Dr. Gorski – Choosing the Right Contract Research Organization (CRO)

Presented by Dr. Gorski on 28 April 2020  Watch the Webinar 

Thank you, thank you very much. And I am very happy to be kicking off our webinar series today. And thank you all for joining us. As the title of my talk is Choosing the Right Contract Research Organization, or CRO. My objective today is really to share with you some tangible exercises in choosing the right contract research organization. I just want to give a little bit more background on myself.

My 18 years in big PHARMA as a bench scientist, as a team leader in pharmacology I collaborated with several teams. So, that included chemists, safety, regulatory and even external outsourcing. When I left big PHARMA and then, I joined the global CRO I kind of sat on the other side of the table. So, I was no longer the client or the sponsor, but now I was the service provider. So, although some of my examples may be pharmacology biased, I do hope that the examples and the stories that I share with you today are not only relevant and helpful, and I really hope that they’re applicable to your search for the best fit CRO.

So, today’s webinar, the outline for today is we’ll go through what is a CRO, what are some of the services that they provide, a little bit of the market watch, the trends that are out there from 2018 onward to 2027. Introduce you to who’s who in the CRO world. And then, we want to get into the meat of it, which is checking the boxes before you commit, which are five characteristics that I think are important when you’re technically interviewing a CRO partner. And then, we’ll have some key takeaways and conclude with a Q&A session.

So, initially the pharmaceutical companies used to carry their own discovery work, along with every other element to get the drug to market. And I mean, soup to nuts, from the beginning all the way through to the end, aside from the clinical phases. And CROs were once really they were kind of thought of as a service company or a fee for service. And to be honest, in the 80s and 90s, it also had a little bit of a negative connotation. So, if you’re sending the work outside and you’re not doing any of the work inside, does that mean that now you’re going to be having layoffs or now you’re going to be downsizing. But clearly, that’s not today’s results. Nowadays, the research work required by bio techs and other pharmaceutical companies, they range from designing essays to planning and running the clinical trials, to even launching the product. And this is all done through outsourcing with CROs.

So, a contract research organization, it’s a company that provides support to pharmaceutical, bio technology and even the medical device industries. And this is all services that are done based on a contract basis. So, some of the specific services that you’ll find that a CRO can provide in the biological side, there’s animal studies, if they have a vivarium. Pharmacology and PK studies that perhaps you can’t perform in house. Toxicology studies, safety studies, ADME studies.

Chemistry, and this is big, chemistry synthesis, generating enough active pharmaceutical ingredient or API manufacturing, radial leveling synthesis. Formulation, drug product manufacturer, clinical trial manufacturer, perhaps there’s a formulation that you’re going forward with that’s going to be presented in humans that you need some outsourcing help with, or even expertise with.

In the clinical side, and this holds almost probably 60 to 70% of the CRO services is clinical. And that’s from phase one to phase three centers. And they carry all of the also product management along with it.

Regulatory, filing IND applications, which are investigational new drug applications, five 10K applications, grant submissions, nondisclosure agreements. These all fall under the umbrella of regulatory services provided by specific CROs that actually are experts in that area. And marketing, approval and distribution of a new drug. All services from end to end provided by a CRO.

And I promise the questions won’t be hard. There’s only two. I do have our first poll question. So, our first poll question, I promise there’s no wrong answers. What best describes the industry you currently work in? Are you part of a CRO company that provides services? Are you in clinical research, drug discovery, preclinical, academia or other? If you wouldn’t mind clicking on an answer.

Great. So, based on the results it looks like we have an even Steven kind of group here today. So, with our CROs, potential CRO… Sorry, the individuals that are currently in CROs, we have 15%. 20% in drug discovery with 25% in academia and 40% in other. We don’t have any clinical research folks with us today. Close that.

So, CROs, they can be international full service organizations or they can be very small niche specialty groups. They really do this to fulfill any… What the client’s requirements would be. Increasingly, contract research organizations or CROs, they become now more of a partner. They don’t just provide the technical support but they also provide strategic scientific support. In addition, CROs are really expected to make comprehensive services available throughout all of drug development, seen here. From the target ID, lead optimization, all the way through to marketing.

