Contents

• This report is based on the following questions -
• Question 1 (2000 words)
• You are employed by a publicly listed ethical pharmaceutical Parma company that believes it has sufficient cash to complete the development of its lead compound, a novel anticancer agent (AB), to the end of Phase II.
• The product is a small molecule prodrug that is orally available. It is converted to its active moiety in vivo by an endogenous enzyme that has previously been shown to have higher activity in tumour samples than in normal tissues, although it is present in some normal tissues.
• You have been asked by the Project Leader to prepare a clinical development plan for AB006 for the lead indication of glioblastoma multiforme (brain cancer). The prodrug has been shown in animal models of brain cancer to cross the blood brain barrier. Sufficient toxicology studies to support the programme have been completed or are ongoing.
• Prepare the following sections of a Target Product Profile (TPP) for AB006 using public domain information. State any assumptions you make.
• Indications and usage
• Dosage and administration
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Briefly describe each of the clinical studies you would include in the plan and, with your rationale, the order in which you would undertake them. For the efficacy studies include the primary endpoint and three secondary endpoints.
• Indicate when in the development programme go/no go decisions would be taken and provide up to three criteria that will form the basis of the decision.
• Question 2 (2000words)
• AlphaBeta Pharma has exhausted its resources on the early-development stage, and the board of directors has decided to out-source all clinical trials of late-development stage to a contracted research organisation (CRO) 

You are the Programme Leader responsible for the development of the compound and the delivery of the project.

Explain your thoughts regarding the advantage and disadvantage of out-sourcing your project to CRO. (40%)
What are the steps you will be taken in order to select the best CRO for the job (20%) and what are you looking for in the CRO (30%)

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