October 12, 2019
Dr. Julio Medina, Founder & CEO, R2M Pharma
Julio Medina is the Founder and CEO of R2M Pharma. Prior to R2M Pharma, he worked at ORIC Pharmaceuticals as the Vice President of Drug Discovery and at Amgen as an Executive Director of Research, where he was responsible for leading the Medicinal Chemistry group in South San Francisco. Previously, he held the position of Director of Chemistry at Tularik. Dr. Medina has successfully led programs on protein-protein interactions, kinases, GPCRs agonist and antagonists, nuclear receptors and enzymatic targets to identify 9 clinical development compounds in oncology, immunology, and metabolic disease therapeutic areas. He is a co-author on 83 publications and a co-inventor on 50 issued and pending patents. He did his post-doctoral studies at Columbia University and received his Ph.D. at the University of Miami.
Whitney Smith: We're here with Julio Medina at R2M Pharma in South San Francisco. Hi Julio, thank you for your time today. Could you tell me a little bit about your background?
Julio Medina: Yes. I started as a medicinal chemist, and I’ve been doing drug discovery research for over 25 years. My career started here in the Bay Area at a biotech company called Tularik, then I moved on to Amgen. Two and a half years ago, I started R2M Pharma.
WS: Great! What's the background for R2M?
JM: We’re focused on the optimization and discovery of small molecule drug candidates. We work with other biotech companies to validate and accelerate their drug discovery programs.
WS: You act as a contract research organization for those companies?
JM: We do act as a contract research organization. In some cases, we invest in those companies to participate in the risk/reward of the projects. We also work on our own programs.
WS: A mixed business model?
JM: Yes, it’s a mixed model. We do the design and synthesis of small molecule during the compound optimization phase. We do some of the in vitro assays that are needed to support the compound optimization. We also help with the DMPK and anything needed from the hit validation to IND filing.
WS: So, you're a trusted partner for your collaborators, helping them generate data as well as helping them understand the data that's generated.
JM: That's right. We work with our partners to put together their research plan. Then, we help them execute that plan.
WS: Wonderful. What do you think R2M is going to be like in two years, three years, five years? What's your goal and hope?
JM: It’s a mix of helping our partners to create value while we establish R2M’s reputation as a first-class research center. As I mentioned, we work with other companies to put together their research strategy. We help them validate their targets in a way that is cost and time effective. We work with them to validate their early projects in a way that is faster and more cost effective than if they created their own infrastructure to start executing their projects. In addition, they get the added benefit of an experienced research team that is in place and has worked together on other projects executing their research plans. The future for R2M would be one where we have helped advance a number of early stage projects and multiple programs into clinical trials and have a track record of creating value for our partners while establishing a sustainable research organization.
WS: A persistent business model. Some companies today are more of a build it and sell it…
JM: We have a long-term vision, which is to get to a stable research platform. We don't want to build the research platform for short-term use. In my view, that is costly and not time efficient. For us and our partners, we want to be focused on putting together a sound research plan and executing on that plan, rather than focusing on building an infrastructure. That's what R2M stands for — Research to Market. We want to create a sustainable research platform.
WS: Can you talk about the primary element or elements of this research platform? I was going to transition a little bit into how we ended up working with R2M. Could you talk about what you think a stable research platform consists of — sort of the big three to five needs that it should fulfill?
JM: Yes, so a stable research platform, to me, is a platform that consistently creates value for its clients by advancing their programs in a professional, timely, and cost-effective manner. It needs to have people who have been trained in the state-of-the-art, who are professionals, and who like what they do. They do it day in and day out. They look for the best practices and are always focused on continual improvement. We want to create that research environment where people can focus on what they do. They can use the current best approaches but keep an eye out for new technology that could have a positive impact and facilitate their work, so they can continue to grow as scientists. Then, we can channel their expertise and knowledge to help companies that are just getting started on their early projects.
