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Raising the Bar in Pharma and Device Development
Episode 375

Luca Emili, CEO at InSilicoTrials

Raising the Bar in Pharma and Device Development

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Raising the Bar in Pharma and Device Development

Episode 375

Recommended Book:

The Foundation Trilogy

Best Way to Contact Luca:

luca.emili@insilicotrials.com

Mentioned Link:

Company Website

 

 

Raising the Bar in Pharma and Device Development with Luca Emili, CEO at InSilicoTrials | Convert audio-to-text with Sonix

Intro:
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Saul Marquez:
Welcome back to the podcast. Today I have the privilege of hosting Luca Emili. He's the founder and CEO at InSilicoTrials Technologies, the first global platform that allows pharmaceutical and medical device companies to accelerate research and development through models and simulations. He's a member of the Cloud Security Consultative Group in EMA and responsible for the collaboration activity with the FDA. With a strong passion for technology, he's focused on the development of the company for the definition of partnerships with research centers, hospitals and pharma and medical devices companies and the development of new innovative technologies and services. Prior to founding InSiliconTrials technologies, he worked in M&A and acted as an investor in some SME companies. He's done a tremendous work in the field. He's also a journalist published more than 40 articles on I.T. Security journals and he's just an outstanding contributor to this field of healthcare. So it's a true privilege to have Luca with us today. And with that I want to open up an introduction to you, Luca. Thanks for joining us.

Luca Emili:
Thank you. Thank you so very much.

Saul Marquez:
So what would you say got you into the medical sector to begin with?

Luca Emili:
It was a consideration based from my past experience in cybersecurity where for 10 years I had the opportunity to dive very deeply into technology and as seen in 2012 how big opportunity could be in the support of clinical trial using state of the art technology to accelerate the experiment, to accelerate the trials, to leverage the data created and then so on. It was at the beginning of the year of the Cloud in the life sciences. And so I have to say now that I was very happy to get into this sector because he's folding a lot written weekly.

Saul Marquez:
Yeah it sure is. And you got in right at the beginning as it was getting into healthcare a lot has changed since then. What would you say today, Luca is the hot topic that needs to be on today's industry leaders and how are you guys focused on it?

Luca Emili:
For sure the efficiency and the processes are extremely important element considering a huge investment that are done every year by the companies. In the pharma 95% of new compound never reach the market. The cost for developing medical device you see is enormous. If we consider that the software is an element that embedded knowhow and that knowledge I think that was significant to a topic is to look at how to leverage software to distribute the knowledge around the company and to make people to be able to act from a more empowered position because they are using tools that are significantly powerful. So as Anderson said in the past that software is eating the word. I think that if you put knowledge into the software and we leverage it we put the people at the center of more activity then you could envision in the future.

Saul Marquez:
You're really a forward thinking in this space, Luca, I mean to think that we could take very, very physical processes and trials in labs, in clinics and make simulations. I mean this is kind of really futuristic thinking. I love to hear some of your thoughts on maybe some project you guys have done or some early work and some of the successes that you've started to see from this.

Luca Emili:
Yeah I've been lucky because what we are doing now in the healthcare in the I started to eat in the security in two thousand years. The point is that the knowledge and the knowhow is very hard to obtain for everyone and in so many different topic and what we are doing now is to make a researcher to put their own components available in a very easy way which is we shot through the internet for the final user. So we are for example are working on a project with FDA where we are in every literary science project providing two companies the opportunity to see how in the MRI safety of an implantable medical device is possible to use a model. These are simulation to see if the design of the product is fine or not. Then we hear out a project with university for example of Malaysia for the evaluation of cardiac safety of a drug. So these are a couple of examples that provide in terms of seconds or a couple of hours results that you know traditional activity could require weeks or months. It also that they use of animals or requiring some painful tests on the patient. So the point is that in this single approach that is not going to change the word in any one day but we could start a process that in the future could really at the beginning reduce the afford for traditional approaches and then in the future sometimes maybe to substitute some of this approach. For example the one using animals and make it thinks a simpler and make things quicker and also less expensive than they are now and also safer. So avoiding that maybe are a lot of the problem caused by long processes that don't take care of safety in the right way.

Saul Marquez:
And no, really appreciate the examples look. So the method by which you go about this what's the technology behind your work?