And consequently, the CROs are actually investing in building new scientific capacity. They have their own RND portfolio that they’re funding, and they really want to develop new expertise and platforms so that they have more capabilities available as a strong, strategic partner. For example, a startup that maybe was start up with mostly chemists and biologist or heavy on the chemistry. And they rely on a partner that may want to guide them through IND enabling phase and so on. Or if they’re a big PHARMA company and there’s a really big push to strengthen their early discovery pipeline, they need a larger screening library that they can’t keep up with. So, they’re going to outsource that.

And a virtual bio tech companies, that don’t have wet labs, they need animal work done or safety studies done and performed in large animals, they would outsource those. So, whether it’s a fill in or a gap in your drug discovery pipeline, there is an expertise that’s required. That expertise should come from a very trusted partner.

So, it’d be missed if I didn’t take at least a few minutes to put a slide in here to speak about this global pandemic that we’re really all experiencing. The COVID-19 shutdown actually may have an advantage, and we’ve seen a large swing actually to the CRO companies, which are allowing organizations to really kind of minimize any of the risks to their workforce while keeping preclinical pipelines active. And so, by doing this, they’re investing in external RND. And there was a survey just done in March last month by Science Exchange. And they said they’re going to follow up on this come maybe May or June. But in that survey they found that only 12 of the 368 preclinical CROs, global, said that they actually closed. That’s only 3% that they had actually closed and suspended operations during this pandemic.

The largest was 67% said that they were actually open and fully operational, with a 30% with a skeleton crew, partially staffed and partially operational, which likely means they’re probably not taking on new projects, but they are continuing work daily and continuing ongoing projects. And just to note that even major CROs, like Charles River Laboratories posted on their website March 12th, which was actually the first day that I was home with my family, that their site said that they will remain fully operational, staff stocked and supplying clients with products and services. So, there’s a lot of news out there with the CROs and how they are really helping out those organizations, those pharmaceutical companies, those bio technology companies from not coming from a stopping halt, but trying to continue the research.

So, a little overview of the CRO market. The entire contract research and development production industry has really, in its own right, evolved into its own major industry. They have their own landscape, they have a predicted 90 billion by 2027. So, they are growing at a rapid rate. In my opinion, and again I reiterate that’s only just my opinion, I think that that’s actually an underestimate. I think the way that this year is going with us maintaining so much virtual work at home, and the CROs open, I really think that those successful studies that people are outsourcing, they may continue to outsource, which could increase those numbers.

There’s also a big, huge growing demand for special contract research organization services. The new technology that’s on the horizon, Crisper, immuno therapies, CAR-T cells, bio specifics. This also influences the landscape of the bio tech and pharma drug development area. So, they need to invest. CROs are investing in cutting edge science. They need to grow their service offerings to facilitate the field. So, they need to be ahead, they need to see what is on the horizon so that they can have those capabilities available and continue to have those capabilities available as the drug development companies pursue their drugs.

So, who’s who in the CRO market? So, there’s a lot of names that you’re going to recognize. Leaders in the market, they can include a mix of public, privately held organizations. Recently collaborations by CRO companies with either nonprofit health organizations or even with government agencies. It really shows that the CROs just, they’re not clinical service providers anymore, but they’re truly actively and I’m going to pause on that, actively involved in the new drug development process.

So, some big names here, and this is a slide that I used just in December of last year. But a lot of the names are still on the same slide. They may have swapped positions, one or two spots up and down, but it really goes to show you the size and the amount of money that is… the revenue that’s in these CRO companies. And obviously the top one, and we’ve all heard of them, is Lab Corp. They’re giant, a giant CRO. They have been pretty much number one based on revenue, based on their service portfolio and on their share revenues. I’ll go in a little bit more detail of a few of these companies in the forthcoming slides. I just wanted to give you an idea of who are the players in the CRO industry.

IQVIA, IQVIA really they primarily focus on phase one through three clinical trials. They really operate in all domains of the clinical and post clinical services. Syneos Health, so Syneos Health, I think it was January of 2018, INC Research merged with Inventive Health and Inventive Health, their parent company was Syneos. So, by marriage, they became Syneos Health. They integrate pretty much all disciplines involving bringing new therapies to market. Anywhere from clinical to the commercial side for basically providing bio pharmaceutical solutions.

