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Lecture Number / Topic / Sub-Topic1 / Introduction / Syllabus, Course Requirements, Semester Work,
Israel Biotech / Yazamut: Key Expressions, Definitions for Israel vs US vs Europe
State of Industry - Overview, Industry Sections: Pharmaceuticals, Diagnostics - Medtech (Medical Devices), Agro-Bio, Environmental Science, Food Industry
2 / Biotech
Start-Up Company / How to start a Start-Up?
Life-Span of a Company,
Toolbox / Enabling Technologies and Tools; Technology Platforms,
Invention Infrastructure,
Academy - Industry, R&D Comparison / Academic Research, Corporate Research (US, Europe), (US, Europe, Israel), Why Government Support of Industrial Research?
Academic Research / Clinical Research versus Industrial Research, Development Strategy, Development along Milestones; Research Collaboration between Industry and Academy/Clinic,
3 / Trends / From Genomics to Proteomics (Post-Genomics), Pharmaco-genomics,
Intellectual Property, Patents, / Writing a patent: a new language; Publish or perish versus patenting in Academy, Medicine, Industry, Assignment by inventor to University; Patents; Trade Mark, Brand Name, Industrial Design. Obtaining enforceable patents; Enforcing patents; Developing patent strategies; IP portfolio
Research Documentation; Notebook Keeping;
Ethical Drugs - Generic Drugs,
4 / Technology Transfer / Technology Marketing, Creating Value through licensing (Out-Licensing, In-Licensing), Exclusive License - Non-Exclusive License,
Israeli Biotech Company based on technology/patents licensed by Universities; University technology transfer entities/companies.
Case Studies (Why did it succeed? Why did it fail?)
Toolbox / Nanotechnology, Bio-Nanotechnology,
5 / Biotech
Start-Up Company / Team: Who is the Boss? Leadership by CEO. Scientist and/or Businessman? Forming a Winning Team; Creating a Learning Institution, CV, Job Interview, Work Contract; Board of Directors, Confidentiality Agreement,
Basic Negotiation Principles
Fee Service Providers (Legal, Tax, Accounting)
Business Plan, Outline of Semester Work: Mission, The Company, Technology, Product, Development Strategy , The Market Place, Marketing Strategy, The Financial Model
6 / Market / Customer, End-User, Locate Demand Needs, Finding Unmet Needs, Me-too Product,
Defining of Market Size, Reimbursement by Health Insurance, Global Village, Analysis of Competitor, Opportunistic Niches, Growth Potential, Opinion Leader, Conventions and Exhibitions,
Healthcare-Economics / Total Disease Management: Prevention, Predisposition Testing, Identifying Patient Population Subsets, Early Diagnosis, Initiation and Determination of Treatment, Monitoring, Surveillance, Invasive, Non-Invasive, Point-of-Care - Bedside Testing, Home Care, Connectivity, Tele-Medicine
7 / Product Marketing / Product Focus , Market Focus , Technology Focus
Case Studies (Why did it succeed? Why did it fail?)
Business Model,
Case Studies (Why did it succeed? Why did it fail?)
Public Debates / Genetically Modified GM Foods, Educating the Customer, Functional Food, Recombinant Industrial Enzymes,
8 / Product Marketing and Manufacturing / Alliances, Strategic Partners, Manufacturing: Outsourcing, Original Equipment Manufacturer (OEM) Case Studies
Patient Rights, Product Liability, Risk of Litigation, Arbitrate versus Litigate, Patent enforcement in Biotech,
Toolbox / Stem Cells, Cancer Vaccines and Gene Therapy
9 / Regulatory Issues / Clinical Trials, Pre-Clinical, Clinical Studies, Phase I, Phase II, Phase III, Post-Marketing - Late Phase III/VI Studies, Regulatory Product Approval Process, GLP, QC/QA, Waste Management, Environment Protection
Public Debates / Animal Rights Activism
10 / Capital Sources
Investor's Perception / Private Investor, Angel, Venture Capital Funds, Institutional Investors, Strategic Partners, Banks
Governmental Sources, Matching Funds, Magnet, Magneton, Bi-National Funds, European 6th Framework Program
Toolbox / Bio-Materials, Tissue Engineering
11 / Incubator Start-Up / Government funded Start-Up, Biotech Incubator, Basic Conditions,
Case Studies (Why did it succeed? Why did it fail?)
Non-Incubator Start-Up / Seed Investment, Smart Money, Quick Money, Expensive Money, Attracting Investors, Management along Expectations,
Case Studies (Why did it succeed? Why did it fail?)
12 / Next Financing Rounds / Company Valuation, Initial Stock Issuance, Investment Rounds, Warrants, Options and other Equity Issues, Exits,
Merger and Acquisitions, Initial Public Offering (IPO)
Toolbox / BioChip, BioArray, Lab-on-a-Chip, BioSensor, Bio-defense,
13 / Presentation Day / 4 Minutes Company Presentations for Investors
(Student Teams)
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Syllabus/369-2-5351/21.10.03