Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Partnering with Australia on Clinical Trials | 2
Why Australia
01
Quality
02
Speed
03
Cost-effective
Partnering with Australia on Clinical Trials | 3
Sophisticated health and medical research environment
Rapid approvals and robust regulatory framework
An ethnically diverse patient population
Quality transferable data
Cost-efficient
Australiais an ideal location for conductingclinical trials
Quality. Speed. Cost.
Partnering with Australia on Clinical Trials | 3
Partnering with Australia on Clinical Trials | 4
Clinical trials are part of a robust and diverse health and medical research ecosystem in Australia
Clinical trials
of the global industry sponsored clinical trials5%
Australia hosts
>95,000clinical trial participants
each year1,880 trials conducted in Australia each year
AUD $1.4 billionspent on clinical trials in Australia in 2019
8,000people
employedin the sector
Source: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au*Health Care Index (2020)
Australia’s healthcare system is world class,
ranking 9th globally*
Partnering with Australia on Clinical Trials | 5
Whole-of-government support for clinical trials
Clinical trials
Strong governmentcommitment
and national action to ensure an efficient, high-quality and vibrant clinical trials environment
A $20 billion endowment fund
Medical Research Future Fund (MRFF) supports translational research and commercialisation
National Mutual Acceptance (NMA)a system for mutual acceptance of scientific and ethical review for multi-centre clinical trials conducted across multiple states
Partnering with Australia on Clinical Trials | 6
Whole-of-government support for clinical trials
Clinical trials
The Australian Government is promoting clinical trials among consumers and healthcare providers, making it easier to engage.
National consumer campaigns to promote participation in clinical trials
Copyright: © Commonwealth of Australia 2014
A searchable clinical trials registry accessible to the public.www.anzctr.org.au/TrialSearch
Partnering with Australia on Clinical Trials | 7Australian Trade and Investment Commission | 7
Quality01.
Partnering with Australia on Clinical Trials | 7
Partnering with Australia on Clinical Trials | 8
Quality
A sophisticated health and medical research environment
medical technology and pharmaceutical companies
1,278 ASX-listed life sciences companies
160world-class medical research institutes
>55
clinical trial networks
>50biobanks
>50 people employed in research and MTP sector
68,000universities focusing on clinical research
>40
Partnering with Australia on Clinical Trials | 9
Quality
Quality data from Australian clinical trials is accepted in key jurisdictions
Data from studies conducted in Australia can be used to support international regulatory applications, including the US FDA and the European Medicines Agency (EMA)
Partnering with Australia on Clinical Trials | 9
Clinical trials conducted in Australia do not require US FDA Investigational New Drug (IND) application approval
Partnering with Australia on Clinical Trials | 10Australian Trade and Investment Commission | 10
Speed02.
Partnering with Australia on Clinical Trials | 10
Partnering with Australia on Clinical Trials | 11
Clinical trial process allows flexibility without compromising quality
Partnering with Australia on Clinical Trials | 11
Streamlined approval system, including the CTN and CTA schemes
Simplification of clinical trial delivery by removing tariffs on clinical trial kits and placebos
World leading intellectual property (IP) system
Speed
Rapid approvals and robust regulatory framework
Partnering with Australia on Clinical Trials | 12
Approval by human research ethics
committee
Notify regulatory authority (Therapeutic Goods Administration)
Four-page template form submitted electronically
Notification acknowledgement.
Trial begins
Submission for ethical review
Study documents including protocol, investigator brochure, informed consent
Submission for site governance review
Legal documents including clinical trial agreement, indemnity agreement and insurance coverage
Speed
Streamlined clinical trials notification scheme
1 DAY 5 - 7 DAYSAPPROX 4 – 6 WEEKS
Partnering with Australia on Clinical Trials | 13Australian Trade and Investment Commission | 13
Cost-effective03.
