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Biology 116-Biotechnology. Ralph M. Sinibaldi, Ph.D. . Course Goals. Technical training for research, development or production positions in biotech Conceptual training in molecular biology and biotechnology Biotech Industry overview Soft skill training Resumes Interviews

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Biology 116-Biotechnology

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    1. Biology 116-Biotechnology Ralph M. Sinibaldi, Ph.D. .

    2. Course Goals • Technical training for research, development or production positions in biotech • Conceptual training in molecular biology and biotechnology • Biotech Industry overview • Soft skill training • Resumes • Interviews • Project teams and teamwork

    3. Learning Outcomes • Describe the science of biotechnology and identify its product and company domains • Give examples of careers and job responsibilities associated with biotechnology • Understand and apply safety considerations and lab etiquette • Describe how scientific methodologies are used to conduct experiments and develop products • Understand and apply rules of documentation and intellectual property • Describe what intellectual property is and why it is important in biotechnology • Understand regulatory compliance and what agencies are responsible for it • Describe the Human Genome project and be able to discuss its implications

    4. Vocabulary • Insulin – a protein that facilitates the uptake of sugar into cells from the blood • DNA – abbreviation for deoxyribonucleic acid, a double-stranded helical molecule that stores genetic information for the production of all of an organism’s proteins • Recombinant DNA (rDNA) technology – cutting and recombining DNA molecules • Polymerase chain reaction (PCR) – a technique that involves copying short pieces of DNA and then making millions of copies in a short time • Cloning – method of asexual reproduction that produces identical organisms • Fermentation – a process by which, in an oxygen-deprived environment, a cell converts sugar into lactic acid or ethanol to create energy • Diabetes – a disorder affecting the uptake of sugar by cells, due to inadequate insulin production or ineffective use of insulin • Proteases – proteins whose function is to break down other proteins • Antibodies – proteins developed by the immune system that recognize specific molecules (antigens) • Pharmaceutical – relating to drugs developed for medical use

    5. Vocabulary • Research and development (R&D) – refers to the early stages in product development that include discovery of the structure and function of a potential product and initial small-scale production • Pure science – scientific research whose main purpose is to enrich the scientific knowledge base • Virus – a particle containing a protein coat and genetic materials (either DNA or RNA) that is not living and requires a host to replicate • Applied science – the practice of utilizing scientific knowledge for practical purposes, including the manufacture of a product • NIH – abbreviation for National Institutes of Health; the federal agency that funds and conducts biomedical research • CDC – abbreviation for Centers for Disease Control and Prevention; national research center for developing and applying disease prevention and control, environmental health, and health promotion and education activities to improve public health • DNA fingerprinting – an experimental technique that is commonly used to identify individuals by distinguishing their unique DNA code

    6. “New technology is neither inherently good or harmful, this is determined by how man chooses to use the technology”

    7. What is Biotechnology? Biology Technology

    8. Defining Biotechnology Biotechnology is defined as the study and manipulation of living things or their component molecules, cells, tissues, or organs.

    9. Biotechnology Business and Business Strategy

    10. Fact • Most new Biotech Companies Ultimately Fail

    11. Domains of Biotechnology. The major domains of biotechnology include 1) industrial and environmental; 2) medical/pharmaceutical; 3) agricultural; and 4) diagnostic/research

    12. Types of Companies • Product Development • Advantages • Therapeutic products with large markets • Patent protection • High gross margins • Disadvantages • High risk • Long development times • Platform Technologies • Advantages • Shorter development times • Lower risk • Disadvantages • Highly competitive with ever changing technology

    13. Types of Companies • Reagent • Advantages • Short development time • High profit margins • Disadvantages • May not be proprietary • Manufacturing costs driven • Service • Advantages • No manufacturing • Can be highly profitable • Disadvantages • Can underestimate costs

    14. Type of companies • Equipment or Instruments • Advantages • Proprietary • Can bundle with associated reagents • Disadvantages • Significant capital investment • Lower margins on instruments

    15. An Idea or a Technology Projected product(s) or service(s) Market Analysis Business Plan Funding Seed round Friends & Family Early Venture Capital Investor Angel Investor(s) “A” round Venture Capital Angel Investors “B” Round Venture Capital Corporate Investors or Partners “C” Round Exit Strategy IPO or Acquisition Starting a Company

    16. Summary-two pages Market Opportunity Company background- stage & type Market Market analysis Competitors Technology Proof of concept Similar technologies Expert opinions Intellectual property Patent applications Potential conflicts Development Plan Marketing Plan Distribution Management Org chart Bios of Principals Appendices Business Plan

    17. Role of People • Corporate structure • Skill base of employees • Building the right team • Human resources system

    18. Technology • Publications • Patents • Proof of concept for components • Breadboard • Full Working prototype

    19. Types of Finance • Debt Financing • Loans • Credit • Equity Financing • Private stock • Friends & family • Private investors • Angel Investors • Venture Capital funds • Corporate partners

