Biotechnology presentation


6 Δεκ 2012 (πριν από 4 χρόνια και 4 μήνες)

169 εμφανίσεις

Presented by

Megan Hopkins



To define how new developments in biotechnology are
revolutionizing the healthcare industry.

New drugs discovered and developed by the Biotechnology
Industry are being used to treat diseases, that were previously not
available; this technology is novel compared with traditional

These drugs are modified versions of naturally occurring substances
in the body.


Biotechnology is a field of applied biology that involves the
use of living organisms and bioprocesses in engineering,
technology, medicine and other fields requiring bio
Modern use similar term includes genetic engineering as well
as cell

and tissue culture technologies.

Biotechnology draws on the pure biological sciences
(genetics, microbiology, animal cell culture, molecular
biology, biochemistry, embryology, cell biology) and in many
instances is also dependent on knowledge and methods from
outside the sphere of biology (chemical engineering,
bioprocess engineering, information technology, bio

Biotechnology Vs Pharmaceuticals

Most traditional pharmaceutical drugs are relatively simple
molecules that have been found primarily through trial and
error to treat the symptoms of a disease or illness.

Biopharmaceuticals are large biological molecules known as
proteins and these usually target the underlying mechanisms and
pathways of a malady; Biopharmaceuticals can deal with targets
in humans that may not be accessible with traditional medicines.
A patient typically is dosed with a small molecule via a tablet
while a large molecule is typically injected.

Biotechnology Vs Pharmaceuticals

Biotechnology is also commonly associated with landmark
breakthroughs in new medical therapies to treat hepatitis B,
hepatitis C, cancers, arthritis, hemophilia, bone fractures,
multiple sclerosis, and cardiovascular disorders.


Hardware used in Biotechnology

High throughput screening techniques to discover drugs

Animal models to test if drugs have potential therapeutic

Recombinant DNA Technology used to produce drugs

Bioreactors and chromatography to manufacture biotechnology
drugs for clinical trials and patients


Statistical analysis software such as Minitab or SAS

Hardware: Bioreactors

Large steel tank

Cells are grown in mixed environment
where nutrient levels and pH,
temperature and oxygen levels are

While the cells are growing, they
produce the protein of interest in large

The protein can be easily purified from
the cells and other proteins using
purification techniques such as

Software: Statistical Analysis

Used to analyze large datasets

Used to determine statistically if
drug has positive effects on patients

Used various statistical methods
such as correlation, regression and
ANOVA to perform analysis

Different packages exist: Examples
include Excel, SAS, Minitab and

Minitab software

Statistical software package

Allows easy input and analysis of large volumes of numerical

Also allows the user to design clinical trial studies in order to
determine what number of patients are needs and what
groups to study

For example, the program allows the user to run tests of
significance (such as ANOVA, t
test, f
test) and
correlation/regression analysis.

Such analysis allows the user to determine if the effect is
statistically significant.

Information System Review

Computerized data information systems are routinely used to
store and analyze clinical trial data

The Food and Drug Administration guidelines requires that
firms conducting clinical trials have appropriate systems in
place (FDA, 2007)

The computerized systems should be designed: (1) to satisfy the
processes assigned to these systems for use in the specific study
protocol (e.g., record data in metric units, blind the study), and
(2) to prevent errors in data creation, modification,
maintenance, archiving, retrieval, or transmission (e.g.,
inadvertently un
blinding a study).

Information System: Clinical Trials

Used by clinical trail administrators, nurses, physicians, study
directors and data analysts

System must be capable of accurately capturing and
analyzing all aspects of clinical trial data


CliniProteus is a scalable and flexible integrated solution
intended to cater to the needs of the clinical research
organization of any size (Matura et al, 2007)

XML based flexible clinical trials data management
framework in .NET environment that can be used for
efficient design and deployment of Electronic case
forms (eCRFs) to efficiently collate data and analyze
information from multi
site clinical trials.

CliniProteus Features

The system has the following functionality to support clinical

End User Administration

Patient registration


Verification of eCRF data entry

Maintain inclusion/exclusion criteria, adverse event log

Visit management

Shipping & handling of Samples

Clinical sample data integration

Customized reports

Research analytics.

Advantages of Biotechnology Trend

New or improved cures and therapies for previously
untreated diseases being developed. Major indications include

Autoimmune diseases such as arthritis, MS and Crohns Disease

Cancer and oncology

degenerative conditions such as Parkinson’s and

Infectious diseases such as Hepatitis, AIDs and common flu

Filling pipelines of pharmaceutical companies and creating
new Biotechnology companies.

Disadvantages of Biotechnology Trend

Relatively unproven drugs and technologies

Low success rates of drugs in clinical trials which cost a lot of

Some concerns over the safety of the drugs

Expensive to produce

Drugs are difficult to produce relative to conventional small
molecule therapies.

Ethical/Legal issues


Some companies developing therapies using stem cells derived
from pre
term birth tissue

Use of animals for pre
clinical studies to determine if drugs
works in animal models


Drugs and technologies are typically patented, protecting the
rights of the discoverer, but not allowing other companies to
develop drugs, creating potential monopoly.

Potential to sue company if safety issues observed in the field
that were not previously seen in clinical trials.

Informatics Competencies Required

Nursing professionals working in clinical trials with the drugs
would need to be familiar with the following

Data acquisition system used in the clinic to capture data from
the trial including patient information, drug lot numbers,
patient clinical data, etc…

System used to analyze data to determine if drug was working

Functions and Responsibilities of IN
Working with this trend

Collect and enter relevant patient information into data
system; typically the clinical trial protocol will have
instructions on what data to enter.

Administer the therapeutic drug according to the protocol

Collect samples from the patient and store appropriately

Monitor patients symptoms and progress over the duration of
the trial. Enter relevant data into data acquisition system.


Biotechnology companies are developing novel cures and
therapies for previously difficult
treat diseases

Such therapies promise to revolutionize the field of medicine

Nursing professionals should be kept informed of
developments in this important field.

APA Reference Guidelines

FDA, Guidance For Industry: Computerized Systems used in Clinical Investigations,
March 2007.

Mathura, VS; Rangereddy, M; Gupta, P; Mullen, M; Bioinformation. 2007; 2(4): 163


Roth, C. (2001). From alchemy to IPO. Cambridge, Massachusetts: Perseus

Wikipedia: The free encyclopedia. (2004, July 22). FL: Wikimedia Foundation, Inc.
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