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mRNA Lecture Series 2: Lecture Four – Regulation of the mRNA platform, opportunities and challenges
May 28 @ 8:00 am - 10:30 am AEST
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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 – 10:30am
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):
8:00am: Guest arrival, registration, networking breakfast
8:45am: Welcome and opening remarks
9:00am: Presentations and Q&A
10:15am: Networking, tea and coffee
10:30am: Close
Format: In-person only
Venue: Treasury Theatre, Lower Plaza, 1 Macarthur Street, East Melbourne VIC 3002
Facilitator: Dr Amanda Caples, Chair of Scientific Advisory Group, Victoria’s Lead Scientist
Speakers:
Dr Carolyn Tucek-Szabo, Senior Director, Global Regulatory Sciences – Australia/NZ & Policy & Liaison – Southeast Asia, Moderna
Professor John Skerritt, Enterprise Professor, Health Research Impact, University of Melbourne
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.
Dr Amanda Caples, Chair of Scientific Advisory Group, Victoria’s Lead Scientist
Amanda is Victoria's Lead Scientist, a role that aligns and connects Victoria’s science, technology and innovation capability with business needs and with government’s economic development activities.
Amanda has led the development of industry and science and innovation policy in Victoria since joining the Victorian Public Service in 2002 as the inaugural Director of Biotechnology. During this time, she has delivered major policy reforms, a range of programs, global partnerships and landmark initiatives.
Amanda is experienced in clinical trials, regulatory affairs, business development and licensing through prior roles with international pharmaceutical and biotechnology companies.
Amanda has led the development of industry and science and innovation policy in Victoria since joining the Victorian Public Service in 2002 as the inaugural Director of Biotechnology. During this time, she has delivered major policy reforms, a range of programs, global partnerships and landmark initiatives.
Amanda is experienced in clinical trials, regulatory affairs, business development and licensing through prior roles with international pharmaceutical and biotechnology companies.
Dr Carolyn Tucek-Szabo, Senior Director, Global Regulatory Sciences - Australia/NZ & Policy & Liaison – Southeast Asia, Moderna
Carolyn is an Immunologist (Monash University, Faculty of Medicine) with 30 years of experience in Academia and Biotechnology/Pharmaceutical industries. She held research positions at the Necker Institute, Paris and the Sloan-Kettering Cancer Institute, New York, and studied Intellectual Property Law at Melbourne University, Carolyn held a senior scientific role in a Global Life Sciences Consultancy prior to joining GlaxoSmithKline Australia in 2010 and was Director of Regulatory Affairs until 2021.
She joined Moderna in October 2021 during the COVID-19 pandemic. Her current role dually focuses on regulatory pathways for future mRNA vaccines and medicines for Australia and Global Health Programs.
She joined Moderna in October 2021 during the COVID-19 pandemic. Her current role dually focuses on regulatory pathways for future mRNA vaccines and medicines for Australia and Global Health Programs.
Professor John Skerritt, Enterprise Professor, Health Research Impact, University of Melbourne
John is currently Enterprise Professor in Health Research Impact at the University of Melbourne and an Adjunct Professor in the Faculty of Medicine and Health of the University of Sydney.
He retired as Deputy Secretary of the Australian Department of Health and Aged Care in April 2023, having had line responsibility for over 1200 staff involved in four Australian regulators - regulation of medicines, biologics and devices (as head of the Therapeutic Goods Administration), regulation of gene technology and industrial chemicals and control of drug import, export and production.
John is active on many national and international boards and advisory committees, including advising on the establishment of a mRNA vaccines and medicines industry in Australia. John is also a member of the boards of Medicines Australia and AusBiotech, Chair of the Scientific Advisory Council of the UK-based Centre for Innovation in Regulatory Science and a member of the board of the Centre for Regulatory Excellence at the National University of Singapore.
He has a First Class Honours degree and university medal in pharmacology and a PhD and is the author of over 300 publications in many fields and earlier patented and commercialised over a dozen biotechnology products in Australia and internationally. In a previous role he was deputy agency head and the most senior scientific leader in Australia’s Foreign Affairs portfolio, and led the negotiation, design and implementation of over $ 1 billion in collaborative research and development programs between Australia and countries in the Asia-Pacific region. Professor Skerritt was part of the leadership of Australia’s COVID-19 response and one of its public faces undertaking over 100 interviews and media conferences.
He retired as Deputy Secretary of the Australian Department of Health and Aged Care in April 2023, having had line responsibility for over 1200 staff involved in four Australian regulators - regulation of medicines, biologics and devices (as head of the Therapeutic Goods Administration), regulation of gene technology and industrial chemicals and control of drug import, export and production.
John is active on many national and international boards and advisory committees, including advising on the establishment of a mRNA vaccines and medicines industry in Australia. John is also a member of the boards of Medicines Australia and AusBiotech, Chair of the Scientific Advisory Council of the UK-based Centre for Innovation in Regulatory Science and a member of the board of the Centre for Regulatory Excellence at the National University of Singapore.
He has a First Class Honours degree and university medal in pharmacology and a PhD and is the author of over 300 publications in many fields and earlier patented and commercialised over a dozen biotechnology products in Australia and internationally. In a previous role he was deputy agency head and the most senior scientific leader in Australia’s Foreign Affairs portfolio, and led the negotiation, design and implementation of over $ 1 billion in collaborative research and development programs between Australia and countries in the Asia-Pacific region. Professor Skerritt was part of the leadership of Australia’s COVID-19 response and one of its public faces undertaking over 100 interviews and media conferences.
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