A Conversation with Greg Simon
Amy Abernethy speaks with Greg Simon of the Biden Cancer Initiative about opportunities for innovation in the current healthcare system in order to accelerate treatment options for cancer patients.
Geoff Calkins: I'm thrilled to be introducing our next guest, we're being joined by a very well known name in the industry. Greg Simon served as the executive director of the White House Cancer Moonshot Task Force initiative launched by President Obama, led by Vice President Biden, and aimed to dramatically accelerate efforts to prevent, diagnose and treat cancer through innovative collaborations. Greg is now president of the Biden Cancer Initiative, a nonprofit building upon progress made by Cancer Moonshot. Greg joins us this morning to talk about their vision. We'll watch a short video and then please welcome Greg and Amy to the stage.
Amy Abernethy: Terrific.
Greg Simon: Thank you.
Amy Abernethy: Welcome. So I think what would be wonderful as we get going Greg is, you've been a life force in both Washington and in healthcare for a long time. Tell us a little bit about how you went from lawyer to BCI and also what motivates you in that process.
Greg Simon: Well, it certainly wasn't planning I can tell you that. I was an unemployed rock and roll drummer at 28 after being on the road for five years, and I was in the White House by the time I was 40. No parent wants me to talk to their children about career planning. It was actually a combination of some very simple things which a lot of people don't do anymore. Number one, answer your phone, because I got the opportunity after I got out of law school to be a lawyer on a congressional committee I had never even heard of until they hired me, because a friend of mine from law school was this staff director and needed a lawyer.
I showed up and a lot was going on, the Challenger blew up six months after I was on this committee, which was the space science and technology committee, the friend who hired me left I became the staff director after six months, which is unheard of. Jarvik was talking about the artificial heart, and Jim Watson was coming around lobbying us for the human genome project. And I was like, "Are you crazy? Do you know how long it takes people with that pipette to do those phosphorus thing?" And sequencing on machines weren't even talked about. So one thing led to another and I was in biotech when they started in the mid '80s, in genetic engineered food and organisms in the environment, and then when I ended up working for Al Gore by answering my phone, I got deeper into biotech but not healthcare so much.
But when I left the White House, I was asked to start an organization called FasterCures by Mike Milken and that's when I really got into how can we take this system we've inherited from previous centuries and bring it up to date. And the irony of getting into the Cancer Moonshot was I was working in New York, hadn't talked to the Biden's Chief of Staff in eight years and when I got this call, "Can you come see Biden to run the Moonshot tomorrow morning at eight O'clock?" And I'm like, "Well, I'm in New York, and I have an appointment with my leukemia doctor." Because I had just finished six months of chemo, which they didn't know in Washington.
And so the kid on the phone, he was a kid said, "Oh, no problem, you can come in next week." And I hung up and I thought, "What am I stupid?" So I called my leukemia doctor who's a great guy, he's a cellist, I'm a cellist. I'm a leukemia patient, he's a leukemia doctor, we had a lot in common. And I said, "Marty, I've got this invitation to go see Biden for the Cancer Moonshot but I was supposed to see you tomorrow." And he said, "What are you stupid?" And so next thing I knew, I'm working in the Cancer Moonshot and I'm working in the same office I had been in 20 years ago, which was kind of mind blowing, and when we left Biden asked me to stay on and do the Biden Cancer Initiative. So somehow I gave up drumming and ended up being in the cancer business and just to be authentic, decided to get cancer on the way. But I'm doing fine, I'm doing fine. Strange, stranger things happen.
Amy Abernethy: But answer your phone.
Greg Simon: Answer your phone. Since I left law school, two things about my career. I've loved every single job I've had, which is a rare thing to say. I always win the worst job contest for when I was a chicken gutter at a fast food frozen food place, that is the worst job ever. But answer your phone, and know when to leap because I took leaps into jobs that paid less and I was not qualified, because as a man I do not feel that I'm obligated to look at the qualifications in an application. And my wife to this day says, when are you actually going to get a job you're prepared to do? So it's a combination of opportunity and willingness.
Amy Abernethy: Willingness. So thinking about that opportunity and willingness, and now thinking about the Biden Cancer Initiative, two things that strike me, FasterCures, BCI, how does the nonprofit space think about pushing forward something so important as advancing how we think about improving healthcare? What does that look like for you?
