This document summarizes a 20th anniversary magazine published by BioWorld. It provides an overview of the publisher's history acquiring BioWorld in 1994 and evolving it into an online enterprise. It then thanks various people who have contributed to BioWorld over the years, including customers, previous owners, editors, reporters, sources, and partners. It expresses gratitude to the biotechnology industry for being an interesting subject to cover over the past 20 years.
3. 1|BioWorld®
20thAnniversaryEdition
My company, now AHC Media LLC, acquired BioWorld shortly
thereafter, and I have been its publisher ever since. For those
of us working on these products, we have enjoyed a truly
terrific ride. We’ve reached, in 2010, the 20th anniversary of
thebusiness.OneoftheearliestBioWorldpublicationswehave
in our archives is a magazine product, BioWorld, the “Premier
Issue” as it was dubbed, dated November/December 1990.
Preceded by both online and fax variations, the magazine
edition would expire after just one further issue. We have
since evolved into an almost entirely online enterprise, leaving
both the glossy pages and the faxes behind. Returning to our
roots, however, we are celebrating our 20th with the magazine
publicationyouseehere–alookbackatbiotechnologythrough
the prism of BioWorld’s two decades and a look ahead at
developments to come.
I can think of no more appropriate use of this space than to
thank a host of people who have contributed to that ride.
The thank yous begin with our customers. Our circulation
data does not stretch all the way back to 1990, but certainly we
have readers who have been with us since the February 1994
acquisition. Thank you for subscribing. Thank you for making
us better every day with your insights and comments. Every
move we make, every headline we write is with you in mind.
Keep your suggestions coming.
I want to thank David Bunnell, whose Io Publishing Inc.
nurtured BioWorld through its founding three years, and from
whom we purchased the BioWorld assets. Cynthia Robbins-
Roth, founding editor in chief, invited me to lunch during that
first San Mateo visit, although by then she had moved on and
her BioVenture View was an indirect competitor. We became
great friends and have been so ever since.
BioWorld has benefited from the energy and
professionalism of a wonderful staff over the 16 years of our
management. I can’t name everyone here but I’ll thank the six
managing editors who have directed BioWorld’s daily coverage
from our Atlanta newsroom with vision, hard work and sound
journalistic judgment — Lynn Yoffee, Charles Craig, Jim Shrine,
Randy Osborne, Brady Huggett and Glen Harris. Jim Stommen
served for a period as executive editor of both BioWorld and
our med-tech unit, with its flagship, Medical Device Daily. Plus,
we’ve had three remarkable marketing managers getting the
word out: Paige Stanfield, Chris Walker and Jane Cazzorla.
Amongourreporters,Imustsingleoutthelate,greatDavidLeff,
who wrote colorfully and astutely for us for 12 years about the
sciencethatformsthefoundationofthebiotechnologyindustry.
He certainly elevated our esteem in the sector in the process.
I know the reporters themselves would find me remiss if I
did not mention their sources over the years — the thousands
of company executives, analysts, scientists, attorneys and other
industry insiders who have (usually) returned their calls and
answered their questions. Many of you are also subscribers, so
we double our thanks.
We’ve had excellent business relationships with a number
of industry partners and players. Special thanks go to Mark
Dibner of BioAbility; Robert Kilpatrick and the Technology
Vision Group; Alexandra Scott and the International Business
Forum; Matthew Chervenak of General Biologics; and Carola
Schropp of the EBD Group. BIO, the Biotechnology Industry
Organization, has been both a subject of our stories, as well as
a source. We’ve been each other’s customer. We’ve exhibited
at BIO every year since 1995. We’ve enjoyed, particularly, a
relationshipofmutualrespectwithitstwolongtimepresidents,
Carl Feldbaum and Jim Greenwood.
And thank you, finally, to the biotechnology industry as a
whole. Whether sporting a lab coat or a business suit, you are
a smart, upbeat, innovative group. Your optimism has been
infectious.Ican’timagineabetterindustryforustobecovering.
Keep the news flowing. We’ll continue to cover it as no one else
in the industry has: every business day for the last 20 years.
I first visited BioWorld’s offices on the second floor of a commercial building on
South B Street in San Mateo, Calif., in January 1994. The business, then about three
years old, consisted mainly of a daily, faxed newspaper, BioWorld Today; a weekly
look at financial trends in the sector, BioWorld Financial Watch (since renamed
BioWorld Insight); and a nascent online news and data service.
6. BioWorld®
20thAnniversaryEdition|4
On behalf of the Biotechnology
Industry Organization (BIO), I want to
recognize and applaud BioWorld on its
20th Anniversary as one of the most
highly regarded and well-recognized
trade publications providing insights
and vital coverage of our industry.
Shortly after BioWorld opened
its doors, BIO was formed through
the merger of the Association of
Biotechnology Companies and the
Industrial Biotechnology Association.
The goal of our organization was for the
entire industry, from young start-ups to
established companies, to speak with
one voice on important public policy
issues at the state and national levels.
That continues to be our primary focus
at BIO – to bring together the industry
and advocate for large and small
companies alike with one voice.
Similar to BioWorld, one of our
association’s goals is to communicate
the contributions and promise of
biotechnology to address many of
the world’s problems. At the 2010
BIO International Convention, we
will release a report on the value
of biotechnology titled, “Healing,
Fueling, Feeding: How Biotechnology
Is Enriching Your Life.” The report tells
the promising story of biotechnology
through data and anecdotes capturing
some of the many contributions of our
industry, which I’ve highlighted below.
We believe this report and this
year’s convention are occurring at a
defining moment for our industry. We
arrive in Chicago during a period of
great uncertainty and great hope for our
industry.Theglobaleconomicdownturn
has hit our industry hard but the
fundamentals — the brilliant promise of
our science — remain strong.
This event gives us the opportu-
nity to celebrate our accomplishments,
discuss our common challenges, learn
about new technologies and trends,
and seek new opportunities for invest-
ment and collaboration. It also gives
us the opportunity to assess the great
achievements of the overall industry,
and look to the future for what we hope
to accomplish to move innovation for-
ward and help better our world.
The past 20 years have propelled
the biotech industry to contribute to a
better and more sustainable way of life.
Thanks to modern biotechnology, we
live longer and healthier lives, enjoy a
more abundant food supply and higher
nutritional value, use less and cleaner
energy and have safer, more efficient
industrial manufacturing.
Today, there are more than 250
biotechnologyhealthcareproductsand
vaccines available to patients, many
for previously untreatable diseases.
Our companies continue to innovate
at a breathtaking pace, developing
medicines that are providing hope
where there once was none and new
tools to allow for more personalized
and effective care. More than 13.3
million farmers around the world use
By James C. Greenwood
President and CEO, Biotechnology Industry Organization
Biotechnology
THE HOPE AND PROMISE OF
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agricultural biotechnology to increase
yields, prevent damage from insects
and pests and reduce farming’s impact
on the environment. And more than
50 biorefineries are being built across
North America to test and refine
technologies to produce biofuels and
chemicals from renewable biomass,
which can help reduce greenhouse
gas emissions.
We have high hopes for the next
20 years. We have a lofty goal — as an
industry, we must continue to leverage
cutting-edge innovations to address
looming challenges and help create
a brighter future. Already, we have
made significant progress in meeting
this goal and have only tapped a small
fragment of the many potential uses —
and benefits — of biotechnology.
Biotechnology helps us answer
the world’s most pressing challenges:
resource sustainability, environmental
stewardship, water scarcity, an aging
population and cancer, to name just
a few. The biotech industry is an eco-
nomic growth engine, providing high-
quality jobs for researchers and scien-
tists, and generating employment for
millions of workers in other industries.
Every day, research scientists explore
new ways to improve our quality of life
using biotechnology applications.
In health care, more than 600
new biotechnology medicines are
currently being developed and tested
for more than 100 diseases that could
yield promising results in the near
future. Researchers are capitalizing
on genetic information to develop
promising new cures for cancer,
including therapeutic vaccines, and
— through personalized medicine —
working to help the right patients get
the right treatment at the right time.
Fulfilling the promise of personalized
medicine truly could transform the
delivery of health care within the next
20 years. And promising new work
on malaria, tuberculosis, and dengue
fever may prove the key to developing
vaccines for deathly diseases that
plague the world.
While great progress has already
been made to improve crop yields and
the nutritional value of our food sup-
ply, we can expect further positive im-
pacts in the near future. Through new
biotechnological innovations, scien-
tists are in the process of developing
salt-tolerant, drought-resistant crops
and opportunities for leveraging cur-
rently non-productive land. Continued
advances in the area of genetically en-
gineered animals will enable research-
ers to enhance food production and
expand scientific knowledge. Also
promising are applications that would
reduce the environmental footprint of
our farms.
Biotechnology may pave the way
for a 21st century industrial revolution
that moves our economy away from
a petrochemical-based economy to
a more green and cleantech focused,
bioprocessing-based economy. This
could lead to the emergence of a new
“home grown” value chain, giving every
state the opportunity to sustainably
leverage biological resources. And
industry scientists are deploying
new tools, such as synthetic biology
and genetically enhanced microbes
that require only sunlight and carbon
dioxide, to enable bioprocesses for
biofuels and chemicals.
As an industry, we must continue
our proud tradition of researching
and developing breakthrough new
products and technologies that address
some of the greatest challenges
facing our global population and our
planet. It is the passionate, committed
people in our industry who conduct
the vital research and development
work that will help treat previously
untreatable diseases, grow more crops
on available land, prevent pollution
and environmental degradation at
the source and develop advanced,
renewable sources of energy.
Year round, we remain committed to
advocating on behalf of the industry
to create a policy and regulatory
environment to support the important
work that is being done every day.
The value of biotechnology is often
either overlooked or misunderstood
by policymakers and the public. They
must be made aware of the value
that biotechnology brings to society
and everyday life in order to make
informed decisions that will affect
future biotechnological innovation.
BIO has the privilege and honor
of telling the biotechnology story
to the world. We hope that you will
take a moment to read the value of
biotech report, which you can access
at valueofbiotech.com. And feel free to
use the information and stories within
the report to tell others about the
enormous promise and potential of the
biotech industry.
Again, we applaud the long-
standingcommitmentofBioWorldover
the past 20 years to provide accurate
and fair reporting of our industry. We
stand ready to advocate and support
the industry as it continues to deliver
on the promise of biotechnology to
help heal, fuel and feed the world for
years to come.
THE BIOTECH INDUSTRY IS AN ECONOMIC
GROWTH ENGINE, PROVIDING HIGH-QUALITY
JOBS FOR RESEARCHERS AND SCIENTISTS, AND
GENERATING EMPLOYMENT FOR MILLIONS OF
WORKERS IN OTHER INDUSTRIES.
