SeerPharma Symposium 2025

Day 1 - Monday 17th March 2025

08:45-09:00 - Introduction

Biju Kishor | Director, SeerPharma

09:00-09:20 - AI and Emerging Technologies Use in Training

Artificial Intelligence (AI) and emerging technologies are rapidly advancing, influencing every aspect of business operations, including the pharmaceutical and medical device industries. SeerPharma partnered with The University of Melbourne's Master of Biotechnology program to conduct a comprehensive survey of the industry to demonstrate the potential uses of these technologies. This session from one of the students in the program, will discuss and share results from this study.

Urja Bag | Content Design Consultant, SeerPharma

09:20-10:00 - Pharmaceutical Manufacturing: Interactive Exercise; Conducting a GMP Audit

Utilising VR technology from Uptale, our team will showcase a pharmaceutical manufacturing facility and walk you through a simulated audit exercise. Scenarios from common observations will be showcased, and attendees will be asked questions to help uncover issues.

Aaron Bennett | GMP Trainer/Consultant, SeerPharma

Mahtab Ameri | Program and Product Manager, SeerPharma

Nicolas Couturier | Sales & Partner Manager APAC, Uptale

10:00-10:30 - Morning Tea Break

10:30-11:30 - Radiopharmaceuticals

Overview of radiopharmaceutical manufacturing from SeerPharma Director – Andrew Giles. Showcase common challenges and issues in radiopharmaceutical manufacturing, sharing perspectives from one of SeerPharma’s clients.

Andrew Giles | Director, SeerPharma

11:30-12:00 - MasterControl: Roadmap to Industry 4.0

Digital transformation is reshaping industries at an unprecedented pace, and the Life Sciences sector is no exception. MasterControl stands at the cutting edge of this evolution, driving large-scale digitalization to empower organizations to achieve new levels of efficiency and compliance. This presentation will showcase MasterControl's latest innovations, designed to eliminate manual processes across quality and production teams, streamline operations, and enhance regulatory adherence—all while accelerating the journey toward Industry 4.0. Discover how these transformative solutions are enabling life sciences companies to stay competitive in an increasingly digital world.

Matt Lowe | Chief Strategy Officer, MasterControl

Ciarán O’Keeffe | Director, BD & Sales APAC, MasterControl

12:00- 13:00 - Lunch

13:00-13:30 - Kompetency AI: Use a Chatbot Assessor for Training

By using advanced multi-agent AI chatbots, realistic scenarios can be created that test decision-making, critical thinking, and problem-solving in real time. We will present a Quality incident (scenario) to you and interact with an AI chatbot to gather the relevant and appropriate information to fill out a form. By observing the interactions with the chatbot, we will then assess our level of competency.

Ian Lucas | Director, SeerPharma

Sharaf Goussous | CEO and Founder, XponixAI

13:30-14:15 - TGA Lessons from the Field: Observations from Biological GMP inspections

Advanced Therapy Medicinal Products (ATMPs) are complex medicines based on genes, tissues, or cells. They present opportunities for innovative treatments but also pose unique challenges to the current regulatory environment. This session will provide a GMP inspector’s insights of recent domestic and international inspections as understanding deficiencies raised at other manufacturing sites is valuable information that may better prepare you for your next TGA inspection

Amanda Louise | GMP Inspector - Blood and Biologicals, TGA

14:15-15:00 - Cell and Gene Therapy (ATMP): Successful Media Fills

There a lot of challenges involved in the manufacture of Cell and Gene Therapies such as the complexity of the process, product and analytical methods, specialized equipment, scalability, and in most cases, manual processing. As we know, humans are the main cause of contamination in a cleanroom environment, so how do ensure that our media fills (aseptic process simulation) will be successful? In this workshop we will walk you through the fundamentals for successful media fills for cell and gene therapy.

Michelle Peake | Senior Consultant, SeerPharma

15:00-15:30 - Afternoon Tea Break

15:30-16:30 - Compounding Pharmacy: Case Study

In this session, we will workshop key Facility Design considerations for a Compounding Pharmacy, using the analogy of a domestic kitchen design.  We hope this is a fun experience for you to explore the following key design considerations, whilst learning about best practice design considerations and understanding typical deficiencies in design.

• Process Flow
• Material / People / Waste Flow
• Gowning
• Material Decontamination
• Cleaning / Environmental Monitoring
• HVAC design and testing requirements
  

Jo Sherriff | Engineering Compliance Manager, SeerPharma

16:30-17:00 - Ardacious: Use of AR Technology in Industry Training

Learn about the Ardacious Training Platform - an Augmented Reality training and assessment software. Built with over 20 years of hands-on education experience, Ardacious delivers immersive and experiential learning outcomes that allow participants to immerse themselves in realistic scenarios, without needing to leave the classroom.

