E Mag Biopreneur April08

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A Q u a r t e r ly Ma g az in e fo r

B i o p r e n e u r s

Art : Sanjoy Rakshit

Vol.1, No.1, April 2008





N C P U , T a f t l a w M e d z y m , t e c h n o e d i t s Page 3

Copyright © 2008, Biopreneu r. All right s reser ved.

Prologue:

W e know that every business is related to either inventive or innovative products or

services and it must face some ups and downs throughout the phases of its

development. Ultimately, and quite fortunately, a stage usually appears in typical

development that can offer some comfort and satisfaction to participants of most

business ventures. But purists in any field will advocate neither satisfaction, nor

comfort alone, for its own sake. It is dedication, business zeal, will power to prove

proficiency, an d t he u nforgett able love of a product t ha t en tices most people involved

to continue serving business goals. Our focus and our prime concern in this book is

to explore bioventure an d th e jour ney of a bioventurer .

B ioventure represents a microcosm of the world at large concentrated into the small

word of biological venture capital. As far as biopreneurs are concerned we have to

define a scenario with a different kind of light—a light of a different color and

temperature. It is an interesting and exciting a time for people wanting to

appr eciate t he world of bioventu re. And th is is plainly becau se biotechnology, withemergent educational, governmental, and industrial support, is moving toward its

wave crest.

W e can think of bioventure being a sleek aerodynamic car racing on three wheels—

technology, management, and capital. Each wheel is extremely sophisticated, and

must be taken care of appropriately to drive the car to an ultimate and optimal

destination. After spending many years learning and teaching, when I joined the

practiced field of authentic business, I realized the need for the proper

understanding of those three driving wheels. As people from the field of research

work, and management, we may be aware of the greater issues related to our own

unique ar eas of interest, but to be a tr uly successful biopreneur we must h ave a

comm an ding gras p on all thr ee driving wheels in our bio-business.

W hen we look a t t he world of bioventure we find severa l cases wh ere people inten ded

to invest heavily, but due to a lack of suitable knowledge they decided to shy away.

There a re insta nces where compa nies ha ving a potent ial to expand their horizons by

meeting a mere few necessities—such as patenting their ideas, and technology.

Simply having enough information and facts regarding selling intellectual property

or research-based material to pharmaceutical establishments may help some

budding biovent ur es to succeed. But in sufficient informa tion also cau ses compa ra ble

ventu res t o lag behind oth er m ore aggressive compet itors.

W hen these r ealizations stru ck m e, I felt th ere was a lack of one extra ordina ry itemin our imm ediate a rea which could solve our collective problems. Tha t extr aordina ry

item was a qu ality study cur riculum tha t m ight be of assistance to all people in t he

field of bioventure. My intent is that this study material must contain substantial

information for all—upcoming entrepreneurs, people from the field of management,

an d su ited investors. This would not only to serve gettin g people from va rious fields

under the one roof—bioventure—but it would also create a feeling of unanimity

within bioventur e.





W orking together has always been a fun for people like us. Now we have the means

to create that same fun—multiplied—by networking our talents, invented drugs,

and various other biotechnological products. At the same time there could be an

additional benefit waiting for each of us involved, in the form of earned capital. In

all honesty, that is simply one future that I dream of for bioventure. The best

possible future relies on greater understanding among the people associated with

this business. This will be possible only if we can integrate our knowledge and

experience, and opera te wit hin each oth er’s r espective fields of expert ise. If we can

appreciate the views that those among us want to share, and vice versa, then a

tr easu re t rove in bioventu re is not far off.

