Learning Curve

Michael Caputo:  Hello and welcome to Learning Curve.  Thanks for stopping in.  If you've listened before, thank you very much.  If you're new to this, you better come back and listen again.  My name is Michael Caputo.  I am assistant secretary for Public Affairs, the United States Department of Health and Human Services. 

As the host of Learning Curve, I'm bringing you along as I talk to the brilliant people that I meet as I'm working in my position as assistant secretary here in Health and Human Services.  I came to this job without a real deep knowledge of healthcare, and I actually have the advantage, a blessing in fact, to learn about healthcare through the smartest people I've ever met in my life.  And I bring them on my podcast so you can meet them, too, and enjoy my learning curve as much as I'm enjoying it. 

And today I'm really honored to have with me Dr. Moncef Slaoui, who is the chief advisor to Operation Warp Speed.  Dr. Slaoui, thanks for joining us.

Moncef Slaoui:  My pleasure.  Thanks for having me.

MC:  My pleasure, really.  That's, you know, people out there are listening, understand, that you're not from Alabama when they hear your accent.  That sounds vaguely French to me.

MS:  Yes, well I grew up in Morocco speaking Arabic and French.  Those are my two mother tongues.  So, yeah, there is an accent in there.  But I've spent two-thirds of my life outside of Morocco.  A little bit more than two-thirds.  Mostly in Europe, in Belgium, and in the U.S.

MC:  So what was life like growing up as a young man in Morocco?

MS:  Well, I grew up in a well-educated, well-to-be family.  And I was always very shocked by the social differences in a developing country in the 1960s.  The differences were very, very pronounced between different parts of society.  But, you know, the weather was great.  I was a reasonably good student and a good kid.  I think.  So my parents tell me.  And so it was comfortable and smooth but always attentive to people that couldn't afford healthcare, for instance, or couldn't afford education.  And that has actually set my principles in life for the long-term.

MC:  It's interesting because you actually went into a business and an industry as a scientist that gave you an opportunity to actually serve those underserved populations.  And, from my perspective, vaccines, which is really your background, are really designed, especially in the COVID environment, the coronavirus environment, to serve the underserved.  I mean, look at the people who are deeply affected by the virus, it's the elderly, it's the low-income communities.  We're learning more and more about this virus.  But Operation Warp Speed, the people who are listening, want to know more about what Operation Warp Speed is.  What is it?

MS:  Yes, so Operation Warp Speed, for me, is a continuation, as far as my personal decision to join it, of my interest and effort to really make sure that the remarkable progress that medicines and, you know, pharmaceuticals, and understanding biology, and the basic sciences, are affording today in terms of improving human health and life.  To make those technologies and those progress available to those who can't afford them. 

Operation Warp Speed is really about the, I would say, the ultimate solution or resolution to controlling the coronavirus pandemic. 

MC:  Right.

MS:  Through vaccination, at the end of the day, but in the process of making the vaccine also through identifying therapeutics.  And --

MC:  These are treatments for COVID, right?

MS:  Yes.  So we are focusing on either accelerating treatments to be developed and help patients live -- save their lives, decrease their hospitalization time, prevent them from getting hospitalized.  And then, at the same time, accelerating the development of vaccines that will ultimately allow us to reopen society and live life like we used to live it. 

MC:  You come at this with incredible credentials.  You have a Ph.D. in molecular biology and immunology from the University of Brussels, Belgium.  You have postdoctoral studies at Harvard Medical School, Tuffs University School of Medicine, and you were a professor of immunology in Europe, specifically at University of Mons in Belgium.  And you also have an MBA from IMD in Switzerland, a top school.  And you spent 30 years at GlaxoSmithKline in a number of different leadership positions.  I haven't spent 30 years in one place in my entire life.  I can't -- 30 years at GlaxoSmithKline.  That must have been an incredible experience.

MS:  It was amazing.  I loved, frankly, every day of the 30 years.  I don't miss it today.  I retired, but I loved every day of it.  I learned everything I have done through those 30 years.  Discovering vaccines, discovering how teams can be made to work at the level that you can't ever achieve on your own.  Discovering medicines.  Discovering big business.  Discovering the social responsibility aspects of what large companies have to do and take care of, particularly those involved in health care.  It was an incredibly enriching experience.

MC:  And mostly in research and development, right?  You were in -- you were chairman of the pharmaceutical research and development, you were chairman of global research and development, vaccines and oncology.  I mean, you've run the gamut over at GlaxoSmithKline.

MS:  Yes, I was fortunate to work for 15 years in the vaccine division of GlaxoSmithKline.  I was running research and development but also over time running different aspects of the business.  And then the next 15 years of my 30 years, I joined the pharmaceutical part of the corporation and run global R&D for GlaxoSmithKline, but I was also on the board of the company and effectively their number two leader at the corporation in partnership with the CEO.  And looking over all after the vaccine business.  So there was a very interesting mix between the science, the business, and the social responsibility of a large company.

