COG West Coast: Outsourcing to Australia Tips for Success, Oranee Daniels

In early November the Pharmaceutical Business Conference Group hosted the inaugural COG West Coast meeting in Burlingame, California. Dr. Oranee Daniels, an experienced physician-scientist with expertise in translational medicine, clinical pharmacology, and biotech startups, presented on recently outsourcing clinical studies to Australia.

Oranee's presentation covered the rationale for considering Australia, including pros and cons, shares insights from her own experience, and provided key takeaways for companies considering outsourcing trials there.

Key Takeaways

• Significant cost savings can be achieved by outsourcing trials to Australia, especially if the sponsor company is eligible for Australia's generous research and development tax rebate. Savings could amount to 60% of comparable US costs.

• Australia's clinical research infrastructure is high-quality and well-developed. This includes a strong network of expert investigators, ethical review committees, labs, and an advanced healthcare system to support trials. Data quality is reliable.

• Startup timelines can be faster than in other regions. However, Australia's smaller population limits patient recruitment capacity somewhat. Additional planning is needed to account for time zone differences.

• Some upfront investment is required to establish an Australian entity to claim the R&D tax credit. Logistical overhead exists in coordinating teams across Pacific time zones.

• Australian research personnel are experienced, realistic, and collaborative. Contracting models may differ from typical CRO relationships in the US. Local knowledge helps navigate regulatory and contracting norms.

Australia offers a compelling destination for outsourcing early phase or proof-of-concept clinical trials for cost-conscious biotech companies, contingent on eligibility for the generous R&D tax credit.