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.

Series Overview:

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 2024, 8:00am – 11:00am

Lecture Four: Regulation of the mRNA platform, opportunities and challenges | Tuesday 28 May 2024, 8:00am – 11:00am

Registration:

BioMelbourne Network Members: $0
BioMelbourne Network Non Members: $85

Who should attend?

• Professionals seeking to improve knowledge and foster connections in the RNA industry
• mRNA technology professionals developing products for the local or global market 
• Executives, scientists, researchers, manufacturers and industry service providers engaged in the RNA technology landscape.

This lecture series is delivered in partnership with mRNA Victoria and the State Government of Victoria.

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.

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

David Herd, Chair, BioMelbourne Network

Series 2: Lecture Three:

Preparing for Disease X 

Countries around the world have extracted valuable learnings about pandemic preparedness from the COVID-19 pandemic.

Now the global focus of researchers, companies and governments is turning to preparation for the next pandemic – Disease X.

But how do you prepare for a pandemic when you don’t know what the disease will be?

This session will explore research, infrastructure and processes under development to prepare for the emerging threat of Disease X.

Our speakers will discuss the following topics:

• Introducing disease X, detection and prevention – Professor Brendan Crabb AC, Director and CEO, Burnet Institute
• Moderna’s mRNA platform, pandemic preparedness, and global public health – Jacqueline Miller, Senior Vice President Infectious Diseases, Moderna
• Preparing for the known unknown: better data for better decisions – Professor Jodie McVernon, Director of Doherty Epidemiology, The Peter Doherty Institute for Infection and Immunity; Member, World Health Organization.

Facilitator: Professor Brendan Crabb AC, Director and CEO, Burnet Institute

Opening remarks: Ms Phoebe Dunn, Acting CEO, mRNA Victoria

Speakers:

Professor Brendan Crabb AC, Director and CEO, Burnet Institute

Jacqueline Miller, Senior Vice President Infectious Diseases, Moderna

Professor Jodie McVernon, Director of Doherty Epidemiology, The Peter Doherty Institute for Infection and Immunity; Member, World Health Organization

Hosts:

Valentina Tan, Research and Industry Development Officer, mRNA Victoria

David Herd, Chair, BioMelbourne Network

Series 2: Lecture Two: 

mRNA Clinical Trials: Enhancing Research-Clinician Collaboration to Accelerate Patient Outcomes

The agility of the mRNA platform provides new opportunities for innovation in the delivery of clinical trials that could accelerate and improve the drug development process. This lecture will explore the opportunities of mRNA clinical trials for researchers, clinicians and the broader sector and speakers will share their experiences from conducting their own mRNA clinical trials.

The intended audience is those that have an interest in developing an mRNA candidate to take to clinical trials, researchers who have non-mRNA candidates who are exploring an accelerated option using the mRNA platform, and industry professionals, students and academics who are interested to learn more about the workforce opportunities to support the mRNA industry in the future.

Guest speakers:
Professor Riccardo Dolcetti, Head, Clinical and Translational Immunotherapy, Peter MacCallum Cancer Centre
Dr Iris Depaz, Country Medical Lead & Head of Medical Vaccines, Sanofi ANZ
Associate Professor Jennifer Short, Director, Monash Centre for Advanced mRNA Medicines Manufacturing and Workforce Training

Facilitated by:
Dr Kylie Quinn, Vice-Chancellor’s Research Fellow, School of Health and Biomedical Sciences, RMIT University

Series One - Lecture One 

Introduction to the Intellectual Property Landscape, the Product Development Pathway and Leveraging Existing Capabilities in the Development of New RNA Therapeutics

Guest Speakers:
Rachel Sciascia, Legal Practitioner Director, Deloitte Legal
Dr Patricia Vietheer, Director, R&D Strategy & Planning, Biointelect
Dr James Patterson, Executive Director Manufacturing, mRNA Victoria

Opening Remarks:
Michael Kapel, Chief Executive Officer, mRNA Victoria
Dr James Patterson, Executive Director Manufacturing, mRNA Victoria

Series One - Lecture Two

Fireside Chat with Professor Robert Langer, Co-Founder of Moderna, Institute Professor at MIT

Professor Robert Langer is an American chemical engineer and Co-Founder of Moderna. He is one of twelve Institute Professors at the Massachusetts Institute of Technology, holds over 1,400 granted or pending patents and is one of the most highly cited researchers in the world.