MC:  I mean, this kind of a record, all these degrees you have, and all these seats you've had, and, you know, supervising position you've had, as well as your work since you retired from GlaxoSmithKline as a private investor, et cetera.  You've got to be what, a 125 years old? 

MS:  [laughs] Actually, I'm just 61 a few days back.  And --

MC:  Happy Birthday.

MS:  Thank you.  And, yeah, I mean 30 years, you accumulate incredible experience.  And also since I retired, I had the privilege to join a number of company boards to help those companies grow.  Some of those companies are heavily involved in the coronavirus response.  I left those boards since then, of course.  And I also joined a venture capital firm.  My interest is really to continue to enable innovation, to penetrate the healthcare system, either through medicines, or vaccines, or diagnostics, or whatever it is.  To improve human life and health.

MC:  In fact, you spent a lot of time developing vaccines at GlaxoSmithKline and elsewhere that are really focused on the underserved, the, you know, the lower income people.  I look at the list: Cervarix, to prevent cervical cancer, Mosquirix -- if I mispronounce one of these, please tell me, a candidate to prevent malaria, Rotarix, to prevent rotavirus gastroenteritis.  I said that correctly, right.

MS:  Yes.

MC:  Shingrix, to prevent shingles, and Synflorix, to prevent pneumococcal disease.  Not only do I not know what these are, I have trouble pronouncing them.  These are, some of them, some pretty damaging and deadly diseases, aren't they?

MS:  All of those are --

MC:  Yeah.

MS:  -- very damaging and deadly diseases.  And what's important to note is infectious diseases are very -- are an equal opportunity disease provider.

MC:  Especially among vulnerable populations.

MS:  Actually, amongst all populations.

MC:  Right. 

MS:  What happens as we develop vaccines, one of them is especially for vulnerable populations, but what happens is in the developed world, we have different strategies to diminish the impact of these infections.  So for instance, if I take rotavirus infections, this infant gastroenteritis, what it takes -- if you have that in your baby, if you don't hydrate the baby appropriately, if you don't take care of them appropriately, they die.  And that virus used to kill about half-a-million infants.

MC:  Good lord.

MS:  Mostly in the developing world.  That disease is as frequent, for instance, in the U.S., but the infants don't die.  They may be hospitalized.  They may be ill for a day or two and then they recover because they're well taken care of.  So the vaccine actually serves a global population but has the most impact in those who can't afford appropriate healthcare systems. 

MC:  Well, I mean, your work in under-researched diseases earned you the recognition from Fortune magazine of one of the 50 greatest world leaders.  I know you've gotten a lot of accolades in your career.  I mean, it's that kind of recognition for your work that brought you to the notice of the president of the United States, and which brought you in to be interviewed to be the chief advisor to Operation Warp Speed.  And you bring extensive experience in vaccines and medicines to Operation Warp Speed and this whole long career in the field of life sciences.  And when you got the call to come and interview, when you actually sat down with the president of the United States, how did that impact you?

MS:  Well, first I mean regarding the recognition.  It was specifically around the development of the malaria vaccine, Mosquirix.

MC:  Right.

MS:  And it's a vaccine that we took 27 years, 27 years, to discover and develop.  And whether as a bench scientist when I started in GSK, 30 years back then, or when I was on the board of the company and the number two leader of the corporation, I always committed the same level of resourcing and support to making that vaccine available for disease that exclusively impacts Sub-Saharan Africa, and some parts of Latin America, and Southeast Asia.  Very, very poor populations, for which we committed to make it available to those population at cost.  So it was very, very important for me to effectively, truly translate the progress of medicines and technologies into a vaccine that is exclusively for those who are the most underprivileged. 

When I got the call to potentially join the Operation, Operation Warp Speed, I at first told myself, oh my god, I can't say no to this.   

MC:  Right.

MS:  Then I told my wife, oh my god.  I, you know, I've been retired for three years.  I have a pretty comfortable life doing what I'm doing, investing, and being on board.  Do I want to change this because I know it's going to be an incredible -- incredibly intense process?  However, the attraction of sharing everything I know and I can do with others to help resolve this incredible pandemic, and its amazing impact on not only the U.S. population, which I'm part of, but the world.  That was irresistible call, if you wish.  So I took my car, and drove here to have my interview, and discuss, and it was a done deal, frankly, before I came into the room because this is what I love to do.

MC:  Right.  And when you say you drove, you didn't drive from Seattle -- you're from Philadelphia. 

MS:  Philadelphia, yes.

MC:  Right.  You miss Philadelphia?