James C. Greenwood is
President and CEO of
BIO in Washington, D.C.,
which represents more
than 1,200 biotechnology
companies, academic institutions, state
biotechnology centers and related
organizations across the United States and
in more than 30 other nations. BIO members
are involved in the research and development
of innovative healthcare, agricultural,
industrial and environmental biotechnology
products. BIO also produces the annual BIO
International Convention, the world’s largest
gathering of the biotechnology industry, along
with industry-leading investor and partnering
meetings held around the world.
8. BioWorld®
20thAnniversaryEdition|6
20 years ago, he sat for a BioWorld Q&A. Today, computer genius and
biotech investor Bill Gates is busier than ever.
CLOSED
Microsoft’s
‘Boy Wonder’ Grows
Up — and Up
By Randy Osborne
Staff Writer
W
riting in a BioWorld magazine
feature story two decades ago,
David Bunnell described hearing
news from the editor that his
friend, the famous entrepreneur Bill Gates, was
entering biotech. “‘He is?’ I exclaimed somewhat
incredulously. ‘How so?’” That year, 1990, Gates
become the single largest investor in fledgling
ICOS Corp., of Seattle. “BioWorld visits the
software boy wonder,” trumpeted the headline in
our premier magazine issue.
ICOS, to become best known as Eli Lilly
and Co.’s partner for the erectile-dysfunction
drug Cialis (tadalafil), was bought in 2007 by
Indianapolis-based Lilly for $2.1 billion —
seemingly major bucks, but hardly enough to
make golden Gates exclaim incredulously, even
then. The Microsoft chairman’s presence in the
biotech industry has only grown with his riches.
In 1994, Gates founded the Bill & Melinda Gates
Foundation (then known as the William H. Gates
Foundation) to give back by enhancing health
care in poverty-stricken areas of the world.
Phone calls and email from BioWorld to the
foundation requesting an interview with Gates for
our 20th anniversary issue drew an encouraging
response at first. Then came a follow-up contact
from one of Gates’ staffers, who said he would
“have to decline the opportunity” because of
other commitments.
The chase was on.
Trying to reach him through the foundation’s
bureaucratic strata was probably futile to begin
with, we reasoned. So we tried email to www.
thegatesnotes.com, the website where Bill shares
with fans under categories such as “what I’m
thinking,” “what I’m learning about,” and “my
travels.” Maybe Bill would take a few minutes
from his schedule to tell our readers what he’d
been thinking and learning about since the
BioWorld magazine article in days of yore.
We could ask him a lot of questions about the
10. BioWorld®
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Maybe it was for the best, since Bill has his own, mostly non-biotech
projects going, and he needs to put his efforts there. Maybe he
wouldn’t have had much to say about the industry overall anyhow.
The chat might have been full of awkward silences.
biotech industry, where it’s been and where it’s
going. We could ask him what he meant, in that
original interview, when he said: “In my industry,
we’ve built up a few companies like Microsoft that
are going to be there for a long time. Biotech still
doesn’t really have that. You can say Genentech
sort of surrendered.” Hmm… 1990 was the year
Basel, Switzerland-based Roche AG acquired a
majority stake in Genentech Inc. Was Bill talking
about that? Could we ask him?
Nope. Nothing.
Next we considered firing off 150 characters
on Twitter, where Bill tweets on occasion. Isn’t
this how everybody talks to each other now – by
way of Twitter and Facebook? Bill listed 685,227
Twitter followers at last count. Cutting through
the noise and persuading him to get on the horn
for a real-time chitchat ought to be easy, right?
Sure. We gave that one up before starting.
Continued effort seemed worthwhile. Bill’s
original BioWorld interview contained keen-
minded insights, including his comparison
of biotech with the burgeoning field of
computers. Bill reeled off the commonalities:
“Smart people; a new industry where nobody
really knows the rules and a lot of surprising
things can happen; different ways you can look
at partnerships and distributing products;
situations where you’re friends on one deal and
you’re enemies on the next; a small community
where you’re always running into each other;
an arena in which the courts are totally crazed
with the level of ambiguity — is this thing
protected or is it not? — are you going to be
put out of business with this lawsuit that’s
been running for years, where you basically
have to assume that you’re going to win?”
We assumed we were going to win.
We tracked down David Bunnell, the
writer of the original Bill article and founder
of BioWorld, as well as other important media
outlets. It was Bunnell’s friendship with Bill, after
all, that won him the first interview; possibly
hecouldpullsomestringsandgetusasecondone.
We wrote to Bunnell at www.eldr.com, where
he is co-founder and editor in chief. It’s an
online publication that offers “an enlightened,
entertaining and sometimes edgy approach to
aging through its reviews, articles and interviews,
dynamic photography and artwork,” according to
the website’s self-description.
“Bringing back BioWorld memories for you.”
This was the cheery, inviting — or so we thought
— subject line of an email to Bunnell. “The reason
I’m contacting you is that I’m trying to reach
Mr. Gates for 15 minutes, and cannot penetrate
the wall of his people; I’m hoping you can help,”
we wrote. “Can you? Would you? Thank you for
anything you might do.”
Bunnell declined the opportunity too,
apparently. No reply. Could be that he had just as
much going on as his longtime friend Bill.
We were aging, and getting edgy about it, but
no Bill.
Other avenues were explored — many other
avenues. We contacted friends of friends of Bill.
We tried to find people who knew people who
had once stood in line somewhere in proximity
to Bill. We cajoled public relations people who
seemed like they had important connections. One
warned about the “tall order,” but vowed: “I will
do everything in my power to make it happen.”
Didn’t happen. Not through her power, or
ever at all.
Maybe it was for the best, since Bill has his
own, mostly non-biotech projects going, and he
needs to put his efforts there. Maybe he wouldn’t
have had much to say about the industry overall
anyhow. The chat might have been full of
awkward silences.
Yet we prefer the past, when the world
seemed more manageable and people easier to
reach, just by picking up the phone and waiting
on hold for a few minutes. Bill was talking about
computers when he said the following, but it
seems to fit: “The industry is now dominated by
large companies that are very different from the
ones who started it up, and you get people who
are still very nostalgic for those old days.”
Amen, Bill. Amen.
ABOVE: Bill Gates
12. BioWorld®
20thAnniversaryEdition|10
n 1990, a new group of biotech leaders started to emerge.
Some held positions within the industry, leaving big pharma to run young
biotechcompaniesorrisingthroughthenewlyestablishedbiotechrankstoadvance
cutting-edge technologies. Others hailed from the financial community, from
Washington or from academia. Together, they were poised to take the helm from
the biotech industry’s original founders and navigate through uncharted waters,
nurturing innovation, building infrastructure and overcoming early challenges
along the way.
Twenty years ago, the BioWorld staff compiled a list of those people – the ones
most likely to shape the future of the biotech industry. Based on a combination of
research, interviews and personal opinions, the list served as an early “who’s who”
for the industry.
What happened to those petri dish pioneers, those leaders of the lab and
brainiacs of the boardroom? Let’s take a look at how the members of our original
list have fared over the past 20 years…
In the original issue 20 years ago, BioWorld picked the up-and-coming stars
expected to shape the future of the biotech industry. Where are they now?
By Trista Morrison
Staff Writer
Tracking Biotech’s Original
Movers and Shakers
14. BioWorld®
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Dennis Longstreet
EXECUTIVES
Hollings Renton
THEN: President and chief operating officer of Cetus
Corp., a biotech reeling from the FDA’s rejection of
cancer drug Proleukin (interleukin-2).
NOW: Founded in 1971, Cetus was one of the original
biotech start-ups. Its first claim to fame was scientist
Kary Mullis’ work on the polymerase chain reaction
(PCR), a DNA amplification technique that earned
Mullis a Nobel Prize and provided the nascent biotech
industry with a foundation on which to build. But by
1990, Cetus had turned its focus to drugs, namely cancer
drug Proleukin and multiple sclerosis drug Betaseron
(interferon beta-1b). When the FDA rejected Proleukin,
Renton was brought in to get things back on track.
He did just that. Within
a year, he had engineered
Cetus’ acquisition by
Chiron Corp., where he
took over as president
and chief operating officer.
He oversaw Chiron’s
approval of Proleukin and
Betaseron. Chiron itself
later would be acquired by
Novartis AG, but Renton
didn’t stick around to see
that – he was lured to a
little cancer start-up called Onyx Pharmaceuticals Inc.
Onyx was the brainchild of Frank McCormick, now
director of the UCSF Helen Diller Family Comprehensive
Cancer Center. Back then, McCormick was vice president
of research at Cetus and then at Chiron. Shortly after the
merger, he got funding from venture investors Brook Byers
and Sam Colella to spin out a biotech focused on cancer.
Renton joined Onyx as president and CEO in 1993. He
quickly inked deals with Warner-Lambert Co. (now Pfizer
Inc.) for Onyx’s lead oncolytic virus program and with Bayer
AG for an early stage kinase inhibitor program.
After going public in 1996, Onyx fell victim to the harsh
markets of 2001 and was forced to restructure. Then Pfizer
backed away from its partnership, forcing Renton to make
what he called a “key strategic decision.” Onyx abandoned
its Phase III oncolytic virus program to focus on Nexavar
(sorafenib), then in Phase I/II with partner Bayer.
“We were probably one of the earlier companies to
make a strategic decision to abandon a platform and
focus on a single drug,” Renton said. The bet paid off.
Nexavar gained approval for kidney and liver cancers,
posting global sales of $843.5 million last year and
helping thousands of patients.
Renton retired in 2008 and now serves as chairman
of the board at Affymax Inc., co-chairman of the board at
Portola Pharmaceuticals Inc., and board member for Rigel
Pharmaceuticals Inc. and Cepheid Inc.
THEN: President of Johnson & Johnson’s Ortho
Biotech group, the first standalone biotech
subsidiarytocomeoutofbigpharmaandthe
only company at the time with a monoclonal
antibody on the market (transplant rejection
treatment OKT3).
NOW: Ortho laid the groundwork for a string of
successful J&J biotech subsidiaries, including
Centocor Inc. Longstreet’s influence was
critical to building the big pharma’s
biotech presence, as was that
of James Utaski, who oversaw J&J’s
business development and venture
capital efforts during the same time
period. Over the years, Longstreet moved
up the big pharma’s ranks, eventually
serving as group chairman and managing
four medical device divisions with $4 billion
in sales. After retiring in 2005, he joined
private equity firm RoundTable Healthcare
Partners in 2006, where he still serves as a
senior advisor and sits on multiple
company boards.
“We were probably one of the earlier
companies to make a strategic
decision to abandon a platform and
focus on a single drug.”
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Michael Riordan
THEN: Founder, president and CEO of antisense start-up
Gilead Sciences Inc.
NOW: Drawing on experience from both the medical and
venture capital fields, Riordan (left) founded Gilead when
he was just 29 years old. In addition to making BioWorld’s
original movers-and-shakers list in 1990, he was also named
one of BioPeople Magazine’s most eligible bio-bachelors.
In 1990, Riordan had been pushing Gilead’s scientists
to figure out a way to make antisense work, but to no avail.
