Roger Stein: A bold new way to fund drug research

Prevodilac: Mile Živković Lektor: Ivana Korom

So this is a picture of my dad and me, at the beach in Far Rockaway,

Ovo je slika mog tate i mene

na plaži u Far Rokaveju,

odnosno u parku Rokavej

or actually Rockaway Park.

I'm the one with the blond hair.

Ja sam ovaj plavokosi.

My dad's the guy with the cigarette.

Moj tata je taj sa cigaretom.

It was the 60's.

To su bile šezdesete. Mnogi su tada pušili.

A lot of people smoked back then.

Leta 2009. godine,

In the summer of 2009, my dad was diagnosed with lung cancer.

mom tati je otkriven rak pluća.

Cancer is one of those things that actually touches everybody.

Rak je pojava koja svakog dotiče.

Ako ste muškarac u Sjedinjenim Američkim Državama,

If you're a man in the US,

you've got about a one in two chance

postoji verovatnoća jedan prema dva

of being diagnosed with cancer during your lifetime.

da obolite od raka za života.

If you're a woman, you've got about a one in three chance

Ako ste žena, postoji verovatnoća jedan prema tri

of being diagnosed with cancer.

da ćete oboleti od raka.

Svako zna nekoga

Everybody knows somebody who's been diagnosed with cancer.

kome je ustanovljen rak.

Now, my dad's doing better today,

Sada, mom tati je bolje,

and part of the reason for that is that he was able to participate in the trial

a delom je to zato što

je imao mogućnost da učestvuje u testiranju

of an experimental new drug that happened to be specially formulated

eksperimentalnog novog leka

koji je specijalno napravljen

and very good for his particular kind of cancer.

i veoma efikasan za njegov tip raka.

Postoji preko 200 tipova raka.

There are over 200 kinds of cancer.

And what I want to talk about today

Ja danas želim da pričam o tome

is how we can help more people like my dad,

kako možemo da pomognemo drugim ljudima poput mog oca,

because we have to change the way we think about raising money

jer moramo da promenimo način prikupljanja novca

to fund cancer research.

za finansiranje istraživanja o raku.

So a while after my dad was diagnosed,

Nakon što je mom tati otkriven rak,

I was having coffee with my friend Andrew Lo.

pio sam kafu s mojim drugom Endruom Loom.

He's the head of the Laboratory for Financial Engineering at MIT,

On je šef Laboratorije za finansijski inženjering na MIT,

where I also have a position,

gde i ja radim,

and we were talking about cancer.

i razgovarali smo o kanceru.

I Endru je sam pomalo istraživao,

And Andrew had been doing his own bits of research,

and one of the things that he had been told

i nešto što mu je rečeno

and that he'd learned from studying the literature

i što je saznao proučavajući literaturu,

was that there's actually a big bottleneck.

jeste da postoji veliko usko grlo.

It's very difficult to develop new drugs,

Veoma je teško razviti nove lekove,

and the reason it's difficult to develop new drugs

a teško je razviti nove lekove

is because in the early stages of drug development,

jesr su u ranim fazama razvoja leka

ti lekovi su veoma rizični,

the drugs are very risky, and they're very expensive.

i veoma skupi.

So Andrew asked me if I'd want to maybe work with him a bit,

Endru me je pitao da li bih hteo

možda da radim s njim,

work on some of the math and the analytics

da poradim na nekim proračunima i analizama,

and see if we could figure out something we could do.

da vidimo možemo li nešto da uradimo.

Ja nisam naučnik.

Now I'm not a scientist.

You know, I don't know how to build a drug.

Ne znam kako da napravim lek.

And none of my coauthors, Andrew Lo or Jose-Maria Fernandez or David Fagnan --

I nijedan od mojih koautora, Endru Lo

ili Hoze Maria Fernandez ili Dejvid Fegnan -

none of those guys are scientists either.

niko od njih nije naučnik.

We don't know the first thing about how to make a cancer drug.

Ne znamo ništa o pravljenju leka protiv raka.

But we know a little bit about risk mitigation

Ali znamo ponešto o smanjenju rizika

i o finansijskom inženjeringu,

and a little bit about financial engineering,

i razmišljali smo šta možemo da uradimo.

and so we started thinking, what could we do?

Ispričaću vam na čemu radimo

I'm going to tell you about some work

we've been doing over the last couple years

poslednjih par godina,

a smatramo da to može iz osnova da promeni način

that we think could fundamentally change the way

na koji se rade istraživanja za rak, kao i mnoge druge stvari.

research for cancer and lots of other things gets done.