MS:  I miss my family and my friends.  You know, now I'm staying in a small apartment hotel.  And I don't have friends here, but the good news is, I don't have time to spend with friends anyway.  I frankly work --

MC:  I'll be your friend.

MS:  -- all the time.  Thank you.

MC:  [laughs]

MS:  I'm a very, very early bird. 

MC:  I know.

MS:  I get up at 2:30 or 3:00 in the morning and do some work.  The good news is some of the companies and people we work with are also based in Europe, or Australia, so I often go out for a run, and a walk, and calls while walking, not running.  I run between calls.  And then by 6:00 a.m., I get myself into the office and work until the end of the day.  And then it goes onto the next day and next day.  I go back home on the weekends.  I have a 7-and-a-half years old boy, who I miss, and he misses me, of course.  So, you know, it's demanding but compared to the impact of this pandemic, this is --

MC:  Yeah, but 7-and-a-half-year-old kid, I mean, those are the golden years for a dad.

MS:  Yes, they are, and I miss them, and I miss him, but this mission is very important.  And, you know, I just let go of everything I'm doing, literally, on May the 15th, and since then this is all I do. 

MC:  Good lord.  You know, it's -- I'm amazed over and over again at the sacrifices people make.  You know, I've talked all the scientists, you know, I've done a lot on here on Warp Speed.  If people are wondering, I'm talking to Dr. Moncef Slaoui, who's the chief advisor to Operation Warp Speed.  I'm Michael Caputo, the assistant secretary for Public Affairs, and I am in a really blessed position to be able to talk to all these folks who not only are at the pinnacle of their careers, but they're sacrificing so much.  And because this is the Trump administration, you don't realize it, I guess, maybe when you were offered the position, but part of the deal is you go ahead and you fasten a target on your back, don't you?

MS:  Yes.  Honestly, I think I was naïve when I made the decision.  And I wouldn't change the decision anyway because the problem that needs to be addressed is bigger than anything else I can think of on earth, literally.

MC:  In your career?

MS:  In my career but also just the world.  The world has almost stalled for two or three months, and we tried to reopen it, and we may have to stall it again.  This pandemic has a dramatic impact, the consequences of which will last for a long time.

MC:  Right.

MS:  And we have to do what it takes to help resolve it.  I am very disappointed -- or, first, I've been very surprised and then extremely disappointed by the fact that having made a decision that has nothing to do with my political motivation or opinion, because I think it's irrelevant in front of the size of the problem, I made a decision to come and help solve a problem, whoever is the president, whatever is the administration color.  And I'm amazed that I'm being attacked on a personal basis.

MC:  Right.

MS:  In a way that, frankly, distract my energy and energy of all the teams that we're working together with to deliver.  And therefore, decreases our chances or the speed with which we try to help humanity and the country resolve and address this issue.  I was very naïve.  I thought that, you know, the press in particular was informing, but I now convinced factually that the press has only one objective, which is to shape opinions and to distort information in a way that allows to shape an opinion.  And I find that unethical, extremely disappointing.  And I hope it -- I really hope society will drive towards changing that back to more normalcy.

MC:  I'll tell you, as someone who's been in press relations for 35 years, I don't recognize the media anymore.  I'm convinced that the reporters don't want a vaccine, sir.  They don't.  I know that you're still -- maybe you were naïve, but you're still a very optimistic person.  I'm telling you that there are members of the press that don't want a vaccine.  And you see that in the coverage, I think, of Operation Warp Speed.  I remember sitting down with you when you first arrived.  You were in the conference room, you were going through your paperwork, in-processing with the government is quite a duty.  I remember you telling me how you'd never been through anything like that in your life, and the ethics examination that you went through was fairly fundamental.  You know, I'm -- people in American don't understand the chief advisor to Operation Warp Speed is being paid $1, $1 for the entire project, $1.  Let me ask you Dr. Slaoui.  Where did you spend that dollar?

MS:  Well --

MC:  How many places did you spend it in?

MS:  [laughing] Well --

MC:  It's ridiculous.

MS:  Yes.

MC:  It is, sir.  I mean, we know that upon accepting your position with Operation Warp Speed, you left all the advisory boards and boards of directors of companies that even remotely could conflict with your service as a contractor to the Department of Health and Human Services.  We know that any shares you own were with companies that you earned as -- during your successful career.  You're not a buyer and seller of stock.  You're not a day trader, you know.  And, you know, these were part of your remuneration while you were at GlaxoSmithKline and other companies.  In fact, you sold your shares in Moderna, the company that we hear about right now, and I want to talk to you about Moderna.  They're actually going into critical level trials with a vaccine that has real promise.  You sold your shares in Moderna.  If you had not taken this job, and you kept your shares in Moderna, you would be several million dollars richer today.  Today.  In fact, you walked away from those shares, sold them, and you donated -- or committed to donating, all the value that was gained after the announcement of your involvement, and your actual sale of the shares, to cancer research, and National Institutes of Health research. 

