bioaccess.™: CRO. REGULATORY. COMMERCIALIZATION

View Original

Episode 76: Mona Oliveira, Founder and Co-CEO at BIOLINKER

See this content in the original post

Mona Oliveira is one of the creators and founders of the startup BIOLINKER, which in 2019 was awarded as one of the TOP 500 best startups in the world in the area of biotechnology for the project she coordinates. Double Ph.D. in Biochemistry and Nanotechnology from USP (Brazil) and IJS (Slovenia). During her academic career, she has accumulated awards and honors for performance and scientific excellence, publishing in annals and journals of international renown. Currently, he is Co-CEO of BIOLINKER acting in scientific operations and negotiations. After three years of foundation, BIOLINKER was approved for several accelerations and closed contracts with significant industries and institutes in Brazil and the world and had been achieving its goal of revolutionizing the way of making recombinant protein in the world.

BIOLINKER is a solutions company for the synthesis and purification of recombinant proteins. You design the protein and we produce it for you in a fast, practical, and high-quality way. We operate in the pharmaceutical, food, and academic markets.

Watch the video

See the episode’s transcript

Julio Martinez-Clark: (00:00)
Welcome to the LATAM Medtech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Today our guest is Mona Oliveira. She is one of the creators and founders of the startup called BIOLINKER in Brazil, which in 2019 was awarded as one of the top 500 best biotechnology startups in the world. So I'm very pleased, Mona, to have you here it is an honor to speak to you today and to find out from you what experiences you've had in Brazil, what best practices you can tell our listeners and for newer companies outside at Brazil in the US or Europe. Brazil is kind of a mystery. It's a huge market. It's a sexy country but it is difficult to navigate. It has this reputation of, it's a very protective country, you have to spend a lot of time, the bureaucracy of Brazil and all that. So I wanted to talk about all that today. So let's get started, Mona, how are you doing today?

Mona Oliveira: (01:27)
Thank you for the invitation. I'm very happy to be here to tell for all about how it is doing here in Brazil, how it is the due business in Brazil. It's like a very big adventure to be here, but it's my country, so I know a lot of things about here. It's, it's amazing too.

Julio Martinez-Clark: (01:57)
Yeah. I'm sure, I'm sure you have a lot of accumulators experience that you wanna share today, and I appreciate that. Thank you again. All right, Mona, so let's get started talking about your journey. How is it that you got to where you are today? How is it that you got to start BIOLINKER? What's the story behind all that?

Mona Oliveira: (02:15)
All right. I am an academic, I am scientist. So I starting my journey to be an academy, learning a lot. I did medical veterinary for graduation. After that. I did master in biotechnology and PhD and biochemistry nanotechnology. It was a double degree between Brazil and Slovenia. So I went to Slovenia and then everything changed in my mind. Since the beginning, I loved to do translational science. Like I want to do, do applied science to change the world. I think every scientist love this idea, but someone's like more theoricall but I really appreciate to do some applied science and in Brazil the scientist professional, it's very defficult to be a professional scientist, it's a close place. There aren't a lot of position in industry. It's always in university, the position to be scientists, and then you need to be professor too. I love both things, but when I went to Slovenia, I married a Slovenian guy, and then my life changed a bit, and it was the point that I learning about companies, startup companies, startup ideas and startup accelerations process and I always have a lot of ideas but in that time BIOLINKER borned. I starting to make the process to accelerate and get money for BIOLINKER and we got an investment for buyer. They want to invest $100,000 on the idea of BIOLINKER And for me, this was like opening the door. It was a new world, even doesn't know how to do PT and how to talk business. I was a pure scientist for lab in focus how to do things, not how to solve problems. it's a different way to solve problems but when you are scientists, you are focus in a process and how to improve process and how to discover new details and it was exactly that point that Biolink start but unfortunately we didn't went to this investment in Ireland. And then I apply in Brazil to get money and BIOLINKER back to Brazil, and I come in with my family and we start the company here in San Paulo. So we got a lot of investments here because we are only the only company in Latin America doing this. So what we do, we are working to accelerate the protein process. So we have a self repro expression systems. It's honor for the company. We develop a cell line, is that improve the process for protein expressions, protein folding, with toxic proteins. We have a very fast at moment for Latin America production of protein. So we did solutions since the dna to proteins, we designed the dna, designed the process to solve the proteins and increase the weed of expressions and facilitate to purification process in the end. That's very important because this is a responsible for 70% of fail in production of proteins. It's not a easy way, it's not, there aren't easy way to make proteins. Proteins very fitted, every different protein. You have a different protocol. It's hard need specialized people. So we are planning to automat this process in the future. That's why we got this word in Paris, and we still working on this now.

