Trials with Maya Z

Maya: Hello everyone! This is Maya Z and I'm together here with Tony Perez, one of my dearest friends and one of the most experienced clinical research professionals that I've seen and that I've ever met. Tony is a fortune of knowledge. It's hard for me to introduce Tony because he's been [00:01:00] working with both pharma and smaller, even the smallest biotechs as well, and has been included and involved in multiple advisory boards.

And many more things to say. Tony, let me give the word to you and introduce yourself.

Toni: Thanks, Maya. Well, I'm Tony Perez. I was born in Barcelona. I'm a physician and I am a specialist in intensive care, and I joined the pharma industry 36+ years ago. I devoted most of my life to the pharma industry in Switzerland, and also in Spain. And my main two areas of expertise are oncology and infectious diseases, or the other way around.

And I've been given work with large, large pharma companies, always in the headquarters and companies with the size of 80,000 employees to companies with the size of [00:02:00] two employees.

Since January 2007, I've been a consultant for different companies and nowadays I'm working for 4-5 and the headcount of all of their ranges between 2-10.

Therefore, I'm really heavily involved on a daily basis in small companies with all the good things and almost no one, but think about that because

Maya: Wow. That's good to hear. Most people actually see more challenges in smaller companies. But see, you are a true innovator and you get excited about starting new things and working on new projects. That's great. Actually, your working and being involved in that many smaller companies is the reason why I invited you to discuss because we had a lot of discussions in the past on all sorts of topics - [00:03:00] COVID-19 - we had such an interesting conversation back then. Today, I wanted to invite you and discuss, actually, what are the challenges of biotech companies when they're planning their clinical trials.

And we will focus today primarily on these smaller biotech companies, the ones that have up to 10 people, for example, because we discussed that with different sizes of companies, you face different challenges. But there are many, many, many, many biotech companies, the size of up to 10 people, who are now starting to think about their clinical trials or are in the middle of planning trials.

And we wanted to address some of their challenges. And as I said, you're a fortune of knowledge, so it'd be great to hear from you, which are the top challenges that you saw in the past, and maybe also tips on how they can overcome these challenges.

Toni: Well, if I need to summarize, there are 2. The main two that come to my mind are resources. With [00:04:00] small biotechs, the budget is in the hundreds of thousands at the very best, maybe single-digit millions if you are gifted, but they spend it over time, which means years. And the second is experience. In a very small company, there is no time to teach.

Everybody should know as much as possible in their own areas of expertise. You need to have your sleeves always rolled and to do everything. And it doesn't matter the titles, or the positions you had in the past. You have to do everything, which also gives you the freedom to create. You cannot blame any management or, any organic lab.

You are the backbone of the organic lab. That will be my two most relevant points, resources, and [00:05:00] experience when we speak about companies up to, let's say, 10 FTs.

Maya: Mm-hmm. Got it. When we speak about resources, how are they related to the planning of a clinical trial? What sort of resources do you actually need when you're planning your next trial or next phase, for example, when you're a small biotech company?

Toni: Depending on the company, you rely on a few investors sometimes in your network. Or maybe some companies that like to invest in small biotechs in organizations like all these European community organizations that provide grants and also in some grants that come from some, how can I say, some entities within a given country that tries to boost the science and the work from [00:06:00] some biotechs. These are the three main sources of resources. And then you need to - often when you start and when you plan a trial, very often, you know in advance that you don't have the money to pay the whole trial. Then alone the trial or when the trial progresses, you need to try to bring in more money because otherwise you already know in advance that you don't have the money to pay for the trial which maybe is going to last cost to cost a couple of years, and you know that you have money for maybe the first 9 months, 12 months, but certainly not for the total 24 months. And this is completely different from a big company. This is with regard to resources.

Maya: Yeah. So does it mean that what you're trying to achieve is you start a clinical trial and you hope for positive results that will allow you to go to the next investor and say, "Hey, I have these amazing results and yes, give me some more money to continue the research?"

