Selected Presentations from Pharma & Device Forum 2024

Not all presentations from the Pharma & Device Forum are able to be shared. Below are those where permission has been granted by the speaker.

Watch a video of images taken at the 2024 Pharma & Device Forum (2024 GMP Forum).

Day 1

Plenary

  • Pharma & Device Forum, Welcome -Trevor Schoerie, PharmOut
  • Our Responsibilities in Sustainable Pharmaceutical Manufacturing – Nic van der Nol, PharmOut
    This presentation explores the concept of sustainability in the pharmaceutical industry, emphasizing the need for responsible practices in manufacturing. It discusses the historical development of sustainability and the current challenges faced, such as the increasing power consumption and waste of AI. ​ The presentation highlights the importance of early intervention and the adoption of techniques to reduce environmental impact, including energy reduction, use of renewable resources, and waste management. It also emphasizes the role of sustainability in promoting health and well-being. ​ Overall, the presentation suggests that the pharmaceutical industry can contribute to a sustainable future by meeting present needs without compromising the ability of future generations to meet their own needs. ​
  • How to think outside the box and work inside it – Jason Clarke, Minds at Work
    This presentation emphasizes the importance of balancing profit and quality while also promoting innovation. ​It highlights the challenges posed by bureaucracy, regulatory environments, and risk aversion. The presentation encourages thinking outside the box and taking calculated risks to drive growth and success. It also emphasizes the need for effective risk management, quality assurance, and competitive pressure. Overall, the presentation advocates for a proactive and forward-thinking approach to business that considers community expectations, productivity, and consumer satisfaction.
  • What exactly is AI and how do we go about validating it – Matt Schoerie, QikSolve
  • Enhancing the crucial role of plant isolates in ensuring pharmaceutical safety – Wojciech Sleczek, bioMerieux
    This presentation discusses the importance of in-house isolates in ensuring pharmaceutical safety. ​ It highlights the sources of microbial contamination in manufacturing facilities and emphasizes the need for environmental monitoring. ​ The use of in-house isolates in growth promotion testing and other tests is explained, along with the selection criteria for these isolates. ​ The challenges and considerations in implementing in-house isolates are also discussed, including the cost analysis and the option of outsourcing. ​ The presentation concludes by emphasizing the relevance and benefits of in-house isolates and the expertise of BIOBALL® in converting isolates into a ready-to-use format.
  • Navigating PIC/S GMP Version 17 Part I and Annex 1 Updates – Ashley Isbel, PharmOut
    In this informative presentation, the updates to the PIC/S Guide to GMP were discussed, with a focus on the revisions in Annex 13 and the introduction of Annex 16. The changes in Annex 13 include expanded requirements for the Product Specification File and longer retention periods for the Clinical Trial Master File. Annex 16 provides detailed information on the responsibilities of Authorized Persons (APs) and emphasizes the alignment between Annex 16 and the TGA’s guide for RFS. The presentation also touched on implementation challenges and successes in Annex 1, as well as upcoming updates to other annexes. Overall, it provided valuable insights into the evolving regulatory landscape and the importance of compliance in the pharmaceutical industry.