The programs were sold to Isis Pharmaceuticals Inc., which
continues to advance antisense today. Gilead then turned
its focus to aptamers, which were later sold to Eyetech
Pharmaceuticals Inc., Archemix Inc. and others. But the
seeds that would one day grow Gilead into a $7 billion HIV
and liver disease powerhouse were already being planted:
Riordan recruited John Martin, now chairman and CEO;
John Milligan, now president and chief operating officer;
and Norbert Bischofberger, now chief scientific officer.
That early dream team picked up rights to some antiviral
technologies that had fallen through the cracks during the
merger of Bristol-Myers Co. and the Squibb Corp. Although
only in preclinical, they would one day become HIV drug
Viread (tenofovir disoproxil fumarate) and HBV drug
Hepsera (adefovir dipivoxil). Riordan left Gilead in 1997
and spent several years traveling in Europe and Asia. He’s
working on a nonprofit at the intersection of human rights
and digital media, but prefers to keep the project under the
radar for the time being. And – attention, ladies – he hasn’t
settled down to marriage yet, so you’ve still got a chance to
capture this bio-bachelor’s heart.
James Sherblom
THEN: Chairman and CEO of Transgenic Sciences Inc.,
a pioneer of manufacturing recombinant products in
transgenic animals.
NOW: Sherblom hailed from Genzyme
Corp., which back then was no stranger
to supporting its early stage enzyme
research with diverse acquisitions.
He employed a similar strategy at TSI,
acquiring lab-testing service firms to
helpfundthetransgenicmanufacturing
programs. TSI was sold to Genzyme,
and Sherblom founded Seaflower Ventures to seed new
life science and medical technology start-ups. The firm
was involved in funding Geltex Pharmaceuticals Inc., which
developed Renagel (sevelamer hydrochloride) and was later
bought by partner Genzyme for $1 billion. Seaflower is well-
respected in the early stage venture industry, and Sherblom
still serves as managing general partner. He also co-founded
the Massachusetts Biotechnology Council, which has grown
into a powerful regional biotech industry organization
representing more than 600 member organizations.
Ron Unterman
THEN: A pioneer in environmental biotechnology, Unterman
left General Electric to co-found Envirogen Inc., a start-up
focused on bioremediation of hazardous wastes.
NOW: UntermanservedaschiefscientificofficerasEnvirogen
went public and was sold to engineering and technology
firm Shaw Environmental. He later joined the Slater Center
for Marine and Environmental Technologies, a Rhode Island
venture firm.
Roger Salquist
THEN: Chairman and CEO of Calgene Inc., which held the
future of agricultural biotechnology in its hands as the first
biotech to pursue approval of a genetically engineered food.
NOW: Salquist got his FDA approval of the Flavr Savr tomato,
although it proved too expensive for commercial success.
Nevertheless, he negotiated Calgene’s acquisition by
Monsanto Co. in 1996 and then founded venture firm Bay
City Capital in 2007. Bay City has helped fund dozens of
biotechs and still invests actively in the space today. Salquist,
however, retired in 2003 to serve as chairman of the Connect
entrepreneurship program at the University of California,
Davis. He later moved on to a position as chairman of lipid
profiling company Lipomics Inc.
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Virginia Walker
THEN: Vice president of finance at California Biotechnology Inc. and a champion
of creative biotechnology financing.
NOW: Walker organized the first conference of the association of biotechnology
financial officers. She also helped turn around CalBio, which later became Scios Inc.,
nowaJohnson&JohnsonsubsidiaryfocusedonmarketingheartfailuredrugNatrecor
(nesiritide). But the biotech industry lost her talents as she took senior finance
positions with General Electric, semiconductor company Intersil Corp., software
developer OSE Systems/Enea and high-tech consulting firm Jamison Group.
Art Benvenuto
THEN: A former Eli Lilly and Co. executive
who took the helm of Marrow-Tech Inc.,
serving as chairman, president and CEO
of the regenerative medicine firm.
NOW: Marrow-Tech changed its name to
Advanced Tissue Sciences Inc. and won
FDA-approval of Dermagraft, a bioen-
gineered, cryopreserved tissue used to
treat diabetic foot ulcers. But the firm
went bankrupt trying to fund its portion
of a joint venture with Smith & Nephew.
Dermagraft, however, lived on: the tech-
nology was sold to Advanced BioHealing
Inc., which successfully markets it today.
Benvenuto (right) went on to serve as
chairman of the life science group at RA
Capital Management LLC, and he served
on several biotech boards. Today he is
chairman and CEO of Micell Technolo-
gies Inc., an early stage firm developing
bio-coatings for drug-device combina-
tion products. And Benvenuto wasn’t
the only ATS alum to impact the indus-
try: ATS Chief Medical Officer Ron Cohen
became founder, president and CEO of
Acorda Therapeutics Inc., which recent-
ly won FDA approval of Ampyra (dal-
fampridine) to improve walking ability
in patients with multiple sclerosis.
John Groom
THEN: A Smith Kline & French
Laboratories alum who left big
pharma to serve as founding
president and CEO of Athena
Neurosciences Inc.
NOW: Groom engineered Athena’s
$600 million takeover by Elan
Corp. plc. in 1996, which gave the
big pharma access to soon-to-be-
approved muscle spasticity drug
Zanaflex (tizanidine hydrochloride)
and seizure drug Diastat (diazepam).
Elan also took over development of
a little multiple sclerosis antibody in
Athena’s pipeline: back then it was
known as Antegren, but it would one
day become a blockbuster under the
brand name Tysabri (natalizumab).
Groom joined the Elan ranks,
eventually serving as president and
chief operating officer. Known as
a charismatic leader, he retired in
2001 and now serves on several
biotech boards.
Alan Timms
THEN: Traded a high-level position with G.D. Searle & Co. (now part of Pfizer Inc.)
to serve as president and CEO of Glycomed Inc.
NOW: Timms had decades of big pharma experience gained first at Sandoz (now
part of Novartis AG) and later at Searle, where he served as president of research
and development. He left to run his own consulting company, but after just two
years he was recruited to the top spot at Glycomed, a biotech founded by Brian
Atwood, who later went on to found venture firm Versant Ventures. Glycomed’s
carbohydrate chemistry platform proved difficult to advance, however, and
Timms left the struggling company during a 1994 restructuring, just prior to its
acquisition by Ligand Pharmaceuticals Inc. Timms returned to his consulting
firm until he retired in 2001; he also served on several biotech boards.
Glenn French
THEN: President of Applied Immune
Sciences Inc.
NOW: Applied ImmuneSciences Inc., an
innovator in cell and gene therapies,
soldone-thirdofitselftoRhone-Poulenc
Rorer Inc. in 1993. The big pharma
(which would eventually form part of
Sanofi-Aventis Group) bought the rest
in 1995, at which point French moved
on. Like so many other early biotechs,
Applied ImmuneSciences produced
more than one future biotech leader:
scientific founder Thomas Okarma
went on to become president and CEO
of stem cell pioneer Geron Corp.
17. 15|BioWorld®
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David Blech
FINANCIAL COMMUNITY
THEN: Founder of at least a dozen biotechs including Genetic Systems
Corp., Celgene Corp., Icos Corp. and Neurogen Corp., as well as the head
of biotech investment firm Blech & Co., which was seeking to “rescue”
struggling companies.
NOW: Blech kept founding biotechs – among them Alexion Pharmaceuticals
Inc. and Neurocrine Biosciences Inc. He shook up many traditional venture
capitalists with his unorthodox funding approaches and decision-making
based on what he referred to as an intuitive sense about people.
But Blech’s empire came crashing down when his investment firm got
into trouble for buying and selling stocks to and from brokerage accounts
that he controlled, which created the illusion of liquidity. His firm failed to
open its doors on Sept. 22, 1994 – known on Wall Street as “Blech Thursday”
– sending ripples through the entire biotech sector and stranding several
biotechs that had depended on his support. Blech later pleaded guilty to
criminal securities fraud.
But that wasn’t the end for Blech – like so many of the biotech companies
he invested in, he would rise again from the ashes. The Seattle Times
reported a few years ago that he was consulting for Intellect Neurosciences
Inc., an antibody firm working on disease-modifying Alzheimer’s drugs.
And the Times also noted that his family owns about $25 million worth of
biotech penny-stocks.
Denise Gilbert
THEN: An analyst with County Na-
tional Westminster Bank (a.k.a.
County NatWest) known for insight-
ful, substantive commentary that got
beyond the hype.
NOW: As investment banks began to
sense biotech’s potential, Gilbert was
one of the original financial analysts
hired to cover the industry. After
advancing through analyst positions
with Smith Barney Harris & Upham
and Montgomery Securities, she
moved to the corporate side as chief
financial officer and executive vice
president first at Affymax Inc. and
later at Incyte Corp. In 2000, she
left Incyte to bicycle around the
world. She later served as CEO of
privately held bioinformatics firm
Entigen Corp. before branching
off on her own as an independent
consultant. Gilbert serves on the
boards of Dynavax Technologies
Corp., Cytokinetics Inc. and KaloBios
Pharmaceuticals Inc.
Yasunori Kaneko
THEN: Head of corporate finance for Paribas Capital Markets Ltd.’s
investment banking division, where he was known for pioneering strategic
alliances between U.S. and Japanese biotech companies.
NOW: Kaneko (right) left Paribas to serve as chief financial officer and senior
vice president at antisense pioneer Isis Pharmaceuticals Inc., which he took
public in 1991. He then headed finance and business development at Tularik
Inc., a company started by fellow Genentech Inc. alum David Goeddel, now a
managing partner with venture firm The Column Group. At Tularik, Kaneko
oversaw several big pharma partnerships and took the biotech public in 1999,
five years before it would be acquired by Amgen Inc. He left Tularik to join
Skyline Ventures, an active health care investment group. According to Skyline’s
website, Kaneko “committed to golf several years ago after an unfortunate
heading incident at a team reunion for his junior All-Star soccer team.”
18. BioWorld®
20thAnniversaryEdition|16
Nancy Olson
THEN: A former general partner at
venture firm Sequoia Capital who was
independently backing young biotechs.
NOW: In 1993, Olson was
recruited to run health
care investments for St.
Paul Venture Capital.
She backed companies
like Biopsys Medical Inc.
(bought by Johnson and Johnson),
Santarus Inc. (now public) and Pro-
metheus Laboratories Inc. (profitable
and soon to be public). When St. Paul
launched its health care-focused Fog
City Fund in 2000, Olson was appoint-
ed as the fund’s sole managing partner
and continued to provide seed funding
for firms like BioLucent Inc. (acquired
by Hologic Inc.) and Somaxon Pharma-
ceuticals Inc. (now public). She consid-
ers herself extremely fortunate to have
been investing on behalf of a single
limited partner for 17 years, and as Fog
City Fund winds down, she has taken
an active role in nonprofits including
the University of California, Berkeley,
the Girl Scouts of the San Francisco Bay
Area and the San Francisco Opera.
Joe Lacob
THEN: Partner at venture firm Kleiner,
Perkins, Caufield & Byers.
