Study guide for Exam 1: Thursday September 28, 2007
125 points, 'guided essay' format. The readings and handouts for each night are possibilities for exam material, but mainly as they relate to the Objectives below.
Objectives for What is Biotechnology?
August 23, 2007
No specific objectives, but make sure that you, as a Biotech 540 smarty-pants, can NOW answer all the First Night questions!
Objectives for Biotechnology Timeline 2007 and Questions
August 28, 2007
Objectives specific to this lecture focus on Cohen, Boyer, Paul Berg, and Asilomar - the initial succecss (and concerns) of rDNA work - up through the end of Part 2.
1.Identify Nobel-winning scientists and their research stated above. Why? because every self-respecting Biology major SHOULD!
2.Explain how the Cohen-Boyer partnership resulted in 'the birth of biotech' (aka Cloned beef to cloning), the role of Robert Swanson developing the biotechnology company Genentech
3.Explain the major results of the Cohen-Boyer 1974 PNAS paper. We will go over this paper in class Tuesday evening
4. What were the major recommendations of the 1974 paper "Potential Biohadards of Recombinant DNA molecules? What was the outcome of this manuscript?
5. What were the major conclusions from Asilomar conference and what are their significance in the use of recombinant DNA technology? Be able to discuss the the initial concerns and recommendations that surround this important event.
Objectives for Surfing the First Wave: rDNA drugs and Drug case studies
August 30, 2007 and Sept 4, 2007
1. Know all the "parts" of a eukaryotic gene
2. Describe how restriction enzymes function to create recombinant
DNA
3. Describe how bacteria can be used to produce eukaryotic proteins
For each of the companies studied, be able to
list:
1. The Protein Product: what human protein is formulated
as the drug?
2. Indication: why is the drug prescribed and what it
does it do in the body?
3. Other notes we will discuss in class (Alternate forms of this drug, competing products on the market, "the
dark side", etc)
4.You do not need to know who licenses
what drug to what company, the annual revenues, the company history, or the
dates of FDA approval...
5. Material on the readings may end up as exam material
- so read those carefully!
Objectives for Biotech's Second Wave: mAb Drugs plus MOAs
September 6, 2007
- When making monoclonal antibodies, what is the purpose of: the immunized mouse (and its poor spleen)? What are myeloma cells and why are they so useful in this technique? What is a hybridoma? How are experimental conditions set up to select for hybridomas?
- What is meant by the terms chimeric monoclonal antibody and humanized monoclonal antibody?
- For each drug listed below, be sure to know:
(1) The Target: what human protein is recognized by the mAb?
(2) Indication: why the mAb is prescribed and what it does it do in the body?
| Transplantation: Oncology: T-cell Autoimmune: Misc: |
Orthoclone
OKT3, Simulect , Zenapax |
Objectives for Investing in Biotechnology
September 11, 2007:
- You will not be tested on your knowledge of compound interest, stocks, bonds, or other assets! That material is all there to educate you about investing...hopefully you will be motivated to get a jump start on your financial future $$$$$!
- The Rule of 72 is a very important concept. Ask Albert Einstein.
- Please know the characteristics of companies worth your investment dollar, as provided by The Fool.
- Be able to explain what an IPO is and the benefits and costs to a company that goes public.
Objectives for Clinical Trials - TWO lectures:
September 18 (Dr. Michael Turik) and Sept 20, 2007 (kmarrs)
- Describe the acronym ADME/Tox and how these 4 criteria influence the drug level and pharmacological activity of a drug candidate
- Explain the purpose of an IND and what pre-clinical data must be presented to the FDA to justify the testing of the drug in humans (look in both our web notes and Dr. Turek's slides, especially slides 25-27, 39). When must the FDA make their deteminiation after the IND is submitted, and what are two alternate outcomes of the FDA decision?
- Compare and contrast Phase I, II, III, and IV clinical trials (look in both our web notes and Dr. Turek's slides, especially slides 28-32). For each stage, be sure to have a rough idea of how many years, how much $$, and how many patients (where applicable) would be involved at each stage.
- Distinguish between inclusion and exclusion criteria for a clinical trial.
- Compare the 3 main routes to get a drug into the bloodstream (parenteral, enteral, and pulmonary) - advantages and disadvantages.
- Explain the 6 'way cool' drug delivery options manufactured by Alza: OROS (ex: Concerta), D-trans (ex: Nicoderm, Estroderm, Fentanyl), Stealth Lisposimes (ex: Doxil), DUROS (ex: Viadur), E-Trans (ex: E-Trans Fentanyl), Macroflux (no products yet!)
- Important: Compare and contrast the three process that can speed up NDA consideration and FDA approval:
- Fast Track
- P- (priority) Designation (and PDUFA Date calculation, vs. S-Designation)
- Accelerated Approval (surrogate vs. primary endpoint, continuation of clinical trials).
- Describe Compassionate access and criteria for Treatment IND consideration
- Explain the Orphan Drug Act, why it was implemented, how it provides an incentive to pharmaceutical companies, and describe a few Orphans!
Objectives for Post Modern Science - Joe Petolino, PhD, DowAgrosciences
September 25, 2007:
We'll just wait and see...but of course make sure you can describe, in your OWN words, the meaning and implications of Post Modern Science, circa 2007....