Welcome to Day 2 of the Biotech fundamentals course, recap of day 1 learnings and overview of the day’s Agenda, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
This ppt have a detailed source about the Biosafety issues in Biotechnology and their implements over by the government. It have a topics about the issues in antibiotic resistance gene , GMO crops etc.
This ppt have a detailed source about the Biosafety issues in Biotechnology and their implements over by the government. It have a topics about the issues in antibiotic resistance gene , GMO crops etc.
Impact and risk assessment of biotechnological alterations on agriculture.Also discusses the biasness towards other similar practices and its disparagement.
'The Regulatory Landscape of Genome Editing' - Panel Discussion during the Steffi Friedrichs
During the 8th Plant Genomics and Gene Editing Congress: Europe, held on the 4th and 5th March 2020 in Rotterdam, a panel of experts explored and discussed 'The Regulatory Landscape' of Genome Editing:
OECD activities related to modern techniques of biotechnology and genome editingOECD Environment
This presentation highlights OECD's activities related to modern techniques of biotechnology including genome editing in light of previous OECD conferences and workshops and technical products, such as consensus documents.
Starvation and malnutrition are the major concerns in today’s world. According to FAO’s report, a total of 842 million people in 2011-13 were estimated to be suffering from chronic hunger, regularly not getting enough food to conduct an active life.
The total population of the world was 7.406 billion in 2012. The growth rate is 1.2% per year. Global cereal utilization for 2013-14 is projected to be 2,413 million tons, 3.2% higher than in 2012-13. Agricultural land is decreasing rapidly every year. Hence, more production in less agricultural area is necessary for feeding the whole lot of population.
My presentation to MSU's International Short Course
Biosafety and Biotechnology for Lawyers, in coordination with the AU/NEPAD African Biosafety Network of Expertise (ABNE)
The age of gene editing - Workshop on innovations in food and agriculture sys...OECD Environment
The workshop took place in Paris on 25-26 February 2016. Its central aim was to discuss with experts how scientific, technological, and farm practice innovation can improve productivity and sustainability in the food and agricultural sector, with a focus on international collaboration on gene editing techniques. It was introduced in the form of a presentation entitled ‘The Age of Gene editing’, produced by Steffi Friedrichs (STI), which played a pivotal role during the expert discussions.
Intellectual Property for Accountants. This deck is the launch presentation for the Nicholas Weston White Paper, “Definitive Guide to Intellectual Property for Accountants” (2015 Edition) held at William Buck in Melbourne on 25 November 2014. The presentation deck is not intended as a substitute for the White Paper which contains sections on Protecting intangible assets, Patents, Trade Marks, Domain Names, Registered Designs, Copyright, Licensing and royalty rates, Valuing IP rights, Tax implications and benefits (including Capital gains tax (CGT) and Income tax, Trade mark taxation, Tax deductions, Withholding taxes, GST treatment, the R&D Tax Incentive, Stamp Duty in each State and Territory), the Personal Properties Securities Act 2009 (PPSA), using the Freedom of Information Act 1982 (FOI) in the context of IP, Details Oppositions, Appeals and Injunctions, and has some handy ATO References. It also contains a Test of your IP awareness and a summary with Four things to remember about IP for Accountants.
The event was attended by Directors, Associates and Senior Managers from all William Buck divisions - Audit, Business Advisory, Tax, Corporate Advisory, Wealth Advisory.
In this presentation:
• Definition of Aquaculture and agriculture
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
Impact and risk assessment of biotechnological alterations on agriculture.Also discusses the biasness towards other similar practices and its disparagement.
'The Regulatory Landscape of Genome Editing' - Panel Discussion during the Steffi Friedrichs
During the 8th Plant Genomics and Gene Editing Congress: Europe, held on the 4th and 5th March 2020 in Rotterdam, a panel of experts explored and discussed 'The Regulatory Landscape' of Genome Editing:
OECD activities related to modern techniques of biotechnology and genome editingOECD Environment
This presentation highlights OECD's activities related to modern techniques of biotechnology including genome editing in light of previous OECD conferences and workshops and technical products, such as consensus documents.
Starvation and malnutrition are the major concerns in today’s world. According to FAO’s report, a total of 842 million people in 2011-13 were estimated to be suffering from chronic hunger, regularly not getting enough food to conduct an active life.
The total population of the world was 7.406 billion in 2012. The growth rate is 1.2% per year. Global cereal utilization for 2013-14 is projected to be 2,413 million tons, 3.2% higher than in 2012-13. Agricultural land is decreasing rapidly every year. Hence, more production in less agricultural area is necessary for feeding the whole lot of population.
