C08. Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Tracks
Clinical Research
| Thursday, June 5, 2025 |
| 11:15 AM - 12:15 PM |
| Parkside 1 |
Chair & Speakers
Krista Applebee
Director Project Delivery
Avance Clinical
Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Biography
Paula Buschhaus
Project Manager
Avance Clinical
Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Abstract
Early-phase clinical trials are crucial for the development of new therapies, providing essential data on safety, tolerability, pharmacokinetics, and initial efficacy. Australia, a world leader in early-phase clinical trials, particularly healthy volunteer Phase 1 studies, benefits from fast regulatory approvals and top-tier research teams. However, a key challenge remains: how can we better encourage sponsors to continue their later-phase trials in Australia rather than moving them overseas?
This session will bring together experts from clinical sites and CROs to discuss the latest trends and innovations in early-phase trial design and execution, as well as strategies for ensuring a smooth transition from Phase 1 to Phase 2 and beyond. Industry leaders will share real-world examples and best practices for accelerating timelines, improving trial efficiency, and managing risk.
By fostering collaboration between clinical sites, CROs and the biopharmaceutical industry, this session aims to enhance the effectiveness and speed of clinical development, ultimately delivering new therapies to patients faster and more safely. Attendees will gain a clearer picture of why Phase 1 pull-through is a challenge and how to overcome it, practical ideas for fostering stronger collaboration between stakeholders, and actionable strategies to help Australia retain and grow its clinical trial opportunities.
This session will bring together experts from clinical sites and CROs to discuss the latest trends and innovations in early-phase trial design and execution, as well as strategies for ensuring a smooth transition from Phase 1 to Phase 2 and beyond. Industry leaders will share real-world examples and best practices for accelerating timelines, improving trial efficiency, and managing risk.
By fostering collaboration between clinical sites, CROs and the biopharmaceutical industry, this session aims to enhance the effectiveness and speed of clinical development, ultimately delivering new therapies to patients faster and more safely. Attendees will gain a clearer picture of why Phase 1 pull-through is a challenge and how to overcome it, practical ideas for fostering stronger collaboration between stakeholders, and actionable strategies to help Australia retain and grow its clinical trial opportunities.
Biography
Paula Buschhaus is an experienced clinical research professional with over 15 years in the pharmaceutical and CRO industry. She specializes in clinical trial management, study start-up, and regulatory strategy across the Asia-Pacific region. Paula is passionate about collaborative leadership, mentoring, and delivering high-quality, patient-focused research.
Brandon Pallas
Head of Business Development and Performance
Linear Clinical Research
Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Abstract
Early-phase clinical trials are crucial for the development of new therapies, providing essential data on safety, tolerability, pharmacokinetics, and initial efficacy. Australia, a world leader in early-phase clinical trials, particularly healthy volunteer Phase 1 studies, benefits from fast regulatory approvals and top-tier research teams. However, a key challenge remains: how can we better encourage sponsors to continue their later-phase trials in Australia rather than moving them overseas?
This session will bring together experts from clinical sites and CROs to discuss the latest trends and innovations in early-phase trial design and execution, as well as strategies for ensuring a smooth transition from Phase 1 to Phase 2 and beyond. Industry leaders will share real-world examples and best practices for accelerating timelines, improving trial efficiency, and managing risk.
By fostering collaboration between clinical sites, CROs and the biopharmaceutical industry, this session aims to enhance the effectiveness and speed of clinical development, ultimately delivering new therapies to patients faster and more safely. Attendees will gain a clearer picture of why Phase 1 pull-through is a challenge and how to overcome it, practical ideas for fostering stronger collaboration between stakeholders, and actionable strategies to help Australia retain and grow its clinical trial opportunities.
This session will bring together experts from clinical sites and CROs to discuss the latest trends and innovations in early-phase trial design and execution, as well as strategies for ensuring a smooth transition from Phase 1 to Phase 2 and beyond. Industry leaders will share real-world examples and best practices for accelerating timelines, improving trial efficiency, and managing risk.
By fostering collaboration between clinical sites, CROs and the biopharmaceutical industry, this session aims to enhance the effectiveness and speed of clinical development, ultimately delivering new therapies to patients faster and more safely. Attendees will gain a clearer picture of why Phase 1 pull-through is a challenge and how to overcome it, practical ideas for fostering stronger collaboration between stakeholders, and actionable strategies to help Australia retain and grow its clinical trial opportunities.
Biography
Brandon Pallas is the Head of Business Development and Performance at Linear Clinical Research Ltd., where he oversees the initial stages of new clinical trials, leading the Business Development, Start-Up, and Project Management teams.
Brandon has a diverse academic background with degrees in Physics, Electrical Engineering, and Biomedical Engineering. He began his professional career in Maxillofacial Surgery before transitioning to Clinical Trial Supply Chain consulting in Europe. Since returning to Australia in 2023, he has been a key member of the Linear team.
Ms Malia Rogers
Director Of Regulatory Operations
Novotech
Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Biography
With over 19 years of experience in the clinical research industry, I am currently the Director of Regulatory Operations at Novotech, a leading global CRO. My career has been dedicated to advancing clinical trial operations, with a strong focus on regulatory strategy, trial start-up efficiency, and cross-sector collaboration.
Previously, I served as Operations Director for New South Wales at Novotech, where I led regional initiatives to expand clinical trial capabilities and strengthen partnerships with sponsors and sites. My professional journey also includes key roles at other global CROs, where I gained extensive experience navigating complex regulatory environments and delivering high-quality outcomes across diverse therapeutic areas.
I am passionate about impactful work that improves patient outcomes and accelerates access to innovative therapies. A strong advocate for Australia’s role in global clinical research, I actively contribute to initiatives that position the region as a preferred destination for high-quality, efficient trials.
At ARCS 2025, I look forward to sharing insights on regulatory operations, fostering collaboration, and driving innovation in clinical trial delivery.
Carolyn Luscombe
Therapeutic Strategy Manager
Novotech
Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
Biography
Carolyn Luscombe PhD is an Early Phase Therapeutic Strategy Manager for Novotech based in Melbourne, Australia. She received a PhD at University of Melbourne in Microbiology and Immunology where she evaluated antiviral drugs for chronic viral infections. Carolyn has 30 years of experience in drug development and 20 years in clinical research and taking products from drug discovery through to Phase 2 studies in Australia and Thailand. She was an Assistant Professor at Colorado State University. She has worked as an executive scientific and clinical development team member in biotech companies in Canada, USA and Australia and has patents for antiviral and immune modulation investigative products. Her specialty is the translation from preclinical studies to first-in-human trials for a broad range of indications and recently focuses on early phase clinical programs for autoimmune, neurological and infectious disease indications for Novotech’s local and global clients.