Toni: [00:07:00] Yes. That is what is happening nowadays in all the activities I'm doing in all these companies. Then you need to start. There are these rounds - round A, round B, different rounds to raise money, to raise interest, to try to attract investors. That is daily life, which in 100% of the cases relies on the CEO who attends meetings, and rounds of investors in order to bring the money to the company to pay for a trial that is planned, and sometimes the trial that is already ongoing, but you already know that you have a limit.

Your horizon is no more than 9 to 12 months in most cases. You know that you have money for the next 6 or 9 months, but it is difficult to [00:08:00] think beyond that point.

Maya: Hmm. Yeah. Yeah. Makes sense. And you mentioned that the other challenge is the experience - how to plan a clinical trial. I've heard stories where CEOs of biotech companies are speaking with investors and they're pushing them, "Okay, but give me how much, like, give me the budget", but they don't know how to calculate the budget because they're not coming from, let's say, precisely clinical research experience.

So how do they overcome that?

Toni: In most of the cases, they try to at least bring to the small company people with experience and people who may help them in the branch of investors or people who may help them at the time to foresee what will be the total cost because it's gigantic. I can tell you that nowadays, the cost of a single patient, in some trials, we may speak about ranges from 50,000 to [00:09:00] 150 euros per patient which is a lot of money. Then, if you start thinking about trials with 100 or 300 patients, then you start a company in millions. When a few militaries, I told you that in these companies, they come in hundreds of thousands, maybe 1 million, 2 million at most, and then in all cases, what I realized is that the more experienced the staff of a small biotech is, the better, because, as everybody knows, experienced people have agendas, contacts. They certainly know what they know, and they certainly know that there are many things that they don't know, but they know whom to talk to.

Maya: How to figure it out?

Toni: And that makes things much easier, much faster. It is extremely important not to spend money on [00:10:00] people with our experience, because maybe at the end of the day, they're very expensive, but sometimes you cannot do that.

But that is probably one of, how can I say, the tips for success bring to your company, a small one. People with experience, everybody knows what should be done. Everybody is an expert and you don't waste time teaching about square one concepts in clinical trials or in the pharma industry, then usually you need to have someone good in finance, which probably is the main role of the CEO.

You need to have a physician who knows diseases and medicines and clinical trials, and then ideally the other one should be more scientific.

Maya: Mm-hmm.

Toni: And then from there you may try to find [00:11:00] people with an area that is beyond my knowledge, but I know that is very important, which is manufacturing and production.

This is a key area, which is extremely important. And then what you usually do is contract out data management statistics. You contract out monitoring, you contract out regulatory affairs, you contract out pharmacovigilance either using single individuals or contacting our company that can provide to you almost everything I just said.

Maya: Like a clinical research organization, for example.

Toni: Because sometimes they can cover everything from medical writing. They can cover all that I just mentioned.

[00:12:00]

Maya: I actually have two questions now. I'll start with the first one. I am actually running my own business. I know how important it is to have people, experienced people, but also being a startup, I know that sometimes you can't afford these people. So I wonder if in the biotech space, for example, it is a good idea if you hire experienced people, but maybe part-time, for example. If they're not full-time committed to this company, do you think that they will still provide goods, would it still be beneficial for the company even if they're part-time?

Toni: Well, I forgot. You're absolutely right. I forgot to say in all cases it's part-time people. [00:13:00]

It's almost,

Maya: Anything is working well?

Toni: It's part-time people and then everybody should know that all of them have limitations. They have limits. Because why? Because you cannot cover everything.

The main way to be successful is to hire external, experienced people in order to try to advance the program. And then there is a broad spectrum, a broad plethora of services companies that can be of, but, and then here is when you need to build a ranking. Of course, now we are speaking about clinical trials. Then, you need to try to contact a CRO or a segment - part of the CRO.

Or maybe freelance. Sometimes, the monitors are freelance, but [00:14:00] data and statistical performance is provided by another company. And then you contact a company with expertise in regulatory affairs. You contact another company with expertise in pharmacovigilance. That also has a problem because the more service companies that you contract out, the more they need to speak to each other.