We want to let the research drive the funding,

Hoćemo da istraživanja upravljaju finansiranjem,

not the other way around.

a ne obrnuto.

So in order to get started,

Prvo, da vam ispričam

let me tell you how you get a drug financed.

kako se finansira neki lek.

Imagine that you're in your lab -- you're a scientist, you're not like me --

Zamislite da ste u laboratoriji -

vi ste naučnik, niste kao ja -

vi ste naučnik i razvili ste

and you've developed a new compound

novi lek za koji smatrate da bi mogao

that you think might be therapeutic for somebody with cancer.

da leči nekoga ko ima rak.

Well, what you do is, you test in animals, you test in test tubes,

Prvo testirate na životinjama,

testirate u epruvetama,

but there's this notion of going from the bench to the bedside,

ali imate osećaj da idete od klupe

do bolesničke postelje,

and in order to get from the bench, the lab, to the bedside, to the patients,

a da biste došli od klupe, iz laboratorije,

do bolesničke postelje, do pacijenata,

you've got to get the drug tested.

morate da testirate lek.

And the way the drug gets tested

Lekovi se testiraju kroz niz,

is through a series of, basically, experiments,

u osnovi, eksperimenata,

putem velikih ispitivanja,

through these large, they're called trials,

da bi utvrdili da li je lek bezbedan

that they do to determine whether the drug is safe

and whether it works and all these things.

i da li ima očekivano dejstvo.

So the FDA has a very specific protocol.

Agencija za lekove ima određeni protokol.

In the first phase of this testing,

Prva faza testiranja,

which is called testing for toxicity, it's called Phase I.

testiranje toksičnosti,

zove se Faza I.

In the first phase, you give the drug to healthy people

U prvoj fazi, dajete lek zdravim ljudima

and you see if it actually makes them sick.

i proveravate da li će se razboleti od njega.

In other words, are the side effects just so severe

Tj, jesu li sporedna dejstva toliko ozbiljna

that no matter how much good it does,

da bez obzira koliko je dobar, neće biti vredan toga?

it's not going to be worth it?

Da li uzrokuje infarkt, ubija ljude,

Does it cause heart attacks, kill people, liver failure?

utiče na otkazivanje jetre i slično?

Ispostavlja se da je to velika prepreka.

And it turns out, that's a pretty high hurdle.

Trećina lekova ispadne u toj fazi.

About a third of all drugs drop out at that point.

In the next phase, you test to see if the drug's effective,

U sledećoj fazi, testira se efektivnost leka,

and you give it to people with cancer

tada dajete lek ljudima koji imaju rak

and you see if it makes them better.

i pratite da li im zaista pomaže.

To je još veća prepreka. Ljudi odustaju.

And that's also a higher hurdle. People drop out.

U 3. fazi testirate lek na veoma velikom uzorku,

And in the third phase, you test it on a very large sample,

gde pokušavate da utvrdite pravu dozu,

and you're trying to determine what the right dose is,

i da li je bolji od dostupnih lekova?

is it better than what's available today? If not, then why build it?

Ukoliko nije, zašto ga pravimo?

When you're done with all that,

Kada završite sa svim tim,

what you have is a very small percentage of drugs

mali procenat lekova

that start the process actually come out the other side.

koji krene u proces, zapravo izađe na tržište.

So those blue bottles -- those blue bottles save lives,

Te plave bočice, te plave bočice spasavaju živote,

i vrede milijarde,

and they're also worth billions, sometimes billions a year.

ponekad nekoliko milijardi godišnje.

So now here's a question:

Tu se postavlja pitanje:

if I were to ask you, for example,

da vas pitam, na primer,

to make a one-time investment of, say, 200 million dollars

da investirate jednokratno

200 miliona dolara

to buy one of those bottles,

da kupite jednu od tih bočica,

so 200 million dollars up front, one time, to buy one of those bottles,

znači 200 miliona dolara unapred, jednokratno,

da kupite jednu bočicu,

I won't tell you which one it is,

neću vam reći koja je to,

and in 10 years, I'll tell you whether you have one of the blue ones.

a za 10 godina, reći ću vam da li je to jedna od ovih plavih.

Does that sound like a good deal for anybody?

Zvuči li vam to kao dobar posao?

No. No, right?

Ne. Ne, zar ne?