Greg Simon: Yeah. So foundations do a lot of important things that companies don't want to do, but one of the things they do is they really build trust with the patients they represent. So cystic fibrosis, pretty much every family touched by cystic fibrosis was part of the Cystic Fibrosis Foundation, and they all contributed knowing that they were going to invest that money in a company that got, ended up getting bought by Vertex. So they invested $150 million over 15 years and they got a check for $3.3 billion after the first drug for cystic fibrosis was approved in over 25 years. So they brought trust in people to the companies that were doing the drug development work.
On the other hand, we didn't end the oil crisis by starting a foundation for the discovery of oil. So we need to figure out for cancer, alzheimer's and schizophrenia, how do we really capture private sector investment in these areas? Because at the end of the day they're the ones who make nearly all the drugs, and we need to meld the mentality of the foundations, and the trust they have with patients, and the perspective that they have from patients with the commercial sector, because we could save everybody a lot of time and a lot of lives if we didn't have this mental wall between the nonprofit world and the for profit world. It's getting very blurry now.
Amy Abernethy: It is getting blurry now. And you've talked a lot about this idea of building and rebuilding the whole ecosystem to move that forward. How do you think building and rebuilding the ecosystem, who are stakeholders that you think need to come to the table, can you talk a little about that?
Greg Simon: So, yeah. So as an example, 10 years ago when I was at FasterCures, I've kind of been on the, I love NIH, but I do not love a lot of what they do, that's just inertia from World War II. No, very few grants for women, very few grants for young people, very few grants for minorities, cycle times that don't comport with the real world. So I had written a report with David Baltimore and Gail Cassell from Lilly and Alan Leshner from AAAS, that we should take apart the NIH intramural program, which is $3 billion a year and make it into a crown jewel campus, not a another division three university, which is what it is now. And I get in trouble for saying that, but it's just not cutting edge. And it should be, and by cutting edge, I mean, they should, they did nano that was a good example. They convinced Clinton to fund vaccine development that's a good example, but now with immunology we need, there are a lot of questions that you cannot afford to answer it at your university lab. So NIH could do that.
Greg Simon: The other thing is, I was in England on my way to Morocco, I'm geographically challenged, and I was reading a book on crazy places in London. So how many of you know who John Snow is? Not Game of Thrones Jon Snow. John Snow developed chloroform, and he was in London in 1854 when 500 people died of cholera in one month, in one neighborhood. And of course London was basically built on an open sewer then. So he noticed that at a brewery that paid people in beer, none of the people got sick. So he went to the city fathers and said it's the water. And they said, "No, it's not. It's God. God did this. It's our sins." So he thought, "Well, it's the water." And so he went to the pump and took out the handle from the pump. And that's the saying in London is John Snow's pump, because there's no handle if you can't use it, and as a result the cholera epidemic stopped, and they figured out it's the water.
So that's how I feel a lot about the pump that keeps us from sharing data, that pump that makes people focus on tenure, the pump there that people focus on numbers of papers rather than impact of the papers. All of those pumps have been there a long, long time, they keep pumping out the same stuff, and we need to break the handle. There's no reforming it. I think you just have to come in with a whole new model, take the handle out of the old pump, put it in the new pump.
Amy Abernethy: So what's interesting is I think you've got an entire room of people that are energized by the idea that we can disrupt and do things faster, and find better solutions for cancer faster. Let's move that conversation around disruption to how you start to think within BCI and more broadly about data and technology. Where do you see data technology, software development helping to disrupt in the cancer space?
Greg Simon: Well first, the fact that data sharing and the use of data is such a controversial thing in cancer is pretty outrageous. I mean, if you think about the financial markets and the amount of data that goes into every transaction all over the world, and you can get that information immediately if you know what you're doing, it gives you a big market edge to know what just happened. In cancer, we know what just happened five years ago. And as I like to say, we make fun of hoarders. I had an uncle who was a world class hoarder. He was born, raised and died in the same house, and it was to the ceiling with stuff. And every 10 feet it was really cool stuff, but that 10 feet was garbage and then my dad's ticket home from World War II on the Queen Mary, my grandfather's ledger all the members of Congress about how to end the depression in the south. But it was all, all of that stuff had been in that house his whole life. And that's what all of our medical institutions are, they're my uncle.
