What to Expect
ARCS Australia and DIA will co-host a focused, one-day Summit bringing together regulators, industry, researchers, clinicians and patient leaders to accelerate the safe, effective and equitable delivery of cell and gene therapies across Australia and our region.
Agenda (subject to change)
08:00–08:30 — Registration opens
08:30–08:45 — Opening Remarks
DIA Representative; ARCS Representative
08:45–10:00 — Session 1 — Charting Australia’s Advanced Therapies Landscape: Momentum, Challenges & Opportunities
Session Chairs: Tim Boyle (CEO, ARCS); Tamei Elliott (Director, Global Scientific Content, DIA)
- Simon Cool — Smart CRC
- Chris Alma — Cell and Gene industry expert
10:00–10:20 — Morning Break
10:20–12:00 — Session 2 — Global Perspectives: Translating International Insights into Local Action
Session Chairs: Maria Vassileva (Chief Science & Regulatory Officer, DIA); Lesbeth Rodriguez (Director, Regulatory Affairs, Bayer)
Focus: Regulatory convergence (FDA/EMA/APAC), platform technologies, cross-border data & ethics, and international access models.
- Ana Hidalgo-Simon — Professor, Leiden University
- Maria Vassileva — Chief Science & Regulatory Officer, DIA
- Josephine Lembong — Associate Director, Scientific Affairs, ARM
- Malou Gemeniano — VP, Regulatory, CMC, BlueRock
- Warwick Shaw — Market Access, Cell and Gene Therapies, JNJ
- Jon Beaman — MHRA
12:00–13:00 — Networking Luncheon
13:00–14:30 — Session 3 — Bridging Innovation & Access: Advancing Equitable and Sustainable Delivery
Session Chairs: Erin Evans (CEO, InGeNA); Tamei Elliott (Director, Global Scientific Content, DIA)
- Marco Barsanti — Sales Director, Integrated DNA Technologies
- Colman Taylor — Chief Vision Officer, HTAnalysts
- Laura Issa — Disability and Rare Disease Advocate, CureSPG75
- Warwick Shaw — Market Access, Cell and Gene Therapies, JNJ
14:30–15:00 — Break
15:00–16:40 — Session 4 — Building the Engine for Scale: Activating Australia’s Advanced Therapies Ecosystem in APAC
Session Chairs: Marguerite (Maggie) Evans-Galea (Deputy Director, Strategy & Planning, ARMI, Monash University); James Wabby (Head, Global Regulatory Affairs, Emerging Technologies, Combination Products & Devices; AbbVie)
Focus: Manufacturing, infrastructure, regulatory alignment, and connecting diagnostics, data, therapeutics & workforce; positioning Australia as an APAC hub.
- Leanna Read — Chair, SMART CRC
- Toshihiko Okazaki — Professor & Head, Cell and Gene Medicine Unit, Osaka University Center for Future Medicine
- Hassan Chaudhry — Senior Consultant, IQVIA
- Stephen Thompson — CEO, VVMF
- Bev Menner — CEO, CTPL
- Heather Donaghy — Director of Strategic Development, Cell and Gene Therapies, Therapeutic Innovation Australia
16:40–17:00 — Closing Remarks & Key Takeaways
DIA Representative; ARCS Representative
Summit committee
- Dr Erin Evans — CEO, InGeNA (LinkedIn)
- Dr Marguerite Evans-Galea AM — Deputy Director, Strategy & Planning, Australian Regenerative Medicine Institute, Monash University (LinkedIn)
- James Wabby — Global Head, Regulatory Affairs (CoE) Emerging Technologies, Devices & Combination Products, AbbVie (US) (LinkedIn)
- Lesbeth Rodriguez — Director, Regulatory Policy & Science, Bayer (LinkedIn)
- Maria Vassileva — Chief Science & Regulatory Officer, DIA (LinkedIn)
- Tamei Elliott — Director, Global Scientific Content, DIA (LinkedIn)
- Young Joo Park — VP for Asia Pacific, DIA (LinkedIn)
- Nav Lee — Director of Growth & Engagement, ARCS (LinkedIn)
- Anna Megalakakis — Associate Director of Education, ARCS (LinkedIn)
Stay informed
Registrations are now open. We’ll continue to update this page as the agenda is confirmed. Register here.
Practical information
- Venue: Sydney Marriott Hotel At Circular Quay, 30 Pitt Street, Sydney NSW 2000 - Henry Lawson Room
- Timing: One day, in-person program on Wednesday, 25 February 2026 (Sydney time).
- Format: Plenary keynotes, expert panels and practical sessions.
FAQs
When will registrations open?
Registrations are open now. Register here.
How much does it cost?
Early Bird rates only available up to 25 Jan 2026. All prices are in AUD and inclusive of GST.
Early Bird member — $600Early Bird non-member — $900- Standard member — $750
- Standard non-member — $1,250
Patient advocates only
Four (4) individual Patient Advocate Access Passes are available for $250 AUD each for the Cell and Gene Therapy Summit.
Please email arcs@arcs.com.au with your therapeutic area of interest to be considered for a pass.
Successful applicants will be contacted and must arrange their own travel.
Accommodation Options
|
Hotel / Apartment |
Type |
Link |
|
Pullman Quay Grand Sydney Harbour |
Premium / Serviced |
|
|
Four Seasons Hotel Sydney |
Luxury |
|
|
Shangri-La Sydney |
Luxury |
|
|
InterContinental Sydney (IHG) |
Luxury |
https://www.ihg.com/intercontinental/hotels/gb/en/sydney/sydha |
|
Paradox Sydney |
Mid-range |
|
|
Little National Hotel Sydney |
Mid-range |
|
|
A by Adina Sydney |
Serviced apartment |
|
|
The Sebel Quay West Suites Sydney |
Serviced apartment |
|
|
Meriton Suites Pitt Street, Sydney |
Serviced apartment |
https://www.meritonsuites.com.au/our-hotels/nsw/sydney-cbd/pitt-street/ |
|
YHA Sydney Harbour – The Rocks |
Budget / Hostel |
https://www.yha.com.au/hostels/nsw/sydney-surrounds/sydney-harbour/ |
|
Rendezvous Hotel Sydney The Rocks |
Mid-range / Value |
https://rendezvoushotels.com.au/book-accommodation/sydney/rendezvous-hotel-sydney-the-rocks/ |
|
Sydney Harbour Hotel |
Budget / Mid-range |
Partners
Supporting Partner
Sponsorship and Exhibition
For details on sponsorship and exhibiting opportunities, pricing and booth availability, please refer to the Summit Prospectus or contact emacmahon@arcs.com.au.
Become an ARCS Member
Join ARCS to unlock member benefits including early-bird rates, discounted event pricing, complimentary Interest Area webinars, networking and more. Become a member now.
© 2026 ARCS Australia & DIA. Information subject to change. Last updated: .
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