kind of make us chuckle a little bit and go, “OK, well at least people are kind of thinking out of the box and thinking of new ways to tackle old problems.”
|ClinicalBid:||It’s funny. I never know what people are going to say when I ask that question, but I can certainly say I was not expecting to hear the phrase “female condom” today.|
|Lenore:||Glad I surprised you!|
|ClinicalBid:||Thank you though. You certainly did. Obviously with ClinicalBid we're all about trying to make this environment a little more efficient. You've been doing this for a while. You've seen a lot of good protocols, a lot of bad protocols, a lot of good trials, a lot of bad trials. If you were to give advice to any Sponsor/PI planning a trial, what kind of best practices or common mistakes would you advise somebody to either adopt or avoid?|
|Lenore:||Where we see the biggest disconnect is timing. The race to market is so fast because in the cosmetics industry, it's much shorter timeframe versus the drug industry. It’s sometimes eight months from concept to launch and that's really just not enough time to build in all the testing needed. I would definitely advise clients, if possible, not to be in a big rush, which a lot of clients are.Take the time to talk to their CROs to ask how long a study will actually take to execute. I think if clients were a bit more prepared with the information from their side of the table with study details in advance of presenting a project to our lab, we can in turn be better prepared to walk them through their project with respect to timeline and budget. This communication is so valuable to us to really be able to direct them in the right way.|
|ClinicalBid:||So preparation is key, correct?|
|Lenore:||We really have such a wide range of clients. We have the small mom and pop companies (more commonly known as “Independent or Indy Brands”) that may have a family product that they want to get out there. It's their grandmother's recipe from Greece for skin cream and she has beautiful skin. We have the large companies who've been doing this for years. And even within this spectrum, we still see different levels of preparation, knowing what you want to achieve is so important in achieving it.
Having trust is super important. Our staff is really built from the ground up. As I mentioned, I've been here for almost 15 years now. And I started in the lab and then moved into sales and then moved into running three labs across the country. I remember what it's like to be the one putting the probe on the skin, measuring the moisture content, and working directly with our test subjects. From this experience, I can work backwards from a client trying to develop a study saying, “You really want to design it like this….”
Many of our staff have been built from the ground up, started working in receiving, logging, products and are now managing our lean process across the board. We’ve really invested in our people, which I think makes us different. Our turnover is quite low. People stay and we try to empower them and recognize talent when it's there, recognize what we can build on. We have people who've been in the industry for 15-20 years who have seen it all. That creates a foundation of knowledge as to what we can do for the client. With that in mind, the more information the client comes to us with, including timing, budget expectations etc, the more on target we can be about the testing program that we can build for them.
|ClinicalBid:||How many people work at CRL specifically?|
|Lenore:||We have three sites. One is in Piscataway, New Jersey, one's in Austin, Texas and one in Winston Salem, North Carolina. And across those three sites, we have a staff of 112.|
|ClinicalBid:||What is your study/work calendar like on an annual basis?|
|Lenore:||Our panelists are a little bit scarce in the summer, so it's a little bit harder getting people in the door because everybody's away. Our study schedule was definitely a little bit lighter in the summer months than it is during the winter; but we run studies of all different sizes and time span. So we run one-day studies, 12 weeks studies, year and a half studies. There are constantly different studies going on in different departments of the building and across all three of our sites on a regular basis. And almost all of our studies are based on panelists. We have people coming in and out of the building constantly. It’s a very busy atmosphere. We have clients onsite auditing us, monitoring our studies. Our clients really get to see what we do on a regular basis. We have an open-door policy and clients come in. They're here as long as they want, whenever they want. If they want to see their subjects, they're welcome to do that.|
|ClinicalBid:||What’s the largest study you have done?|
|Lenore:||We have just completed a 12-week trial on 220 women for an anti-aging regimen.|
|ClinicalBid:||I’m sure my wife would love to know what that product was! I’m also pretty sure you can’t tell me. Oh well. Stepping outside your role for a second, if you could do anything to change the industry that you work in. Something that would perhaps move the needle. Any ideas around that? You've been doing this for a long time.|
|Lenore:||It would be great if companies we worked with weren't afraid to talk about budgets and timelines. I've been a client too. I've worked for Unilever. I've been the one placing the studies at this lab, so I understand it. It’s like the clients feel they're giving away some type of leverage if they talk about what their budget is. Without open conversations, it just produces more churn back and forth of study details instead of just coming right out and saying where they need to be.
For an efficacy study, I can design 10 different studies with that budget. I really just need to know what that budget is and know what you want. I think just having that transparency with the client would be so helpful. Some clients are very open about it and some aren't. I don't know if that's something industry-wide that you could ever make a sweeping change. I just think it's important to have the conversation up front about the budget and timing.
|ClinicalBid:||Excellent! This has been great, very informative. As we wrap up so I can let you get back to your important work, is there somewhere this fall that people can meet you, walk up and shake your hand?|
|Lenore:||Absolutely. We will be at the Sunscreen Symposium 2019 at Disney in Florida from September 12-14.|
|ClinicalBid:||Well we encourage everyone to go out and meet you. I am sure you have the smoothest hands in the industry, with all of that product you try. Again, thank you for your time. I am sure our readers will find it very interesting and compelling.|