NOW: Lacob is one of the few on this
list who, 20 years later, is still with the
same company. But don’t let that fool
you into thinking he’s been complacent.
Lacob has managed investments in
more than 50 life science companies,
not to mention several internet
companies and green-tech/alternative
energy companies. He serves on the
boards of several biotech and medical
device firms as well as nonprofits,
and is known within the industry as a
prominent venture capitalist.
THEN: As managing director at investment banking
firm PaineWebber, Papadopoulos was known for
taking risks to finance young biotechs.
NOW: As he rose through the PaineWebber ranks,
eventually becoming chairman of the bank’s
biotech-focusedsubsidiary,Papadopoulosbecame
known as the industry’s consummate deal maker
and financier. He managed complex acquisitions
like Warner-Lambert Co.’s $2.1 billion buyout of
Agouron Pharmaceuticals Inc., and he developed innovative mechanisms to
help fund research.
Among the funding models he popularized were Special Purpose
Accelerated Research Corporations, or SPARCs, which were similar to R&D
limited partnerships but involved spinning off a product to be funded as
a separate publicly traded company rather than a private investment
opportunity. He also conceived the tracking stock concept, which helped
Genzyme Corp. reorganize its business units.
One of Papadopoulos’ most innovative inventions was the use of
Regulation D filing exemptions to allow sophisticated private investors to
invest in biotech start-ups. The approach, used for both ICOS Corp. and
Athena Neurosciences
Inc., “brought venture
capital to the masses,”
Papadopoulos said.
Few of Papado-
poulos’ creative financ-
ing mechanisms have
survived to the pres-
ent day. Symphony Capital’s funding model contains echoes of the old R&D
limited partnerships, but for the most part, as tax benefit loopholes were
closed, simpler financing approaches like registered direct offerings and
PIPEs took precedence. Still, many say the industry couldn’t have matured
without Papadopoulos’ help.
AfterPaineWebber,Papadopoulosservedasvicechairmanofinvestment
bank Cowen & Co. until his retirement in 2006. But his influence extended
beyond banking. He doubled as a venture capitalist, pouring his own money
into biotechs like Anadys Pharmaceuticals Inc., Cellzome Inc., and Exelixis
Inc., which he co-founded and still oversees as chairman. He remains an
active investor and board member of several other biotechs, including BG
Medicine, Regulus Therapeutics Inc., Joule Biotechnologies Inc. and Biogen
Idec Inc.
Papadopoulos also gets credit for raising the bar on biotech conferenc-
es: The banking conferences he sponsored during the industry’s early years
were known for bringing together the top minds in the business and chang-
ing the intellectual level at which business was discussed. He still hosts an
exclusive biotech conference each year in Greece, which serves as the main
funding source for a nonprofit he co-founded with Harvard Medical School’s
Spyros Artavanis to provide support and guidance to Greek scientists.
Stelios Papadopoulos
“[Regulation D filing
exemptions] brought venture
capital to the masses.”
19. 17|BioWorld®
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Larry Bock
THEN: General partner with Avalon Ventures,
a then-young life science and high-tech
investment firm that is still active in biotech
company formation.
NOW: Bock had biotech in his blood: his
father, Richard Bock, was one of the original
biotech brokers. With that kind of pedigree,
it was no surprise when Larry Bock ditched
a job at Genentech Inc. to return to business
school and try his hand at venture capital.
In the 1980s, Bock was trying to recruit
Harvard neurologist Dennis Selkoe to start
a biotech company. Kevin Kinsella, founder
of Avalon Ventures, was pursuing Selkoe
as well. The two “decided to collaborate rather than compete,”
Bock said, and the result was Athena Neurosciences Inc., which
would later be bought by Elan Corp. plc. Bock and Kinsella
worked so well together that they collaborated again on Vertex
Pharmaceuticals Inc. and Genpharm International Inc. (now
part of Bristol-Myers Squibb Co.) – and then Bock finally joined
Avalon full-time.
Over the years, Avalon sowed the seeds that would grow
into much of the biotech industry as we know it today. It founded
Sequana Therapeutics Inc. (now part of Celera Corp.), Pharming
Group NV, Neurocrine Biosciences Inc., Ariad Pharmaceuticals
Inc., Pharmacopeia Inc. (bought by Ligand Pharmaceuticals
Inc.), Onyx Pharmaceuticals Inc., Caliper Life Sciences Inc.,
Idun Pharmaceuticals Inc. (acquired by Pfizer Inc.), Aurora
Biosciences Corp. (acquired by Vertex), Conforma Therapeutics
Corp. (bought by Biogen Idec Inc.) and many others. Yet some
have noted that Kinsella’s investment in the hugely successful
Broadway musical “Jersey Boys” made him more money than his
biotech ventures.
Around 2003, Bock felt the biotech venture capital business
was starting to get crowded, so he moved to the still nascent
nanotech field. He joined CW Group, where he founded Illumina
Inc., and later moved to Lux Capital Management, where he
founded Nanosys Inc. and Genocea Biosciences Inc. But while
building nanotech start-ups, Bock noted that it was difficult
to recruit American scientists because the next generation
was placing its bets on other career paths. Inspired by the
science festivals he saw on a family trip to Europe, he started
a nonprofit “to get people excited about science again.” His
San Diego Science Festival attracted about 250,000 attendees
last year and is now gearing up to go nationwide. Bock and his
wife also founded Community Cousins, a nonprofit aimed at
matching families of different ethnicities to create friendships
and destroy racism.
[Bock started a nonprofit] “to get
people excited about science again”
Chris Gabrieli
THEN: Launched the healthcare practice at Bessemer
Venture Partners.
NOW: Gabrieli led Bessemer’s investments in bio-
techs like Affymax Inc., Isis Pharmaceuticals Inc.,
Sirtris Pharmaceuticals Inc. (now part of GlaxoS-
mithKline plc) and others. He shifted his focus to
politics and education about a decade ago, running
for various offices in Massachusetts and found-
ing Massachusetts 2020, an initiative focused on
expanding public school hours. He also serves as
chairman of the National Center on Time & Learn-
ing, and he co-authored a book called Time to Learn:
How a New School Schedule is Making Smarter Kids,
Happier Parents, and Safer Neighborhoods.
Ken Kelley
THEN: Partner with Institutional Venture Partners.
NOW: Kelley oversaw the funding of 20 biotech and
medical device firms during his tenure at IVP. In the
mid-1990s he founded IntraBiotics Pharmaceuticals
Inc. (now Ardea Biosciences Inc.), taking the
company public in 2000. He went on to fund more
start-ups as general partner at Latterell Ventures,
and he later formed his own consulting firm, K2
Bioventures. Kelley now serves on several boards
and holds the CEO spot at PaxVax Inc., a biotech he
founded in early 2007.
20. BioWorld®
20thAnniversaryEdition|18
Rep. Robert
Kastenmeier, D-Wis.
THEN: As chairman of the House Sub-
committee on Courts, Intellectual Prop-
erty and the Administration of Justice,
Kastenmeier was pegged to “make or
break” the Boucher bill, an initiative de-
signed to protect biotech process pat-
ents against foreign competitors.
NOW: The Boucher bill, formally known
asthe“BiotechnologyPatentProtection
Act,” made the rounds in Congress
for several years before passing as
a set of amendments to the patent
law. It addressed the fact that while
host cells used to produce genetically
engineered proteins were patentable,
the process of producing the protein
within the cell was not. The Boucher
bill influenced later legislation such
as the 1995 “Biotechnology Patent
Process Protection Act.”
Back in 1990, the Boucher bill
was a controversial topic within the
industry, with the Association of
Biotechnology Companies speaking
out against it while the Industrial
Biotechnology Association supported
it. The situation was just one of many
in which the two industry trade groups
found themselves at loggerheads,
making it difficult for biotech interests
to gain any political traction. That
changed in 1993, when the two merged
to form the Biotechnology Industry
Organization (BIO), which has served
as biotech’s political voice ever since.
Kastenmeier, meanwhile, lost his
1990 re-election bid to Republican
Scott Klug.
Margaret Mellon
THEN: Director of the National Wildlife
Federation’s biotechnology policy center.
NOW: As a scientist, Mellon had more
credibility than the average gadfly, and her push to get politics out of science
at federal agencies was aligned with the biotech industry. But she was no
fan of agricultural biotech, having co-authored books like Ecological Risks of
Engineered Crops and Hogging It!: Estimates of Antimicrobial Abuse in Livestock.
She drew attention to the potential risks of releasing untested genetically
modified organisms, and her reasoned voice of opposition was critical in
positioning agricultural and environmental biotechnology as real issues that
deserved real legislative consideration.
Mellon left the NWF to serve as senior scientist and director of the food &
environment program at the Union of Concerned Scientists, a science-based
nonprofit. She also serves on the U.S. Department of Agriculture's Advisory
Committee on Biotechnology and 21st Century Agriculture.
Jeremy Rifkin
THEN: President of the Foundation on Economic Trends and a biotech naysayer
who fought access to genetic information, argued about side effects associated
with Genentech Inc.’s growth hormone and sued the FDA over quality issues.
NOW: When you see protestors dressed like tomatoes outside of BIO’s annual
conference, you have Rifkin to thank for it. He was one of the first anti-biotech
activists, making frequent television appearances in which he condemned
agricultural biotechnology and genetic engineering. One of his 17 books, The
Biotech Century: Harnessing the Gene and Remaking the World, poses such
questions as “Will artificial creation…mean the end of nature?” and “What
will it mean to live in a world where babies are genetically engineered and
customized in the womb?”
When it became clear that the U.S. was going to embrace agricultural
biotechnology, Rifkin shifted his focus on that front to Europe, and he has had
an impact in shaping the anti-biotech sentiment overseas. He still runs the
Foundation on Economic Trends, but he’s become somewhat more mainstream
over the years, turning his attention to topics like green energy, sustainable
development and employment in an automated world.
REGULATORY
21. 19|BioWorld®
20thAnniversaryEdition
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22. BioWorld®
20thAnniversaryEdition|20
Greg Simon
THEN: As staff director of the investigations and oversight subcommittee of the
House Committee on Science, Space and Technology, Simon was trying to strike
a compromise between biotech and environmental groups regarding field tests
of GMOs.
NOW: Simon was open-minded, listening to the arguments of
the agricultural biotech industry and its opponents, such as
Jeremy Rifkin and Margaret Mellon. He made sure that key
Democrats remained open-minded as well instead of yielding to
environmental extremists, and his push for conservative, regulated
progress propelled the U.S. to become one of the only countries that
supported ag-bio.
Simon served as Vice President Al Gore’s chief domestic policy
advisor on economic, science and technology issues from 1991 to
1997, overseeing the NIH and the FDA. He and a group of other
biotech regulatory experts, known as the “Clone Heads,” influenced
the development of the regulatory framework for biotechnology products. He
also played a significant role in the creation of the international space station and
revamping the telecommunications industry.
