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March 4, 2019 Issue



Using Artificial Intelligence and Simulation Technologies, PRO-FICIENCY is creating Online Experiential Learning Frameworks for Medical Professionals, Clinical Trial Investigators and Patients participating in Clinical Trials



David D Hadden

Co-CEO & Co-Founder




Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 4, 2019


CEOCFO: Mr. Hadden, what is the concept behind Pro-ficiency™?

Mr. Hadden: I have been working on the concept behind Pro-ficiency for twenty years. My background is in using artificial intelligence and other technologies to create online experiential learning frameworks for medical professionals. The simplest analogy to use is that of a flight simulator for medicine. Image if we trained our pilots using PowerPoint and lectures. It would not work. In fact, before flight simulation technology was invented, flying was pretty dangerous. Simulation training is experiential learning -- learning by doing. Research indicates that with experiential learning you learn faster, and you retain more. It creates a muscle memory-like affect, so that when you are faced with those situations you can respond intuitively, instead of just having the information intellectually steeped into your brain through reading and lectures. Didactic learning approaches give you information, but it’s not available in the right way when you are faced with the actual situation.


CEOCFO: How would a company use Pro-ficiency? How does it work?

Mr. Hadden: Pro-ficiency uses clinical simulation to train clinical trial investigators and patients who participate in clinical trials. I invented this approach in my last company, TheraSim, and I focused on using simulation to train practicing physicians. After that I started Pro-ficiency with my partner, JoAnne Schaberick. Pro-ficiency is transforming training from a burdonome cost center in clinical trials into a powerful human performance management system.


A pharmaceutical company will spend hundreds of millions of dollars on a set of clinical trials for a drug candidate in order to prove the benefits of a medication to improve human health. However, they use two thousand year old technology to prepare their physicians to do that, which are basically lectures. They have big meetings, they put them in a room and they lecture them for eight hours with PowerPoint slides about what they need to do. Ninety percent of that information goes in one ear and out the other. Our approach is to create online experiential learning opportunities for the clinical trial investigators and their staff. Pro-ficiency technology models the things that they do in the clinical trial. The investigators go online to interact with a simulated patient to practice the decision making and skills they need to perform well for that clinical trial. Perhaps that simulated patient is a potential candidate for that clinical trial, so they can ask them questions and make decisions as as to whether or not they would be eligible. If they are eligible then that patient will appear again and the learner will practice the various procedures and assessments they need to conduct. Perhaps the patient is having an adverse reaction to the study drug, such as a side-effect, and the learner needs to decide what to do about that. Maybe they are asking about an over the counter drug that they are taking, and the investigators need to determine if there is a contraindication with the study drug. In real life, investigators have to be able to navigate all of those things.


CEOCFO: Why do these seasoned clinical investigators not know how to do this already?

Mr. Hadden: That is a good question. Imagine I have been trained as a pilot my entire life. I know how to fly airplanes. However, here is a brand new airplane with all different controls. Is it basically still just an airplane? Yes. However, perhaps there is no longer a yoke but a joystick and many controls and procedures are different - possibly more advanced. The fundamentals are the same, but there are crucial differences. Along the same line, every clinical trial protocol is different. They have different interactions, dosing parameters, assessments that have to be conducted when the subjects come in, etc. Many of the things we require investigators to do are counter intuitive to their medical training.


CEOCFO: Would you give us an example?

Mr. Hadden: For example, let us say that it is a depression study. The patient comes in says, “I am feeling really rotten.” You say, “I am so sorry to hear that, maybe if you go for a walk everyday and get out of the house, it will help.” You cannot do that. Normally, yes. If I am a psychiatrist then I want to help my patient in any way I can, and having a good bedside manner is really important. However, in a clinical trial, it is destructive, because is is so powerful. It is called the placebo effect. I am making that patient feel better, but is it the drug or is it my counseling? If you take all of the patients that are on the placebo arm of the study and you council them in addition to giving them the sugar pill, they are going to feel better! They might even do better than the treatment arm. It is because you are providing another form of treatment. That is very powerful and can derail a study.


However, this is completely counterintuitive to physicians. They want to do everything they can for their patient, but because they are actually participating in scientific research, they cannot do that because it contaminates the data. Our simulation training reinforces appropriate behaviors, that might be counter-intuitive to standard practice.


CEOCFO: Who sets up the simulation for any given scenario? Is it the company? Are you doing it for them? What are you selling them and how are they using it?

Mr. Hadden: The pharmaceutical company gives us the protocol, the Magna Charta of how we build the training. Think of the simulation as a “choose your own adventure” book, but digital and online. And instead of text, it’s a hundred very short videos. There is a movie that just came out on Netflix called Bandersnatch that is a “choose your own adventure” movie with multiple endings, depending on the choices that you make. Our videos are high production value and very engaging. We want the investigators to enjoy the experience. The training they take currently is like watching paint dry. 96% of the investigators that go through our training actually enjoy it, which is shocking! Also, if our learners engage, then they get through it faster. And every time someone makes a mistake, we launch a corrective action to make sure all knowledge and skill gaps are filled.