~~ Biopreneur Editorial Board

~~~~ *** ~~~~Taft Stett inius & Hollister LLP – www.taftlaw.com

Founded in 1885, Taft Stettinius & Hollister LLP continues to focus on the future, offeringsolutions and opportunities in an ever-changing world. Taft has more than 200 attorneys whopractice in a wide range of legal areas and service both U.S. and international clients, from start-up t echnology companies to publicly traded and internat ional corporations.

Medzym – www.medzym.com Medzym, Inc. is a privately held biotechnology company focused on building molecular

therapeutics based on effective platform technologies. Company’s current focus is on Age-related eye disorders- (1) eye-diseases, (2) Anti-Inflammatory/Allergy, and (2) Cardio-vascular.

Nort hern California Polytechnic (NorCal Poly) University (NCPU) is located in Silicon

Valley.California. The mission of NCPU is to provide students with amultidisciplinary and intercultural understanding of the world that enriches theirlives while actively participating in the global marketplace of commerce, culture,and technology. NCPU offers graduate degree programs, general educat ion,services and activities to enhance the academic and personal development of

students.

Technoedits is providing technical writing, editing and copywriting services to the

biotech/high-tech organizations. Biopreneur uses tecnoedits for its selective needs andservices. For more information contact [email protected].

PATRONS

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mailto:[email protected]









WHO ARE BIOPRENEURS?Mi yu k i S h ir a t a n i a n d R y a n B a id y a

Cup er t i no , Ca l i fo r n i a

Biopreneurs or bioentrepreneurs are

normally adventurous, innovative,

analytical, problem solvers. PhD

training in any given field gives the

primary skills and core knowledge of

that field. However, there is anotherwhole set of skills and understanding

that is not covered in normal PhD

training. That aspect is the

understanding of entrepreneurship

itself, which makes it easier to

manage and administer the aspects of

a specific business. With bioventure

comes extreme complexity that

requires business knowledge and

understanding. To become an

established and successfulbioentrepreneur no one can avoid the

business aspects of such a venture. A

successful biopreneur must acquire

and command the necessary basic

knowledge of general business

practices. Plan ning a business and t he

execution of that plan to achieve real

success are two completely different

aspects of bionventure, or of any

business. A person may have to go

through an intermediary phase, or

phases—becoming a technicalma na ger—and m ight also have to be a

lead scientist or researcher as well.

The transition from technical

contributor to technical manager is

not easy. Globally, in biotechnology,

scientists are often given the

responsibility for projects and people

without much thought or additional

management training. This is

especially true in the case of

biopreneurs who want to establish a

business without outsideadministrative help. If they transition

perfectly—i.e. they understand the

proper place and roles of

administrative people and mold

themselves in accord with that—

th ey’ll gain t he sa me out come a s

having outside managers brought into

the team. The fact is that some

biopreneurs make the transition

rather well, though many experts

agree that the industry has had arough time in such transitional

phases; it needs improvement. So, to

reach the peak in your business, you

cannot underestimate the need forefficient management styles.

Try to understand what happens

within th e minds of ma ny biopreneur s.

Failure in the transitional stage to

manager occurs because most people

with a PhD in biotechnology, while

chalking out a business plan, focus onth e scientific an d t echnological aspects

of the whole matter. As they consider

their potential product and related

incidentals, they see it only from a

scientist’s point of view. Thus when it

comes t o the adm inistrat ive a spects of

the venture, they believe that





implementing supervisory skills is

simply a matter of time and gaining

experience. They expect it to be a ba sic

learning situation while they operate

their n ew business.

Sta n Sewitch, a h uma n r esources (HR)

consultant in San Diego, contradicts

that all too common belief saying,

"Management is not an additional set

of responsibilities requ iring n ew skills

to be added to one's professional

repertoire," he continues,

"Management is an entirely different

career from that of the individual

contributor in science." Sewitch,

form er dir ector of hum an resour ces for

Mycogen, San Diego, CA, USA, addsthat technical professionals too often

believe that managing people is a

skill-set to be acquired. In most cases,

they find out t oo late th at th is isn't th e

case. It’s best to take Sewitch’s advice

seriously from the very outset of a

project.

A researcher willing to set up a

business based on h is or h er concept in

biotechnology, known as a biopreneur

in the industry, must achieve several

useful qualities to reach the goal of

becoming a successful businessman.

Along with gaining managerial

awareness it is also advantageous to

know how they themselves are

different from other businessmen. It

surely helps them to smooth out any

pertinent difficulties while adding

indispensable qualities. It is essential

to prospective biopreneurs to prepare

for the future by learning and

planning for their bio-venture. They

must understand, along with otherthings, prior to commencing their

business, their own drawbacks and

weaknesses and how they may

overcome t hem or a t least be pr epared

to face them.

TRAITS OF A RESEARCHER AND A BUSINESSPERSON

RESE ARCHE R BIOPRE NEU R (Science+ Business)

Determinant & Stubborn Determinant

Ambitious Ambitious with rea lism

Pr oblem solver Pr oblem solver & delegat or

Un boun d Explorer Disciplined Explora tion

Risk tak er Risk tak er & hedger

Leader ship (some cases) Leader ship & Team Player

Cheer leader (some cases) Cheer leader

Sales person (some cases) Sales person

Ha rd worker Ha rd worker

From the above chart it is quite clear

that researchers and biopreneurs are

different in fundamental ways. You

can recognize one thing clearly; if you

are willing to become solely a

researcher you may follow one path,

inventing new things day in and day

out. But if your goal is to become a

successful businessman you will have

a somewhat different pa th way to ta ke.

Table 1: Characteristic differences between Researcher and Businessperson





If fortune is inviting you to become a

biopreneur you must choose a special

lifestyle— one where you must play

both roles—researcher and

businessman. Along with the

characteristics that a researcher

exhibits a biopreneur carries

additional attributes which demand

particular attention. For example, a

researcher’s character-set insists on

being ambitious. In contrast the

character of a biopreneur requires

ambition based on reality. That

“reality” makes an ideal situation

because in bioventure you must work

to promote yourself along with your

compa ny’s br an d. Ther e is n o place for

airy ambition as you are required toma ke a pr ofit for your investors. In th e

case of bioventure, you will be forced

into certain obligations such as:

competitive intelligence, task-

management, finding investors and

funding, tax concerns and monetary

returns for your investors, marketing

strategies, concrete branding—the

future of your brand, reworking

corporate structure etc. These things

will prevent you from exploring new

product-lines without ample concernfor profit in the venture. Thus, still

retaining characteristics of a

researcher, which you truly are, you

will also think and execute things like

a businessman. That means not to

embellish, so that you will become an

ideal biopreneur.

Valuable opinions

Co-founder and Chairman of

Responsys, Inc., Anand Jagannathantalked about the characteristics

required to be an entrepreneur.

Entrepreneurs need to have

determina tion a nd dr ive, the a bility to

face rejection, a nd t hey need t o be risk

takers. They must know their “value

proposition” with respect to customer

“pain points.” Most successful

entrepreneurs, Jagannathan suggests,

have a clear definition of their

personal success that goes beyond

reaching the IPO stage, an ability to

listen an d ada pt to cust omer ’s

requirements, and the ability to

recognize and seize opportunity.

Though it may be easy to read or

listen to this, it’s really very difficult

to follow through. And, to materialize

th e whole concept is even ha rder .

Mr. Bipin Shah, a successful

entrepreneur, now a V.C. in the

Silicon Valley, once presented advice

to the new entrepreneurs:

•• SStt aa rr tt oonn llyy iif f yyoouu aa rr ee ccoomm mm iitt tt eedd f f oorr tt hh ee lloonn gg hh aa uu ll

aa nn dd pp rr eepp aa rr eedd tt oo ggoo tt hh rr oouu gghh

tt hh ee uu ppss aa nn dd dd oowwnn ss ..

•• SStt aa rr tt oonn llyy iif f yyoouu hh aa vvee tt hh ee

ddeeeepp eess tt p paassssiioonn f f oorr wwhh aa tt

yyoouu aa rr ee ggooiinn gg tt oo ddoo..

•• SStt aa rr tt oonn llyy iif f yyoouu aa rr ee

pprr eeppaa rr eedd tt oo ““ f f aa ii ll”” iif f tt hh iinn ggss

ggoo ““ww r r oonn gg”” aa nn dd tt hh eeyy ““d d oo…… ””

•• SStt aa rr tt oonn llyy iif f yyoouu aa rr ee

aa bbssoolluu tt eellyy ccoonn vviinn cceedd tt hh aa tt

yyoouu aa rr ee k k ii lllliinn gg aa r r eeaall p paaiinn

tt hh aa tt eexxiiss tt ss iinn tt hh ee mm aar r k k eet t

t t ood d aa y y ..

Though an old familiar story but

probably novel to new entrepreneurs—

starting anything new always has risk

factors, which could lead to failure. If

you are inclined to stop at this point,

or move on to other tangential visions,

you m ay never retu rn to your dr eam of

establishing a real bio-venture and itwill rema in merely a fant asy. Whether

it’s a n ew, or an est ablished ventu re,

risk is always an innate part of the

game. But you have to stick to your

original choice of acquiring success.

Gururaj “Desh” Deshpande rejected

thoughts of returning to his life as a





professor and software engineer—Re:

book titled From Financial Flop to

Billionaire. After his first failure,

Desphande stayed the course, always

true to his original vision. Now a very

successful entrepreneur, he relates: “A

manager means doing things (the)

‘right way’ and a leader means doing

the ‘right things.’” If it's something

you really believe in, he asserts,

"…you're going to ma ke it h app en."

Here, before you decide which role fits

you best, you have to know exactly

what right thing and exactly which

right way… Reading theories and

building a business plan, based on

theory alone, is not very hard, maybeeven a little too easy. Your planning

must be based first on reality. After

tha t you ha ve to be prepared to pursue

essential intermediate goals in order

to achieve success. First and foremost,

you m ust consider possible risk factors

tha t you or your compan y may need t o

face. Risks have to be faced; not

succumbing to your fears will make

you an ultimat e winner .

Leader ship—It’s ExpectedOutstanding leaders in business have

the ability to convince others. You

must have the ability to inspire your

peers and to execute things at the

right time. You have to motivate

investors and pa rt ners to have faith in

your abilities and concepts, so that

they do not waver to invest or support

your decisions.

It is particularly true that gainingsomething is frequently easier than

retaining it. Leadership is that same

sort of thing. As a leader you may

ha ve to ma ke decisions with out ha ving

all the information at hand, but your

decisions will have to be a strong

enough so that no one will want to

oppose you afterward. Though only

real experience helps true leaders to

make decisions effectively,

nonetheless, many times intuition,

based on personal and concrete

understanding, is also a great and

positive ass ist.

You have to stick to your decisions

until a time when you find significant

flaws in them. Here you will have to

mindful that as a leader you must not

play the part of a dictator. Good and

generous leaders have their goals

focused on their team’s goals. You

have to be always ready to listen to

your people because they may, in fact,

have better ideas in mind than you.

You mu st bu ild a good team to execut ewhat you think. Thus capable minds

should surround you—their

suggestions, comments and

interpretations will always be helpful.

You should try to remain the center-

point of the team, and so your

communicating skills will keep them

in concert. You have to be strongly

connected to your team-members,

ready to listen to and talk to them as

needed.

It may appear to be the job of

ma na gers but you a lso mu st learn h ow

to separate your inner being—

compartmentalizing yourself as

required for a group venture. You

must know how to gain the qualities

needed to accomplish th e du ties of full

leadership. You have to sanction

yourself with powers like ego-power,

self-power an d agency-power. And it is

your soul-power—the power of yourspirit—that will keep you totally

responsive to all appropriate feedback.

Tha t power will never lead you to feel-

on-top of anyone, nor beneath anyone

either. Also ego, if used positively, can

make you self-aware; it can increase

positive values in your life. But

remember, your ego-power must not





BIOPRENEUR

become tactless egotism—self-centered

selfishness—optimally it should

lightly touch egoism , i.e. self-interest.

That difference subtlety prevents you

from losing your hu ma nity.

As Deepak Chopra has shared, you as

a leader have to have the ability to

look and listen—not normal looking,

and listening—you must not be

blinded to observing reality. For the

best possible future of your business,

you must not be deaf to free-flowing

ideas and advice from your partners

and your subordinat es.

Interestingly, this vision is not

only for you, but also for the sake of social justice and environmental

responsibility. After all you must be

responsible for any harm caused to

am bient su rr oundings if it’s caused by

your bioventure. So you ought to

cultivate a sense of consciousn ess, an d

social-environmental awareness.

Consciousness differentiates tangled

hierarchies. Consciousness is

necessary to virtually connect with

reality. And so, it is a sense of

consciousness, and awareness, thatevery human being, whether in

business or any field or job, must

possess, for the betterment of society

an d the environmen t in genera l.

A Simple Philosophy

Business is a service for the society

and money is the by-product of that

service. Every time, as you think of

building a new venture, you ought to

remind yourself of that sta tement . Theby-product of the business is your

profit and it is the living blood of your

company, but the service you provide

to society must not be any less than

oxygen. That might be considered yet

an other responsibility, but as a leader

you have to be prepared for such

concepts.

Leadership is dependent on time and

circumstances. You must be prepared

to prove your abilities every time you

are faced with requisite

circumstances. You have to create a

wholly positive environment for

ongoing pr ojects. As a leader you ha ve

to have understand synchronicity—a

sense of co-ordination, and a sense of

harmony within several jobs. A leader

feels, visualizes, takes a risk, and

accomplishes a comm itmen t t o pick u p

broken pieces, as he or she moves

along to meet various goals. A leader

never loses the winning spirit.

Nearing the end of this section, Iwould like to recap and philosophize.

It’s not wrong to say th at leaders, and