Simon made a quick sojourn into the private sector, starting his own
consulting firm, before teaming up with Michael Milken in 2003 to fund
a nonprofit called FasterCures. The group works to boost funding for
disease research organizations; increase patient participation in research;
build networks between nonprofits, philanthropists and the industry; and
otherwise speed new drugs to market. Simon also served as part of the Obama
administration's transition team reviewing the Department of Health and
Human Services. Last year, he left FasterCures to serve as senior vice president
of public policy for Pfizer Inc.
David Beier
THEN: Vice president of government
affairs at Genentech Inc.
NOW: Beier was one of the first lobbyists
to work Capitol Hill for the biotech in-
dustry, and as such he was instrumental
in shaping early legislation, including
successfully lobbying to keep orphan
drug exclusivity provisions in the Or-
phan Drug Act. In 1998, he became
Vice President Al Gore’s chief domes-
tic policy advisor. He then served as a
partner with the Washington law firm
of Hogan and Hartson until 2003, when
he accepted the role of senior vice presi-
dent, global government affairs for Am-
gen Inc. He continues in that role today,
serving as a member of Amgen’s CEO
staff and overseeing health care policy,
corporate affairs, domestic and inter-
national government relations, health
economics initiatives, pricing, payor
planning, philanthropy and corporate
communications. He also serves on the
board at Aryx Therapeutics Inc.
Lisa Raines
THEN: Director of government relations
for the Industrial Biotechnology
Association.
NOW: Like David Beier, Raines (left) was
oneofthefirstbiotechlobbyistsandwas
instrumental in keeping orphan drug
exclusivity provisions in the Orphan
Drug Act. She joined Genzyme Corp. as
senior vice president for government
relations in 1993 and had a hand in just
about every piece of biotech legislation
to emerge during the 1990s, including
the Prescription Drug User Fee Act
of 1992, the Biotechnology Patent
Protection Act of 1995, the FDA Export
Reform and Enhancement Act of 1996
and the FDA Modernization Act of 1997.
Raines developed a reputation as
an intelligent, hard-working, passionate
and loyal figure on Capitol Hill. She
alwaysspokehermindandwasn’tafraid
to go head-to-head against big pharma’s
deep-pocketed trade associations when
necessary. She also took on the biotech
industry, convincing cash-strapped
CEOs that FDA user fees were the only
way to help an underfunded agency
keep up with its workload.
On Sept. 11, 2001, Raines was
aboard American Airlines flight 77 from
Washington D.C. to Los Angeles, on her
way to a Genzyme sales meeting in Palm
Springs, Calif. All 64 people on board
the plane – including Raines, then 42
years old – were killed when terrorists
hijacked the aircraft and crashed it
into the Pentagon, killing another 125
people on the ground.
23. 21|BioWorld®
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Alfred Gilman
THEN: Professor of pharmacology at the University of Texas
Southwestern Medical Center and discoverer of G proteins.
NOW: Gilman (right) and other researchers defined the G
protein-coupled receptor pathway, one of the most common
mechanisms for getting information from the outside of a
cell to the inside to regulate the cell’s function. It is estimated
that between one-third and one-half of all drugs work in this
pathway. Gilman’s discovery earned him the nickname “G-
Man” and a Lasker Award in 1989. A few years later he was
awarded the Nobel Prize in Physiology or Medicine, which he
shared with fellow G-Man Martin Rodbell, now deceased.
Gilman was elected as dean of UTSW Medical School in
2005. But for the last few years, he’s left the research world
to serve as chief scientific officer of the Cancer Prevention
Research Institute of Texas (CPRIT). Modeled on the
California Institute for Regenerative Medicine, CPRIT is a
state agency empowered to spend $3 billion over 10 years on
cancer research in Texas. Gilman also serves on the boards of
Regeneron Pharmaceuticals Inc. and Eli Lilly and Co.
SCIENTISTS
Philip Leder
THEN: Founding chairman of Harvard
Medical School’s department of genet-
ics and one of the first researchers to
use transgenic mice to study cancer.
NOW: Leder, like many of the scientists
on this list, remains at his post 20 years
later. Perhaps this reflects that while
investors and entrepreneurs expect
rapid returns, scientists understand
that making important discoveries and
proving them out takes a lifetime.
Leder’s genetically engineered
“oncomouse”wentontobroadlyimpact
the study of cancer, and the concept of
mimicking human diseases in mice has
become a standard in biotech research.
His work was recognized with a Lasker
Award and the National Medal of
Science. Earlier in his career, he also
contributed to the deciphering of the
genetic code, figuring out which letters
corresponded to which amino acids.
He is now the John Emory Andrus
Professor of Genetics at Harvard.
Robert Langer
THEN: Professor of chemical and biochemical engineering at the Massachusetts
Institute of Technology and a pioneer of controlled-release drugs and
biodegradable polymers.
NOW: Langer’s discoveries sin-
gle-handedly shaped the drug
delivery industry. Over the years
his combination of science and
business acumen has helped
found about two dozen com-
panies, including Enzytech Inc.
(now part of Alkermes Inc.),
Momenta Pharmaceuticals Inc.,
Pervasis Therapeutics Inc., Bind
Bioscienes Inc. and Selecta Bio-
sciences Inc. His work has been
recognized with the National Medal of Science, the Millennium Technology Prize
and numerous other awards.
Langer is known for his creativity and his solutions-based approach to
melding material science and pharmaceuticals. In addition to drug delivery,
he contributed to early work in angiogenesis and tissue engineering. He now
serves in the top post of “Institute Professor” at MIT, where he runs the world’s
largest biomedical engineering lab. His research focuses on polymers for the
delivery of genetically engineered proteins and nucleic acids, including siRNA,
and nanotechnology.
24. BioWorld®
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Catherine Mackey
THEN: Director of plant genetics at
DeKalb Genetics Corp. and the first
scientist to report solid data on
genetically engineered corn.
NOW: Originally a Pfizer Inc.
scientist, Mackey moved to DeKalb
as part of Pfizer’s divestiture of its
genetically modified seed business.
After advancing through the DeKalb
ranks and launching three products,
she played a role in the firm’s $2.5
billion sale to Monsanto Co. Mackey
then came full circle by returning
to Pfizer to lead its genomics and
proteomics programs.
By 2001, Mackey had risen to the
position of senior vice president of
global research and development at
Pfizer. She now runs Pfizer’s oncology-
focused facility in La Jolla, Calif., and
manages the big pharma’s external
research networks in the Western
U.S. She also serves on the boards of
several San Diego nonprofits.
R. Michael Blaese
THEN: Chief of the cellular immunol-
ogy section of the NIH’s National
Cancer Institute.
NOW: Another gene therapy pioneer,
Blaese worked with W. French
Anderson on early clinical trials for
ADA-SCID. He went on to serve as
president and chief scientific officer
of the Molecular Pharmaceuticals
Division of Kimeragen Inc., a genetic
surgery company that merged with
ValiGene SA. Blaese has dedicated his
life to studying and treating children
with rare genetic disorders, and
he is currently chief of the Clinical
Gene Therapy Branch at the National
Human Genome Research Institute.
He also is working on gene therapies
for cancer and HIV.
Scott Putney
THEN: Vice president of molecular
biology and AIDS vaccine specialist at
Repligen Corp.
NOW: The development of an AIDS vac-
cine has proven more difficult than
anyone could have imagined. Encour-
aging data emerged from the recent
combination of Sanofi-Aventis Group
SA's ALVAC HIV vaccine with the AIDS-
Vax product from VaxGen Inc., Genen-
tech Inc./Roche AG and Global Solu-
tions for Infectious Diseases, but much
work remains to be done. Repligen
eventually dropped its AIDS vaccine
program, and Putney went on to run
protein and molecular biology for Al-
kermes Inc. He led efforts to develop
an inhaled human growth hormone,
then went to work for Alkermes’ part-
ner on the product, Eli Lilly and Co.
W. French Anderson
THEN: Chief of the molecular hema-
tology branch at the NIH’s National
Heart, Lung and Blood Institute and a
pioneer of gene therapy.
NOW: After conducting the first safety
test of a gene therapy in humans, An-
derson used the approach to replace a
defective gene in a young girl with ad-
enosine deaminase deficiency-related
severe combined immunodeficiency
(ADA-SCID), an immune deficiency
disorder also known as “bubble boy
disease.” ADA-SCID has become one
of the more successful endeavors
within the troubled gene therapy
field. He joined the University of
Southern California faculty and later
served as director of the Keck School
of Medicine’s gene therapy labs. In
2007 he was convicted of sexual
abuse of a minor and is currently
serving a 14-year sentence. He main-
tains his innocence.
Steven Rosenberg
THEN: Chief of surgery at the NIH’s
National Cancer Institute.
NOW: He is chief of surgery at the
NIH’s National Cancer Institute, and a
professor at the Uniformed Services
UniversityofHealthSciencesandatthe
George Washington University School
of Medicine and Health Sciences.
Rosenbergisknownforadvancingboth
immunotherapies and gene therapies
forcancer.Hepioneeredtheearlywork
on interleukin-2 as a cancer therapy,
providing data that were instrumental
to Cetus Corp.’s and Chiron Corp.’s
development and eventual approval
of Proleukin. He was also the first to
conduct gene therapy trials in cancer,
the indication which has subsequently
become among the most advanced and
generated the most industry interest
in the gene therapy field. He currently
is working on a melanoma vaccine.
Special thanks for
helping us locate and
profile these leaders goes
to: Jill Anderson, Brian
Atwood, Gil Bashe, David
Beier, Art Benvenuto, Jeff
Bird, Larry Bock, Lou
Bock, Ray Briscuso, Carl
Feldbaum, Stephanie
Fischer, Alfred Gilman,
Robert Langer, Robert
More, Nancy Olson,
Stelios Papadopoulos,
Richard Pops, Hollings
Renton, Michael Riordan,
Cynthia Robbins-Roth,
Greg Simon, Alan Timms,
Troy Wilson
26. BioWorld®
20thAnniversaryEdition|24
Trying to guess who will emerge as the movers and shakers of the biotech industry
over the next 20 years is akin to trying to find a needle in a giant stack of … needles.
The sector has grown and expanded since its early days thanks to the tireless and
inspiring work of so many. And even more executives, investors and scientists
are stepping up every day, leaving the BioWorld staff with the unenviable task of
narrowing down to a handful the people we think will influence biotech over the
next 20 years. We considered the current trends in deal-making, the changing
financing models and the latest scientific breakthroughs, and we sought some
outside nominations to help us get a sense of the big players in biotech today whose
influences could easily stretch across the next two decades and beyond.
Some on this list will seem no-brainers. Others will raise some eyebrows. Regardless,
this opinionated list is a personal one to BioWorld and is certainly not intended to
be all-inclusive. If you think we’ve left out someone, let us know.
In the meantime, here are, in no particular order, our predictions for the future.
Join us in 2030, and we can see how well we’ve done.
Who Will Shape
Biotech Over the
Next 20 Years?