Partnering with Australia on Clinical Trials | 13
Partnering with Australia on Clinical Trials | 14
Cost-effective
Reports show Australia is
28% cheaper than the US before tax incentives, and
60% cheaper after tax incentives, for early-phase clinical trials
Source:Frost & Sullivan, Australia: Preferred destination for early phase clinical trials, 2016
Partnering with Australia on Clinical Trials | 15
Cost-effective
Favourable exchange rate and a generous R&D tax incentive boosts Australia’s attractiveness
Partnering with Australia on Clinical Trials | 15
Companies with an annual aggregated turnover of less than A$20 million receivea 43.5% refundable tax offset, uncapped
Companies with an annual aggregated turnover of more than A$20 million and all other eligible entities receive a 38.5% non-refundable tax offset*
*Entities may be able to carry forward unused offset amounts to future income years
Partnering with Australia on Clinical Trials | 16Partnering with Australia on Clinical Trials | 16
Clinical trials
Australia is an ideal location
Strong economic & cultural ties with Asia supported by Free Trade Agreements
Seasonal differences
Investigators, clinical networks and trial facilities of a global standing
Globally recognised key opinion leaders in major therapeutic areas
Use of digital expertise and analytics in patient recruitment
Contract manufacturing capabilities to support clinical trials
An ethnically diverse population
Partnering with Australia on Clinical Trials | 17
Clinical Trials
Clinical trials started in Australia 2015-19
8,4097% growth in clinical trials started in Australia in CY2015-19
14.5% pa growth Phase I activity Clinical trial by phase started in Australia in CY2015-19*
*with clinical phase reported
482 434 538 606 601
971 11071159
1235 1276
2 0 1 5 2 0 1 6 2 0 1 7 2 0 1 8 2 0 1 9
Industry Sponsored Non-Industry Sponsored
115 134 164 171 198
196 184209 261 253
229 214229
265 22484 8274
83 80170 157208
177 202
2015 2016 2017 2018 2019
Phase I Phase II Phase III Phase IV Device
Note: *with clinical phase reportedSource: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au
Partnering with Australia on Clinical Trials | 18
Clinical Trials
Clinical trials by therapy area in Australia CY2015-19
Number of clinical trials started
4.6%
7.7%
4.9%
6.9%
10.7%
9.6%
9.5%
3.2%
14.1%
14.6%
CAGR%(CY2015-19)
Note: *Select therapy areas shownSource: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au
0
50
100
150
200
250
300
350
400
2015 2016 2017 2018 2019
Oncology
Public Health
Mental Health
Cardiovascular
Musculoskeletal
Metabolic and Endocrine
Oral and Gastrointestinal
Respiratory
Neurological
Ophthalmology
Partnering with Australia on Clinical Trials | 19
Clinical Trials
Australia’s R&D response to COVID-19 global pandemic
Australia involved in the clinical trial activity of many COVID vaccine candidates
Hundreds of Covid-related research studies being conducted throughout Australia
Clinical trial activity resumed mid 2020,thanks to Australian governments and MTP sector COVID response
The Australian Institute of Infectious Disease (a $650 million project) will be the largest centre of excellence in the Southern hemisphere
Breakthrough and Innovation Funds by State and Federal governments
The Australian Government invested over $350 million to support vaccine research and development
Partnering with Australia on Clinical Trials | 20
Find out more
Australian Clinical Trial Handbook
tga.gov.au/publication/australian-clinical-trial-handbook
Australian Clinical Trials
australianclinicaltrials.gov.au
Medical Research Future Fund
beta.health.gov.au/initiatives-and-programs/medical-research-future-fund
MTPConnect
mtpconnect.org.au/Australia’s Clinical Trials Sector (2021)
Medicines Australia
medicinesaustralia.com.au
AusBiotech
ausbiotech.org
Partnering with Australia on Clinical Trials | 21
How Austrade can help
Our assistance includes
Austradeaustrade.gov.au/contact
Providing insight on Australian capabilities
Identifying potential Australian service providers
Helping international companies identify potential investigators and sites