I think you've absolutely eliminated the opportunity for any financial gain coming out of your role in Operation Warp Speed.  Any reasonable person would know that.  Yet, we see front page articles in the New York Times.  Other articles in the Washington Post, from reporters who have trouble counting change, who are trying to count your wealth, who don't acknowledge the fact that you have accepted immense losses financially in order to take this job that pays you $1, that keeps you away from your family, that keeps you up all day long.  Sir, I don't know anybody in this building that works harder than you do.  And we see these stories over and over again.  Why the hell do you continue to do this?

MS:  Frankly, because it -- well, first what you describe is absolutely right.  And, as I said, extremely disappointing.

MC:  I mean, you've gone well beyond what requirements there are federal law.  Well beyond.

MS:  Yes.

MC:  The ethics regime here in HHS is the most robust in the American government and they signed off. 

MS:  And also, I have to say, I have a personal compass in ethics and people who know me personally know that.  And I have never been about the money, ever.  Nothing I have ever done was about the money.  I was fortunate to have very senior roles that I believe I have totally earned the right to have them, that were well paid, and therefore I have amassed the wealth, and people can see the way I live, and what I do with my wealth, if they are interested.  But it's been extremely painful for me that anybody would even think that I took this job to enrich myself or my former colleagues, or -- I mean, it is insulting to the deepest of my personal fibers, and crosses all my ethical lines.  If I had the possibility, I would like someday to sit down with the journalist that wrote that, and look at that person in the face, and ask that person, "I know what I have been doing for now, ten weeks in this role, day and night.  I know what I'm doing every day to try and help all the population, including you journalists.  What have you been doing?"

MC:  Right.

MS:  How are you helping in this pandemic?  What is your objective?  Why are you doing this?

MC:  What is their role?

MS:  And what evidence do you have that I would be doing anything wrong?  I have done everything, and I am prepared if somebody has an interesting idea that does not destroy my retirement, because there's no reason for me to destroy my retirement, I'm happy to listen to any ideas.  And I said, any accretion in value of everything I own that has anything to do with COVID, which is my GlaxoSmithKline shares, any accretion in value by the end of my mission will look -- if there has been increasing value with it, I'll sell those shares, and I'll give that incremental value to the NIH for research.

MC:  Right.

MS:  I have no interest in making any gain.  As you said, I maybe out of a job for six months or nine months, I don't know how long it's going to take in this role, but I'm not making a penny.

MC:  No, you are.  You're making 100 pennies.

MS:  Yeah, I'm sorry, you're right.

MC:  You're making 100 pennies.

MS:  I'm making $1, which I --

MC:  We're going to pay you with pennies, by the way.

MS:  Yes, maybe at the end of the process, but I haven't seen it yet.  But I'm not here for that.  So, you know, it's very disappointing.  I think people need to get back to having values, to having a moral compass, to really realizing what it is that they're doing.  And that there is always a human being on the other side of any smear that they put forward for -- that's politically motivated. 

MC:  Noah Weiland, of the New York Times, wrote a story that danced all around but never yet called you a criminal, saying you had the opportunity to commit crimes, and so therefore it was worth a frontpage article in the New York Times.  I can tell you, sir, I will not speak to Noah Weiland.  He calls my phone; I don't answer it.  It's unethical reporting, right.  We've seen this also in other publications. 

I want to tell you as someone who's been involved in this for 35 years, who has had a target on my back, as well, there is a reason they're doing this.  First of all, the New York Times will not be satisfied with vaccine development unless the New York Times is in charge of vaccine development.  And then we will fail, right.  There are people in the United States government on the Democrats side, we've seen these calls for all kinds of ethical stuff on you from the Democrats, they are calling for -- because they do not want a vaccine.  I know that's hard to believe, but the people who are abusing you, and who are beating down Operation Warp Speed, and the incredible historic work that's going on, they don't want a vaccine until November 4th.  I don't want to talk about politics here, but November 3rd is an important day.  They don't want a vaccine now because of politics, sir. 

And I know you.  You don't have a political bone in your body.  You weren't -- you weren't ready for this, were you.

MS:  No.  I mean, again, and I, frankly, am working very hard not to be involved in the politics --

MC:  Yeah.

MS:  -- because it's not my interest.  I have my opinions.  I don't want to be involved in the politics.  I want to help resolve the pandemic.  That's my objective, and I am resentful for actions that knowingly or unknowingly curtail that effort.

MC:  Right.

MS:  That's inappropriate.  That's wrong.  That's unethical.