BioWorld Says…
Severin Schwan
He’s among a new genera-
tion of young big pharma
CEOs, having risen rapidly
through the ranks to take
the helm at Roche AG in 2008, just in
time to lead the charge on the largest-
ever biotech acquisition with the $46
billion buyout of Genentech Inc. Since
taking over, Schwan has garnered a
reputation for rattling some of the staid
big pharma traditions – even going so
far as to cast his lot with BIO instead of
the pharma lobbying group – and has
demanded continuing innovation even
as other pharmas move into the less
risky generic space. He’s also known
for his collegiate-style management,
a sign that he could make good on his
pledge to preserve Genentech’s culture
of innovation, which bodes well for the
industry overall.
John Maraganore
The CEO of pioneering
RNAi firm Alnylam Phar-
maceuticals Inc., Mara-
ganore is well known
for his science-driven management
approach, and he’s been a strong
proponent of innovation over repur-
posing or generic drug development.
Under his leadership, Alnylam has
become a go-to firm for RNAi-based
intellectual property and has devel-
oped ALN-RSV01, the first RNAi drug
to hit clinical proof of concept. And,
in an industry currently facing some
tough decisions as the R&D failure
rate increases, with more money
spent and less to show for it, Mara-
ganore has been particularly forceful
in his belief that solid science must
trump marketing-based decisions
and such nebulous calculations as
net present value.
Peter Hecht
Hecht has been CEO of Ironwood Phar-
maceuticals Inc. since its founding in
1998. He gets credit for recognizing
the potential of bowel drug linaclotide
early on and prioritizing it ahead of
more advanced programs – similar
to how Amgen Inc. peered through a
haze of competing products and saw
the early potential in Epogen (epoetin
alfa). Linaclotide went on to generate
good Phase III data, attract a trio of
lucrative partnerships and pave the
way for Ironwood’s $216 million IPO –
which some would say opened the cur-
rent IPO window. Public investors are
learning to love Hecht for his focus on
long-term value and his often uncon-
ventional, Warren Buffett-esque tech-
niques, such as investing his own mon-
ey into every financing, incentivizing
his board with stock, and hand-picking
his IPO investors. Whether Ironwood
becomes the next Amgen or Hecht
goes on to something else, there’s little
doubt he’ll have an impact.
Sol J. Barer
The chairman and CEO of Celgene
Corp., Barer has been a driving force
behind the firm, which has become
one of the top biotech market caps
since it merged with partner Pharmion
Corp., in a $2.9 billion deal disclosed
in late 2007. Bearded, scholarly
Barer, with multiple degrees from
Rutgers University, continues to lead
Celgene to strong earnings, thanks
to sales of such products as Revlimid
(lenalidomide), Vidaza (azacitidine)
and Thalomid (thalidomide), while
pushing ever-forward with new
programs in inflammation and solid
EXECUTIVES
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tumors. And, throughout Celgene’s
considerable growth, he’s been known
for maintaining the same culture of
entrepreneurship that the company
boasted 20 years ago.
David Goeddel
He’s the self-effacing scientist who
was among those powering Genen-
tech Inc. in its first years. Now he’s a
managing partner with The Column
Group, a venture capital firm focused
on investing in the neglected area of
early stage drug development. Known
for gene cloning expertise, Goeddel
laid the groundwork for a handful of
strong-selling Genentech products. He
co-founded Tularik and was president
and CEO until Amgen Inc. bought the
firm in 2004 for $1.3 billion. Now he’s
heading up NGM, a start-up focusing
on diabetes and skeletal muscle health.
Richard Pops
He’s the high-profile CEO of Alkermes
Inc., who retook that position in late
2009, more than two years after he
departed. Back in the saddle, his first
move was to launch a strong push for
growth and innovation in the face of
economic hard times, when others
were hunkering down. Congenial
and widely respected, Pops serves on
several biotech boards as well as the
Biotechnology Industry Organization
and the Pharmaceutical Research and
Manufacturers of America. He’s not
just a thinker; he’s a doer. And we can’t
wait to see what he does next.
Carol Gallagher
Hired as CEO of
privately held Calistoga
Pharmaceuticals Inc.,
Gallagher is charged with
building a business development
strategy for the small Seattle-based
firm working on isoform-selective
PI3 kinase inhibitors. After serving in
key roles in a handful of big pharma
and biotech companies, she perhaps
is best known for leading the Rituxan
(rituximab) commercialization team at
Biogen Idec Inc., getting that product
to the $1 billion mark. As biotech
moves away from one-pill-fits-all
to a more personalized medicine
approach, executives like Gallagher,
who have a knack for finding the right
patient populations, talking to the
right doctors and bringing on board
the right partners will be even more
crucial to success.
Edwin Moses
Moses heads up Ablynx
NV, a firm that develops
domain antibody-derived
therapeutics and has
managed to buck the tough financing
trends in Europe. He took over as CEO
in 2004, got the firm through an IPO
in 2007 and, at the start of 2010, the
Ghent, Belgium-based firm had more
than two years of cash in its coffers.
And his business savvy likely will con-
tinue giving a boost to the European
biotech industry. To date, Moses has
been involved in financing rounds
totaling more than €300 million and
has led a number of deals, including
the £316 million cross-border merger
between UK-based Oxford Asymmetry
International and Evotec Biosystems,
of Germany.
Ron Cohen
When BioWorld’s first
biotech all-stars list came
out in 1990, it included
Art Benvenuto, then Co-
hen’s boss at Advanced Tissue Sci-
ences Inc. But Cohen wasn’t destined
play second fiddle for long: In 1995,
he founded Acorda Therapeutics Inc.
His physician’s background gave him
the patient-focused outlook he used
to tap into advocacy group networks,
raise venture money, advance his lead
product into Phase III trials for spinal
cord injury and multiple sclerosis,
take Acorda public, build a niche sales
force, bag an ex-U.S. partnership and
gain FDA approval of Ampyra (dal-
fampridine) for the improvement of
walking ability in multiple sclerosis
patients. Moving forward, Cohen’s
job will be to silence the skeptics and
prove Ampyra’s commercial viability,
all while advancing Acorda’s next gen-
eration of neuroregenerators.
Chris LeMasters
He’s a company builder who hails from
the business development rather than
the finance side. He spent six years
with Eli Lilly and Co. before jumping to
the biotech world to run business de-
velopment at Conforma Therapeutics
Corp. He oversaw Conforma’s eventual
acquisition by Biogen Idec Inc., then co-
founded spinout Cabrellis Pharmaceu-
ticals Corp. and oversaw its takeover
by Pharmion Corp. He and the former
Cabrellis team then started Tragara
Pharmaceuticals Inc. and in-licensed
a cancer and inflammation drug, and
LeMasters simultaneously started up
Aarden Pharmaceuticals Inc. to de-
velop drugs targeting protein tyrosine
phosphatases. We have no doubt that
this is just the tip of LeMasters’ compa-
ny-founding iceberg.
Personalized Medicine
Many insiders agree the personalized
treatment approach will be the wave
of the future. As executive director of
the Personalized Medicine Coalition,
Edward Abrahams is poised to play
a key role. The coalition already has
grown from its original 18 founding
members in 2004 to more than 160
today. Abrahams previously served as
executive director of the Pennsylvania
Biotechnology Association, where
he spearheaded the successful effort
that led to the Commonwealth of
Pennsylvania’s investment of $200
million in the state’s biotech industry.
Then there’s Mara Aspinall, former
president of Genzyme Genetics, who’s
hailed as being at the forefront of
personalized medicine, and serves
on the board of the Personalized
Medicine Coalition. She’s now
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president and CEO of diagnostics firm
On-Q-ity Inc., which is working on
DNA repair biomarkers for predicting
treatment response and microfluidic
chip technology for monitoring
circulating tumor cells, and is an active
member of the federal Secretary of
Health and Human Services’ Advisory
Commission on Genetics. And
Randy Scott, executive chairman of
Genomic Health, and Kim Popovits,
president and CEO of Genomic
Health, are working to improve the
quality of cancer treatments through
genomic-based treatment decisions.
Scott founded Genomic Health after
watching a close friend struggle
with cancer and wondering why the
molecular make-up of specific tumors
had not become the basis for cancer
care. The personalized approach
could set a new standard for health
care if these and other supporters
have their way.
Daphne Zohar
Her name is synonymous
with innovation. Her
venture firm, Puretech,
bridges the so-called
“valley of death,” meeting with aca-
demics to identify promising early
stage technologies and funding them
to the point of licensing or company
creation. She started Solace Pharma-
ceuticals Inc., Follica Inc., Satori Phar-
maceuticals Inc. and many others,
but one of her most ambitious and
creative projects to date is Enlight
Biosciences LLC. Enlight arose from
Puretech’s realization that big phar-
ma was intensely interested in new
academic technologies that could aid
drug discovery, even if venture inves-
tors had little appetite for funding
such endeavors. Zohar brought to-
gether Pfizer Inc., Merck & Co. Inc., Eli
Lilly and Co., Johnson and Johnson,
Abbott and Novartis AG in a precom-
petitive partnership that funds those
technologies. Such precompetitive
deals are said to be the wave of the
future, and Zohar is riding the crest
of that wave.
Clarke Futch
He’s the co-founder and
managing director at
Cowen Healthcare Royalty
Partners. He previously
served as a partner at Paul Capital
Partners, where he led royalty-related
investments for the Paul Royalty
Funds. He helped pioneer the use of
securitization with pharmaceutical
royalties as a means of alternative —
and flexible — biotech financing and,
over the past two years, has helped
raise nearly $2 billion dedicated to
the royalty finance market. He joined
CHRP along with co-founder Todd
Davis and Gregory Brown, all of whom
were lured to Cowen from Paul Capital
and had worked as a team on royalty-
based investments.
Francesco De Rubertis
He’s a partner at Index Ventures, a
UK- and European-based VC firm
that has been breaking the mold for
biotech investing and dealmaking for
the past several years. De Rubertis
helped secure the impressive $190
million Phase I-stage deal between
private Dutch biotech PanGenetics
BV and Abbott, and is a fan of asset-
centric investment models, which are
designed to get new compounds into
the industry without having to fund
whole companies. He’s also focused
on funding much-needed early stage
investments and public equities, and
his name is sure to be a staple in the
European venture community for
years to come.
Robert (Bob) More
Though you’d never know it from
his humble persona, More is one
of the venture guys every biotech
wants to have on its board. Prior to
joining Frazier Healthcare Ventures
two years ago, More spent 12
years with Domain Associates. He
was involved with investments in
ESP Pharma Inc. (acquired by PDL
BioPharma Inc.), Esprit Pharma Inc.
(acquired by Allergan Inc.), Novalar
Pharmaceuticals Inc. (gained FDA
approval) and many others. But
plenty of VCs offer experience — what
More adds is an uncommon dose of
common sense. Biotechs report that
he’s one of the few investors who
starts a company by asking why it
deserves to exist rather than just
whether or not he can make money
off of it. And while More doesn’t shy
away from giving portfolio companies
a reality check, he’s a true believer in
biotech’s potential. We can’t wait to
see what he funds next.
