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Nucleus Network

  • Cameron Johnson, Nucleus Network

We would like to share the Australian value proposition to small biotech's and virtual's due to the positive impact Australia has on clinical trials.

Some of the compelling benefits are;

1. Speed - There is a favorable regulatory pathway- you can have FPI in about 5-6 weeks and you do not need an IND to commence your phase 1. Many sponsors come to Australia, then file their IND with data in hand. This saves time and money.

2. Quality - Data generated in Australia is accepted by the US FDA and EMA. You can do the early clinical development in Australia then to the US/EU for Phase 2/3.

3. Cost - There is a government tax Incentive policy in place that provides a significant 41% Cash Rebate for all work completed there. This includes manafacturing, lab PK/PD, shipping fees, all clinical work. Due to the lower cost in general in Australia, you can expect to save approximately 60% of the cost if the same study was conducted in the United States.

  • Date:Wednesday, October 17
  • Time:9:45 AM - 10:00 AM
  • Room:Olympic
  • Location:2nd Floor
  • Session Type:Company Presentation
  • Presentation Type:Global Innovation Hub
  • Additional Information/Comments:Though we are a service provider, we work with many of the providers in Australia. Our CEO, Cameron Johnson, has the experience and gravitas to represent Australia in a gneralized overivew and not to be company specific. This information has the ability to save comapnies from going under due to the lower cost and speed of getting into clinic. Additonally, due to the savings, this allows them to come back to the US or EU for Phase 2 and or 3 with more capital. We find most are not aware of this R & D Tax policy, but once they are, they are very interested in looking at Australia for early clinical development.
  • Country/Region:Australia
  • Country/Region Presentation Title:The Australian Value Proposition
  • Organization Description/Mission Statement:Nucleus Network is Australia’s largest and most experienced CRO specializing in the conduct of First-in-Human (FIH), Phase I Clinical Trials. Our clients include international Biotechnology and Pharmaceutical companies, with over 90% of our current client base from the U.S. We have extensive experience in the conduct of early phase study designs in healthy volunteers and patient populations, e.g. FIH SAD and MAD, Drug Interaction, Food Effect, Bioequivalence, Crossover, TQTc, Ethnopharmacology, Vaccines, ADME. Nucleus Network conducts approximately 50-60 studies annually, with 25-30 of these being true First-in-Human studies (SAD/MAD). We have extensive experience with both biologic and small molecule products across most therapeutic areas. Due to Australia’s Clinical Trial regulatory process, Sponsors don’t require an IND or IMP and Australian data is accepted for regulatory submission by FDA and EMA. We have been audited by the FDA and EMA, and previously ANVISA certified. All our Clinical Trial data is measured against the highest quality regulatory standards. Favorable exchange rates and an internationally-accessible R&D Incentive Scheme gives Australia a competitive edge as the destination for conducting Clinical Trial research.
  • Organization
  • Reason #1:Speed- FPI in just 6 weeks
  • Reason #2:IND not needed to commence PH 1 in Australia
  • Reason #3:Quality- data is accpeted by FDA and EMA
  • Reason #4:Savings of about half from the US or EU
  • Reason #5:Faster start-up and lower cost enables sponsors to get more drugs into clinic.
Cameron Johnson
Nucleus Network