And of course, it's a very, very risky trial position,

I naravno, veoma je rizična pozicija,

zato je veoma teško naći finansije,

and that's why it's very hard to get funding,

ali prva procena

but to a first approximation, that's actually the proposal.

je zapravo ponuda.

Morate da finansirate sve to od početka.

You have to fund these things from the early stages on.

Potrebno je mnogo vremena.

It takes a long time.

So Andrew said to me, he said,

I Endru mi je rekao:

"What if we stop thinking about these as drugs?

"Šta ako prestanemo da razmišljamo o njima kao o lekovima?

Šta ako počnemo da razmišljamo o njima kao o finansijskim sredstvima?

What if we start thinking about them as financial assets?"

They've got really weird payoff structures and all that,

Imaju čudnu strukturu otplate,

ali hajde da odbacimo sve što znamo

but let's throw everything we know about financial engineering at them.

o finansijskom inženjeringu.

Let's see if we can use all the tricks of the trade

Hajde da iskoristimo sve trikove zanata

da otkrijemo kako da učinimo te lekove

to figure out how to make these drugs work as financial assets.

finansijskim sredstvima?

Let's create a giant fund.

Hajde da oformimo ogroman fond.

U finansijama znamo šta raditi

In finance, we know what to do with assets that are risky.

s rizičnim sredstvima.

Stavimo ih u portfolio i pokušamo

You put them in a portfolio and you try to smooth out the returns.

da obezbedimo povraćaj investicije.

Malo smo računali i ispostavilo se

So we did some math, and it turned out you could make this work,

da ovo može da uspe, ali da bi uspelo,

but in order to make it work, you need about 80 to 150 drugs.

potrebno vam je 80 do 150 lekova.

Now the good news is, there's plenty of drugs

Dobra vest je da ima mnogo lekova

that are waiting to be tested.

koji čekaju testiranje.

Rekli su nam da lekovi na listi

We've been told that there's a backlog of about 20 years of drugs

čekaju po 20 godina

that are waiting to be tested but can't be funded.

na testiranje, ali ne mogu da nađu finansije.

In fact, that early stage of the funding process,

Ta rana faza procesa finansiranja,

ta Faza I i pre-klinička ispitivanja,

that Phase I and preclinical stuff,

that's actually, in the industry, called the Valley of Death

to se u toj industriji zove Dolina smrti

jer tu lekovi odlaze da umru.

because it's where drugs go to die.

It's very hard to for them to get through there,

Veoma je teško proći kroz to

i naravno, ako ne možete proći kroz to, ne možete stići do kasnijih faza.

and of course, if you can't get through there,

you can't get to the later stages.

I mi smo sabrali i izračunali da,

So we did this math, and we figured out, OK,

zapravo, treba vam oko 80 do recimo, 150 lekova

well, you need about 80 to, say, 150, or something like that, drugs.

ili nešto slično.

I onda smo još malo računali, i rekli,

And then we did a little more math, and we said, OK,

dobro, to je fond od oko

well, that's a fund of about three to 15 billion dollars.

3 do 15 milijardi dolara.

So we kind of created a new problem by solving the old one.

I tako smo stvorili novi problem

rešavajući stari.

We got rid of the risk, but now we need a lot of capital,

Otklonili smo rizik, ali nam treba veliki kapital,

a možemo ga dobiti samo

and you can only get that kind of capital in the capital markets.

na tržištu kapitala.

Venture capitalists and philanthropies don't have it.

Kapitalisti ga nemaju. Filantropi ga nemaju.

Ali moramo da dovedemo ljude na tržište,

But we have to figure out how to get people in the capital markets,

koji obično ne investiraju u to,

who traditionally don't invest in this, to want to invest in this stuff.

da žele da investiraju.

I opet nam je pomogao finansijski inženjering.

So again, financial engineering was helpful here.

Zamislite da taj megafond počinje od nule,

Imagine the megafund starts empty,

and what it does is it issues some debt and some equity,

i on zapravo ispostavlja dug

i kapital,

and that generates cash flow.

i to stvara tok novca.

That cash flow is used, then, to buy that big portfolio of drugs that you need,

Onda se novac koristi za kupovinu

tog portfolija potrebnih lekova,

and those drugs start working their way through that approval process,

i ti lekovi počinju da izlaze

kroz proces odobrenja,

i kako prolaze kroz svaku fazu,

and each time they go through a phase of approval,

dobijaju vrednost.

I većina njih ne uspe,

they gain value.

