What is Biotechnology Biotechnology is a broad term that applies to all practical uses of living organisms -- anything from microorganisms used in the.

Slides:



Advertisements
Similar presentations
Overview of the Keys to Successful Commercialization Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. Tucson, Arizona October 18, 2001.
Advertisements

Fundamentals New Anthrax Countermeasure* Vi Pham**, Zachary Taylor** and Miguel Bagajewicz University of Oklahoma - Chemical Engineering (*) This work.
Randomized Controlled Trial
Regulatory Clinical Trials Clinical Trials. Clinical Trials Definition: research studies to find ways to improve health Definition: research studies to.
Regulatory Framework Leigh Shaw, Director.
Bellwork Information (software, media, telecommunications, hardware) Services (healthcare, consumer, business, and financial services) Manufacturing (consumer.
Biomarkers Data Center Product Overview Partnership between DMS Data Systems and Cambridge Healthtech Institute.
Pharma/BIOTECH industry overview
Targeted Cancer Therapeutics, LLC Investor Presentation.
Genomics Research and Intellectual Property Genome Canada GPS Series April 28, 2011 Presented by: Jamie Mills
Operations management Session 17: Introduction to Revenue Management and Decision Trees.
Clinical Trials Importance in future therapies. What are the Requirements to Produce New Drugs? Drug must work significantly better than a control treatment.
Clinical Trials — A Closer Look. The Food and Drug Administration (FDA) is the main consumer watchdog for numerous products: Drugs and biologics (prescription.
Project IMPACT IMPACT National Medical Association What African Americans Should Know About Clinical Trials You’ve Got the Power!
Clinical Trials Medical Interventions
HIV Clinical Trials Janice Price, M.Ed, RN HIV Clinical Research Program Coordinator Swedish Medical Center Seattle, WA USA.
ClinicalTrials.gov Stephen Kiyoi
Welcome! February 28,  What is biotech?  FDA process  Investor concern  Stock profile.
Stock Market Basics. What are Stocks? Stock is ownership in a publicly traded company. Stock is a claim on the company’s assets and earnings. The more.
Yale Pharmaceutical & Biotechnology Society EQUITYRESEARCHCLUB.
Stock Market Basics ©2011 Cengage Learning. All Rights Reserved. May not be scanned, copied or duplicated, or posted to a publicly accessible website,
ICARE Member Reports ETP seeks to improve incentives and encourage commercial investment in new therapies. (Treatments reach patients only by commercial.
Academic Clinical Trial Do’s & Don’ts for Partnering with Pharma CCAF San Diego, CA April 14, 2014 J. Eric Bubbers, Ph.D.
Pharmaceutical Industry Analysis Nature of the industry: Highly defensive and 15% of U.S. population aged over 60→Highly mature. Main forces are the suppliers,
Stages of drug development
401(K) PLANS. Essential Questions Why Do We Need to Save for Retirement? What are the best options for Retirement Savings? How should I go about choosing.
July 2015 PRABHAVATHI FERNANDES, PhD Founder, President and CEO How the PATH Act Can Rejuvenate Antibiotic R & D.
Presented by Jeanne Nguyen.  Setting Priorities  Making a Budget ◦ How to Start a Budget ◦ How to monitor  Qualified Funds (401(k), Roth, IRA, and.
Excerpts Taken from slideshow of Jason Lee An Introduction to Stocks.
Testing People Scientifically.  Clinical trials are research studies in which people help doctors and researchers find ways to improve health care. Each.
1 Value Assessment of Development-Stage Assets Pharmaceutical Products, Medical Devices, and Related Intellectual Property Frank S. Castellana, M.D., Eng.Sc.D.
Dr Caroline Barelle MBA Giving birth to a biotech where’s the pain relief ?!
Judith E. Brown Prof. Albia Dugger Miami-Dade College Ways of Knowing about Nutrition Unit 3.