Room 103

  • Quality Matters in Pharmacovigilance – Carl Bufe, PharmOut
    This presentation provides an overview of the importance of quality management systems (QMS) in pharmacovigilance (PV). ​ It highlights the key components of PV systems (PVS) and QMS, emphasizing their role in monitoring drug safety, complying with regulatory requirements, and ensuring adherence to safety standards. ​ The presentation also discusses the regulatory framework for PVS and QMS, the impact of data protection laws on PV, and the significance of compliance monitoring and inspections. ​ It concludes by emphasizing the value of continuous improvement, learning from failures, and the critical role of accurate data collection and analysis in effective pharmacovigilance.
  • CMC and Regulatory Challenges – Ahsan SyedAli, QBiotics
    This presentation discusses the challenges faced in the areas of CMC (Chemistry, Manufacturing, and Controls) and regulatory compliance. ​ The CMC challenges include capabilities, specific requirements, future scale-up, small batches, and the need to transfer technology between companies. ​ The regulatory challenges involve knowing when and how to communicate with regulators, as well as dealing with the diverse global regulatory framework and post-approval variations. ​ The presentation also highlights the importance of company and quality culture, risk management, and cost management in addressing these challenges.
  • Tips for conducting successful GCP inspections – Silvana Sekuloski, PharmOut
    This presentation covers the importance of Good Clinical Practice (GCP) in clinical trials. ​ It emphasizes compliance with GCP requirements, participant safety, and maintaining the quality of investigational products. ​ The presentation discusses the obligations of clinical sites and investigators, considerations for consent and protocol compliance, and tips for GCP inspection preparation. ​ Overall, it aimed to educate and prepare participants for GCP inspections to ensure credible and accurate clinical trial data while protecting participant rights.
  • Pharmacovigilance Considerations in Low-Risk Medicines – Rachel Gordon, H&H Group
    In this presentation, Rachel Gordon discusses the pharmacovigilance considerations in low-risk medicines, specifically complementary medicines in Australia. ​ She provides an overview of the regulatory framework, the current pharmacovigilance system, and the unique challenges in ensuring their safety. Rachel emphasizes the importance of pre-market safety assessments, post-market surveillance, and adverse event reporting. ​ The presentation highlights the need for specialized expertise and ongoing monitoring to enhance patient safety and maintain consumer confidence.
  • Keep Calm and Recall: A considered approach to Recalls in Australia, Carl Bufe, PharmOut
    This presentation provides a comprehensive overview of the recall procedure in Australia. ​ It covers the definition of a recall, recall statistics, the roles of manufacturers and sponsors/suppliers, the steps involved in the recall process, the development and implementation of a communication strategy, reporting on the action, reviewing the recall, and exceptions to the recall procedure. The presentation emphasizes the importance of having a written procedure, conducting mock recalls, and understanding the risk-based classification and levels of recalls. ​ It also highlights the role of the Therapeutic Goods Administration (TGA) in overseeing recalls and ensuring public health and safety. ​

Room 104

  • Device-formulation interfaces – Paul Wynne, Monash
    The Medicines Manufacturing Innovation Centre (MMIC) specializes in total synthesis, prodrug development, synthetic modification, purification, specialized formulation, stability and storage, bioanalysis, plant extraction techniques, and fractionation and purification, with examples including toothbrush and toothpaste, artificial blood vessels, NSAID drugs as promoters of angiogenesis, silylation of glass surfaces, and metal oxide films on steel, among others. ​
  • SaMD/SiMD innovations and trends for use – Susan Cheong, PharmOut
    This presentation provides an overview of SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device), including their definitions, examples, key innovations, market outlook, and challenges, as well as predictions for their future growth in the healthcare industry. ​
  • Case studies Single Use sensors, non-contact temperature monitoring, hygienic level monitoring – Sandeep Bagga, Emerson
    This presentation highlights Emerson’s leadership in automation technology and software, providing solutions for critical industries. ​ Key points include a wide range of products such as control systems, analytical instruments, wireless gas monitors, and flow meters, enabling sustainability, productivity, and safety. Case studies demonstrate the effectiveness of Emerson’s solutions in addressing challenges related to product quality, process optimization, sustainability goals, personnel safety, and fire detection.
  • DEAL or No DEAL: Australian Medical Device Regulations – Anne Saletti-Hayes, PharmOut
    This presentation provides an overview of the Australian regulations for medical devices. It covers the definition of a medical device, the classification system based on risk, the requirements for registration and supply in Australia, the role of the Therapeutic Goods Administration (TGA) in regulating medical devices, the essential principles for the development of safe devices, and the specific considerations for in vitro diagnostic (IVD) devices. ​The presentation emphasizes the importance of compliance with regulatory requirements and highlights the key steps and documentation needed for listing a medical device on the Australian Register of Therapeutic Goods (ARTG). ​
  • Know your product better – Material characterization for your medical device – Sheng Sheng Su, Anton Paar
    In this presentation, Anton Paar, a global leader in high-precision measuring instruments and automation solutions, will discuss their expertise in material characterization of medical devices. ​They offer a wide range of measurement technologies, including density and concentration measurement, rheometry, polarimetry, and particle analysis. ​Anton Paar’s application solutions cover areas such as rheology additives, structure recovery in 3D printing, photo-crosslinking of biomaterials, hydrogel tribology, fatigue testing, syringe testing, stiffness determination, and zeta potential measurement. With their extensive knowledge and innovative solutions, Anton Paar aims to provide valuable insights into the material characterization of medical devices.

