Conference Agenda 2025

Antibody-drug conjugates (ADCs) represent a rapidly evolving class of biotherapeutics that combine the specificity of monoclonal antibodies with the potent cytotoxicity of small-molecule drugs. While offering significant therapeutic promise, ADCs present unique and multifaceted challenges in bioanalysis due to their inherent heterogeneity, complex pharmacokinetics, and multiple analytes of interest, including total antibody, conjugated antibody, free payload, and metabolites. This presentation will explore key analytical elements in developing and validating bioanalytical methods for PK and immunogenicity tests and also provide a case study.

Formulating involves combining ingredients into precise ratios and interactions to create something functional whether it's a new drug or a cosmetic product. Seen as an art form, this involves creativity in composition from selecting ingredients and their levels not just for efficacy and safety but for elegance, synergy, and innovation. Aesthetics involving harmony between stability, function, and experience of smell, texture and visual appeal. Formulators often develop a recognizable approach or 'handwriting,' or signature style or technology like artists or perfumers. Packaging and presentation are part of the 'formulation' from aesthetic, symbolic and functional choices. Thus formulating is emotional and cultural. And by the way it should have efficacy and be safe! Art form vs science vs AI will be discussed

The opportunities of using real world veterinary clinical models of spontaneous disease in the de-risking, providing proof of concept and development guidance for human pharmaceutical development.

As biological therapeutics—including proteins, peptides, and mRNA—rapidly expand their market presence, the pharmaceutical industry faces analytical and validation challenges distinct from traditional small molecules. Biologics present unprecedented complexity due to their structural heterogeneity and inherent instability, requiring innovative analytical approaches and rigorous validation methods to accurately assess purity, potency, stability, and bioactivity. This presentation explores specific validation considerations unique to biologics, highlighting the importance of embracing advanced analytical strategies to ensure robust product quality and regulatory compliance within this rapidly evolving pharmaceutical landscape.

This presentation provides a strategic overview of the nonclinical regulatory requirements necessary to support global clinical trial initiation, with a focus on First-in-Human (FIH) studies. It covers a broad range of therapeutic modalities, including small molecules, biologics, and advanced therapy medicinal products (ATMPs). The session outlines the objectives and design of key nonclinical studies, pharmacology, pharmacokinetics, and toxicology, within the framework of ICH, OECD, and Good Laboratory Practice (GLP) guidelines, and highlights regulatory expectations from major health authorities including the FDA, EMA, and TGA. The presentation also highlights study design considerations unique to oncology products and ATMPs, along with emerging trends such as use of MABEL and mechanistic modeling for early dose selection. Attendees will gain insight into building a scientifically robust and regulatory-compliant nonclinical development plan to enable safe and efficient transition to clinical trials.

Formulation science plays a pivotal role in enabling both therapeutic efficacy and user-centred design across pharmaceutical and consumer health products. In this talk, Dr. Michael Andrews Luke, Director at Formulytica, draws on nearly 20 years of experience developing innovative delivery systems and formulations across the biotech, pharmaceutical, and skincare sectors. Michael will explore how advanced formulation technologies, such as nanoparticles, topical delivery systems, and aerosol foams, are overcoming longstanding challenges in stability, absorption, and patient compliance. Through practical case studies, he will highlight strategies that have successfully translated early-stage ideas into market-ready solutions. The talk will also address the interplay between scientific innovation, regulatory strategy, and commercial objectives in accelerating product development.

The Clinical Study Protocol provides a foundation for a study to be run successfully. It defines the rationale and scope of the study, and provides all relevant information for stakeholders. When Protocol development is approached in conjunction with clinical design, many challenges can be identified and corrected in the early stages of the study, saving time and money in the long run. In this presentation, we will explore the process of Protocol development in clinical trials, including ICH-GCP guidelines and regulatory requirements. Working with an experienced CRO provides access to expert consultation to improve efficiency and maximise outcomes for your clinical trial. We will examine how to best approach Protocol development as an integrated part of clinical study design.

The ICH Q5A is the most important regulatory guidance document used worldwide as the standard for ensuring viral safety of all kinds of biological products. Though the scope of the document is limited to biologics derived from cell substrates the guidance is either frequently referenced or the principles of virus risk mitigations are copied in guidance documents for other biologics like vaccines and cell and gene therapy products. The ICH Q5A was recently significantly revised, and the revision was released end 2023. The presentation will outline and comment the most important changes and detail the consequences for the industry to ensure viral safety of traditional (recombinants, mAbs) and advanced (gene therapy) product modalities in their manufacturing processes.

The opportunities for specific phases of trials and for different therapeutic areas vary across AsiaPac. The speaker will overview these opportunities and the emerging influences on trial placement.

In today's fast-paced pharmaceutical landscape, bridging the gap between early-stage development and clinical manufacturing is a critical challenge—especially for clinical-stage biotech and pharmaceutical companies. This presentation will explore how integrated Contract Development and Manufacturing Organizations (CDMOs) can streamline this transition by offering end-to-end services that unify formulation development, analytical support, and scalable batch manufacturing under one roof.Drawing on real-world project experiences, we will highlight the strategic advantages of small-medium scale GMP manufacturing for clinical trial supply—allowing for flexibility, accelerated timelines, and cost-effective iteration before tech transfer to large-scale providers. We will provide insight into how early coordination between development and manufacturing teams enhances scalability, reduces risk during technology transfer, and improves regulatory alignment.This presentation will provide actionable frameworks for leveraging CDMO partnerships to achieve clinical and commercial milestones more efficiently—transforming innovation into viable, ready-to-scale pharmaceutical products.

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Chronic wounds remain a significant challenge in clinical care, driving the need for effective, scalable topical therapies. Tissue Repair has isolated a unique active ingredient, a bioactive saccharide (Glucoprime), designed to enhance re-epithelialization and modulate inflammation. This presentation will outline the end-to-end pharmaceutical development journey of its chronic wound product TR-987, from design through to: - Pre-clinical and clinical evaluation - CMC development - Scale-up readiness Key aspects of the development program included: - Development and optimization of the drug substance manufacturing process - Drug product development, optimization, and assessment of skin tolerability - Pre-clinical testing - Characterization of the drug substance and drug product - Development and validation of test methods to support release and stability - Stability under ICH conditions Mechanistic assays and preclinical wound models demonstrated that TR-987 significantly accelerates wound closure and supports tissue regeneration. The drug substance and drug product exhibited excellent physicochemical stability over 12 months under ICH conditions and retained bioactivity across different temperature conditions. A comprehensive CMC package and a scalable manufacturing process were developed before commencement of Phase III clinical trials (US and Australia) under an IND. This case study demonstrates the critical role of formulation science and CMC strategy in translating novel biologically active pharmaceutical ingredients into therapeutic solutions.

The success of any clinical trial is dependent on its data. While the importance of the data itself is self-evident, its format, storage, and handling are equally so. Through various examples, this will highlight the importance of strategic data handling at the outset of a study. The differences and choices one makes within their electronic data capture (EDC) platform of choice will dictate analytical ease and data quality. In addition, data structuring and formatting decisions also feed into this and other processing tasks, such as CDISC and ADAM datasets. Being aware of and choosing the right choices for your study will streamline workflows and ultimately contribute towards the success of a clinical trial.

COMING SOON

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