BIO 221 Assignment 6 - Workforce 3 One

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Dec 5, 2012 (4 years and 6 months ago)

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BIO 221

REGULATORY AFFAIRS COMPLIANCE IN BIOMANUFACTURING




ASSIGNMENT
6

Read the following news article and then answer the questions that follow.

Asthma
-

ZaBeCor's Investigational New Drug Application Approved By
t
he FDA

17 Nov 2008



ZaBeCor
Pharmaceuticals ("ZaBeCor" or the "Company") announces today that the
United States Food and Drug Administration ("FDA") has approved the Company's
Investigational New Drug Application ("IND") for the treatment of asthma. This approval
enables the Company
to proceed with Phase I clinical trials in humans for its asthma
drug candidate, Excellair(TM). The IND review included ZaBeCor's clinical development
plan, Phase I clinical trial protocols, manufacturing plans and extensive pre
-
clinical
studies.


Excellai
r(TM) is part of ZaBeCor's extensive intellectual property and is based upon
research conducted at the University
o
f Pennsylvania School
o
f Medicine. Excellair(TM)
focuses on applications of siRNA to the molecular protein Syk kinase. The release of
biologi
cally active mediators in many inflammatory pathways, including those operable
in asthma, is initiated by Syk kinase.


"We are very pleased to have our IND approved by the FDA and we look forward to
commencing Phase I clinical trials," said Alan D. Schreib
er, M.D., Founder, Chairman
and Chief Executive Officer of ZaBeCor. "This is an important milestone for ZaBeCor
and indicates confidence in our intellectual property and data. We are delighted to
continue the development of our asthma drug candidate, Excel
lair(TM), which we
believe will be a groundbreaking treatment for patients worldwide."


Asthma, a chronic pulmonary disease that makes breathing difficult due to inflammation
or blockage of the airway, affects more than 22 million Americans and is a major
cause
of hospitalization in children. Worldwide, there are approximately 150 million asthmatics.


About ZaBeCor


ZaBeCor Pharmaceuticals is a biotechnology company focused on the development of
siRNA, antisense and other molecular technologies for the tre
atment of asthma, allergy,
arthritis, cardiovascular disease and other inflammatory disorders.


Questions

1.

Name the company that received approval for its IND.

2.

What did IND approval allow the Company to do?

3.

What was included in the IND?

4.

What is the function

of Excellair™?

5.

What is the basic mechanism of action of Excellair™?

6.

What is the basic cause of asthma?

7.

Describe the focus of the Company.