It was the best of times. It was the worst of
times. It was the age of innovation. It was the age of stagnation. On the one side,
we have those who argue that technology is advancing so fast we have achieved a
second-derivative rate of change – the acceleration of acceleration. On the
other side are those who claim we haven’t seen true innovation since the 1970s;
we are simply getting better at using the innovations we have. We are either
powering forward, or barely moving at all. Which is it?
OF TIMES: THE SECOND MACHINE AGE
Brynjolfsson and Andrew McAfee argue persuasively in The Second Machine Age that about 30 years since the proliferation of computers, we are on the
cusp of an unprecedented period of
second industrial revolution came with the invention of electricity. Change didn’t follow immediately then either. Factory owners just replaced their steam
engines with electrical ones. It was
30 years - a whole generation - before factory owners began to redesign their factories to take advantage of the flexibility electricity offered, and
to combine this new invention with
other related innovations, like the light bulb, to see productivity leap forward.
it is with the new machine age. Computers proliferated in the 70s and 80s, and we thought our world had changed dramatically because we could create a
document on a computer without White
Out, or race a Pacman around a screen
eating little green dots. The generation that invented the computer couldn’t
yet see its true potential.
took the next generation to realize the computer’s digital, exponential, and
combinatorial potential, according to Brynjolfsson and McAfee. Digital, because
computers give access to more data than ever before. Exponential, because a
child’s play station today is more powerful than a military super computer in
1996. And combinatorial, because each innovation can be combined with other
innovations to make even more innovations. Today, you can write an app and
reach a million users just by putting it on the Facebook platform, which in
turn is built on the Internet, which is built on the Web. When we put these
advances together we see an explosion of innovation, unlike anything seen
of the most exciting developments is computers that can learn. Computers like
Watson, the famous computer that beat the world Jeopardy champion in 2010. Now,
learning computers are working in call centers, in legal and banking industries.
They are even transforming the medical profession as computers advance
in diagnostics and surgery.
the book - and if you can’t make time for the book, I recommend the Ted Talk -
is not a lament for the end of the labor force in a world where computers do everything
from taxes to translation. Rather, it’s an upbeat treatise embracing the boundless
possibilities of a new world, while proposing policies to maximize innovations
and collaborations that emphasize what Brynjolfsson and McAfee call the race
with (not against) machines. In their view, a team of computers and humans can beat
any humans, or any computers working alone.
WORST OF TIMES: ZERO TO ONE (TECHNOLOGICALSTAGNATION SINCE THE 70S)
the other side, we have Peter Thiel, co-founder of PayPal and Palantir, the
first outside investor in Facebook, and an early investor in SpaceX and
LinkedIn. In Zero to One: Notes on Startups, or How to Build the Future,
Thiel argues that we are in an age of stagnation, but we’re too dazzled by our
shiny mobile toys to notice. Progress should go beyond what’s happening in
Silicon Valley, he says. As the slogan of his venture capital firm the Founders
Fund admonishes, “We wanted flying cars; instead we got 140 characters.”
Twitter is a great company, but it’s not advancing society.
you want to see stagnation, argues Thiel, look to Microsoft, Oracle, or Hewlett
Packard. These companies were once innovators, but now they just churn out
marginally improved browsers and operating systems. To put your money in these companies
is to place a bet on a future of incremental, and essentially inconsequential,
line of thinking, too, can be persuasive. In fact, at times, I felt he was too
generous in praising innovation over the last half century. Thiel advances the Manhattan
project and the interstate highway systems as the sort of innovation he’d like
to see more of today. These projects were advancements, to be sure, but innovations?
We already knew how to build roads. The interstate highway system just built
more of them, and standardized the exits. The Manhattan Project culminated in
the atomic bomb, but Einstein’s theory of relativity was published in 1905. In
fact, both projects were essentially just very, very expensive system upgrades.
STAGNATION OF PHARMACEUTICAL INNOVATION
then, does our industry fall within the scope of innovation? Are we racing
ahead, or just plugging along? Thiel argues that investing in large pharma is a
bet against technology, since most of what pharmaceutical companies are doing is
figuring out ways to extend the lifetime of patents and block smaller companies.
