Biotechnology:

A Changing Science that is Changing Us

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Advances in biotechnology have brought
us better applications in agriculture,
health and medicine, forensics, industry
and the environment

> To improve our quality of life DNA in a bottle

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18,000 - 9000 BC
domestication of plants and
animals
4,000 BC
Classical Biotechnology
bread and wine making using yeasts
1,500 AD
Production of yogurt and
sauerkraut using of bacteria
1800
Prdxn of Vaccines
1940s
Prdxn of antibiotics
1970s
Development of recombinant
DNA technology and the
Birth of the Biotech Industry

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The biotechnology industry originated in the 1970s, based largely
on a new recombinant DNA technique published in 1973 by Stanley
Cohen of Stanford University and Herbert Boyer of the University of
California, San Francisco and the contributions of Paul Berg on the
discovery and use of restriction enzymes

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* Amounts are in U.S. dollars in billions
Market Capitalization, 1994-2005
US Biotech Industry

Ernst & Young LLP

U.S. Biotech Industry Statistics: 1994-2005
BioWorld

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1st Product of Modern Biotechnology INSULIN

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> Affordable, safe, and less immunologic affording children with type 1 diabetes a
relatively normal life; and adults with type II diabetes a better quality of life

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Biotechnology is changing our lives significantly

In medicine, genetic testing could be done on newborns

to screen for potential diseases that could be prevented
through early intervention
Infants and young children could be
vaccinated with safer vaccines or
combination vaccines, thus reducing infant
mortality and morbidity rates.

Biotechnology has created more than 200 new

therapies and vaccines, including products to treat
cancer, diabetes, HIV/AIDS and autoimmune
disorders

Major Areas of Biotech

Contributions in Health

Vaccines
Diagnostics
Gene Therapy

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Medicines

Intron A®
(Alpha-interferon)
hairy cell leukemia/
genital warts/ non-
A, non-B hepatitis/
hepatitis B/chronic
malignant
melanoma/

Medicines

BioTropinT
M

Human
Growth
Hormone

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 Medicines

Humalog®
(recombinant
insulin)

Medicines

Alferon N®
(interferon alfa-N3,
human leukocyte
derived)
Treatment of genital
warts

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 Medicines

Avonex®
(recombinant
interferon beta 1-
alpha)
Treatment for
multiple sclerosis

Medicines

Herceptin®
(trastuzumab)
Treatment for
some types of
breast cancer

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 Medicines

Albutein®
Human
Albumin

Biotech in Human and Animal Health

New Biotech Drugs/Vaccine Approvals, US FDA

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 Many new biotech drugs against cancer and autoimmune disorders are
based on the development of genetically engineered humanized antibodies
expressed and harvested in yeast, insect or mammalian cells.

Breast cancer: Herceptin from Genentech 1998

trastuzumab) is a monoclonal antibody that

has been genetically engineered to bind to
a specific protein called HER2 (or the
HER2/neu protein), a protein receptor over-
expressed on the surface of some breast
cancer cells

Rituxan (Rituximab) for Non-Hodgekin’s Lymphoma

Zevalin (Ibritumomab)
Avastin (bevacizumab)for metastatic colorectal cancer
Erbitux (Cetuximab)

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Rheumatoid Arthritis: ENBREL
•recombinant protein made by the
Biotechnology company Amgen ; ENBREL is Improves quality of life of children and
very similar to a human protein called Tumor adults born with this autoimmune
Necrosis Factor (TNF) Receptor disorder
• Seventy-four percent of study participants
with + response

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Prevents Organ Transplant rejection: (monoclonal antibodies

Orthoclone OKT3 (Muromonab) from Ortho Biotech, 1986
Simulect (Basiliximab) from Novartis, 1997
Zenapax (Daclizumab) from Roche, 1997

Rheumatoid Arthritis: ENBREL

•recombinant protein made by the
Biotechnology company Amgen ; ENBREL is
very similar to a human protein called Tumor
Necrosis Factor (TNF) Receptor
• Seventy-four percent of study participants
with + response
Humanized antibodies

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Synagis (Palivizumab) [June 1998] Medimmune

ReoPro (Abciximab) [Dec 1999] Centocor / Eli Lilly

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Engerix-B®
(recombinant
Hepatitis B vaccine)

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 %

TriHIBitTM
childhood immunization between 15-
18 months for acellular pertussis,
diphtheria, tetanus and HIB disease

Tripedia®
vaccination of infants 2, 4 and 6 months of
age and first booster at 15-18 months
primarily for whooping cough

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 DRUG APPLICATION
ABX-EGF lung cancer, breast cancer, bladder,
(panitumumab) pancreatic, colorectal cancer, kidney and head
Abgenix and neck cancer.
ABX-MA1 metastatic melanoma cells
Abgenix
ACP-103 Parkinson's Disease, adjunctive therapy for
Acadia schizophrenia (Hallucinations, Psychoses)
Onconase (ranpirnase) Ribonuclease anti-cancer drug,
AlfaCell
Entereg (alvimopan) pain management of POI and OBD
Adolor
Teverelix,, D63153 prostate cancer
Æterna Zentaris Inc
Lobaplatin Small cell lung cancer, breast, chronic
Æterna Zentaris Inc myelogenous leukemia (CML)

