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  • 1. "Business for Bioscience - a Course for your Reference", Oxford Brookes University Business School An introduction to Biotechnology business for professionals working in the sector The following text describes the extensive contents of the Business for Bioscience course, which you will find the perfect complement to the IBC, as well as a most effective desk reference for life sciences, biotech and pharmaceutical desk knowledge issues in your workplace. Seminar 1 Key issues in managing a Bioscience Enterprise  The business of bioscience - Growing a bio business - The planning process - Funding strategies  WebCT eLearning platform and online content - An introduction to business planning - Business models and strategy - Business plan structures M0 Business Plan Assignment  Business plan course assignment and criteria  Example business plan UKTI Industry Briefing Course “Bioscience for Business” 1
  • 2. Module 1 Developing a Knowledge-Based Business M1a Entrepreneurial Development of Knowledge-Based Industries  Introduction to Business Development and Knowledge-based Businesses - Knowledge-based industry - The knowledge- infrastructure and developing new businesses - The business idea - The business plan  The Role of the Classical Entrepreneur - The classical entrepreneur - Creating a commercial proposition - Opportunities and entrepreneurship in the biotech industry  The Industry Life-cycle and the Environment - The industry life-cycle concept - Biotech industry life-cycle - Different skill-sets required as an industry develops - Influence of the business environment  The Basic Ingredients of a Business - Markets and customers - Product strategy and planning - People - Business Structure - legal and organisational - Management systems - Finance M1b Producing a Business Plan  Introduction to Business Planning - Learning Outcomes - Why bother with a business plan? - Purpose of a business plan - Fundamental approaches to business planning  How to Structure a Business Plan - Learning outcomes - Business plan structures - High Tech business plans - Wheatley Biopharm: example MS Word template UKTI Industry Briefing Course “Bioscience for Business” 2
  • 3. Module 2 Sector Overview M2a Sector History  Bioscience Sector History to 1990 - Introduction - The Emergence of the Modern Bioscience Industry - The Science of Biotechnology - Scientific Knowledge and Research & Development - Biotech Industry in the USA - Development of UK Biotechnology in the 1980s - Europe - The Problems Facing Biotechnology Companies - Relationships between Biotechs and Pharmaceuticals  Bioscience Sector History 1990 to 2005 - Introduction - OECD Statistical Definition of Biotechnology - Defining a Biotechnology Company - Growth of a Global Industry - Biotech and the Capital Markets - Development of Technologies and Biotech Products - Specialisation - Alliances and Consolidation - Summary and Conclusions  Case Study - The Development of Powderject plc - Powderject Presentation (Steve Harris CFO) M2b Sector Structure  Overview of Key Bioscience Sub-Sectors - Introduction - Red, Green and White Biotechnology - Bioscience Research Products and Services - Diagnostics and Devices  Sector Locations and Clusters - Introduction - Specific Geographic Areas UKTI Industry Briefing Course “Bioscience for Business” 3
  • 4. Module 3 Commercial Strategies and Strategic Planning M3a Commercial Strategies  Developing a Commercial Strategy - Strategic Plannning – Key Concepts and Elements - The External Environment - The Internal Environment  Biotech Business Models and Strategies - Role of Technology Transfer Organisations - Classifying Biotech Companies by Business Model - Development Strategies  Alliance Strategies and the Partnering Process - Why are Alliances Formed? - Key Factors in Alliances - The Partnering Process - Alliance Models and Trends in Partnering  Additional Considerations - Strategic Marketing - Pharmacoeconomic Analysis - Outsourcing or Virtual Project Development  Case Study - Human Genome Solutions Inc  Summary M3b Strategic Planning  Introduction to Strategic Management - What is Strategy? - What is ‘Business Strategy’ and Strategic Management? - The Nature of Strategic Decisions - Core Areas of Strategy  The Strategy Process - Analysis, Development and Implementation - Approaches to the Strategy Process - A Strategic Decision-Making Hierarchy - The Strategy Framework  The Entrepreneurial ‘Vision’ and ‘Mission’ - The Entrepreneurial Vision - Mission Statements - Developing a Mission Statement UKTI Industry Briefing Course “Bioscience for Business” 4
