Lynne Clapham

Principal Toxicologist

Preclinical toxicity testing can be viewed as the jam in the sandwich between early development/proof of concept studies and human clinical trials. Initially the sandwich is a single layer of jam, but as the clinical program progresses from one clinical Phase to the next, more layers are added, until a multi-decked sandwich is reached. The thickness of the layer of jam is an indication of the amount of data/studies required to support each clinical Phase. The first layer is often the thickest (but not necessarily the most expensive). The information required for each jam layer is influenced by the objective and the participant population (patient or healthy subject) of the clinical Phase being supporting, plus all nonclinical and clinical information previously gathered. The focus of this presentation is: how to decide what nonclinical studies are needed and when: factors which can be overlooked and consequently slow or derail a nonclinical testing program; second species testing in the Australian nonclinical space; leverages off the Australian tax advantages to support non-clinical toxicity testing. Reference will be made to appropriate ICH (International Conference on Harmonisation) and US FDA guidance documents.

Richard Buchta

Managing Director

The approach to pharma product development is often misguided by lack of information on the product profile and end user, patient, medical professional and health system. What can we do early in the development program to address these issues, can advance the product development pathway through clinical trial, regulatory approval and health funding. Some insights from past programs as well as where development could be enhanced by technology and AI are discussed.

Luke Edington

Clinical Project Manager

Running a successful clinical trial demands a meticulous approach to management, requiring both strategic planning and hands-on execution. This presentation offers a practical guide to the key elements of clinical trial management, covering essential topics such as study design, site selection, data quality assurance, monitoring and patient recruitment. Additionally, we will delve into the critical roles and responsibilities of key stakeholders, highlighting how their collaboration is pivotal to trial success. Through practical strategies and real-world examples, this discussion aims to equip professionals with the knowledge and tools necessary to effectively manage clinical trials, ensuring high-quality, reliable outcomes.

Michael Andrews Luke

Director Innovation and Biologics Deputy Managing Director

Michael will discuss case studies (including biologics) focusing on how CDMO takes a new drug from concept to clinic, which often involves significant effort to optimise the formulation, excipients, and manufacturing processes. The presentation will also provide an overview of how products are developed from an academic lab to a scalable, stable, effective, and quality drug product suitable for human clinical trials. In addition, the presentation will delve into the importance of engaging early with CDMOs or CMC consultants and avoiding the common pitfalls of early-stage biotech startups.

Dr Matthew Borg

Biostatistician

Although data analysis takes place after subjects have completed the clinical trial, the best analytic choices often occur before the trial has begun. Pre-trial considerations present an opportunity to refine the study design, ensuring it effectively addresses the study aims and minimises potential biases. During the trial, important issues to consider include unbiased patient recruitment and outcome measurement, effective management and minimising missing data. Post-trial issues include selecting appropriate statistical methodology, accounting for confounding variables and correct interpretation of the results. Addressing these issues is essential for maintaining the integrity and value of the study while optimising resource use. Early identification of these issues is the most important step to addressing them, as potential issues can be anticipated and mitigated before they can occur. This requires a collaborative effort across all team members. This presentation will discuss common analytic issues and how to manage them, both proactively and reactively, including case studies.

Rudy Flach

Senior Vice President R&D

The presentation will provide an in-depth overview of formulation development within a Contract Development and Manufacturing Organization (CDMO). It will explore the comprehensive process of transforming a pharmaceutical compound from initial concept to a market-ready product. Key topics include pre-formulation studies, excipient selection, formulation strategies, process optimization, filter validation, PUPSIT, and scale-up for manufacturing. Attendees will gain insights into the critical role of analytical method development and regulatory compliance in ensuring product efficacy, safety, and quality. Case studies will illustrate the collaborative efforts between CDMOs and clients to overcome formulation challenges, accelerate development timelines, and bring innovative therapies to market efficiently.

Helen Ormandy

Senior Director, Clinical Operations

The APAC region is now the largest contributor to new clinical trials with more than 50% of the trials world-wide, followed by the US and Europe. Negative growth has been observed in ROW, particularly in Europe. Whilst each APAC country has its own unique clinical trial landscape, some of the APAC countries offer large patient populations, ease of regulatory compliance, lower cost, high-quality standards and excellent clinical research sites. Whilst China’s regulatory reforms have accelerated drug approval that has resulted in a large increase in trials, this trend is now slowing in the face of broader economic forces. Australia retains its place within APAC as a well-known destination for early development, with the Clinical Trial Notification scheme supporting fast start-up. The Australian government’s “Clinical Trial Activity Initiative” aims to provide $750 million over 10 years between 2024/2025 and 2033/2034. This will support clinical trials addressing rare cancers, rare diseases and unmet needs, and bring investigator-led clinical studies to Australia.

