Australia's Cell and Gene Catalyst will move ahead, establishing its inaugural Steering Group and opening recruitment, formally signalling the important next step in advancing cell and gene accessibility in Australia.

The Steering Group to lead the Cell and Gene Catalyst (the Catalyst) is comprised of AusBiotech, Medicines Australia, CSL Behring, Novartis, Pfizer, Therapeutic Innovation Australia and Cell Therapies. The Catalyst will bring to life the Regenerative Medicines in Australia: A Strategic Roadmap for the Regenerative Medicines Sector through leadership, advice and support, as the Catalyst seeks to create an end-to-end world-class value chain that can discover, develop, manufacture, and distribute cell and gene therapies to Australian patients, while creating jobs, commercialising research, and exporting Australian therapies to the world.

Leveraging the Regenerative Medicines Consortium Project's exceptional foundation work throughout 2020-2021 that has cemented and benchmarked Australia's place on the global RM map, the Catalyst, a joint venture between national peak industry bodies AusBiotech and Medicines Australia, will advance regenerative medicines policy, mobilise resources, build community engagement, establish shared measurement practices and support aligned activities.

To drive and deliver on the Catalyst's national strategy, a General Manager is now being recruited for a two-year period.

The Catalyst is also being supported by the Victorian Government's Australian Medtech Manufacturing Centre (AMMC) to help examine manufacturing barriers and explore new opportunities for growth to unlock the potential for cell and gene manufacturing in Australia.

A new role will be established for a dedicated 'Project Manager, Cell and Gene Therapy Manufacturing' to develop a 'blueprint' report to build on the work published in Australia's Regenerative Medicines Manufacturing Capacity and Capability, to determine what is needed to manufacture more cell and gene products locally, and develop specific recommendations and a strategy document addressing: workforce skills development, attraction and retention; strengthened collaboration across the value chain; opportunities for secure long-term investment; and positioning Australian manufacturing capability in global markets.

This role will work in harmony with the Catalyst and its General Manager, which will drive the broader Strategic Roadmap.

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AusBiotech CEO, Lorraine Chiroiu said: 'Australia offers a wealth of opportunity in cell and gene therapies, and the formation of the Cell and Gene Catalyst's Steering Group is a powerful step towards realising our national potential. The leadership and commitment demonstrated by this group is notable, and denotes the significant impact these treatments may have for Australia and Australians.'

Medicines Australia CEO, Elizabeth de Somer said: 'Cell and gene therapies are at the forefront of innovation and have the potential to revolutionise how we treat serious diseases. The Cell and Gene Catalyst is a timely initiative that will bring together global companies with Australian SMEs to drive better healthcare outcomes and help build an Australian innovation-led economy fit for the 21st century. Medicines Australia is pleased to partner with key players in the Australian life sciences ecosystem to make this a reality.'

CSL Behring's ANZ Executive Director and General Manger Loretta Croker said: 'CSL Behring is proud to support the Catalyst in advancing access to cell and gene therapies in Australia. We look forward to collaborating with our partners and translating this effort to those people living with rare and serious diseases.'

Pfizer Rare Disease Lead, Developed Asia, Koray Koksal said: 'The COVID-19 pandemic has shown us what can be achieved when we collaborate with a sense of urgency to solve health challenges. Cell and gene therapies hold vast potential to deliver breakthroughs that change patients' lives across the country. To achieve this, we must continue to invest in innovation, improve the speed of access to new treatments, and solve affordability challenges. The Cell and Gene Catalyst will ensure we have a strong, coordinated voice to advance these issues and to reduce the burden of disease.'

Cell Therapies Pty Ltd CEO, Peter Giannopoulos, said: 'Australia's Cell & Gene Therapy ecosystem is burgeoning and now is the time for Australia to invest in building sovereign capabilities and capacity, from translation of basic research through to delivery of cutting-edge products to patients. We are delighted to be part of the CGT Catalyst Steering Group and look forward to contributing to the growth of an industry that can do so much for so many patients in need.

Victoria's Minister for Industry Support and Recovery Ben Carroll said: 'Our support for this programme will help advance our capabilities in cell and gene manufacturing - backing our medtech sector to be at the forefront of innovation for the benefit of all Victorians.'

Contact:

Media

Karen Parr

Director

Communications & Policy

AusBiotech,

E: kparr@ausbiotech.org

M: +61 (0) 420 729 123

About the cell and gene opportunities in Australia

Cell and gene therapies offer tremendous promise and hope, with some calling the therapies the most important discoveries of our future. To capitalise on the opportunities that the burgeoning cell and gene sector can deliver to the Australian economy and society, the Cell and Gene Catalyst has been established.

Globally, investment in cell and gene reached AU$32.8B (or US$22.7B) in financing in 2021, with over 1,220 clinical trials of RM being conducted worldwide. There is an opportunity for Australia to be a regional hub in the Asia Pacific region known for leading cell and gene research, clinical trials, translational know-how and manufacturing capabilities.

About the Cell and Gene Catalyst's Steering Group

AusBiotech

AusBiotech is Australia's biotechnology organisation, working on behalf of members for more than 35 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

Medicines Australia

Medicines Australia represents the discovery?driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia's mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and researchbased prescription medicines industry.

Cell Therapies Pty Ltd

Cell Therapies Pty Ltd is an Australian-based, globally-active commercial contract development and manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. A leader in this groundbreaking field, our expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for nearly 20 years.

CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring

Novartis Australia and New Zealand

Novartis is the largest Australian medicines company improving the lives of more than 2.8 million patients across Australia and New Zealand. From generics to gene therapy, we are committed to accelerating patient access to life saving treatments. We are reimagining medicine by using innovative science and technology to address challenging healthcare issues and our rich pipeline has 200+ projects in development and an industry leading clinical trial footprint in Australia. Our unbossed, curious and inspired culture unites our 700 employees, it is what unleashes the power of our people and is at the heart of the work we do each day.

Pfizer Australia

Breakthroughs That Change Patients' Lives: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. Find out more about Pfizer.

Therapeutic Innovation Australia

TIA is a network of 25 national translational research infrastructure facilities in biologics and vaccines, cell and gene therapies, and small molecule pharmaceuticals. We aim to provide Australian researchers with access to infrastructure that enables efficient translation of therapeutics to improve human health. Our investments ensure facilities are coordinated, comprehensive, accessible and responsive to the needs of the Australian translational research community. We work to strengthen links between academic researchers and the private sector to enrich the Australian medical innovation ecosystem.

Victorian Government's Australian Medtech Manufacturing Centre (AMMC) is a $20 million initiative established to strengthen connections between manufacturers, researchers and innovators to grow Victoria's medtech manufacturing sector.

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