The product to be developed is a monoclonal antibody. Your firm, ABC Biologicals inc. is developing a proprietary monoclonal antibody to treat cutaneous T-cell lymphoma, a cancer of white blood cells.

The product to be developed is a monoclonal antibody. Your firm, ABC Biologicals inc. is developing a proprietary monoclonal antibody to treat cutaneous T-cell lymphoma, a cancer of white blood cells.

This biopharmaceutical product is a humanized monoclonal antibody that targets and bind specifically to a cell surface molecule, CD545. The molecule, developed in your laboratory, has been characterized in research and has been shown, in a transgenic mouse model, to bind to cancer cells, leading to their death. To be effective in mice, the product is given by subcutaneous injection. Your firm now wishes to develop the monoclonal antibody product and apply for market approval.

Questions:

Provide an overview of the project from preclinical studies to IND of the monoclonal antibody product development; including purpose, scope, technical, and management objectives.

1. Provide the composition of the project team enlisted for this project. Identify team members, their affiliations and locations, and authorities & responsibilities, and the rational for these choices.

2. Describe the team communication plan to include types of communication and frequency of meetings.

3. Describe metrics that would be used to measure the progress of the project.

4. Describe the methods the project manager will apply for allocating, tracking, and managing resources allocated to the project.

5. Identify the major risks this project is likely to encounter. Outline the risk assessment and risk management plans for the project, focusing on risk mitigation early in the project. Describe the roles of the project manager in risk management.

6. Describe your plan for identifying actual problems or issues and resolving them as a team.

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