B20. Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Tracks
Reimbursement
Thursday, June 13, 2024
2:45 PM - 3:45 PM
C3.2

Chair & Speakers

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Dr Paul Fennessy
Principal
Paul Fennessy Advisory

Chair: Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Abstract

Cell and gene therapies are increasingly providing a treatment pathway for those with either no other treatment options or with a rare disease. While a handful of therapies are currently approved in Australia, the FDA predicts it will be approving up to 20 new cell and gene therapies a year, and there are some three thousand of these therapies currently in clinical trials globally. This bodes well for patients, but our health system and its stakeholders - from policy makers, governance, funders, pharma, health departments, hospitals and clinicians - are not ready to deliver these therapies. How can the health system prepare itself to deliver this tsunami of high cost therapies and ensure patient access to these (often life-saving) treatments? This forum will discuss existing health sector gaps (with examples), demonstrating where lack of preparedness is impacting communication, funding, informed decision-making and equitable access, and consider opportunities for which each stakeholder can be responsible to ensure our health system is prepared/ready to deliver cell and gene therapies when approved - compared to more than a year wait as reflected in some of the approved therapies.

Biography

Paul Fennessy has 35+ years experience in medical research, as an MSAC/PBAC evaluator, as Manager of the Genomics & Health Technology Unit in Victoria's Department of Health (VicDH) for 20 years and as Victoria's representative on various national committees, including for horizon scanning and genomics. He has policy, funding and implementation experience across national, state and hospital sectors. He proposed the development of the National Health Genomics Policy Framework, oversighted implementation of cell and gene therapies in Victoria and jointly developed the National Framework for assessing, funding and implementing highly specialised therapies and highly specialised services. Paul Fennessy Advisory was established early 2023 to assist stakeholders navigate the policy, funding and implementation space decisions focussed on expediting assessment, reimbursement and provision of new and emerging health technologies to patients.
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Ms Nicholette Conway
Director
Axis Health Co.

Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Biography

With over 25 years of experience, Nicholette has worked in pharmaceuticals, medical devices, and diagnostics, with a commitment to equitable patient access to innovative treatments. She has worked with precision medicine and health tech startups, biotech and medtech scale-ups, and worked in major pharmaceutical companies including Eli Lilly, Amgen, MSD, and Bayer. Her expertise spans clinical development (Phase 1-3), Health Technology Assessment (HTA) new product planning (NPP), market access, and reimbursement (MSAC & PBAC), and she has successfully led commercial strategy, product development and implementation projects across oncology, rare diseases, infectious diseases, chronic disease, reproductive technologies, and genetics. Her approach is pragmatic and holistic, includes broad and diverse stakeholder engagement, and especially the inclusion of patients and their care givers to guide care. Nicholette is the current Board Chair of Genetic Alliance Australia and is passionate about enabling patient access to new technologies and precision medicine through multi-disciplinary collaboration.
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Michelle Lorentzos
Paediatric Neurologist/Head, Neurogenetics Service
The Children's Hospital at Westmead (Sydney Children's Hospitals Network)

Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Biography

Dr Michelle Lorentzos is a paediatric neurologist with a specific interest in gene replacement therapy and advanced therapeutics. She is the Clinical Trials Medical Lead at The Children’s Hospital at Westmead, providing leadership and advocacy for the development and implementation of clinical trials across the Sydney Children’s Hospitals Network, and is also an investigator on several gene therapy trials for Duchenne muscular dystrophy. Michelle completed her medical degree at The University of Sydney in 2007 prior to specialist training in paediatric neurology at The Children’s Hospital at Westmead. She is passionate about acknowledging the broad impacts of disease and disability in children and her PhD contributed to an improved understanding of psychological conditions experienced by children and young people with neurological disorders. Prior to undertaking her medical studies, Michelle obtained a Communications degree at The University of Technology, Sydney, and she has maintained a strong interest in the role of communication in health equity and outcomes.
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Gretchen Poortinga
Program Operations Director, Centre Of Excellence In Cellular Immunotherapy
Peter Maccallum Cancer Centre

Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Biography

Dr. Poortinga was part of the team that established the Centre of Excellence in Cellular Immunotherapy (CoE CIT) at the Peter MacCallum Cancer Centre. The CoE CIT was established to collaboratively and rapidly identify, develop and deliver globally competitive CAR-T and other cell-based immunotherapy breakthroughs for the treatment of cancer. As Program Operations Director, Gretchen works with clinicians, scientists, and other experts to synergise activities across the multifaceted program. Gretchen integrates the CoE CIT with its manufacturing partner Cell Therapies Pty Ltd and liaises with government and industry partners to coordinate key endeavors in the cell and gene sector. Through these efforts, Gretchen helps drive the translation and acceleration of innovative cell-based technologies into the clinic, maximising the Centre’s outputs for Australian patients and researchers. Prior to her role with the CoE CIT, Gretchen was a Senior Research Fellow at the Peter MacCallum and an Honorary Fellow in the Sir Peter MacCallum Department of Oncology, University of Melbourne, conducting highly translational research, including that which formed the basis of a first-in-class phase 1 clinical trial in haematologic malignancies.
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Emma Bonser
Chief Executive Officer
Genetic Alliance Australia

Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Biography

Emma is the CEO of Genetic Alliance Australia. She has 18 years of diverse experience in health communication, strategy, digital health innovation, policy and advocacy within the life sciences and NGO sector in ANZ and Asia. In all areas of her work she is driven by the courage and resilience of family members living with rare conditions. With over 25 years as an informal carer and advocate she has deep compassion and admiration for the rare community. She has worked specifically in rare disease for over eight years, most recently leading the Rare Disease Gene Therapy business for a multinational life sciences company across South Korea and ANZ. She has previously been a member of Rare Voices Australia (RVA) and Rare Disorders New Zealand (RDNZ) Round Table of Companies, the Cell and Gene Therapy Catalyst Consortium and the Industry Genomics Network Alliance (InGeNA). Currently pursuing a Master’s in Public Health focused on Global Health, Emma is interested in the overlap of rare genetic diseases, health equity, and technology. She has previously launched a telehealth start-up, mentored within a digital health incubator and delivered an NGO telehealth strategy in Cambodia aimed at reducing health inequity in rural provinces.
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Julia Warning
Principal Policy Officer
NSW Ministry of Health

Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?

Biography

Dr Julia Warning is Principal Policy Officer, Advanced Therapeutics in the NSW Office for Health and Medical Research (OHMR). Dr Warning has a Bachelor of Science (Hons) and PhD (Paed). Dr Warning has significant experience in developing, implementing and evaluating policies and programs that support and accelerate advanced therapeutics research, manufacture and translation into the health system.
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