INDIGO BioSciences’
New Release
H. Dean Bunnell, President and CEO, INDIGO Biosciences, Inc.,
spoke with Future Pharmaceuticals. The interview appeared in Future
Pharmaceuticals Vol. 1 2009 issue. Reprinted here with permission.
Future Pharmaceuticals:
Please provide some background on
INDIGO Biosciences products and
services. When did INDIGO Biosciences get started and how has the
company evolved since its founding?
DEAN BUNNELL: INDIGO
Biosciences was founded in 2005
by two Penn State professors. They
developed a number of assays for use
in screening compounds and various
types of toxicology applications;
the word got out and people started
asking them to conduct tests. During
that time they developed a very
robust family of nuclear receptor
assays and, in 2007, we started seeing a change in the marketplace and
decided to move into the manufacture
and sale of single-use assays.
FP: What kinds of companies
could benefit from your products
and services?
DB: Our customers are currently
pharmaceutical companies. We
work with anyone involved in drug
discovery, drug development or preclinical activity, and toxicologists.
We’re even seeing interest from
nutraceutical companies (people
that make food supplements, etc.).
They want to test their products to
validate their claims.
Also in
this issue
page 3
FP: Do you have additional new
assay kits coming out soon? If so,
what are they?
DB: We are about to introduce our
first product. A peroxisome proliferator activated receptor (PPAR)
gamma assay for drug development initiatives targeting diabetes
and obesity. That will be followed
closely by three additional products,
an LXR beta assay (cholesterol
and inflammation indications), a
mineralocorticoid assay (hypertension indication), and an estrogen
receptor alpha assay (numerous
estrogen-related indications).
Editor’s Note: All four of these
products are now available.
FP: What makes your assay kits and
screening services superior to your
competitors’? What would compel
someone to switch to INDIGO?
DB: I’d like to address the assays
first. These assay products that we
are bringing onto the market really
offer something different to users.
They are single-use, frozen, wholecell nuclear receptor assays and
they’re targeted at high throughput
screening applications. They are
very robust, optimized assays.
continued on next page …
page 5
page 6
1 INDIGO BioSciences New Release 2 ProSanos Wins Award 3 Follow-On Biologics | Penn State
Cancer Institute 4 Understanding Your Leadership Style | Life Sciences VC Investment Increases
in Q2 | Top 10 Life Sciences Apps 5 Harrisburg University Programs Recognized | J.D. Brown
Center for Entrepreneurship | Murata Business Center Receives Honor 6 Events Calendar
Volume 6 Issue 2
[ a publication of life sciences greenhouse of central pennsylvania
»
www.lsgpa.com
continued from front page …
To look at the bottom line: these assays will
save people time, money and reduce risks
associated with their discovery and development programs.
On top of that, we’ve designed these products to be as easy as possible to use so that
anyone in the laboratory environment can
simply take one of these frozen assays out
of the freezer, thaw it, feed it, dose it, read
it, then dispose of it.
FP: You mentioned you have changed your
business model to the manufacture and sale
of single-use assays vs. screening. Can you
tell us more about what led to that decision?
DB: We saw a problem with people wanting
us to test drugs that they didn’t feel comfortable sending outside their companies
because of the possibility of compromising
their Intellectual Property. The technical
innovation that allowed us to contemplate
transitioning from being strictly a service
provider to being primarily a product provider was our development of a proprietary
cryo-preservation process that we have
trademarked as CryoMite. This process
allows us to freeze live cells and bring them
back extremely robust with a survivability
rate of 95 percent and above.
At the same time, we noticed a time and
cost pressure on pharmaceutical companies for keeping their pipelines full and a
stronger move into high throughput screening.
In other words, people want to screen more,
faster. It just seemed like a good fit that
we could supply a product that would allow
people to screen quickly with minimal involvement and cut their costs by not having
to maintain live cell cultures in-house.
In the screening environment, most
pharmaceutical companies are hesitant to
release test compounds outside of the company because of the risk of compromising
their Intellectual Property. So the business
in that area is very limited and we saw a
greater opportunity by making a product that—instead of having to send test
compounds to INDIGO—could send frozen
assays to companies with drugs that they
wanted to test where there’s IP associated
with the compound or molecule.
FP: Tell me about your management team:
Who are they? And what are their roles in
the company?
DB: Dr. Jack Vanden Heuvel, our Chief
Scientific Officer and Co founder, is a
well-known toxicologist. He has over 15
years of experience in toxicological analysis, analytical processes and assay design.
He’s been a major factor in bringing this
family of assays forward over time.
