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Running First-in-human and Vaccines Studies in Australia

The regulatory environment in Australia offers a significant strategic opportunity for international biotech companies who can take advantage of a uniquely fast and pragmatic regulatory pathway for early phase clinical trials.

A US Investigational New Drug (IND) submission is not necessary to initiate first-in-human clinical trials in Australia. FIH trials in Australia are of high quality and are acceptable to other regulatory agencies in support of later Phase clinical trials.

During this brief we will discuss:

  • The latest research and trends of early phase clinical trials globally and in Asia-Pacific, with a focus on Vaccine studies
  • How the Australian regulatory requirement compares with the US, and what are the benefits for biotechnology companies to involve sites in Australia
  • How to take advantage of the Australian R&D Government refund (of up to 43.5%)
  • Feedback from sponsors and investigators
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Dr. Stewart Walker

Stewart Walker

President, CoSec USA

Stewart has over a decade of experience in the corporate regulatory compliance industry and strong record of supporting US-based executives to navigate the complexities of the regulatory landscape. Understanding that a complex web of regulatory requirements can demand more time from executives than actually running their businesses, Stewart is happy 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.

Dr. Paul Griffin

Dr. Paul Griffin

Principal Investigator at Nucleus Network

An Infectious Diseases Physician and Microbiologist, Dr. Paul Griffin was appointed as the Director of Infectious Diseases at Mater Health Services in 2013. In addition, Dr. Griffin continues appointments as Principal Investigator at Nucleus Network, as Visiting Scientist/Honorary Research Fellow at Mater Medical Research Institute and Queensland Institute of Medical Research, and also as Senior Lecturer at the University of Queensland. Dr. Paul Griffin's primary research interests include clinical trials in the field of infectious diseases particularly malaria human challenge and transmission-blocking studies, as well as the detection of antibiotic resistance particularly VRE by mass spectrometry in the clinical microbiology laboratory.

Dr. Jeff Loutit

Dr. Jeff Loutit

Chief Medical Officer at QPEX biopharma

Dr. Loutit is responsible for global clinical development, and medical and regulatory affairs. Dr. Loutit has 19 years of experience in anti-infective and pulmonary drug development. Prior to Qpex, he was Chief Medical Officer at Mpex, Rempex, and The Medicines Company where he was responsible for the global Phase 1 through 3 clinical development and post-approval studies in the US and/or Europe of inhaled levofloxacin, oritavancin, intravenous minocycline, and meropenem-vaborbactam

Dr. Simone Flight

Dr. Simone Flight

Senior Consultant at Novotech BioDesk

Dr. Simone Flight, a Senior Consultant within BioDesk, has worked for over eight years’ in early drug development and more than 13 years’ in the pharmaceutical industry including ten years’ as a regulatory affairs consultant, consulting on international projects from early proof of concept, facilitating marketing authorisation approvals and coordinating post marketing activities. Simone has also worked for three years’ in RA and compliance within a multinational pharmaceutical company. Simone is currently Chair of Novotech’s Institutional Biosafety Committee, a commercial committee who facility entry of therapies that are Genetically Modified Organisms into clinical trials.

Arsalan Arif
moderator

arsalan arif

Founder & CEO, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.