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Room 106

Day 2

Room 103

  • Systematic literature reviews for TGA-regulated medicine applications – Mary Nteris, Enimera
    This presentation provides an overview of systematic literature reviews (SLRs) for TGA-regulated medicine applications. ​It explains that a SLR is a comprehensive and structured literature search followed by a considered and balanced review. ​ SLRs can be submitted as evidence in applications, either in exceptional circumstances or to complement a condensed development strategy. ​The success of the SLR approach depends on whether it is acceptable to the TGA, how it is conducted, and the evidence obtained. ​The presentation outlines the five steps of a SLR: feasibility, search, exclude, screen 1, and screen 2. ​ It also provides tips and references for further information.
  • Future-Proofing Medicine: AI’s Role in Predicting Clinical Trial Success, Saurabh Jain, Triakey
    AI-powered Clinical Trials can predict outcomes with over 90% accuracy, enabling near-perfect capital allocation and reducing the need for real-world trials. ​ The focus of clinical trials worldwide varies across different areas of research. TRIALKEY.AI offers AI-powered solutions for clinical trials. ​ Contact them at www.TrialKey.ai or saurabh@trialkey.ai for inquiries. ​
  • Transitioning from GCP to GMP for New Product Commercialisation – Celine Madsen, Paradigm Biopharma
    This presentation is on transitioning from Good Clinical Practice (GCP) to Good Manufacturing Practice (GMP) for new product commercialization. ​It discusses the difference between GCP and GMP, strategies for a successful transition, challenges and opportunities in the transition, and concludes with a Q&A session. ​ The presenter, Celine Madsen, expresses her own views and clarifies that they may not reflect those of her employer or associated parties.
  • Practical application of GCP to Trial sites for Investigational drugs and devices – Suzanne Elliott, Gallipoli Medical Research
    The presentation provides information on the practical application of Good Clinical Practice (GCP) guidelines to trial sites for investigational drugs and devices. ​It includes insights from the TGA Good Clinical Practice (GCP) Inspection Program and highlights various GCP issues related to investigational products, sponsor-supplied devices, and protocol compliance. ​ The document emphasizes the importance of early discussions and awareness in areas such as trial management, protocol compliance, participant protection, and documentation. ​
  • Comparison of regulatory pathways in the EU and US – Nicoletta Muner, Canary Regulatory Affairs
    The presentation provides a comparison of regulatory pathways in the EU and US, including information on the regulatory authorities (EMA and FDA), accelerated pathways, expedited programs, clinical trial regulations, medical device regulations, and differences in labeling requirements. ​ It also includes case studies on contrasting scientific advice and the approval of specific drugs. ​
  • Our journey to deliver the future of ophthalmic medicine – David Valade, PolyActiva
    This presentation is about PolyActiva a Melbourne-based company focused on developing a novel drug delivery platform for ophthalmology. ​They have a suite of intellectual property and are currently working on a pipeline of ocular implants for various indications, including glaucoma and post cataract surgery.​ Their sustained release platform, Prezia, offers precise, controlled, degradable, versatile, and adaptable drug delivery. ​ They have demonstrated the safety and efficacy of their drug delivery platforms in humans and are actively pursuing regulatory approvals. PolyActiva is committed to addressing the challenges in drug delivery for ophthalmology and improving patient outcomes. ​
  • Unveiling US FDA Regulatory and Compliance for Topical Products – Mir Ali, Rationale
    The document provides an overview of the US FDA regulatory and compliance requirements for topical products, including information on the FDA’s mission, key definitions, regulatory standards, the importance of compliance, and specific guidelines for manufacturing and distribution.

