FAQs

How is the fee structure, determined for client projects and variations?
The MMIC operates on a time engagement model with fees calculated based on the scope of work designed in consultation with our clients and understanding of activities and timelines.

Does MMIC have a simple, easy contract ready for immediate client use?
The MMIC uses a standard proforma template for our research services agreement (RSA) prepared by Monash University that outlines the research services and key deliverables and milestones. Significant amendments to standard terms and conditions can be considered but may impact timelines.

How are agreed out-of-scope and project changes addressed?
The MMIC understands that the scope of work can change based on evolving results and priorities. In working closely with our clients, project changes can be accommodated through contract variations to the research services agreement.

What are the IP ownership arrangements in working on MMIC projects?
As part of our engagement with industry, any developed IP from our engagement is transferred to the client subject to full payment of fees for the research services.

What is the depth and breadth of experience of the technical team?
The MMIC has a dedicated team of technical leads in formulation, analytical chemistry, biologics, chemistry and respiratory delivery who all have extensive experience working on industry-based projects. Please visit our ‘About Us’ page to learn more about them.

What is their experience in facilitating technology transfer?
The MMIC can work closely with clients and their research and manufacturing partners as part of the technical transfer process, including troubleshooting and consultancy. For local clients, our team can come onsite with manufacturers to support the transfer process.

Can MMIC facilitate introductions to CRO’s, GMP Manufacturers, Regulatory Affairs, IP & Financial Consultants?
With a strong focus on supporting the pharmaceutical sector with innovative ideas and solutions, we can also introduce clients to our network of GMP manufacturers, regulatory affairs, IP and affiliated services that can complement and further your development program.

Does the MMIC team have commitments that are outside their client-based projects?
As an industry-focused research facility within the Monash Institute of Pharmaceutical Sciences, our team are fully dedicated to working with our industry clients and are not tied to traditional academic metrics, e.g. publications

Does MMIC have a track record of successfully working with both Australian and international clients?
The MMIC works with a range of Australian and international clients. Please refer to our 'Success Stories’ page for some examples of how we have supported our clients.

Is the MMIC a GMP facility?
The MMIC is not a GMP facility. However, in undertaking our preclinical services, we consider GMP requirements, especially in relation to method transfer to manufacturers.

What systems and processes are in place to ensure research work is conducted to appropriate quality standards?
The MMIC operates under the ISO9001 quality management system but is not a GMP facility. This provides opportunities for the MMIC to ‘sandbox’ and optimise formulations, processes and assays prior to technical transfer to client facilities.

What type of equipment, research infrastructure, and specialist expertise does the MMIC have access to?
As part of the engagement with the MMIC, our clients have access to the advanced equipment and capabilities within the Monash Institute of Pharmaceutical Sciences and Monash University, which are part of our advanced preclinical services. This includes advanced capabilities through the Monash Research Platforms and commercial access arrangements through the Australian Synchrotron.

Is MMIC able to work with cytotoxic and related oncology products?
The MMIC can undertake preclinical development activities with cytotoxic compounds using established facilities and procedures. Please connect with us to discuss options.

What are the areas and type of compounds where MMIC has the most expertise?
The MMIC works with a range of drug molecules, from small molecules to emerging biologic therapeutics to develop new formulations for parenteral, oral, topical and respiratory administration. Please refer to 'Our Services' page for more information.

How does the MMIC approach developing new formulations?
The MMIC understands the need to develop stable and safe formulation prototypes that are clinically and commercially viable. With this focus, we develop formulations using pharmaceutically accepted excipients relevant to the administration route and development stage.