followers, co-create each other.

Leaders, followers and environments

co-arise within the same space and

time. It is rule itself th at different iates

the ruler from others. Although there

are several points or characteristics

that may help an entrepreneur to

manage the role of the ruler , there is

nothing that is fixed in any business.

Rules work for business, but businessis never for the sake of rules. Rules or

basic guidelines to prepare your

business are conceived from previous

business experiences.

As a leader you will have to mak e your

own rules. Time will allow such

opportunities. Then why talk about

not-making-rules or avoiding it? Why

listen to other people? It is for a

breakthrough or to invent new orbetter rules, when you will reach new

vantage points of understanding—

newer positions of understanding,

th us m odifying older ru les.

Knowledge is only a stairway that

leads you to a level of success—you

have to become successful first, by





devising your own strategy. When

your strategy is proven, you will

establish your own rules in which to

rule your business, a s you s ee fit. This

tipping point will be perceived as the

birth of a real industry leader. …Hats

off!

Inside th e Minds of Biopren eur s

Now you know or at least have a

vague n otion of wha t a biopreneur is, a

hint of the managerial aspects of the

job, as well as t he r ole an d th e ways of

a lea der. Now let’s ta ke a brief jour ney

through the mind of a biopreneur.

What they hold in their minds makes

them different from other r esearchers,

as it also makes them known to theworld! What is the inspiring source of

such strong will-power! According to

Mr. Olaf Isachson, the author of

Joining the Entrepreneurial Elite, the

ten most traits of entrepreneurs,

includin g biopreneu rs possess, are:

• They are in charge of their own

destiny. Contradicting this,

anyone can say that every man

is the master of his own

destiny, it is true! But the

winning drive is this: Like

other people, entrepreneurs,

when problems arise, do not

leave their destiny in hands of

an unforeseen circumst ance.

• T hey are non-conform ists, able

to be stand-alone or be with

people. It is their iron mettle

that helps them to face any

situation. They know how to

mold themselves in accordancewith a given situat ion.

• They move beyond the local, the

provincial, the familiar and the

tried and true. In short they

are t rue r isk-takers.

• They avoid time-consuming

trifles and are swift to make

decisions. True leadership is

always a part of their

character. Always, even in the

roughest and hardest

situations, they remain cool

and calm—to make the right

an d best decisions.

• There are no obstacles, only

challenges and temporary

setbacks. The word obstacle

does not exist in the vern acular

of biopreneurs. It is a merely a

challenge, as th ey love to call it,

and obviously it is a challenge

th at m akes them so excited and

charged.

• The harder they work the more

energy they generate. Theygenerally possess nonstop

energy to go on, and on, and

on…

• They love what they do, and

their devotion and passion

allows t hem to move beyond the

confin es of th emselves. Th e

passion and love for what you

are about to do will make its

outcome much better, and of

cour se gen era lly positive.

• They are visionaries and their

biggest competitors are

themselves. It is ultimately

their unique vision and

decisions that make up

responsibilities for t he futu re of

their ventures. Certainly, if

they are wrong, they will

reverse an imminent

catastrophe.

• T hey seldom give up. Failure is

not in their vocabulary. Jus tlike the word obstacle they are

not ready to think of failure. A

small piece of advice here: it is

better to have confidence, not

thinking of failure or obstacles,

but you have to keep your eyes

open for anything of that sort





too, so that you find yourself

and your people ready to face

it, if it a ppears in t he futur e.

• They firmly believe there are no

sins of commission—only those

of om ission. That may differ

depending on the individuals.

However, it is also a particular

trait tha t biopreneurs possess

quite pr oudly.

Pa ths to success

We always like to know and teach,

especially when we know a lot about

business, leadership, etc., or about a

formula that may bring success. I do

not think there is any generalized

formula or equation that can be usedto define su ccess. However, this does

not prevent us from exploring and

finding a clust er of form ula s, or sets of

characteristics, that may give us a

foreseeable indication of a pathway to

success. In bioventure this information

is quite valuable. It is actually based

on experience as well as the

experiments of others who might

inform us about possible, though not

100% flawless, paths to success. One

th ing might be applicable to X, th ough

it may not equally be applicable to Z,

an d so on. A group of scholar s at

MIT’s Sloan School of Management

did research on this subject for five

years . Accordin g to th eir studies here

is th eir m odel for s uccess:

• Success takes a balance of forces.

Techn ology is not a lways necessar y

an d is almost never su fficient.

•Due to the power of opencommunication by the virtue of the

Internet revolution, the business

model of future company might be

a huge corporation or it might be a

very small enterpr ise.

• Decentralization is key phrase of

th e future. In order to be

successful one must make

decisions based on ones proximity

to the knowledge of his or her

customers.

• True activities, not the corporate

organization charts, will become

the primary building blocks in a

business. Out-sourcing and

alliances will eliminate the need

for huge personnel, and becomes

the enabler of the small

businessperson intent on staying

lean but growing into a big

business.

• Companies large and small will be

both global an d local. They will

need the local touch and all will

face global compet ition.• The most impacting discovery of

this research is regarding the

coming golden era of

m icroenterprises—a vision that is

saturated in the power of Internet.

Given the low cost of

communications, everyone can be

well informed and thus will make

good decisions . The high ly

motivated, the creative and

innovative, the biopreneur, will

convert imparted data and

knowledge into business wisdom,

and build successful companies to

compete with gorilla-corporations.

As I already ha ve ment ioned th ese are

possible ways; it dep ends u pon you, a s

you are the sole responsible agent for

the future of your company. It is

useful and a wise decision for the time

being to read these ideas to

comprehend the right way before youmake any hasty decisions. No one and

nothing in particular will bring

success unless you understand and

decide what is good for you. It is well

said that success is the progressive

realization of a worthy goal. Success





comes from the ability to feel

compassion.

Success Redefined

Inderjit Singh, founder and CEO of

Infiniti Solutions and also TIE

Singapore, a member of parliament in

Singapore, he has shared the story of

his entr epreneursh ip. Acquiring a

seat in government or joining a

multinational company formerly

defined success in Singapore. This

might resonate with many of us who

have known success in Japan, or have

equated it to signing-up with a

multinational organization, or gaining

a governm ent position. Singh climbed

the ladder of success in Singaporethrough the same means. But then he

attempted something a bit different;

he was able to acquire venture

funding from inside of Singapore, and

from abroad. In doing this he

ultimately realized his

entrepreneurial dream by changing

previously construed, or tacitly

defined, limits.

He said, as a member of par liamen t he

championed the cause of transformingSingapore from a corpora te bas ed

economy into an entr epreneur ial one

by addr essing all concerns,

impediment s, and challenges to

entr epreneur ship—his mission

leaving: “no stone left u nt ur ned.”

Accordin g to him t he k ey

characteristics required to be a

successful entr epren eur ar e as follows:

1) Determination

2) Risk-taking 3) Leadership

4) Number one sales person and

nu mber one cheerleader

5) Problem solver

So you see t he ba sic tra its required to

be a successful entrepreneur stay

sam e. It is only th e met hod of utilizing

these traits that change. Over the

course, methods change with things

such as the mind, time, and

circumstances.

Though not directly connected to

bioventure let us share another

important success story. A well

circulated story, if not well known, is

one in which Ireland was looking to

become a major center for Microsoft

and wanted a major server hub.

Unfortunately, Microsoft’s

investigat ion revealed tha t Irela nd’s

electronic infrastructure could notsupport it because it did not have

enough resident bandwidth. So

everything stopped. What to do now!

There was no looking back and no

crying tears of woe. Ireland took on

the enterprise, implementing the

required bandwidth building it to the

latest specifications in a very short

span of time. The rest is history, thus

establishing Ireland as a global center

of excellence in Internet activity. And

that is how one should be prepared forany forthcoming or unforeseen,

unexpected, problem. Now then two

questions ar ise:

How would an other count ry h ave dealt

with such a challenge?

How are other countries prepared to

participate in similar dynamic and

global marketplaces?

The problem and its solution

will remain at their places we just

have to find them out. Now that we

have enjoyed a little bit of success

kind a thing, let us explore some new

ways to attend success:





Some Critical Success Fa ctors In Biopr eneu rs

! Str ong Will Power Tha t Ca n Motivate Oth ers.

! Ear ly Conta ct With Successful Ent repreneur s.

! Exposure To Success St ories And Cas e Stu dies.! Gain Practical, Real World Experience Before, During And After

PhDs.

! Be Willing To Be Un usu al/Unconvent iona l.

! Agree To Embr ace Risk, And Possibly Fa ilur e.

! Ready To Leave A Lar ge Compa ny.

! Great Idea To Sta rt With.

! Excellent And P ass iona te Team - Near And Long Term Vision.

! Ability To Chan ge Cour se Mid Strea m.

! Execution, Execution And Execution!!

! Strategic And Marketing Brilliance.

! Fr ugality & Excellent Cash Mana gement.

! Support Network - VCs, Board, Advisory Board And Other Value

Add People.

Though it may look like

bringing the same old line in front

again, I should like to remind you

again that things are not to be

followed strictly. Those are important

yet very flexible ru les. Those tools ar e

for the sake of your business and your

business is not there to prove their

practicality. Every ruler creates

his/her own r ule but it’s only after you

be sure of calling yourself a ruler inbusiness.

Sum up

As someone once said, the best

of us is not what we do but what we

inspire in others. Thus when we sha re

our experience and knowledge it

increases. Whatever the way we

choose or wherever we move to work

the basic knowledge and way will

remain the same. We may face failure

and obstacles only to remember,

“Fa ilure is one of th e ma jor m ilestones

of an entrepreneur and each obstacle

is an opport un ity”. It’s not a th eory, as

a theory is also based on what we

learn out of our failure and

experiment, but our own flaw andfailure will teach us the right way to

success. It will make us winner one

day. Everything is dependant on our

mind as Silicon Valley is not a

geographical location it is just a “state

of mind”. Think as a winner and you

will find yourself as a winner. If you

Tab le 2 : S ucces s F ac to r s i n B ioven tu re





loose the vigour of your mind you will

be nowhere in near fut ure.

If experiment is the only thing

tha t you ha ve in h an d, do it sincerely,

genuinely and with an inimitable

passion for t hem. With th e hum an life

span longer and the business cycle

shorter, the opportunities are

immense for those with the

motivation, the temperament, a nd t he

guts to do it their way. There was no

one-way, there is no one-way and

there will be no one-way. It was the

biopren eur ’s wa y, it is t he biopren eur ’s

way and it will be the biopreneur’s

way.

(This artilce is taken from a book

titled – Biopreneurs: the Molecular

Millionaires)

M i yu k i S h i r a t a n i currently is in charge of int ernationa l logistic for Devicenet, US A,

Inc. S he ha s over 10 years’ international and m ulticultural experience (J apan, US ,

India) in both IT and biotech in du stries. S he also held responsibilities of

international m arketing com m un ications at S harp E lectronic Corp., Osaka , Japan;

and sale/ custom er relations at J US CO, J apan. S he received h er BA at Kansai

Gaidai Un iversity, Osaka , J apan, and MBA at the S an J ose state University, CA.

Ryan Ba id ya is an entrepreneur a business strategist and who has 12+ years of

experience in biotech. He lau nch ed several biotech an d h igh-tech b usin esses in S ilicon

Valley/ US A, and T okyo/ J apan. He found ed BioZak and B ioZak-Infobase, and

served as one of the foun din g m ana gem ent. Prior to that he was w ith Genprobe, ,

HyseQ; and GeneAsia. He serves as an ad visor to Golden-Em bryo, Pune/ Ind ia; and

KZA IS oft corp., Durgapur/ Ind ia. He gave num erous lectures on life sciences an d bio-

business topics at conferences, primarily in US A, and J apan. He auth ored articles,

patents, and com m entaries. Dr. Baid ya received his MS from IIT Kanp ur, PhD from

the University of California, Santa Cruz and MBA from the San Jose State

Un iversity, CA..





Bio-bu s ines s – a new Gold R ush :

Bio- business comprises over 10

tr illion d ollars or 30 p ercent of the

global economy. Coun tr ies th roughout

th e world h ave identified new

opportu nities in t he bio-busin ess

ar ena a s the n ext hot technology ar ea

an d ar e investing in tr aining their

scientists, setting up state-of-the-art

life science an d t echn ology kn owledge-

clust ers, esta blishin g viable

biotechnology industries to fuel

growth in bio-business ar eas.

In th e recent year s, there is morewillingness a nd pu sh for cross-

disciplinar y work an d ventu res

between h igh-tech an d biotech.

Professional and business investors

ma y find biotech a s a new Gold Rush

of our t ime. Biotech offers in finite

opportu nities as long as hu ma n beings

reside on t his planet.

It is considered t ha t t he bio-business

is going to be the fast est gr owing

sector of th e world economy dur ingthis centur y. Some even designa te th e

21st centur y as the bio-century . This

work shop is designed t o provide non-

bio professionals a broader

under stan ding of the field, and t he

opportu nities lie with in. Can you

afford be sim ple a spectat or?

P a ra d igm o f Bio -bu s ines s :

The biotech bu siness is witnessed ineveryday life from tooth pas te t o th e

medicine cabinet. I t occupies more of

our persona l economics, an d social

rela tionships, from h appin ess to love

tha n wha t we may realize. With the

recent convergence of IT an d na notech

with biotechnology, th e Bio-field is

growing a nd en abling more economic

opport un ities to be lat ched on t o.

As every discipline goes th rough its

roller-coaster of highs and lows, bio

ha s gone th rough its own high an dlows in th e mid 80s, while th e IT-

dot.com ha d its day in th e late 90s.

During th is roller coaster ride man y

fared well in th e game while

consider able others lost a big chun k of

th eir portfolio net wort h; however, th e

fundam entals remained the same and

th ose who maneu vered with sound

under stan ding of the field far ed th e

best.