Most of them don't make it, but a few of them do,

ali neki uspeju,

a one koje dobiju vrednost, možete da prodate,

and with the ones that gain value, you can sell some,

i kad ih prodate,

and when you sell them,

imate novca da platite kamatu na obveznice,

you have money to pay the interest on those bonds,

ali imate i para za sledeću fazu testiranja.

but also to fund the next round of trials.

Gotovo samo-finansiranje.

It's almost self-funding.

Radite to tokom transakcije,

You do that for the course of the transaction,

and when you're done, you liquidate the portfolio,

kad završite, likvidirate portfolio,

otplatite obveznice i možete

pay back the bonds, and you can give the equity holders a nice return.

vlasnicima kapitala da date lep povrat.

I to je bila teorija i pričali smo o tome malo,

That was the theory, and we talked about it,

we did a bunch of experiments,

uradili gomilu eksperimenata,

i onda smo rekli, hajde da zaista pokušamo s testiranjem.

and then we said, let's really try to test it.

We spent the next two years doing research.

Naredne dve godine smo proveli istražujući.

We talked to hundreds of experts in drug financing and venture capital.

Pričali smo sa stotinama stručnjaka za finansiranje lekova

i preduzetnički kapital.

We talked to people who have developed drugs.

Pričali smo s ljudima koji su razvijali lekove.

We talked to pharmaceutical companies.

Pričali smo s farmaceutskim kompanijama.

We actually looked at the data for drugs,

Zapravo smo pogledali podatke za lekove,

over 2,000 drugs that had been approved or denied or withdrawn,

preko 2000 lekova koji su odobreni, odbijeni

ili povučeni

and we also ran millions of simulations.

i takođe smo sproveli milione simulacija.

Sve to je trajalo dosta vremena.

And all that actually took a lot of time.

But when we were done, we found something that was sort of surprising.

Ali kad smo završili, otkrili smo nešto iznenađujuće.

Zapravo je bilo moguće strukturisati taj fond

It was feasible to structure that fund

such that when you were done structuring it,

tako da kada biste s time završili,

zapravo biste mogli da dobijete obveznice s malim rizikom,

you could actually produce low-risk bonds that would be attractive to bond holders,

atraktivne vlasnicima obveznica,

koje bi vam dale dobit od oko pet do osam procenata

that would give you yields of about five to eight percent,

and you could produce equity

i mogli biste dobiti kapital

koji bi vlasnicima kapitala obezbedio povrat od 12%.

that would give equity holders about a 12 percent return.

Ovaj povrat neće biti toliko atraktivan

Now those returns aren't going to be attractive to a venture capitalist.

jednom kapitalisti.

Kapitalisti su oni tipovi koji žele da ulažu mnogo

They want to make those big bets

and get those billion dollar payoffs.

i dobiju profit u milijardama dolara.

But it turns out there are lots of other folks that would be interested.

Ali se ispostavlja da ima dosta drugih ljudi koje to interesuje.

To je tačno na idealnom mestu

That's right in the investment sweet spot of pension funds and 401(k) plans

kod penzionih fondova

i svih drugih stvari.

and all this other stuff.

So we published some articles in the academic press,

Objavili smo i neke članke u akademskim časopisima.

Objavili smo članke u medicinskim zbornicima.

in medical journals, in finance journals.

Objavili smo članke u finansijskim zbornicima.

Ali publicitet nismo dobili

But it wasn't until we actually got the popular press interested in this

sve dok u ovo nismo uvukli

i popularnu štampu.

that we began to get some traction.

Želeli smo da uradimo nešto više od toga da ovo predočimo ljudima.

We wanted to do more than just make people aware of it.

We wanted people to get involved.

Želeli smo da uključimo ljude.

Onda smo uzeli sav naš kompjuterski kod

So we took all of our computer code and made that available online

i učinili smo ga dostupnim na internetu

under an open-source license to anybody that wanted it.

pod licencom otvorenog koda,

za sve koji su ga želeli.

And you guys can download it today

I vi možete to danas da preuzmete

ako želite da eksperimentišete i vidite da li ovo funkcioniše.

if you want to run your own experiments to see if this would work.

To je bilo veoma efektivno, jer su ljudi

And that was really effective,

because people that didn't believe our assumptions

koji nisu verovali u naše pretpostavke

mogli da probaju svoje pretpostavke da vide da li one rade.

could try their own and see how it would work.

Now there's an obvious problem, which is,

Tu postoji očigledan problem, a to je -

is there enough money in the world to fund this?

da li na svetu postoji dovoljno novca da se ovo isfinansira?