Julio Martinez-Clark: (07:31)
So the company is now a Brazilian company. You guys produce these proteins, right? That's the end product for the local market or are you also exporting to other countries?

Mona Oliveira: (07:44)
Yeah, we starting export now as I for other companies, but it is in beginning process to export.

Julio Martinez-Clark: (07:54)
Is it a market for that outside Brazil?

Mona Oliveira: (07:56)
Oh, yes. It's a huge market for only for service for proteins like we do it now, it's $63 billion the market but each protein can have your only market. We did antibodies expressions, for example, for one company, this antibody synthetic only have its own market like three billions for this or even more, 70 millions like that. For self protein expression the market is smaller. They are a new technology. It's 260 million the market right now. But it's growing and we want to be one, like, it's very nice. It's amazing technology. Like they are very fast to make protein, but it's still not scale process because of the arranges still expensive and we need to improve some points here. It's like a year project yet, we are working now for the future, but this technology, we enable a lot of things in the future, probably. That's amazing. I love it.

Julio Martinez-Clark: (09:26)
I can tell you love it. Yeah. So is it just you, you have a co-founder? What's the structure of the company? Yes, of course. We do not do anything alone. I'm this girl like that, I love people, I'm leader. I love to convince people and I have a amazing people around me. It's like, I always say that I am nothing without you and you nothing without me. Right now we are three partner-founders. But we got an investor recently in December. So he is coming to the partners process. But we are 11 people, 11 amazing people working every day to make protein for Brazil, of Brazil.

Julio Martinez-Clark: (10:26)
Okay. So let's talk about Brazil. Let's talk about the industry. Let's talk about the regulatory challenges, all that. What's the process within ANVISA? ANVISA is famous for being difficult, right? And bureaucratic and everything takes forever and corrupt sometimes, right? There's corruption. That's what people hear in the United States. In Europe.

Mona Oliveira: (10:52)
It's political.

Julio Martinez-Clark: (10:53)
Political, exactly. It's very political. So let's talk about that. What are your thoughts on ANVISA?

Mona Oliveira: (11:00)
Okay. It's like after Covid 19, they're starting to be more transparent and also they open channels to communication with. So it start to be more clear to me how they work and not. So it's like there are a lot of gossip about ANVISA. So, but I don't like gossip. So I starting to dig, dig in to discovery better. How does really work? Because it's like you're worrying about everything that say ANVISA or regulatory process. Even that I didn't have a education for that. So it's like that I'm learning every day. But it's like you said before, I hear a lot of history about ANVISA. Right now we are with new plant that is bigger for regulatory process. And then I start to talk in this tenure with the ANVISA, they answered me well, they do all instructions. For at moment my relationship is going well, and I really advise to everyone that come here trying to use these channels to communication directly with ANVISA if it's possible. Of course, it's in Portuguese, so you need to translate but they answer very fast in two days. Right now, I guess it's because of Covid 19, after Covid 19, they starting to make more fast process and more clear process too. And I am very happy because it's like, there are a way to discover better. You don't have a lot of informations on the website, but any doubt you go in the channel and writing and they answer you.

Julio Martinez-Clark: (13:24)
Yeah. I found that very weird. I spent about an hour, hour and a half or so looking for something for medical device regulations and for the CADASTRO and REGISTRO and I couldn't find much information. I found more information in English than in Portuguese. I mean, from other sources not from ANVISA. So anyway, but your product is regulated by ANVISA So you've gone through the regulatory approval process of your manufacturing. How does it work?

