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SVSM Pharmaceutical Drug Proposal

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by

Madeleine N

on 24 June 2013

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Transcript of SVSM Pharmaceutical Drug Proposal

Pharmaceutical Drug - Baramiss
- American Medical Association (AMA) officially considers obesity a disease

- Create a pharmaceutical drug that increases metabolism and decreases appetite, so that along with a healthy diet and exercise, those who take it can return to a normal weight

- Drug will bind to the thyroid hormone receptor proteins, which are significant in changing food into energy
Economic Feasibility
Using the grant of $5 million, we will conduct the preclinical research necessary to create a testable drug as well as begin the first phase of clinical trials.

Other federal grants would be necessary to bring the drug through clinical trials and mass production

Overall, the necessary budget will be around $4 billion

The money is needed to hire the scientists (organic chemists, physiologists, biochemists, toxicologists), provide the materials and tools to create the drug, and undergo the experiments.
Feasibility
Community Benefit
People who take Baramiss will become physically healthier. There will be a decrease in weight related problems such as heart disease, heart attacks, and Type 2 diabetes.



Economic Potential
Scientific Significance
The new drug (Baramiss) has a closely related stimulating effect of the thyroid hormone. In this case, it aims to increase the activity of fat tissues to burn off excess energy, thus promoting the loss of weight.

Discovering the new drug will also lead to other extraordinary ideas and concepts based off our drug's chemical makeup.

There will be an increase in employment of drug researchers, and once the product is created, manufacturing jobs will also increase.

Baramiss reduces unnecessary appointments, injuries, and surgeries due to obesity (heart disease, arthritis, diabetes, high cholesterol and blood pressure, etc.)

Objective
Drugs of this nature have been created before. They have not been particularly effective but this proves the feasibility of such a product.

We have prior knowledge of the research for this drug. We are trying to make it super effective.
Year 3
Year 4
Year 6
Target Identification
identifying the function of a possible therapeutic target and its role in the disease
Confirmation of Hits
an assessment of the small molecule that is evaluated and tested to identify possible lead compounds
Identification of Actives
team will begin to define the new composition of matter by linking the chemical structure to the change of the drug
Selection of Optimized Chemical Lead
Year 5
Pre-IND Meeting with the FDA
Year 2
Human Proof of Concept
To submit an IND application, all the components of the drug should be addressed, and all the requirements of the IND and regulatory agencies should be met and agreed upon.
Year 1
Clinical Proof of Concept
The drug should meet Investigation New Drug (IND) objectives set by the FDA as well as the
Safety and Tolerance Assessments.
Target Validation
Identification of Chemical Lead
Year 7-8
Selection of a Developmental Candidate
$100,000
requires a demonstration that a molecular target is directly involved in a disease, and the drug is likely to have a therapeutic effect
$162,000
$232,000
Thanks for your consideration!
A lead molecule will be produced for use in clinical trials.
$195,000
$291,000
A molecule will be chosen to be used and produced for clinical trials. It must meet specific criteria before it can be produced (acceptable toxicity levels, in vivo activity, and feasible manufacture).
$230,000
chemical lead, which is a stable synthetic drug-like molecule, is determined for its specificity in the drug
$243,500
$37,000
$620,000
Preparation and Submission of an IND Application
Team will prepare for a meeting with the FDA, and adjust plans for clinical trials if necessary.
$1.5 million
Total
$3.95 million
To proceed to clinical trials, the IND must clear the drug, a dosage must accepted, and there must be evidence that the drug works for humans.
$620,000
Full transcript