Why Emerald for Oncology PoC?
Scientific Leadership from the Start
Our dedicated early phase oncology team brings deep medical scientific and regulatory expertise, supported by long standing partnerships with global and regional Oncology KOLs. This enables robust tumour type feasibility, biomarker driven cohort expansion, and informed go/no go decisions early in development.
Regulatory Speed Built In
We design PoC pathways to optimise regulatory timelines across regions:
- Australia & USA: Final protocol to FPI in 8–12 weeks
- China & Europe: 3-5months driving Last patient in (LPI) in dose escalation cohorts typically within 6–10 months
- ROI Advantage: Enrolment 2–5× faster than US/EU alone at 20 -50% cost of USA
Our teams manage IND (USA), TGA CTN (Australia), CTIS (Europe), and CFDA/NMPA (China) processes in parallel to minimise delays.
Early Phase Oncology Expertise (Phase I/II)
We execute complex oncology trials, including:
- PoC First in Human (FIH) ADC, Bi-Specifics and Cell and Gene therapy programs
- Adaptive designs, Superiority, Umbrella, Basket Trials
- Predictive biomarker driven tumour expansion for early efficacy signals
Integrated PK/PD laboratory partnerships enable rapid turnaround and faster clinical insights.
Cell & Gene Therapy (CGT): Australia & China Advantage
Emerald Clinical offers specialised cell and gene therapy PoC expertise, leveraging regulatory and operational advantages in China and Australia:
- China IIT and manufacturing ecosystem experience
- Deep clinical expertise in targeted CGT, cytokine release syndrome, persistence, and toxicity management
- Early and parallel OGTR, CTA/CTN, HREC, and TGA alignment in Australia to de risk submissions and execution
A Lean, Sponsor Centric Partnership Model
Built for Speed and Agility
- Lean global local operating model
- Rapid contracting and site activation
- Adaptive trial execution without CRO overhead complexity
Direct Senior Access & Rapid Communication Sponsors benefit from hands on senior leadership, real time updates, and proactive risk mitigation—keeping early phase programmes tightly controlled and decision ready.
China-to-Global Acceleration We support biotechs executing FIH/FIP in, Australia, China, Europe, anchored by USA IND dossier, enabling faster global data packages and earlier value inflection points.
Our Commitment
Emerald Clinical is committed to expediting targeted oncology therapies that address critical unmet needs—delivering speed, scientific confidence, and early value creation in Proof-of-Concept development.
Contact Us to Find Out How We Can Help Shape Your Clinical Design
Meet our experts
Luke Gill MSc, MBA
Luke Gill, VP, Head Global Oncology, brings more than 25 years of leadership experience spanning global clinical development, operations and strategic partnerships across the biotech and CRO sectors.
He has successfully built and scaled oncology organizations, leading programs from first-in-human and translational studies through PoC to pivotal Phase III trials and regulatory submissions.
Luke holds an MSc in Neuro and Molecular Pharmacology and an MBA, combining deep scientific understanding with strong financial and commercial leadership.
He has held senior executive positions within international CROs, where he was responsible for multi-regional oncology portfolios, operational excellence programs and strategic alliances with leading biotech and pharmaceutical partners across the USA, Europe and Asia-Pacific (including China). His leadership has driven measurable gains in clinical readouts, delivery quality and biotech satisfaction.
Tamara Murdock
Tamara has over 25 years of clinical research experience in pharmacology and therapeutic areas including oncology, metabolic disorders, cardiology, and dermatology. A distinguished leader in Early Phase, she has worked in a Phase I unit in Australia and with Australian-based CROs. Her expertise and deep passion guide clients to accelerate their early-phase research and transform promising ideas into groundbreaking medical advancements. As Global Head of Early Phase Research, she is dedicated to ensuring that studies are conducted with precision, efficiency, and the highest scientific and ethical standards. Her commitment to excellence and strategic vision make her a trusted partner in bringing new therapies to life.