B10. Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
Tracks
Prescription & Non-prescription Medicines Regulation
| Wednesday, June 4, 2025 |
| 1:30 PM - 2:30 PM |
| C2.2+C2.3 |
Chair & Speakers
Dr Elaine Blair
Senior Director, Regulatory Affairs APAC
PTC Therapeutics
Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
Abstract
Facilitating expedited medicine approvals aligns with the interests of patients, sponsors, and health authorities, ensuring timely access to essential treatments while upholding safety and efficacy standards. Advancements in science have led to increasingly complex therapeutic products, requiring collaborative regulatory efforts. Through harmonisation, convergence, and reliance, agencies can streamline approvals, ensuring both patient safety and timely access to innovations. In this presentation we will discuss some of the expedited approval pathways such as the ACCESS Consortium and Project Orbis and highlighting their practical implementation such as eligibility criteria, processes, timelines, costs, and associated challenges. Additionally, the discussion will feature industry insights into effectively navigating these pathways within organisations, supplemented by perspectives from diverse sponsors and regulatory consulting experts, offering a comprehensive understanding of strategic approaches to fast-tracking approvals.
Biography
Dr Elaine Blair has over 25 years' experience in the pharmaceutical industry, with extensive knowledge in a wide range of therapeutic areas including oncology, rare diseases and gene therapy. Elaine is currently Senior Director, Regulatory Affairs APAC at PTC Therapeutics and is responsible for regulatory matters and strategies for countries in the APAC region. PTC is a global biopharmaceutical company that provides therapies for people living with rare diseases. Elaine holds a PhD from the University of Sydney. She is passionate about supporting regulatory affairs and education and has been an active member of ARCS since 1999. Over the years, she has served as convenor of the regulatory education sub-committee, member of the conference advisory committee, and as a Chair/Speaker at ARCS conferences.
Joelle Chia
Director
Pharma To Market
Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
Abstract
Facilitating expedited medicine approvals aligns with the interests of patients, sponsors, and health authorities, ensuring timely access to essential treatments while upholding safety and efficacy standards. Advancements in science have led to increasingly complex therapeutic products, requiring collaborative regulatory efforts. Through harmonisation, convergence, and reliance, agencies can streamline approvals, ensuring both patient safety and timely access to innovations. In this presentation we will discuss some of the expedited approval pathways such as the ACCESS Consortium and Project Orbis and highlighting their practical implementation such as eligibility criteria, processes, timelines, costs, and associated challenges. Additionally, the discussion will feature industry insights into effectively navigating these pathways within organisations, supplemented by perspectives from diverse sponsors and regulatory consulting experts, offering a comprehensive understanding of strategic approaches to fast-tracking approvals.
Biography
Joelle Chia is currently the co-Director at Pharma To Market. She is a registered pharmacist, with over 18years in regulatory, pharmacovigilance, quality departments for drug and biotech MNCs. She possesseshands-on experience performing submissions in regulatory affairs and conducting pharmacovigilance activitiesfor innovator drugs, generics, medical devices, complementary medicines and cosmetics in Asia, including forSingapore. She is also experienced in regulatory strategy for Asia, due diligence for mergers and acquisitions,interactions with health authorities, and representation in trade associations.
Dr Orin Chisholm
Program Director, PMDD Programs
University Of Sydney
Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
Abstract
Facilitating expedited medicine approvals aligns with the interests of patients, sponsors, and health authorities, ensuring timely access to essential treatments while upholding safety and efficacy standards. Advancements in science have led to increasingly complex therapeutic products, requiring collaborative regulatory efforts. Through harmonisation, convergence, and reliance, agencies can streamline approvals, ensuring both patient safety and timely access to innovations. In this presentation we will discuss some of the expedited approval pathways such as the ACCESS Consortium and Project Orbis and highlighting their practical implementation such as eligibility criteria, processes, timelines, costs, and associated challenges. Additionally, the discussion will feature industry insights into effectively navigating these pathways within organisations, supplemented by perspectives from diverse sponsors and regulatory consulting experts, offering a comprehensive understanding of strategic approaches to fast-tracking approvals.
Biography
Orin is the program director for the postgraduate programs in Pharmaceutical and Medical Device Development at the University of Sydney. She has academic appointments with UNSW and Arizona State University, USA. Orin has previously spent many years in industry roles and is a consultant in regulatory affairs. She is on the Board of the Association of Graduate Regulatory Educators (USA) and on the editorial advisory committee for the Regulatory Affairs Professionals Society (RAPS) in the USA. Orin received the Organisation for Professionals in Regulatory Affairs (TOPRA), UK award for excellence in regulatory education in 2017; became a Senior Fellow of the Higher Education Academy (UK) in 2018 and was elected a Fellow of RAPS in 2021. Her research focuses on regulatory science, workforce development and pharmaceutical policy.
Michael Parker
Director, Regulatory Affairs
AstraZeneca
Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
Abstract
Facilitating expedited medicine approvals aligns with the interests of patients, sponsors, and health authorities, ensuring timely access to essential treatments while upholding safety and efficacy standards. Advancements in science have led to increasingly complex therapeutic products, requiring collaborative regulatory efforts. Through harmonisation, convergence, and reliance, agencies can streamline approvals, ensuring both patient safety and timely access to innovations. In this presentation we will discuss some of the expedited approval pathways such as the ACCESS Consortium and Project Orbis and highlighting their practical implementation such as eligibility criteria, processes, timelines, costs, and associated challenges. Additionally, the discussion will feature industry insights into effectively navigating these pathways within organisations, supplemented by perspectives from diverse sponsors and regulatory consulting experts, offering a comprehensive understanding of strategic approaches to fast-tracking approvals.
Biography
Mike has a Pharmacy background and a PhD in Pharmaceutical technology. He has worked in the pharmaceutical industry for over 35 years in various roles across Pharmaceutical Development and Regulatory Affairs in both the UK and Australia.
Mike is currently Director of Regulatory Affairs for AstraZeneca in Australia and New Zealand where he has the honour of leading a fantastic team of regulatory affairs professionals dedicated to bringing life changing medicines to patients in both countries.
Outside of work Mike is married to Fiona, a professor and world-leading expert in contact lenses and ocular surface disease. Between them they have three grown-up children all currently studying or working in the UK.
Mike is a keen (but slow) runner and has been a supporter of Arsenal Football Club for too many years to mention.