During this fireside chat, Professor Langer dialed in live from Boston and spoke about his career, shared lessons he learnt along the way, and participated in Q&A facilitated by Professor Christopher Porter, Director of the Monash Institute of Pharmaceutical Sciences.

Guest speaker (live streamed from Boston):
Professor Robert Langer, Co-Founder, Moderna & Institute Professor, Massachusetts Institute of Technology (MIT)

Facilitator:
Professor Chris Porter, Director, Monash Institute of Pharmaceutical Sciences, Monash University

Series One - Lecture Three

Exploring the Clinical Trials Landscape 

The third lecture in the mRNA Victoria and BioMelbourne Network lecture series is focused on clinical trials and associated considerations. The session will be chaired by Michelle Gallagher (CEO, Opyl) and will include presentations from three speakers followed by a Q&A panel discussion. The intended audience is those that have an interest in the progression of RNA based candidates from preclinical development to clinical trials and the steps taken in order to ensure the appropriate decisions are made for study design and execution. The emphasis will be on specific considerations for progressing RNA based candidates to clinic and where the field can progress in the future.

We are fortunate to have three speakers with expertise across a range of facets associated with clinical trial screening, planning and delivery.

Guest speaker (live streamed from Boston):
Dr Jason Lickliter, Chief Medical Officer, Nucleus Network
Professor Elizabeth Hartland, Director and CEO, Hudson Institute of Medical Research
Dr Paul Burton, Chief Medical Officer, Moderna (USA)

Facilitator:
Michelle Gallaher, CEO, Opyl

Series One - Lecture Four

Enabling RNA Technology

The fourth lecture in the mRNA Victoria and BioMelbourne Network lecture series focuses on enabling technologies and their application for the development of RNA based products. The session will be chaired by Professor Michelle McIntosh (Director, Medicine Manufacturing Innovation Centre) and will include presentations from three speakers followed by a Q&A panel discussion.

The intended audience is those that have an interest in the development of RNA based candidates with an emphasis on the CMC (chemistry, manufacturing and control) considerations for progressing an asset through the clinic and eventual commercial production.

Guest speakers:
Dr Natalie Curach, Senior Director Business Development, Gingko Bioworks
Professor Frank Caruso, Melbourne Laureate Professor and NHMRC Leadership Fellow, The University of Melbourne
Dr Craig Sheehan, Senior Scientist, IDT Australia

Facilitator:
Professor Michelle McIntosh, Director, Medicine Manufacturing Innovation Centre, Monash University

Series Two - Lecture One

The RNA Platform: The Breadth of Possibility Beyond mRNA

The first lecture in Series 2 focused on the RNA platform and its different modalities beyond mRNA.

RNA is an emerging global modality that promises treatments for previously ‘undruggable’ diseases. While the COVID pandemic proved the efficacy of mRNA vaccines, RNA as a platform technology has broader implications across multiple modalities such as mRNA, anti-sense oligonucleotides, short-interfering RNA, self-amplifying RNA, circular RNA and aptamers. It can also be used to encode other functional biological molecules such as monoclonal antibodies and cytokines.

This lecture provided an insight into the breadth of the RNA platform potential and the flexibility it provides to target a range of disease types.

Facilitator:
Associate Professor Misty Jenkins AO, Laboratory Head, Immunology Division, WEHI

Speakers:
Professor Marco Herold, Chief Executive Officer, Olivia Newtown John Cancer Research Institute
Dr Vi Wickramasinghe, Head, RNA Biology and Cancer Laboratory, Peter MacCallum Cancer Centre
Dr Christopher Wraight, CEO and Director, RAGE Biotech

Host: 
Valentina Tan, Research and Industry Development Officer, mRNA Victoria