Biotechnology Basics Quiz
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Questions and Answers

What does the term 'biotechnology' consist of?

  • Life, Technology, and Knowledge
  • Cells, Organisms, and Products
  • Bio, Technos, and Logos (correct)
  • Science, Technology, and Agriculture
  • Biotechnology only focuses on living organisms.

    False (B)

    What is a primary purpose of biotechnology?

    To develop products and/or services beneficial to human welfare.

    The term biotechnology is derived from the Greek words for life, technology, and ______.

    <p>thinking</p> Signup and view all the answers

    Match the following areas of biotechnology with their descriptions:

    <p>White biotechnology = Industrial processes using enzymes Green biotechnology = Agricultural applications Blue biotechnology = Marine and aquatic applications Red biotechnology = Medical applications</p> Signup and view all the answers

    Biotechnology is solely a part of the health sector.

    <p>False (B)</p> Signup and view all the answers

    Which organization's meeting is referenced in relation to biotechnology statistics?

    <p>OECD</p> Signup and view all the answers

    What is the average cost of generating a single new drug?

    <p>$500 million (D)</p> Signup and view all the answers

    It takes approximately 15 years for a new drug to go from discovery to the marketplace.

    <p>True (A)</p> Signup and view all the answers

    What are the main phases involved in clinical trials for drug testing?

    <p>Phase I, Phase II, Phase III</p> Signup and view all the answers

    Novel foods must undergo a safety assessment before being placed on the EU market according to the ________ Regulation.

    <p>Novel Food</p> Signup and view all the answers

    Match the following regulatory entities with their area of regulation:

    <p>FDA = Drugs EMA = Drugs EU Novel Food Regulation = Foods National Competent Food Authority = Food safety assessments</p> Signup and view all the answers

    What is the first step in the drug development process?

    <p>Laboratory and Animal Models (D)</p> Signup and view all the answers

    Products considered 'substantially equivalent' can follow a simplified application procedure.

    <p>True (A)</p> Signup and view all the answers

    What two main agencies regulate drug approval in the US and Europe?

    <p>FDA and EMA</p> Signup and view all the answers

    What does Intellectual Property primarily refer to?

    <p>Creations of the mind and intellect (A)</p> Signup and view all the answers

    Industrial property rights and intellectual property rights are considered separate concepts worldwide.

    <p>False (B)</p> Signup and view all the answers

    What legal title confers the right to prevent others from commercially exploiting an invention?

    <p>Patent</p> Signup and view all the answers

    Intellectual Property seeks to protect _____ goods, which are products of human intellectual activity.

    <p>intangible</p> Signup and view all the answers

    Match the following types of Intellectual Property with their examples:

    <p>Trademark = Logos Copyright = Literary works Patent = Technical inventions Sui Generis Law = Cultivars</p> Signup and view all the answers

    Which of the following is a requirement for an invention to be patentable?

    <p>The invention must have novelty (D)</p> Signup and view all the answers

    A patent guarantees the invention will remain a secret for a specified period of time.

    <p>False (B)</p> Signup and view all the answers

    What is the primary purpose of intellectual property rights?

    <p>To protect creators' rights and prevent unauthorized use of their work.</p> Signup and view all the answers

    ____ refers to the exclusive rights granted for a certain period in exchange for invention disclosure to the public.

    <p>Patent</p> Signup and view all the answers

    Which of the following best describes the role of the World Intellectual Property Organization (WIPO)?

    <p>To provide legal protection for original creations (D)</p> Signup and view all the answers

    What year was the first biotech IPO?

    <p>1980 (D)</p> Signup and view all the answers

    What was the first genetically engineered drug released?

    <p>Human insulin (C)</p> Signup and view all the answers

    Roche acquired Genentech for US$ 46.8 billion.

    <p>True (A)</p> Signup and view all the answers

    What are the primary focuses of agricultural biotech?

