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You are currently the manager of the clinical research department in a busy (nonprofit) oncology practice). As such, you are often tasked with planning new ventures and directions for the research department.

Translational research” is a term that has been used in the scientific community for about 20 years, and is also a process that crosses many disciplines and meanings. Please read the attached article regarding the definition of translational research.
In this exercise, students will use their knowledge and perspective of translational research to develop a staffing model for an early phase I research site. Because “translational research” is interpreted in many different ways, I expect that each student will define the term in the way that she or he will then develop into her/his staffing budget. Consequently, I will be grading this assignment for consistency and reasonable
assumptions along with justification. There is no “right” or “wrong” answer, I expect that you will use due diligence to make decisions on salaries, training and other requirements to establish a quality research module.
You are currently the manager of the clinical research department in a busy (nonprofit) oncology practice). As such, you are often tasked with planning new ventures and directions for the research department.
To everyone’s surprise a patient donates a substantial amount of money to the practice, with the directive that $20 million dollars will be used to start a translational research module within the research department. The Vice President of the practice has tasked you with investigating a model for an early Phase I translational research department and developing a staff start-up budget and justification. These are the details of your assignment:
3-4 pages total (5 points)
References and citations if you use any literature or other material (5 points)
1. 2-3 paragraphs defining translational research as it relates to early translation of a drug from animal studies to human studies (T1 research) (20 points)
2. 2-3 paragraphs exploring the overall resource needs of a translational
research facility that conducts early Phase I studies (include what happens just prior to a Phase I study and the definition of Phase 0 studies) (20 points)
3. Your first year budget for staffing will be $1.5 Million dollars for support of 25 people. Your goal is to open 5 new studies in the first 4 months and another 15 in the next 8 months – how will you spend the money? (45 points – reasonable numbers, justification, and salaries using internet resources and academic research)
4. 1 paragraph conclusion discussing your budget and why it is reasonable. (5 points)
Please complete a table similar to the one below:
Staff Position Justification Annual Salary Benefits
Salary &
Investigator This position will
focus on review of
the basic sciences
of the
development of
the drug. S/he will
collaborate with
$100,000 $33,000 $133,000
1/13/2019 Module 2: Exercise 1 – Translational Research 2/3
Exercise 1 Translational Research
the clinical
researcher and
the basic scientist
to ensure safety…
100 total points possible.
**Keep in mind that you are defining the type of module that you will be staffing and
justifying through your definition of translational research.

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