Dr. Bruce Sherf, our Chief Technical
Officer, joined INDIGO in mid 2008. He
brings 16 years of molecular biology experience and assay design, development and
manufacturing. He has been a major force
in bringing our frozen assays to the point
where we’re ready to introduce them into
the market.
FP: What does INDIGO’s management
team see as the biggest challenge facing
your company?
DB: I think what we’re looking at, forward
speaking, is keeping up with customer
demand and the acceleration of the
production of new assays as we move
forward. I think those will be our two
biggest challenges.
FP: As an early-stage biosciences company,
you’ve created a great market opportunity
with a unique research tool that seems to
be ideal for pharmaceutical researchers.
Is there room for new investors? And if so,
what kinds of investors are you looking for?
DB: There’s always room for new investors; INDIGO is looking for equity investors, particularly angel investors and
early stage venture capitalists.
FP: I heard you recently completed a beta
testing, would you like to speak to the results?
DB: Sure, we’ve just completed an
extensive beta test on these products
prior to releasing in the marketplace.
The response was very positive. All of
the feedback we’ve received has been
extremely supportive and people are
eager for us to begin to sell our products
into the marketplace.
H. Dean Bunnell, President and CEO of
INDIGO Biosciences, Inc., has thrived for
nearly 35 years leading successful startups
and large multinational companies in various
industries including biosciences, Internet,
telecommunications, RF and microwave
technologies and software analysis tools. His
experience includes Kaman Industries, Locus
Inc., Mitsubishi, California Eastern Labs &
NEC Corporation, Aercom Industries, Litton
Industries, MAXTECH, Inc. and Vertex Communications. At INDIGO Biosciences, Mr.
Bunnell is transitioning the company’s business model in order to become a premiere
global developer and producer of unique,
frozen, single-use whole-cell nuclear receptor assay products for use in drug discovery,
drug development and preclinical activities.
Source: Future Pharmaceuticals, Vol. 1
2009. www.FuturePharmaUS.com
[ ProSanos
Recognized
CEO of ProSanos Corp., Jonathan Morris,
MD, pictured at the ProSanos booth at
June’s DIA conference. Jon has good
reason to smile after learning that ProSanos’
joint project with GlaxoSmithKline,
SAEfety Works ®, was named by Bio-IT-World
as one of the ten 2009 Best Practices
Awards Winners.
Congratulations!
page 2 [ life sciences greenhouse of central pennsylvania
»
www.lsgpa.com
Follow-On Biologics: A Primer
T
o grasp the notion of a follow-on
biologic, one must first understand
the difference between a “regular” drug
and a biologic.
The vast majority of prescription drugs are
manufactured through chemical synthesis,
meaning that they’re made by combining
specific chemicals, usually resulting in
what’s considered a “small molecule” active
ingredient. In comparison, biologics, which
include most vaccines and many recent
breakthrough therapies (e.g., Erythropoietin),
are “manufactured” in a living organism–
like yeast or bacteria. This process often has
many steps and usually results in a “large
molecule” active ingredient.
As the name implies, large molecules are
very complex and can be much more difficult
to characterize scientifically; some of the
components of a finished biologic may
actually be unknown.
Consequently, biologic manufacturers can
only guarantee product consistency and
quality by ensuring that the manufacturing process always remains substantially
the same. By contrast, chemical drug manufacturers can use varying manufacturing
processes to achieve the same end results.
These results can be easily confirmed
through laboratory analysis of the finished
product. The ability to confirm, with relative
ease, the fact that one small molecule is
substantially the same as another paves
the way for generics.
A generic drug by definition is any drug
product whose patent life has expired and
can be copied from the originator with
permission from the Food & Drug Administration (FDA). Generic drugs must have
the same active ingredient, strength,
dosage form, and route of administration
as the “original” drug, and act the same
way in the body.
Follow-on biologics (a.k.a., biosimilars) can
best be described as large molecule generics
manufactured in living organisms. So far
the FDA has been reluctant to approve
follow-on biologics. There are two key
reasons: 1) some regulators are concerned
that their safety and efficacy are not as
easily assured as with generics; and 2)
it’s not clear that the intellectual property
law that governs production of small
molecule chemical generics also applies
to highly complex, large molecule followon biologics.
The debate over whether or not to allow
follow-on biologics and under what conditions began more than a decade ago, but
may soon come to a head as lawmakers,
scientists, biotechnology companies and
other stakeholders grapple with how to
balance the desire to expand access to
medicines with the need to protect patient
safety and promote further biomedical
innovation.
