Product Production Pipeline - CTE Online

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1 Δεκ 2012 (πριν από 4 χρόνια και 9 μήνες)

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1

Product Production Pipeline (P
3
) Study

Developed with Ellyn Daugherty, San Mateo High School


Most biotechnology companies fall into one of four categories:



Production and Sales of Pharmaceuticals



Production and Sales of Industrials



Production and Sales of

Agricultural Products



Development and Sales of

Biotechnology Instrumentation
and Reagents.


No matter what the produ
ct of a biotechnology company
, the goal is to get the product to
market as quickly as possible. Often there is a period of Research and De
velopment (R &
D) where a lot of money is invested in trying to produce a
product on a small scale. Much
testing is conducted, as the protocols for small and then large
-
scale production are
determined. If the product is a pharmaceutical, it must undergo
strict testing (Clinical Tests),
under the guidance of the FDA (Food and Drug Administration), before it can be marketed.
It takes anywhere from 10
-
15 years for a company to take a product through all these steps.
We say that the potential marketable pro
duct is in "The Product Pipeline.” The pipeline is
different at every company but follows the basic outline below:


ID a potential product


R&D with assay development and quality control


Pre
-
clinical
Testing


Manufacturing (small scale)


Continued te
sting for safety and efficacy
(including Clinical Trials

1,2,3 for pharmaceuticals)


Marketing


Background Research

First, you need to become knowledgeable in all the steps of the product pipeline outline.
Complete the following steps:

1. Research exactl
y what happens in the Research and Development (R&D discovery)
stage, pre
-
clinical testing, clinical trials 1, 2 and 3, and marketing. Be specific in your
research:


-
Define what happens at each stage. Make sure to include the science occurring at


each
stage.


-
Name interested parties involved in each stage.

2. While researching, copy and complete the table below on the next blank page in your
notebook.


Basic Outline of the Product Pipeline

R&D
(Discov
ery)

Pre
-
Clinical
Testing

Clinical
Trial
(Phase)
1

C
linical
Trial
(Phase)
2

Clinical
Trial
(Phase)
3

Marketi
ng








2


3. Go online to Genentech’s website. On the home page, click on Genentech’s
Development Pipeline. Choose one product in the pipeline at stage 1, one product in the
pipeline at stage 2 an
d one product in the pipeline at stage 3. Copy and complete the table
below on the next blank page in your notebook.


Genentech’s Product Pipeline

Genentech
Product Name

Current Stage
of Product

How does the
product help
society?

Other
Interesting Fact






Semester Project

Like a Sales and Marketing Specialist would do, study and report on a product that has
been recently brought to market, or about to be.


1. Review the products the instructor has identified as being appropriate for this study. Select

one
that you think would be interesting to do extensive research on. Get a manila folder and title it
with your name, the date, and the product name. This will be an exhaustive research folder into
which all research documents will be placed.


2. Using

search engines and searchable databases, find as many companies as possible involved
in the research or production of the product. Print a hard copy of the web pages that have
information you feel will be helpful to completely understand the history, str
ucture and function of
your product.
Give

each reference a number

in the upper right hand corner of the page
. Keep
track of the information you collect about your product by making a “Bibliography”, recording the
reference #, title of the article or page,

and the URL.

Use citation machine to make your
bibliography.


3. Determine the single company that is furthest along in the pipeline of "your" product.
Go online
and find the annual report for the company. You may need to write or call the company for

the
annual report if it cannot be found online.

Annual reports usually have, within it, a basic product
pipeline for the company's potential products.
Most

annual reports are available online (but
require a lot of paper).
Only print information about y
our drug, not the company.
If you choose
to print your own copy, you may not use the school’s facilities for this purpose.

If your
company’s annual report is online, you may simply provide a link in your final presentation (no
printing required).








3

4
. Once you have identified a product and a company that produces it, become an expert in the
product.
Gather information to answer the following questions
:


A.

What is the structure and function of the product?

B.

What market it will serve?

C.

How large a market

will it serve?

D.

Where is it in the product pipeline?

E.