As a part of that, we needed to identify an informatics platform that could enable data sharing for the lifetime of our company, in a way that was transparent and easy to use. That's where the collaboration with CDD Vault came into play. One of the things that we like is that it is in the cloud. It's very easily accessible by us, as well as by our partners. Because our collaborations are very flexible, sometimes we generate the biological data as well as create the chemical matter. In some cases, our partners do the testing on the molecules that we synthesize. When working with CDD Vault, they can be inputting the biological data and we can be creating the molecules or vice versa, and all that happens in the cloud. That's good.
WS: Okay. That's a great high-level description of what you were looking for in a system. Can you talk through the journey? Did you have experience with other informatics systems?
JM: Absolutely. I've been working in the biotech industry for over 25 years, as I mentioned before. I have evaluated different systems during that journey. For us, the main factor in choosing CDD Vault was the ease of implementation — how intuitive and easy the system is to use. It provides all the key pieces that we need. One of the key pieces is the compound registration and the inventory, and how it puts that together with the capturing and the visualization of the biological data. Also, the ease of sharing information across different companies is key. The ease of implementation, the ease of use, is very intuitive. Sometimes you get systems that are very powerful, but only one person who is trained with all the “ins and outs” of that system can use it. Most of us like systems where it's so easy to use that it doesn't require a big learning process to use it or get value from it. That is one of the things we like about CDD Vault.
The other thing is that the database provides a lot of flexibility, which makes it very easy to integrate with the needs of the programs. What I mean by that is, for example, when we register compounds, we like to have the NMR spectra and the HPLC traces available as well. It’s very easy for us to not only upload a PDF file of the NMR, but we can also link it to the FID traces so that we can go back and re-process the data if we need additional information. For us, again, having a system that is easy to implement, easy to use, and that provides all the integrated capabilities is important to us.
WS: When you're searching for new technology, whether it's informatics technology, or lab equipment, or whatever, do you have a process that you go through? I’m asking in order to maybe help other companies understand what folks do in order to get to a solution that fits their needs. A related question is: were there any surprises in that search? Are there things that made you very happy or made you very frustrated or both?
JM: Well, that's a great question. When we go into a search like this, you look at what you have used before and you start with that — what you liked and disliked about what you used before. The other thing that you rely on is your network. Word-of-mouth is important, especially in the scientific community, because as scientists we tend to be very critical…
WS: …yeah, my family hasn’t noticed that…
JM: [laughs] We tend to be very critical and very vocal about what we like and what we don't like. We tend to be very demanding as well. Because, that's the process that gets us to improve. This is part of that process of improvement, identifying the flaws, and then building up on the opportunity to overcome them. That's the process that we engage in whenever we look at technology. What have we used before? What’s one thing we liked about it and didn't like about it? What is out there that provides advantage over that? We ask these questions in order to identify the things that are out there that can provide an advantage. We do our research like everybody else, but we also rely on the network...
WS: …word of mouth…
JM: …word of mouth to try to identify what has worked for others as well.
WS: Fantastic. That makes a lot of sense. From our perspective as vendors, we see that a lot of people face an uphill battle when they go to start a company and look for new technology if they haven't gone down that road before. We often try to find ways to connect people, network with people, and just those conversations — “This is what worked for me, this is what didn’t work for me” — can be very useful.
Was there anything that surprised you in the search process? Is there anything that delighted you or frustrated you? Again, not necessarily with informatics systems, but with trying to build a company from the ground up.
JM: No. Building a company from the ground up is very rewarding and is a lot of fun. There are a lot of challenges, obviously. But — oh, my God — what a great journey! It’s good, it’s very rewarding, and I’m enjoying the opportunity that I have every day.
WS: What's been the impact of having our system in place or other systems in place in terms of going forward with your original vision? Have you found that the execution has been straightforward?