C o m m o n S e n s e s n o t c o m m o n

t r a i t s :

Comm on sense of funda ment al

doctr ines in most busines ses is

un ivers al an d applicable all of th e

time—either in a depressed or vibran t

economy. What chiefly differ ar e th e

business and t he intr insic model tha t

follows t he business. Kn owing th e

specifics a nd u ndersta nding th e

un ique-nat ur e of th e field gives oneprofessiona l tools, skills, a nd wit t o

win a r ace of apparen t a mbiguity.

People fail in th eir endea vors n ot just

becau se th ey do not kn ow, but

moreover because of confusion and

lack of confiden ce which a rises from

th e weak u nderst an ding of the

int er linkin g of th e ma ny ‘bio-pa rt s’.

Biotech, by virtue, has its own specific

an d u nique distinction. Ha ving

spher ical kn owledge an dun derst an ding of the field would help

one to mak e pru dent decisions eith er

for bu siness investm ent or for car eer

developmen t with in th e field.

R y a n B a i d y a





P a t e n t P r o t e ct i on fo r L ife S c ie n c e I n v e n t i on s :

U n i q u e C h a lle n g e s fo r Ap p li ca n t s

Dr . Ade l a i de K . Le i t ze l an d Dav i d A . M an c i no

Taft Stettinius & Hollister LLP, Cincinnati, OH, USA

S ynops i s - Life sciences invent ors face a r igorous st an dar d for t he writt en

disclosure in pat ent a pplicat ions. Each pat ent a pplication must provide an

extensive, highly detailed am oun t of tea ching tha t en ables a hypothet ical person of

ordina ry skill in t he a rt to practice a claimed invent ion with even a modera te

am ount of breadth . The United States Pa tent a nd Tradem ar k Office is also very

careful about th e scope of an y invent ion t ha t is claimed in th e paten t ap plicat ion.

For exa mple, if there is an y potentia l for over-reaching of invent ion scope or a

claim ed app licat ion in gene th era py (which th e Pa ten t Office does not yet r ecognize),

th e pat ent a pplican t will face rejections requirin g tha t th e claim scope be

appropriately narr owed. The applicat ion can be strength ened by the appr opriate u seof deposits a nd a claim str at egy focused on th e invention ra th er t ha n th e invention’s

potential

In th e United Stat es, patent

protection can be obta ined for a ny

novel, non-obvious and useful

invent ion tha t is a process, machine,

ma nu factu re, or composition of

ma tt er. Generally, paten t protection

provides a n inventor with a right to a

monopoly on his or her invention for a

limited nu mber of years (or if th einvent or is not pra cticing the

invention, a r ight to a r easonable

royalty for oth ers’ use of the pa ten ted

invention). In excha nge for this

limited monopoly, th e inventor m ust

provide th e public (via th e pat ent

disclosur e) with a clear description of

th e invention an d th e process of

ma king and u sing the invention so

that the public can m ake and u se the

invent ion wh en t he m onopoly expires.This is the fundamental trade-off in

th e pat ent policy – the public, th rough

th e inven tor’s det ailed disclosure of

the invention in the pat ent, obtains

knowledge of the technology, while the

invent or obta ins a limited m onopoly to

the technology.

An inventor obtains paten t

protection by submitt ing a pa tent

application th at distinctly claims an d

describes his or her novel, non-

obvious, an d useful invention. The

application undergoes examination bya Pa tent a nd Tradema rk Office

Exam iner who determines if th e

invention is novel, non-obvious, and

possesses a clear u tility. In addit ion

the P atent Examiner determines if the

pat ent application’s deta iled

disclosure, kn own as th e specificat ion,





“cont ain[s] a writ ten description of the

invention, an d of the ma nn er an d

process of mak ing and u sing it, in such

full, clear, concise, an d exact ter ms a s

to enable any person skilled in t he ar t

to which it pert ains…to ma ke an d use

th e sa me” (35 U.S.C. §112, 1st

par agraph ). In other words, the

application mus t pr ovide a clear

writt en description of th e invent ion so

th at a h ypoth etical person “skilled in

the art ” would be able to ma ke an d

use th e invent ion (i.e., would be

“ena bled”). Inven tions in r apidly

developing techn ologies such a s t he

life sciences face pa rt icular challenges

with regard to these written

description and enablementrequirements.

The “cla ims” of an y issued

patent ar e the numbered paragraphs

at t he end tha t describe in detail the

exact scope of th e subject m at ter

covered by, or protected by the pat ent .

They are a na logous t o the boun dary

descriptions in a pr operty deed,

describing in deta il the boun dar ies of

th e paten t protection. The claims of a

paten t a pplicat ion are compa red bythe Pa tent a nd Tradema rk Office

Exam iner against th e present stat e-of-

the-art in th e present technological

field (kn own a s “prior ar t” and

including prior patents, publications,

ar ticles, litera tur e, and other

techn ologies in th e pu blic doma in).

Often times, the ma jority of the paten t

exam inat ion pr ocess involve a form al

negotiation between t he pat ent

applicant and the Examiner regardingthe precise langua ge of the pa tent

claims . Not only do th e invent ions

covered by th ese claims need t o be

novel and non-obvious over the prior

ar t, but the claims m ust also be fully

supported by the written description of

th e pat ent specification. In other

words, a patent application cannot

claim an “an ti-gra vity” ma chine if th e

pat ent specification fails to describe

how to make an d use such a ma chine.

Often biotech inventions occur

at t he nexus of hum an ingenuity and

highly complex n at ur al compositions

of ma tt er. The Applican t is faced with

th e challenge of describing a vira l

strain, hybridoma cell line, transgenic

an ima l, or a newly isolat ed gene in

such a wa y tha t it could be made or

used. Scientists routinely write

protocols tha t det ail the wa y

someth ing was m ade or isolated but

would be t he first to acknowledge

na tu ra l var iat ion in biological

ma terials. Where words alone areinsu fficient to describe th e invent ed

biological m at erial, t he P at ent Office

allows deposits of many types of

biological materials with a Patent

Depository such as t he American Type

Cult ur e Collection (ATCC). Referen ce

to an d ident ificat ion of the deposited

ma terials in a paten t application

fulfills t he wr itten descript ion

requiremen t for the deposited

ma ter ials. The benefits of depositin g

ma terial must be weighed against thecost and inconvenience of depositing

the mat erial.

In a ddition to depositing an y

claim ed biological m at erials, pa ten t

app licat ions for life science m at erials

should teach possible alterations

extensively. The Pa tent an d

Tra dema rk Office considers th e art of

biotechnology new and highly

unpr edicta ble, thus general teachingsof how to design variants are usually

not consider ed su fficient ly described to

pr ovide t he scope of coverage m ost

pat entees desire. Suppose an inventor

ha s isolated a novel nu cleotide

sequen ce encoding a high fidelity,

th ermostable polymera se and ha s

crea ted a mut an t form with extremely





high fidelity an d wishes t o obta in

paten t protection on t he origina l

sequence and the improved sequence.

The inventor claims his sequences and

variants tha t ha ve at least 95%

identity and ar e capable of

synth esizing DNA. In the applicat ion

the inventor sh ould describe an y

variants that he made, any variants

tha t he planned to make, any residues

tha t ar e part icularly crucial, an d any

residues th at he pr edicts could be

altered without impacting the

pr otein’s funct ion. Describe all th e

variant s tha t were made, even the less

successful ones.

These less successful var ian tsindicat e cha nges that can be ma de

without significant ly impa cting

activity and p rovide direct tea ching of

variant s within t he scope of the

invent ion. If th ere is a region of th e

protein t ha t will ha ve less impact on

activity, th e inventor should indicat e

tha t sh e recognizes tha t var iations in

tha t region ar e covered. If ther e are

regions t ha t a re cru cial for a ctivity,

the inventor sh ould describe the

subset of variations tha t m ight beaccepta ble. Alter ing a glycine residue

to alan ine, for example, might be

tolerat ed better t ha n a ltering glycine

to tryptopha n. If mu ltiple var iations

might yield different results, the

inventor should describe the potential

combina tions. Pr ovide at least one

specific functional assay for the

protein and provide a broad range of

resu lts ind icat ive of fun ction.

Deposit, describe, a nd don’t

stret ch. Suppose an inventor has

discovered an assay system t ha t

allows him to rapidly screen numerous

compoun ds for a par ticular a ctivity

th at he hopes will yield a m ulti-

million dollar medication. The

inventor should claim: the assay

system ; any n ovel componen ts of the

assay system; methods of using the

assay system; methods for performing

th e assa y to identify compoun ds with

a s pecific measu ra ble activity; an d

novel compounds tha t ar e in han d. If

th e identified compoun ds sha re well-

defined stru ctura l similarities, the

inventor should try to claim the genus

of str uctur ally similar compounds

with th e act ivity. Avoid “r each -

th rough” claims th at at tempt to cover

compoun ds t ha t could be discovered

using the novel assay.

In a nother exam ple, suppose

an invent or h as developed a n ovel

met hod of assaying a biomar ker forwhich an abnormal level correlates

with a par ticular disease state. The

invent or claims m eth ods of using th e

bioma rker assa y, compar ing the

results to a sta ndard, and

cha ra cterizing th e bioma rker level as

abnormal.

In the current Pa tent and

Trademark Office environment such

broad claims a re likely to face writt en

description rejections (a rejectionbased upon th e examiner’s ar gument

th at t he claims are not support ed by

th e written description of the paten t

app licat ion). Such broad claims will

cau se th e examiner to question

whet her t he invent ion is sufficiently

described to indicat e tha t t he

Applican t wa s in possession of th e

invention. At the very least the

app licat ion sh ould include nar row

claims tha t indicate wheth er anincreased or decreased biomarker level

corr elates with t he par ticular disease

sta te. The specification should

describe data corr elating the altered

bioma rker level with the disease th us

demonstrat ing that t he Applican t was

in possession of th e invent ion.





BIOPRENEUR

In a similar scenar io, the

invent or, a well-known eyebrow

specialist, h as identified a set of genes

expressed differen tly in diseased

eyebrow sam ples tha n hea lthy

eyebrow sam ples. Recognizing th e

importa nce of early diagnosis in

eyebrow disease, th e specialist invent s

a met hod of detecting eyebrow disease

based on th is differen tial expression.

The specification provides clear

evidence th at differen tial expr ession of

th e gene set occur s in ea ch of th e top

five eyebrow diseases.

The a pplicat ion claims met hods

of detecting eyebrow disease t ha tinclude t he steps of assa ying th e

eyebrow disease relat ed gene set in a

subject, compar ing the r esults t o a

predetermined standar d, and

cha ra cterizing a subject with the

appr opriate increases or decreases in

gene expression levels a s a subject

with eyebrow disease or without

eyebrow disease. Such claims ar e

likely to face a “non-enablemen t”

rejection based on th e exam iner’s

ar gument t ha t the meth od couldidentify arm pit diseases or bigtoe

diseases a s well as eyebrow disease,

thu s th e claims ar e not enabled for

met hods of detecting eyebrow disease.

To reduce the likelihood of

th ese types of non-enablemen t

rejections, include claims th at indicate

the novel method is tissue preferred.

For exam ple, provide claim s with th e

step of providing an eyebrow tissuesam ple from t he subject.

Additionally, methods that rely

on differen tial expr ession of a gene set

face increased scrutiny by th e Pa tent

an d Tradem ar k Office. While not as

firm ly rejected as gene ther apy claims ,

ther e is an increasing concern a bout

the var iability an d

repr oducibility of th e a vailable

differen tial gene expression assa ys,

par ticularly microarr ay based

methods and t he impact t hat

altera tions in th e microarra y ana lysis

softwa re’s un derlying assum ptions

could ha ve on t he a na lysis of

microarray dat a.

It is not clear to what extr eme

th e P aten t Office will tak e th is

concern ; however, it is advisable t o

teach suita ble softwar e progra ms a nd

a r an ge of par am eters th at could be

used in the microarr ay data a na lysis.

If the Pat ent a nd Tra demar k Office

regards microarr ay data a na lysisprogra ms a s a na logous t o sequence

homology progra ms, it ma y become

necessar y to specify a pr eferr ed

microarr ay data a na lysis progra m to

be used with t he invention.

Fin ally, provide claims th at

distinguish the invention from gene

therapy. The Pat ent and Trademark

Office does n ot consider gene t her apy

a viable technology; th erefore, a ny

claim th at could be const ru ed to covergene therapy is considered not enabled

for t he full breadt h of th e claim .

There ar e num erous acceptable

ways to delineat e the claims a nd th e

app ropriat e way of doing th is depends

on th e actu al invention. For instance,

th e Pa ten t Office routinely accepts us e

of th e ter m “isolat ed” tr an sform ed

cells or t issue to distinguish t he

claimed material or methods fromgene ther apy.

In s um ma ry, life sciences

invent ors face a rigorous st an dar d for

written description a nd ena blement in

pat ent applicat ions. Each paten t

application must provide an extensive,

highly detailed am oun t of tea ching to





provide a wr itten description t ha t

enables a claim with even a moderate

am ount of brea dth . The application

can be strengthened by the

appropriate use of deposits and a

claim str at egy focused on t he

invention r at her tha n t he invention’s

potential.

*****************************

ADELAIDE K. LEIT ZEL is a patent agent in the biotech area and w orks w ith th e

attorneys at T aft S tettinius & Hollister LLP wh o practice in the area of Patent

Prosecution. S he holds a Ph .D. in genetics and m olecular biology from th e University

of North Carolina and received her undergraduate degrees in biology and history

from Davidson College in Davidson, North Carolina. Her research recently was

published in the journa l Yeast . Dr. Leitzel also is a registered patent agent with the

U.S . Patent & T radem ark Office.

DAVID A. MAN CINO is a Partner and Co-Chair of the Intellectual Property

practice of Taft S tettin ius & H ollister LL P. Mr. Man cino’s scope of practice inclu des

patent a nd int ellectual p roperty (“IP”) litigation, paten t preparat ion an d prosecution,

IP opinion work, IP licensing, technology agreements, IP training and client

coun seling as it relates to techn ology, IP protection an d bu siness strategy. Mr. Mancino, a registered patent attorney, litigates and prosecutes patents in many

technical areas including: medical and surgical devices, prosthetics, software,

busin ess m ethods, electrical circuits, compu ter system s, comp ut er netw orks,

semiconductor device technology, and many other mechanical and electro-mechanical

techn ologies. He obtain ed his law degree from th e University of Cincinn ati S chool of

Law in 1994.

T o a u t h o r s : Contributingaut hors a re requested to

submit a short 1-2

par agr aph proposal for

ar ticles relevan t t o th e bio-

business au diences. Em ail:

biomkt [email protected]





Wh y d o m a n y c a n c e r p a t i e n t s r e l a p s e e ve n a f t e r

r e m o va l of t h e ir t u m o r ?

T h e p r o m i s e o f t a r g e t e d t h e r a p y a g a i n s t c a n c e r s t e m c e lls

An u r a a g S a r a n g iNeu roscience progra m, Vander bilt U niversity, Nas hville, TN, USA.

Why do ma ny can cer pat ients relapse even after r emoval of th eir tum or? How do

these aggressive tum ors spread a nd meta stasize to oth er par ts of the body? Why

has the current treatment regimen of surgery, chemotherapy and radiation therapy

failed to provide long-term su rvival for man y can cer pa tient s? These a re difficult

questions. As a potential answer, the can cer stem cell theory tha t is now at t he

forefront of cancer resea rch offers a n int riguing explana tion.

Cells that make up a patient 's tumor

may be organized in a hierarchical

ma nn er. At the top of this hiera rchy

are malignant cells that behave like

stem cells, being able to divide and

give rise to themselves and to other

tu mor cells. This sma ll subset of cells

may init iate and maintain tumor

growth. Some stu dies ha ve shown

that injecting as few as a 100 of these

cells can grow an aggressive brain

tumor (glioblastoma multiforme) inthe brain of an immunocompromised

mouse. The implicat ions of such a

findin g ar e enorm ous. These cancer

stem cells (CSC) can give rise to a

heterogeneous mix of cells as seen in

the morphology of many aggressive

tumors. If these cancer stem cells

survive the current treatment

regimen, then they may cause the re-

growth of a tum or in a patient. These

cells may invade surrounding normal

tissue or move to another location in

the body an d form a met ast atic tumor.

Current treatment modalit ies treat

the tumor as a bulk enti ty and try to

eliminate as many tumor cells as

possible. However, ta rget ed th era py

against these cancer stem cells can

provide a better means of eliminating

a tum or complet ely. Can we isolate

and eliminate them? How? How do we

spare the normal stem cells in the

body while trying to eliminate the

cancerous ones? Resear chers in

academia and industry are finding

creative approaches in the pursuit of

such a targeted therapy.

It is certainly not easy to isolate these

cells from solid tumors (brain, breast,

prostate tumors, etc.) and maintain

them in culture. However, it ispossible to isolate t hem with t he us e of

distinct cell-surface markers or

modified culture methods that favor

stem cell ma int ena nce. Recent ly,

isolation and characterization of these

cells from many solid tumors have

revealed many interesting findings:

they constitute only a rare population

of cells (between <1-5%) within the

tumor and they utilize inherent

molecular mechanisms that promote

resistan ce to radiation th erapy or drug

tr eatm ents. These findings suggest

that CSC are a hard target to go after.

At the same time, they also provide

clues that can be exploited to develop

therapies based on eliminating them.

Elucidating the molecular

mechanisms thr ough wh ich these cells





maintain their stem cell state, give

rise to tumor cells, resist standard

therapy, and metastasize will give us

a handle on how to target them

specifically. Resear chers ha ve

identified approaches that can

specifically target CSC or their

microenvironm ent . For exam ple,

Duke university researchers recently

demonstrated that CSC recruit their

own vasculature for nutrient support.

They also showed that preventing the

growth of new blood vessels effectively

reduced CSC nu mbers. Researchers

in Italy have suggested another

approach relying on the signaling

molecule bone morph ogenet ic protein's

(BMP) ability to terminallydifferentiate CSC into tumor cells.

This type of "differentiation therapy"

could render differentiated CSC more

susceptible to existing treatment

modalities.

The biopharma industry is exploring

opportunities to quickly bring to

market therapies based on CSC

eliminat ion. The pace of indu str ial

development in this area is picking up

as companies are generating more

exciting results related to theeffectiveness of th is appr oach. Some

of the key players in this field are

Genentech, Oncomed

Pharmaceuticals, GlaxoSmithKline,

an d Stemline Thera peutics. It may be

a matter of time before such targeted

therapies are on th e market.

Just as normal stem cells rely on

developmental cues and molecular

signaling path ways during th e growth

of an organism, CSC may utilize someof these same pathways in an

unregulated manner to support tumor

growth. Genen tech's app roach relies

on chara cterizing a nd int erfering with

these pathways to promote tumor

regression. In collaboration with

Curis, Genentech is developing

compounds that inhibit the Hedgehog

signaling pathway that is known to

play a role in CSC maintenance,

tumor growth and metastasis in skin,

brain, pancreatic, prostate and

gastrointestinal cancers, among

others . Ph ase I clinical tr ials of a

Hedgehog antagonist are currently

under way along with plans of sta rting

a P ha se II trial by this year.

Oncomed Pharmaceuticals is

employing a screening approach to

identify and develop monoclonal

antibodies that may specifically target

CSC populations. They isolate CSC

from primary human tumors, create

xenograft models of these tumors by

injecting t hese cells into mice, and t est

a panel of antibodies against thesean imal models t o determ ine promising

can didates for furt her testing. This

type of approach may identify a wider

range of potential therapeutic

candidates that can be employed

against specific tumor types.

Init iation of clinical t rials of their lead

candidate is expected to start this

year.

Some of the currently available drugs

may also eliminate CSC.

GlaxoSmithKline's Tykerb is currentlyapproved for patients with advanced

breast cancer that has spread to other

par ts of th e body. Recent ly, in two

independent Phase I clinical trials,

Tykerb was found to reduce CSC

numbers by as much as 50% in some

breast cancer patients when

adm inister ed along with Genen tech’s

Herceptin and slow the spread of the

tumor to the brain in combination

with Roche’s Xeloda . Theseencouraging results have prompted

GSK t o re-position Tykerb for deta iled

stu dies relat ed to its effect on CSC.

SL-401 from Stemline Therapeutics is

also a biologic compound in Phase I

clinical trials currently that has

demonstrated the ability to inhibit

tu mor growth by ta rgeting CSC. SL-





401 targets Interleukin-3 receptor,

overexpressed in Acute Myeloid

Leukaemia stem cells, and delivers a

toxin to the cells thus eliminating

them . On a very encour aging note,

one of the patients in the study, who

had been refractory to standard

chemotherapy, achieved a complete

response with SL-401 treatment

demonstrating the compound's potent

ant i-tum or activity.

As the cancer stem cell field matures,

we are likely to see more therapies

that are designed specifically against

these malignant cells within cancers.

Many technical challenges remain in

the quest towards targeted therapy

against CSC. But it is now

increasingly clear that surpassing

th ese hur dles will open up a pr omising

new and effective approach to cancer

t reatment

Anuraag Sarangi is currently pursuing a Ph.D. in the Neuroscience program at

Van derbilt Un iversity. His research focuses on th e role of the Hedgehog signa ling

pathway in brain tu m or stem cells. Prior to joining V and erbilt, he com pleted a M.S c.

in Compu ter S cience from Ind iana Un iversity in 2004. An uraag also serves as the

Co-Director of th e Tenn essee Biotechn ology Association S tu den t Ch apter.

Globa l Bu s iness Acce le ra t ion

Thr ough a n a ffiliation with th e Biopren eur

It is simple and easy and effective - ask how





B I O P R E N E U R S’ B IT E S

B u s in e s s P l a n Tip s F o r Th e E n t r e p r e n e u r o r I n t r a p r e n e u r

Sherr i Dohema nn

Or th o-McNei l Neu r ologics , Inc .

The bottom line - Are you an entr epreneur or Intr apr eneur? Inn ovation an d

customer knowledge should go hand in hand:

If you a re an entr epreneur , then your

customers ar e many and varied and

include pat ients, payers,

doctors/clinicians , r egulators, an dinvestors.

The good news is that you’ll always be

learn ing; a solid ha ndle on inn ovat ing

and knowing your customers and their

needs will put you a hea d of your

competitors.

The following 4 item s a re some

business plan sections r equired to

approach any investor and help you

under stan d your customers, including

lar ge compa nies for exit str at egy

options.

The da ys of winn ing on t hink ing up of

just a h ot technology inn ovat ion a re

over. Ther e is still funding to be ha d,

mer gers to be ma de, and IP O’s,

however answer those questions

before th ey stop you in your tr acks.

1) Detailed an d accur ate a ssessment

of customer or pipeline need

fulfillmen t/complem ent with

technology based on current tr eatm ent

trends.

2) Accurate assessment of any current

organizat ion’s eith er compet itors or

potent ial buyers capability measu red

against disruptive market changes-

Cartesian method.

3) Under sta nd govern an ce of lar ge

organizations tha t m ay be your

corp ora te invest or: who assesses, who

signs off decides, an d why et c.

4) Innovation, why it's now sur vival,

not just growth a nd why it's easier for

small companies to innovate and

perh aps for lar ge compa nies to buy.

L oo k in g a t y o u r c o m p a n y a n d a n y

p a r t n e r la r g e c o m p a n i e s:





When looking at a compan y part ner or

ass essing your own compa ny, World-

Class Operations and finance-ceteris

par ibus-is th ere t he vision to see

where your science/ technology

innovation fits with t he cust omer ? Do

you a nd your par tner compa ny know

how you'll gain cust omer comm un ity

support for the innovation?

However, you need to know how it fits

th eir pr actice reality in physiological,

pat ient pr ofile, fina ncial, an d pra ctice

deta il-to win funding from invest ors;

th at ’s what t hey’ll ask t o see. Ha ve a

reimbursem ent plan based on a

mar ket a ssessment knowing what

payer will see what value in yourproduct a nd why.

My perspective is tha t th e crea tion of

a plan t o win in th e mar ketplace

sta rts by being able to accur ately

ass ess your organizat ion's capa bility

to move this inn ovat ion forwa rd. Also,

you'd need t o see wha t h as t o be done

to increase that capability and propose

appr opriate governan ce chan ges

su pport ive of th e vision. This

requires th e necessar y comm itment

from the n eeded levels for t he cha nges

an d the right resources. The

comm un icat ion t o reinforce th e

agreement s enables the changes in

roles an d responsibilities to support

th e vision.

It seems critical tha t t he correct

cur rent capabilities and business

environment be accurately perceived

for your business an d your part ner

invest or or co-promoter . This would

be combined with horizon s cann ing

capability for wh ere t he tr ends of th e

ma rket a re going.

Days where large firms can capitalize

on- ways of doing th ings an d

techn ologies to scales u p of th e ma sses

for exten ded periods are sa id to be

over in technology mar kets becau se of

disruptive innovat ion. That is why

innovation seems necessar y for

sur vival, not just growth n ow.

Where ar e some places whereentrepreneurs or intrapreneurs can

learn more and net work?

http://www.FountainBlue.biz Lessons

in Funding

From th e Fount ain Incuba tors’ Pan el:

T ip s o n Wo r k i n g w i t h I n c u b a t o r s

# Incuba tors could be virtua l or

brick a nd m ort ar, a nd will work with you to suit your needs.

# Incubators can support you in

building your strategy,

developing your tech nology,

conn ecting you wit h fun ding

sources, connecting you with

qua lity service providers,

providing a sha redinfra stru ctur e, creat ing a

comm unity of entr epreneur s,

etc.,

# Underst an d t he options for

incubat ing compa nies and t he

value each one provides. Also

under stan d wha t your objectives

are to ensure that they are in

alignment with the

opportu nities pr esented.

T h o u g h t s o n S e c u r i n g F u n d i n g fo r

Ear ly St age L i fe S ci ence S t a r t -Ups

# Bootstrap for as long as

possible, while still making

progress.

http://www.fountainblue.biz/







# Understand when and why you

should take money and

resea rch h ow you

# can connect with the right

investors (private? Angel? VC?

Foundat ion) at th e right t ime.

# Understand the value of the

funder beyond the money - will

they provide expertise,

connections, operational

support, coaching, etc.

# When considering funding,

ensure that it will position your

company well for additional

an d futu re funding.

# SBIR gra nt s ar e a good option

for early sta ge drug

development,

however pha se one fundin g is

relatively small and gran t

findings in general

ar e episodic ra ther t ha n

cont inual. In addition, th ere

are restrictions on

how the grant monies can be

applied, although th ere is no

equ ity loss for

the findings.

* Research STTR NIH grant shttp://grants.nih.gov/grants/funding/sbir.htm,

DARPA grants

http://www.darpa.mil/body/off_programs.html,

RAID NIH gran ts

http://dtp.nci.nih.gov/docs/raid/raid_pp.html,

an d other govern ment grant options

http://www.grants.gov/search/search.do?oppId=15474&flag2006=true&mode=VIEW

* Research funding opport un ities fromprivat e foun dat ions on specific

diseases if it is relevant to your star t-

up.

Oth er Th oughts on Bu ilding Your Life

Science Compa ny

* Consider opport un ities for n ew ways

to deliver, pa ckage, and app ly etc.,

kn own dr ugs or deliver plat form s or

devices in other ways.

* The business model may evolve as

you go, with th e developm ent of

your technology, clinical trials, needs

in the m ark et, etc., Str ucture your

funding, partn ership and other

str at egies accordingly.

*Consider corpora te developmentpar tner s, investors, or gran ts (

primarily for institutions-research).

* Out sourcing developmen t m ay be an

efficient option, but choose t o

ret ain developmen t of th e core

technologies.

* Perform dru g/product developmen t

an d business development in

parallel.

* Pr otect your IP wh en work ing with

potent ial part ners, funders, etc.,

* Select your co-found ers care fully,

an d under stan d the role each will

play in t he su ccess of the compa ny.

http://grants.nih.gov/grants/funding/sbir.htm,
















* Roles of the co-founders will evolve

as t he compa ny grows. A funding

event will likely impact t he roles of

the founder s.

inform at ion from th e Ventu re Ca pital

Industry: www.nvca.org

Partnering conference information:

www.biowindhover.com.

news, info, lear n a bout la rge compa ny

partners : www.windhover.com

news, event s, an d part nering

information:

http://www.devicelink.com/mx/

Check out th e week's activities at

http://eweek.stanford.edu venture

speed rounds, Biomedical technology

showcase, and more

S h e rr i Do h em a n n is a Senior Sales professional at Ortho-McNeil Neurologics, with

eight years of experience representin g 13 m olecular enti ties to #11 d ifferent specialists

for a ran ge of 6 disease states. S he is a volun teer organizer for th e Foun tain Blu e Life

Sciences Forum, an organization that offers education and networking to life science

entrepreneurs & th eir team s such as staff m embers, advisers, board m em bers, and

investors. S herri completed a BS degree in Com bined S ciences, an in terdisciplinary

natu ral sciences degree from S anta Clara University and a ttended S tanford

Biodesign's Em erging En trepreneurs in B iomedical Techn ology in 2007. .