What has its history been in the product pipeline?

F.

When is the product
expected to first reach market?

G.

What obstacles are there, if any, to reaching market?

H.

Are there any concerns or cautions about the p
roduction of the product?

I.

How much money is it expected to produce for the company?

J.

Are any other companies in serious competition to bring this product to market?

K.

Any other interesting info?


5. Collect all the information you have gathered into your exh
austive research folder/binder. Use
the Bibliography as
your
Table of Contents. Make sure every bit of information has a
bibliographical entry on it (
APA format
).
Actively read

all documents
highlighting

all answers to
the above ques
tions.


6. Produce

a PowerPoint®
or Google
presentation (no more than 15 slides)
that clearly describes
the history, structure, function and market for "your" product
. Make sure each slide is interesting
to look at, has an appropriate amount of information and is easy to r
ead from around the
audience seating area. Include information on all the questions asked above. One slide should
have a product pipeline diagram on it (timeline). Be prepared to make an oral presentation (10
min) to the class describing your product and
its market. (See Deadlines below).


7. After your presentation turn in a hard

copy of the entire
presentation to the instructor, along with
the exhaustive research folder.


Project Deadlines

End of Week 1



Product identification, Set
-
up of Exhaustive R
esearch Folder and Bibliography,
5 articles/documents, actively read and recorded into folder.

End of Week 3




Minimum of 15 articles/documents, actively read and recorded into folder.
Acquisition of Annual Report

End of Week 5




Rough draft of PowerPoin
t® presentation submitted to the Instructor

End of Week 7



Final version of PowerPoint®
or Google Presentation
and Exhaustive Research
Folder ready to present.


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Ideas for Product Pipeline Products, like those below, can be found on http://www.bio.com

Prod
uct





Description

Roundup Ready™ Soybeans


Herbicide resistant soybeans

Pulmozyme®





A treatment of cystic fibrosis

Bovine Somatotropin




Growth hormone for livestock

Thrombopoietin




Blood
-
clotting agent

IndiAge® cellulase




Cellulose
-
digesting enz
yme

Bollgard™ Cotton




Insect resistant cotton

Nutropin™





Human Growth Hormone

t
-
PA






Tissue Plasminogen Activator

Spezyme® starch enzyme



Starch
-
digesting enzyme

Herceptin





Treatment for one type of breast cancer

Copalis™ Technology



Immunoa
ssay detection kits

BNX® cotton seed




Herbicide
-
resistant cotton

D
ual
-
Luciferase™ Reporter Assay

Gene expression measurements

Rituxan™





Treatment of some kinds of lymphomas

VISTIDE™





Systemic treatment of cytomegalovirus retinitis

Premise™75





Te
rmiticide

EPOGEN®





Red blood cell production for anemia

Kogenate®





Treatment of hemophilia

Glucobay®





New treatment for diabetes

Zenapax®





Anti
-
interleukin2 antibody

HCV antibody test




Antibody test against hepatitis

Avonex®





Relapsing mul
tiple sclerosis

Humalog®





Treatment for diabetes

Intron
-






Treatment for hairy cell leukemia, genital warts, etc.

Proleukin, IL
-





Treatment for kidney (renal) carcinoma

New Leaf® Potato




Insect
-
protected

Pimagedine





For diabetic kidney dis
ease

Retavase®





Thrombolytic agent

Neupogen®





Infection prevention for cancer/transplant patients

GS 4104





Influenza virus treatment and prevention

Xerecept





Brain tumor

Dimebon





Alzheimers

Cankaid





Dental pain

Ano128





Treatment of acn
e

Oxyderm





Treatment of acne

HIV DNA Vaccine




HIV Vaccine

Contrave





Obesity

Dronabinol





Obesity

Fosamax





Osteoperosis

Prolacria





Dry eye syndrome

Xolair

(liquid form)




Asthma

Enbrel






Asthma

Soberal





Alcoholism

Naloxone Hydrochlori
de



Narcotic addiction

TA1790





Erectile Dysfunction

WC3026





Contraception

Trivora





Contraception