To learn more about this topic, visit:
www.bio.org
www.lifescienceleader.com
Penn State Cancer Institute
The Penn State Hershey Cancer Institute
opened in July 2009 and is the first in
the region to offer RapidArc radiotherapy
technology, a new breakthrough in cancer
treatment.
The Institute’s new home is approximately
178,000 square feet. The building’s design
creates an environment supportive
of patients, families and staff.
page 3 [ life sciences greenhouse of central pennsylvania
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www.lsgpa.com
Understanding Your
Leadership Style (Part I of II)
By: Juanita Neifert, LSGPA Project Manager/HR Specialist, with over 15 years human
resource management experience.
Webster’s defines leadership as: “the capacity to lead; the act of or an
instance of leading; and/or the office or position of a leader.” Simply
put, leadership is the art of motivating a group of people to act towards
achieving a common goal. This is easier said than done. Why? Part of
the issue with motivating a team is that they are made up of individuals
with unique thoughts, ideas, personalities, and feelings. Everyone will
not respond in the same way to the same request. Another problem might
be your leadership style, or lack thereof. So how can you tell what kind of
leader you are? Here are some of the most common styles for your review.
[ Autocratic – In Autocratic leadership, a leader exerts high levels of
power over his or her employees or team members. People within the
team are given few opportunities for making suggestions. Many people
resent being treated like this–who wouldn’t? Because of this, autocratic
leadership often leads to high levels of absenteeism and staff turnover.
[ Bureaucratic – Bureaucratic leaders work “by the book,” ensuring that
their staff follow procedures exactly. This is an appropriate style if your
work involves serious safety risks (such as working with machinery or
toxic substances or at heights), or where large sums of money are involved.
In most other situations, the inflexibility and high levels of control can
not only demoralize staff, but can diminish the organization’s ability to
react to changing external circumstances.
[ Charismatic – The charismatic leader injects huge doses of enthusiasm
into his or her team, and is very energetic in driving others forward.
However, charismatic leaders tend to believe more in themselves than
in their teams. In the eyes of the followers, success is tied up with the
presence of the charismatic leader.
[ Democratic or Participative – Although a democratic leader will
make the final decision, he or she invites other members of the team to
contribute to the decision-making process. This not only increases job
satisfaction by involving team members in what’s going on, but it also
helps to develop people’s skills.
Life Sciences Venture
Capital Investment
Increases in Q2 2009:
Up 47% Over Q1
 Biotechnology  Software  Medical Devices & Equipment
$1.46
bil.
1500
1200
$888
mil.
900
$576
mil.
600
0
While the transformational leadership approach is often a highly effective
style to use in business, the reality is that there are many ways to lead.
The challenge is to match your own style with the needs of the organization, the work involved and the skill levels and experience of the members
of your team. And a good leader will find him or herself switching instinctively between styles according to the people and work they are dealing
with. This is often referred to as “Situational Leadership.”
In the next issue, “The Six Styles of Entrepreneurial Leadership.”
$644 $628
mil. mil.
1Q 2009
2Q 2009
Year to Date
Source: PricewaterhouseCoopers/National Venture Capital
Association MoneyTree™Report, Data:Thomson Reuters
Top 10 Life Sciences Related
Apps for the iPhone and
iPod Touch
10.
9.
abTimer: A lab timer that allows for 4 sepaL
rate timers with descriptions. (@iTunes.com)
Measures – Unit Converter: a great help
when working with odd units like the English
system. (@iTunes)
8.
7.
Primer Jot: A very simple way to keep your
primers and oligos in order. (@iTunes)
6.
Evernote for iPhone: Allows you to synchronize anything from notes, photos, snippets and
even files. Great app for taking notes that you
can later check on your computer, or viceversa. (@iTunes)
5.
Solutions: For when you have trouble with
your solubility calculations or just don’t want to
keep running numbers through your calculator.
(@iTunes)
4.
Molecules: Lets you glimpse at molecules in
3D, allowing you to rotate them and zoom in
to see their structure. (@iTunes)
3.
iCut DNA: Allows quick access to the restriction enzyme database (REBASE) and detailed
info on each restriction enzyme. (@iTunes)
2.
1.
PubSearchPlus: Gives you full-text access to
PubMed search. (@iTunes)
[ Transformational – A person with this leadership style is a true
leader who inspires his or her team with a shared vision for the future.
Highly visible, they spend a lot of time communicating with their team.
They don’t necessarily lead from the front, but rather tend to delegate
responsibility amongst their teams.
$452
mil.
