BioPharma
A clinical programme that gets you to data is one thing. A clinical programme that gets you to the next round of capital is another.
Book a commercial evidence review.
Contact usFor small biotech in Australia and New Zealand, clinical trials are both the asset and the cost. The Clinical Trial Notification (CTN) pathway in Australia can be faster and cheaper than equivalent jurisdictions for early phase work. Running a trial is not the same as building a commercially defensible evidence package. Parallaxis works alongside founders, management teams and investors to make sure the programme is designed for the claim that drives value, the endpoints that drive market access, and the story that drives the next raise.
The Regulatory Landscape
CTN in Australia. Clinical Trial Notification is the primary pathway for early phase clinical trials in Australia. It can be faster and cheaper than equivalent jurisdictions, the TGA is notified rather than required to pre-approve. Trials register on the ANZCTR.
Most biotechs will need both. Starting in Australia for early phase work can be materially faster and cheaper. The trade-off: evidence generated in ANZ must be designed from day one to support a future IND, not retrofitted later.
The strategic anchor for the programme. Built before the protocol is written, the TPP defines what the product must deliver, to whom, against what comparators, at what dose and dosing frequency, to be commercially viable. Every endpoint, every comparator arm, every inclusion and exclusion criterion should be traceable back to it.
Beyond the regulators, reimbursement decisions are made by the PBAC in Australia and equivalent bodies in the US and EU. Designing for market access from the start costs far less than retrofitting.
Where Companies Get Stuck
Endpoints that satisfy regulators but do not move payers or investors.
ANZ early phase data that does not transfer to a US IND because it was not designed to.
Market access ignored until Phase 3, when the cost of new endpoints is enormous.
The Proof We Build
- Target Product Profile: the commercial north star.
- Endpoint and comparator strategy designed for claim, payer and dual regulator.
- ANZ to US pathway design with evidence built to travel.
- Investor-ready evidence narrative.
- Market access roadmap against the programme.
Common Questions
CTN is a notification scheme. The sponsor notifies the TGA after HREC approval and the trial proceeds without TGA pre-review. CTA requires TGA assessment before the trial can start.
A structured statement of what the product needs to deliver: population, indication, comparators, endpoints, dosing, positioning. Built before the protocol, not after.