Parexel, number four on the list there, they have, again, a very strong focus on clinical and post clinical work. They’re a little light in the preclinical space. But again, if you remember from the slide before, there are 67% and that was in 2018. It was really clinical services provided by the CROs. PRA, PRA Health Sciences, again, clinical support trials. A little tid bit about them is I believe in 2018 in Asia, Bio Pharma Asia named them the best CRO in 2018. They’ve provided a lot of services to some 85 products that are currently on the market.

PPD, sitting there at number six. That’s Pharmaceutical Product Development. They’re a privately held organization. They’re the only one on the list actually. This company has a pretty strong portfolio, again, preclinical, clinical, post clinical and even some commercialization services. They’ve got over 40 service portfolio units and the fact that they’re private. In 2018 they were trying to remain on this list and by being very competitive and what is everybody else doing, acquisitions, mergers. They had an acquisition with Synexus, which is a patient recruitment company. So, again, they are investing in themselves, merging, trying to create portfolios, service portfolios so that they can attract other bio tech and pharmaceutical companies. Pretty much stay in the game.

Charles River, number seven, again a name probably most of you are familiar with. I think it’s the oldest company on the list here. I think they’re 1940s or maybe even the early 1950s. They’ve worked on probably 80 to 85% of the drugs approved by the FDA consistently year after year. They are global, 80 facilities, 20 countries, worldwide. We’ll have a little slide about them, just to go in a little bit more detail highlighting some of their assets.

Icon. Icon, not headquartered in Boston or North Carolina, which most of these are. Actually, they’re headquartered in Dublin, Ireland. They have a strong portfolio, again post clinical services. And to compete with Lab Corps and the IQVIA’s in the world, they’ve had a few acquisitions as well to it was IBM Watson, I think they have partnered with. And they’ve partnered with 100,000 Gnome Project. And they did this in order to expand their oncology research platforms.

WuXi. WuXi is the youngest on the list. They only, I believe, started operating in 2000. Their headquarters are actually in Shanghai, but they do have facilities here in the US. I have a slide that highlights some of their five core service portfolio units that they provide.

And then, finishing up this list is MedSpace Holdings. MedSpace, it’s considered a mid size CRO. Again, they provide services mostly for the phase one through three drug. And they’re also in the medical device development services area. This is a unique CRO that I just wanted to highlight because they’ve kind of stayed on this list and they’ve grown organically. They’ve invested in themselves. They have not gotten into the mergers and acquisition space that a lot of the other names on this list above them have. So, they have kind of just been around since around the early 90s and have really just continued to reinvest in themselves.

So, just a few slides highlighting, as I said, a couple of the companies there. Lab Corp, they just had their quarter earnings, I think, they’re calling February of this year on the right hand side. So, they had a really strong finish according to Adam Schechter, who is their CEO. It’ll be interesting to see how they make out in the second quarter, third quarters. They’ve been in the news as of yesterday. You may have seen it. Lab Corp has now a COVID-19 antibody test that was approved in the FDA. Self administered test, haven’t taken it yet. It’s being sold for $119. But they’re obviously the big ones in the game, and they are doing their part in order to help this global pandemic.

One of the key acquisitions for them was in 2014, Covance, which in itself is a $6 billion company. So, they really are leading the diagnostics, the comprehensive clinical laboratory services, really end to end solutions for developing and commercializing diagnostics.

IQVIA, again they were formally known as Quintiles. You may have known them as Quintiles before. They’re known as a human data science company. Again they focus on the phase one through four of clinical trials. They have the highest number of service portfolio units, which probably helps why they’re number two on the list. And they’ve recently launched, this was just earlier this year, AdvoCare. So, they truly believe in patient centricity, they really want to make sure that they can retain and make available for all their sponsors efficient patient recruitment’s in their studies to run the clinical trial. So, AdvoCare was one of their platforms they announced earlier this year.