    <p>Environmentally friendly solutions and crop adaptation.</p> Signup and view all the answers

    Which color of biotechnology is associated with industrial processes?

    <p>White (A)</p> Signup and view all the answers

    Roche acquired Genentech in _____ year.

    <p>2009</p> Signup and view all the answers

    Match the type of biotechnology with its primary focus:

    <p>Green = Agricultural processes White = Industrial processes Blue = Marine resources Red = Human health</p> Signup and view all the answers

    Companies involved in blue biotechnology often have low research and development costs.

    <p>False (B)</p> Signup and view all the answers

    What is a common funding source for biotech start-ups?

    <p>Angel investors and venture capital</p> Signup and view all the answers

    What major challenge do most biotech firms face compared to big pharma?

    <p>Ongoing product revenues (B)</p> Signup and view all the answers

    Corporate spin-offs have a higher success rate than _____ spin-offs.

    <p>university</p> Signup and view all the answers

    All biotech product candidates are considered significant for the company's success.

    <p>True (A)</p> Signup and view all the answers

    What is the immediate consequence of product failures for biotech firms?

    <p>They must report the failures.</p> Signup and view all the answers

    Which area does white biotechnology NOT focus on?

    <p>Crop adaptation (D)</p> Signup and view all the answers

    Match the funding type with its description:

    <p>Angel Investors = Early-stage investment from wealthy individuals Seed Investors = Initial funding to start a business Venture Capital = Investment from firms in exchange for equity Friends and Family = Support from personal networks</p> Signup and view all the answers

    The product development process is essentially the same for both _____ and biotech firms.

    <p>pharmaceutical</p> Signup and view all the answers

    Which of the following is NOT patentable?

    <p>A new scientific theory (A)</p> Signup and view all the answers

    Aesthetic creations can be patented under the European Patent Convention.

    <p>False (B)</p> Signup and view all the answers

    What kind of practical invention may arise from a new scientific discovery?

    <p>An invention that utilizes the discovery to create something useful.</p> Signup and view all the answers

    A discovery that a material is heat-resistant is not patentable, but a _____ incorporating the material may be patentable.

    <p>fireproof safe</p> Signup and view all the answers

    Match the following patent categories with their descriptions:

    <p>Scientific theories = Not patentable Discoveries = Not patentable Improved understanding of processes = Potentially patentable when involving a practical invention Computer programs without attributes = Not patentable</p> Signup and view all the answers

    Which of the following statements is true?

    <p>A process to extract a previously undiscovered material can be patented. (C)</p> Signup and view all the answers

    An invention derived from a mathematical method can be patented.

    <p>True (A)</p> Signup and view all the answers

    What must a discovery lead to in order for a patent to be granted?

    <p>A practical invention or application.</p> Signup and view all the answers

    Which of the following is NOT patentable under the European Patent Convention?

    <p>Diagnostic methods (B), Surgical treatment methods (C)</p> Signup and view all the answers

    An invention must have a technical character to be patentable.

    <p>True (A)</p> Signup and view all the answers

    What are the four criteria for patentability?

    <p>technical character, novelty, inventive step, industrial application</p> Signup and view all the answers

    Products, substances, or compositions used in any method can be __________.

    <p>patented</p> Signup and view all the answers

    Match the following patentable subject matters with their examples:

    <p>Discovery of lightning = Explanation of mold contamination inhibiting bacterial growth Invention of an apparatus = Isolation of a fungus and its growth medium Treatment by surgery = A physical intervention requiring medical skills</p> Signup and view all the answers

    Which of the following databases can be used to search for patents in the USA?

    <p>USPTO (C)</p> Signup and view all the answers

    It is possible to patent a treatment method for animals under the European Patent Convention.

    <p>False (B)</p> Signup and view all the answers

    Name one type of invention that can be patented.

