Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading: Aims, Significance, Innovation, Approach, Future, Citepublished experimental details in the Research
Strategy section and provide the full reference in the Bibliography and References Cited section
The paper should be addressed in this format:
• Choose a targeted pathogen and propose to develop a vaccine
• Cover all the ten steps for vaccine development
• 10 pages limit (not including the references )
• 1,5 – double spaced
Most Importantlydescribe how you are going to develop the vaccine (organize in accordance to the aims) can be overview describing in general how the program going to be carry out and break down the approach to the specific aims, for example,
Aim 1 identify critical antigen (describe the use of methods to identify the critical antigen that will be used in the development of the vaccine and describe any challenges and how you can overcome them ) is there any pitfalls and how you can address them and is there any backup plans if any of the aims did not work
In the process of writing the significance & invitation and approach Its possible that you can not cover all the 10 steps, for example, toxicity and clinical trials, distribution and access, those may be hard because it’s a new vaccine but try your best to cover them
The breakdown for each section from the organization point should cover the following:
Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.
List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
If is there multiple Specific Aims, then you may address Significance, Innovation and Approach for each Specific Aim individually, or may address Significance, Innovation and Approach for all of the Specific Aims collectively.
You Have to PUT 2-3 Aims in your paper
Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.
Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.
Explain how the application challenges and seeks to shift current research or clinical practice paradigms.
Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.
Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.
Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless Addressed separately include how the data will be collected, analyzed, and Interpreted as well as any resource sharing plans as appropriate.
Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.
Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.
Future : how you think this vaccine could move forward and how would it be tested and how you have thought ahead about whether people are going to accept it and how would it be distributed and delivered
THE TEN steps for developing a vaccine
1. Define Disease (Allows identification of pathogen)
2. Define Pathogen (diagnostic test)
3. Is there Immunity (If not you are in trouble)
4. Correlates of Immunity one or many? (Ab? Ag? CMI?)
5. Critical Antigens – one or many?
6. Animal Model? Does it predict protection?
7. Prototype Vaccine – Preclinical Proof of Principle
8. Safety and Toxicity, GMP, Stability: File IND Application
9. IND = Approval to conduct Clinical Trials
• Clinical trials (Phase I, II, III)
b) Phase I – human safety/toxicity
c) Phase II – efficacy
d) Phase III – extended studies / other drug(s)
E)NDA -> FDA Approval
10- FDA Approval (and indication)
1. Distribution / Access