About the Event

mRNA LECTURE SERIES 2:

Based on the demand and success of the first lecture series, mRNA Victoria and BioMelbourne Network, are pleased to host a second series of four lectures beginning in November 2023 for the Victorian RNA community.

These lectures present an opportunity for global leading specialists in the RNA field to share their knowledge with the local RNA community. The accompanying networking sessions are an opportunity to foster connections between researchers, industry and government to build a connected and collaborative ecosystem in Victoria.

Explore Series 1 and 2 lectures and recordings here

Series 2 comprises four lectures:

Lecture One: The RNA Platform: The Breadth of Possibility Beyond mRNA | Friday 10 November 2023, 8:00am – 11:00am
Lecture Two: mRNA Clinical Trials: Enhancing Research-Clinician Collaboration to Accelerate Patient Outcomes | Tuesday 20 February 2024, 8:00am – 11:00am
Lecture Three: Preparing for Disease X | Thursday 11 April, 8:00am – 11:00am
Lecture Four: Regulation of the mRNA platform, opportunities and challenges | Tuesday 28 May 2024, 8:00am – 11:00am

SERIES 2 | LECTURE FOUR – REGULATION OF THE MRNA PLATFORM, OPPORTUNITIES AND CHALLENGES

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: Treasury Theatre, Lower Plaza, 1 Macarthur Street, East Melbourne VIC 3002
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.

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