The leading Asia-Pacific biotech specialist CRO Novotech is collaborating with biotech and pharma news platform Endpoints News for a webinar about the strategic and quality benefits of running first-in-human vaccine studies in Australia.
According to Novotech:
“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.
The rapid Australian and New Zealand regulatory and ethics processes often means biotech companies can initiate their clinical programs and commence dosing within a single review cycle of 6-8 weeks from submission.
As a result, many biotechnology companies can commence a first-in-human clinical trial in parallel to the preparation of a US IND submission.”
During this webinar, experts 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
The webinar will be led by Endpoints News Publisher Arsalan Arif. Participants will include leading experts from the Australian clinical trial sector:
- Dr. Paul Griffin, Principal Investigator at Nucleus Network
- Dr. Jeff Loutit, Chief Medical Officer at Qpex Biopharma
- Dr. Simone Flight, Senior Consultant at Novotech Biodesk
- Stewart Walker, President, CoSec USA
Webinar: Running First-in-human and Vaccine Studies in Australia
Broadcast time: August 11, 2-3pm EDT
Novotech has teams on the ground in the key Asia-Pacific countries and has just signed its 30th Partnership agreement which is a program with leading medical institutions throughout the Asia-Pacific giving Novotech clients unique access to some of the top researchers, investigators and key opinion leaders.