MC:  It's inhumane.

MS:  I agree. 

MC:  It isn't just for America.

MS:  Of course.

MC:  This is for the world.

MS:  It is for the world.

MC:  You know, and I can tell you, I remember sitting down with you when you first came, and I told you this is going to pass.  It'll last about a week.  They got to come at you.  They got to understand with your ethics requirements, and that you met them, and then they'll move on to try to destroy the Operation Warp Speed in another way.  But they've never moved on.  They've never moved on because they -- I think these reporters are so deeply unethical and so filled with hatred that they have to assume that somehow or another, you're as unethical as they are.  And I think that's really what you're facing.  But, indeed, as the chief advisor to Operation Warp Speed, all of America is facing that headwind here.  These reporters are treating you with such disrespect because they want you to leave, sir.  They want you to leave Operation Warp Speed.  I can tell you that I believe that all the way in my aorta.  I believe it.  They want you to leave Operation Warp Speed so the president's program, Operation Warp Speed, which is designed to achieve a vaccine in record time, without sacrificing safety and efficacy, and all the standards, the gold standards that the FDA presents, they want you to leave because they want the president to fail.  If in the meantime, the world does not get a vaccine faster than normal, or doesn't get a vaccine at all, so what.  Doesn't matter.  They're after the president, not you.  They're after the president, not you.  It's disgusting to me. 

But yet, you're making incredible strides.  Let me tell you, I heard Dr. Fauci say that we never expected to make this kind of headway.  That we're actually -- I heard Dr. Redfield say, from the CDC, say that this has never been achieved in the history of mankind. 

MS:  Yep.

MC:  The things that you and your colleagues at Operation Warp Speed are doing, they're succeeding, aren't they?

MS:  Well, up to now it's been incredible.  I have to say between older partners from human health services and the Department of Defense within the operation, and the companies with whom we work very closely, that are the sponsors of the vaccines, the speed and the progress is incredible.  This virus was described in the middle of January.  Six-and-a-half months later, we have started two phase 3 trials for vaccines.  Normally, it takes at least five years to do this.

MC:  Wow.

MS:  And what's extraordinary is that we haven't cut any one of the key scientific corners, I would say, whether from an efficacy standpoint or from a safety standpoint.  And we're testing these vaccines in very large trials to make sure that we understand their behavior from a safety standpoint but also make sure that they are truly effective against the coronavirus, such that hopefully by this fall, when these vaccine trials, the first ones, read out, we may be able to have very clear evidence that we have vaccines that are safe, that are effective, and that can be used.  Probably first in those who need them the most, which are the people at risk, the elderly people, people with comorbidity, people with --

MC:  Low income.

MS:  -- lower socioeconomic income.

MC:  The vulnerable populations.

MS:  The vulnerable populations.  And then step by step into the rest of the population.  That, I think, is an extremely challenging objective, but every week that pass by, my belief that it is an achievable objective increased.  Every single week.  And I'm convinced we will have effective vaccines, and I'm convinced it will happen at a pace that is unprecedented.  Are we going to have them in 10 months, or 12 months, or 13 months?  I can't predict with that level of precision, but it's going to be incredibly fast. 

MC:  It's great because -- I witness this from, you know, one step away.  And I see the excitement in that office, in Operation Warp Speed.  I know you're traveling all over the country, visiting with your public-private partners, taking a look at vaccine development as it goes forward.  I get reports on this every single day.  And some days I see you, you look very excited, and I want to ask you what's going on?  And you're quite tight lipped about it because a lot of this stuff moves markets. 

MS:  Yeah.

MC:  And in fact, there are some companies out there that are claiming that they're a part of this, and they're not. 

MS:  Yep.

MC:  And then they see a burst of value in their share price on the stock market, and people sell their shares, and get rich.  And Operation Warp Speed moves on without them.  What do you think of the companies who profit off of false news on the development of a COVID vaccine to save the world?

MS:  I think it's unacceptable. 

MC:  It really is.  And I think what people -- when you hear Operation Warp Speed, and you think about vaccines immediately because there is a feeling in the country, in the world, that we can never move forward without a vaccine.  Is that true?

MS:  I think the real solution to this pandemic is to have vaccines that will protect people.  I mean, in the meantime we're also working very hard in finding therapeutics.  If this infection was treatable, and people wouldn't be dying, or spending weeks in intensive care, maybe also its social impact will be less.  So we're working on all fronts.  But the really --  

MC:  It's a combination.

MS:  -- the long-term solution is a vaccine. 

MC:  And the short-term solution?

MS:  -- the short-term bridge is the therapeutics or the medicines.

MC:  Are you as equally enthusiastic about the therapeutics you're seeing?