Activist Shareholders
They are already leaving an imprint
on biotech. Billionaire investor Carl
Icahn has pushed through some of the
biggest acquisition deals of the past
few years, such as ImClone Systems
Inc.’s $6.5 billion buyout by Eli Lilly and
Co. and MedImmune Inc.’s $15.2 billion
takeout by AstraZeneca plc, and he
continues to push companies via not-
so-subtle approaches (i.e., proxy fights
and aggressive grabs for board seats)
to do what’s best for shareholders.
Whether that pushing is good or
bad for the industry is debatable;
but, if there’s money to be made in
biotech, Icahn’s not going away any
time soon. Also raising the profile of
activist investors is Biotechnology
Value Fund. Partners Mark Lampert,
Oleg Nodelman and Matthew Perry
have been putting the pressure on
portfolio firms that fail to act quickly
after clinical failures and waste cash
reserves rather than returning money
FINANCIERS
29. 27|BioWorld®
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SCIENTISTS
to shareholders. After all, they say,
more money returned to shareholders
means more money to invest in a new,
promising biotech venture.
Bill Gates
He and his wife started the
Bill & Melinda Gates Foun-
dation, which has provid-
ed a substantial amount of
funding — $22.6 billion, in fact – over
the years for translational research. In
biotech circles, the Gates Foundation
is best known for supporting research
on HIV/AIDS, malaria, polio, childhood
vaccines and neglected diseases. Now,
there are even biotechs being founded
specifically with the aim of targeting
those diseases. Among its many initia-
tives is the Grand Challenges Explo-
rations award, launched in 2008 to
provide initial grants of $100,000 two
times a year for research in the area
of global health, with successful proj-
ects given the opportunity to receive
follow-on grants of up to $1 million.
With those kinds of programs and a
globe-spanning approach, the Gates
Foundation’s impact on world health
is just beginning.
Robert Lanza
Let’s face it, Lanza is one
of our biotech celebri-
ties. He’s even been in-
terviewed by Barbara
Walters. He’s the chief scientific offi-
cer at Advanced Cell Technology Inc.,
adjunct professor at the Institute for
Regenerative Medicine at Wake For-
est School of Medicine and a stem
cell pioneer whose discoveries range
from animal cloning to generating
induced pluripotent stem cells. At
ACT, Lanza heads a team that has
been able to grow stem cells into ret-
inal cells to potentially treat macular
degeneration and Stargardt disease.
He’s authored more than 20 scientif-
ic books, holds a number of patents
and, in the years ahead, he’s certain
to hold a key role in the burgeoning
field of regenerative medicine.
Christoph Westphal
A biologist and serial entrepreneur,
Westphal had a hand in establishing
(among others) Alnylam Pharmaceu-
ticals Inc., Momenta Pharmaceuti-
cals Inc. and Acceleron Pharma Inc.,
as well as Sirtris Pharmaceuticals,
which was founded in 2004 and sold
to GlaxoSmithKline plc for $720 mil-
lion in 2008. These days, Westphal
heads up the GSK Center of Excel-
lence for External Drug Discovery
in Boston, targeting age-related dis-
eases, which will no doubt grow in
importance as the baby boomers age
over the next 20 years.
Craig Venter
A biologist-entrepreneur and presi-
dent of the nonprofit J. Craig Venter
Institute, Venter has been called one
of the 21st century’s leading scien-
tists, but he is best known for mapping
the human genome. Venter and his
team at Rockville, Md.-based Celera
Genomics in 2000 announced they
had developed a rough draft of the
human genome using the whole shot-
gun sequence technique, which was
different than the approach used by
the National Institutes of Health in its
parallel Human Genome Project. Ven-
ter’s genome research work appeared
in the February 2001 issue of Science,
while the NIH’s published that month
in Nature. Venter’s current work is
dedicated to human, microbial, plant
and environmental genomic research
and seeking alternative energy solu-
tions through genomics.
Larry Norton
The deputy physician-in-chief for
breast cancer programs at Memorial
Sloane-Kettering Cancer Center,
Norton is a medical oncologist best
known for folding mathematics
into the biotech mix. His work as a
“biomathematician” has included
the development of the dose density
therapeutic approach that employs a
math-based model to deliver cancer
drugs for maximizing the killing
of cancer cells while minimizing
toxicity. It’s an approach that
defied traditional dosing methods,
but Norton’s tenacity was able to
overcome the industry’s initial
skepticism. He also serves as the
principal investigator of a program
project grant from the National
Cancer Institute aimed at better
understanding breast cancer in the lab
to create new treatment approaches.
Marc Tessier-Lavigne
He made an industry name for
himself as vice president of research
drug discovery at Genentech Inc.,
and became chief scientific officer
after the merger with Roche AG in
2009. Before Genentech, Tessier-
Lavigne – who discovered the role
of netrins in 1994 – was well known
in academia, and his jump from
Stanford University to Genentech
raised a few eyebrows. Genentech,
though, created a position that let
him oversee a broad spectrum of
research. It’s just the right slot for
a person with the energies and
acumen of Tessier-Lavigne, who
also co-founded the neurology firm
Renovis Inc. in 2000.
Eric Lander
Lander is a biology professor at
the Massachusetts Institute of
Technology, co-chair of President
Obama’s Council of Advisors on
Science and Technology and a
founding director of the Broad
Institute.Hewasaleadingcontributor
to the international Human Genome
Project and under his leadership,
30. BioWorld®
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the Whitehead/MIT Center for
Genome Research (which formed
the core of the Broad Institute) was
responsible for developing many of
the key tools of modern mammalian
genomics. Lander also is known
for his development of a molecular
taxonomy for cancers, grouping them
according to gene expression and
information, such as their response
to chemotherapy treatment.
Susan Desmond-
Hellman
She’s the former head of
Genentech Inc.’s oncol-
ogy division and a pioneer
in cancer research. She joined the big
biotech as a clinical scientist in 1995
and, during her more than 13 years at
Genentech, some of the company’s big-
gest drugs gained approval, including
Avastin (bevacizumab), Lucentis (ra-
nibizumab) and Herceptin (trastuzum-
ab). She left Genentech after the Roche
acquisition and took a job as chancel-
lor at the University of California, San
Francisco, an institution that’s hardly a
slacker in the world of biotech research.
She was selected by Forbes as one of
the seven most powerful innovators in
2009, and if she returns to the corpo-
rate fold at some point, it seems likely
that good things will follow.
Francis Collins
A physician-geneticist
and director of the Na-
tional Institutes of
Health, Collins is best
known for spearheading the Hu-
man Genome Project – the U.S.-led
international effort to map and se-
quence all human DNA. His team in
2000 revealed a working draft of
the human genome sequence, with
the reference sequence completed
in 2003. Before being named NIH
chief, Collins served as the director
of the agency’s National Human Ge-
nome Research Institute, where he
oversaw the discoveries of several
genes, including those responsible
for cystic fibrosis, neurofibromato-
sis, Huntington’s disease, a familial
endocrine cancer syndrome, genes
for Type II diabetes and the gene that
causes Hutchinson-Gilford progeria
syndrome. As NIH head, Collins will
be instrumental in securing funding
for government-sponsored research
and setting priorities for what could
become the next generation of bio-
tech products.
Richard Pazdur
The director of the FDA’s Office of
Oncology Drug Products has been
called the cancer drug czar critics
love to hate. Pazdur, who left his
faculty job at the University of
Texas MD Anderson Cancer Center
in Houston in 1999 to join the FDA,
is known for reiterating at agency
advisory committee meetings that
the approval process is “not merely a
screening process for drug activity”
– always remaining insistent that
cancer medicines must show clinical
benefit. He has authored more than
160 peer-reviewed papers about
oncology, has written chapters for
more than 30 oncology textbooks
and is the editor of two standard
reference oncology texts.
Steven Nissen
He’s the chairman of the depart-
ment of cardiovascular medicine at
the Cleveland Clinic Foundation in
Ohio and has been known in recent
years for raising drug safety issues
with medications such as Merck &
Co. Inc.’s no-longer marketed COX-2
inhibitor Vioxx (rofecoxib), GlaxoS-
mithKline plc’s diabetes drug Avan-
dia (rosiglitazone) and stimulants
used to treat attention deficit hy-
peractivity disorder. Nissen, who
has served on various FDA advisory
committees and has testified before
Congress about drug safety, was the
co-author of a June 2007 meta-anal-
yses published in The New England
Journal of Medicine, which reported
there was a significant increase in
the risk of heart attacks and car-
diovascular-related deaths linked
to Avandia. Nissen’s main research
focus has been on the use of intra-
vascular ultrasound imaging in as-
sessing progression and regression
of coronary atherosclerosis. Some in
the industry respect him, others call
him a gadfly. But he’s influencing the
safety standards to which all drugs
are held.
President Barack
Obama
The 44th U.S. president
not only solidified his
place in history as the
first African-American elected
commander-in-chief but also as the
first president to get a major piece of
health care legislation enacted since
Lyndon Johnson signed Medicare
into law in July 1965, achieving the
victory of ensuring health insurance
coverage for nearly all Americans
that many of his predecessors,
including Bill Clinton, Harry
Truman and Theodore Roosevelt,
had failed to do. The health reform
law also for the first time provides a
pathway for regulatory approval of
follow-on biologics. It’s too early to
say how much of an impact the new
law will have on biotech, but we’re
certain to see some repercussions
– good and bad – over the next 20
years and beyond.
REGULATORY/LEGISLATIVE
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S
ince the first biotech drug – Genentech Inc.’s genetically engineered human
insulin product Humulin – gained approval in 1982, the industry’s impact
on human health continues to grow. During the past two decades
alone, more than 200 biotech drugs have hit the market. We’ve seen
the promise of monoclonal antibodies, kinase inhibitors and other
biologically targeted drugs become reality, often providing the best – and,
sometimes, the first – treatment options to millions of patients around the
globe. These drugs have extended lives and improved the quality of lives for
people afflicted with disease.
And biotech is far from stopping. What will see in the next 20 years?
Will we have a host of RNAi-based drugs on the shelves? Will embryonic
stem cell therapy live up to its potential? Will nanotechnology prove
the wave of the future? Based on these examples of the industry’s
success so far, we can’t wait to find out.
The Right ‘Time’
GLEEVEC’S APPROVAL
MAKES HISTORY
The FDA’s 2001 fast-track nod made
Novartis AG’s Gleevec (imatinib) the
first in a new generation
of cancer chemotherapy
agents. The Bcr/Abl-tar-
geted drug even made the
cover of Time in May of that
year, hailed as a magic bul-
let for curing cancer. Thanks
to Gleevec, several cancers,
including chronic myeloid
leukemia, transformed from
fatal diseases into chronic
illnesses. Before Gleevec,
roughly 30 percent of pa-
tients died within five years of being
diagnosed with CML. Gleevec lowered
that rate to 10 percent. Besides earn-
ing scientists Brian Druker, Nicholas
Lydon and Charles Sawyers the Lask-
er award in 2009, the introduction of
Gleevec opened the door for a host of
other drugs designed to go after cancer
on a molecular level. It also validated
the then-emerging rational drug de-
sign approach.
