Join our upcoming Masterclass to gain the expertise needed to confidently navigate the critical transition from research to clinical development. Tailored for biotech startups, this session will equip you with the knowledge to turn scientific discoveries into impactful therapies.

Key areas we'll explore include:

Defining target disease/condition in preclinical and clinical studies
Designing animal studies to yield safety and efficacy data including sufficient for transition to clinical trial: pharmacodynamics, pharmacokinetics and toxicology considerations
Manufacturing for clinical trials including GMP and quality considerations
Understanding the quality and regulatory standards leading to safe and effective product for clinical use

Brief agenda:

2:30pm: Registration and passing through security

3-3:10pm: Welcome by Camille Shanahan, General Manager of Jumar Bioincubator

3:10-3:30pm: Keynote Speakers present

3:30-3:40pm: Audience Q&A for Keynotes

3:40-4:00pm: Panel discussion

4-4:25pm: Audience Q&A

4:25-4:30pm: Wrap up

4:30pm onwards: Networking and refreshments

Keynote Speakers:

Dr Nick Wilson, Senior Director and Head of Translational Science at CSL
Dr Nick Wilson is Senior Director and Head of Translational Science at CSL Limited and is an Honorary Fellow of the University of Melbourne. He completed his PhD in the Department of Medicine, University of Melbourne before joining DNAX Research Institute (Merck), Palo Alto, California working on novel cytokines and human immunology. He then moved to Elan Pharmaceuticals, South San Francisco leading a team screening for novel therapeutics. Nick joined CSL in 2008 and has held multiple positions of increasing responsibility. In his current role as Head of Translational Science he oversees a global team of more than 80 scientists. Translational Science is a global function within CSL at the intersection between preclinical and clinical development which focuses on biomarker discovery, compliant assays for non-clinical and clinical studies, as well as human proof-of-mechanism research.

Dr Gary Waine, Associate Director of CMC Science at CSL
Dr Gary Waine is the Associate Director of CMC Science at CSL, responsible for writing CSL’s global CMC technical dossiers for clinical trials and licensing applications. Gary joined CSL in 2002 and held multiple positions in Regulatory Affairs prior to moving to Chemistry, Manufacturing, and Controls (CMC). Leveraging 25+ years in the pharmaceutical industry in both Regulatory Affairs and CMC Science has been instrumental in ensuring the acceptance of CSL’s products by global regulatory authorities from Phase 1 clinical trials through to marketing applications.

Industry Expert Panel:

Dr Julie Monk, Associate Director of Pharmaceutical Development at RAGE Biotech
Dr Julie Monk is an Associate Director of Pharmaceutical Development at RAGE Biotech, overseeing RAGE’s preparation for their first in human clinical trial. Julie has 20+ years’ experience working as a medical writer across the drug development pipeline, more recently within early clinical development at CSL Limited and at Monash University. She has a special interest in understanding how preclinical data supports the execution of clinical trials and ultimately the marketing authorisations of oligonucleotides, biologics, and cell and gene therapies. Julie holds a PhD in Biochemistry and Molecular Biology and a Bachelor of Arts (Cinema Studies) / Bachelor Of Science (Biochemistry and Molecular Biology, and Genetics) from the University of Melbourne.

Dr Catherine Osborne, Director at Aliquot Solutions
Catherine led Crux Biolabs for 6 years from 2017 to 2022. Crux Biolabs is a commercial lab service that specializes in ISO-accredited immunology tests for clinical trials. These days Crux runs a wide range of specialist tests for international biotechs in their 1000 sqm lab in Melbourne outer east, but at the start of 2017 it was just a 2-person team running tests for the local academic market in a 100 sqm lab. When Catherine finished up at Crux at the end of 2022 the team was 24 people and the majority of the clients were US biotechs running immuno-oncology trials. Before running Crux, Catherine had 10yeas as a bench scientist; completing her PhD in microbiology at the University of Melbourne, and then postdoctoral positions at CSIRO, University of California, Berkeley and Monash University. After leaving the bench in 2012 her first commercial role was as an Account Manager at Thermo Fisher Scientific, then becoming the Business Development Manager at Jomar Life Research before leading Crux Biolabs in 2017. Catherine is currently supporting a range of contract research services around Australia to grow their businesses with her company Aliquot Solutions.

Dr Jason Lickliter, CMO at Nucleus Network
Dr Jason Lickliter is the Chief Medical Officer of Nucleus Network, an early-phase clinical trials organization with units in Melbourne and Brisbane, Australia, and Minneapolis, USA. He has a medical degree from the University of Queensland and completed training in medical oncology at the Royal Melbourne Hospital and University of Minnesota Medical Centre. Research training included PhD studies at the Walter and Eliza Hall Institute and postdoctoral research in translational immuno-oncology at the University of Minnesota. Dr Lickliter has wide-ranging experience in the design, implementation and performance of phase 1 clinical trials. He has over 20 years of experience as an investigator for phase 1 oncology patient studies. Since joining Nucleus Network in 2012 he has been principal investigator for over 200 early-phase clinical pharmacology trials, including multiple first-in-human studies of cutting-edge therapeutic technologies.

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

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.

About

Jumar Bioincubator acts as a first home for biotech startups, providing affordable lab and office space, practical support, and community activities to unlock the potential in early scientific discoveries.

Jumar Bioincubator was established by CSL, WEHI and the University of Melbourne. Together, with backing from innovation investor Breakthrough Victoria and operator Cicada Innovations, the mission is to connect early-stage and scaling biotech ventures with the support they need to progress discoveries towards real-world treatments and therapies and build a critical mass of scientists with the knowledge and confidence to run successful biomedical ventures.

Contact the host of Jumar Masterclass: Setting Yourself Up For Success When Moving From Pre-Clinical To Clinical

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