~~~~ *** ~~~~

for G lo b a l Ma r k e t i n g a n d B r a n d in g s t r a t e g y:

B i o p r e n e u r is a valu e-added option

tell your st or ies, invent ions a nd p rofiles to the global

biopreneurs

be with crowd that drives the engine, not drags it.

http://www.nvca.org/


http://www.biowindhover.com/?&utm_source=BioWin08&utm_medium=email&utm_campaign=BioWin08


http://www.windhover.com/




http://eweek.stanford.edu/











India

Bio





BioIndia ™ India h as been pr oviding the

developing world comp rise of 2/3 of th eworld’s population with t he n ecessa ry

medicines from common cold to HIV,

from antibiotics to anti-diabetics for

the past severa l decades. Over these

periods India ha s developed a well-

developed drug m an ufactur ing

industry that now poised to compete

with multina tional phar ma ceuticals

compa nies su ch as , Pfizer, Roche,

Merck and GSK globally. Initia l

model of the Bio-indu str y was t oprovide medicine to t he bottom of the

pyram ids emerging as th e model to

provide cost saving options to t he top

of the pyra mid (CK Pr aha lad).

Indian ph arm a an d biotech

corporations have obtained clearance

from F DA to lau nch severa l generics

drug in USA and m any are in th epipelines. More an d more biotech and

phar ma compa nies in India ar e

par tner ing with their count er par ts in

USA for p re-clinical a nd clinical

stu dies – an em erging bio-out sourcing

economy.

India ha s developed a solid

infrastructure for pre-clinical and

clinical stu dies t ha t is approved a ndrecognized by FDA. Recent ly FDA

expressed its intend to house

inspectors and a gents in India to

ass ist India n a nd USA bio-compa nies

in th eir drug development ,

manufacturing and regulatory

processes and compliance protocols –

A step forwa rd for BioIndia .

# Clinical tr ials in India is

growing a t a 60% AAGR# Crossed USD 100 million in

2004.

# By 2010, the indu str y will

spen d USD 300M+ on clinical

tr ials in India.

# 240 inter na tiona l studies

recru iting su bjects = 1.2% of

the total studies worldwide

# 66% of inter na tional clinical

trials are Pha se III

# 207 sites FDA register ed

# 40,000 subjects par ticipat ed inclinical trials to date (<0.02% of

population)

• India compa nies ha ve

ap proxima te sh ar e of 35% in

DMFs an d 25% in ANDAs

filing globally

• Second a nd t hird tier

comp an ies have a ggressively

scaled u p ANDA/DMF filing in

th e US mar ket over th e last 2-3years

In th is section we will bring fort h

what ’s been h appening in th e

biobuiness in In dia.

Biopharma76%

Bioservices8%

Bioindustry

8%

Bioagri6%

Bioinformatics2%

Composition of Indian Biotech Industry





B IO-B U S I NE S S E S I N I NDIA

Q1-2008

T he E x-P r e s iden t o f In d i a , Mr A.P .J . Abdu l Ka l am ask ed

Bio-ind u s t r y to p r odu ce 40% of wor ld ’s gene r ic d r u gs .

In Mar ch a t Vadodara , while addressing a gath ering here to celebrate t he

cent ena ry function of Alembic Ltd, th e form er P resident of India, Mr A.P.J.

Abdul Kalam said the global production of pha rm aceuticals, bra nded a nd

generics put together is nea rly $550 billion.

The domestic pharm aceuticals indust ry, at present, h as a tur nover of $12.5

billion of gener ics for domestic and export ma rket s a gainst th e production of

$78 billion wort h of gener ics in th e world. He called at ten tion to th e need for

India to cont ribut e 40 per cent of the world’s generic drug pr oduction an d

focus on er adication of diseases such a s ma laria an d tu berculosis.

Re d d y ’s La b o r a t o r i e s is t o a c q u i r e p a r t o f D o wCh em ica l ’s bu s ines s i n UK.

Dr Reddy's Labora tories (Hyderaba d, Ind ia) ent ered into a definitive agr eemen t

with Dow Chem ical Compa ny (USA) to acquire a portion of Dowpha rm a Sm all

Molecules business a ssociat ed with its opera tion in Mirfield an d Cam bridge, UK.

Thr ough th is acquisition Dr . Reddy’s Labora tories will acquire th e ass ociat ed

product-port folio, technologies, intellectu al pr opert y, tra dema rk s, and t he

cust omers. Dr. Reddy's will a lso receive a non-exclusive license to Dow's Pfenex

Expr ession Technology for biocat alysis developmen t. The t ra nsa ction is expected t o

close by the end of April, 2008 pending r egulatory a pproval.

