Biotechnology presentation

aquaaniseBiotechnology

Dec 6, 2012 (4 years and 10 months ago)

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Presented by

Megan Hopkins
-
Brady

Biotechnology

Objectives:


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
pharmaceuticals.



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

Biotechnology


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
-
products.
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
-
robotics).

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.


Technologies


Hardware used in Biotechnology


High throughput screening techniques to discover drugs


Animal models to test if drugs have potential therapeutic
benefits


Recombinant DNA Technology used to produce drugs


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


Software


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
controlled


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


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


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
JMP

Minitab software


Statistical software package


Allows easy input and analysis of large volumes of numerical
data


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


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
-
report
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
trials:


End User Administration


Patient registration


eCRF


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


Neuro
-
degenerative conditions such as Parkinson’s and
Alzheimer's


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
money


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



Ethical


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



Legal


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.

Summary


Biotechnology companies are developing novel cures and
therapies for previously difficult
-
to
-
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

165.


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


Wikipedia: The free encyclopedia. (2004, July 22). FL: Wikimedia Foundation, Inc.
Retrieved September 18, 2010, from
http://www.wikipedia.org