This module covers the following key areas:

 The team approach to Research and Clinical Development.

 The module will discuss the important input from: Clinical Development, Intellectual property,

 Commercial Teams. Portfolio management. Business management.

 Global Regulatory Affairs

 Regulatory Objectives, Regulatory Agencies, Global Regulatory Package.

 The Global Process, Hearings and approvals, what does an approval provide?

 Risk Management and post approval obligations.

 Commercialising a product

 What is the market? How do you design a product for a market? How do you launch your product?

 How a Pharmaceutical Company is structured

 Functions within the company, the governance and obligations? What is the current Pharmaceutical environment? How is it changing? Industrial relations. Investor relations.

 Pharma Industry challenges.

 Strategic Partnering and Business development. How is it run? Searching for products. Initial evaluation. Due Diligence. The teams involved

 Financial analysis. Introduction to all parameters studies. PYS, IRR eIRR NPV eNPV ROI etc. The Business case. Compilation and delivery of the Business case. Media Training,

 Communication Skills. Disclosure Committees

 Product and Science Due Diligence.

 Where DD fits in the process. What the initial assessments will have told you and what the difference is here between early evaluation and Due Diligence

 What the team looks like. What e rooms are, what paper rooms are like?

 How a team is formed, who sits on the team and why? Where a bench scientist may sit, what they will be doing? What is the meeting like, who does what? What are you looking for, what interactions do you have with their scientists

 Who rights the report, who takes notes? What's the legal standing of the reports? What do you do with the report? The kind of issues you find, what are the problems? What to look for. What to consider as an employee in Discovery? One day someone may undertake DD on your work

 Clinical Development

 Strategic Clinical Development and Medical affairs. Study types, Phase 1 2 and 3. The requirements pre toxicology for commencement of each phase. Multi-disciplinary teams. The role the scientist may play in metabolite identification, sample analysis etc.

 Centre selection, Advisory board, Safety Board and Regulatory clearance.

 Ethics boards. Use of contract organisations. Data interpretation, audits

  

 Introduction to Financial Evaluation of Science and Product Evaluation

 The Financial Director in a Strategic Partnering and Business Development Team, what role do they play? A financial business case. What do you look for, what parameters do you study, what are the terms and what do they mean. What information do you need for a business case? Who do you need to influence?

 What measures would make a business case approvable, i.e. what are the acceptable limits for a pre-clinical, phase 1, phase 2 opportunity etc.? Venture capital, what does this mean?

 How does it work? Basic Financial parameters.

  

 Pharma Strategic marketing.

 International marketing. Customer relations. Risk management.

 Entrepreneurship and the challenges of setting up a company

 Small and medium enterprises. Spin out and commercialising research. Biotech industry.

 Raising Funds.