Charles River, again specializing in a lot of the preclinical, clinical laboratory services. They have a very diverse portfolio. They use several animal models, several disease animal models. They’re very gifted in their surgical skills. They’re cross fostering across sites, I think, from a preclinical perspective is very good. They also supply biomedical products, and the one thing I wanted to highlight here for those of you in the animal health space is that they’re also a major key player in the veterinary CRO market, which obviously has a price value that’s high and attractive. But veterinary CRO market, Charles River is one of their key CROs.

And as I mentioned, they have touched several, several drugs that have been approved by the FDA and they do this yearly. So, Gen News actually was interviewing several CRO leaders earlier this year, and so Pete Gaskin here, who’s the senior director of Scientific Advisory Services at Charles River Laboratories. Great quote here, it just says that the number of small virtual bio tech companies is rising. They’re increasingly outsourcing work earlier. They have over 5,000 clients, many which are small and virtual. And again, there’s that word, they’re flexible, they’re adapting, that we want to continue to adapt our organizational design to make sure that we meet their needs. And in this space, we see an expanding amount of customers who want to use a single source for discovery and safety assessment.

And finally, just one more slide on the who’s who. WuXi, again, I said they’re only 20 years young. They offer the five core units here seen on the left hand side. A lot of the small [inaudible 00:21:03] biologics, medical device testing, cell therapy, gene therapy. They’ve also been in the news and obviously, headquartered in Shanghai, they were also forced to close and shut down. But they have been providing insight on testing solutions for COVID-19 epidemiological investigations, diagnosis, and have been doing their best, again, to help with this global pandemic.

So, I mentioned I want to kind of get into some of the characteristics that you might want to look at when you are interviewing, essentially interviewing, a CRO partner. And so, these are the five characteristics that I’m going to talk about, which are costs, quality, capabilities, customer service, as well as experience.

So, that’ll bring us to our second poll, which is really basically going to ask you what is the characteristic that you would choose, that you think that is so important when you want to choose a CRO partner? Is it costs? Is it quality of work? Is it capabilities, customer service or experience? You can just take a few seconds to click on one of those. I know there’s probably more than one answer, but if you could just choose one.

Excellent, quality of work. So, costs 15%, quality of work 40%, yeah. It’s true. All of these are what you look for in a partner. But quality of work is definitely one that I think we all agree is pretty important.

So, you have to do your homework before head strong going in and trying to pick a partner. So, you want to prioritize your needs before you commit. So, of those five attributes, which one do you prioritize? Which we just did. And so, I had the distinct pleasure of meeting Mr. Berra, actually several years ago. He had presented me with an award. I went to Montclair State University, I’m located here in New Jersey. He’s a long time resident and actively involved in his community and he was presenting me this award. So, I just thought it was interesting that this quote, it really resonates with me and particularly on this subject that we’re addressing today. So, you’ve got to be careful if you don’t know where you’re going because you might not get there.

And so, you don’t want a CRO company, when you’re sitting down to look about what’s going to be your best partner, you really want to be sort of in the driver seat. You want to know what is it you’re looking for, what are those qualities that you’re looking for and then, proceed down the list. So, my best suggestion is before you engage is that you always check out all your CROs that you’re interested in, look at their website, look at their capabilities first.

Products, services that they offer, what research phase do they concentrate in. And I mean, concentrate in, not just they’ve highlighted it. What are they really, really good at? What therapeutic areas do they have? What labs do they provide? Clia Labs, BL1, what kind of lab space do they have? What’s their Vivarium like, if they have one? What certificates, licenses? These are all part of things that you can actually do up front before, because it’s on the websites. So, you can actually do some homework before you start to choose and narrow down, say, five or six CROs that you want to actually engage with and interview with.

So, a capability of an organization, it refers to the way its people and systems work together. Individuals have competencies, while organizations have capabilities. Okay? The CRO must be capable of meeting the technical demands of your study. And their methods must be validated, and I bolded validated here. So, validation goes beyond, and I’m doing air quotes, we’ve done it once and it really looked good. Okay? So, that’s great, you’ve done it once, but I need to know that you’re going to be able to do this, say, 100 times before I’m going to have confidence in partnering with you.

