Overview of Biotechnology

CENG 109 Class 2

Outline for this class

Technology timeline for Biotechnology Multidisciplinary nature of Biotech Global landscape of biotechnology Facts and momentum of biotechnology industry Business timeline of medical biotechnology Risks and rewards for medical biotechnology development

History of Biotechnology: A Technology Timeline

~4000-6000 B.C.: Microorganisms were used to make bread, cheese, and beer 1863: Mendel discovered the rules of trait inheritance through studying pea plants 1953: Watson and Crick reveal the doublehelix model of DNA 1961: Monod and Jacob discovered mRNA. 1965: Edman developed chemistry enabling automatic protein sequencing 1966: Genetic codes determined (Kohrana and Nirenberg)

History of Biotechnology: A Technology Timeline

1973: Cohen and Boyer created the first recombinant DNA using bacterial genes 1974: Milstein and Kohler created a immortal cell line that would produce large amounts of antibodies (hybridoma technology)

History of Biotechnology: A Technology Timeline

1974: The National Institute of Health forms a Recombinant DNA Advisory Committee to oversee research safety and ethics. 1977: Genetically engineered bacteria was used to make human protein

History of Biotechnology: A Technology Timeline

1981: The first gene-synthesizing machines were developed. The first genetically engineered plant was reported. Mice were successfully cloned 1983: PCR (polymerase chain reaction) was perceived 1983: The discovery of the first tumor suppressor gene 1985: Human Genome Project began 1987: Recombinant microbes were field tested for its ability to protect strawberry from frosting

History of Biotechnology: A Technology Timeline

1989: Microorganisms are used to clean up oil spill; The gene responsible for cystic fibrosis is discovered.

http://www.battelle.org/environment/exxon-valdez.stm

History of Biotechnology: A Technology Timeline

1991: The first federally approved gene therapy treatment is performed successfully on a 4-year old girl suffering from an immune disorder. 1994: The first breast cancer gene was discovered. Genetically engineered tomatoes (Flavr Saver ) available in market 1997: Dolly was cloned; The field of bioinformatics, which combines DNA chips, PCR and computer programs was developed to accelerate the study of genes 1998: Human skin is produced in vitro; Embryonic stem cells are used to regenerate tissue and create disorders mimicking diseases. The first complete animal genome for the elegans worm is sequenced.
graphics from www.agbio.com

History of Biotechnology: A Technology Timeline

2000: "Golden Rice," modified to make vitamin A, promises to help third-world countries alleviate blindness. 2001: The working draft sequence of the human genome is published 2001: siRNA named molecule of the year in Science Magazine
References: http://www.biotechinstitute.org/what_is/timeline.html Appendix A, From Alchemy to IPO by Robbins-Roth

Biotechnology is a science of many disciplines

Biotechnology is the Integrated use of biochemistry, microbiology and engineering sciences in order to achieve technological (industrial) application of the capabilities of microorganisms, cultured tissue cells and parts thereof (www.efb.org)
Figure from Introduction to Biotechnology by Thielman et.al.

Products of Medical Biotechnology

Drug Betaseron Ceredase Developer Chiron/Berlex Genzyme Treatment of human disease conditions Multiple sclerosis Gauchers disease

Engerix B Epiver Epogen Genotropin Humulin Intron Neupogen Procrit

Genentech Glaxo SmithKlein Amgen Genentech Genentech Biogen Amgen Amgen

Hepatitis B vaccine Anti-HIV Red blood cell enhancement Growth failure Diabetes Cancer and viral infection Neutropenia reduction Platelet enhancement

Top 10 selling biotechnology drugs from Ernst & Young LLP, Biotechnology Industry Report (2000)

Landscape of Global Biotechnology

Landscape of Global Biotechnology

Landscape of Global Biotechnology

Facts about biotechnology industry

Biotechnology is a US$30 billion a year industry that has produced some 160 drugs and vaccines. There are more than 370 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, including various cancers, Alzheimers disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis. Market capitalization, the total value of publicly traded biotech companies (U.S.) at market prices, was US$311 billion as of mid-March 2004. Biotechnology is one of the most research-intensive industries in the world. The U.S. biotech industry spent $17.9 billion on research and development in 2003.
From www.biotechinstitute.org

Biotechnology industry is a key driver for drug development

Levinson, Global Industry Perspective, Beyond Borders: Biotechnology Report 2005

R&D productivity of big pharmaceutical companies has stayed flat

160 140 120 100 80 60 40 20 0 1995 1996 1997 1998 1999 2000 2001 NDA submissions FDA approvals

Biotechnology industry is a key driver for drug development

Sources: PhRMA and Center for Drug Evaluation and Research

Biotechnology industry is a key driver for drug development

www.bio.org

History of Medical Biotechnology: A Business Timeline

First expression of a human gene in bacteria Method developed for Reading DNA sequences Centocor founded First monoclonal antibody diagnostic kit approved for marketing Chiron, Genetics Institute, Genzyme Founded Gene Synthesizing machines developed Amgen founded Genetech initial stock offering U.S. Supreme Court rules that life forms are patentable First product sales of recombinant insulin Orphan Drug Act passes

Cohen and Boyer construct recombinant DNA in bacteria

Genentech founded DNA sequencing discovered First monoclonal antibodies produced

Cetus founded

Biogen Hybritech founded Recombinant human insulin produced

FDA approves first recombinant DNA product, human insulin for marketing

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(presentation material from Prof. Langer, MIT)

History of Medical Biotechnology: A Business Timeline

Human growth hormone approved by FDA Cetus reports polymerase chain reaction technology Tissue plasminogen activator approved by FDA Erythropoietin approved by FDA Human Genome project started First U.S. patent on transgenic animal granted First human gene therapy attempt Roche acquires 60% of Genentech Healthcare reform creates uncertainty -interferon approved by FDA

Number of public companies falls for the first time Alliances among drug and biotech firms increase Legislation introduced to reform FDA Market for biotechnology stocks reaches all time high2 284 products in clinical testing or awaiting approval

Chiron clones and sequences entire HIV genome

FDA approves -interferon, first recominant vaccine Eli Lilly acquires Hyberitech

Amgen becomes a Fortune 500 company Factor VIII approved by FDA

Trade treaty extends patent life to 20 years Product development failures keep investors away

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(presentation material from Prof. Langer, MIT)

Risks and Rewards in Medical Biotechnology

More than 60 million people have been helped by the biotech drugs and vaccines A drug that would delay by 5 years the average age at which Alzheimers disease strikes would save US$50 bn annually; the same delay in the onset of Parkinsons disease would save US$3 bn, and delaying the onset of cardiovascular disease and strokes by 5 years would save US$67 bn. - President of BIO Cost of biotech drug development
= US$125- US$ 359 million

Typical product development path in medical biotechnology

www.bio.org

The patent system allows biotech companies to recover the development cost
What is a patent?
A patent is a set of exclusive rights granted by a state to a person (the patentee, usually the inventor) for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which is new, inventive, and useful or industrially applicable. (from Wikipidea)

During the patent period, the costs of development and research may be recovered in the market.

Landmark Patents Supporting the Commercial Development of Biotechnology

1980: The first patent on engineered living organism granted to Chakrabarty

Picture from Biotechnology: demystifying the concepts

1988: Harvard Mouse