And sometimes it's better to contract a CRO that you know belongs to a single system, a single unit, and then there are the secondary service companies in case you can afford to pay for something, which is nice to have, different than what I just said that is you must have for a clinical trial then we can speak about marketing, competitive intelligence, pricing, positioning, branding, [00:15:00] all these areas which are certainly important in biotech is extremely, extremely difficult.

Maya: Speaking about clinical research organizations, it's a very interesting topic. The dynamic between sponsors and CROs is, let's say, well-known. So I wonder, I've heard many companies saying, "Oh, we prefer the big CROs. Because they have it all and we can trust them. They have the experience."

But then there are the others saying, "We prefer the smaller CROs. Maybe they don't have everything, but they're more flexible and they can customize their services according to our needs. In your practice, actually, when would you recommend a big CRO and when would you recommend a smaller CRO, for example? Or maybe going with multiple vendors for different services? I know it's a big topic.

Toni: No, but I was just in real life yesterday on this topic and I was dealing with several [00:16:00] That may apply to the vast majority, but not certainly for everybody, is that when you are in small biotech, the top 10 CROs forget it, because you are nothing for them, you're nothing. They have much more personal in a, in a canteen than your company. Forget it.

If You go for very, very small CROs, they used to have limited capacities. They may not provide the whole full services and the quality could be good, could be not that good. Probably the best is to try to find a middle-sized CRO with less than, I would say, less than several thousand people, but not tens of thousands of people.

And also, if one day you have the opportunity to look at 3, 4, or 5 budgets for a proposal that you have made, you [00:17:00] immediately know which one it is by simply looking at the budget. Because there are CROs that are known to be 2-3 times more expensive than the average. Then the big CROs provide extremely good state-of-the-art services, but the prices are extremely, extremely high. Then my advice is, as usual, you need to contact for a clinical trial around 3, 4, or 5 CROs. Trimming limits them, either not the top 10, not the bottom 10, of course, and then something that really works, chemistry, and whether they have the real experience. When you have in front of you someone who says, "I was confronted with this situation 3 times last [00:18:00] year, you merely notice the body language, the words, the advice. Wow. He or she knows a lot and there are multiple examples where you immediately know when you ask for a given clinical trial in a given indication, it's not the same.

The one who says, "Yeah, we have done some, maybe I will pass to you some information. All you said - we have done all these trials, all these patients, all these phases, all these countries in these years, in this indication." Wow. This CRO knows what we are looking for.

Maya: I completely agree with you, but at the same time, I've heard of another perspective. Very often, in the biz defense meetings, biotech companies, especially the small ones, are to meet a very experienced team from the CRO. But that doesn't mean that this is the team that they're going to work with, and they suddenly end up with a team that hasn't experienced these things. [00:19:00] And I'm not saying that they're less professional or they'll do less work, let's say, let's put it that way. They won't put in enough effort. But, what you now said, yes, I'm impressed by their experience. It's not always guaranteed that you're going to get exactly this experience once you start working with the So, sometimes experience comes with the team, right?

Toni: I fully agree with you, but it also must be understood that it's not the same to be a small client and to be a big client. Let me also defend, this because I also collaborate sometimes with CROs, but sometimes the CROs are approached by a small biotech and the one who has the experience is the CRO, not the biotech. It's both ways. It's both. Then it is understandable that when you are in a small company, you ask for a bid for a single trial, it's not the same when you act on behalf of a big [00:20:00] pharma company, and you ask for a bit for the whole problem. Four phase 1s, three-phase 2s, and three-phase 3s values. And then the way you are treated is completely different, absolutely normal.

That happens everywhere in the world. And also, what I told you is a two-sided experience. There are small biotechs where there is no experience. Then the CRO immediately noticed that "Wow, they have no clue at all what to do. They ask very basic questions and also it creates some type of, how can I say, the mismatch between the CRO, or the other way around.

Then we need to understand that there are multiple scenarios and we need to look at all of them because there is no one size fits all.