Luca Emili:
We have created the platform where we are able to integrate many different components. So basically we have for the medical device a technological solver so software that make a fun and dynamic simulation in the structural dynamics duties for example we're working with the RCC. We have a biotech company that is using open source solver. So we have many solver in the platform side. On the other side we are embedding components that come from the pharma industry. So where does simulation are created starting from a clinical testing or in vitro testing and then become a model that is possible for a user to test. So we are multiple layer platform. We're starting from a web interface go into the structural component based on Microsoft knows where we are CBT activation with those who are also on the guidelines and the GSP compliance and then go to their specific component that created the single model of the platform.

Saul Marquez:
There is a lot going on there Luca and you guys make it work. If so no doubt you guys are definitely among some of the brightest minds in the business and I know a lot of listener base in the pharma and med device field always are looking for four ways to become more efficient and raising this efficiency standard in the development of devices and drugs. Give us a time when maybe you had a setback in the work that you're doing and what you learned from that to make you better.

Luca Emili:
Well a setback and is a day related to the time sometimes to convince someone that they do not understand what are the potential that make worth to think about it and to go in this direction is it not your platform nor your approach. We are doing a lot of evangelization around the world and so it's not that why we talk about this so that people get your love immediately. We approach because they think we the traditional mindset that we have a racial way to create the demo so some results. So this is something that we have changed a little since the beginning because we started not to give for granted for everyone that is obtuse and need to be like that and we have copy some activity done in other industry and that to make the people understand that they already living in a place where for example you are trusting the software for your health or for your life as well. For example if should talk about the automotive industry now. Every car is developed through modeling simulation but more important there are a lot of systems in the car not just the new self-driving system but also all systems like the IBS that are based completely on the software and the people he's trusting on that. So once we received their consideration how can I trust a software for the results. You say you trust trusting radio software for results in other fields because the ABC is a software we combine with mechanical part electronic parts. So you're trusting assessing software is a matter of trusting our software in a new area creating pathways before that is going to complement the traditional activity and that get value because you can reach the softer more more by experience and make it better through time.

Saul Marquez:
Luca, this is a great great example that you bring up this type of work. This predictive modeling in software is already being done. You mentioned automotive what other industries are using it?

Luca Emili:
Consider that all aerospace development now are done 100 percent with Mullaney simulation. Most of the electronics are using simulation for the device design of the of the tool. So there are in sports a lot of company using it. I can mention something that gives you that idea of the potential the Formula One has decided to change the rule and to let from I think next year and a couple of years a full use of fluid dynamics software to develop the car means that it is so powerful as a technology. They they they have created this limitation until now will not let people develop the car using moulding situation something new the fore simply happening in the America's Cup. So the creation of new wealth are using modest simulation.

Saul Marquez:
Amazing.

Luca Emili:
Yes.

Saul Marquez:
It is amazing and I think one of the one of the interesting things is that these large vessels, these high speed machines that are in train that's that's just unpredictable often can use simulations in the air and the water on the road. Why can't we use it and help? And I think it's a beautiful thing that you and your team are doing look at to bring this to us for health care. What's one of your proudest experiences you've had to date with your company?

Luca Emili:
We gave the opportunity to company to use an activity to see how and how to do it from 11 month planet beginning in 4 days because they had many options in terms of development that could make them run a very very long bench testing etc. and they've been able with the right setting leveraging the cloud to have these results in some base also going to a design that there was not one of their initial preferred design because as you said Whilst we take experience in other industry in this environment we're not starting from scratch we can leverage a treasure around the word because as I said every car, every new car, every new plane is developed using modern simulation and we are taking these very sophisticated tools and moving into healthcare. Of course there are differences every one of the people is different from a car so you have to keep an eye count suspects but it's not something that is completely new. It's something that is completely validated some is completely used, it's something that people rely on significantly. It's a starting point.

Saul Marquez:
Yeah no it's definitely fascinating Luca, and some great examples there. It's just interesting. And so today is the is the FDA accepting the use of these technologies for validation and proof for their approval?

Luca Emili:
I can though that is not only they're accepting but they are pushing towards some modeling simulation. Scott Gottlieb who's the new commissioner by FDA started seems to begin to talk about modern simulation in Jacksonville by any medical device development and in 2016 FDA released a guidance on how to provide FDA with the results of simulation to set a little bit of a standard on how to receive a document because otherwise you could be you could have two pages or 1000 pages for them would be not easy to work through it. And the numbers are increasing so more than 10 percent last year of their requests have been presented with component of modernist way showing it's increasing. Also in Europe is something starting because there is a new medical device regulation that is mentioning the modeling simulation as a way to provide information in parallel or instead of clinical evidence used for the approval of medical device by modified bodies. All around the world there is a movement towards small simulation as it happened in other industry also.