  • 5. - The Next Step – Reviewing Where We Are Now  Analysing the External Environment - Framework for Analysing the External Environment - PEST Analysis – Analysing the External Environment - Analysing the Industry Environment - Competitor Profiling and Market Strengths - Customer and Market Segmentation - Outcome of the External Analysis  The Internal Strategic Audit - Adding Value and the Transformation Model - The Value Chain - Auditing Operations - The Human Resource Audit - The Financial Audit - Outcome of the Internal Strategic Audit  Identifying and Evaluating Strategic Options - Synthesising the Analysis - Core Competencies of the Organisation - Framework for Determining Strategic Options - Strategies for Development and Growth - Generic Competitive Strategies and Competitive Advantage - Conclusion UKTI Industry Briefing Course “Bioscience for Business” 5
  • 6. Module 4 Intellectual Property Law M4a IPR Patents and Biotech  Overview of Intellectual Property Law - Introduction - The Intellectual Property Rights - Sources of UK Intellectual Property Law - International Regulation of IPR - Remedies for Infringement of IPR - Intellectual Property Law and Competition Law - Exhaustion of IP Rights in the EU - Abbreviations Used in this Module - Table of Main Features of IP Law  Patent IP - Introduction - The Applicant Must Be Entitled to the Grant of the Patent - Four Key Requirements of the Invention - Overview of Application for Grant of a Patent - Steps in the Application Process - Infringement  Biotech Intellectual Property and Patents - Review of Intellectual Property and Biotechnology - Biotech Patent Rights - Filing Biotech Patent Applications - The US Patent System - Patent Costs - Confidentiality, Ownership and Research Exemption - Patentability of Biological Materials - Building up a Patent Portfolio M4b Details of Other IPR  Copyright and Moral Rights - What is Copyright - Copyright Ownership - Copyright Permissions - Copyright Law - Infringement and remedies - Moral Rights  Design Right and Passing Off - Introduction - Registered Design Right - Unregistered Design Right - Passing Off UKTI Industry Briefing Course “Bioscience for Business” 6
  • 7.  Trade Marks - Introduction - What is Registrable as a Trade Mark - What is Not Registrable as a Trade Mark - Applying for Registration in the UK - Transmission of Ownership - Infringement - Defences - Remedies - Removal from the Register for Non-use - European Community Trade Marks - Choice of System - Appendix - Cases on Infringement  Confidential Information - Introduction - Nature of Confidential Information - Protectable Confidential Information - Types of Confidential Information - Duty of Confidence and Third Parties - Pre-requisites to Liability - Defences to an Action for Breach of Confidence - Remedies for Breach of Duty of Confidence - Employer/Employee Relationship - Confidential Information and Franchise Arrangements - Appendix – Cases on Confidential Information UKTI Industry Briefing Course “Bioscience for Business” 7
  • 8. Module 5 Introduction to Management M5a What is Management ?  Introduction to Management Skills - Managerial Competencies - Self-Management Competency  Knowledge and Skills for Learning  Keeping a Learning Diary  The Nature of Management - What is Management? - The Process of Management - What Makes an Effective Manager - The Nature of Managerial Work - Management Roles  The Development of Management Ideas - An Historical Perspective - Early Practices - The Classical Era - The Behavioural Era - Total Quality Management - A Contingency Perspective  Managerial Behaviour and Effectiveness - Managers' Attitudes and Management Style - Getting Things Done Through People - Management by Objectives - Developing a Management Style M5b Personal Development and Communication  Managing Your Personal Development - Managerial Development - Learning as a Key Competence - The Learning Cycle and Learning Styles - The Learning Environment - Developing Self-Insight and Addressing Development Needs - Identifying Development Needs and Setting Objectives - Choosing Development Activities - Producing a Development Plan  Effective Communication - The Communication Process - Communication Skills UKTI Industry Briefing Course “Bioscience for Business” 8
  • 9. - Non-Verbal Behavioiur - Active Listening - Giving and Receiving Feedback - Communicating Assertively - Interviewing Skills M5c Problem Solving, Decision Making and Planning  Problem Solving and Decision Making - Closed and Open Problems - Problem Solving Process - Types of Thinking - Problem solving techniques - Defining the Problem - Generating Alternative Solutions - Decision Making Process  Thinking Purposefully About the Future - Planning - Key Result Areas (KRA) - Setting Goals - Strategic Planning Process SEMINAR 2 - Managing Organisations  Managing Intellectual Capital  Critical Evaluation of Management Theories UKTI Industry Briefing Course “Bioscience for Business” 9
