Clinical Research Director of a small pharmaceutical research company

The following post has two assignmentgs namely;

1.Clinical Research Director of a small pharmaceutical research company

You are a Clinical Research Director of a small pharmaceutical research company. The CEO has asked for a presentation to the Board about the possibility of developing a new anti-inflammatory analgesic. The discovery group has a candidate molecule with positive animal pharmacodynamics in three different animal models of arthritis (carrageenan, silica, hydralazine), and three models of pain (rat tail flick, skin prick guinea pig, and rat paw pressure). The candidate is not an inhibitor of cyclo-oxygenase 2 (COX-2), and is not chemically related to any other currently-approved non-steroidal anti-inflammatory drug (NSAID). This candidate has molecular weight 487 Daltons, and is readily absorbed as an oral formulation in dogs and rats. Gastric erosions were seen in the rat at doses > 200 mg/kg, which was 30-fold higher than the doses effective in the pain and arthritis models. Elevations in blood urea nitrogen (BUN) were seen in both dog and rat at doses > 4-fold higher than those effective in the pain and arthritis models. Overall, in 14-day toxicology, the most sensitive species appears to be the dog, and the NOEL is 10 mg/kg. There have been no QT prolongations observed, and the hERG channel test was negative to beyond 1 mM. Describe how you would select an indication for clinical trial development and provide a target product profile in tabular form. Put together an outline clinical development plan using a cartoon to describe the chronology of the clinical phase 1, phase 2, and phase 3 studies. Presuming safe passage in clinical phase 1 (stating any reasonable assumptions that you would make), provide a detailed study design for the phase 2a study, including how you chose dose size / frequency / interval, study endpoints, statistical plan and a power calculation. [25% of module score, 1500 words maximum]

2.Presenting law relating to company directors’ duties and remedies for breach strike

To what extent does the present law relating to company directors’ duties and remedies for breach strike an appropriate balance between promoting economic activity and safeguarding shareholder interests? Formulate reasoned proposals for how, in your view, the system could be improved. In preparing your report you need to address the following areas 1. The historic basis and rationale of directors’ duties; 2. The current rules governing directors’ duties; 3. A review of the literature to assess the advantages and disadvantages of the current system and proposals for reform; 4. Your proposals (including the rationale) and how they compare to other jurisdictions, and 5. What those proposals would achieve by reference to striking a balance between competing considerations. 1. What is the Professional Practice Research Report (PPRR)? The PPRR is a self-study module to be completed by students seeking the LPC LLM award. The PPRR gives you the opportunity to demonstrate your ability to carry out an in-depth investigation into a topic linked to one of the core practice areas or elective subjects and to present your findings in the PPRR assessment. The assessment will consist of a written report of no more than 3,000 words which should demonstrate a critical awareness of developments and current issues in the topic under discussion.