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Nw biotech fundamentals day 2 session 1 introduction
The document outlines the content from the second day of a biotechnology fundamentals course, covering topics such as industrial applications, medical devices, agriculture, and aquaculture. It discusses the definitions of key terms like biotechnology, cleantech, and medical devices, as well as patent types and the biotechnology industry's development process. The course emphasizes the importance of regulatory bodies and the evolving landscape of the life sciences sector.
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Nw biotech fundamentals day 2 session 1 introduction
- 1. Biotech Boot Camp Abiotechnology fundamentals course Day 2 Presenters: Nick Weston + Viktoriia Hristova Melbourne, Brisbane, Sydney 28 May - 18 June 2014
- 2. • Introduction • Industrialapplications and clean-tech • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up Presentation Overview Day Two 2
- 3. • Introduction • Industrialapplications and clean-tech • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up Presentation Overview Day Two 3
- 4. Biotechnology 4 Let’s recap fromyesterday A resilient sector that serves a diverse set of markets, across: • Dx and medical devices • agricultural products from animal health to seeds and crop protection • Rx (biomedical drugs) • bio-based industrial products such as enzymes for industry chemical processes and bio-remediation, bio-plastics and bio-fuels (cleantech)
- 5. The term “lifesciences" is used to connote sciences concerned with the study of living organisms (as opposed to physical sciences), including biology, botany, zoology, microbiology, medicine, human therapeutics, veterinary therapeutics, physiology, the ‘omics’ (eg: proteomics, genomics), biochemistry, biotechnology, and related subjects Biotechnology 5 Definitions
- 6. The term “medicaldevices and diagnostics" is used to describe any instrument, apparatus, appliance, material or other article, and the software to run it, intended by the manufacturer to be used for human beings to: • diagnose, prevent, monitor, treat or alleviate disease, injuries or handicaps • investigate, replace or modify the anatomy or a physiological process, or control conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means Biotechnology 6 Definitions
- 7. The term “industrialbiotechnology" is the application of molecular biology technology to modify the biological function of an organism to generate industrial products and processes • biomass-based materials such as fuels and chemicals; and • the treatment of waste water and producing energy using more efficient measures Biotechnology 7 Definitions
- 8. The term “cleantech"recycling, renewable energy (wind power, solar power, biomass and hydropower, biofuels), information technology, green transportation, electric motors, green chemistry, lighting, and many other appliances that are now more energy efficient. It is a means to create electricity and fuels with a smaller environmental footprint and minimise pollution Biotechnology 8 Definitions
- 9. The term “agriculture"is the science, art, or practice of cultivating the soil, producing crops, and raising livestock and in varying degrees the preparation and marketing of the resulting products The term “aquaculture" is the cultivation of freshwater and marine resources, both plant and animal, for human consumption or use Biotechnology 9 Definitions
- 10. The ‘Valley ofDeath’ 1 0
- 11. The ‘Valley ofDeath’ 1 1
- 12. Bioeconomy success 12 Source:Burrill Transforming Healthcare Report 2014, (originally in PwC Moneytree) Strong global pipeline
- 13. Bioeconomy success 13 Source:Scientific American Worldview 2013 Australia No.7
- 14. Bioeconomy success 14 Source:PwC Bioforum Q1, 2014 Australia still strong for secondary raisings
- 15. Three criteria fora granted patent • It must be novel • It must be non-obvious • It must have commercial utility In Australia there are two types of patent applications available • Standard Patents • Innovation Patents Intellectual Property 1 5 Patents
- 16. Utility Patent Protectsthe way in which an invention is made, how it is used or how it functions - Expires 20 years from the effective filing date Design Patent Protects new ornamental design for an article of manufacture - Expires 14 years from the date of grant Plant Patent Protects distinct and new plant varieties - Expires 20 years from the effective filing date Intellectual Property 16 Patents
- 17. Intellectual Property 17 QUT-2004 Typicalpatent process and cost $0 $50,000 $100,000 $150,000 $200,000 Provisional Application PCT Application National Phase Entry Examination Renewals Months 0 12 30 Patent granted Cumulative cost Defence >$1m