Mona Oliveira: (14:09)
Right now, we are regulated for CT and E bill, that bio, bio safety, they call National Center of Bio Safety Security in Brazil that they regulate all ogm, our organism genetic can modified that we work on. So we have this number and everything and conform it with them. And any other product we do they know for ANVISA, we starting to have some products now to start to be regulated for ANVISA. That's in the field of KY process because after covid 19, the company was cat up for, to work into to do covid 19 testing. So for this kind of product, we need ANVISA registrations. That's why I started to talk with ANVISA but it's in process. So I would say that for now, my experiences is going well, they answer me back. For example, I didn't know. And then there are any information about how many tests you need to do to validate your test and Anvisa, for example. So I wrote, then they answer me with the number and the process, and it was very clear for me. And then it was more easy than people talk to me before. So I really advised, just talked with them directly. So that's, trying to talk directly and also in Brazil it is a cultural problem, when you don't have this regulation very clear, the problem is even the people that work inside that sometimes doesn't know how, and then they give you information wrong or one people say, yes, you can do. Other people say, no, you cannot

Julio Martinez-Clark: (16:36)
Contradictory information inside the agency

Mona Oliveira: (16:38)
Inside the agency, yeah. This is complicated a foreigner. It's crazy. They say, no, it's not possible.

Julio Martinez-Clark: (16:50)
Wow. Interesting. So, I guess there are plenty of regulatory consultants in Brazil. If a company wants to do business in Brazil, they should probably hire the services of a consult to deal with that, trough ANVISA. So let's talk about doing business in Brazil, uh, in general, starting a company, having employees. How is it, I mean, is it difficult? Is it, is it bureaucratic? what do you think about it?

Mona Oliveira: (17:29)
Yeah, for open a company here is very fast, the process. I think still a problem, the fees, the accounting process is crazy. Yeah, I'm p d, but I do know nothing about this, I'm still learning about. it's a very complicated, the accounting process, but there are plenty of counters that work into you with different prices. It's very important to know a little bit about, because they do some wrong process too. So I really advise, I have a tree before I finish with one.

Julio Martinez-Clark: (18:30)
Really? You tried three accountants before landing over one that you use today. Wow.

Mona Oliveira: (18:36)
Yeah. And then still we are used today, doesn't know how to, because we are working with, government invest projects. So there are different process to the declarations, and they don't know, and they don't know about my product. That's really innovated, and I have a issue with this, but if you are working with not innovative process, it should be easier.

Julio Martinez-Clark: (19:07)
Okay, so you are receiving funds from the Brazilian government and is there a lot of funds? Is there a lot of support from the government to innovate? Like what you're doing?

Mona Oliveira: (19:18)
Yeah, for Sao Paulo that the state that have more funding for that.

Julio Martinez-Clark: (19:27)
Oh, because is also the richest state. Is that correct? T.

Mona Oliveira: (19:30)
Yes.

Julio Martinez-Clark: (19:30)
Rio de Janeiro is in another state, right?

Mona Oliveira: (19:36)
Yeah, Ok,

Julio Martinez-Clark: (19:39)
and correct me if I'm wrong, but I traveled to Brazil. I spent about a year dealing with Brazil, going back and forth many times. I even spent about three months in Brazil. I traveled to Rio, Salvador, Sao Paulo, Salvador for Carnival

Julio Martinez-Clark: (19:59)
I'm from Salvador.

Julio Martinez-Clark: (20:00)
Brazil seems to have like one big city. And that's Sao Paulo right? Rio .de Janeiro it's more like fun. The beach and the music. And the carnival is not really a business city per se, is that correct?

Mona Oliveira: (20:22)
Yeah. it's a megalopolis And everything happens here, you can connect well, for business, I really advised to be here because it's easy logistical and everything's here but it sometimes right now, for example, the government, the federal government want to make more business in Amazon. So they start to give a lot of money and project to companies go there.