The data is born there, lives there and dies there, it never leaves the building. People think if they take the data for a walk to ASCO that they're doing something wonderful when all they're doing is taking it for a walk. So how do we really enforce with people that this isn't just data about stock transactions, which is immediately available, this is a data about human life and health, which is the most important asset. So we can't get from data, to information, to knowledge, to wisdom if we don't share the data. And every other science goes, yeah, cancer is really bad. I was talking to your cardiologist, "Oh man, cancer is really bad." And I'm like, he says, "We've been sharing data in cardiology since the Framingham study, and all the astrophysicists use the same telescopes, they have to share data." There's just, it's just got to happen and there's no problem with it that can't be solved by three good people sitting in a room figuring it out. I really believe that.
Amy Abernethy: So one of the things I'm really proud of is in this room, people are actually sharing not only ideas but ideas about how they're working with the data and how we're going to move this forward. Within BCI you've had a number of activities intentionally trying to stoke sharing as well as the creativity that goes into working with the data. Do you want to talk a little bit about that?
Greg Simon: Yeah. So our mission is to, like the Cancer Moonshot was, was to double the rate of progress in preventing, detecting, diagnosing, treating and surviving cancer. And to do that, and because we work with Joe and Jill Biden, we have this incredible convening power. So we picked six topics that we think really make a difference in creating a new system, data sharing, data standards, clinical trials, patient navigation, prevention, and access to care.
So we have really smart people like you on our advisory committee that we've carved into working groups, and we asked them, don't start with a blank piece of paper, find something that's working and then figure out which one that is most likely to scale, bring it back, work it over, and then with the Biden’s visibility and your brains, how do we get people to adopt it and scale it?
Because a critical moment in all of our careers is explaining what we do to our mother. And my mother just couldn't understand what I was doing because every time I told her what I was working on, she said, you mean they don't do that? Mom, I'm getting people to share data. You mean they don't share their medical data? Mom, I'm trying to get them to have standards about how they do pathology, and how they do responses to drug. You mean they don't have standards on how do they know what they're doing? And so I finally just said, "Mom, we're trying to create the cancer research and care system that you think we already have." And that's really the truth, because until you're in the system you don't appreciate how much you do not have that system, and the more you're in the business, when you get sick, God forbid, and you go in the hospital, all of that knowledge doesn't do you any good because they've got their way of doing things and you are a trouble if you try to change it, especially from the wrong side of an infusion needle.
So the working groups we have are doing terrific stuff, and then we will bring them back, work them over with our board and with our advisory committee. But the fact of the matter is, everything about our lives has changed dramatically in the last 40 years except how we do medical research. And that's just unacceptable. And the way we, smart phones, and computing, and telecommunications, we're still using a system where you couldn't copy anything. We're still using a system where you share a big annual meetings and the rest of the time you're on your own. This doesn't make any sense, and it's killing people. And that's probably the worst thing is that we're losing people to treatable cancers because of the system not seeing them and not doing the right thing, just the way planes crash when the flight attendant doesn't want to tell the pilot that the wings are in the wrong position because surely he knows what he's doing, right?
Amy Abernethy: Right. Well, so let me ask it. Like we were talking over there about one of the examples of how you're stoking forward, a sharing activity, and what it actually looks like. And I think for the audience that would make it very tangible. Do you want to talk a little bit about what's going on for example, in the PD-L1 biomarker piece?
Greg Simon: Yeah. So I was at a meeting with five of the biggest cancer centers with one of their funders, so they're like trying to tell the truth. And as Trump says, I try to tell the truth when I can. So I asked them how many of you trust pathology reports from these other institutions? And one head of an institution said, I don't trust them from my institution. So we started looking at how can we help develop standards for things you think we already have standards for, and what we came up with was, what's happening now is you have 1,200 trials in immunotherapy, which is almost immoral to the patient population because a lot of those trials are not going to be done well or done right, that's a lot of people. And the question is, how do you measure a response to a checkpoint inhibitor?
