B05. Navigating the Future: Regulatory insights and innovations in advanced therapeutics
Tracks
Prescription Medicines Regulation
| Thursday, June 13, 2024 |
| 11:15 AM - 12:15 PM |
| C2.2+C2.3 |
Chair & Speakers
Laura Collie
Senior Medical Advisor
NSW Ministry of Health
Chair: Navigating the Future: Regulatory insights and innovations in advanced therapeutics
Abstract
The mission of the Advanced Therapeutics team in the Office for Health and Medical Research (OHMR), is to support the research and development of next-generation and precision therapies to help pull advanced therapeutics into the health system. Key to this is the approach to support regulation and system preparedness for implementation and uptake.
This session will explore the Regulatory challenges and innovative approaches to:
• Registering bacteriophage as a therapeutic good, providing access for all Australians to phage therapy as a third major intervention for infectious diseases and to help address the global health threat of Antimicrobial Resistance (AMR).
• Support non-animal technologies by building networks and collaborations to address the regulatory challenges, given the drive to refine, reduce, and replace animal model use in drug development (3Rs).
This session will explore the Regulatory challenges and innovative approaches to:
• Registering bacteriophage as a therapeutic good, providing access for all Australians to phage therapy as a third major intervention for infectious diseases and to help address the global health threat of Antimicrobial Resistance (AMR).
• Support non-animal technologies by building networks and collaborations to address the regulatory challenges, given the drive to refine, reduce, and replace animal model use in drug development (3Rs).
Biography
Dr Laura Collie is the Senior Medical Advisor to the NSW Office for Health and Medical Research (OHMR), and to the NSW Chief Health Officer. Dr Collie is a Public Health Physician, with a Bachelor of Science (Immunobiology), Bachelor of Medicine/Surgery, Master of Public Health (Infectious Disease Epidemiology and Control), Graduate Diploma in Environmental Health Practices, and is currently undertaking a Professional Doctorate in Public Health through the UNSW Future Health Leaders Program that examines how health decision makers can better support knowledge translation through partnership with health and medical researchers. Dr Collie established the Advanced Therapeutics team within OHMR to support the development and delivery of next generation therapeutics into the NSW Health system.
Kerry Watts
Senior Project And Policy Officer
NSW Ministry of Health
Navigating the Future: Regulatory insights and innovations in advanced therapeutics
Abstract
Biography
Kerry is a FANZCAP consultant pharmacist in compounding and research, author of the NSW Health Policy Directive Preparation of Pharmaceutical and advanced therapeutic products, SHPA fellow, member of the SHPA Compounding Leadership Committee, SHPA representative member of Standards Australia ME060 Controlled Environment Committee, training facilitator for Medisca® Australia, and a hearing member for the Pharmacy Council of NSW.
Natalie Pavuk
Senior Policy Officer
NSW Ministry of Health
Navigating the Future: Regulatory insights and innovations in advanced therapeutics
Biography
Natalie spent more than 25 years in the biopharma industry, the NSW Ministry of Health. In previous roles, as Head of Data, Analytics & Insights, and Catalyst for Innovation Programme Management & Strategic Partnerships, Natalie has built organisational capabilities and best practice in innovation programs; competitive intelligence; advanced analytics and data management. Deep expertise in research, horizon-scanning, analytics and problem-solving are invaluable in identifying and addressing the evolving challenges and opportunities in accelerating advanced therapeutics into the healthcare system.
Julia Warning
Principal Policy Officer
NSW Ministry of Health
Navigating the Future: Regulatory insights and innovations in advanced therapeutics
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.
