Despite the devastating impact on human life and the economic and social disruption caused, the COVID-19 pandemic solicited positive outcomes driven by innovation, collaboration and the need to adapt to the changing environment. As we emerge from the calamity, what is now in focus for the supply of medicinal products and the pharmaceutical industry? What regulations have been updated? How are our regulatory agencies adapting to the post-pandemic world and what innovations have they implemented? What innovation or collaboration has the industry kept post-pandemic or currently pursuing?

The answers to these questions will be explored throughout the program, beginning with the a plenary featuring an update from the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and a call to arms for the implementation of the backbone to robustly support the manufacture personalised treatments such as cell and gene therapies that we need in our medicinal "toolbox".

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  Jenny Burnett

  Head, Manufacturing Quality Branch at Therapeutic Goods Administration

Dr Marguerite Evans Galea AM, AusBiotech

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  Jenny Burnett

  Head, Manufacturing Quality Branch at Therapeutic Goods Administration
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  Lisa Bennett (Chair)

  Senior GMP Consultant and Trainer at SeerPharma
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  Marguerite Evans Galea

  Director, Cell & Gene Catalyst of AusBiotech

By the time we come together for this meeting, the revised requirements of the EU & PIC/S Code of GMP Annex 1 - Manufacture of Sterile Medicinal Products will be in force in Europe and many other regions of the world. What are we hearing from industry and regulatory agencies on the implementation across the globe?

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  Bruce Loxley

  Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK

Since the 25th of August 2023 the EU GMP Annex 1 and PIC/s Annex 1 is in force and since the publication in 2022 a lot of global discussions going one. During the presentations the Engineering Contamination Control Strategy related to the Annex 1 will be presented. Where are the highest risk to the sterile product and how to protect those areas. Starting from First Air to Barrier and Transfers as well as cleaning and other important topics.

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  Richard Denk

  Senior Consultant Aseptic Processing & Containment at Skan AG

Technology is rapidly evolving, and no-where more so than in the healthcare industry. We are seeing a merging of the pharmaceutical and medical device spaces, with new and exciting combination products being developed delivering the benefits of both, to patients in way that weren't possible before. Regulators around the world have differing approaches for managing these various boundary, combination, integrated, co-packaged and co-labelled products, leading to complexities for organisations marketing our products in multiple jurisdictions.

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  Daniel Flewellen

  Senior Consultant / Contracting Services Manager at Seerpharma

Vaxxas is an Australian-based biotechnology company aiming to develop and commercialize a novel needle-free technology for vaccine administration. The company has developed a proprietary high-density microarray patch delivery system, dry-coated with a pandemic influenza vaccine. A US FDA Investigational New Drug (IND) application is targeted to support a Phase I clinical study. This single entity combination product presents a new dose form and route of vaccine administration for which no product specific guidelines or standards exist. CGMP 21 CFR requirements for the drug, device, and biologic constituents apply to the product. This presentation will describe regulatory challenges, development considerations, lessons learned, and potential opportunities encountered to date.

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  Kerrie Way

  Principal Regulatory Affairs Associate at Vaxxas Pty Ltd

Not only do the regulatory requirements for Advanced Therapy Medicinal Products vary in different regions, but the classification of such products also varies widely. This mix of tailored human tissue regulations, standard medicines regulations, exemptions, multiple agencies and multiple languages makes navigation of the requirements complex, especially for organisations looking to enter multiple markets.

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  Janet Macpherson

  BDM, Cell Therapy Enterprise, APAC at Cytiva

This presentation offers a comprehensive overview of the latest developments in the cell and gene therapy (C&GT) field, encompassing both global market trends and regulatory updates. With a focus on approved therapies, expected approvals, and ongoing clinical trials, valuable insights into the sector's growth potential and emerging applications are revealed. We delve into the key drivers and challenges influencing C&GT market dynamics, along with exploring technology innovations that aim to enhance process quality and productivity.
Shifting our focus to regulatory trends, we assess the evolving global regulatory environment, including the status of C&GT filings. A particular emphasis is placed on new guidance documents and regulations, with a focus on quality control measures to ensure product safety and efficacy. Lastly, we highlight the significance of developing standards in the C&GT domain, aiming to foster international harmonization and facilitate advancements in this transformative therapeutic area.

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  Juliana Gutierrez

  Scientific Affairs Manager at bioMérieux

The US FDA has proposed the Quality Management Maturity (QMM) rating system to incentivise drug manufacturers to achieve higher levels of QMM. The US FDA hopes that transparent QMM ratings could empower manufacturers to improve the effectiveness of their Pharmaceutical Management System (PQS), in turn leading to increased flexibility to make post-approval changes using the tools described in ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

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  Gerry McKiernan

  Director of Increment4

ICH Q12 provides the framework to facilitate the management of Post Approval Changes (PACs) in a more predictable and efficient manner across the product life cycle within ICH regions. It aligns with the stated intention of increasing acceptance of science and risk-based approaches manifested in ICH Q8-11, and the understanding of the Pharmaceutical Quality System (PQS), as pre-requisites to enable post approval flexibility.

This presentation will look at the definition of what ICHQ12 calls “Established Conditions” (ECs) and how they can be incorporated to advantage in Submissions. What can then follow at PAC proposal, is that a PACMP (a PAC Management Protocol) can be written, which when implemented significantly streamlines and accelerates changes to enable faster access of medicines to patients. This assumes that the ECs are still met when defining the PAC.