    <p>Isolated antibiotics</p> Signup and view all the answers

    Flashcards

    Biotechnology definition

    The application of science and technology to living organisms, parts, products, and models to change living or non-living materials for knowledge, goods, and services production.

    Biotechnology disciplines

    A multidisciplinary field combining concepts and methods from various scientific areas to make useful products or services.

    Bio

    Greek word meaning "life"

    Technos

    Greek word meaning "technology"

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    Logos

    Greek word meaning "thinking"

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    OECD

    Organisation for Economic Co-operation and Development

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    M3

    A module/lesson focused on business models & customer feedback

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    M4

    A module/lesson focused on financial analysis

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    First biotech IPO (Initial Public Offering)

    The initial public offering of a biotechnology company's stock on a stock exchange.

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    Genetically engineered drug—human insulin

    A medicine produced through genetic engineering techniques, in this case, to treat diabetes.

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    Genentech acquisition by Roche

    Swiss pharmaceutical company Roche bought Genentech in 2009 for $46.8 billion.

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    Agricultural Biotech

    Biotechnology applied to agriculture, focusing on environmentally friendly solutions, genetic engineering, and climate change mitigation.

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    Industrial Biotech

    Biotechnology used in industrial processes, employing enzymes and microorganisms to create products using biomass.

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    Marine Biotech

    Biotechnology focused on extracting and using resources from the ocean for numerous applications (food, medicine, etc.).

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    Biotech Business

    Companies in the biotechnology industry face unique challenges compared to large pharmaceutical companies, often lacking the safety net of continuous product revenue.

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    Venture Capital for Biotech

    Investing in biotech companies involves high risk but also high potential rewards. Success hinges on creating products with strong revenue streams.

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    Biotech Company Formation

    Biotech companies can be formed in various ways, including by independent scientists commercializing technology or as spin-offs from established institutions.

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    Spin-off companies

    Companies created from the technology of an existing institution or company.

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    Sustainability Elements In Business Plans

    Essential components of a successful business plan, encompassing market analysis, financial projections, management acumen (team), and strategic aspects like market strategy and financial estimates.

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    Funding Biotech

    Early-stage biotech funding often relies on 'friends, family, or fools' initially, later progressing to angel investors, seed capital, and venture capital.

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    Product Development in Biotech

    Biotech investors often focus on the product development process to assess risks in potential biotech products.

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    Drug Development Time

    It takes approximately 15 years to bring a new drug to market, from discovery to FDA approval.

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    Drug Development Cost

    The average cost of developing a single new drug is $500 million.

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    FDA Role in Drug Regulation

    The Food and Drug Administration (FDA) regulates the safety and efficacy of drugs in the US by overseeing clinical trials and approving new drugs.

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    Phases of Clinical Trials

    Clinical trials involve humans and have three phases: Phase I (safety), Phase II (safety and efficacy), and Phase III (expanded trials).

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    Novel Food Regulation (EU)

    The EU's Novel Food Regulation sets rules for authorizing new food products and ingredients, requiring safety assessment before market entry.

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    Substantially Equivalent Food

    Foods with similar composition, nutritional value, metabolism, intended use, and level of undesirables can follow a simplified approval process.

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    Heavily Regulated Sectors

    Besides pharmaceuticals, other industries with strict regulations include cosmetics, medical devices, and chemicals.

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    Pharmacoeconomics Definition

    Pharmacoeconomics studies the costs and benefits of pharmaceutical products and services.

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    Pre-clinical Trials

    Pre-clinical trials test potential drug safety on animals and cell cultures before human trials can start.

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    Intellectual Property

    The legal protection of original creations of the mind, such as inventions, literary works, and symbols used commercially.

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    World Intellectual Property Organization (WIPO)

    An international organization responsible for administering intellectual property treaties and promoting global intellectual property protection.

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    Intangible Goods

    Assets that have value but are not physical, like inventions or designs.

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    Industrial Property

    Legal protection for inventions, trademarks, industrial designs, and geographical indications.