If you’re using multiple sites, ensure that the capabilities at one site are identical to other site. Are they cross fostering all of their skillset? Do they have multiple people working at different sites? To you, it should be seamless, but it’s very important that you capture not only their capabilities, but their capacity.

So, I once had a client ask me, we had not signed any contracts yet. They asked about a platform that was available. And it was limited to maybe one or two assays a week, I’ll say. And I said, “We would be able to run your study.” And she asked me flat out, she goes, “But we’re a really small company, so if a Murk or a Pfizer or a Lilly comes around do we get bumped?” And I kind of looked at her funny because I thought that was kind of unethical the way that somebody would do that. But it actually did happen to them and that’s why they were actually looking for another CRO company. So, although they are small, they wanted to know that they were also getting the service that we would give to a larger company.

Quality control, so the quality of the study. So, there’s a saying that I have that I wouldn’t have someone else do it unless I could do or do it the same, I guess. And so, what you do in house and the studies that you can perform in house should be as good as you can get outside. Now, we know that that’s probably likely not going to happen. But you should expect some high quality, what you would expect from in house. They must have a process that provides quality assurance and monitoring. And make sure that’s directly linked to compliance with regulations. A CRO may have the right capability but they might not produce the highest quality work. So, that’s something that you really want to keep in mind is if they don’t have SOPs in place or they don’t have somebody checking the stock system or the shipping or check boxing when they’ve dosed animals or having the proper blood tubes when they need to collect blood. There should be something in place that has a check box that says, yes, we have quality control in place and we assure that all of these systems are in place and running smoothly. If they don’t, ask why they don’t have that.

You could also review any of their certificates. If they claim to have very good relationships with the USDA and IACUC and ILAC certification, ask to see them.

Experience, so we’ve, possibly all of us, have interviewed or at least have interviewed someone. We look at their resume. We skim down and we look at their experience, right? We want to know where they’ve been, how long they’ve been there, what they’ve done, and are they appropriate to take on the job description? So, you’re going to do the same for your CRO partner. You’re going to review the credentials and not just of the business development person who is discussing it with you. You can also ask to know who could possibly be on the project team, who are the specialist on the team, who are the people that are going to be running the team, how long have they been there? Do they have experience in the area that you’re interested in, oncology, whether it be obesity or NASH or immuno therapies. Do they have the experience and have they run it multiple, successful times?

Have they published their data? That’s another easy way to do it. So, you can Google, you can use Pub Med. You can go to clinicaltrials.gov. You can look to see if they’ve been published. You can ask have they published anything in posters, have they presented anything? Now, again, most companies may remain anonymous, so they’re likely not to put anything out there. But if a CRO company is invested in themselves and they have an RND platform, and they’re working to build a capacity, they might actually have it out there for a symposium or a lecture that’s either coming up or has been in the past. So, a good way to do that is just go under news or blogs or their White Papers or their case studies right directly on their website.

So, a CRO with an excellent reputation will always be happy to provide at least one or two references. So, I have one example. And again, I apologize for being biased in my pharmacology background. But, I was outsourcing a study and it was a noise sensitive study. And the study just didn’t seem right to me, and obviously we were virtual while we were talking about the studies and they were running them. And until I actually physically went to the CRO, I didn’t realize that they were actually moving the animals in the morning before collecting these basal samples. So, the technician was fabulous, they were skilled, it was great. They handled animals well, they bled the animals well, they did exactly what was on paper. But they didn’t understand that it was a noise sensitive study. And so, the animals actually hadn’t settled down. So, they didn’t realize or they weren’t experienced in that type of assay.

So, these are things, just again, it may be nitty gritty, it may be very granular, but this is your study. This is your baby. You want to make sure that your partner is the right partner to do the right job.

Costs. Be aware of unit costs and line items. So, you’re dating a CRO, you may be shopping around, you may get a quote. You may see line items, not just a total cost. Low cost proposals can be very attractive. It may not account for all the study specifications and it could lead to higher unexpected costs down the road. So, you want to always review the quote and always ask questions.

Ask for discounts. I’m not saying apply a discount code when you fill it out. But if you’re promising three studies or X amount of work they may be able to provide you with a discount on the final bottom line dollar.