My presentation to MSU's International Short Course
Biosafety and Biotechnology for Lawyers, in coordination with the AU/NEPAD African Biosafety Network of Expertise (ABNE)
The age of gene editing - Workshop on innovations in food and agriculture sys...OECD Environment
The workshop took place in Paris on 25-26 February 2016. Its central aim was to discuss with experts how scientific, technological, and farm practice innovation can improve productivity and sustainability in the food and agricultural sector, with a focus on international collaboration on gene editing techniques. It was introduced in the form of a presentation entitled ‘The Age of Gene editing’, produced by Steffi Friedrichs (STI), which played a pivotal role during the expert discussions.
Intellectual Property for Accountants. This deck is the launch presentation for the Nicholas Weston White Paper, “Definitive Guide to Intellectual Property for Accountants” (2015 Edition) held at William Buck in Melbourne on 25 November 2014. The presentation deck is not intended as a substitute for the White Paper which contains sections on Protecting intangible assets, Patents, Trade Marks, Domain Names, Registered Designs, Copyright, Licensing and royalty rates, Valuing IP rights, Tax implications and benefits (including Capital gains tax (CGT) and Income tax, Trade mark taxation, Tax deductions, Withholding taxes, GST treatment, the R&D Tax Incentive, Stamp Duty in each State and Territory), the Personal Properties Securities Act 2009 (PPSA), using the Freedom of Information Act 1982 (FOI) in the context of IP, Details Oppositions, Appeals and Injunctions, and has some handy ATO References. It also contains a Test of your IP awareness and a summary with Four things to remember about IP for Accountants.
The event was attended by Directors, Associates and Senior Managers from all William Buck divisions - Audit, Business Advisory, Tax, Corporate Advisory, Wealth Advisory.
In this presentation:
• Definition of Aquaculture and agriculture
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
Nw biotech fundamentals day 2 session 2 industrial applications and cleantechNicholas Weston Lawyers
In this presentation:
• Definition of Industrial applications and clean-tech
• The technical stages of product development project
• The state of the art – key drivers of innovation
• Regulatory nuances
• Pre-clinical and in the clinic issues
• Future trends
• Challenges and opportunities
• Case studies and examples
This presentation covers:
• Definition of life sciences
• The stages of a therapeutic drugs or vaccines R&D project
• The state of the art
• Regulatory nuances
• Pre-clinical and in the clinic issues
• Future trends
• Challenges and opportunities
• Case studies and examples
This presentation covers:
• Definition of life sciences
• The stages of a therapeutic drugs or vaccines R&D project
• The state of the art
• Regulatory nuances
• Pre-clinical and in the clinic issues
• Future trends
• Challenges and opportunities
• Case studies and examples
Nw biotech fundamentals day 2 session 4 medical devices and diagnosticsNicholas Weston Lawyers
In this presentation:
• Definition of Medical devices and Diagnostics
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
BioTech Journey through the Phases of Commercializing a ProductCBG Benefits
This presentation was delivered by Breck Arnzen of the ArnzenGroup and Susan Nemetz of The NemetzGroup at the HR BioTech Connect Group meeting in January 2013.
They shared a variety of guidance to help companies navigate the process of commercializing a product in the BioTech industry.
Speakers:
Paul Chipperton, Vice President, Business Development & Marketing, matREGEN
Nina Chagnon, Director of Business Development, MaRS Discovery District
For more information and the webcast link: http://www.marsdd.com/Events/Event-Calendar/BioEntrepreneurship/2007/business-models-12192007.html
The introductory slide deck is based on a Biotechnology Fundamentals course we delivered to AusIndustry (Australian Government, Department of Industry) R&D Tax Assessors in May/June 2014. It covers the broad concept of biotechnology from its historical relevance to its impact in the achievement of contemporary objectives in the fields of medicine, plant and animal sciences, in food, marine and environmental sciences, drawing comparisons with conventional technologies, introducing the concepts of bioethics, patenting and other regulatory issues and providing non-science professionals with a basic understanding of the science, technology, regulatory and commercial environments driving the biotechnology sectors, delivered in bite sized portions. The first deck is a Welcome and Overview covering:
• Definition of biotechnology
• Historical relevance
• Contemporary objectives with overview of industry sub-sectors
• State of play
Designing of drug delivery system for biotechnology products considering stab...Smaranika Rahman
Biotechnology is the broad area of biology involving living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use".
8 Best Differences Between Biotechnology And Bioengineering | Future Educatio...Future Education Magazine
Here are 8 differences of biotechnology and bioengineering: 1. Advancing Medicine and Healthcare 2. Feeding the World 3. Environmental Sustainability 4. Renewable Energy 5. Industrial Applications
Dr. James Hughes - Combating Antimicrobial Resistance: The Way ForwardJohn Blue
Combating Antimicrobial Resistance: The Way Forward - Dr. James Hughes, Professor of Medicine and Public Health with Joint Appointments in the School of Medicine and the Rollins School of Public Health at Emory University, from the 2014 NIAA Symposium on Antibiotics Use and Resistance: Moving Forward Through Shared Stewardship, November 12-14, 2014, Atlanta, Georgia, USA.
