The SMART CRC is proposing four closely integrated research programs, (1) biomanufacturing, (2) bioseparation, (3) biomaterials and (4) clinical enablement. These programs will each have program co-leads from research and industry to coordinate the research projects that will be conducted within the respective programs. Those collaborative projects will produce solutions to industry challenges that are fundamental to unlocking the tremendous potential of regenerative medicine in Australia and elsewhere.

The impacts of the solutions will be amplified by the SMART CRC’s Future workforce program that will fill the skills shortage and train the next generation of personnel across the regenerative medicine ecosystem.

The illustration below reflects the proposed research programs.

 

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Research Program 1: Biomanufacturing

The biomanufacturing program will address sector-wide regenerative therapy manufacturing challenges to develop a cost-efficient pipeline to bring new therapies to market for the benefit of Australian communities.

The program encompasses cell and cell-based therapies and will address wide-ranging industry bottlenecks in process development, bioprocess manufacturing, cryopreservation and scale-up of regenerative therapies, diagnostics, and quality assays and metrics.

Indicative outcomes include:

  • Access to high-value cells, tissues and banks from screened donors

  • Customised process development for cell-based therapies at scale to support commercial manufacturing

  • Detailed quality management systems to facilitate regulatory acceptance

  • Mechanism of action studies that underpin clinical efficacy and end use applications

  • Potency and identity assays to ensure batch and product consistency

  • Safety and efficacy testing to accelerate clinical translation

 

Research Program 2: Bioseparation

This program will develop and optimise bioseparation technologies and platforms which overcome specificity, throughput and quality challenges.

This program spans separatory activities related to cells, tissues, tissue products, fluids, biologics and small molecules.

Indicative outcomes include: 

  • Novel surfaces and processes that increase target specificity

  • Purification of regenerative compounds from bodily fluids, cells and tissues

  • Separation at scale for enhanced downstream manufacturing

  • Well-defined parameters for manufacturing consistency

  • Pathways to commercialising purified products

 

Research Program 3: Biomaterials

This program will tackle the increasing consumer need for personalised devices which are safe, effective and cost- efficient.

This program includes 3D printed metal and composite devices, degradable scaffolds, surfaces and coatings, tissue engineered products, platforms and processes.

Indicative outcomes include:

  • Cost-effective manufacturing of personalised 3D printed devices

  • Biocompatible and biodegradable materials for high-value applications

  • Improved safety, toxicity and efficacy of implantable devices for commercial readiness

  • Identification and analysis of interactions between materials and body tissues

 

Research Program 4: Clinical enablement

As the regenerative therapies sector grows, pathways for clinical enablement need to be developed, optimised and implemented.

To address this growing sector need, this program will focus on streamlining access to pre-clinical models, establishing quality metrics and analyses that reflect mechanism of action, and the design of clinical trials and their coordination.

Indicative outcomes include:

  • Improved in vitro and ex vivo preclinical models to accelerate clinical impact

  • Pathways to translate therapies into clinical products

  • Use of biomarkers for clinical decision making and the establishment of quality assays

  • Improved clinical trial design, optimisation, enrolment and data analysis

  • Alignment with regulatory requirements to accelerate translation

 

Future Workforce training program

Regenerative therapies is a highly specialised field using cutting-edge technology with increasing demands for a highly-skilled workforce across the entire value chain. The SMART CRC will deliver an education and training program to facilitate skills development.

The SMART CRC Future workforce training program will be multi-faceted and strategic, developing:

Technical (manufacturing) expertise

  • Online and hands-on training for skills needed in process development and GMP manufacturing

Specialist (commercialisation) expertise

  • Training in the unique translation and commercialisation expertise required for developing regenerative therapies

  • Business of Regenerative Medicine Symposia

Industry-aligned PhD program

  • Recruitment and oversight of a significant number of Higher Degree by Research (HDR) candidates

  • Placement of students and PhD candidates into industry settings to offer an unmatched professional development experience, and

  • Incorporation of skills development into higher education courses.

 

Technology Transfer

SMART CRC will strongly focus on ensuring research outcomes are transferred through the many phases needed to reach health professionals. This will include:

  • Business, regulatory and IP services with commercialisation and technology expertise.

  • Technology evaluation and development, supporting company conception and launch, and

  • Market assessments and diligence, financing, investor engagement and portfolio management.