A payment plan. You’re not paying for everything up front, are you paying it overtime? And then go, no go, milestones. So, this is kind of important too when it comes to cost. If you’re running a study and it could be anywhere from a three week study to a one year long study. It involves, let’s just say, blood draws or some diagnostics. If you go halfway through this study and you realize that you need to pull out of this study, are you now obliged to pay for the entire study? So, can you interject milestones? Where the first five months of the study are now… They’re prorated, you have them, you’ve paid for them, you want that data. But you now need to pull out. Are you obliged to pay for this full 10 month study? Again, just questions that you should keep in mind that if you’re interviewing to find out if the partner is right for you, you might just want to ask certain situations that could come up.

Communication, so I know I had phrased it as customer service, but I think communication is as much a part of customer service. All operations within a CRO, whether it be procurement or the business development, research operations, should all be transparent. And they should all be talking and linked with each other. This prevents duplicate activities, it prevents miscommunications. You don’t want study meetings where the team members don’t know your key study points. So, ask them how do you communicate?

There is nothing more uncomfortable than getting a phone, a weekly 30 minute teleconference, where you spend the first 15 minutes trying to get the new person up to speed about your study. Your time is valuable, their time is valuable, agendas, weekly meetings. They should communicate to you as often as you want to be communicated to. That could be weekly updates, it could be emails on the timelines, it could be just milestone markers. There should be SOPs in place if somebody leaves. If somebody who’s running your study, who’s running assay, who’s collecting the blood samples, who’s shipping the blood samples? Lee is. How does that impact your study?

As long as your study is ongoing and will not be impacted by the change, you want to make sure that you can reconsider the relationship. If there’s a high turnover rate, you may want to reconsider. This doesn’t happen that often, but again, just tips to keep in mind that if it should impact your study, you want to know ahead of time before investing in this partner.

And again, it is a two way street. You have to be upfront and you should be transparent just as much. CROs are experts in the services, that’s why you’re attracted to them. And the client or sponsor, you have knowledge, specific knowledge, about either your trial or your drug substance. Both sides should appreciate the value that each other brings to that side of the table. So, I would say there that communication is essential.

So, with that, I’ll just end with some takeaways. Do your diligence. I hope I’ve stressed that. Be patient. Some of these tips can go a long way to narrow down two or three finalists. Always exercise caution in your final selection. And remember that if you’re paying a little bit more for service, quality and experience, that you may… you need is often the way to go. So, you may get what you pay for. So, just remember that paying a little bit more might get you the quality and experience that you need.

So, with that, I thank you for your attention and I will open it up for any questions that you may have.

Thank you Dr. Gorski. And then, as a reminder, if you have any questions please feel free to submit them through the Q&A function at the bottom of your screen. So, our first question is… Yeah, I guess they are talking. Would you also talk about CRO on devices?

For medical devices, in the medical device industry? Yes. Actually, a few of those top 10 CROs are heavily involved in the medical device industry. It doesn’t necessarily have to be a specialty or a niche CRO, but I know some of those on the list, if you do glance through their website, have a lot of experience in the medical device industry. But the same tips will apply.

Whether it’s preclinical, clinical medical device, excuse me. That those tips, the communication, the quality, the work experience, those all still apply when you’re soliciting to partner with them.

So, along that lines, would you say that the criteria for choosing a CRO company would be the same for medical devices?

Yes, I would say. They may range from say, cost maybe, more than quality or experience or capabilities may weigh heavier. But that’s all in your corner and what you feel, again, prioritizing what it is that you need to get the best product forward.

Our next question, what services do you think are currently under provided by CROs and those you think will have the most growth in the next few years?

Hmm. So, obviously the vaccine world and the infectious disease world, and also the rare diseases. And I just say these because the last six months when I’ve been expanding and looking up the trends in the CRO companies and where big pharma is leading, I think that those are some of the areas where the CROs are going to have to jump ahead. The capabilities and to engage with those companies and the small startups. Not everyone’s going to have the expertise to develop a vaccine. Or they’re not going to have the expertise in a rare disease. They may have the expertise in the science, but they may not have the expertise to bring that molecule forward, say, as a drug. So, they would have to rely on a CRO.

