Functional overview of the biotechnology industry

Chia sẻ: Tôn Nữ Thùy An | Ngày: | Loại File: PDF | Số trang:36

Thêm vào BST

Báo xấu

45
lượt xem 5
download

Download Vui lòng tải xuống để xem tài liệu đầy đủ

Appreciate the diversity of biotechnology applications and the fundamentals of biotechnology, distinguish biotechnology from traditional appreciate the diversity of biotechnology applications and the fundamentals of biotechnology, distinguish biotechnology from distinguish biotechnology from traditional traditional pharmaceuticals, understand the value proposition of biotechnology companies,... As the main contents of the document "Functional overview of the biotechnology industry". Invite you to consult

Chủ đề:

Bình luận(0) Đăng nhập để gửi bình luận!

Lưu

Nội dung Text: Functional overview of the biotechnology industry

Functional Overview of the Biotechnology Industry • To accompany For more information: Yali Friedman, Ph.D. Building Biotechnology info@thinkbiotech.com www.BuildingBiotechnology.com ISBN 9780973467666 • Relevant pages are cited within presentation • Type CTRL CTRL-LL to toggle Presentation starts fullscreen view on next page
Functional Overview of the Biotechnology Industry Presentation to accompany BUILDING BIOTECHNOLOGY www.BuildingBiotechnology.com
Objectives • Appreciate the diversity of biotechnology applications and the fundamentals of biotechnology • Distinguish biotechnology from ‘traditional’ traditional pharmaceuticals • Understand the value proposition of biotechnology companies • Appreciate i why h ddrugs are the h most common application li i of biotechnology • Appreciate the interplay of legal, regulatory, and commercial factors
The Pillars of Biotechnology Scientific Intellectual Abilities p y Property Commercial Bi t h l Biotechnology Commercial Regulations Factors
What do Biotechnology Companies do? BUILDING BIOTECHNOLOGY Chp 6 Use molecular biology to develop useful products and services RED Drugs, diagnostic tests • Large profit margins • FDA mandates that all drugs must be proven safe and effective prior to marketing • History of successful regulation GREEN Enhanced crops, molecular farming (non-drug) • No regulatory legacy • Development costs similar to drugs, profits are not WHITE Industrial processes • Energy production, production waste degradation degradation, environmental remediation • Unresolved safety concerns, and issues in scalability
Ecology Æ Physiology Æ Molecular Biology Source: EPA
Ecology Æ Physiology Æ Molecular Biology NIST
Ecology Æ Physiology Æ Molecular Biology
Ecology Æ Physiology Æ Molecular Biology
What is Molecular Biology? BUILDING BIOTECHNOLOGY Chp 3 Molecular biology is the study of biological processes at their most fundamental level Groups of bodies Ecology • Species and groups of animals, plants, and microbes Parts of bodies Physiology, botany, microbiology (virology) • Tissues • The structures that compose animals, plants, and microbes • Organs • How these structures interact with each other and the environment • Individual cells • Eg. Pharmacology, neurology, immunology Molecular biology • The chemical and physical interactions within individual cells Parts of cells • The p processes that underlie p physiology, y gy, botany, y, etc. • Large L and d Eg. What distinguishes heart from hair cells? small molecules How is food processed into energy and physiological structures? How do signals from the environment cause biological responses? Parts of molecules Chemistry & Physics • The processes that form the basis for molecular biology Parts of atoms
Why is Biotechnology Usually Associated with Drugs? Emphasis is on drugs, because: Drugs are less expensive than hospital treatments • Save healthcare payers time and money Drugs are the only effective treatment for some conditions • Fill unmet market needs Post R&D, drug production costs can be very low • High markup • Years of patent-protected sales Interrupting biological processes is easier than modifying or creating them Cost to develop non-drugs may be similar to drugs, but profits are smaller
Pharmaceutical vs. Biotech Drugs BUILDING BIOTECHNOLOGY pp. 36-37 Synthetic (Pharmaceutical) Drugs • Chemically synthesized • Typically small and water soluble • Can withstand stomach acids and enter bloodstream Aspirin sp – 21 ato atoms s Biologic (Biotechnology) Drugs • Biologically synthesized • Typically large proteins, not necessarily water soluble • Cannot C withstand i h d stomach h acids id • Cannot cross into bloodstream Epogen – 1297 atoms
Drug Delivery BUILDING BIOTECHNOLOGY pp. 64-65 Alza Implant Liposome Patch Dosed
Delivering Biologics BUILDING BIOTECHNOLOGY pp. 64-65 Challenge • Must invest in developing effective delivery methods • Patient compliance Opportunity • Possible to increase efficacy, safety • Patches and favorable dosage regimens can improve compliance Selling twice as much drug by doubling adoption and compliance is similar to selling two drugs, without the cost of developing two drugs
Taxol: A Traditional Pharmaceutical Anti-cancer drug • In 1980 it was discovered that taxol interferes with structural proteins to prevent cell division Production issues • Only natural source was slow-growing, endangered Pacific Yew • Six 100-year old trees required to treat just one patient Synthetic synthesis • Three methods have been developed developed, none are economically efficient Semi-synthetic synthesis • Taxol precursors are extracted from yew needles and converted to taxol
Biotechnology has Revolutionized Drug g Development p BUILDING BIOTECHNOLOGY pp. 10-11, 36 Injected insulin directly supplements an insufficiency in diabetics Prior to 1982, insulin was primarily extracted from pig pancreas • 50 pigs sacrificed to produce sufficient insulin for one person for one year • Risk of disease transmission,, shortages, g , immune system y rejection j Use gene splicing to insert human insulin gene into bacteria • Plentiful supply • No risk of animal disease transmission • Reduced risk of immune system rejection Traditional pharmaceutical methods involve chemical synthesis and biological extracts and pharmaceuticals are often indirect effectors Biotechnology uses biological synthesis and biologics are often direct effectors
The Pillars of Biotechnology Scientific Intellectual Abilities p y Property Commercial Bi t h l Biotechnology Commercial Regulations Factors
The Path From Science to Drugs BUILDING BIOTECHNOLOGY Chp 4 Discovery Development Commercialization Develop formulation Find and refine leads Scale manufacture Pilot-scale manufacturing Predict toxicity Market drug Determine safety and Project commercial appeal Distribute and sell efficacy Identify Find and Pre-clinical Market and sell Clinical trials target refine drug testing drug
Genentech is a Prototype for Biotechnology gy Business Development p BUILDING BIOTECHNOLOGY pp. 13, 184 • Initially focused on applications of one innovative technology • The only biotech company that has never traded below it IPO price its i • Profitable for all but two of its years as a public corporation • Successfully y diversified beyond y its original g commercial focus
Genentech’s Value Proposition Efficiently manufacture large quantities of biological drugs to satisfy unmet needs 1973: Stanley y Cohen and Herbert Boyer y demonstrate gene g splicing p g • Enables production of human proteins in bacteria, yeast, cell cultures 1976 Boyer 1976: B and d Robert R b t Swanson S form f Genentech G t h Proof-of-principle: somatostatin 1982: Recombinant human insulin licensed to Eli Lilly 1985: Genentech becomes first biotech company to market its own drug - hGH