Project leadership: Final Assignments Overview You are asked to prepare a presentation of a project plan for either

1. Project leadership
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Project leadership: Final Assignments
Overview
You are asked to prepare a presentation of a project plan for either
senior management or the project team. As you prepare your
presentation keep in mind the four stages of a project: Initiation,
Planning,
Execution and Closeout and incorporate these into your plan (you
may not need to include them all
depending upon the assignment). Think about the resources you need
for the project, the studies you
need to perform, timeline, and what success/closure looks like. Use all
the resources you have available,
slide presentations, texts of reading assignments, your notes and your
classmates.
You have 10-12 minutes for your presentation (15 minutes
maximum). Think about all you have learnt so
far about giving presentations. Introduction, presenting your
case/information, and a conclusion (what is
the importance/impact/benefit). Think about timing, how many slides
do you need, don’t have too
many. Leave time for questions. Timing is important as you have to
be considerate of other presenters

2. and your listeners. Think carefully about what you want to say, keep
to the message, and be precise and
concise. Make sure each slide has a clear message that you wish to
communicate.
When you are not presenting be an active listener. You are either on
the senior management team or the
project team. Think of a helpful question to ask the speaker. Ask at
least one question of one speaker
during the class.
You have a choice out of three assignments. Choose ONE from the
selection below for your end of
course final presentation.
1. Project Initiation scenario
This is a kick-off meeting for a new clinical research project. You are
initiating a new project and you are
presenting to your new project team. Your project aim is to provide a
new therapy for multiple sclerosis
that will benefit patients and be an improvement over current therapy.
Your drug has been through
pre-clinical development and is clinic ready. You need to define the
project goal and charter using the
target product profile format. Introduce your team, who is on your
team and why have you chosen
them, and their role on the team and how they add value to the
project. Provide an overview of the
key stages in your clinical project plan and what is needed to get to
end of phase 2 proof-of-concept. Provide an organizational plan for

3. the team to show how you propose to achieve this. Include concepts
such as objective setting, team building, team meeting organization
and scheduling, communication strategy, and a proposed timeline
with key milestones and Go/No go decisions (you have three years
for this project).
Prescribing information for the antibody drug Tysabri is provided on
Blackboard Learn. Note: this
contains prescribing information for both multiple sclerosis and
Crohn’s disease. Focus only on multiple
sclerosis. 2. CMC Scenario
The research department has discovered a new molecule (mAb Z) and
management is very excited about
its potential for improving outcomes in a particular type of cancer.
The research team also thinks that if
mAb Z works for this type of aggressive cancer, that it will be
successful in many other types of cancer
and has potential to be a multi-billion dollar blockbuster for the
company. The antibody has gone
through research, and the team is preparing for the non-clinical
studies to support the IND. You have been requested by your
management to pull together a CMC team and develop a CMC plan to
get mAb Z into the clinic. The project you have been requested to
manage is to plan, manage and execute the studies required for all
CMC activities from cell line development through manufacture of
clinical supply to support the IND and the start of the clinical trials.
Your plan should include a project objective, stakeholders, CMC team
members that you will need to plan and execute, key milestones, a
communication plan, a CMC timeline, and a description of
success(closeout). Because of the excitement around this molecule,

4. management is keen to go as quickly as possible, but you also must be
successful. Your plan should highlight at least one