Harmonisation of PAC requirements worldwide, particularly through the implementation ICH Q12, will ensure consistent global regulatory expectations for PACMPs. Change categorization of PACs should be based on science and risk-based approaches, and product/process knowledge and understanding, including full knowledge of what the ECs are.

Agencies can adopt some or all of the tools in ICH Q12 in a sequential fashion (e.g. early adoption of PACMPs) but full adoption per the guideline, without additional requirements will be required to achieve the full intended benefits.

Fundamental to full implementation is the acceptance of the ICH M4Q CTD dossier and the principles for science and risk-based development in ICH Q8-11.

Challenges to implementation can be addressed with robust training and awareness programs; cross-business unit strategy; external cross-industry and Health Authority knowledge sharing in Conferences such as this!

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  Bruce Loxley

  Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK

Since formal adoption of final ICH Q12 Guideline for post-approval change management by the US Food and Drug Administration (FDA) in May 2021, the Center for Drug Evaluation and Research (CDER) has received several biologic applications applying ICH Q12 principles. During this presentation, an overview of ICH Q12 implementation in the US is provided. Experiences gained from FDA ICH Q12 pilot program and post-implementation submission assessment for biologics are shared, and lessons learnt from these experiences are summarized for future considerations.

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  Qing (Joanna) Zhou

  Review Chief in the Office of Biotechnology Products, CDER at US Food and Drug Administration

The use of Artificial Intelligence is rapidly becoming of interest to the pharmaceutical industry, with the potential to revolutionise processes and drive innovation in areas such as:
• Drug Discovery and Development - to analyse data and identify potential drug candidates, modelling to predict drug efficacy and safety, drug formulation and delivery systems.
• Clinical Trials - to identify suitable patient populations, predict patient responses, optimise trial protocols and real time monitoring of patients
• Regulatory Compliance - AI use within pharmaceutical quality systems to assist with regulatory and GMP compliance, data review and trend analysis
• Pharmaceutical Manufacturing - Digital Twins, AI in product visual inspection, analysis of viable Environmental Monitoring, predictive analysis of maintenance requirements, reducing downtime and improving overall manufacturing efficiency.
• To further its application in our industry collaboration between pharmaceutical companies, AI experts, and regulatory agencies is crucial to ensure the responsible and ethical implementation of AI technologies.

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  Micheal Schafferius

  Application Specialist for Separation Technologies and Quality at SARTORIUS

This presentation will highlight some recent innovations in pharmaceutical modeling and provide an overview of the current regulatory background. An industry perspective of the perceived hurdles for broader implementation and use will be presented, particularly in the context of AI/ML models. Output from key regulatory publications (e.g., FDA FRAME and EMA AI Concept Paper) and fora (PQRI AI/ML workshop, EMA QIG Listen and Learn) will be addressed.

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  Ben Stevens

  Director, CMC Policy and Advocacy of GSK

The APAS Independence is an IVD device used in clinical microbiology laboratories for the routine screening of culture plates. Using ML-based AI it interprets images of plates to determine if microbial growth is present and if the growth is potentially significant for a specific clinical indication. Achieving regulatory clearance has involved in-depth discussions with FDA of testing methodologies to demonstrate safety and performance. The session will describe how these learnings have been applied to support the application of the APAS technology for environmental monitoring of sterile manufacturing areas (APAS PharmaQC) and discusses evidence needed when implementing APAS PharmaQC as an alternative to the current microbiological method.

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  Julie Winson

  Director, QA & RA of LBT Innovations

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  Lisa Bennett (Chair)

  Senior GMP Consultant and Trainer at SeerPharma
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  Piper O'Keeffe

  Student at University of Melbourne
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  Micheal Schafferius

  Application Specialist for Separation Technologies and Quality at SARTORIUS
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  Ben Stevens

  Director, CMC Policy and Advocacy of GSK
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  Julie Winson

  Director, QA & RA of LBT Innovations
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  Connor White

  Student at The University of Melbourne

The development and conduct of analytical testing during the early stages of investigational medicinal products (IMPs) identifies drug substance, product and in-process boundaries for which that biologic, fusion or therapy progresses through the clinical phases of safety, efficacy through to registration. The Regulated Biomanufacturing group at CSIRO has been established to provide a local cGMP manufacturer for Phase 1 biologics to support local SMEs and accelerate them into first-in-human (FIH) trials.
Whilst the selection of analytical tests is informed by ICH Q2(R1), an in-depth knowledge of the molecule developed during research, process development and reference characterization provides the critical information to select the appropriate tests and the associated specifications and range.
In this presentation, we will use case studies to discuss the impact of tests developed for Identity, Purity and Potency and discuss how the conduct and outcome of these assays is critical to the success of Phase 1 drug products.

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  Patrick James

  CSIRO

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  Patrick James

  CSIRO
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  Mylinh La

  Senior Lab Manager at CSIRO
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  Dean Whelan

  Quality Operations Team Leader and QC Manager, Regulated Biomanufacturing Group at CSIRO

The inability to travel and work in person changed business operations and processes worldwide as we adapted in an attempt to maintain equilibrium. Switching from paper to electronic records, holding virtual meetings, working from home, as we faced these challenges in industry so did our regulatory agencies.

As we emerge from the COVID-19 pandemic and can move away from the innovative ways of working, which of these are we keeping and what should we leave behind?

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  Adam Thomas

  Post-Doctoral Scientist, Life Sciences Division at Burnet Institute

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  Chris (Kwangyong) Nam

  Director, Quality Assurance of Samsung Bioepis

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  Lisa Bennett (Chair)

  Senior GMP Consultant and Trainer at SeerPharma