Well, each company develops their own tests for this. And when they, when somebody put them all together to see if they were congruent, there was only a 15% overlap in the results. Well, that's bad for patients, it's bad for the FDA, it's bad for the company. So we're working now with the National Institute for Standards and Technology, and a whole bunch of people in immunology to come up with, how do you set a standard to measure response to an immunotherapy drug? PD-L1 will be today, and when we get that process done, we would go to the FDA and have them adopt it, and you'll put it out for comment and then enforce it. But there will be other markers. There's tumor mutational burden, there's something called STK that predicts non-response to an immunotherapy drug, which is really important, because we don't want to give you a targeted autoimmune condition if you're not going to respond well. You'll just get diabetes and it won't do anything about your cancer.
So this is really important and the companies realize it's important and they're working with us, and that is a critical, critical thing. Just like when we were in the Cancer Moonshot, we created a blood profiling consortium to do liquid biopsies to predict cancer, and it was companies, the FDA, Walter Reed, a lot of technology companies, putting together an atlas of what's meaningful and what's not meaningful when you measure cancer cells in the blood.
Amy Abernethy: So drilling on the companies that are working with us, how do they work with you and what does that look like?
Greg Simon: So it's funny, because the good news is because the Biden’s have such an authentic motive for being involved, which is a very sad one. People are more than willing to work with us because they trust the Biden’s are trying to do the right thing. And there's no other agenda, we don't give out money, we don't lobby regulatory agencies, et cetera.
So what we find is people kept showing up, companies, consulting companies, technology companies, how can we work with first the Cancer Moonshot and now the Biden Cancer Initiative? And we said, we're only eight people, we're kind of crowded in here, we're in a shared workspace, but if you want to work with us, tell us what you're doing and how you plan to double its impact, and if we can help you by introducing you to people or with ideas, that's how you can work with us.
So companies started coming saying, we want to be part of your clinical trial reform movement. We want to be part of the blood biopsy consortium, we want to be part of this standard setting thing because they need a neutral corner, they know that we're trying to do this in a practical way, we're not coming at this from a theology. And oftentimes people want to do too much with this and we don't have the bandwidth for that. But if we can help start conversations with pharma for instance, around pediatric clinical trials, and around these new standards for immune response, they're not going to come to a meeting with Biden and lie to him. They're going to come and say, here's what we're doing, here's our problem, and we've had several meetings with industry, and it's very candid exchange as they say in the diplomacy business, but they know that he's coming at it from a, how do we all work together standpoint. And if you're inside Pharma, that's a breath of fresh air.
Amy Abernethy: So the other part that's interesting to me is how fast it's moved. So as I think about it there's two aspects to that. One is it's been moving so fast that people don't want to get left behind, so that's really good. And then the second is it's been moving so fast that then also allows you to now intersect with the next place, such as the FDA. Can you talk a little bit about the kinds of things that you've seen happen in this very short period of time in terms of movement and speed?
Greg Simon: Yeah. It's been fascinating. When we were in the White House, we had 80 something collaborations we put together between February and the end of the year. And by collaborations, I mean people doing real things now, not a white paper that we're going to do this in three years. So whether it was a donation for survivorship training for nurses, or Lyft and Uber providing free rides, people were collaborating around the patient journey, because at the end of the day, the question I ask everybody, whether it's a government agency, an individual, or a company, or foundation, the question I ask is how do you touch the patient on their journey in cancer? And if you haven't thought of it that way, think about it that way and then come back and tell me. And people surprise themselves when they really think, where do I touch the patient in their journey?
So when we just had our most recent summit that you saw on the video, September, we had another 57 collaborations. Everything from Airbnb allowing you to give away your room to a medical patient, using the Airbnb infrastructure for free, or a new organization designing clinical trials with Lynch Syndrome patients.
Lynch Syndrome is a genetic condition that brings on colorectal cancer and endometrial cancer in 20 somethings, letting them design the trial. We have international collaborations around proteomic and genomic data, we have a collaboration with the Global Ventures for health and for cancer in Africa. So if you ask people what can you do to double your impact on patients in their journey, they will surprise you. They just have never been asked that way.
Amy Abernethy: So let's actually move to the conversation around patients. And I think that there are two areas that might be particularly interesting and intriguing to this conference. One is as it relates to how as BCI you've been thinking about clinical trials and clinical trials in patients, and you want to kind of start to explore that with us?