Ralf Muhlberger | CEO and Co-Founder, Ardacious

17:00-17:30 - Closing Remarks and Networking

17:30-19:30 - MasterControl Cocktail Event at Loop Roof Top Bar

For those of you who purchase an in-person ticket, please also join us on the Monday evening for a complimentary cocktail mixer event at the nearby Loop Roof; sponsored by MasterControl.

Day 2 - Tuesday 18th March 2025

08:45-09:00 - Introduction

Biju Kishor | Director, SeerPharma

09:00-10:00 - Medical Devices

Integrating effective risk management into design inputs during medical device development. The requirement for devices to apply risk management throughout the product lifecycle has been a requirement for some time. Identifying hazardous situations that could occur from using a new device, and subsequent harms is a key element of risk management and when done at the Design Input stage of development, will influence the overall design and use of the device. This interactive workshop will take a hardware and software component of a medical device and apply risk management during the design input stage, to identify the hazards, hazardous situations and subsequent harm.

Hayley Cameron | Medical Device Consultant, SeerPharma

10:00-10:30 - Morning Tea

10:30-11:30 - Logistics and Secondary Packaging

Challenges for a distribution service provider when looking to offer a secondary repackaging service. Distribution providers can operate in Australia without a requirement for a GMP licence. They are able to distribute therapeutics products manufactured in Australia, or receive therapeutic products imported into Australia which are either on the ARTG or through the SAS/S19A pathways and distribute them for use to wholesalers or end customers. This interactive workshop will take a wholistic gap assessment approach to identifying activities required to ensure distribution service providers are ready to take the next step and to be able to offer a secondary repackaging service.

Daniel Flewellen | Director, SeerPharma

11:30-12:00 - Commercial and Legal Considerations with Manufacturing Therapeutic Goods 

This workshop will cover the key aspects of effectively collaborating with contract manufacturers, emphasising the importance of quality and GMP agreements in mitigating risks. It explores the potential consequences of mismanagement, including product liability claims, regulatory challenges, and consumer law complaints. Additionally, it delves into alternative dispute resolution strategies to safeguard partnerships and restore trust when issues arise, ensuring long-term success and compliance in the manufacturing process.

Kelly Griffiths | Partner (Regulatory & Disputes), Gadens

12:00- 13:00 - Lunch

13:00-13:30 - UTS: Interactive Exercise

Where do people go to get a good grounding in GMP? On the job training is great, but can be narrow or outdated. In this session learn about the university-accredited graduate programs in Good Manufacturing Practice (GMP) which are delivered by SeerPharma in partnership with the University of Technology Sydney. A key part of the program is developing critical thinking and collaborative problem solving. The session will include an activity to spark your brain cells and competitive spirit into action!

Jacqueline Berry | Senior Consultant/Lecturer, SeerPharma

13:30-14:15 - MasterControl: Adoption of AI into QMS and MES

Generative AI is disrupting industries worldwide - from finance and retail to manufacturing - and the Life Sciences sector is no exception. However, the highly regulated nature of Life Sciences introduces unique challenges and opportunities when integrating AI. In this session, discover MasterControl's vision for harnessing AI to transform Quality Management Systems (QMS) and Manufacturing Execution Systems (MES). Learn how its AI-powered solutions are designed to support quality and production professionals, streamlining workflows, enhancing decision-making, and driving efficiency—all while navigating the complexities of regulatory compliance.

Matt Lowe | Chief Strategy Officer, MasterControl

Ciarán O’Keeffe | Director, BD & Sales APAC, MasterControl

14:15-15:15 - Platform Approach for mRNA Investigational Medicinal Products (IMPs)

The presentation elaborates on a platform approach for mRNA Investigational Medicinal Products (IMPs) within the framework of an upcoming ISPE guideline, emphasizing the application of prior knowledge and Quality by Design (QbD) principles. Key topics include the strategic use of platform technology and methods, mRNA manufacturing, and the application of QbD principles to IMPs. A case study discusses the platform approach that can be taken when developing similar products, focusing on dosage forms, quality attributes, process parameters, and control strategies. Challenges such as determining batch numbers for early-phase clinical trials, assessing design space robustness, and limited regulatory guidance for IMPs are also discussed.

Francesco Cicirello | Senior Director Quality Compliance, BioNTech

15:15-15:45 - Afternoon Tea

15:45-16:45 - Organisational Culture: Embracing Citizen Developers: Empowering Innovation from Within

A citizen developer culture is a business practice that encourages employees to create applications for their organization without needing to involve IT. This session will highlight the significance and potential of citizen developers within an organisation. It will also showcase the impact of citizen developers on business agility, innovation and efficiency, plus provide insights on how to foster and support a citizen developer culture. The workshop will get you to create a governance model for citizen development, that you can hopefully use in your organisation.

John Montalto | Director, Apex JM Consulting (PQE)

16:45-17:00 - Closing Remarks and Networking

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