    20. Other Sources of Funding • Grants • SBIR • NIH, NSF, USDA, NASA, NIST • Stage I- $100,000.00 • Stage II- $750,000.00 to 1 million • ATP- 2 million up to 32 million • DARPA- national defense applications • Corporate partnerships • Marketing & Distribution relationship • Equity

    21. What appeals to investors • Technology • Business Plan • Management Team • Multiple Products

    22. Compensation • Salary • Bonus -10 to 30 % of salary • Must achieve aggressive goals • Stock options • Founder’s • Employee

    23. Corporate Structure Hierarchical

    24. Corporate Structure-Matrix

    25. Corporate Structure-Hybrid • Hierarchical & Matrix Combined • Departmental Organization • Multidisciplinary Project Teams

    26. Decision Making • Technology-based • Research • Manufacturing • Resource-based • Marketing-based

    27. Reducing Chances Large and Unpredictable Capital Requirements Long Product Development Cycles Regulatory Issues with Product Rapidly Changing Market Forces High Probability of Late Stage Product Failure Rare Instances of Sustained Profits Increasing Chances Capital Requirements Kept Low Well-Defined, Predictable Business Milestones Clear, Market-Oriented Business Plan Critical Mass to Successfully Compete Experienced Management Relevant to Strategy Being Pursued Sustainable Business

    28. Evolution of Company • Production-based • Technology-based • Market-based

    29. Marketing SWOT analysis • Strengths • Weaknesses • Opportunities • Threats

    30. Safety

    31. Safety Values • Safety is not just a priority but a value • Safety is an unwritten rule, a special norm, the workers should follow in all circumstances • It is a value that is never questioned or compromised

    32. Safety Habits • Safe for you and me • Prevent accidents by noticing at-risk situations and behaviors • Live safely at home, at work, and everywhere you go • Teach an attitude, promoting safety

    33. Personal Safety • Right to work in a safe workplace • Responsibility • Protect your circle of safety and know how it may influence others • Illness and Injury prevention program

    34. Work Environment • Organize safety for everyone • Remove tripping hazards • Do not store heavy items up high where they may fall • Do not rush or run in the workplace • Cleanup any liquid spills immediately • Report any potential hazards

    35. Stress can lead to accidents • Recognize personal burn-out • Get enough sleep • Get professional help • Respect emotions of coworkers • Develop active listening skills • Develop positive, healthy relationships with coworkers

    36. Emergencies • Medical response • Earthquake • Fire • Chemical spills • Regional disasters

    37. What to do • Know emergency numbers-911 etc. • Be prepared and have a plan • Follow plan • Stay calm • Consider immediate need and response • Communicate with others • Know safety procedures, tools & escape routes

    38. Neighborhood or regional disaster • Home communication plan • Know alternative routes • Know who are your neighbors • Be a good citizen • You may have to stay where you are

    39. Emergency Evacuation Plan • Assist those who need help to get to the protected area • Know who is present and absent • Communicate with other tenants • Be prepared for first aid and medical responses

    40. Medical responses • Immediate first aid • Notify response teams, call 911 • Provide assistance and comfort • Transport to trauma or urgent care facility

    41. Earthquake Safety • Stay calm, shield yourself from falling objects • Prevent falling objects by storing heavy objects low and tie down equipment • Keep aisles and routes clear • Follow evacuation plan

    42. Fire Safety • Report fires immediately-response time is critical • Know locations of fire fighting equipment • Extinguishers • Fire blankets • Fire alarm • Know when to evacuate & get everyone out • If smoke is present stay low, crawl if necessary • Know evacuation route

    43. Fire Extinguishers • Classification • A- Ordinary combustible • B- Flammable Liquid • C- Electrical • D- Combustible metal • P-A-S-S • Pull-Aim-Squeeze-Sweep • Aim at the base of the fire and sweep • Limited time and quantity of extinguishing material

    44. Personal Protection • Actively work to prevent & avoid accidents • Protect working space • Protect coworkers • Secondary containment- create boundaries & layers of safety appropriate for conditions and scale of work

    45. Working with hazards • Create a safety zone, CONTAIN • Know the hazard, PROTECT • Protect yourself • Protect those around you • Protect environment around you • Safe to touch, DECONTAMINATE • Secondary & tertiary zones reduce the chances of injury or disaster

    46. Personal safety attire • Lab coat • Safety glasses • Closed-toed shoes • Gloves when appropriate

    47. Chemical safety • Know the hazards-MSDS sheets • Specialized training may be necessary • Proper storage of chemicals • Use proven well thought-out protocols • Additional personal protection attire may be required • Face shield • Chemical goggles • Latex gloves and aprons • Additional shielding • Adequate ventilation • Proper disposal of chemicals

    48. Radiation safety • Proper training • Shielding • Monitoring equipment • Geiger counter • Wipe tests • Proper storage and disposal of radioactive materials

    49. Radiation Safety • Commonly used isotopes • 14C, 35S, 32P, 3H, 125I, 131I • Geiger counters • Different probes • Scintillation Counters • Radiation exposure badges

    50. Lab Etiquette & Lab Operation