For U.S. biotech & life-science companies · Phase 2 onwards

Your trial moves while New York sleeps.

Antipode Clinical takes U.S. drug candidates that have finished Phase 1 into Phase 2 and later clinical trials in Australia. We set up the local sponsor, clear ethics and the TGA notification, pick and manage the sites, structure the R&D rebate, and can co-fund the Australian portion. The data is generated to ICH-GCP so it can support your FDA filings.

A Berkshire AI, Inc. company · Delaware, USA

New York --:--  
+14 h
Sydney --:--  

Send a question at the end of your day and the Sydney team has a working day to answer it before you're back at your desk.

Why Australia

Faster to first patient. Cheaper once the rebate lands.

Australia runs Phase 2 and later trials under the same TGA Clinical Trial Notification scheme it uses for first-in-human work. Ethics approval comes first, then the sponsor notifies the TGA, and the government refunds a large share of eligible spend.

4–6weeks

Typical time from ethics submission to a study ready to start under the CTN scheme.[1]

43.5%

Refundable R&D tax offset on eligible Australian spend, for groups with turnover under A$20M.[2]

GCPto FDA

Australian Phase 2 data, run to ICH-GCP, can support your End-of-Phase 2 meeting and U.S. filings. No U.S. IND is required to run the Australian study itself.[3]

~60%

Lower net cost than an equivalent U.S. early-phase study once the rebate is applied, per industry estimates. Your figure depends on design and sites.[4]

The pathway

From your data room to a dosed patient.

The steps below run in order. Timing is indicative and assumes a program with completed Phase 1 safety and PK data and drug supply ready for a Phase 2 study.

Week 0

Program review

We read your mechanism, Phase 1 results, CMC status and target indication, and tell you plainly whether Australia fits the program and what it will cost.New York

Weeks 1–2

Australian sponsor

A CTN has to be lodged by an Australian sponsor. We incorporate and run a local subsidiary for you, or act as local sponsor, and register it for the R&D Tax Incentive.Sydney

Weeks 1–4

Sites, CRO and protocol

We shortlist sites and CROs for your indication, negotiate budgets, and adapt the protocol and investigator brochure for Australian ethics review.Sydney

Weeks 3–6

HREC approval and CTN

A Human Research Ethics Committee reviews and approves the study. The sponsor then notifies the TGA, and the site can open.Sydney

Study conduct

Oversight on your behalf

We sit on the sponsor side: tracking enrolment, spend and data quality against plan, with a weekly report timed for your Monday morning.Sydney → New York

After 30 June

Rebate and FDA bridge

We prepare the R&D Tax Incentive claim after the Australian financial year closes, and assemble the clinical package for your End-of-Phase 2 meeting and Phase 3 planning.New York + Sydney

What we do

An operator and a co-funder in one engagement.

Antipode combines two things we already do in Australia: sponsoring our own clinical program, and co-funding trials for listed biotechs. You can use either side on its own.

Operate

Run the Australian trial

  • Local sponsor entity, company secretary and R&D registration
  • Site and CRO selection, budgets and contracts
  • Ethics submissions and the TGA Clinical Trial Notification
  • Sponsor oversight through last patient out
  • ICH-GCP data package for FDA use, including End-of-Phase 2 meeting preparation
Fund

Close the cash gap

  • The rebate is paid after the financial year closes, often many months after the spend
  • Where a program passes our diligence, we co-fund the Australian portion against its expected rebate
  • Terms are set per program and tied to named clinical milestones
  • No platform fees on programs we do not fund
We are not a CRO.CROs run sites and monitor data. We choose them, contract them and hold them to your plan, so our interest stays with the sponsor.
We are not your lawyers or tax advisers.We work alongside Australian counsel and R&D tax specialists, and introduce them where you don't already have them.

Rebate estimate

What the R&D Tax Incentive could return.

Enter the spend you expect to incur in Australia. The figures show the arithmetic only. Whether each dollar is eligible depends on the activity, the entity and the registration.

A$

Sites, local CRO fees, investigator costs and Australian staff. Overseas manufacturing and offshore data work generally don't qualify.

FX

Example rate. Replace it with today's rate.

Eligible Australian spendA$3,000,000
Offset rate43.5%
Estimated refundA$1,305,000
In U.S. dollarsUS$858,553

Paid as cash after the Australian financial year ends on 30 June and the claim is lodged. Larger groups receive a non-refundable offset instead, which reduces tax payable rather than paying cash.

Who this is for

Programs that gain the most from starting here.

Assets with a clean Phase 1

Small molecules and biologics moving into Phase 2a proof-of-concept or Phase 2b dose-ranging, where a faster start brings the efficacy readout forward.

Repurposed and well-characterised drugs

Phase 2 proof-of-concept on a known molecule in a new indication, where speed and cost decide whether the study happens at all.

Venture-backed teams watching runway

Seed to Series B companies that need a clinical readout before the next raise and can't fund a U.S.-priced study.

Founder

Dave Parmar

Founder & CEO · New York

I've sponsored a trial in Australia and co-funded others. Antipode packages what we learned for U.S. companies that haven't done it before.
Training
Bachelor of Science in Pharmacology, University of Otago, New Zealand.
Aurelix Bio
Founder of a Sydney clinical-stage company sponsoring a Phase 2b program of a repurposed small molecule in Australia.
Point8 Capital
Founder of a Sydney investment firm providing clinical trial co-funding facilities to ASX-listed biotech companies.
RoseRx
Co-founder of RoseRx (formerly Rosemary Health), a conversational AI platform for pharma HCP and patient engagement, backed by Breyer Capital.

Send your program

Tell us about the molecule. We'll tell you if Australia fits.

A two-page summary is enough for a first read. Please include:

  1. Mechanism of action and target indication
  2. Phase 1 safety, tolerability and PK results
  3. CMC and drug supply status
  4. Proposed first study and its main endpoint
  5. Cash runway and the readout you need before your next raise
Email hello@berkshireai.app

We reply within five business days. We'll sign your mutual NDA before you share anything confidential.