Note: Program is subject to change.
Tuesday, October 21, 2025
|
Track 1
|
Track 2
|
Track 3
|
Track 4
|
|
|---|---|---|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
|||
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights | |||
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
|||
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked | |||
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner | |||
|
Track 1
|
Track 2
|
|
|---|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
|
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights | |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
|
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked | |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner | |
|
Track 3
|
Track 4
|
|
|---|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
|
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights | |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
|
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked | |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner | |
|
Track 1
|
|
|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner |
|
Track 2
|
|
|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner |
|
Track 3
|
|
|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner |
|
Track 4
|
|
|---|---|
| 8:00 AM - 1:00 PM |
Site Tours Offsite - various locations |
| 9:00 AM - 1:00 PM | Navigating Global Pre-IND Meetings and Scientific Advice Meetings: Best Practices and Strategic Insights |
| 9:00 AM - 5:00 PM |
AusBiotech Invest Crown Melbourne |
| 2:00 PM - 5:00 PM | Australia’s BioPrecincts Unlocked |
| 6:00 PM - 10:00 PM | Clinical Trials Sector Dinner |
Wednesday, October 22, 2025
Thursday, October 23, 2025
Friday, October 24, 2025
|
Track 3
|
|
|---|---|
| 7:30 AM - 9:30 AM | Practical Application of New Approach Methodologies (NAMs) to support First-In-Human (FIH) Clinical Trials: Strategies, Challenges, and Regulatory Perspectives (invite only) |
| 8:30 AM - 9:30 AM |
Networking breakfast
|
| 9:45 AM - 10:30 AM | Innovation with integrity: Building global trust in digital health |
|
Friday room move 1
|
|
|
INDUSTRY ENGAGMENT AND UPDATES
|
|
| 10:35 AM - 11:20 AM | Session 11C: TGA’s global focus: A small regulator in a big world |
|
Friday room move 2
|
|
| 11:25 AM - 12:10 PM | Session 12C: Innovating first-in-human trials: The role of New Approach Methodologies (NAMs) in modern drug development |
|
Friday room move 3
|
|
|
INDUSTRY ENGAGMENT AND UPDATES (Cont...)
|
|
| 12:15 PM - 1:00 PM | Session 13C: Innovating first-in-human trials: The role of New Approach Methodologies (NAMs) in modern drug development (cont...) |
| 1:00 PM - 2:00 PM | Closing reception and lunch |
|
Track 1
|
|
|---|---|
| 7:30 AM - 9:30 AM | Practical Application of New Approach Methodologies (NAMs) to support First-In-Human (FIH) Clinical Trials: Strategies, Challenges, and Regulatory Perspectives (invite only) |
| 8:30 AM - 9:30 AM |
Networking breakfast
|
| 9:45 AM - 10:30 AM | Innovation with integrity: Building global trust in digital health |
|
Friday room move 1
|
|
|
ADVANCED MANUFACTURING
|
|
| 10:35 AM - 11:20 AM | Session 11A: Regionalised therapeutic and vaccine manufacturing |
|
Friday room move 2
|
|
| 11:25 AM - 12:10 PM | Session 12A: Strengthening sovereign capability through advanced life sciences manufacturing |
|
Friday room move 3
|
|
|
EMERGING TECHNOLOGY (Cont...)
|
|
| 12:15 PM - 1:00 PM | Session 13A: Structuring success: Legal, IP and deal-making in global biotech |
| 1:00 PM - 2:00 PM | Closing reception and lunch |
|
Track 2
|
|
|---|---|
| 7:30 AM - 9:30 AM | Practical Application of New Approach Methodologies (NAMs) to support First-In-Human (FIH) Clinical Trials: Strategies, Challenges, and Regulatory Perspectives (invite only) |
| 8:30 AM - 9:30 AM |
Networking breakfast
|
| 9:45 AM - 10:30 AM | Innovation with integrity: Building global trust in digital health |
|
Friday room move 1
|
|
|
CLINICAL TRIALS
|
|
| 10:35 AM - 11:20 AM | Session 11B: Starting at the end: Aligning R&D strategy with commercial objectives |
|
Friday room move 2
|
|
| 11:25 AM - 12:10 PM |
Session 12B: The importance of diverse community engagement in clinical trials and how can we adopt a more inclusive approach to increase access to all participants Sponsored by: PARATUS CLINICAL |
|
Friday room move 3
|
|
|
VOICE, VISION AND VALUE (Cont...)
|
|
| 12:15 PM - 1:00 PM |
Session 13B: Indigenous knowledge, modern science: Bridging the gap in health and biotechnology Sponsored by: CSIRO |
| 1:00 PM - 2:00 PM | Closing reception and lunch |
|
Track 3
|
|
|---|---|
| 7:30 AM - 9:30 AM | Practical Application of New Approach Methodologies (NAMs) to support First-In-Human (FIH) Clinical Trials: Strategies, Challenges, and Regulatory Perspectives (invite only) |
| 8:30 AM - 9:30 AM |
Networking breakfast
|
| 9:45 AM - 10:30 AM | Innovation with integrity: Building global trust in digital health |
|
Friday room move 1
|
|
|
INDUSTRY ENGAGMENT AND UPDATES
|
|
| 10:35 AM - 11:20 AM | Session 11C: TGA’s global focus: A small regulator in a big world |
|
Friday room move 2
|
|
| 11:25 AM - 12:10 PM | Session 12C: Innovating first-in-human trials: The role of New Approach Methodologies (NAMs) in modern drug development |
|
Friday room move 3
|
|
|
INDUSTRY ENGAGMENT AND UPDATES (Cont...)
|
|
| 12:15 PM - 1:00 PM | Session 13C: Innovating first-in-human trials: The role of New Approach Methodologies (NAMs) in modern drug development (cont...) |
| 1:00 PM - 2:00 PM | Closing reception and lunch |