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                                                                                       Dr. Moira Gunn

2005 Unedited Tech Nation Interview

Elizabeth Holmes, President & CEO, Theranos


        Tech Nation/BioTech Nation Elizabeth Holmes - Theranos + Moira Gunn – 2005


Interviewer: Moira Gunn, Host, Tech Nation

Guest: Elizabeth Holmes, President & CEO, Theranos

Source: Raw, unedited 2005 interview with Elizabeth Holmes recorded at KQED in San Francisco

Audio Length: 11:42

Recording Date: April 21, 2005

Air Date: MAY 3, 2005, Tech Nation (on its Segment: BioTech Nation), NPR Now, SiriusXM

Transcript Release Date: June 24, 2018

Tech Nation Media retains full rights regarding this transcript, the raw audio it reflects, and the final edited audio which aired over NPR Now and other broadcast and Internet venues. Attribution should be given as “Unedited Tech Nation interview with Elizabeth Holmes, President & CEO, Theranos, by Dr. Moira Gunn, KQED, May, 2005”. Re-publishing and/or re-airing on any medium beyond “fair use” requires the express written permission of Tech Nation Media. Contact technationmedia@gmail.com.

GUNN: (unintelligible) what you’ve been doing?

HOLMES: No, it hasn’t. Well, if I use traditional words to describe what we’re doing, it’s hard, because people then associate it with conventional processes for analyzing drugs in development or [yeah] whatever aspects we may be applying our technology to, but, um, if you, I’m a visual person, so I don’t really want to talk about it, I like to sort of write it down and display it and say, OK, look at the process as it’s done traditionally, and now, take each component and look at us putting the, both, actually, with respect to our technology, new components together in a certain way, as well as, um, with respect to the process, and taking different parts of the process [uh-huh] and (unintelligible) condensing them.

GUNN: Great. [So] It’s hard. It’s hard. That’s the challenge. It’s like. The funny thing is is that visual words work really well on the radio. [yeah] Because people are driving along or whatever. They see a vision. That’s funny, but it’s a good thing. OK? (to engineer) You’re rollin’?

GUNN: The Center for Drug Evaluation and Research at the FDA has just reported that … (to engineer) yeah, it’s me with the, with the mouth, the creaky sound… yeah, yeah, no, no, no, no, I’m glad you did, OK. (restart) The Center for Drug Evaluation and Research at the FDA has just reported that in 2004, over 400,000 Americans reported adverse drug reactions, and 100,000 Americans died. And on the benign side, other research shows that 40% to 60% of all patients don’t benefit from drugs they’re prescribed. Why can’t we figure out in advance who will have an adverse effect, and why certain drugs aren’t going to work?

HOLMES: Well, I think that part of it has to do with the fact that there is no mechanism in place to deal with monitoring patients on an individualized basis today. So, when we began Theranos, what we focused on was creating a customized medicine tool that could be used in the home by every patient, so that every day, a patient can get real-time analysis of their blood samples, and look at not only how drugs are reacting in their body, but how other, may it be, metabolic or physical, sort of, factors contributed to how well a given drug works in them as an individual.

This is, is different to the traditional process of sending a patient into a clinic at random time points, trying to get a sample of their blood and then analyzing at that second in time what the drug is doing, because it gives you a much better and much more complete understanding of all of the factors that contribute to how well a drug works or does not work, like, if the patient’s taking other drugs, which happen to cross-interact. So, the ability to begin bringing monitoring, as we call it, into the home, we believe, could fundamentally change the way that both patients are treated, as well as drugs are developed.

GUNN: I guess right now it’s called the “RDX Metabolic Profiler”?

HOLMES: That’s absolutely right.

GUNN: Well, we’ll get those marketing people on that. [haha] I think it may be called something else by the end, something handy by the end, but now tell us, exactly, how big is it? What does it do? What do you gotta do if you’re using it?

HOLMES: So, it’s a handheld device, and it’s fully integrated. The only thing you have to do is hold your finger, or you could actually use any part of your hand or your arm, up toward the device, and it takes a very small sample of blood. So small that you can barely feel it. Thanks to the art of glucose monitoring, small blood sampling has really …

GUNN: So it extracts a little from your hand?

HOLMES: Exactly. It’s a little teeny needle that pulls a little teeny drop of blood, and when it gets the drop of blood, basically it runs it through, what we call, a biochip, which separates out all the cells and other types of analytes in your blood which could traditionally clog a biosensor, and then, in real time, run many different chemistries. So, looking for different, in this case, targeted markers, like the drug concentration, or concentrations of other proteins that may be in your blood that are indicative of either [Adverse drug reaction] risk [Adverse drug reaction.] Exactly.

GUNN: Okay, so once it identifies that? What does it do? Just tell you?

HOLMES: So, when you do that-

GUNN: A big screen says, “Sit down”?

HOLMES: No, the patient doesn’t see anything. It’s a very small handheld device, so once the device begins working, it’s a real-time event in which the blood sample is analyzed, and, and when it separates all the cells out and it identifies the markers it’s looking for, the first thing that happens is you get a signal, and it’s basically reflective of a concentration, or the presence or absence of certain cells you may be looking for.