I've told you there's enough drugs, but is there enough money?

Rekao sam vam da je lekova dovoljno,

ali da li ima dovoljno novca?

There's 100 trillion dollars of capital

Trenutno je 100 biliona dolara kapitala

currently invested in fixed-income securities.

uloženo u hartije od vrednosti sa fiksnim prihodom.

That's a hundred thousand billion.

To je stotinu hiljada milijardi.

There's plenty of money.

To je dosta novca.

(Laughter)

(Smeh)

Ali shvatili smo da je neophodno više od novca.

But we realized it's more than just money that's required.

Moramo da motivišemo ljude, da ih uključimo

We had to get people motivated, involved,

and get them to understand this.

i da oni ovo razumeju.

And we started thinking about all the different things that could go wrong.

Tako smo počeli da razmišljamo o svemu što bi moglo da krene po zlu.

Koji su izazovi koji bi mogli da se ispreče?

What are all the challenges that might get in the way?

Imali smo dugačak spisak, tako da smo

And we had a long list.

We assigned a bunch of people, including ourselves,

gomili ljudi dodelili različite delove ovog problema,

different pieces of this problem.

uključujući nas same,

And we said, could you start a work stream on credit risk?

i rekli smo, možete li da počnete rad na kreditnom riziku?

Could you start a work stream on the regulatory aspects?

Da počnete rad na pravnim aspektima?

Da počnete rad na tome

Could you start a work stream on how you would manage so many projects?

kako biste zaista upravljali sa toliko projekata?

Skupili su se svi ovi eksperti

And we had all these experts get together and do these different work streams,

i radili na različitim stvarima

i onda smo održali konferenciju.

and then we held a conference.

Konferencija je održana prošlog leta.

The conference was held over this past summer.

Moglo se ući samo uz pozivnicu.

It was an invitation-only conference.

Sponzor je bilo Američko društvo protiv raka

It was sponsored by the American Cancer Society

u saradnji

and done in collaboration with the National Cancer Institute.

sa Državnim institutom za rak.

We had experts from every field we thought would be important,

Imali smo stručnjake iz svih polja za koja smo mislili da su bitna,

including the government, and people that run research centers,

uključujući vladu, ljude koji vode

centre za istraživanje i tako dalje,

and for two days they heard the reports

i dva dana su sedeli i slušali izveštaje

sa tih pet aktivnosti i pričali su o tome.

from those five work streams, and talked about it.

To je bio prvi put da su ljudi

It was the first time the people who could make this happen

koji zaista ovo mogu da ostvare

sat across the table from each other and had these conversations.

sedeli jedni nasuprot drugih

i pričali o ovome.

Now these conferences, it's typical to have a dinner,

Kod ovakvih konferencija, obično postoji večera,

and at that dinner, you get to know each other,

i na toj večeri

se pomalo upoznajete,

sort of like what we're doing here.

nešto nalik ovome ovde.

I happened to look out the window,

Slučajno sam pogledao kroz prozor,

and hand on my heart,

i s rukom na srcu, gledao sam napolje

on the night of this conference -- it was the summertime --

na noć konferencije - bilo je leto -

i to sam video, duplu dugu.

and that's what I saw, a double rainbow.

Mislim da je to bio dobar znak.

So I'd like to think it was a good sign.

Since the conference, we've got people working between Paris and San Francisco,

Od konferencije, ljudi rade

između Pariza i San Franciska,

dosta različitih ljudi radi na ovome

lots of different folks working on this

kako bi pokušali da vide da li to može i da se ostvari.

to try to see if we can really make it happen.

We're not looking to start a fund, but we want somebody else to do this.

Ne razmišljamo o osnivanju fonda,

ali želimo da neko uradi ovo.

Još jednom, zato što nisam naučnik.

Because, again, I'm not a scientist.

I can't build a drug.

Ne mogu da napravim lek.

I'm never going to have enough money to fund even one of those trials.

Nikad neću imati dovoljno novca

da finansiram samo jedno od ovih istraživanja.

But all of us together, with our 401(k)s,

Ali svi mi zajedno, sa našim penzionim planovima,

with our 529 plans, with our pension plans,

osiguranjima, štednjama,

all of us together can actually fund hundreds of trials

svi mi zajedno zapravo možemo da finansiramo stotine istraživanja

and get paid well for doing it

i budemo dobro plaćeni za to

and save millions of lives like my dad.

i spasimo milione života poput mog oca.

Hvala vam.

Thank you.

(Applause)

(Aplauz)