Greg Simon: Clinical trials. Wow, so all the people trying to, there's so many companies trying to match the right people to the right trial, and I tell them it's like Blackjack. You have to sometimes play a card in blackjack you don't want to play, but if you play that card a hundred times that way you'll win 51 out of a hundred, but those 49 are really painful. So when I watched clinical trials try to relate to patients, the 49 times out of 100, they're not, and that's a really bad ratio.
So there are several big issues with clinical trials. Number one, it has gone from being an altruistic endeavor, which was unethical to talk to patients about as treatment, to being a form of treatment. And the old guard just can't stand this, but it's true in cancer, 75% of the first therapies fail, there are many conditions for which there is no standard, there are many standards that don't work very well, a lot of the treatments are off label. So what you end up with is the clinical trial is your only access to that drug in your last months.
And you've met Stephanie, I think a young woman who was on her deathbed, sent home to die by Sloan Kettering at 25 years old with stage four colon cancer from Lynch Syndrome. And her sister found a clinical trial at Hopkins online, and her sister is just a person, not a doctor. And it was an immunotherapy trial, and it melted her tumors, and she's the happiest person you're ever going to meet. So clinical trials have had a major change in function number one. Number two, is the joke I told Amy earlier, was clinical trial experts will say that every trial is delayed by six months after it's ready to go, in the trouble of finding patients.
And so I was interviewing somebody who said this one time, and I said, "Well, let me be Stephen Colbert just a minute. Why don't you start recruiting patients six months sooner?" And the answer is they don't think about it, they don't think about it. They're thinking about the scientific medical part and all the rules and regulations, and then they go, "Oh, let's find a couple of hundred people who are willing to have a stick needles in them."
So when I was at Pfizer for two and a half years in the middle of all this answering the phone, we did two really important things. We sent thank you letters to people who were in clinical trials. We honor the military at every ball game because they put their lives on the line for us, so do patients in clinical trials. So we sent them a thank you letter, they were astounded, doctors were astounded. Other pharma companies I told were astounded, and I'm like, where were you raised?
And then we gave the 150,000 patients who go through a clinical trial for Pfizer every year the option to opt into a network to get feedback to Pfizer about their experience in the trial. Was your medical care better? Was it too painful? Did you know what to expect? Do you know what happened in the trial? You would never take a trip if you didn't have as much information as you do about your plane, your hotel, where you're going to sit.
We put people in clinical trials, they don't know the first thing about what's going to happen, how long it's going to be, how many times are they going to get stuck with a needle, who's going to pay for my lost work, who's going to pay for my kids? We just say, you want to be in a trial? And they kind of focus on the trial part and go, I don't think so, and we can't blame them really.
So we're trying to make it easier for people to first find trials in their zip code, explain what the trials are about, explain what the expectations are, what their responsibilities are, and work with patients to design the trial. Patients have a very different view. Atul Gawande's most recent book 'Being Mortal', if you haven't read it, you've got to read it. Because he says the problem is with the end of life care, is we never ask the one simple question before we start dealing with the elderly, “how would you like the rest of your life to go?”
And if you ask a cancer patient that, you get a very different answer than a doctor would give you. So we've got to start listening to them, and the other thing I have to say, which I find funny as a lay person, even worse as a former lawyer. When we talk about real-world evidence now being allowed at the FDA, I'm like, what were we using? Unreal world evidence, real unworld evidence, real world non-evidence? And the answer is we were using people that look like pure-bred white mice, people with one condition who were otherwise healthy. That doesn't happen. I have glaucoma and chronic leukemia, and the leukemia gave me squamous cancer cell, none of us is one thing. So real-world evidence, hello. Thank you, we're glad you're here.
Amy Abernethy: Let's keep it! So following on that real-world evidence and patients point of view, talk to me a little bit about how you think patients perceive robot evidence besides no duh, and this issue of using data that's currently existing in service of real-world evidence generation, and maybe even the question of privacy in there.
Greg Simon: Yeah. So, well, let me start with privacy first. Privacy, schmivacy. I have yet to meet a cancer patient whose biggest concern is privacy. Their concern is surviving, their concern is that the right person won't see their data. They're not worried that the wrong person will see their data because they already know they have cancer. So they're not, privacy is important that people don't talk about you in the coffee break room, or they send your stuff to Page Six. But in terms of privacy, anything that people do have to do with privacy that delays their getting care, and then delays getting access to their medical records, and delays getting second and third opinions is a total misunderstanding of HIPAA. End of that rant.
