Manufacturing clinical trial material is one of the most complex and high-stakes stages of product development. For startups, the right manufacturing decisions early on can save millions and months of delay. This Masterclass explores how to plan, partner, and execute manufacturing for clinical trials — balancing cost, safety, and regulatory compliance.

Participants will gain practical insights into:

Phase-appropriate GMP and what’s truly required at each stage.
Choosing between in-house production or outsourcing to CDMOs
Managing risk, cost, quality, and legal obligations.
Understanding key regulatory and supply chain considerations.

Masterclass Facilitator:

Rachel Jensen, Director at Centre for Biopharmaceutical Excellence
Rachel has over 20 years of experience in the biotech industry spanning commercial operations, strategic compliance, and business management. As a Director at CBE, she provides specialised consulting in strategy and commercial development. Previously, she held senior roles at CSL across diagnostics, antivenoms, and plasma therapeutics, including leading ANZ Marketing and establishing the New Product directorate. Combining a science background with commercial acumen, Rachel brings strategic insight and practical solutions to support business growth, stakeholder engagement, and product commercialisation across Australia, New Zealand, Asia, the US, and Europe.

Speakers:

Steve Williams, Director at Centre for Biopharmaceutical Excellence
Steve has over 45 years of experience in the biotechnology, pharmaceutical, and medical device industries, providing strategic regulatory and compliance solutions across the Asia-Pacific, with a focus on Hong Kong and China. With more than 25 years in consulting, he specialises in GMP, auditing, training, and quality systems to international standards. Steve has led projects in GMP compliance, risk management, and CAPA implementation, and developed numerous training courses in GMP, GLP, validation, and quality systems. A registered auditor with the Australian Pesticides and Veterinary Medicines Authority, he also conducts GMP licensing audits globally.

Justine Mann, CEO at CBE Pure Solutions
Justine has a MBA in strategic business management, and more than 25 years of extensive technical and cross functional experience, ensuring compliance with Australian and International regulations and standards. As a senior leader with extensive technical and management experience in Sterile Manufacturing and Quality Operations in the Pharmaceutical, Biotechnology and Medical Technology industries, Justine has worked on assignments in USA, Europe and Asia. Justine is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) on behalf of the Australian government, a technical assessor for National Association of Authorities (NATA) and current President for the Parenteral Drug Association, Australian chapter.

Justine Walter, SVP of Product Development at PolyActiva
Justine has over 25 years of experience in the biotechnology, pharmaceutical and fine chemical industries covering process development, GMP manufacture, analytical chemistry and leadership of cross-functional teams. At PolyActiva, she manages CMC activities for PolyActiva’s drug delivery products, which are in Phase I and II clinical studies. Prior to joining PolyActiva, Justine held positions as Operations Manager at Boron Molecular and Project Leader at IDT Australia. Justine has a PhD in chemistry from the University of Melbourne.

The masterclass will be followed by an optional tour of Jumar Bioincubator. Let us know in the registration form if you're interested in participating.

NOTE: You may be photographed or videoed while attending this event for marketing purposes: please approach the organiser if you have questions, concerns, or do not wish this to happen.

About

Jumar Bioincubator serves as a ‘first home’ for 30+ biotech ventures in Australia, providing affordable lab and office space alongside practical support to advance early scientific discoveries. Residents gain access to world-class facilities, a dedicated support team, and curated entrepreneurial training and events.

Established by CSL, WEHI and the University of Melbourne, and backed by Breakthrough Victoria with Cicada Innovations as operator, Jumar’s mission is to connect early-stage and scaling biotech ventures with the support needed to translate discoveries into real-world therapies and build a community of scientists equipped to lead successful biomedical ventures.