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Biotechnology and Bioethics

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Biotech & Bioethics 2/13/06. Biotechnology and Bioethics ... GCPs - Good Clinical Practices. ICH EC, MHW, FDA. Biotech & Bioethics 2/13/06. Animal Care ... – PowerPoint PPT presentation

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Title: Biotechnology and Bioethics


1
Biotechnology and Bioethics
Biotechnology and SocietyBIS 411 Monday and
Wednesday 330-535UW1-020
Class Number 12 February 13, 2006 Introduction
2
How to Reach Me
E-mail sgg_at_u.washington.edu sgilbert_at_innd.org
Office UW1-246 Office hours 230 to 320 pm
Mon Wed Or by appointment
3
Evaluation
Participation throughout course (can receive
out of class lectures) Editorial 2/13/06 Ltrs
to representatives 2/15/06 Final Project
paper or ??? Choice of topic or format
2/22/06 Final project due 3/08/06 Final class
survey 3/08/06 Detail on web site
4
Class Participation
  • Participation throughout course
  • Speaking up in class
  • Complete web based surveys
  • Submission of news items or stories related to
    bioethics or society

5
Current Bioethical Issues
  • Seattle Times 2/10/06 - Warning on ADHD drugs
    urged
  • UCS Pharma Crop Database - http//go.ucsusa.org/fo
    od_and_environment/pharm/index.php

6
New Web Sites
United Nations Educational, Scientific, and
Cultural Organization - Global Ethics Observatory
- www.unesco.org/shs/ethics/geobs UW - Human
Subjects Division http//www.washington.edu/resear
ch/hsd/index.php
7
New Web Sites
A short film made by two 13-year old students
about the history and consequences of the
development of the atomic bomb.  It is
remarkable!   Watch it here http//www.linktv.org
/programming/programDescription.php4?codenuclear_
genie
8
Interesting Seminars
  • Jewish Federation of Greater Seattle
  • Who is a Parent? Old Questions Need New Answers
    Parenthood and Assisted Reproductive Technology
  • Presented by Julie Shapiro
  • Associate Professor, Seattle University School of
    Law
  • Julie Shapiro will be looking at the way Assisted
    Reproductive Therapy raises new questions about
    parentage and some of the possible ways of
    answering them. She will discuss the
    reproductive technologies of today, the statutory
    influences on determining parentage and some
    puzzling cases in recent times.
  • Date Tuesday, February 28
  • Time 12noon-130pm
  • Location Jewish Federation of Greater Seattle
  • 2031 Third Avenue
  • Seattle, WA 98121
  • Cost Cost is 15 per person, which includes a
    bagel sandwich

9
Interesting Seminars
Breast Cancer Fund's community forum on Breast
Cancer and the Environment to be held on
Thursday, February 23, 2006 at 600-900 p.m. at
Fred Hutchinson, Arnold Building (Public Health
Sciences), 1st floor conference room. They
request RSVP by February 20th using their form on
the website. http//www.breastcancerfund.org/site
/apps/ka/ct/contactus.asp?ckwKXLdPaEb1370033en
pkJUI0NJIjIUL6NXKgLMJ9PTKoKYI7MWKkLTKcNYJuIbG
10
Interesting Seminars
Seattle Chapter of the Indus Entrepreneur (TiE)
will discuss "Seattle Biotech 2010 Opportunities
and Challenges" Feb 16 600 pm - Bellevue
http//www.tie-seattle.org/
11
Our Health, Our Environment
Environmental Health Lecture Series Town Hall,
1119 Eighth Avenue 700 to 830 p.m. Feb 15th -
Frederick vom Saal, PhD- Plastic Promises Better
Living or Bodily Harm? March 9th - Jonathan Patz,
MD, MPH- Climate Change Is Our Health at
Stake? (info at www.iceh.org)
12
Socially / Ethical Responsible Actions
  • Taking the bus
  • Biking not driving

13
Daily Quote
none
14
Editorials
none
15
Class 13 2/15/05
UW - Human Subjects Division http//depts.washing
ton.edu/hsd/index.html
16
Interlocking Players
Science
Government
Business
  • Investigates
  • Cautious
  • Incremental
  • Truth Seeking
  • Regulatory
  • Settle Disputes
  • Seeks Compromise
  • Forced Decisions
  • Mandated to Protect
  • Profit
  • Directed Research
  • Seeks to Raise Funds
  • Seeks Access

PUBLIC / CONSUMERS
17
GOVERNMENT AGENCIES
  • FDA - Food and Drug Administration
  • EPA - Environmental Protection Agency
  • OSHA - Occupational Safety and Health
    Administration
  • CPSC - Consumer Product Safety
  • Commission

18
Regulatory Demands
  • GLPs - Good Laboratory Practices
  • GMPs - Good Manufacturing Practices
  • GCPs - Good Clinical Practices
  • ICH EC, MHW, FDA

19
REGULATORY DEMANDS
  • Animal Care AAALAC, USDA, NIH
  • QAU / QC
  • Validation
  • CDC (animal imports)

20
New Drug Attrition Rate
100,000 New Compounds
CRO - Accelerates selection - Refines efficacy
- Saves time money
Preclinical Evaluation
Clinical Evaluation
100 Tested in Humans
10 Marketed Drugs
2 Drugs Return a Profit
21
Drug Approval Process
File IND
File NDA
Goal - reduce preclinical development to 3-4
years by employing state of the art biological
sciences technology
22
Biotechnology and Bioethics
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