SERIES 2 | LECTURE FOUR – REGULATION OF THE MRNA PLATFORM, OPPORTUNITIES AND CHALLENGES
May 28 @ 8:00 am - 11:00 am AEST
The urgency of the pandemic provided a fast-tracked approval opportunity for mRNA vaccines, made possible by international regulatory and industry co-operation, 24/7 evaluation processes and many other factors. In non-pandemic times, regulatory agencies across the world are now being faced with the challenge of updating their approval processes to assess this new platform technology. An Australian working group including leaders from biotech, pharma, regulatory science and government has published a world-leading pre-print article that draws on experience with regulation of biosimilars, cell and gene therapies and antibodies to provide practical guidance to regulators on how a platform technology approach can be applied to regulation of future mRNA vaccines and therapies. In addition to regulation of mRNA at the commercialisation stage of development, we’ll also examine implications of Australia’s OGTR (Office of the Gene Technology Regulator) legislation on development of mRNA candidates for clinical trials, and the potential future challenges for the self-amplifying RNA field.
mRNA technology promises hope for new treatments for rare diseases and hard to treat cancer, but regulation of this new technology could slow the approval of new medicines if regulatory agencies aren’t engaged early. This lecture will provide attendees with up-to-the-moment insight into work underway to develop new processes for regulation of mRNA therapies and vaccines that could see Australia play a world-leading role in regulatory science.
Lecture Four Details:
Date: Tuesday 28 May 2024
Time (AEST):
7:45am: Guest arrival, registration
8:00am: Networking breakfast
9:00am: Welcome and opening remarks
9:15am: Presentations and Q&A
10:30am: Networking, tea and coffee
11:00am: Close
Format: In-person only
Venue: Melbourne CBD
Facilitator: Carolyn Tucek-Szabo Ph.D., Dip IP Law, Senior Director, Global Regulatory Sciences – Australia/NZ & Policy & Liaison – Southeast Asia
Hosts:
Valentina Tan, Research and Industry Development Officer, mRNA Victoria
BioMelbourne Network
REGISTRATION (IN PERSON ONLY)
BioMelbourne Network Members: $0
BioMelbourne Network Non Members: $85
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CANCELLATION POLICY
Full refund given up to 7 days prior to the event.
No refunds within 7 days of the event.
About mRNA Victoria
mRNA Victoria is responsible for leading the Victorian Government’s commitment to establish a world-class mRNA and RNA industry in Victoria, by supporting supply chain, research and development for pre and clinical research, commercialisation and manufacturing investments.Its role is to identify key capabilities, gaps, opportunities and lead the Victorian Government’s engagement, investment and partnerships with domestic and international companies, researchers and stakeholders to build RNA capability.
This lecture series is delivered in partnership with mRNA Victoria and the State Government of Victoria.