Room 104

  • Plant based medicines – Trevor Schoerie, PharmOut
    This presentation provides information on plant-based medicines, regulations and cultivation requirements, the Australian Register of Therapeutic Goods (ARTG), types of medicinal products, the law and medicinal cannabis, the United Nations Single Convention on Narcotic Drugs, garlic as a medicinal plant, and licensing regulations and rules. ​ It also discusses selecting genetics, planning considerations for different products, types of growing structures, and the impact of various structure types. ​ The document is presented by Trevor Schoerie, the Managing Director of PharmOut. ​
  • Cultivating Success: The Potential of Tissue Culture Techniques in the Cannabis Industry – Adel Zarei, Pharmacrop
    The presentation discusses the role of tissue culture techniques in the cannabis industry, including the importance of tissue culture in cannabis propagation, media optimization for cannabis tissue culture, cleaning programs to eliminate pathogens, and the conservation of cannabis germplasm. ​ It also mentions the production of synthetic seeds and the potential for rapid propagation and pathogen-free plants through tissue culture.
  • The role of genetics in Medicinal Cannabis’ commercial-scale operations – Jesus Diaz, ECS Botanics
    This presentation discusses the role of genetics in medicinal cannabis, the history of cultivation, modern breeding techniques, strain development trends, and breeding targets for cultivation, production, sales, customers/patients, and commercial-scale operations. ​ It also mentions the use of advanced breeding techniques to introduce novel cannabinoids. ​
  • Reflecting on all the guests he has interviewed over the years – Tad Hussey, KiS Organics
    This presentation contains advice from various experts in the field of agriculture and soil health. Topics covered include soil balancing, soil testing, the importance of canopy in determining yield, the use of mycorrhizal fungi, the impact of light intensity on cannabis growth, the role of pH in organics and living soils, and the benefits of using calcium silicate to mitigate plant stress. The experts also emphasize the importance of proper nutrient uptake, the need for accurate information in pest management, and the use of beneficials in early stages of plant growth. Overall, the document provides a comprehensive overview of key factors and strategies for successful farming and plant cultivation.
  • Testing plant-based medicines – Russell Kinghorn, Pharmalytics
    Pharmalytics is a GMP consulting laboratory that provides comprehensive testing services for plant-based medicines. ​ With licenses from TGA and APVMA, they offer testing for raw materials, intermediates, API’s, and finished products. ​ Their state-of-the-art facilities and experienced team ensure accurate and reliable results, particularly in the testing of cannabis and other plant-based molecules.
  • Clearance verification processes including unapproved medicines – Trevor Schoerie, PharmOut
    The presentation provides information on the regulations and definitions of therapeutic goods, including medicines, biologicals, and medical devices. ​ It explains the two pillars required for all pharmaceutical products before they can be sold, the types of medicinal products, the Australian Register of Therapeutic Goods, and the pathways for approving manufacturers. ​ It also discusses GxP regulations, GMP clearance for overseas manufacturers, and the licensing and certification process for Australian manufacturers. ​ The document mentions the PIC/S Guide to GMP, the GMP clearance process, and the responsibilities of sponsors. ​ It also highlights the international agreements and arrangements for GMP clearance, including mutual recognition agreements and memorandums of understanding. ​ The document concludes with information on the TGA and Health Canada’s extra-jurisdictional inspections agreement. ​
  • Labelling requirements for unapproved and listed medicines – Mary Nteris & Priscila Cardoso, Enimera Regs +
    This presentation provides an overview of labelling requirements for listed and unapproved medicines. ​It covers basic concepts of labels, assessing artwork, regulatory frameworks, compliance assessment, and specific requirements for herbal medicines. It also emphasizes the importance of meeting quality standards for medicinal cannabis products and highlights the prohibition of advertising unapproved therapeutic goods to the public. ​