More presentations at http://www.swinecast.com/2014-niaa-antibiotics-moving-forward-through-shared-stewardship
Lustrumlezing paul stoffels de rol van innovatie voor de gezondheidszorg van ...Michiel Stoffels
Ter gelegenheid van het 40 jarig bestaan van de Universiteit werd een reeks lustrumlezingen georganiseerd. Voor de faculteit Gezondheid en Levenswetenschappen hadden we de eer Dr. Paul Stoffels - Worldwide Chairman , Janssen Pharmaceutical Chief Scientific Officer, Johnson & Johnson - te mogen ontvangen.
Similar to Nw biotech fundamentals day 2 session 1 introduction (20)
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
This presentation explores a brief idea about the structural and functional attributes of nucleotides, the structure and function of genetic materials along with the impact of UV rays and pH upon them.
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
Multi-source connectivity as the driver of solar wind variability in the heli...Sérgio Sacani
The ambient solar wind that flls the heliosphere originates from multiple
sources in the solar corona and is highly structured. It is often described
as high-speed, relatively homogeneous, plasma streams from coronal
holes and slow-speed, highly variable, streams whose source regions are
under debate. A key goal of ESA/NASA’s Solar Orbiter mission is to identify
solar wind sources and understand what drives the complexity seen in the
heliosphere. By combining magnetic feld modelling and spectroscopic
techniques with high-resolution observations and measurements, we show
that the solar wind variability detected in situ by Solar Orbiter in March
2022 is driven by spatio-temporal changes in the magnetic connectivity to
multiple sources in the solar atmosphere. The magnetic feld footpoints
connected to the spacecraft moved from the boundaries of a coronal hole
to one active region (12961) and then across to another region (12957). This
is refected in the in situ measurements, which show the transition from fast
to highly Alfvénic then to slow solar wind that is disrupted by the arrival of
a coronal mass ejection. Our results describe solar wind variability at 0.5 au
but are applicable to near-Earth observatories.
Deep Behavioral Phenotyping in Systems Neuroscience for Functional Atlasing a...Ana Luísa Pinho
Functional Magnetic Resonance Imaging (fMRI) provides means to characterize brain activations in response to behavior. However, cognitive neuroscience has been limited to group-level effects referring to the performance of specific tasks. To obtain the functional profile of elementary cognitive mechanisms, the combination of brain responses to many tasks is required. Yet, to date, both structural atlases and parcellation-based activations do not fully account for cognitive function and still present several limitations. Further, they do not adapt overall to individual characteristics. In this talk, I will give an account of deep-behavioral phenotyping strategies, namely data-driven methods in large task-fMRI datasets, to optimize functional brain-data collection and improve inference of effects-of-interest related to mental processes. Key to this approach is the employment of fast multi-functional paradigms rich on features that can be well parametrized and, consequently, facilitate the creation of psycho-physiological constructs to be modelled with imaging data. Particular emphasis will be given to music stimuli when studying high-order cognitive mechanisms, due to their ecological nature and quality to enable complex behavior compounded by discrete entities. I will also discuss how deep-behavioral phenotyping and individualized models applied to neuroimaging data can better account for the subject-specific organization of domain-general cognitive systems in the human brain. Finally, the accumulation of functional brain signatures brings the possibility to clarify relationships among tasks and create a univocal link between brain systems and mental functions through: (1) the development of ontologies proposing an organization of cognitive processes; and (2) brain-network taxonomies describing functional specialization. To this end, tools to improve commensurability in cognitive science are necessary, such as public repositories, ontology-based platforms and automated meta-analysis tools. I will thus discuss some brain-atlasing resources currently under development, and their applicability in cognitive as well as clinical neuroscience.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
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Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
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Ultraviolet-visible spectroscopy is an analytical method that can measure the amount of light received by the analyte.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Nw biotech fundamentals day 2 session 1 introduction
1. Biotech Boot Camp
A biotechnology fundamentals course
Day 2
Presenters: Nick Weston + Viktoriia Hristova
Melbourne, Brisbane, Sydney
28 May - 18 June 2014
2. • Introduction
• Industrial applications and clean-tech
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up
Presentation Overview
Day Two
2
3. • Introduction
• Industrial applications 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 from yesterday
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 “life sciences" 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 “medical devices 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 “industrial biotechnology" 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
15. Three criteria for a 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 Protects the 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
18. Patents Trade Secrets
Protects against 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
beta blockers
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 of Molecular 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
The TGA 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
Before a 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
24. Basic overview of the 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 sciences development 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 sciences development process
26 Graphic: Aptuit 2014
Discovery
Disciplines
Development
Disciplines
Recap
27. Typical life sciences development 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
29. Sector is approaching middle 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
• Industrial applications and clean-tech (morning tea)
• Aquaculture and agriculture
• Medical devices and diagnostics
• Summary and wrap-up (finished by lunch-time)
Presentation Overview
Today
30