Oncophage Metastatic melanoma, Kidney cancer (renal

Antigenics Inc. cell carcinoma)
AG-702 Genital herpes
Antigenics Inc.
V -Protectants® (AGI- chronic inflammatory diseases, such as
1067) atherosclerosis, rheumatoid arthritis and
Atherogenics asthma
Vivitrex Alchol Dependence
Alkermes

Cancer : many biotech drugs in Phase II and III clinical trials against
cancer are antibody drug candidates

Drug discovery process Nature Reviews Drug Discovery 5

Despite their relatively small budgets

compared to big pharma, biotech companies
have large porfolios of drugs in the pipeline,
evidence that biotechnology is driving
innovations in the development of new and
novel therapies against human diseases

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 Gene Therapy

Gene Therapy
In gene therapy, a faulty
or missing gene can be
replaced to correct a
genetic cause of a disease.

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 To replace damaged tissues or organs

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 Latest News on stem cell research
Induction of pluripotent stem cells from adult human
skin cells using direct reprogramming

Shinya Yamanaka, The

Japanese scientist who
created pluripotent
stem cells without
destroying embryos
www.bioedge.org/

This could lead to the generation of patient-specific stem cells eliminating the problem
of tissue rejection and the ethical issues associated with the use of embryos to derive
ES cells.

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Bone Connective Skin

Tissue

Cartilage, blood & blood vessels, muscles, nerves, cornea, liver

& pancreatic tissues, heart valves

Biotechnology in DNA investigation

match organ donors with recipients in

transplant programs: beneficiary -patient
determine pedigree for seed or livestock
breeds: beneficiary - farmer
authenticate consumables such as caviar,
meat and wine: beneficiary -consumer

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Diverse Applications
DNA identification

• Identify kinships, catastrophe victims

• Exonerate or implicate people accused of crimes
• Identify contaminants in air, water, soil, food
• Confirm pedigrees of animals, plants, foods, wines

Diverse Applications

Bioanthropology
• Understand human lineage
• Explore migration patterns through time

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 study migration of different
population groups based on female
genetic inheritance

study mutations on the

evolutionarily stable Y chrom.
to trace lineage and migration

What we’ve learned so far from

the Human Genome Project

The human genome is nearly the

same (99.9%) in all people

Only about 2% of the human genome

contains genes, which are the
instructions for making proteins

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 Other Lessons from the
Human Genome Project

Humans have an estimated 30,000

genes; the functions of more than half
of them are unknown

Almost half of all human proteins share

similarities with other organisms,
underscoring the unity of live

Diverse Applications
Microbes for energy and the
environment
Microbes thrive in every
environment on earth,
but the vast majority DO
NOT cause disease.
Understanding them at a
basic level will enable
use of their diverse and
sophisticated abilities.

• Clean up toxic wastes

• Capture excess carbon to help
reduce global climate change
• Generate clean energy sources
(e.g., hydrogen)

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Diverse Applications

agriculture, livestock
breeding, bioprocessing

• Make crops and animals more resistant to

diseases, pests, and environmental
conditions
• Grow more nutritious and abundant produce
• Incorporate vaccines into food products
• Develop more efficient industrial processes

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Consumers enjoy biotechnology foods

such as
•Papaya – delayed ripening
•Soybean – disease resistant
•Corn – disease resistant
•Meat – more tender, less fat, more milk
With biotechnology, food can be produced with less
pesticides, nutritionally-enhanced, requiring less water,
produced in less favorable climates (too hot, too cold,
too salty, too dry) with the potential to eradicate famine.

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Independent tests of Bt corn, which is enhanced with a naturally
occurring soil microbe that protects plants from insect pests such as
the Asiatic corn borer, showed that the biotech corn:

•Improved yields 41 percent during the Philippines wet season and

27 percent during its dry season;

•Improved farmer profitability 25 percent, on average, over non-Bt

varieties.

•Boosted farmer incomes enough so they could provide a minimum

of 2,000 kilocalories per capita per day for their families. Income
derived only from non-Bt corn was not adequate to meet this
minimum requirement, according to the tests conducted by the
STRIVE Foundation in the Philippines.

Source: Council for Biotech Information

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 Ethical, Legal, and Social Implications
of Genome Information and of Biotechnology

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• Advances in drug and drug delivery systems – for

new treatments of human diseases
• cancer, infectious, auto-immune, mental illness,
etc.
• New approaches in tissue engineering and gene
therapy
• Alternative energy sources (using new enzymes
produced in bacteria)
• New advances in diagnostics – gene analysis,
patient-specific therapies
• Genetic testing will become commonplace

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To learn more about the technology that will be

shaping our lives and its underlying science and
applications,

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 Ethical Issues in Genome genetic testing

Genetic information :

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