Maya: Yeah, definitely. With clean files it's, it's a range. Yeah, definitely.

Toni: Fully agree with you.

Maya: And Tony, what [00:21:00] would be your advice if, let's say, you're a small biotech company? Your background as a CEO is not clinical research. You are new, you have this amazing idea, this great innovation, and at the same time, you don't come from a clinical research background. And maybe, or maybe not, you don't have someone on the team, for example, that has this background. But you really want to do this clinical trial and you're meeting these CROs and maybe you don't have this know-how internally, but you are willing to work on that. So what would be your tip in that case?

Toni: The best is to try to trust in those people who you give full confidence. What you say is true, and I've been confronted with this situation. I must say that in the majority of cases with a very good positive outcome, there are always exceptions. My advice is the same that I will give to anybody. [00:22:00] If you have the power, if you decide that you entered an area where you do not have the knowledge, bring one. Trust her, trust him, and follow her advice. Follow his advice. I would say there are many, many areas where I am actually ignorant and in paperwork, taxes, I sign, I pay. I don't ask. I trust. It makes my life easier. But it is true that sometimes you have newcomers who they believe that they know and make everybody's life difficult. But this is a general principle, okay? If one day you are a CRO and you have a very brilliant idea, but you enter an area that you don't know, bring people that you trust. Give them freedom and follow their advice.

Otherwise, it's immediately easy to perceive [00:23:00] that the CEO has no clue at all. And there are billions of anecdotes about that, but generally speaking, you need to, in the other one, you are an expert. Do your best. Try to explain everything. Try to demonstrate till one day people trust you and they say, "Okay, you know, do it."

I will try to do it. You need to also provide this kind of confidence or you need to gain this type of confidence from others. If one day I would be the CEO of an idea that I have no knowledge of, which will not happen, that is what I will do. I will bring to me people that I know, "Okay, I am here to help you. What do you need? Come to my office." Only when you think that I can be of help. Otherwise, you are experienced enough. Do it. These are the goals of the company. These are the limits. Let's try to work together. But I think that [00:24:00] this advice applies to almost everything

Maya: Everything. You're right. Yeah. You're literally describing what leadership means - to know, to lead where you know what you're doing, and then empower others that know more than you, to give you advice, and then guide you, in their areas in a way. So if I am to summarize, if you're a small biotech company, it's best to, of course, attract money, but if you believe in your idea, go for it. There are different ways you can get some money and then maybe plan for milestones. Maybe not plan for the entire clinical trial, but start somewhere and then prove that your idea is really a good one, and then continue. And then, yes, get some people, advisors, consultants, maybe even part-time, but get people that really understand their space and then trust your partners. [00:25:00] I also agree with you that sometimes it is hard to find the right business partner, the right clinical research organization, or any sort of other partners. But if you are to invite them to work with you, you better trust them. And I like what you said, actually, find a way to get this chemistry, this balance between know-how, personal skills, and yeah, you like each other in a way.

Toni: I'm telling you something it seems to me that you know even better than me because you also have your staff, you have a lot of workers. I don't think that I'm saying anything new to you, but you know, it's just to say whether we coincide also in this opinion among many others that we coincide.

That is true. At least my senior staff is people that I trust. They know what to do and I don't have time to teach them. They should be fully aware of their area of expertise. And then maybe there are other employees that you don't need to [00:26:00] be on top of. There are some organics, but it happens to you, we'll say every time that we speak, I know that you want someone and one is on board.

These are the rules of the game.

Maya: Go. Go and conquer the world. Exactly. Tony, thank you so much. I really hope that different stakeholders will listen to this episode and learn. Maybe not even learn, but just get some sort of validation of some of their questions on top of their heads. And I really hope that there will be even better collaboration between vendors and sponsors.

And at the end of the day, everyone wants the same thing. Better medicine, better treatment for everyone, and it's important to collaborate. Thank you so much once again, Tony.

Toni: Excellent. Thank you. Thank you.

[00:27:00]