$1.08
bil.
300
[ Laissez-Faire – This French phrase means “leave it be” and is used to
describe a leader who leaves his or her colleagues to get on with their
work. It can be effective ONLY if the leader monitors what is being
achieved AND communicates this back to his or her team regularly.
$638
mil.
$1.28
bil.
The Chemical Touch: An intuitive Periodic Table
app that also comes with an extra functionality
that includes all the amino acids with detailed
info, including chemical structure. (@iTunes)
Promega: Allows you to check the protocols
and applications guide as much as needed.
(@iTunes)
Source: http://my.biotechlife.net
visit us online today for more news [ page 4
Guidebook Recommends
Several Harrisburg
University Programs
The 26th edition of Rugg’s Recommendations on the
Colleges lists six of the University’s undergraduate
programs: Biotechnology, Computer and Information
Sciences, Geography and Geospatial Imaging, Management & eBusiness, Chemistry, and Forensics.
The recommendations in the 2009 issue are based on
interviews with students, monthly evaluations from
secondary school counselors, and responses to questions sent to more than 1,000 counselors.
For more information, contact the University at 717.901.5146 or
Connect@HarrisburgU.edu; or visit on the web at HarrisburgU.edu.
J.D. Brown Center for
Entrepreneurship
The J.D. Brown Center for Entrepreneurship is an initiative of York
College of Pennsylvania. Entering its fourth year, the Center has established
itself as a hub for entrepreneurs who are looking to start businesses or grow
their existing businesses. Center consultants are available to provide assistance with idea and new product validation, marketing plan development,
prototype development assistance, and referrals to avenues of financing.
Entrepreneurs are supported either directly or through referrals to SBDC,
SCORE, SBA, the Ben Franklin Technology Partners initiatives and other
strategic partners. The Center also features a Women Business Center
Organization that supports women entrepreneurs via education on best
practices in business. A new speaker series will begin this Fall, and will
offer a series of timely topics.
[ M
urata
Business Center
Receives International
Honor
The National Business Incubation
Association (NBIA) has awarded its
Soft Landings International Incubator
designation to the Murata Business
Center in Carlisle.
Through its Soft Landings program,
NBIA recognizes incubators that have
demonstrated the capability of helping
nondomestic companies enter the
incubator’s domestic market. Murata
Business Center does just that. Accentuating its standard incubation services
with assistance tailored specifically
to nondomestic firms, the Center
provides help with international trade
issues, import and export laws, and
visa/immigration requirements.
Murata joins just 13 other business incubation programs from around the world
that have earned the designation since
NBIA began the program in 2005.
This summer, the Center opened a business incubator to support the physical
needs of entrepreneurs starting and growing their businesses. In addition to
the services and connections described above, the tenants are supported by
the Center through administrative personnel, internet access, telephone
connectivity and meeting rooms.
Center services and classes are available for review on their website at
www.jdbctr.edu. Contact Michael March, Executive Director, directly at
717-815-6601, for more information.
R&D Performed by Industry: Pennsylvania Ranks Ninth in U.S.
F un d s e x p e n d e d b y P e nns y lva n i a bus i n e ss e s , 2 0 0 3 - 2 0 0 7
(Dollar Amounts Reflected in Millions)
2003
2004
2005
2006
2007
National Rank
% change 2003-2007
Rank % change
__________________________________________________________________________________________________________________
$709.1
$800.5
$884.6
$981.9
$1,038.7
9
46.5%
18%
Source: SSTI.org/DigestTables
page 5 [ life sciences greenhouse of central pennsylvania
»
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If you are receiving this publication in error, or wish to be removed
from our mailing list, please contact info@lsgpa.com. For information
about funding opportunities and business support services provided
by the Life Sciences Greenhouse of Central Pennsylvania, visit us
online at www.lsgpa.com.
Events Calendar
october 16
november 17
November 16–17
Women on the Move
Lancaster PA
http://vc.hacc.edu
Marketing for Small
Businesses on a Budget
York, PA
www.yorkkiz.org
BioTech2009
Philadelphia, PA
www.biotech2009.org
The Life Sciences Greenhouse is a public/private venture whose mission is
to commercialize bioscience technologies. Clients include university-based
researchers and technology development groups, emerging companies, and
companies seeking to expand or relocate. LSGPA provides direct early-stage
investment, targeted business development services, and connections to
strategic partners.
[ life sciences greenhouse of central pennsylvania
H
igh-Energy-Density Capacitors created by LSGPA
portfolio company Strategic Polymer Sciences, Inc.