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    Copyright

    Legal protection for original works of authorship, including literary, artistic, musical, and dramatic works.

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    Patent

    Exclusive rights granted for an invention, allowing the patent holder to exclude others from making, using, or selling the invention.

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    Patentable Criteria

    For an invention to be patentable, it must be novel, have inventive activity, and be industrially applicable.

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    Novelty

    The invention must be new and not previously disclosed to the public.

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    Inventive Activity

    The invention must not be obvious to a person skilled in the relevant field.

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    Industrial Application

    The invention must be capable of being produced and used in some industrial activity.

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    Patentable Invention?

    An invention is patentable if it is new, involves an inventive step, and is industrially applicable. It must be more than just a scientific theory, discovery, or mathematical method.

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    Non-Patentable Examples

    Examples of things that are not patentable include scientific theories, discoveries, mathematical methods, presentations, aesthetic creations, and purely intellectual ideas.

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    Discoveries vs. Inventions

    While a discovery itself is not patentable, an invention based on a discovery can be patented. For example, a new material discovered in nature is not patentable, but a process to isolate or extract it or the isolated material itself is.

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    Improving Existing Processes

    Even if a theory on how an existing process works is not patentable, improvements based on that understanding can be patentable.

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    Industrial Applicability

    An invention must have industrial applicability to be patentable. It means the invention can be manufactured and used in some industrial or commercial context.

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    Abstract Ideas

    Abstract and purely intellectual ideas, like philosophical concepts, are not patentable. Patentability requires a concrete technical solution or application.

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    European Patent Convention (EPC)

    The EPC is an international agreement that establishes a common set of rules for obtaining patents in Europe. It defines what is and is not patentable.

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    Article 52: Patentable Inventions

    This article of the EPC lists categories of inventions that are not patentable, including scientific theories, discoveries, and mathematical methods.

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    Patentable Subject Matter

    Inventions that are eligible for patent protection, meeting criteria like novelty, inventive step, and industrial applicability.

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    Non-Patentable Subject Matter

    Discoveries, natural phenomena, mathematical methods, and certain therapeutic methods are not patentable, as they lack the required inventive aspect.

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    Technical Character

    An invention must have a technical feature or solve a technical problem to be patentable. It can't be just an abstract idea or concept.

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    Inventive Step

    The invention must not be obvious to a person skilled in the relevant field. It should offer a non-obvious and inventive solution.

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    Treatment/Diagnostic Methods

    Methods used to treat diseases or diagnose conditions in humans or animals are generally not patentable, except for the specific products or compositions used.

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    Drawings in Patent Applications

    Patent applications typically require drawings or diagrams to illustrate the invention and its features.

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    Patent Databases

    Online resources like the European Patent Office, USPTO, and WIPO provide access to patent information, allowing searching and retrieval of patent documents.

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    Study Notes

    Innovation and Creation of Businesses in Bioengineering

    Program

    • The program outlines weekly topics and activities for a course on innovation and business creation in bioengineering.
    • It details theoretical classes and practical class challenges.
    • The schedule covers topics from introduction to the class, to intellectual property, market analysis, business models, and financial analysis.
    • Practical exercises and discussions are part of the course.

    BioBusinesses Regulation

    • The slides emphasize the range of topics related to biobusinesses regulation, from DNA-manipulation, to genetic engineering, and plants and bacterial cultivation
    • The word cloud includes concepts like: disorders, monoclonal, DNA, organisms, resistance, cells, manipulation, treatments, problems, diseases and genetico

    Biotechnology

    • Biotechnology is a science-driven industry sector
    • It uses living organisms and their derivatives to produce products and processes.
    • It is a multidisciplinary field
    • It marshals concepts and methodologies across disciplines to develop beneficial products and/or services to human welfare

    Biotechnology Industry

    • One of the most research-intensive industries worldwide
    • Requires extensive skills and technical knowledge
    • Strong linkages with universities, and other companies in biotechnology
    • Capital-intensive, with significant resources needed throughout an organization's life cycle
    • Medium to very long product development times
    • Necessitates ethical clearance, especially for animal or human testing
    • Subject to strict regulations
    • Intellectual property protection is crucial for success in biotechnology.

