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6 Δεκ 2012 (πριν από 5 χρόνια και 1 μήνα)

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BIOBUSINESS

Mr. Fusco

What is BioBusiness?


BioBusiness focuses on many
aspects of business within the
biotechnology industry.


Areas of concentration include the
biotechnology business concept,
biotechnology regulations, funding,
marketing, business development, and
business etiquette.


Case studies will be used to illustrate
successful and failed biotechnology
businesses and products.

Why BioBusiness?


Biotechnology continues to
revolutionize approaches to scientific
fields, most notably within healthcare,
industry and agriculture.


Since those areas create many
consumer products, there is an
increasing need for versatile individuals
that are capable of not only developing a
new product, but also bringing it to
market.


These individuals require education
within both the biotechnology and
business sectors.

Four Pillars of
Biotechnology

Although many
opportunities exist, there
are many distractions
along the way, including
scientific, regulatory,
political, economical,
social, & commercial
influences.

Defining Biotechnology


The biotech industry is not
clearly defined by products
and services, rather by
enabling technologies.


In terms of BioBusiness,
biotechnology shall be
defined as “the application
of molecular biology for
useful purposes.”


Applications


With the diversity of applications of
biotech, there are 2 modes of
development:
products

&
services
.


Products include: drugs, reagents,
research tools, industrial enzymes,
& specialized crops.


Services include: selection of lead
drug compounds, clinical trial
management, manufacturing &
genetic testing.

In the beginning…


The modern biotech industry
developed from the
pharmaceutical industry.


As medical knowledge advanced,
a focus on symptom
-
based
treatment replaced older
techniques, such as bloodletting
and led to research on the effects
of medicines and the use of
substances as drugs.



Also improved understanding of microorganisms led to a better
knowledge regarding treatment of infectious diseases caused by
microbes.


Growth


The growth of these
industries paralleled the
growth of knowledge in the
field biology.


The first biotech companies
were formed in the late 1970s
and 1980s.



This industry was guided by the emergence of
knowledge within the molecular biology field, as
well as tools to manipulate organisms at the
molecular level.

Important Milestones


Frederick Sanger



Determined
protein sequence of insulin
(developed numerous techniques to
sequence proteins


later enabled
creation of 1
st

biotech drug


Humulin)



Herbert Hauptman and Jerome
Karle



X
-
ray crystallography (made
it possible to determine molecule

s
3D structure)


Important Milestones


James Watson, Francis Crick, &
Maurice Wilkins



structure of
DNA (gene expression & heredity
could be understood)


Robert Holley, Har Gobind
Khorana, & Marshall Nirenbergy



deciphering genetic code
(translation)


Werner Arber, Dan Nathans, &
Hamilton Smith



discovery of
restriction enzymes & their
application to molecular genetics

Important Milestones


Stanley Cohen & Herbert Boyer



DNA splicing


Paul Berg, Walter Gilbert, &
Frederick Sanger



Berg for
biochemistry of nucleic acids, others
for base sequences of nucleic acids


Kary Mullis & Michael Smith



PCR & site
-
directed mutagenesis
(permit the modification of genetic
sequences which effectively
reprogram genes)

Genentech


Herbert Boyer

&
venture

capitalist

Robert Swanson

formed Genentech in 1976.


Genentech, one of the first
biotechnology companies, aimed
at commercializing the
gene
splicing technology

by producing
recombinant human insulin (to
treat diabetes) in bacteria.


Prior to 1976, drugs were either chemically synthesized or
extracted from living sources.


In the case of insulin, 50 animals had to be sacrificed to obtain
enough for 1 person for 1 year.

Genentech


Genentech capitalized on a positive
market sentiment towards
biotechnology and raised $35 million
in an
initial public stock offering
(IPO)

before FDA approval of
Humulin.


They did not have resources to fully
develop and commercialize Humulin
as a drug though.


So, they licensed manufacturing and
distribution rights to Eli Lilly


dominant supplier of beef & pig
insulin.

Genentech


Genentech later became first biotech company to
market its own biopharmaceutical


human growth
hormone (1985).


Since then, it has produced several products, was
bought by Roche Pharmaceuticals, and resold on public
markets.


Genentech serves as a prime example for biotech
product development and corporate growth.


They licensed to a larger partner in order to develop
sufficient funds to research, develop, and
commercialize its own products.