S u v e n a n d E li Li ly s ig n e d S e c on d D r u g d i s co ve r y

C olla b o r a t i o n i n C N S t h e r a p e u t i csSuven Life Sciences Limit ed, (Hyder aba d, India) ann oun ced in Mar ch 2008 tha t it

signed a second collabora tive pre-clinical R&D agr eemen t with Eli Lilly in t hether apeut ic ar ea of centra l nervous system disorders (CNS).





Under the terms of this agreement Suven will be responsible for identifing and

selectin g dur g candidat es for CNS. Suven will receive up-front pa yment for th e

R&D works an d in add ition t o th at Suven will receive milestone pa yment s for

potent ial dru g can didates in th e ra nge of $19 million t o $23 million per can didat e

molecule. The compa ny is also ent itled to futu re r oyalties on net sa les of an y

products t ha t m ay be su ccessfully comm ercialized from th e collabora tion.

U S p h a r m a c e u t i ca ls in d u s t r y t o a d o p t In d i a n

P h a r m a c o p oe ia s t a n d a r d sAs the US sta ndar d has no monogra phs for an tiretrovira l dru gs, the US drug

ma ker s would follow th e Indian P ha rm acopoeia Commission’s stan dar ds man ua l for

HIV/AIDS drugs. By expan ding th e scope of a coopera tion deal signed in 2006

between t he US P ha rma copoeia and t he Indian Pha rm acopeia comm ission, the US

will be now publishing monogra phs, or a set of referr al sta nda rds, developed by the

Indian Pharmacopeia Commission for about 51 anti-AIDS drugs.

Pha rm acopoeia is the drug stan dards ma nua l for th e pharm aceuticals indust ry

published per iodically by different coun tr ies to help dru g man ufactur ers a s well as

the r egulators to follow the pa ra meters for m aking a st an dard dr ug. Curr ently, the

US P ha rma copoeia an d British Ph ar ma copoeia ar e the two widely referred

pharmacopoeias in the world.

F DA Ap pr oved Na t co ’s AP I fa c i li t i e s i n In d iaIn Ma rch 2008, the US F ood a nd Dr ug Administra tion h as a pproved Nat co Phar ma ’s

Active Pharmaceutical Ingredients (APIs) facility at Mekaguda in Mahaboobnagar

distr ict, Andhr a P ra desh for pr oduction of some a dditiona l products. The appr ovedproducts in clude Ima tinib Mesylat e (medicine for blood can cer), Anast ra zole (brea stcancer), Gra nisetron (nausea ) and Rizat ripan (migraine).

Ac c e n t u r e i s e x p a n d i n g i t s li fe -s c ie n c e s o p e r a t i on

i n I n d iaAccentu re envision high gr owth in t he life-sciences down-str eam processes

out sourcing prima rily becau se of un cont rollable cost an d n eed to expedite lab-to-

ma rket pr ocess. More an d more phar ma compan ies are looking to places where

sta ble, reliable and regulatory compa ra ble infrastr uctures a re in place.

Accent ur e’s life science R&D cent re in Ban galore is its lar gest in t he world with

2,500 employees compr ising doma in expert s such a s clinician s, nu rses, scientists

an d bio-stat istician s apa rt from t echn ology professiona ls. Accentur e is , th erefore,

looking at expan ding th e scope a nd scale of its lifescience opera tions in In dia .

Accent ur e ma y double the n um ber of employees in its R&D centr e and a lso sprea d to

more cities in India to att ra ct t alent.





S tem C yte , Apo l lo -h osp i t a l an d C ad i l a c r ea t ed a jo in t

ven t u r e fo r s t em-ce ll p r odu c t s

Stem Cyte Inc.( Arcadia, Californ ia) ann ounced the form at ion of a joint ventu re,

StemCyte India Therapeutics Pvt. Ltd., in India with Apollo Hospitals and Cadila

Ph ar ma ceuticals. The joint -vent ur e compa ny will provide stem cell th era pies

derived from u mbilical cord blood to tr eat pat ients with cert ain m alignan t blooddisorders, such as leukemia, lymphoma and myeloma; sickle cell anemia and

tha lassemia; and immun e deficiency diseases. The Stem Cyte India Therapeu tics will

cont ribut e to the clinical st udies t o develop cell th era pies for poten tial diseas es withno possible cure ava ilable at pres ent .

"The joint vent ur e ena bles us to combine StemCyt e's proven cell th era py products

with Apollo and Cadila's expertise in the Indian healthcare arena for the benefit of

one of the world largest pa tient populations," said Kenneth J . Giacin, cha irma n a nd

th e chief execut ive officer of St em Cyte. He ad ded, "Moreover, St emCyte Ind ia

Therapeu tics is a n importa nt part of our global expansion stra tegy.”

Creat ion of New Ventu re, StemCyte In dia, Continu es StemCyte's Intern at iona l

Expan sion a nd Ut ilizes the St ren gths a nd Regiona l Expert ise of Apollo Hospitalsand Cadila Pharmaceuticals

T h e U S i s s e e k i n g a d d i t i o n a l sc ie n t i fi c , r e g u l a t o r y

a n d t e c h n ic a l c olla b o r a t i on w i t h I n d i a a s a m e a n s

t o im p r o ve h e a lt h c a r e o u t c o m e s fo r p a t i e n t s in U S A

a n d a r o u n d t h e w o r ld .

On Ma rch 18 in Wash ington DC, the U.S.-India Busin ess Coun cil (USIBC) hosted

the Mr. Micha el O. Leavitt, Secretar y, U.S. Depart ment of Health a nd H uma n

Services. Secreta ry Leavitt h ighlighted th e need collabora tion as a mean s to

impr ove hea lthcar e outcomes for pa tient s around th e world. Secreta ry Leavitt

sha red a bout his desires for grea ter scient ific, regulat ory and t echnical collaborat ion

between th e U.S. an d India. A centra l goal of th e Coalition for Hea lthy India is to

foster grea ter regulatory har monization between t he U.S. and In dia, resulting in

decreased costs a nd increased pa tient safety.





B IO -B U S I N E S S E S IN ASIA

Q1-2008





B I O -B U S I N E S S E S IN & AROUND

J AP AN, S. K O R E A, S I N G A P O R E & C H I N A

Q1-2008

N S B P o s t e c h , I n c a n d F r e d H u t c h i n s o n Ca n c e r R e s e a r c h C e n t e r t o

Co ll abo ra t e on Deve lopm en t o f New Clas s of P r o t eomic Microa r ra ys

In Ma rch NSB P ostech (Sout h Korea) an nounced tha t it has ent ered int o a

collabora tion a greement with Fr ed Hu tchinson Ca ncer Research Center (FHCRC) to

coordin at e th eir effort s an d t o deter min e th e efficacy of the NS B's Nan oCones

sur face technology in creat ing high qua lity proteomic microar ra ys to be used in t he

study of hum an diseases.

NSB is a South Korean biotech company which possesses a proprietary microarraytechn ology and a grea t dea l of expert ise in na no-scale contr olled sur face chemistr y.NSB ha s agreed t o fund th e collaborat ion.

Ant ibody or protein m icroar ra ys ar e glass m icroscope slides ont o which very sm all

am ount s of thousan ds of differen t a nt ibodies or pr oteins h ave been a ffixed at

distinct locations. Ant ibody microar ra ys can be used to simu lta neously deter min e

th e level of each an tibody's specific binding par tn er in complex mixtu res su ch as

blood so th ousan ds of different assa ys can be perform ed with sm all am oun ts of sample.

R A VE N B I O T E C H N O L O G I E S A N D B I O P R O C E S S I N G T E C H N O L O G Y I N S T I T U T E

AN N O U N C E C OL L ABORAT ION T O ADVANCE D ISCOVE R Y OF S T E M C E L L

AN T I B O D I E S

In April Raven biotechnologies, inc.(Singapore), a privately held company focused on

th e discovery a nd development of monoclona l an tibody ther apeu tics (MAbs) for

cancer, a nd th e Bioprocessing Technology Inst itut e (BTI) (Sa n Fr an cisco, CA),

an noun ced a R&D collabora tive agreem ent for th e discovery of novel cancer stem

cell antibodies.

Un der t he t erm s of th is R&D agreem ent , Raven biotechn ologies, Inc will license its

proprieta ry whole cell imm un ization techn ology to BTI for use with BTI's stem cells.Raven will screen th e resu lting an tibodies aga inst it s collection of can cer lines, and

cancer stem cell lines. Raven will ret ain th e right s to th e ant ibodies BTI gener at es

using Raven's immunization technology for use in cancer therapeutics and

diagnostics; an d BTI will ha ve th e rights to the an tibodies it gener at es for a ll oth er

stem cell therapies.





Masimo PVI(TM) Cleared for Market in Japan

P VI cou ld h e lp c li n i c i ans a s ses s a pa t i en t 's fl u id r e sp ons ivenes s

non invas ive ly , acco rd ing t o a new s tu dy pu b l ished i n 'Anes th es i a &

Analges ia '

In April, J apa nese Ministr y of Hea lth, Labor an d Welfare (MHLW) appr oved

Masim o’s (Irvine, CA) PVI m easu rem ent . PVI is an in dex au toma tically derived

from the Masimo plethysmographic waveform, which has been demonstrated to

noninvasively assess fluid responsiveness in mechanically ventilated patients and

can h elp clinicians a ssess if a pat ient's cardia c function is compr omised.

PVI ma y help clinicians a nd em ergency professiona ls to determ ine if a pa tient is

dehydrated or over-hydrated-enabling more accurate fluid administration decisions-

all by simply referring to the nu mer ical Masimo PVI value th at is continu ouslydisplayed on Ma simo Rainbow SET P ulse CO-Oximeters .

PVI is a dyna mic new indicator of fluid r esponsiveness t ha t does not requir e an

invasive procedure or manual calculation, yet has been demonstrated to be sensitive

to cha nges in preload an d to be an a ccura te pr edictor of fluid r esponsiveness in

mechanically vent ilat ed pa tients

Naglazyme Approved by Japanese Ministry of HealthIn Ma rch, BioMar in Ph ar ma ceutical Inc. (Na sda q: BMRN) (Novato, CA) ann ounced

tha t AnGes MG, Inc. (Osaka, J apan ), BioMar in's ma rket ing and distribution part ner

gran ted appr oval for its Ma rk eting Applicat ion for Na glazyme(R) (galsulfase) fromthe J apa nese Ministry of Health, Labor an d Welfare (MHLW) for t he tr eatm ent of

pat ients with Mu copolysaccha ridosis VI ( MPS VI). Na glazyme was appr oved by the

U.S. Food an d Dru g Administ ra tion (FDA) in May 2005 an d by th e Eur opean

Commission (EC) in January 2006.

As th e first dr ug appr oved for MP S VI treat ment , the F DA and EC both gave

Naglazyme an orphan drug status, conferring seven years of market exclusivity in

the U nited Stat es and 10 years of ma rket exclusivity in the E ur opean U nion.

Naglazyme a lso obtained orphan drug st atu s in J un e 2007 from th e MHLW inJapan .