MS:  Yes, it's much, much harder to help somebody who's already ill because they're so, as you can read in the newspapers or listen in the media, the manifestations of this disease are many, many different disease because they depend on your health status to start with.  So we have to design medicines that impact different people that have different manifestations of disease.  So it's much harder to address as a problem than equipping healthy people with an immune response that would prevent them from being sick when they encounter the virus.

MC:  The way you explained it to me, and the way we've explained to the media and the world, we're achieving warp speed in developing vaccines by, you know, vaccine development.  You know, I'm going to be really simple minded on this because I'm simple minded, is it's vaccine development, it's manufacturing, and it's distribution.  That arc, right.  But what you've done at Operation Warp Speed is you've broken that arc into three parts.  You are developing a vaccine, or vaccines, more than one candidate, and when they look to be somewhat promising, you're starting manufacturing in parallel to the development.  So you're manufacturing multiple vaccines while multiple vaccines are being developed, and the ones that look promising, you're also setting up a distribution network, designing it anyway.  So that basically, the three parts that take a, you know, years to accomplish, are being done in parallel.  And that's how you're achieving a lot of your time savings.

MS:  Absolutely.  It's a very big financial risk, but it doesn't cut any one of the important sets of information and understanding of the functioning and performance of the vaccines or the medicines.  But for all the programs, and we have eight of them for vaccines, we [unintelligible] vaccine in terms of how to manufacture it, or how to early on, or how to test it in patients in the clinic.  And at the same time, we're building, equipping, refurbishing manufacturing facilities, hiring the talents to work into them, training the talent, and starting to manufacture the vaccines in hundreds of millions of doses for each one of those vaccines, before we know whether the vaccines will be effective.

MC:  Right.

MS:  And it's the only way to do it very fast.  If we had to -- imagine there would be a headline that says, oh, a great vaccine has been tested, and it saves people life, it's 100 percent protective, and we're going to need another year-and-a-half or two years before we can give it to you because we have to now build the manufacturing, et cetera, et cetera.  It would be unacceptable.  So that's how we're speeding up and we're taking very significant financial risks, but this is how we will deliver vaccines at warp speed.

MC:  It's interesting to me because it's different with therapeutics, isn't it?  There's not the three-part arc of development.  How are you assisting the process of therapeutics?

MS:  For therapeutics, it's partially the same.  But therapeutic development is much faster than vaccines because you're dealing with people who are ill and you treat them.  They may be in hospital, they may be, if you don't treat them, they may unfortunately die, and within days, sometimes within a week or two, so very quickly you can measure the impact of your therapeutic.  So what we are doing actually is to organize very well-harmonized and controlled clinical trials where we test many different medicines according to the same protocol, and while we're testing them, which only takes maybe a month-and-a-half or two months, we're already also starting the manufacture.  Now, we will only -- because the clinical development is so fast, we may not already have millions of doses of the medicine, but we will have already maybe 100,000 or 200,000 doses to start treating patients.  Our plans, we are in the clinical -- a number of candidate medicines, and our plans is maybe to have some as early as September or October.

MC:  Really?

MS:  That read out, yes.

MC:  I hear a lot of talk about convalescent plasma.  Could you describe what this is?  I mean, it's not new. 

MS:  No.  Convalescent plasma is a methodology that has been used for hundreds of years, which is in this particular instance, you know, there are a lot of people who get infected with the coronavirus, COVID-19, they recover.  After they have recovered, they have in their blood a lot of antibodies against the virus.  Those antibodies can be harvested from the patients that have recovered from coronavirus infection, and purified in such a way that they are then called plasma that contains the antibodies against the coronavirus.  When somebody acquires coronavirus, and is now infected and in hospital, for instance, giving them that plasma in their blood, adding antibodies to their system, may help them fight the virus better.  We are running clinical trials with such methodology.  There is an extended access program where up to 40-some-thousand patients have been treated with convalescent plasma, plasma derived from convalescent patients.  There is early evidence that suggests that this may be helping them.  We need more data to confirm that early evidence, so we're hopeful. 

It is known anyway that plasma can support and help when transferred to a weak or ill person because there's many good components that are in our bloods that are added to the subject, so there's no harm to expect from receiving convalescent plasma.  There's an expectation for benefit.  There's early evidence for benefit.  They're working very hard to confirm that evidence on the one hand.  On the other hand, we're working very hard to produce what we call monoclonal antibodies that are much more characterized, much -- always the same.  You realize that convalescent plasma you have a certain amount of plasma from one patient, and then you use plasma from another patient, and another plasma from another patient.  So there are differences between batches of plasma.  We are working to -- with a number of companies to make monoclonal antibodies that can be -- which are antibodies against the virus that also can kill the virus, like the convalescent plasma does, but now it's always the same antibody, and we can produce enormous amount of it.  And those are also being tested in the clinic.  And those actually are the intervention that we hope will give us positive data in September or October.