For the next question, this attendee gave a hypothetical situation. Let’s say our CRO says that they can do a study in Cambridge for $1 million. Or they can do it within their own facility in China for $750K. Is that the same… That is for the same quality, and up to FDA standards. I guess what are your thoughts for comparing prices if they say they’re the same quality and up to standards, but different price ranges?

So, different price ranges, yeah. So, two different quotes, two different companies, but let’s say identical experience or quality? Is that how it’s pretty much written?

Yes.

So, you are going to find a different range in the quotes. So, a highly qualified, valuable CRO is going to price their studies for what they’re worth. There is probably some line items there, doing studies overseas, shipping, getting blood samples shipped back and forth or supplies back and forth or permits that are needed for international shipping. Those things might be underlying costs. I would look very carefully at the difference. And if cost is important and you feel you’ll get the same quality and delivery of the results, then you could probably go with the lesser study.

But it brings a very good point though, having one in the states versus now you’re doing a study overseas. I found there was really no discretion between clients when I was speaking with them, of whether they wanted it done in states or overseas. It really came down to the permits, the shipping. That was really a sponsor or a client’s decision whether or not they wanted to keep it within boarders or overseas.

Hmm. In terms of cost considered, change orders, amended, SOWs, are something to consider as well? When you are making changes to a study protocol… Oh, sorry, this is more of a comment than a question. Sorry.

No, and please share comments as well. Yes, please.

Let me reread that. Sorry.

Sure.

In terms of cost to consider, change orders, amended, SOWs are sometimes to consider as well. Take care to get your study outline as final as possible. When you are making changes to the study protocol, make sure you ask for the potential costs associated with the request to changes.

It’s a very good point. It’s a very good point. And I can tell you from experience, on both sides of the table, that sometimes you won’t even get down to that nitty gritty of actually designing the experiment to the final detail until you’ve really engaged and almost accepting a quote or signing a contract. That’s not to say it can’t be done, so that’s a very valid point is, let’s just say I go to six week study and I want to add on another two weeks. That’s something that should be discussed upfront and like you said, in the SOW and in the study design. You can always lay out options. Always put the options on the table.

Next question, what are your key advices for a CRO startup?

Ooh. That’s a great question. So, for CRO startup, well my first would be is look at your competitors, look at what their value propositions are. Look at their business plans. What’s going to separate you from them? What’s valuable that you can provide? What service you can provide? Obviously you can look at the market and you want to make sure that what you have is valuable, whether it be opening up a vivarium, or whether it be chemistry synthesis. I don’t think you’re talking about starting up a Clia Lab or a central lab for clinical studies. But that’s possible too. And again, I would say that you look at the landscape and just put down in writing your business proposal and see if it vets well.

Is there a database or resource to find relevant CROs?

A database for CROs? I’m not aware of one. That doesn’t mean there isn’t one. What I’ve typically done in my experience, at least for the last two years, is I’ve gone through my network and I’ve gone through obviously the internet, and I’m very big on Pub Med and Clinical Trials to see if they have experience or if they’ve been published and validated. And then, you always have their A reference or a company or someone that has used them, which you can always go back to refer to.

Startups are usually short on cash. Are there CROs that take equity?

I don’t have an answer for you, and I don’t want to say yes or no. But I would be happy to do a little digging and see if that’s true or not. Or if there’s someone else on the webinar that could also weigh in. Please, share that in an email. I’m not aware of it. I know they do plans. I don’t know about equity. Now, sharing a project is another thing, right? If you’re a startup and you need a certain assay developed, I know that CROs are very much interested sometimes, like I said, they’re investing in their RND. And they may share the costs to develop the assay because they may now use that assay going forward for other clients. And that’s just an example of where you may be able to get your answers or your assay or your results by sharing the development and having the CRO actually take on the work.

Next question, what are you seeing as far as changes, if any, in how startups that come to CROs are being funded? Do any CROs help with funding, such as funding channels, as an additional service that they can provide?