So from the...I think as a former patient and as, well, I'm still a current patient actually. Patients don't know what to think about the medical system because just one example. If you've ever had a really serious medical problem, you probably first talked about it to your friends, your spouse, or someone who cares about you. And then they say, well, you'll get over it, or you really should go to the doctor on that one. And then when you go to the doctor, you're kind of intimidated to describe, because you only have that 10 minutes, and they got that coat on and they're looking at you, and who do you end up talking to? The nurse and then the pharmacist. So patients don't think, I mean I'm the same way. I don't spend a lot of time calling my doctor and saying, these pills I got made me feel this way or that way because I'm never going to reach my doctor. So I'll talk to the nurse practitioner's office, if I know my pharmacist as I used to in a small town, I talked to them about it.
So for patients, what they consider important they do not see reflected in the medical system. Once again, when we were at Pfizer, we brought in rheumatoid arthritis patients to meet the researchers in Groton, Connecticut who were working on rheumatoid arthritis. They had never met a patient with rheumatoid arthritis. It's like Christopher Reeve used to say he was the first person in a wheelchair that people working on spinal cord injury had ever met. So the researchers at the end of the day said two things. One, we had no idea how painful people found it to give themselves an injection. And secondly, we had no idea how many people couldn't afford it.
Amy Abernethy: Interesting.
Greg Simon: So patients are dying literally for their viewpoint to be absorbed in the system and change the trajectory of everything we do.
Amy Abernethy: So one of the things that makes me think, is that we focus right now on data coming from the electronic health record as a foundational data set.
Greg Simon: Yeah.
Amy Abernethy: But you've just reminded us that many of the viewpoints that are critical here are sitting elsewhere. How do you imagine going and finding those viewpoints, what do you think are the ways that we can merge data sets and start to make sure we've got a fuller picture?
Greg Simon: Somehow Amazon knows every book I'm reading, every video I've been watching, and they know how to get stuff to my house overnight. So somebody knows how to use data, when they want to follow you around they know how to use data. The moment I found myself on a network in Morocco, I started getting the harassing cell phone calls again, they found me. So there's a big misconception about data sharing. In the current world, it can stay in your house and still be found by all these other people because it can be tagged, and it can become part of a federated virtual database. So the key is how do we measure what data is there and how good it is? So what we have to define data, it's not just whatever you put in there.
How do we want to organize that data so that people can share knowledge, not just data? Like tumor board knowledge, it's like Marty Tenenbaum's done. Where he says, "We need to get all the tumor board studies and opinions and deliberations, and share those because that's real knowledge about how to treat this cancer this day." That's really cool thing to think about.
But the bigger picture with data is, as Jill said in the video, we already know so much that we don't know we know. This is true as individuals in our own personal lives, your memoir is always smaller than your reservoir of memory, and it's true as a society, we know more than we consciously know. And the only way we're going to use that information is to purposefully and aggressively let more people see it because they will see things in it that you don't. And just the study with ovarian cancer that found that the distinguishing feature of people taking the same drug in their five year survival was who was on a statin. It wasn't a question, it just happened to be the thing.
Amy Abernethy: So the kind of follow on point from all of this as we think through it is, all of those different datasets about us are important and should be a part of our own individual ecosystem of data. But it's got to be organized and prepared and of high enough quality. Do you anticipate Biden Cancer Initiative pushing forward in that space as it relates to data quality and other activities?
Greg Simon: Absolutely. First you already have a legal right to get your medical record data, but very few people know how, they don't want to go through the trouble. So we're definitely working to help popularize what your rights are as a patient. We just joined Eric Lander with Count Me In, which is for metastatic breast cancer and a few other cancers, and making, having people share their data with this huge database at MIT, and the Broad Institute.
The problem has always been that so much of what affects your health today was five or 10 years ago and you'd have no idea where that data is now, because the systems let's say they basically started around 2009 with the Economic Recovery Act. Well, I'm 67 years old and two weeks, most of my life was before 2009. I have no idea what was in my childhood record. I have no idea when I had my tonsils out, when I had surgery, I have no idea what they, what else they found.