CHAPTER 13Slide 1 of 5 Chapter 13. MAKING YOUR MONEY GROW - AN OVERVIEW The ABCs of Putting Your Money to Work… Evaluating Risks, Tax Consequences… Investigate.
The Stock Market Game Instructions 1.You will be given $100,000 to invest. 1.You will have to make at least one trade per day, buying.
Diversification Selecting Investments. List your top 10 foods!
11-1 Copyright © 2010 Pearson Education, Inc. publishing as Prentice Hall Part IV: Start-up Financial Strategy Chapter 11: Funding the Technology Start-up.
Overview Industry Overview Impacted Industries Science Business Issues Examples Where do you fit? Getting Involved Websites Other Resources.
Commercialization of Cellular Therapies. Pharma & Biotech Growth Rates Have Been Declining Over The Last Decade Source: IMS Health 2008.
What are Drug Royalties?  Rights on the sales of different prescriptions drugs.
Developing medicines for the future and why it is challenging Angela Milne.
INVESTING BASICS. A. THE STOCK MARKET STOCKS- UNIT OF OWNERSHIP IN A CORPORATION. STOCKS EXPLAINED.
Unit 2: The Stock Market Lesson 11: Mutual Funds & ETFs.
WHAT SHOULD I THINK WHEN ASKED TO BE IN A CLINICAL TRIAL? Robert L Page II, PharmD, MSPH Professor University of Colorado Schools of Pharmacy and Medicine.
FDA Office of Orphan Products Development
Experiences (and frustrations) in Developing a Biotech Company in Idaho.
“Journey of a Drug” From Test Tube TO Prescribing Physician.
DIVERSIFIED STOCK MARKET GAME. DIVERSIFIED Difficult to determine how an investment will perform Strategy is key  “Don’t put all your eggs in one basket”
McGraw-Hill/Irwin Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved. CHAPTER PLAYLIST SONG: “BIG MONEY“BIG MONEY” BY GARTH BROOKS.
Investing Fundamentals. Investing for the Future: Goal Setting Investment goals should be specific and measurable. Develop your goals by asking questions:
SUCCESSFUL INVESTOR By Greg Fisher California Academy of Math & Science.
Managing Your Investments Chapter 11 Page 259 Personal investing – using your savings to earn a financial return
E-Clinical
Clinical Trials and You Ellen Valentine, M.S., CCC-SLP Community Outreach and Education Program Science Park Research Division, Smithville, Texas.
httpwww.youtube.com/watch?v=DhxD6sVQEYc:// The Drug Discovery Process.
STOCK MARKET. INVESTMENT  Definition- act of redirecting resources from being consumed today so they may create benefits in the future.
Drug Development Process Stages involved in Regulating Drugs
Drug Discovery &Development
Regulatory– Terms & Definitions רגולציה - מונחים והגדרות
Clinical Trials — A Closer Look
Clinical Trials Medical Interventions
INVESMENT RISKS FATIN ABD ALKREEM.
Research Overview Jacqueline French, MD Chief Scientific Officer
9.4 Product Quality Control
Clinical Trials.
Student Investor Learning Activity
Investment Opportunity and
A Real World Application of the Scientific Method
3.4 Building a Better Cancer Treatment
Presentation transcript:

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

BACKGROUND & OVERVIEW 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 IPOs

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 drugs 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 (DOS ) 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

CLPA (Nasdaq) dropped 69% in one day

INVESTING IN BIOTECH STOCKS (DOS Continued) Be Passionate Learn All About Your Company's Biotechnology Know Your Risk Tolerance Invest Money That You Dont Need

INVESTING IN BIOTECH STOCKS (DONTS) Dont Forget About the Business Dont Buy a One-Hit Wonder Dont Buy on Margin

HOW TO EDUCATE YOURSELF Ernst and Youngs Biotech 99 Report Access Excellence by National Health Museum Tutorials at Street.com Scientific American Articles BioMedNet.coms 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