- 18. Patents Trade Secrets Protectsagainst independent discovery No protection against independent discovery or reverse engineering 20 years of protection Protection lasts as long as secret Scope for publication of development No opportunity for publication Enforcement: infringement Enforcement: breach of confidence, breach of contract, breach of fiduciary duty Protection can be broadened beyond specific discovery/development Protection specific to particular secret Intellectual Property 18 Patents v. Trade Secrets
- 19. The genomics era 19 penicillins sulphonamides aspirin psychotropics NSAIDS H2-antagonists betablockers lipid lowerers ACE-inhibitors Biotech drugs chronic degenerative disease associated with ageing, inflammation, cancer drugs against targets identified from disease genes 1900 20301950 1960 1970 1980 1990 2000 2010 2020 2040 NewTherapeuticCycles 1st generation 2nd generation 3rd generation natural products and derivatives serendipity receptors enzyme genetic engineering cell pharmacology/ molecular biology genomics/proteomics/metabolomics Source: CMS, Lehman Brothers research
- 20. • Association ofMolecular Pathology v Myriad Genetics (2013) • Naturally-occurring DNA is not patent eligible • cDNA is patent eligible because it is not naturally-occurring • Data protection • 5 years Au, 6 years China, 10 years EU, 12 years US • Hatch-Waxman Act extension (U.S.) (lesser of 5 years from regulatory approval or 14 years of effective patent life) • Second medical use patents Intellectual Property Idiosyncrasies of protecting biologics - Patents 20
- 21. Prescription medicine regulation 21 Recap TheTGA is accountable for the quality, safety, efficacy and timely availability of drugs and medical devices in Australia Performance targets for TGA drug evaluation and approval were set and are included in the Regulations The TGA operates on a 100% cost recovery basis
- 22. Prescription medicine regulation 22 Recap Beforea drug (prescription or non-prescription), medical device, vitamin, nutritional, ‘TCM’, ‘alternative medicine’ or herbal product can be marketed in, imported to, or exported from Australia it must be listed on the Australian Register of Therapeutic Goods (ARTG) by the TGA New chemical entities and applications which require expert advice are referred to the Advisory Committee on Prescription Medicines (ACPM) for its non-binding recommendations
- 23. Prescription medicine regulation 23 Recap Alsoregulatory channels for Biologicals Biosimilars Medical devices IVD GMOs (GT Register or licensing regime)
- 24. Basic overview ofthe life sciences 24 Recap 2003 2014 • Biotechs that wanted to emulate bigpharma (a build model) • Bigpharma wants to emulate biotech (a buy model) • Small molecule blockbusters • Antibody drug conjugates • Cell based therapies • Treatments that regulate or alter genes • Trial and error drug projects • Therapies designed to precisely target molecular drivers • Treatment of symptoms • Treatment of causes • Move to curative medicine • Human Genome Project completed at cost of $3billion • Illumina can sequence genome for <$1,000
- 25. Typical life sciencesdevelopment process 25 Graphic: Aptuit 2014 A life sciences biotech project starts with high throughput screening identification of promising drug targets in the lab (hits) that undergo in vitro testing for safety, specificity and efficacy (candidate), proceeds to testing in animals and then humans and ends in regulatory approval for marketing. The focus of regulatory approval is on the safety and efficacy of the drug in humans. Most countries have a government agency to regulate and oversee the path to drug approval (approval).
- 26. Typical life sciencesdevelopment process 26 Graphic: Aptuit 2014 Discovery Disciplines Development Disciplines Recap
- 27. Typical life sciencesdevelopment process 27 Graphic: Aptuit 2014 Drug Design & Discovery Preclinical Biosciences API Development & Manufacture Solid State Chemistry Pharmaceutical Sciences Computational Support Synthetic chemistry, small scale product synthesis NMR, Chiral separation, UPLC/MSMS….. Recap
- 28. Typical life sciencesdevelopment process 28 Graphic: Aptuit 2014 Recap
- 29. Sector is approachingmiddle age Hundreds of drugs and diagnostics approved Technologies are proving their value (eg MaBs) Biotech has plenty of scope for further innovation Data analytics driving medical breakthroughs Foundation built for substantial growth Challenges remain State of play 29 Recap
- 30. • Introduction • Industrialapplications and clean-tech (morning tea) • Aquaculture and agriculture • Medical devices and diagnostics • Summary and wrap-up (finished by lunch-time) Presentation Overview Today 30