So what we're trying to make people realize is when you go to the doctor and you sign an informed consent that says they can have your credit report and they can have your insurance, you need to ask them to commit to you that they will share your data with anybody you tell them to, whenever you ask them to, and fast. And we have a birth certificate that's governed by law, we have a death certificate that's governed by law. We need a life certificate that's governed by law that says everything that medically happens to you in your life should go into one record that you have access to all your life without you having to be a data scientist to figure it out.
Amy Abernethy: Interesting. So as we think about where the whole real-world evidence space ultimately goes, these initiatives ultimately going to contribute to that space in the future and as they're stoked along, wrapping back to one of the things that you said before, like how companies get involved and help. Part of it is that they stoke some of these conversations as you pointed out. Activities like we've got a lot of life sciences companies here in the room today, do you have advice or requests of what they can do with BCI right now to move the real-world evidence space forward specifically?
Greg Simon: Well first, people need to make it just de rigueur that they're going to be sharing clinical trial data with the world regardless of the outcome of the trial, that soon as it's audited you know it's real. That should not be something people think about, it should be automatic. Secondly, people need to start talking to patients long before they get into the therapeutic area to find out if what you think of as an endpoint, patients think of as an endpoint. And you're not going to get the patients trust at the end of the process, you get it at the beginning of the process.
A friend of mine has a company that crowd sources clinical trial design of off patent drugs by putting the properties of the drug on the internet, and then people write in a protocol they think would be appropriate, for in this case, MS. And 10,000 people did that, 600 stayed on as advisors and the FDA eventually approved this protocol that was crowd written.
So we need to, if I were a life science company, my most important human capital would be my patient advisory group. Absolutely, because they're going to surprise you guaranteed. And in terms of working with us, we're interested in access and cost of care, so we need a real honest discussion about the value of medicine. We are adamant about the standards of its approach, and anybody who's developing an immunotherapy drug needs to be part of the standard setting process.
Amy Abernethy: They should be a part of your team.
Greg Simon: Absolutely. And there are no lone actors here, this is a group sport. It's a group sport. Part of the group is the patient, part of the group is the company, part of the group is the government, and if you don't take it that way you waste money, waste time, and you're not going to get to patients fast enough.
Amy Abernethy: So in the last minute, BCI has done a remarkable thing, and moving things forward in the U.S. in literally like two years, the things that you've moved forward. How do you see your responsibility, our responsibility on the world stage, and also how do you interact and bring in what's outside of the United States and the best of the best into your thinking here?
Greg Simon: So when we were in the White House we did 12 memoranda of understandings with other countries around proteogenomic data sharing. And while we've been in the Biden Cancer Initiative, Vice President Biden spoke at a proteum conference in Ireland. He just opened an international health institution at Imperial College in London, we're working with Cancer Research UK and a lot of things.
Here's the challenge. When I go give a speech in Sweden and I realized that they don't have to worry about the cost of cancer drugs, it changes the conversation immensely. Changes that immensely, because the biggest problem I have here is that even if a $300,000 drug is knocked down to $100,000, the co-pay is still out of pocket, is out of range for somebody making $30,000 a year.
But here's the biggest problem I've run into. I've been on two panels with African doctors, and breast cancer’s deadly there. Why? Because everybody knows that every time that somebody has breast cancer goes to the doctor they die. Why do they die? Because they've seen seven other people on average who were not helpful at all, minister, tribal leader, before they got to the doctor. And so a treatable cancer becomes untreatable.
So when you talk about patient activism in Africa, it's much, you can't put it on the patient. They don't know that they should go to the doctor first, not the minister. And so the medical community has to really be out there. And that was a real eye-opener for me, it was very sad. But cancer is a global problem, it's a global solution, and just as every other industry is global, we need to share data here as a global enterprise so that we can create this system that mothers in Germany and Australia think we have.
Amy Abernethy: Totally agree. Thank you very much, and we really appreciate your time here.
Greg Simon: My pleasure. Thank you.
Amy Abernethy: Thank you guys.
November 7, 2018
- Greg Simon, JD — President at Biden Cancer Initiative
- Amy Abernethy, MD, PhD — Former Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health