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What is Biotechnology. Biotechnology is a broad term that applies to all practical uses of living organisms -- anything from microorganisms used in the fermentation of beer to the most sophisticated application of gene therapy. BACKGROUND & OVERVIEW. Risky Market
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What is Biotechnology Biotechnology is a broad term that applies to all practical uses of living organisms -- anything from microorganisms used in the fermentation of beer to the most sophisticated application of gene therapy.
BACKGROUND & OVERVIEW • Risky Market • Uncertainty Switch from Biotech to Pharma. • Affect of Economic Fluctuations
The Mapping of Human Genome Fast Drug Approval Convergence of Nanotechnology with Biotechnology Advanced Computer Technology Databases Partnerships and Collaborations New financing in Biotechnology Increase in Biotech IPO’s BACKGROUND & OVERVIEW
CLINICAL TRIALS & FDA • What is FDA (Food and Drug Administration)
Pre-Clinical Trials • Studies in cell cultures and animals • 1 in 1000 make it to human testing • Patents last 20 years from this point • Last average about 5 years
Phase 1 • First use of drug in humans • Test for safety and side effect • Limited number of patients • Ranges from 1 to 3 years • Chances just under 30%
Phase 2 • Test for ideal dosing range of the drug • Larger number of patients • Last average of 2 years • 60% of chance to be approved
Phase 3 • Treatments compared to common or standard therapies • Random choosing • Goal ; experimental therapy more beneficial than standard therapy • Double blind therapies • At least 1000 patients • Averages between 3 and 4 years • 70% chance of being approved at this point
Phase 4 • To continue evaluation of the drug’s safety • This stage starts after the drug is on the market
For the investor • Costs and time consuming • Ranges between $350 million and $500 million • Companies with many product on the market • Large pipeline • Cash for funding new drugs
INVESTING IN BIOTECH STOCKS (DO’S ) • A Small Part of a Well-Diversified Portfolio • Products That are in Late Stage Clinical Trials • Significant Partnership Arrangements • Stocks with Broad Pipelines • Avoid Stocks That are Hyped in the Press
INVESTING IN BIOTECH STOCKS (DO’S Continued) • Be Passionate • Learn All About Your Company's Biotechnology • Know Your Risk Tolerance • Invest Money That You Don’t Need
INVESTING IN BIOTECH STOCKS (DONT’S) • Don’t Forget About the Business • Don’t Buy a One-Hit Wonder • Don’t Buy on Margin
HOW TO EDUCATE YOURSELF • Ernst and Young’s Biotech 99 Report • Access Excellence by National Health Museum • Tutorials at Street.com • Scientific American Articles • BioMedNet.com’s Daily Newsletter
HOW TO FIND NEXT HOT BIOTECH STOCK • Red Herring Magazine • FDA Approval Process • Center Watch web page (tracks clinical trials) • BioSpace.com • FDA Web Site (upcoming meetings) • Pay Attention to Alliances • Want Free Trading Advice