There are many parameters and challenges in the journey of biologics (and indeed all new drugs) from conception and discovery through to commercialisation, including drug discovery, the establishment of a manufacturing process for the active ingredient and its dose formulation design and development, suitable packaging, and determination of shelf life and storage conditions for both active and drug product.
In addition to establishing the scientific parameters for any new drug and planning for process scale-up to facilitate drug supply for use in clinical trials, compliance with regulatory requirements from the TGA (and international regulators) must be addressed early in the development process, when appropriate manufacturing and testing facilities are identified and accessed. Successful commercialisation also requires that adequate financing and the initiation and maintenance of patent protection are in place.
These parameters are frequently initiated step-wise, where success in one step is necessary before progressing to the next.
As detailed below, this program addresses a number of these parameters and, in particular, is an opportunity to learn of the TGA requirements for the supply of investigational biologics for use in clinical trials.
The seminar is recommended to all involved in drug discovery and development; drug designers, dose formulators, manufacturing, quality, analysts, microbiologists, and regulatory personnel, together with project and financial personnel.
Key Registration Dates
|
Registration Open
1 February 2026
|
Registration Closes
30 March 2026
|
Program
|
Time
|
Item
|
Speakers
|
|
12.15pm – 12.45pm
|
Registration
|
|
|
12.45 pm – 12.55pm
|
Chair seminar welcome and introduction
|
Prof Pall Thordarson, Director, UNSW Sydney RNA institute
|
|
12.55 pm – 1.25pm
|
Research & Development of Novel Biologics
|
Dr Josh Peterson, Chief Operating Officer, UNSW RNA Institute
|
|
1.25pm – 1.55pm
|
A GMP overview for Biological Medicines; PIC/S PE009-17, Annex 2A and 2B requirements
|
Neale Baldwin, Team Leader/Senior GMP Inspector, TGA
|
|
1.55pm – 2.25pm
|
TGA regulatory requirements for the manufacturing and supply of Investigational Medicinal Products (IMP)
|
Lynn Talomsin, Senior Inspector/Technical Specialist, TGA
|
|
2.25pm – 2.55pm
|
Scaling up for clinical trials and early stage commercial production
|
Dr Elben Guimaraes, Head, GMP Manufacturing, Aurora Biosynthetics
|
|
2.55pm – 3.15pm
|
Afternoon Tea
|
|
|
3.15pm– 3.40pm
|
In vivo genome editing – delivery and translational challenges
|
A/Prof Samantha Ginn, Senior Research Officer, Gene Therapy Research Unit, Children’s Medical Research Institute
|
|
3.40pm – 4.50pm
|
Venture capital investment trends in RNA
|
Dr Prashanth Rajan, Brandon Capital Partners |
|
4.05pm – 4.30pm
|
Patent Strategies – Tips for success
|
Dr Jessica Chadbourne, Principal Patent Attorney, phillips ormonde fitzpatrick
|
|
4.30pm – 5.00pm
|
Establishing Product Value: Key to Successful Commercialisation
|
|
|
5.00pm – 5.20pm
|
Panel Discussion
|
|
|
5.20pm – 5.30pm
|
Questions and Discussion
|
|
Notes: Some speakers may present through a webinar link
Organising Committee
Organised by the RACI NSW Pharmaceutical Group
Event Terms & Conditions
Cancellation Policy D applies to this event. For full details, view our Cancellation Policy. By registering for this event, you agree to, and will be bound by, the RACI Event Terms and Conditions and Event Code of Conduct.
The Pharmaceutical Science Group reserves the right to omit or change presenters and/or presentations without prior notice to seminar/webinar attendees. Also note that the Group may close registration(s) if the venue or webinar licence capacity is filled with prior registrants.
More Information
#NSW