JM: One of the things that I liked was the ease of implementation. It was absolutely very simple and very straightforward. Partially because of the system itself. We talked a little bit about the fact that it works in the cloud. The fact that when you do the demo, you're working with a version that is similar to what you're going to get. That comes across very quickly. It's also something that can be implemented really quickly. Those are the technical aspects.
The other part that was really rewarding was how easy the whole process was, from the people perspective. A lot of business comes down to people, how easy it is to go through the work with the agreements and the paperwork. That was pretty good.
WS: Thank you, that’s great feedback. In terms of our systems, is there anything you'd like to be able to do better or anything in the future you want to be able to accomplish that you can't today?
JM: When we started using the system, we were focused on the compound registration. From that, we have built in the capability of adding information to our compound registration. Then, we started capturing the biological data. The need for processing the biological data for different projects requires a lot of flexibility and could be very complex. For example, some assays are looking just for straightforward inhibition, but some assays are looking for activation and partial agonism — also, you may want to be able to track multiple controls. Therefore, capturing and processing the data sets so you can take information from the reader into the Vault itself and process it by the Vault is good. The team and CDD Vault are very good at actively asking for areas of improvement and rolling out new versions of the Vault that address the suggestions.
What I would like to see going into CDD Vault, in the future, is one section devoted to capturing the in vivo data. I think that we are doing very well with the progress that we have seen. For example, from the chemistry perspective, when capturing the ELN, the laboratory notebooks, I think having a template that allows you to populate PK data for the compounds that you're making in a template fashion — whether it's clearance values, oral bioavailability, or volume of distribution — so that data can be easily imported, would be good.
WS: You’d like to see that “packaged up,” so to speak?
JM: Separately, just like the ELN is. I think that obviously, your focus has been on the main functions, chemistry and biological data. Now, you are focusing on how to put the electronic notebooks from a chemistry perspective and have the template and the dictionary, as you guys call it, your chemical libraries. The molecular weights and densities and all of these things are imported automatically.
People love, by the way, being able to put in pictures like the TLCs into the electronic notebook. All of that is done very easily. Now, if we can move on to how do we capture the DMPK data in a way that is easy for us, regenerating the DMPK data that we get from CROs in their excel spreadsheets. How do we capture that in a way that can be attached to the compound registration?
WS: Okay, fantastic. That's really good. Any other lessons that you'd like to help share with others in terms of your process, your journey?
JM: It’s important to stay open-minded, I guess [laughs]. I'm very goal-oriented and to me, in the beginning, I resisted the electronic notebook because I thought that nothing could be faster or simpler than writing in the notebook that was in front of me in the lab. After I tried the electronic notebook, I learned that compliance was better, sharing data was significantly easier, and your ability to capture information and store information in a way that was useful to the whole team was a lot better. I went from thinking, "This is going to slow me down," to "Oh no, this is actually a must-have."
WS: Other than the research you're doing here, anything in science that is exciting you, that you find interesting? That you're like, "Wow, look at that, that's cool."
JM: Lots of things [laughs]. You know what excites me about science is how it's always evolving. What excites me most today is the prospect of all of the new drugs and technologies that are in the pipeline and their application to personalized medicine. The concept that has been out there for a while, but as multiple treatment options are becoming available more and more, focus is being placed on identifying the patients who could benefit the most from the specific treatments.
For example, we're seeing an increased number of diagnostic kits becoming available to doctors for identifying the enzymes or enzyme-mutations in patients that are likely responsible for their disease and diagnosing the appropriate treatments. Therefore, treating only the patients who are likely to benefit and reducing the number of patients exposed to medications that are not likely to provide a benefit and could be detrimental. We're seeing more and more how personalized medicine is playing out, and that is really exciting!
WS: Thank you for your time, this has been wonderful. I really appreciate it.
JM: Thank you.
A fun bit of trivia: We featured R2M Pharma's Dr. Tien Widjaja in a CDD post when she became our milestone one-millionth user to login to the CDD Vault in April, 2019!