The Australian Regulatory Pathway: An Accelerated Entry into First-in-Man Clinical Trials

Life Sciences, Clinical Trials, Emerging Market,
  • Tuesday, December 10, 2019

Over the last 20 years, Australia has grown to become a destination of choice for the conduct of early-phase clinical trials. This is partly due to the favourable Australian regulatory pathway that exists where the submission of an online Clinical Trial Notification form to the Therapeutic Goods Administration (TGA) means that from submission of documents to IRB for approval to First Patient First Dose takes an average of five weeks. Coupled with the attractive R&D tax incentive program offered by the Australian Government, this model can be used to support an Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) application allowing companies to speed up their drug development process.

Join this free webinar to learn more and understand how the favourable regulatory pathway works in Australia. The featured speakers will draw upon their experience with US biopharmaceutical companies and will discuss the strategies being followed by US biopharmaceutical companies in planning their first in human studies, which are ultimately accelerating their drug development pathway.


Cameron Johnson, CEO, Nucleus Network Pty Ltd

Cameron Johnson is considered one of the most experienced Phase I clinical trial professionals in Australia, having held senior management roles within three of the four established Phase I Australian Clinical Trial companies. Cameron’s Phase I experience extends into Europe and the Clinical Research Organisation (CRO) industry, where he managed clinical trial facilities across Australia and New Zealand. He joined Nucleus Network in September 2013 as Chief Operating Officer before moving into the position of Chief Executive Officer (CEO) in May 2016.

Prior to commencing at Nucleus Network, Cameron was the inaugural CEO of an Australian Phase I clinical trials facility interstate. Responsibilities included the establishment of the company’s corporate structure and company registration. Cameron was Operations Manager to the CEO at an interstate Phase I clinical trials facility. Cameron undertook the operational management of the company’s departments as well as business development initiatives, budget preparations and finance review of management accounts. In 2018, Cameron led the sale and expansion of Nucleus Network, positioning the company for rapid acceleration and capability growth.

Message Presenter

Jon Fairweather, Business Development, PCI Pharma Services

Jon Fairweather is Business Development, Technical Services Executive at PCI Pharma Services for Australia and New Zealand. Jon is responsible for facilitating cGMP Investigational Medicinal Product supply for use in early phase clinical trials through manufacturing, packaging and storage and distribution. He has worked within PCI as Director of Projects, and prior to this has held former roles including company director, COO, BDM, CMC Manager and research scientist at various life science companies. Jon thrives on accelerating products through clinical development locally and growing these opportunities globally.

Message Presenter

Stewart Walker, VP, Business Development North America, CoSec

Stewart has over ten years’ experience in the corporate regulatory compliance industry and a track record of developing lasting, professional relationships. Stewart understands that a complex web of regulatory and reporting requirements can demand more time from executives than actually running their businesses, and he is pleased to represent a company that is committed to understanding its clients’ compliance and governance needs, fulfilling their regulatory obligations, and optimizing every opportunity that the market has to offer. Stewart holds an MA from New York University, and he has spent over 10 years engaged in consultative sales in the US with corporate executives, controllers, and financial reporting managers.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals working in pharmaceutical and biotechnology start-up companies with the following or related job titles: 

  • CEO
  • Clinical Trial Managers
  • Clinical Program Leaders
  • Clinical Operations Manager
  • Clinical Consultants

What You Will Learn

Attendees will learn about:

  • The regulatory pathway that exists in Australia
  • The quality of clinical development in Australia
  • The R&D Tax Incentive
  • The 43.5 percent cash rebate

Xtalks Partner

Nucleus Network

Nucleus Network (Nucleus) is Australia’s only multi-site dedicated phase I clinical research organisation with phase I facilities located in Melbourne (80 beds) and Brisbane (60 beds).  The phase I units are strategically co-located within the Alfred Hospital in Melbourne (approx. 800 bed tertiary teaching hospital) and within the Royal Brisbane and Women’s Hospital (approx. 900 bed tertiary teaching hospital) in Brisbane. This combination also provides Nucleus with access to a combined population of 7.5million people. Nucleus has extensive experience in the conduct of early phase study designs in healthy volunteers and patient populations eg. FIH SAD and MAD, drug interaction, food effect, bioequivalence, crossover, TQTc, ethnopharmacology, ADME etc. Established in 2004, Nucleus has conducted over 750 phase I clinical trials in both biologics and small molecules, with 90% of our clients being overseas (primarily the USA) pharmaceutical and biotech companies.

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