Partnering
Partnering & Licensing
HOME
>
Partnering
>
To carry our new drug candidates into their next stage and into practice, we work with pharmaceutical and biotechnology companies and research institutions in Japan and abroad through joint research, co-development and licensing.
Depending on the asset, the stage of development, the therapeutic area and the territory and scope of rights, we can discuss joint research, co-development, licensing, CMC and access to research materials.
Contents
01
Our approach to partnering
03
From first enquiry to agreement
02
Forms of collaboration
04
FAQ
Contents
01
Our approach to partnering
02
Forms of collaboration
03
From first enquiry to agreement
04
FAQ
Partnering Strategy
Working from a complex-systems approach to drug discovery, Advalife Science has built a structure that connects the discovery and study of new drug candidates with intellectual property, manufacturing and CMC, non-clinical work, and clinical trials and development.
By combining a partner’s development strategy and expertise with our own research and development base, we aim to maximise the value of an asset and move it to its next stage.
The form of the partnership, the therapeutic area, the territory, the scope of rights and the division of development work are agreed case by case. Before a confidentiality agreement is in place we share information within the scope of non-confidential information; once mutual interest and fit have been confirmed, we move to detailed discussion.
Types of Collaboration
01
Joint research
On themes such as new drug candidates, mechanisms of action and non-clinical evaluation, we agree the research plan, the division of roles and the handling of results and intellectual property before starting. We also work with universities and research institutions.
02
Licensing
Licences to the assets, technologies and intellectual property we hold and manage can be discussed by indication, territory, exclusivity, scope of rights and division of development work.
03
Co-development and CMC
Depending on the programme, co-development covering manufacturing and CMC, process development and formulation development can be discussed.
04
Access to research materials
For joint research and scientific validation, access to research materials for research use only can be discussed. Supply of research materials is handled by Medbis Co., Ltd.
Process
From initial exchange of information through a confidentiality agreement, detailed evaluation and negotiation to the final agreement, we proceed step by step as the discussion develops.
STEP 01
Initial Inquiry
Tell us the programme, therapeutic area and form of partnership you have in mind. We provide initial information within the scope of non-confidential information.
STEP 02
Initial Discussion
We confirm the asset, the indication, the stage of development, the territory and scope of rights envisaged and the purpose of the partnership, and consider mutual interest and strategic fit.
STEP 03
Confidentiality agreement (NDA / CDA)
Before detailed information is disclosed, we agree the purpose of disclosure, the scope of confidential information and the terms on which it is handled.
STEP 04
Detailed evaluation and due diligence
Non-clinical and clinical data, CMC, intellectual property and development plans are evaluated in detail, through a data room where appropriate.
STEP 05
Negotiation and agreement
Territory, indication, scope of rights, division of development work, intellectual property and economic terms are negotiated, moving through a term sheet to a final agreement.
FAQ
Q
Can we talk before a confidentiality agreement is signed?
A
Yes. We can exchange initial information about a programme and the scope for partnership within the bounds of non-confidential information. Detailed technical information and data follow once an NDA or CDA is in place.
Q
At what stage can a partnership be discussed?
A
From discovery and basic research through non-clinical work, CMC and clinical development, depending on the programme. The form of partnership — joint research, co-development, licensing — is likewise considered case by case.
Q
Do you work with universities and research institutions?
A
Yes. We welcome joint research and academic collaboration with universities and research institutions in Japan and abroad, on basic research, validation of mechanisms of action and translational research.
Q
Do you partner with organisations outside Japan?
A
Yes. Joint research, co-development and licensing with pharmaceutical and biotechnology companies and with universities and research institutions abroad are all open for discussion. Territory and scope of rights are agreed case by case.
PARTNERING
Discuss a partnership
We welcome enquiries about our assets, joint research, co-development and licensing.