BIOBUSINESS

1. BIOBUSINESS Mr. Fusco

2. 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.

3. 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.

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

5. 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.”

6. 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.

7. Invention vs. Innovation

8. 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.

9. 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.

10. Important Milestones • Frederick Sanger– Determined protein sequence of insulin (developed numerous techniques to sequence proteins – later enabled creation of 1st biotech drug – Humulin) • Herbert Hauptman and Jerome Karle– X-ray crystallography (made it possible to determine molecule’s 3D structure)

11. 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

12. 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)