MC:  Yeah, and we need more than anything else, more than anything else, we need Americans who have been infected with COVID and recovered, to donate plasma, don't we?

MS:  So for the plasma strategy, absolutely.  Everybody who has recovered, who had, in a way, the privilege to survive this pandemic, either because they were helped and supported in hospital, or by the healthcare system in general, I think -- I find it a duty in a way for every convalescent patient to take a moment to go and give plasma.

MC:  Well, actually --

MS:  Because it's [inaudible] --

MC:  -- it's a little more than a moment, right?

MS:  Yeah.

MC:  It takes a couple hours.

MS:  It takes maybe -- couple hours, but that's only a moment in a lifetime. 

MC:  In fact, if convalescent plasma is going to be tested, and proved, and used to cure COVID for patients, to treat COVID patients, we need 175,000 Americans in the month of August to donate plasma.  And anyone who's interested, if you have COVID, if you've had COVID, and you have the antibodies, go to the Red Cross, go to your blood center in your area, and tell them you want to donate plasma for this incredible therapeutic.  That's what we need, isn't it?

MS:  That's what we need and that's, I think, what every responsible American should be doing.

MC:  I don't want to keep you much longer because I know every moment you're here, you're not discovering a vaccine.  I'm even worse than the media on that point.  But I want to ask you about a couple of people.  Carlo D. Notarus Steffani [phonetic sp].  There are two people who are not in uniform in the Operation Warp Speed office.  When I'm there, there's three.  But Carlo D. Notarus Steffani is one interesting character.  He's responsible for what in this organization?

MS:  So Carlo is also volunteering to join the operation and oversee the manufacturing aspects.  So he's part of the team.  He's an incredibly important part of the team.  He has a very long experience having run manufacturing in various pharmaceutical companies and understand it inside out.  This is super, super, hyper high-tech stuff that is made at manufacturing scale in big, big manufacturing buildings that look like -- I don't know, a car manufacturing, except it's sterile and it's unbelievably complex.  And he understands the ins and out of it, and is helping us make sure that the manufacturing facilities, and processes that we are using for the various vaccines, or the various therapeutics, medicines, are appropriate, are likely to work, are designed appropriately, and are run appropriately.  So he is a critical member of the organization.

MC:  He's -- I've had a little bit of time to talk to him.  He's a very interesting guy.  I hope maybe we can have him on Learning Curve at some point, but I really don't want to take a lot more of your time.  Another guy I need to ask you about.  General Gustave Perna.  Straight out of central casting.  What is General Perna in charge of?

MS:  So General Perna, first, I'm -- I love him frankly.

MC:  He's something else.

MS:  He's now a friend.

MC:  Yeah.

MS:  He's an unbelievable person and leader.  Very humble yet very clear, and determined, and driven.  He's able to inspire the organization around him.  He's the chief operating officer of the organization.  I advise him to make the decisions that he ultimately makes.  And he also was running every logistics aspects in the Army and managing an enormous budget for all equipment's that the Army [inaudible]. 

MC:  Moving men.  Moving material.

MS:  He --

MC:  Moving ammunition --

MS:  I can tell you --

MC:  -- all over the world.

MS:  I can tell you, he's able to move mountains.

MC:  Yes, I know.

MS:  I can see that happening.  And he's so instrumental in accelerating the speed at which we are able to refurbish manufacturing sites, build them up, et cetera.  Things that takes years are taking a month-and-a-half, frankly.  It's just incredible.

MC:  I sit in meetings with General Perna and he oftentimes ends them with, "Ladies, gentlemen, we know what we're doing.  We know what your job is.  You know what your deliverable is."  He says -- and then he says, "Okay, press."  He said, "Press."  Which is such -- I mean, I'm Army veteran, you know.  That is like press on, ladies and gentlemen.  And when General Perna says press, you press.

MS:  Yes.

MC:  Like I said, straight out of central casting, a great guy.  Actually left a job that he loves, loves, to do this.

MS:  Everybody, everybody on the team is absolutely passionate, which I think you have to be because it's very demanding.  It's very demanding.  We're spending -- there's a lot of pressure.  There's a lot of tension, but there's a lot of passion, and there's a lot of energy, and emotion, which is driving everybody.  General Perna says also something that I really now adhere to completely.  He always asks, okay, tell me what's the laws of physics, which means really where is it that is impossible beyond that.  You can't go beyond that.  Because he wants us to go all the way to that limit.

MC:  Yeah.

MS:  Which is quite --

MC:  Press.

MS:  -- inspiring and remarkable. 

MC:  Does he ever tell you to press?

MS:  Yeah.  Yeah.

MC:  [laughs]

MS:  We're pressing together. 