Julio Martinez-Clark: (21:00)
Okay. Incentivize companies to build plan or set up their shops there.

Mona Oliveira: (21:07)
Exactly. But you have a lot of problems for logistics

Julio Martinez-Clark: (21:14)
Yeah, exactly. Cause everything is by plain, the roads are not that good, or there are no roads at all.

Mona Oliveira: (21:23)
So you need to prepare for that. Yes, for Sao Paulo, you don't have these problems. They're very easy and connecting and it's usually. I choose here because I got this government investment. So we actually got 1 million of, it's about to $200,000 dolars

Mona Oliveira: (21:52)
That's a good amount. Very good amount. So I guess, I imagine there's a lot of bureaucracy. You have to account for every single penny. You have to report to back to the government, what you're doing with every single penny, right?

Mona Oliveira: (22:10)
Exactly. Every single. But they have like stages of investment process for your idea. So we got actually five times, we actually got now more 1 million now because we got another round of investment, ade investment. So they do a complimentary investment for company that in order to, and bring innovation for the state. So they complimentary the same amount of investment for you.

Mona Oliveira: (22:48)
Okay. They match. Okay. I see. Okay. Interesting. Very good. I'm very happy to see your success. I'm very happy to hear that the government of Brazil has funds to support companies like yours. Innovation, uh, startups. That's, that's, that's great because, uh, Latin America is going through a transition, um, Mona, where there are, uh, switching to a knowledge economy, or they're trying to do something about it. They're trying to diversify their economy. And countries like Brazil has so much talent, so much educated individuals that it's really a shame that, uh, they don't have the opportunities that other people have in the United States. But now with this global world, things are a little easier. People have more access to information and all that. So anyway, So let's talk about trends in Brazil. What's happening in Brazil? What trends are relevant to our discussion today? As you know, this podcast is about helping US European or foreign companies that are looking to do business in Latin America. They wanna do business in Brazil. They wanna know what's going on in Brazil. What political, social trains do you see happening there?

Mona Oliveira: (24:08)
Yeah, trains is, uh, Brazilian is very a techy revolution here for agriculture.

Julio Martinez-Clark: (24:18)
Yeah, yeah. That's a new terminology for me, is a new industry, right? A agritech, I didn't know about it until recently.

Mona Oliveira: (24:27)
Yeah, they call like that the, the startup that working for improving, a agri process. So even Biolink is, is architect.

Julio Martinez-Clark: (24:41)
Oh, you guys are in that sector. Oh, okay.

Mona Oliveira: (24:44)
Yeah. We, we have a customer from this, this market because, uh, you can use proteins on bio seed, you can use proteins for everything. So we, we can play with a lot of market. So we, we are there, uh, it, it's really a lot of investment for that right now. It's a trained, uh, it's now it's starting, They're starting, the investor here, starting to look in biotech too, that I'm very happy with this. I, I receive a lot of calls now.

Julio Martinez-Clark: (25:23)
Really?

Mona Oliveira: (25:25)
Yeah. I feel so special.

Julio Martinez-Clark: (25:27)
Wow. Congratulations

Speaker 3: (25:32)
That's amazing. But three years ago, It was the other way around and nobody understand, like, come on, what's this? Just give money now. I don't believe that.

Julio Martinez-Clark: (25:48)
Wow. But you've proved yourself, I mean, you've proved that the technology works, that there's a market for what you're doing and you know what exactly what you're doing.

Mona Oliveira: (25:56)
Yeah. Huge market that growing a lot too. The bioeconomic key is incredible market. It's amazing. So that's the train for the word bio economy. But for from Brazil, if you have a solution for this architect process, then architect evolution here is really huge. And that you probably have a lot of door open for you. It's the easy way, um, for, for company here, but also biotech, it's necessary for everywhere. So Latin America need a lot of biotech here. So we are open to do corporations with any company that want to come here to join us to this evolutions of bio.