CEOCFO: When you are creating the videos how do you stay neutral and keep your own feeling out of it? How do you create for the general clinician, when perhaps you have a leaning in some other direction?

Mr. Hadden: The things that we are educating learners about are all defined in the protocols they have to implement. There really is not a lot of room for my feeling one way or the other. The director is always trying to make it just as realistic as possible. That is what the physicians appreciate about it, because they go to medical school to treat patients and to do research, but they do not go to medical school to read or to be lectured at in a hotel meeting room. Therefore, we are training them in doing the things they like to do. It is just like a pilot. They enjoy doing flight simulation because it is fun, because they love flying. That is why they are pilots. However, they do not enjoy sitting in a room reading manuals for eight hours.

CEOCFO: How do you portray patient’s reaction in a scenario? How are you able to keep it realistic when you are showing an interaction with a patient who might not react the way you would typically think? 

Mr. Hadden: That is a good question. Basically, we engage experts who are familiar with whatever therapeutic area we are working on, to help us develop the scenarios. However, there is also some creative license that goes into it, because people are people. The experts whom we work with all have thousands of hours doing this, so they are really good at helping to make the scenarios realistic.


CEOCFO: What is your business model? 

Mr. Hadden: It is a combination of services and software. We have created this unique software platform that we can use it to train anybody to do anything. I could create simulations on this platform to show someone how to change the tire of their car. However, we chose clinical trials, because it was the last arena of medicine that has not yet benefited from the power of simulation. It is ripe for innovation. Pharmaceutical companies are using a three thousand year old approach to train people to conduct clinical research on humans. That is how Hippocrates trained his students; by lecturing them. It’s a bit ridiculous that the industry is still doing that today. Imagine if we started training all of our pilots, supertanker captains, astronauts, fighter pilots or tank commanders using lectures. There is a reason why simulation is the gold standard for training. However, there are also reasons why it has not been adopted in a wide spread way. It’s expensive – really expensive. At Pro-ficiency we have developed technology is fast and inexpensive.


CEOCFO: Are you typically working with CROs? Are you working with individual drug development companies? Who is your customer?

Mr. Hadden: Good question! You obviously know the industry! We work with both. We have sponsor customers, which are pharmaceutical companies that have drugs they are trying to get through clinical trials to accumulate the data they need to submit to FDA. However, we also work with CROs. We are located in Research Triangle Park, so most of the big CROs are already here. CROs are a little tricky to work with. It takes longer to develop a relationship with CROs, so we are focusing primarily on going right to the sponsor, the pharmaceutical company. They are the ones that directly experience the benefits of our technology. Our approach is a radically better solution in terms of quality and cost. It also predicts the mistakes that sites are going to make. I can tell you whether a site is good or bad, just from the data that comes out of our training system. Imagine you have ten pilots and nine of them keep crashing the simulator, and one of them aces is every time, which one are you going to choose to fly the real plane! We are focusing mainly on sponsors now, but ultimately we will be partnering with CROs.


CEOCFO: How are you reaching out?

Mr. Hadden: That is hard, because we are self-financed and marketing is expensive. Believe it or not, I would say that ninety percent of our business comes from LinkedIn. We run LinkedIn campaigns relentlessly. Actually, the first conference that we are going to present at, is next week. It is the SCOPE 2019 Conference in Orlando.


CEOCFO: How do you stand out at a conference when there are lots of companies with many ideas?

Mr. Hadden: Well, for SCOPE, we created a virtual reality version of one of our simulations. We are taking the demo to the customer using Oculus Go virtual reality goggles. You put these goggles on and feel like you are actually in the clinic interacting with the patient. You can look around in the environment in 360 degrees and interact with it. It is pretty amazing!


CEOCFO: Are you seeking partnerships or investment? 

Mr. Hadden: We have revenue. We have some anchor customers. Investment always helps to speed things up, but it also comes with its own burden. It takes a long time to get investors and in the amount of time that I would spend trying to go out and find the right fit, I could just sell more. We did an initial friends and family round, but very small. As far as getting a more seasoned or institutional investor onboard; that takes six months minimum. I would rather dedicate the time, effort and energy to acquire more customers. We are basically going to just keep on doing what we are doing, which is to pick one or two conferences a year and keep reaching out on LinkedIn. I have actually sent LinkedIn messages to the CEOs of multi-billion dollar pharmaceutical companies and had that lead to solid business for us.


CEOCFO: What has surprised you as the company has evolved?

Mr. Hadden: People don’t care about training because for a LONG time, it wasn't effective. It was just something you had to do to check the box. Pro-ficiency’s technology creates a dial you can twist to improve human performance and suddenly, your training actually impacts your study outcomes in a measurable way.



“People don’t care about training because for a LONG time, it wasn't effective. It was just something you had to do to check the box. Pro-ficiency’s technology creates a dial you can twist to improve human performance and suddenly, your training actually impacts your study outcomes in a measurable way.”
- David D Hadden





David D. Hadden

(919) 904-0035







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