Room 105

  • Translation to GMP manufacturing of chemical substance or new formulations – Paul Wynne, Monash
    The presenmtation is about the Medicines Manufacturing Innovation Centre and its role in translating chemical discoveries into manufacturable pharmaceutical products.
  • Case study implementing a modern eQMS into a lab – Catherine Micallef, Chemika
    This presentation is about Implementing a modern eQMS and involves migrating paper-based documentation and training records to an electronic system, maximizing efficiency by utilizing existing resources and functions, and validating the system to ensure data migration and user access are accurate. ​ The implementation is done in stages, with each stage focusing on specific areas such as documentation and training, CAPA and Change Control integration, and equipment and supplier modules. ​ Lessons learned include the need for additional training assignments, reliance on the vendor for administration activities, and the importance of not printing documents and having backups of the eQMS. ​
  • Regulatory challenges with TGA licensing inspections – Michael Larcom, Vaxxas
    This presentation discusses the importance of having a TGA Good Manufacturing Practice license, the audience for the presentation, what success looks like in terms of compliance and business operations, and the steps to prepare for a TGA inspection. ​ It also provides a list of what to do and what not to do during the preparation process.
  • Down Stream Processing of ADC’s and mRNA – Anu Srivastava, IDT
    This presentation is about ADCs, or Antibody-Drug Conjugates, a targeted cancer therapy that combines monoclonal antibodies with cytotoxic drugs. ​They deliver the drug directly to cancer cells, minimizing off-target effects. ADCs have shown promise in treating certain lymphomas and are synthesized through bioconjugation techniques.
  • Contained powder handling for sterile & toxic applications – Jason Kavanagh, DEC Group
    This presentation is about the DEC Groups range of powder handling, processing, and containment systems. ​Their comprehensive solutions cover everything from raw material handling to final packaging. ​With a focus on operator and product safety, DEC Group provides technologies for powder handling, particle size reduction, filling solutions, containment solutions, and continuous processing. ​
  • Bridging the gap between freeze drying and spray drying for biologics – Bogdan Zisu, Fluid Air
    The presentation is about the advantages and applications of electrostatic spray drying technology for biologics, including its ability to preserve biological activity and produce powders with distinct characteristics.
  • Sustainability – What is in the Dumpster – Robert Caunce, Baxter Labs
    This presentation is about the journey to minimize waste going to landfill, starting with a review of budgets and setting targets, focusing on sustainability and corporate governance, analyzing the contents of dumpsters, and implementing recycling programs for cardboard, soft plastic, and label backing. The company has achieved diverting 48% of total waste from landfill and producing 30% of electricity requirements from rooftop solar panels. ​ The document also mentions the company’s commitment to sustainability and its collaboration with a national not-for-profit supplier of personal hygiene essentials. ​
  • Supporting cleaning validation through design and automation – Ian Henton-Smith, IWT Pharma
    This presentation discusses the importance of supporting cleaning validation through design and automation in the pharmaceutical industry. ​ It covers topics such as regulatory aspects, design considerations, environmental impacts, and automation. ​ The design of pharma washers is engineered to comply with industry standards and minimize downtime and cross-contamination. ​ The document also emphasizes the need for data integrity and sustainability in the cleaning process.
  • Critical thinking and sustainability in HVAC design and operation – Shane Bourne, PharmOut
    This presentation discusses critical thinking and sustainability in HVAC design and operation. ​It emphasizes the importance of critical thinking in assessing risk and formulating control strategies. Sustainability is defined as the ability to maintain a process over time without depleting resources, and it is broken down into economic, environmental, and social pillars. ​The presentation also provides specific energy-saving methods for HVAC design and operation, such as minimizing heat gain/losses, using high-efficiency equipment, and reducing cleanroom size. ​ Additionally, it highlights the importance of economic sustainability, quality/compliance considerations, and the need for periodic reviews and lean initiatives to enhance operational efficiency. Overall, critical thinking and sustainability are interconnected and essential for successful HVAC design and operation. ​

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