Saul Marquez:
Outstanding so interesting did not know that at all about the FDA process and how they're really embracing these simulations as the way forward. Folks if you're looking to learn more about this space and the work that Luca and his team does check out their web site, it's insilicotrial.com, will leave a link to that in the show notes. It's insilicotrials.com and so getting close to the end here, Luca, tell me about an exciting project or focus you're working on.

Luca Emili:
The combination of the MRI safety of an implantable make a device so we do structural knowledges. So with the capability of modern simulation especially in orthopaedics. Now we are going towards the sort of design of the device based on simulation because. You're able to combine many situations same time so for example the one about the MRI safety. The one about stress test, the one about fatigue and the one about impact or respond to some compatibility test. In all these elements combined together could feed one the other to have results of the design or change changing the design of the device automatically and directly from some generic input at the beginning of the company. We apply these to devices for the knee surgery for a specific cost the autonomy and the outcome is a plate that is a 3D printed. And the design is patient specific based on the combination of many simulation they take care of the MRI safety, their fatigue test, the stress test at the same time. So basically we're designing a device patient specific starting from a generic initial department tries design of a device.

Saul Marquez:
That is fascinating just the the sky's the limit with what you could do with this technology. What are some of the limitations?

Luca Emili:
Well frankly I think it's too early to see limitation on that for sure one element that there is not present at the moment is a full validation of old a model that you could use or all the simulation you if you could do. In fact this is an early mutation journal for the market because if everyone adopts his own tool to make a simulation then they have to do the specific validation is going to be very expensive a very long. We're approaching we have decided to have a trace model body data model online no way that you can provide the design of your tool and to have the results from a model that is validated and the more people is using the model the more companies using this model we see feedback and then we can improve it. So the point is that through the Internet it is a perfect distribution model as that you're going to use for this a webinar as well. We are able to provide one valuable element all around the world to big and mid and then a little size company. The same time we a very accessible cost providing the knowledge embedded in these components easily. So the limitation is the validation for sure. But with this approach like for example that when we are doing then there is a way to help the company to have many validated model available for them.

Saul Marquez:
Makes a lot of sense. Fascinating work. What book would you recommend to the listeners.

Luca Emili:
Well the Trilogy by Isaac Asimov, quite all the book. Let me say it probably from the 80s and before 80s.

Saul Marquez:
What's it about?

Luca Emili:
It's about the life in space say in a very science fiction environment where you have different groups that create a society that take care of and say robotics and an interstellar chips. So easy it's nice that belongs to my childhood let me say but Asimov is one of the father of the science fiction and it's not I don't look at that as an inspiring book for what's happening now but I think that he's very inspiring from the environment a different environment that he has design and it's really intriguing. So that's the book I love.

Saul Marquez:
That is fascinating. The Trilogy by Jacob Asimov.

Luca Emili:
Isaac Asimov.

Saul Marquez:
OK. Isaac Asimov. Outstanding, The Trilogy folks. Check that out arms rocket that help in the search bar type in Luca Emili and you'll find that this entire podcast interview with the show notes as well as a short version of the show notes with links to other things that we've discussed including a link to insilicotrials.com so you can learn some more. This has been a ton of fun, Luca. I'd love if you could just share a closing thought with the listeners and then the best place where they can get in touch with you or learn more.

Luca Emili:
Well there is an effort by many people around the word towards modeling and simulation and I'm happy that I have the opportunity to work with many researcher and to make visible what they're doing because too many times the things are just so in their computer. So I encourage everyone that has done a little piece of software component on modeling simulation to contact me because to get out maybe you can create a significant puzzle that will let the company to have a very nice picture to support you Randi. Everyone can get on me and my email. That is luca.emili@insilicotrials.com.

Saul Marquez:
Outstanding, Luca. Thank you so much for your insights today. Folks I know that you've probably are scratching your head thinking, "Wow. How can I use this?" So take action. Follow up with Luca. Learn some more, collaborate and Luca, I just want to say thanks again for spending time with us.

Luca Emili:
Thank you Saul, thank you very much.

Outro:
Thanks for listening to the Outcomes Rocket podcast. Be sure to visit us on the web at www.outcomesrocket.com for the show notes, resources, inspiration and so much more.

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