  • 10. Module 6 Managing Organisations M6a Individuals and Organisations  Individuals in Organisations - The Organisation as a Collection of Individuals - Understanding Conflict - Attitudes and Behaviour - Attitude Change  Perception - The Process of Perception - Perceptual Distortions and Errors - Management and Gender  Context of the Organisation - The Planning Process - The Planning Process within the Organisation - Management by Objectives - Case Study on Managing by Objectives M6b Structures, Groups and Leadership  Organisational Structures and Systems - Organisation Design - Types of Organisation Structure - Coordination Mechanisms - How Organisations Function - Five Structural Configurations  Groups - Use of Groups in Organisations - Types of Workgroup - The Group Process - Group Communication Networks  Leadership - Power and Influence - Leadership Traits - Leadership Types, Behaviours and Attitudes - Functional Approach to Leadership M6c Managing Change and Motivation  The Complexity of Organisational Change - The Nature of Organisational Change - How to Manage Organisational Change - Key Issues for Change to Happen UKTI Industry Briefing Course “Bioscience for Business” 10
  • 11.  The Nature of Motivation - The Meaning of Motivation - Theories of Motivation  Motivation, Job Satisfaction and Work Performance - The Nature of Job Satisfaction - Role Conflict and Role Ambiguity - The Problem of Alienation - Delegation and Empowerment - The Art of Delegation - How to Empower Staff UKTI Industry Briefing Course “Bioscience for Business” 11
  • 12. Module 7 Marketing M7a Concepts and Processes  Introduction to Marketing - Exchange Processes and Marketing - What is Marketing? - Marketing Activities and the Marketing Mix - The Business Environment and Marketing - Segmentation and Targeting - Marketing Department Activities - Summary  A Further Look at What Marketing Is - The Development of Marketing - What is Marketing?  The Marketing Mix  A Marketing Orientation  Other Orientations  A Management Process  A Specific Function – Marketing Management  A Definition of Marketing - The Marketing Mix - The Marketing Environment - Are Marketing Departments Necessary - Value of the Marketing Concept - Role of Marketing in Organisations - Marketing Planning  Buyer Behaviour and the Buying Process - Needs, Motivations and Wants - A Model of the Consumer Buying Process - Factors Influencing Buyer Behaviour - Organisational Buying Process and Behaviour - Summary  Introduction to Marketing Research - The Need for Good Marketing Research - The Marketing Research Process - Sources of Marketing Research Data - Summary  Marketing Mix – Product - Features and Benefits - What is a Product? - The Product Life-Cycle Concept - Summary  Marketing Mix – Price and Place UKTI Industry Briefing Course “Bioscience for Business” 12
  • 13. - General Approach to the Pricing of Products - Place and Channels of Distribution - Summary  Marketing Mix – Promotion (Communication) - The Process of Communication - Marketing Communication Objectives - Product Adoption Process - The Marketing Communications Mix - Sales Promotion - Advertising and PR M7b BioMarketing  The Role of Marketing in Bioscience - Role of Marketing in Pharmaceutical R&D - Ethical Questions about Drug Marketing  Marketing Strategy - Marketing Case Study – Zantac - Strategies to Survive Patent Expiration  Market Dynamics and Corporate/Business Strategy - Roche’s Strategy in the Healthcare Sector  Pricing - The Pricing Puzzle - Price Controls and How Drug Prices are Calculated  Promotion - Regulation of the Promotion of Prescription Medicines in the UK - PR and Reputation Management  BioMarketing Tools and Models - Market Evaluation Model for Biotechnology - Forecasting New Product Revenue  Market Information - .Fundamentals of the US prescription drug market - Biotech blockbuster forecasts to 2008 - Leading biotechnology players 2002 to 2008 - The DNA RNA Market (April 2005) - The immunotherapies markets 2003 to 2008 - The market of the therapeutic recombinant proteins to 2010 - Trends in biotherapeutics (June2003) UKTI Industry Briefing Course “Bioscience for Business” 13
  • 14. Module 8 Accounting and Finance M8a Management Accounting  What is an Accounting System? - Chart of Accounts and Recording Transactions  - The Chart of Accounts  - What Happens in Business Transactions?  - How are Such Transactions Recorded?  - The Trial Balance  - Sales Ledger and Purchase Ledger - Financial Statements  - The Concept of Profit and the P & L Account  - The Concept of Profit and the Balance Sheet  - Depreciation  Other Fundamental Concepts - Further Accounting Concepts and Principles  - Periodicity  - Going Concern  - Historic Cost Convention  - Realisation  - Matching Principle  - Cash and Profit  - Gross Profit and Gross Margin  - Mark-UP  Cost Accounting - Cost Classification and Cost Behaviour - Costing Methods and Techniques - Break-Even Analysis - Decision Making M8b Financial Management  Financial Decision-Making - Financial Decisions and Capital Structure  Overview of Financing a Business  Choosing a Funding Option  Capital Structure – An Appreciation of Gearing - Investment Decisions  The Use of Funds Raised  Capital Expenditure  Managing Cash Flow - Liquidity and Cash Flow Forecasting  An Appreciation of Liquidity  Cash Flow Forecasting - Working Capital Management  Managing Current Assets and Liabilities UKTI Industry Briefing Course “Bioscience for Business” 14