    Biotechnology Timeline

    • Summarizes significant breakthroughs, discoveries, inventors, and historical milestones in the field of biotechnology.
    • Chronological milestones are presented on a timeline that includes major milestones from antiquity to the present era.

    Biotech Startups & Emerging Companies

    • A list of startups and emerging companies in biotechnology
    • Includes companies in sectors like artificial intelligence, big data, gene editing, precision medicine, gene sequencing, biomanufacturing, synthetic biology, bioprinting, microfluidics, and tissue engineering
    • Lists the trending areas in biotechnology, based on predicted importance in 2025.
    • Shows the percentage for each area
    • The leading trends seem to be Artificial Intelligence, Big Data, Gene editing, Precision Medicine, etc

    Biotechnology Types

    • Categorizes different types of biotechnology activities/applications
    • Classifies by the colors red, yellow, blue, green, dark, white, gold, and orange

    Four Colors of Biotechnology

    • Categorizes biotechnology into different areas via color-coding
    • Red is for health and diagnostics
    • White relates to industrial processes, like chemicals and products, or agriculture/environmental uses.
    • Blue for aquaculture and marine biotech
    • Green relating to agricultural biotechnology

    Red Biotechnology

    • Specializes in medicine and human health
    • Including vaccines, medications, antibodies, genetic engineering for disease treatment
    • Categorized as a heavily regulated sector.
    • It includes high up-front development costs,
    • FDA/EMA approval prior to market entry long time to market.
    • High post-approval profit margins.

    Market Red Biotechnology

    • Dominated by Biopharmaceutical production
    • Genetic engineering is expected to grow significantly
    • APAC region predicted significant growth
    • The market is concentrated with few key players
    • The growth drivers are the rising need for biologic drugs, and personalized medicine

    Humulin

    • Human Insulin used to treat diabetes.
    • Developed from recombinant DNA rather than solely from pig or cow pancreatic sources.
    • Important historical step in biotechnology

    Human Insulin Production

    • A summary of how human insulin is produced using recombinant DNA technology.
    • The process involves inserting human insulin-producing genes into bacteria.
    • The bacteria then produce and secrete human insulin.

    Genentech

    • A biotech firm that partnered with Eli Lilly for the production of their product.
    • Became the first biological company to do an IPO
    • Developed and produced the first genetically-engineered drug.
    • Its first drug release was human insulin
    • Acquired by Roche in 2009

    Green Biotechnology

    • Focuses on agricultural processes.
    • Seeks environmentally sound solutions.
    • Involves plant genetic engineering (transgenic plants)
    • Aims to mitigate climate change.

    Global Agricultural Biotechnology Market

    • Market growth will accelerate by 10% CAGR
    • North America segment predicted the highest revenue contribution.
    • Market is concentrated by a few large players

    White Biotechnology

    • Focuses on industrial processes.
    • Uses enzymes and microorganisms to create products or processes.
    • Produces a broad range of items, from chemicals to materials and fuels.
    • Aims to reduce environmental impact and is an alternative to fossil fuels.

    White Biotechnology Market

    • Market size in 2023 and a predicted market size for 2030.
    • Regional and application-wise breakdowns
    • Key products such as foods and feeds, biomaterials, pharmaceuticals, biofuels, textiles, and biochemicals are highlighted
    • Revenue contribution in 2023 for each segment

    Blue Biotechnology

    • The exploration and valorization of marine organisms
    • Uses resources like algae, bacteria, fungi and invertebrates as raw materials.
    • Involved in food production, energy, medicine, cosmetics, aquaculture, bioremediation and the chemical industry
    • Characterized by high research & development costs

    Blue Biotechnology Market

    • Market will accelerate at 7% CAGR
    • Health care predicted as a major driver of growth
    • The growth is predicted to come largely from the Americas.
    • Market is highly fragmented.