I personally am not aware of any. However, I would imagine that, yes, there are. Only because of the virtual, and I know the quote from I think it was Charles River, that there are so many virtual startups and bio techs starting that I can’t imagine that a CRO would not take advantage of those. That they want to be a part of that discovery research. It’s just… It would be something that I wouldn’t be surprise if they were starting to do if they weren’t already doing it.

Next question, WuXi [inaudible 00:45:34] project themselves as a drug discovery company. Do you see this as a trend for other CRO companies, or has this always been the case?

So, the reason I see it as a trend would be because of the quality of employees that they’re bringing in. They’re bringing in key experts, into their CRO in order to be one, to be obviously competitive with other CROs. But not only that, for their own investments, for their own RND development, for their own capabilities. So, I would see it as, yes, I think they’re becoming stronger in their own industry themselves because they’re taking the individuals that, like myself or other people, that were in major pharma companies and are now part of CROs because of their expertise.

Next question, there is a monkey shortage with various CROs due to COVID. Do you believe CROs will start to prioritize other diseases in the future or continue to keep COVID as a priority?

So, clearly any CRO that is capable of helping with this pandemic is, I would hope, doing so. They’re also engaging with NIH and government agencies in order to provide any resources that they can. Do I think that they will now possibly change their landscape? I don’t know. I don’t know if that will change. I think only the CROs that are capable of benefiting from it will continue to. But I don’t think a CRO that is not involved in, let’s say, developing antibodies or doing diagnostics is now all of a sudden going to go out and hope they get a piece of the COVID-19 pandemic. The reason I showed that slide earlier was just to show that those companies are now in the forefront helping out with the COVID-19 pandemic. But I don’t know if a company is going to… And again, it’s a business decision, to invest more in COVID.

And then, an attendee recommended that scientist.com platform has some sort of database for CRO and capabilities.

Excellent. Thank you for sharing that. Great. So, it’s scientist.com.

Yes. I believe they put scientist.com.

Okay.

Another attendee had mentioned that, I guess they do know some CRO companies that might take equity if the product/tech fits into their criteria for exchange of services or parts of their services.

Excellent. Thank you for sharing that, who shared it.

I guess another question is, are there CROs using artificial intelligence or machine learning?

I am aware of, yes, a few. So, artificial intelligence or the modeling, a machine. That has been now on the horizon for the past few years. I believe on the list, PRA is one of them that I recall is using modeling or machine learning to enroll patients and take databases, electronic medical histories and using them with current and past patients that are enrolled in clinical trials in order to make predictions for a… I want to say, a cleaner, safer study. A successful clinical trial. So, I would say, yes. I think they are going to be starting to evolve and going back to someone’s question before about what do you see on the horizon or trends? That may be probably one of them is the AI or machine learning for CROs.

I guess another question is, we are a small startup that needs to run animal studies. Do we need to hire a veterinarian to audit the CRO?

Very good question. So, no, not necessarily. So, yeah, obviously you’re a small startup. You may not have the vivarium. You do want to ensure that the vivarium, the credentials, the certificates and the technicians, look at their experience. Do they have… If we’re talking rodents, they’re not USDA, but if you’re working with primates or pigs or dogs, and they’re USDA, you want to ensure that they have a clean track record with USDA. They want a clean track record with the FDA. ALLAC accredited. They probably will have their own IACUC committee for the welfare, animal welfare. So, you don’t necessarily have to perform your own audit. I do know that large pharmaceutical companies will have their own veterinary staff go out and audit facilities for the purpose of approving that a site can be approved in their animal procedure statements. But it’s not necessary for the startup company. But it’s a really good question. You should be aware of the vivarium, the standards, any accreditations that they do have.

All right. I think that’s all that we have for Q&As.

Great.

So, I just want to say thank you again, Dr. Gorski for coming on this webinar and for speaking about CROs. And I just want to thank everyone who joined us today for joining today’s webinar. And then, we hope you have a wonderful week. Our next webinar event with Sun Stocks will be called Create An Effective Bio Tech Pith Deck, which will feature Dr. Anthony Schwartz. And that’ll be on Tuesday, May 6th at 1:00 PM.

In the meantime, please reach out to us if we can assist in any way. And I just want to thank everyone for joining us. And I hope everyone stays healthy and safe.