Outline the risk assessment and risk management plans

Assignment Help Biology
Reference no: EM131391229

Company:

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.

Reference no: EM131391229

Questions Cloud

What are some ways that firewalls can filter network traffic : Discussion- What are some ways that firewalls can filter network traffic? Research your answer before you respond.
Explain two data transmission technologies associated : Define each protocol and describe at least two data transmission technologies associated with the protocol. Include the bandwidth limitations of each technology and protocol.
Risk of developing breast cancer : 1. Do Web research to name a gene, other than BRCA1, that increases risk of developing breast cancer when mutant. What is the process or mechanism that the mutation disrupts?
Prepare a consolidated statement of income : Prepare a consolidated statement of income and retained earnings for Cranbrook Corporation and its subsidiary Creston Company for the year ended December 31, 2015
Outline the risk assessment and risk management plans : 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.
Correlation between cell shape and function : Describe the correlation between cell shape and function by selecting two cell shapes and how that shape helps them fulfill their function. Be sure to make good use of the information in your textbook as well any resources you find online. Don't ..
Review the american psychological association requirements : View the American Psychological Association (APA) style report (6th edition). Next, review the APA requirements. Then, explain what you believe to be the most challenging aspect of APA formatting.
Find the spring constant : A 5-kg collar rests on but is not attached to the spring shown. It is observed that when the collar is pushed down 180 mm or more and released,
Hofstedes or schwartzs work : Using either Hofstede's or Schwartz's work as described in our text, discuss which perspectives the parties were most likely coming from and how that affected the negotiation process and the outcome.

Reviews

Write a Review

Biology Questions & Answers

  Immune response to infectious disease

It is a very curcial concept to understand how the immune response is mounted against viruses, bacteria, protozoans and helminthes. For an effective immune response, both innate and adaptive immunity should work together.

  A review on advanced glycated end products (ages)

This Project report elaborates a critical review of important elements attached to Advanced Glycated End Products (AGEs). It is very crucial to understand the process called Millard reaction.

  Plastic as a soil stabilizer

Soil stabilization is the permanent physical and chemical alteration of soils to enhance their physical properties. Stabilization can increase the shear strength of a soil and control the shrink-swell properties.

  Principles of microbiology

This assignment has three parts which contains questions related to Microbiology. It contains basic principles of microscopy, staining techniques in microbiology and microbial growth in the food industry.

  List the biologic functions

Lipid metabolites are often seen as key elements in cellular signaling. Is this unique? Please provide several examples of the function of lipids as key elements in signal arrays and list the biologic functions these signals affect?

  Biologic function relationships

Please describe how one might search for chemical structure, biologic function relationships, involving small molecular weight lipophylic compounds. Provide one example.

  Case study on patient in the haematology laboratory

Write a case study which detailing a scenario of a patient being investigated in the Haematology laboratory.

  Use of pcr and genetic approaches in biotechnology

The use of PCR and genetic approaches in biotechnology

  Describe the role of this enzyme in honey

Glucose oxidase is an enzyme that can be used for measurements of glucose levels by combining this reaction with an oxygen probe.

  Genetic problems

What phenotypic ratio would you get if you crossed a white mouse and a heterozygous brown mouse?

  Prepare an essay on nosocomial infection

Prepare an essay on nosocomial infection.

  Monitoring and recording the blood pressure

To increase the awareness of monitoring and recording the blood pressure of patients and practice measuring blood pressure in a safe environment.

Free Assignment Quote

Assured A++ Grade

Get guaranteed satisfaction & time on delivery in every assignment order you paid with us! We ensure premium quality solution document along with free turntin report!

All rights reserved! Copyrights ©2019-2020 ExpertsMind IT Educational Pvt Ltd