They could be spending time looking for cures to Alzheimer’s, he says, instead
of recycling old ideas and milking profits.
the Eli Lilly employee who reads that passage. Lilly has been betting the farm
on a cure for Alzheimer’s, exhausting avenue upon avenue of possibilities. What
Thiel is missing is that we’re still making huge innovative leaps and bounds in
biochemistry and molecular biology. There is no existing knowledge base - such
as roads, atomic science, or computers - that will, with fine-tuning, eventually
lead to a cure. It’s not as simple as sifting through the available molecules
in the universe until we find the one that, in pill form, will yield what we
seek. That could happen, but more likely when the answer comes it will be
another “Who knew?” moment that brings an innovative combination of ingredients,
such as technology, biochemistry, and perhaps diagnostics together.
innovation is slow to come in our industry, it may be that we’ve not yet grasped
the possibilities of the technologies available to us. We are still struggling
to overcome the empirical nature of our work. It can take a decade from the
time we identify a promising pathway till the time we prove it. Mother Nature sets
some very strict limits on the rate at which cells reproduce, for example, and
a controlled study to prove that a certain compound increases longevity can, by
its very nature, never be completed in a matter of days or weeks. By contrast,
electrical and mechanical models can be tested, revised, and retested in rapid,
sometimes near instantaneous, succession.
other drag on our acceleration is the rigors of government regulation. While necessary
and important, it cannot be denied that the constant checks and double checks,
filings and audits, hamper and add significant cost to any given process, and
thereby reduce the number of potential cures any given company can choose to pursue.
ACCELERATION OF PHARMACEUTICAL INNOVATION
machine age has undoubtedly touched our industry, from inventory management
systems to HPLCs. But I’m not sure we can yet see a ground up revolution in
drug development, such as, for example, the medical profession may foresee in light
of recent innovations in medical diagnostics and laser surgery. Still, there
are changes out there that may be the beginnings of something larger:
The Human Genome
The Human Genome Project (made possible by computers and the Internet) was
completed in 2003, and it may take a generation for us to see how this stunning
new information can be combined with other technologies and methods to
transform drug development.
Test - Imagine a company that has no salaried employees. Led by CEO Randi Altschul,
the Pop Test companies partner with a team of world-class scientists, MDs,
PhDs, and clinicians who share ownership of the company. Altschul comes up with
a visionary idea, honed by her years of experience in startups. The Pop Test scientists
then develop it, their legal team protects it, and their clinical team proves
it, after which they sell it to someone else for commercialization. Their first
breakthrough was the saliva diabetes (glucose) test, now in its last phase before
FDA approval. The company owns four patents for saliva- based detection systems
and clinical data showing sensitivity and specificity for different molecules
in the 95th percentile. They have already expanded the Pop Test
saliva platform to provide a saliva test for cholesterol, uric acid, and liver
tests such as ALT and AST. All this, among other innovative process and technology
products in the company pipeline, and all realized on a shoestring budget
Foldscope - Imagine an optical microscope that can be assembled from a punched
sheet of cardstock, a spherical lens, a light emitting diode, a diffuser panel,
and a watch battery to power the LED. It magnifies up to 2000 times and weighs
8g: enough magnification to spot Leishmania donovani and Escherichia
coli, as well as malarial parasites. Developed by a team lead by Manu
Prakash, an Assistant Professor of Bioengineering at the Stanford School of
Medicine and funded by Bill and Melinda Gates, the Foldscope can be printed on
a standard A4 sheet of paper and assembled in 7 minutes. Suitable for student
and field research and basic diagnostics in the third-world (or any country),
it costs less than a dollar.
- Theranostics brings two schools of thought together to create new value. It
works in both directions: either a diagnostic that distinguishes patients or
disease types, allowing for selection of the most appropriate therapy, or the opposite,
whereby a drug shows efficacy but not for all, and diagnostics are used to identify
those patients for whom it would work.
Endpoints - While not as flashy as a folding $1 microscope, sometimes a little
process tweak can have a huge impact. I mentioned earlier that you couldn’t
prove a biological pathway with the lightning speed that is possible for an electrical
pathway. And yet, we can shorten the process significantly by adopting
surrogate endpoints that may correlate to a real clinical endpoint. For
example, in the case of Alzheimer’s, it may be possible to adopt the removal of
arterial plaque as a surrogate endpoint for a clinical trial, in place of the
actual endpoint, which
would be curing the disease. This shortens the clinical process considerably,
and over time, the true endpoint may be proven.
is a school of thought that says that cures are like fruit on a tree, and the
low-hanging fruit has already been picked. I don’t subscribe to that theory. I
believe ideas are limitless, and the tree is forever growing new fruit. From
computers and the Internet to the Human Genome Project and the Foldscope, our
generation has inherited a tree more heavily laden than any tree before it. We
need only harvest it. It is the best of times.
view this issue and all back issues online, please visit www.drug-dev.com.
Derek G. Hennecke
President & CEO