And when that happens, the electronic aspect of the device takes hold and transmit [sic] that data to our website, where we’ve written what is basically biostatistics algorithms to correlate that information, and profile it. So, we’re actually in the process of redesigning our website, so that patients and physicians can log in, and a nurse can monitor this data, and then say to the patient, you know, “You’re fine.”

Again, the backdrop to all this is when a drug is prescribed, we are coupling the system with the drug. So, if you know, when you go to get a drug, that you have risk of an adverse event, or you’re not sure, or you’re nervous about it, you can monitor yourself for a month, and then evaluate whether or not that drug is the best drug for you.

GUNN: (off-mic) Um. Let’s see, how do I want to say this. Ok, so we got the wireless portion, and we got the thing. Um. Ah. (on-mic) OK, I gotta ask ya. Does it hurt to have the drop of blood extracted?

HOLMES: I can tell you, personally, I hate needles. They make me want to faint. And, um,  I am fine doing with doing this drop of blood. We’ve actually found that … And we’re talking really, really small. You can barely see it. But if you poke yourself in the arm, or actually on the palm of your hand, it doesn’t hurt as much on the finger as if you do it on the fingertip, because there’s many nerves in your fingertip, so it’s more of a pain site, whereas your arm has thicker skin, so you actually get an even smaller drop of blood out, but you don’t hit the nerves that make you feel pain. I mean …

GUNN: And you’ve got plenty of blood to do your assay?

HOLMES: Oh yeah. Absolutely. That’s the beauty of the technology, is that we’re really talking about miniaturization.

GUNN: Now a lot of people are saying, “Well she’s President and CEO. Where are all the engineers that built this?” This is built around your patent.

HOLMES: Yeah. That’s true. Part of the culture of our company is to make sure that we are fully integrated, so people who are working on business development and people who are working on marketing, everything, revolves around the engineering aspects and the technology aspects, and continually striving to be, really, the leader in creating an industry around these personalized monitoring systems.

So, yes, I am actively involved in the technology, and the technology did come from… sort of an integration of work I’ve done in different technical fields, and the concept that if you could bring different technologies together, you could maximize the power behind them. I think it’s very clear that this is a wonderful time for the convergence of, sort of, the electronic and IT infrastructure with bio-systems. In our case, it’s to create biosensors. Um, so …

GUNN: If this is a job interview, I couldn’t ask you, but I can ask you, and it’s the radio, so people are surprised. How old are you, Elizabeth?

HOLMES: I’m 21.

GUNN: You’re 21. And so, you were at Stanford. What were you studying there?

HOLMES: I was studying Chemical Engineering, but I was also involved with Electrical Engineering, and with some biosensing projects.

GUNN: Okay, so you were doing all this. Did you actually build a new technology while you were there? Or did you drop out to do that?

HOLMES: I actually did build other new technologies while I was there. I was working on a project for a major pharmaceutical company, a wireless biosensor, and I was working on another microfluidic project, basically dealing with fluids in very small volumes, which is relevant to what we’re doing now, and then, I actually left Stanford to go work in Singapore. Background on, I guess, story of my life, I have been studying Mandarin for a long time and have spent some time studying in China. I wanted to go back to Asia, but was interested in biotech, and so went to Singapore, because there’s a tremendous amount of resources that are being poured into research there, and got the opportunity to help develop a novel approach in microarray, and was looking at that technology and thinking about the type of sensors I’ve built at Stanford, and realizing that if you could integrate the ability to do high-throughput screening, meaning the detection of many different types of markers into a little teeny chip, like the ones that we had expertise building here, ah, you would really have a powerful sensor, and truly a platform with respect to the ability to say, “Look, we’re going to work toward monitoring anything, anytime.”

GUNN: What’s the status of the device today? Is it still just a prototype? Or are you, where are you?

HOLMES: Okay, our first applications are actually in monitoring acute painkillers, and that device is going into, sort of, the production phase. We hope to release it, actually, to a pharmaceutical partner around mid-to-late this year.

GUNN: So, you’re almost there. You’re almost in manufacture.

HOLMES: Oh, absolutely. I think it’s an iterative process, because what we look at is the ability to monitor different things just based on changing this little cartridge that slides into your handheld reader, so we’ve got the reader, now we’re developing a series of different cartridges for different purposes.

GUNN: (off-mic) That’s great. Now I think I want to do one more here. Um. Ah. (on-mic) Now, how much money have you raised thus far in venture capital funds?

HOLMES: So, in venture capital funds we raised just over 6 million, and then we’ve also raised money from private investors.

GUNN: Ah, hah. Okay, and you’re 21? [Yes] Okay. I’m gonna go to tell my two children, they better get off their duffs, Elizabeth. And I have one more question left for you. What are you going to do when you’re 30?

HOLMES: This. [haha] We have ideas, and actually, the way that we structured our company is to build what we call an innovation division, and already we have next generations of this product in prototype form in-house, and that is with respect to miniaturizing the system to make it faster, to make it more high-throughput, to put it into all sorts of different types of devices that can take us to the point where this is automated, and you don’t even have to touch your finger on the device.

GUNN: No pain. Elizabeth, this [No pain] No pain. No pain. [That’s the objective.] This has been terrific. Elizabeth, come back, see us all the time, every time, we really, (unintelligible) Elizabeth, come back and see us anytime, and we really look forward to seeing you.

HOLMES: All right. Thank you so much.

GUNN: That’s great.

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