    Colors of Biotechnology

    • Categorizes biotechnology by its spectrum of application and practice
    • Provides a breakdown of the 4 colors in biotechnology (red, blue, white and green).
    • Demonstrates the variety of industries and applications involved in the field.

    Patent for Invention vs Utility Model

    • A comparison of patent types
    • Shows how they differ based on novelty, inventive steps, and industrial aplicability
    • Identifies the aspects of each patent that would give advantages or disadvantages depending on the goal.

    Patents and the Idea of Property Protection

    • Definitions associated with intellectual property (IP): concepts and types that are the foundation for ideas.
    • Legal definitions associated with the concept, protection and exclusivity of ideas.
    • Information on different forms of IP, such as copyright, trademarks, and patents

    Intangible Assets

    • A breakdown of tangible goods and intangible goods
    • Categorizes intellectual property as a type of intangible asset.
    • Covers the topic of legal protection of original creations in the form of copyrights, trademarks, patents, industrial secrets, and geographical indications.

    Patents: These are not patentable

    • A list of various aspects that aren’t patentable, such as scientific theories, mathematical methods, presentations, aesthetic creations, or projects related to gambling.

    Regulation-Drugs

    • FDA (Food and Drug Administration) / EMA guidelines and functions
    • Testing guidelines and processes for pharmaceuticals and other drugs
    • Overview of the three testing phases for drug candidates

    New Drug Approvals

    • A list of FDA and EMA drug approvals.
    • A figure that shows the estimated sales in US Dollars of new drugs

    Regulation-Food

    • Rules for novel foods and ingredients in the EU
    • Overview of how the safety of novel-foods is assessed to permit market entry.

    Other Heavily Regulated Sectors

    • A breakdown of other heavily regulated sectors
    • Examples such as automobiles, cosmetics, medical devices, chemicals and construction.

    University-Industry Interactions

    • Role of universities in economic development, particularly in technology
    • Mechanisms of knowledge generation, exploitation (transfer/sharing) within a social, political and financial/economic context.
    • Access to scientific breakthroughs and how this contributes to development and activities
    • Issues like risk sharing, access to resources and equipment are also noted

    Technology Transfer

    • Role and workings of technology transfer entities
    • The functions of universities’ research organizations, licensing, and the creation of new companies to leverage research findings and IP
    • The relationship between R&D, Technology transfer, and the market.

    TecMinho

    • Organization and ecosystem, including the University of Minho’s Innovation and entrepreneurship ecosystem.

    National Framework

    • The framework of initiatives underlining the Portuguese GAPI Network, and underlying organizations supporting industrial property.
    • The partnership with 22 national entities for GAPI's work.
    • The role of universities, technology centers, science and technology parks, and business associations.

    European Framework

    • The structure of the PATLIB network in Europe.
    • The number of countries participating and the list of countries in the EU, as well as countries that partner with the EU system

    Technology Transfer Offices

    • These entities/organizations promote the transfer of knowledge, inventions, creations, discoveries, innovations, and processes from research environments to commercial environments.
    • Their role includes identifying technologies, marketing and technology-based assets , collaborating between universities and industry, facilitating IP and supporting negotiation, and managing licensing agreements

    Anatomy of a Patent

    • Detailed explanation of the parts and importance of the different sections and aspects of a patent.
    • A detailed breakdown of the information included in each page and section, from title to diagrams and claims. This includes background, summary, detailed description, and drawings.

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    Description

    Test your knowledge of biotechnology with this quiz covering its definitions, applications, and regulatory aspects. From the fundamental concepts to drug development processes, this quiz explores various areas within the field of biotechnology.

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