20 Years of
nn
ofofof bbbeieingnng
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A Vast Improvement
AVASTIN SETS THE BAR IN CANCER TREATMENT
It’s hard to believe there was ever a time when the idea
of attacking cancer by starving tumor cells would be met
with derision. But that’s what Harvard researcher Judah
Folkman faced nearly 40 years ago when he proposed
an anti-angiogenic approach to treating the disease.
Fortunately, Folkman persevered, and his work led to the
development of VEGF-inhibitor Avastin (bevacizumab,
Genentech/Roche), approved in 2004 in colorectal cancer.
Since then, Avastin has gained the FDA’s nod in lung and
breast cancers. While the drug does have its drawbacks, its
introduction helped re-energize the oncology space, and it
set a high standard for other drugs to beat.
Making Miracles
RARE, GENETIC DISEASE PATIENTS FIND HOPE
The 2010 Hollywood release “Extraordinary Measures” told
the story of researchers working on the first drug for Pompe
disease, an inherited disorder that disables the heart and
muscles. Prior to the first enzyme replacement
therapy, Myozyme (aglucosidase alfa, Genzyme),
babies born with infantile onset Pompe disease
often died before reaching their first birthday.
But biotech didn’t stop there. Genzyme and Shire
plc have gotten ERTs approved for other lyso-
somal storage disorders, Gaucher and Fabry dis-
eases, and those early successes have prompted
other firms to focus on other rare, genetic indica-
tions. BioMarin Pharmaceutical Inc., for example,
developed much-needed treatments for muco-
polysaccharidosis VI (Naglazyme, galsulfase), MPS I (Aldura-
zyme, laronidase) and phenylketonuria (Kuvan, sapropterin
dihydrochloride). And in 2007, Alexion Pharmaceuticals
Inc. gained approval for Soliris (eculizumab), the first drug
for paroxysmal nocturnal hemoglobinuria. A host of other
candidates is in development, and we may soon see the first
drugs approved in indications like Duchenne’s muscular dys-
trophy, Friedreich’s ataxia and other genetic diseases.
Biotech’s Vision Quest
FIRST DRUGS HIT THE MARKET FOR WET AMD
Before QLT Inc.’s photodynamic
therapy Visudyne (verteporfin)
gained approval in 2000, there were
no available therapeutic treatments
for wet age-related macular
degeneration. The leading cause of
blindness in people over the age of 50,
the “wet,” or advanced form, of AMD
devastates the lives of patients, who
find themselves unable to do everyday tasks such as reading,
driving and recognizing faces. Though it only accounts for
about 15 percent of all AMD cases, wet AMD is responsible for
90 percent of severe vision loss. Biotech is helping to improve
those numbers. Five years after Visudyne hit the market,
Eyetech Pharmaceuticals Inc. and Pfizer Inc. won approval
for the first VEGF-targeted AMD drug, Macugen (pegaptanib
sodium injection), followed in 2006 by the superior Lucentis
(ranibizumab) from Genentech Inc. (now part of Roche AG).
More than 30 drugs currently are in clinical testing.
1990: Reverse
transcriptase
inhibitor AZT
was the only
approved HIV
therapy
JULY 1991:
FDA
approved ddL
(dideoxyinosine,
Bristol-Myers
Squibb), viral
replication
inhibitor
APRIL 1994: The Inter-
Company Collaboration on
AIDS Drug Development
agreed on a protocol to
speed up evaluation of
triple-drug combos
JUNE 1994: Antiretroviral
Zerit (stavudine,
Bristol-Myers Squibb)
was approved
NOVEMBER 1995: FDA cleared 3TC
(lamivudine, BioChem Pharma,
Glaxo Wellcome) in combination
with AZT as a first-line treatment
DECEMBER 1995: The first
protease inhibitor,
Invirase (saquinavir, Roche)
gained approval
MARCH 1996: Two more protease inhibitors —
Norvir (ritonavir, Abbott) and Crixivan (indinavir
sulfat, Merck) — cleared the approval process
(Merck’s drug after a record 42-day review)
JULY 1996: Viramune (nevirapine, Boehringer
Ingelheim) gained approval as the first non-
nucleoside reverse transcriptase inhibitor
JULY 1996: First dual-protease inhibitor trial
– Norvir plus Invirase – reduced HIV RNA
by an impressive 99 percent at six weeks in
120-patient study
SEPTEMBER
1997:
Combivir, a
single-tablet
formulation
of 3TC and
AZT, gained
approval
JUNE 1992: FDA
approved ddC
(dideoxyctidine,
Roche), viral
replication
inhibitor
OCTOBER 1998:
NNRTI Sustiva
(evavirenz, Bristol-
Myers Squibb) was
approved
Biotech’s
Contributions
to HIV:
1990-Present
A Matching Set
HERCEPTIN’S APPROVAL SETS PERSONALIZED
MEDICINE GOAL
Among its other accomplishments in health care, the
biotech industry heralded the shift away from the one-
drug-fits-all style of big pharma to a personalized medicine
approach. The combination of targeted drugs aimed at
subset populations plus diagnostic tests to identify likely
responders is expected not only to improve the chances
of a patient’s successful treatment but also to help reduce
treatment costs per patient. The first and best example of
the drug-diagnostic marriage came in 1998 when Genentech
Inc. (now part of Roche) gained approval of breast cancer
drug Herceptin (trastuzumab), a monoclonal antibody
against the growth factor receptor HER2, in parallel with an
immunohistochemical test kit produced by Dako Corp. and
designed to pinpoint patients with HER2-positive tumors.
33. 31|BioWorld®
20thAnniversaryEdition
FEBRUARY 2002: FDA
approved Procleix (Gen-
Probe Inc. and Chiron Corp.)
for the amplified nucleic acid
test for use by blood banks to
detect HIV viral genes
MARCH 2003: Fusion inhibitor Fuzeon
(enfuvirtide, Trimeris and Roche) was approved
JULY 2003: Gilead Sciences Inc.’s NRTI Emtriva
(emtricitabine) was approved
OCTOBER 2003: ‘Flexible’ protease inhibitor
Lexiva (fosampranavir calcium, Vertex and
GlaxoSmithKline) got an FDA nod
OCTOBER 2001:
FDA cleared
Viread (tenofovir
disoproxil fumarate,
Gilead Sciences),
a nucleotide
analogue reverse
transcriptase
inhibitor
AUGUST 2004:
Truvada, a
combination
Emtriva/Viread
(Gilead) drug,
won approval
JUNE 2006: Prezista (darunavir,
Tibotec), another protease
inhibitor, entered the market
JULY 2006: The first once-daily,
triple-drug regimen, Atripla, was
approved. (Atripla combines
Gilead’s Viread and Emtriva with
BMS’ Sustiva)
JANUARY 2009: FDA gave accelerated approval to
a second-generation NNRTI, Intelence (etravirine,
Tibotec)
APRIL 2009: Pharma giants Pfizer and Merck pooled
their HIV portfolios into a joint venture, ViiV Healthcare,
to create new molecules and more convenient
formulations of existing drugs
SEPTEMBER 2009: For the first time, an HIV vaccine
successfully – albeit modestly – reduced the risk of HIV
infection in humans. The 16,000-patient Thailand study
tested ALVAC HIV (Sanofi) and AIDSVAX B/E (VaxGen)
You Are Here
MAPPING THE HUMAN GENOME
This international research project kicked off in 1990 and became a 13-year endeavor to identify all
the genes in human DNA and determine sequences of about 3 billion chemical base pairs. The project
finished up in 2003, though analysis of the data is expected to have continued impact on biotech
for years to come. It already has spawned offshoots, including the 2006-initiated Cancer Genome
Atlas, a coordinated effort to understand cancer using genome analysis technologies and large-scale
sequencing. Recent technological advancements also have brought genome sequencing down to the
company level, with Complete Genomics detailing in a Science article in late 2009 that it had been able
to complete a human genomic sequence for as little as $1,700. Further discoveries and more efficient
sequencing are sure to come.
Going Beyond the Lab
TECHNOLOGY REVOLUTIONIZES DRUG DISCOVERY
In the 1980s, the discovery of polymerase chain reaction set the molecular biology space on
its head, and advancements over the past 20 years have continued to make basic drug dis-
covery and target research more and more efficient. In 1997, a new DNA technique emerged
that combined PCR, DNA chips and a computer program and offered researchers a vital tool
in the search for disease-causing genes. And the technology is only getting better. We’ve
seen breakthroughs in high-throughput screening, in silico testing and fragment-based
platform technologies, and further discoveries and inventions could one day turn drug dis-
covery into a highly efficient engine to sustain development efforts far into the future.
Of Cells and Cytopenias
FIRST DRUGS FOR MDS
Before 2004, patients suffering from
myelodysplastic syndromes could
undergo a stem cell transplant, at
least if they were healthy enough.
But patients not eligible for the risky
procedure finally gained an effective
treatment option with the approval of
Vidaza (azacitadine) from Pharmion
Corp. (now Celgene
Corp.) MDS, described
as a collection of dis-
orders in which bone
marrow does not func-
tion normally and not
enough blood vessels
are made, can cause
anemia, neutropenia
(putting patients at
high risks for infec-
tions) and thrombo-
cytopenia (increasing
the chances of a severe
bleeding episode).
Roughly one-third of
MDS cases progresses to acute my-
elogenous leukemia, though most pa-
tients die as a result of infection. Fol-
lowing Vidaza, two other drugs hit the
market for MDS: Dacogen
(decitabine, SuperGen Inc.
and Eisai Co. Ltd.) and Rev-
limid (lenalidomide, Cel-
gene). In addition to giv-
ing patients an alternative
treatment option, those
first drug approvals also helped to
draw greater attention to this often-
underdiagnosed disease.
Prognosis Improving
HIV GOES FROM DEATH SENTENCE TO CHRONIC ILLNESS
It’s hard to believe that only 20 years ago, patients diagnosed with HIV/AIDS had only
one treatment option – AZT – and, often, a poor prognosis. When basketball great Magic
Johnson was diagnosed with HIV in 1991, for instance, people still considered the disease
a death sentence. But today there are 30-plus drugs and drug regimens available, and
HIV has become a manageable illness in the developed world. True, patients would like
fewer drugs (and fewer side effects) and the successful development of a preventive
vaccine has so far proved elusive, but the HIV space is one of the most striking examples
of how the biotech and pharma industry has stepped up to the challenge during the past
two decades. Even now, companies continue working to discover better therapies and
vaccines, make dosing regimens more convenient and get the latest treatments to HIV-
infected patients in developing nations. (See timeline below.)