Julio Martinez-Clark: (26:48)
Sorry. Yeah, go ahead. No, I was gonna ask you about all the trends about political trends. I hear that they left is very strong in Brazil now, what's happening? Yeah,

Mona Oliveira: (26:57)
It's election time this year. So this year, we have two important moments in Brazil. One is the word cup that Brazilian really really love. The word cup is always a phenomenal process here. And the other is the election time. So we need to, I do not know how it's going in the last four years but probably we have a new president for Next four years. And in political time, election times, everything can happen.

Julio Martinez-Clark: (27:40)
Yes. But I hear that the left is very strong, right? In Brazil right now. Same Colombia in Peru, same other countries. Look at what's happening in Peru. It's very unstable. I don't know if you've been following the news, but Peru is very unstable. It's too bad. I mean, for investors, for newer companies, for foreign companies to have, uh, political instability is not a good thing.

Mona Oliveira: (28:10)
Exactly, exactly. So probably we are waiting after election, see how we be and then coming.

Julio Martinez-Clark: (28:18)
Okay. Any other trends you wanna talk about, Mona, before we sign off?

Mona Oliveira: (28:24)
I think about, yeah, we really have the dollar. The currency exchange resistance. Exactly. It's favorable fot us.

Julio Martinez-Clark: (28:41)
Okay. The dollar is weak is saying the dollar is very weak. Yeah. Okay. Okay. So the Real is high?

Mona Oliveira: (28:49)
It's exactly, Yeah.

Julio Martinez-Clark: (28:52)
Excellent. That's good for you, not for investors as early.

Mona Oliveira: (29:00)
But for us now, we are planning to get a near investment ca till the end of the year, and then probably 35 million. I am focused on that. I want to grow in the company. I'm working on that now.

Julio Martinez-Clark: (29:34)
Okay. Foreign investors or domestic investors?

Mona Oliveira: (29:36)
Foreign investors. Fantastic. Fantastic. Wow. You really wanna, you really wanna grow the company and take it, uh, global, I guess, Or at least regional in Latin America. Fantastic. All right, Mona, we're very close to the end of the show. Uh, do you have any final thoughts or mores of wisdom or other musics for our listeners? In other words, what would you say to the CEO of a small midsize, uh, company from the US or Europe that wants to do business in Brazil? What would be your final words of wisdom?

Mona Oliveira: (30:14)
I would say that here you have a lot of talent people, the people here at working a lot, and there are a lot of opportunity to, because it's a huge marketing side in Brazil. So mailing for biotechnology company, we still, um, need, uh, this inside of Brazil for solution, for, for problems in America that different from the problems from usc. So it's a, it's very nice opportunity here to growing for this process. after this Brazilian, it's a nice country, so you can enjoy the time here. The weather, the natural, the food, the music. partner, one of my partner is my, my, my husband. He's sloavenian, I thought before. So he loves the weather.

Julio Martinez-Clark: (31:26)
he spoke he learned Portuguese.

Mona Oliveira: (31:29)
yeah, he already knew seven languages.

Julio Martinez-Clark: (31:33)
Seven languages? Wow. Impressive.

Mona Oliveira: (31:36)
Yeah. Slovenia is a small country. So a lot of people speak a lot of language there. It's amazing.

Julio Martinez-Clark: (31:44)
Yeah. I see. I see. All right. Fantastic Mona. So thank you so much for being the show today. It's been a pleasure. It's been a delightful conversation. I'm sure listeners learn a little bit more about Brazil, about your experience and how can people get in contact with you?

Mona Oliveira: (32:03)
Ah, please. Uh, we are in all channels. No, Um, we are Instagram, Biolink, sorry, Biolink, um, we're into, um, Biolink, the Assign Biolink, um, the Facebook, even the TikTok. Yeah. We have, um, a presence market. So sometimes The's not, uh, like, um, the principal channel to communication, but we put some funny movies there. It's really nice.

Julio Nartínez-Clark: (32:49)
Ok, mona. Thank you so much, bye, bye.

Transcribed by Temi