Biotech in business

• IP - Intellectual Property


  Legal rights that result from intellectual activity to protect inventions and innovations (e.g., patents)
• R&D - Research & Development


  The process of investigating, designing, and developing new products, technologies, or processes to advance scientific knowledge and bring innovations to market
• IPO - Initial Public Offering


  The first time a company's stock becomes available for public purchase (i.e., going from private to public)
• FDA - Food and Drug Administration


  The U.S. regulatory agency responsible for ensuring the safety and effectiveness of drugs, medical devices, food etc.
• TGA - Therapeutic Goods Administration


  The Australian regulatory agency responsible for ensuring the safety and effectiveness of drugs, medical devices, etc., but excluding food
• ROI - Return on Investment


  A measure of the profitability of an investment, calculated as the net gain or less relative to the initial cost of investment
• GMP - Good Manufacturing Practice


  A system for ensuring that products are consistently produced and controlled according to quality standards in the manufacturing process
• GLP - Good Laboratory Practice


  A set of guidelines and procedures aimed at ensuring the consistency, reliability, and integrity of scientific data generated during laboratory experimentation
• GMO - Genetically Modified Organism


  Organisms whose genetic material has been altered using genetic engineering techniques to confer desired traits such as increased resistance to pests or improved nutritional content
• VC - Venture Capital


  Funding provided by venture capital firms to start-ups and businesses with high growth potential. Venture capital often plays a crucial role in financing early-stage R&D
• Technology Transfer


  The process of transferring scientific findings and technologies from one organisation, often a research institution, to another, typically for further development and commercialization
• Biosimilar


  A biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Biosimilars aim to provide more affordable alternatives to biologic drugs (like generics for pharmaceutical drugs)
• Regulatory Affairs involve the management and adherence to laws, regulations, and guidelines governing the development, manufacturing, and marketing of biopharmaceutical ("compliance")
• POC - Proof of Concept


  Demonstration or experiment illustrating the feasibility or viability of a concept or idea
• Life of biotech company

  1. Investment is funds spent now in the hope of a future benefit

  2. Money spent on R & D, with no guarantee of a ROI

  3. Investment fails to yield sufficient IP or technology to provide an ROI: After several failures, the company will no longer have enough money (liquidity/capital) to invest in new projects > company goes bust
• Intellectual Property


  • Useful
  • Novel
  • Inventive
• Value of IP to a biotech business

  • IP is essential to biotech business as it represents the value of the biotech company
  • Top how university operates
  • Bottom designed to get products to market
• Inflexion


  The point where the company become profitable
• Biotech companies are historically loss making enterprises
• Who pays for biotech discoveries?

  1. Governments fund most 'basic' biology research (e.g. NIH, NHMRC)

  2. Trusts, philanthropy, and private companies also provide some funding

  3. Most biotech companies put 20% of their profit back into R&D (sometimes much more)

  4. Company R&D is usually an extension upon the basic research from the university sector
• License


  Lease/pay for the rights to produce the product
• Spin-off


  Turn a discovery into a company that makes a product
• Brews to biotech: The story of Genentech

  1. Cohen (1973) demonstrated restriction enzymes used as "scissors" to cut DNA fragments from one source and ligated into a similarly cut "recombinant" plasmid vector

  2. Venture Capitalist (VC) Robert Swanson contacted Boyer to discuss if the technology was ready to commercialise

  3. Cohen returned to academia

  4. Over beers at Churchills Bar in San Francisco, Robert and Herbert both agreed to terms on a coaster to invest together in a partnership. This agreement would eventually become Genetic Engineering Technologies – Genentech. The world's first biotechnology company
• Biotech innovation nexus


  Separate pathways between universities and businesses but been a drive from government for the 2 pathways to come together hopefully to improve innovation potential
• Technology Transfer Offices (TTOs)


  Established to help universities develop inventions and patents
• Bayh-Dole Act (1980)


  Encouraged the utilisation of inventions produced under US Government funding (e.g., university research) by giving clear IP rights to universities and control of their inventions
• By 2010, nearly 200 new drugs were available that were invented in US universities and then commercialised because of the Bayh-Dole Act
• Two main ways biotech companies make money today

  • Using their intellectual property (IP) to create technologies that can be sold for a profit
  • Licensing their intellectual property (IP) to other companies under a specific licensing agreement, allowing other companies to develop technologies using the IP