BioMarin est ablished a ma rketing a nd distribution a greement with AnGes inDecember 2006, th rough which AnGes obta ined exclusive right s to mar ket

Naglazyme in th e Ja panese ma rket. AnGes submitted a m ar keting application to

th e MHLW in August 2007.





Oncolys BioPharma and Tacere Therapeutics to DevelopHepatitis C cure using RNAi technology

In Ma rch, Oncolys BioPh ar ma , Inc. (Tokyo, Ja pan ) an d Tacere Thera peut ics, Inc.

(San J ose, CA,) an nounced tha t t hey ha ve entered into a str ategic alliance an d

license a greemen t t o develop a nd comm ercialize th roughout Asia, Tacere's RNAinter feren ce (RNAi)-based Hepa titis C virus (HCV) compoun d. This agreem ent

resulted from t he str at egic alliance entered into by Tacere a nd Oncolys in J un e

2007, wher eby Oncolys was gran ted a n option t o acquire t he Asian right s for TT-

033.

Under the terms of the agreement, Oncolys and Tacere will form a joint steering

comm ittee t ha t will work with th e Tacere a nd Pfizer steer ing comm ittee t o overseepreclinical r esear ch a nd developmen t effort s for TT-033/OBP-701.

In add ition t o an up-front paym ent , Tacere will be eligible to receive milestone

payments through successful achievement of development, approval, and

comm ercializat ion m ilestones resu lting in total poten tial pa yment s to Tacere of upto $60 million. Upon commercialization of TT-033/OBP-701, Tacere would be entitled

to receive royalties on net sales by On colys. Fur th er, if Oncolys su blicenses it s r ights

under the stra tegic allian ce to any ma jor ph arm aceutical compa ny, the m ilestone

paym ent s an d sales royalties Oncolys receives will be sha red with Ta cere a t

predeterm ined ra tes based u pon t he sta ge of development at which t he m ilestonesoccur.

Corgenix licensed cardio-inflammation bio-marker from Japan

Corgenix Med ical Corpora tion (BB: CONX) (Denver, Colora do) , a developer of diagnostic test kits, licensed a diagnostic technology for s eru m am yloid protein

(SAP), an important serum bio-marker for cardiovascular inflammation from withthe Okayam a Pr efectur e Industr ial Pr omotion Foundat ion, Ja pan.

This exclusive licensing a greemen t provides corgenix worldwide rights to diagnostictechnology measuring serum bio-marker for cardiovascular inflammation detection.

Pr ofessor E iji Matsu ur a a t th e University of Okaya ma Gra dua te School of Medicine,

Dentistry and Pharmaceutical Sciences invented the technology. Corgenix has had

stra tegic allian ces with the scientists a nd a cademic institu tions in Okayam a, J apan ,

since 2001. The Compan y's earlier product Ather Ox(TM) was a lso developed incollaboration with University of Okayama scientists. Present agreement stren gthens

the collaborative relationship with th e Okayam a Pr efectu re a imed at developing

innovat ive an d important diagnostic products in th e future.





China Medical Technologies Completed the Developmentof Prostate Cancer FISH Reagent

In April, China Medical Technologies, Inc. (Beijing, China) (NASDAQ:CMED) ,

an noun ced th e complet ion of developmen t of th e Pr osta te Can cer F ISH Det ection

Kit, a pr ostat e cancer-specific molecula r dia gnostic test based on t he F luorescent in

situ Hybridization ("FISH") technology.

The Kit is designed to detect TMPRS S2 an d ETS gene fusions in pr osta te

pat hological t issues. Dysregulat ion of ETS fam ily mem bers t hr ough fusions withTMPRSS2 are implicated as cancer-causing gene rea rra ngements in prostate cancer,

CMED, a leadin g China-based m edical device compan y, develops, ma nu factu res a nd

ma rk ets a dvanced in-vitro diagnostic products an d high int ensity focusedultrasound tum or therapy systems.

Gastric Cancer Drug Market to Triple by 2012 in ChinaDecision Resour ces, one of th e world's leadin g resea rch an d a dvisory firms focusing

on phar ma ceutical an d health car e issues, forecasts in April 2008, tha t t he Chinese

gast ric can cer dru g mar ket will near ly triple between 2007 and 2012. According to

the new Em erging Markets r eport entitled Gastric Cancer in China; this growth will

be fueled by increased a ccess to health insur an ce an d great er pat ient spending

power, leading t o increased u sage of ta rgeted t her apies. Additiona lly, the pr evalence

of gast ric can cer in China is am ong th e highest in th e world. In 2007, approxima tely

392,000 cases were diagn osed in China , and it is forecast ed tha t t he indication

population will grow 2.3 percent p er year between 2007 a nd 2012.

The report a lso finds t hat J iangsu Simcere's Endostar and Merck KGaA's Er bitux

ar e th e ta rgeted th erapies prescribed most often by Chinese physicians for t he

treatment of gastric cancer. These new targeted therapies will be prescribed to a

greater percent age of the eligible population in China tha n in th e past, benefiting

from in crea sed ph ysician familiarity a nd bet ter efficacy an d toxicity profiles th an

conventional chemotherapy agents. More importantly, surveyed physicians

an ticipate th at some t argeted t hera pies will be included in t he Na tional

Reimbur semen t Dr ug List (NRDL) by 2012, significan tly increa sing pat ientaccessibility to th ese dru gs.

Pandemic Influenza H5N1 Vaccineto be launched in China

Sinovac Biotech Ltd. (Beijing/China)(AMEX:SVA) , a lea ding biotech compa ny

developing human vaccines, announced in April 2008, that Panflu, its pandemic

influen za H 5N1 whole viron ina ctivat ed vaccine, received clear an ce to produce a nd

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ma rket in China by the China Sta te Food and Dru g Administra tion (SFDA). Pa nflu

is the first an d only appr oved vaccine available in China aga inst t he H5N 1 influenza

virus.

Per th e production license for P an flu gra nt ed by SFDA, th e vaccine is appr oved for

production s olely to be supp lied to the Ch inese na tional va ccine st ockpiling program

an d will not be sold directly to the m ar ket . The license a lso indicates th at th e

Chinese government has the exclusive right to initiate Panflu vaccinations in anemer gency or in the event of an influen za pa ndem ic.

Sinovac previously a nn ounced positive top-line r esults of a r an domized, double-

blind, P ha se II clinical tria l of its p an demic influenza (H5N1) vaccine a t t he en d of

2007. The Pha se II clinical trial results were subm itted in Febru ary 2008 to the

SFDA. Sinovac commenced th e development of a pa ndem ic influen za vaccine in

2004. In J un e 2006, the P ha se I clinical tr ial result s indicat ed good immu nogenicityan d safety.

AMDL Signs Exclusive Licensing Agreement with Mygenefor Human Papilloma Virus Diagnostic Kit

AMDL, Inc. (AMEX:ADL) , headqu ar ter ed in Tust in, California, with

opera tions in Sh enzhen , Jian gxi, and J ilin, China , is a vert ically integra ted

specialty pha rm aceutical compa ny. In April, AMDL ann ounced tha t it

ent ered int o an exclusive sublicensing (subject t o certa in ter ms a nd

conditions) agreemen t with MyGene Int ern at iona l, Inc. ("MGI," USA) for th e

MyGene H PV Chip Kit for in -vitro genotype test ing of Hu ma n Pa pilloma

Viru s (HP V).

The a greemen t between MGI a nd AMDL is an exclusive sublicense to use t he

paten ts, tra demar k, an d technology in man ufactu ring, promoting, mar keting,

distribut ing, an d selling the MyGene HP V Test Kit in China (includin g Hong

Kong), Taiwan , Singap ore, Malaysia, Thailan d, Cambodia, and Vietn am .

HP V is th e most comm on sexu ally tra nsm itted infection. Globally ther e ar e

appr oximat ely 330 million women presen tly infected with HP V, with 70% of

existing infections in Asian populations.

ProGenTech received $21 Million Series C FinancingApril 2, 2008 /PRNewswire/ -- Pr oGenTech, biotech compa ny ba sed in Sha ngha i,

China an d Em eryville, CA developing a cont am inat ion free, casset te based

automated nucleic acid purification system, announced in April 2008 that it has

closed a $21 m illion Series C finan cing led by Bay City Ca pital (San Fr an cisco) andDT Capital (Shanghai).

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BIOPRENEURwww.b i opr eneur . org

Compa ny also announced its ma na gement chan ges. Trevor H awkins, PhD joined the

compa ny as Cha irma n an d Chief Executive Officer. Dr. Hawk ins was previously the

CEO of Ph ilips Molecular H ealt hcar e business a nd h eld senior executive roles at GE

and MDS. He was also the Director of th e US DOE J oint Genome Institut e, and led

th e DOE's effort s to sequen ce th e Hu ma n genome. Pr oGenTech’s foun der St eve Yu

become COO and presiden t wh ile foun der J esus Ch ing will serve a s Chief Scientificofficer.

The key advant age of ProGenTech's aut oma ted system is tha t it eliminates th e

possibilities of user exposure a nd cross-conta mina tion by virtu e of its u nique

cassett e-based a pproach. The compa ny's initial products ha ve applicat ions in both

research and medical diagnostics.

Ha ve passion to write on busin ess, sciences an d economics topics th at might

relate to and benefited by the biotech/life sciences/investment professionals –

express it, an d n ot hold it long t o avoid high BP .

…….Biopreneur is therapeutics in many respects…….



ACKNOW LEDGEMENTS

Taft Stett inius & Hollister LLP – www.taftlaw.com Founded in 1885, Taft Stett inius & Hollister LLP continues to focus on the future,offering solutions and opportunit ies in an ever-changing world. Taft has more than 200att orneys who practice in a wide range of legal areas and service both U.S. andinternational clients, from start-up technology companies to publicly traded andinternational corporations.

Taft’s Life Sciences practit ioners assist companies, research institutions, incubators, andscientists protect, develop and commercialize their intellectual property in a wide rangeof technical areas, including: genetics, molecular biology, medical and surgical devices,pharmaceuticals, clinical trials, and bioremediation.

Nort hern California Polytechnic (NorCal Poly) University (NCPU) is

located at the heart of high-tech center in Silicon Valley in California.The mission of NorCal Polytechnic University is to provide studentswith a multidisciplinary and intercultural understanding of the worldthat enriches their lives while actively participating in the globalmarketplace of commerce, culture, and t echnology. NCPU offersgraduate degree programs, general education, services and activities to

enhance the academic and personal development of students.

Technoedits is a Silicon Valley based organization that provides technical writing,editing and copywrit ing services to the biotech/hightech organizations. Biopreneuruses tecnoedits for its selective needs and services. For more information [email protected].

Medzym – www.medzym.com Medzym, Inc. is a privately held biotechnology company focused on building moleculartherapeut ics based on effective platform technologies. Company’s current focus is on

Age-related eye disorders- (1) eye-diseases, (2) Anti-Inflammatory/Allergy, and (2)Cardio-vascular.










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