  • 15.  Use of Ratios  Financial Performance - Measuring Financial Performance and Profitability  Hierarchy of Performance Ratios  Calculating and Using Performance Ratios  Budgeting - Basic Concepts in Budgeting  The Nature and Benefits of Budgeting  Budgetary Planning and Budgetary Control  Fixed and Flexible Budgeting  Cash Budgeting - Other Methods of Budgeting and Managerial Issues  Zero-based Budgeting  Activity-based Budgeting  Managerial Aspects of Budgeting M8c Biotech Fundraising  Introduction to Funding - The Nature of Venture Capital - Effective Business Plans for Investors - The Venture Capital Funding Process  Valuation of Biotech Companies - How Biotech Companies are Valued  Equity Financing - Private Equity and Venture Capital Term Sheets - The Venture Capitalists’ Viewpoint  Resources - Glossary and Funding Associations UKTI Industry Briefing Course “Bioscience for Business” 15
  • 16. Module 9 Research, Development and Regulation M9a Discovery and Pre-Clinical Research  Discovery Research - Discovery Research Introduction - Medicinal Chemistry - Medicinal Chemistry - Combinatorial Chemistry - High Throughput Screening - Small Molecule Synthesis  Pre-Clinical Research - Bioanalytical Techniques - Pharmacokinetics/ADME - Toxicology - Toxicokinetics - Acute Toxicity Studies M9b Product Development  Regulatory Overview - Introduction - Regulatory Submission – European Requirements  Active Pharmaceutical Ingredients - Introduction - Selection of Active Pharmaceutical Ingredient - Characterisation of Active Pharmaceutical Ingredient - Routine Characterisation: Active Ingredient Specification - Stability Profile - Process Development - Manufacturing  Development of Formulated Products - Selection of the Dosage Form - Selection of Excipients - Sourcing of Excipients - Selection of Primary Packaging Materials - Manufacturing Issues - Process Development  Analytical Techniques - Introduction - Impurity Profiling - Importance of Chiral Techniques UKTI Industry Briefing Course “Bioscience for Business” 16
  • 17. - Pharmacopoeial Methods - Bioavailability and Bioequivalence Studies - Dissolution Testing  Validation and Stability Testing - Analytical Validation  Purpose of Analytical Validation  Validation Characteristics  Revalidation of Analytical Procedures  Validation of Bioanalytical Methods - Process Validation  Introduction  Approaches to Process Validation  The Validation Program - Stability Testing  Introduction  Formal Stability Studies  Formulated Product Stability  Established Active Ingredients and Related Formulated Products  Biological and Biotechnology Products - Introduction - Manufacture of the Bulk Product - Methods of Manufacture and Detailed Descriptions - Process Validation and Control - Manufacture of the Formulated Product - Specifications and Acceptance Criteria - Stability Testing of Biological/Biotechnology Products - Labelling UKTI Industry Briefing Course “Bioscience for Business” 17
  • 18. M9c Regulatory Affairs: Clinical Research and Approval to Market a Drug  The Regulatory Environment - Introduction and Historical Perspective - EU Pharmaceutical Regulation - UK Medicines and Healthcare Products Regulatory Agency (MHRA) - European Agency for the Evaluation of Medicinal Products (EMEA) - USA Food and Drug Administration (FDA) - Towards Harmonisation (ICH) - Planning Regulatory Documentation - Regulatory Affairs Department and Scientific Disciplines  - Modular and Non-Modular Approaches  - Standardisation of Report Formats and Review Processes  The World Health Organisation  Clinical Trial Regulatory Approval and Management - Clinical Trial Approval Process in the EU - Clinical Trial Approval Process in the USA - The Clinical Investigators’ Brochure (CIB)  Introduction  Structure and Content of the CIB - Clinical Trial Management  Regulatory Approval to Market a Drug - Regulatory Approval to Market a Drug or Biologic in the EU - Regulatory Approval to Market a Drug or Biologic in the USA  Regulation of Promotion, Post-Marketing Evaluation and Pharmacovigilance - Control of the Promotion of Medicines - Post-Marketing Evaluation and Pharmacovigilance UKTI Industry Briefing Course “Bioscience for Business” 18
  • 19. Module 10 Completing the Business Plan  Evaluating a Business Venture and Plan - How a Business Plan is Assessed - The Elevator Test - Relations with Investors - Final Thoughts and Review UKTI Industry Briefing Course “Bioscience for Business” 19

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