MC:  I -- like I said, there's two guys in there in civilian clothes.  That's you and Carlo.  And then everybody -- I've actually come in from the military, and I worked in the headquarters of the 25th Infantry Division when I was in uniform as an enlisted man.  I've never seen so many generals in one place.  Everybody else is military.  Everybody else in your operation is from -- is active duty military.  And I saw a headline in the newspaper, McClatchy, an infamous news organization, "Officials dispute Trump's claim that military is preparing COVID vaccine distribution.  President Donald Trump says that the U.S. military has an elaborate plan to distribute the coronavirus vaccine across the country at rapid speed but defense administration officials say otherwise."  Bunk.  Bunk.  Every time the president has met with Operation Warp Speed, he's surrounded by uniforms.  Every time you walk into the building, you're surrounded by uniforms.  Your personal attaché is a one-star general, isn't he?

MS:  Yes, he is.  Yes, he is.  And, you know, General Perna and I are working together, literally, every single minute that we're working.

MC:  Right.

MS:  All our meetings are together.  All our meetings at the White House, of course, are together.  So the Department of Defense and the Army is an integral part of the operation.  And the operation is looking at discovering, developing, manufacturing, and distributing, which means the logistical aspect of distribution.  Actually, one of the key areas that the general knows inside out, logistics, the vaccines when we have them.

MC:  I'll tell you, this reporter, Michael Wilner, a Pentagon reporter from McClatchy, Tara Copp, called us and asked us, and I told him we actually don't know what the military is going to do with distribution.  They could be very much involved in the actual delivery of the products here and there.  We don't know.  There are some areas of the country that are very hard to deliver to.  Perhaps the military is going to reach those unreachable areas, right.  You and I have spoken before this about how when people say distribution in the vaccine context, that often refers to the policy.  Who's going to get it first and how, right?  Those decisions aren't being made by anyone near Operation Warp Speed, are they?

MS:  Yes.  The policy decisions will be made by the policy makers, and the Center for Disease Control, and various advisory boards that advise the CDC, will be responsible ultimately for making those decisions.  Now, what you need to realize is that some of these vaccines are for instance, require refrigeration. 

MC:  Yes.

MS:  Not only refrigeration like you have into your fridge, but they are frozen at -20 degrees, or some of them at -80 degrees centigrade, which is extremely cold, extremely difficult to maintain, very hard to transport.  And where the industry is not used in today's world to distribute physically, logistically the vaccines kept at such temperatures.  I can foresee that for those kind of vaccines, having access to the military capabilities, logistical capabilities for the physical distribution of the vaccine, will be very important.

MC:  Right.  President absolutely told the truth about facts that he knew, delivered to him in rooms filled with military people, and the only reason McClatchy wrote this article was to punch the president in the nose.  The only reason they wrote the articles about your ethics considerations was to punch the president in the nose.  And the American people need to understand that the media oftentimes are lying to them because they don't want a vaccine in order to defeat Donald Trump.  To me, I don't understand it.  I know you are apolitical.  I know General Perna could care less about politics.  I know Carlo could care less about politics.  Every single uniform I see in that room, they don't care about politics.  And yet, all the media does -- sir, I have to tell you, I mean, I will presume to speak for people, just normal people, to tell you please don't listen to them.  Don't regard what they say about you and about your operation as important to the American people. 

What these media are saying -- it's disgusting, despicable, unethical.  I went to journalism school.  I don't even recognize this industry anymore.  Don't let them -- don't let them stall you.  Keep moving at warp speed.  I appreciate what you do.  You know all of America appreciates what you do.  Don't let them stall you.  I know you've given up so much: wealth, time with your family, and at an age -- as yet a young man, when you should be relaxing, you're working 18 and 20-hour days, you're traveling the country, you're talking to people all around the world to try to change the way we're going.  We all appreciate it and don't listen to them.

MS:  I have no intent, frankly.  I mean, it does hurt, but I have no intent.  I think the mission is bigger than anything else.  And we have to tackle this and that's what we will do.

MC:  I think you're right.  In the end, when this is over, we're going to reevaluate what the media is and what they've become.  Dr. Monsef Slaoui, the chief advisor to Operation Warp Speed.  You've given me more time than I asked for.  I know I probably kept you longer than -- you're going to miss a meeting.  You're afraid to walk away from the microphone because you'll interrupt my edits.  But you're free to go now, sir.  Michael Caputo, assistant secretary for Public Affairs, at the U.S. Department Health and Human Services with Dr. Monsef Slaoui, a global hero, a national hero, and the chief advisor to Operation Warp Speed.  Thank you for what you're doing, sir.

MS:  Thank you.

MC:  Ladies and gentlemen, have a great day.  We'll talk to you next week.

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