Andrew Watson

Director

Central to any life science manufacturing activity is the cleanroom. Embarking on a new facility for a new product, or an expansion to an existing facility to keep up with demand, or the ever-changing regulations is a daunting and expensive exercise.  Added to this is relative scarcity of design, construction and commissioning expertise.  Overall, while the capital cost is substantial, the ongoing cost of a poor designed or executed project will cost much more in the long run. This presentation will provide some high-level guidance on how to approach cleanroom design.  It will also look at the changing regulations, new innovations and some emerging trends, such as the move from open aseptic processes to closed isolators.

Gillian Ryan

Global Head of Early Phase

Excellent resources, proven experience and financial incentives make Australia and New Zealand a smart choice for First-in-Human and early phase clinical trials. There are 3 key benefits in conducting early phase clinical trials in Australia and New Zealand: Cost-efficiency: The Australian and New Zealand governments offer attractive R&D tax incentives including cash rebates. Coupled with favourable currency conversion, according to a cost comparison study, conducting clinical trials in Australia and New Zealand is cheaper than other major markets before tax incentives. Speed: The clinical trial process in Australia and New Zealand allows flexibility without compromising quality. It avoids duplication of processes, saving the sponsors both time and money. Quality: Australia and New Zealand each has a network of universities, independent medical research institutes, clinical trial networks, biobanks, and CROs. Scientific research conducted in Australia and New Zealand ranks the highest in Asia-Pacific in terms of productivity, impact, and one of the most rigorous patent protection systems in the world. Data from studies conducted in Australia and New Zealand can be used to support international regulatory applications, including the US FDA and European Medicines Evaluation Agency (EMEA).

Ashish Kumar

Product & Sales Manager

Does your skin cream harden in the tube after only 6 months? Cough syrup doesn’t stay on the spoon, nor does it coat the throat? Your carefully formulated microemulsion separates into phases after a day at the beach! Customers keep choosing a different brand for reasons you can’t quite put your finger on – but the viscosities are identical. If these problems sound familiar, then join me as we explore case studies to better understand the differences between viscosity, rheology and the influence of particle characteristics when trying to solve formulation issues, or engineer better products. Plus, learn how to choose the best device for your application, i.e. a viscometer, rheometer or… something in between – along with the pitfalls and advantages of each technique.

Saurabh Jain

Executive Chairman

TrialKey’s AI-powered platform, featuring the trial design simulator TrialGen, harnesses real-world data from over 350,000 trials to create and optimise clinical trial designs with market-leading +92% accuracy. Whether for drugs, medical devices, alternative therapies, or novel conditions, TrialKey enhances success probabilities across all phases, offering comprehensive global capabilities for optimal trial design. TrialGen delivers precise recommendations for key trial elements, including study type, timelines, enrollment numbers, and site selection, ensuring the highest chances of success. Additionally, TrialKey refines existing trials by benchmarking them against competitors, identifying areas for improvement, and minimising the need for costly amendments. Looking ahead, future enhancements will focus on integrating compound/molecule feature creation, further refining the model’s predictive capabilities to offer even more robust and tailored trial designs. This session is crucial for professionals in drug discovery, clinical development, and pharmaceutical research, providing insights into how AI can accelerate the journey from development to market with unmatched precision and efficiency

Justine Mann

Chief Executive Officer

Phase appropriate quality is a pivotal concept in the manufacture of investigational medicinal products (IMPs), ensuring that quality standards and good manufacturing practices are suited to each stage of the product lifecycle. This approach balances regulatory compliance with operational efficiency, adapting quality practices to the unique requirements of preclinical development, clinical trials, and commercial production. In research and development (R&D) phases, minimal but essential quality controls and documentation suffice to support exploratory studies. As products advance to preclinical and clinical phases, quality systems evolve to meet Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards. The expectations for Good Manufacturing Practice (GMP’s) also evolve, emphasising safety, efficacy, and rigorous data management. By implementing phase appropriate quality management and good manufacturing practices, pharmaceutical and biotechnology companies can efficiently navigate regulatory landscapes, mitigate risks, and expedite the development of safe, effective medicinal products. This presentation will consider these elements, through the lens of aseptic manufacturing.

Dilshani Fernando

Quality Specialist

This session offers a concise overview of the Quality Oversight framework, emphasizing its role in clinical trial conduct. The framework integrates Quality Assurance (QA) and Quality Management (QM) to effectively oversee and support daily Quality Control (QC) activities and deliverables. By ensuring consistent oversight, this approach fosters continuous quality improvement. Additionally, the session will demonstrate how the application of this framework enhances various aspects of routine clinical trial operations, illustrated through a real-world example.

Ana Benatti

Head of Quality and Regulatory Affairs

The presentation objective is to discuss the Implementation of Quality System for product sponsors (with no in-house manufacturing). The presentation will provide an overview of the key elements of the product sponsor's quality system and regulatory and GMP expectations. Ana will also share the QBiotics journey on implementing a suitable and meaningful quality system and some learnings from the journey.