U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTH
Working with FDA:Biological Products and Clinical Development
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESNATIONAL INSTITUTES OF HEALTH
Working with FDA:Biological Products and Clinical Development
NCI Technology Transfer Branch:RAID, Intellectual Property, and Technology Transfer Agreements
Donna L. BialozorTechnology Transfer BranchOffice of the DirectorNational Cancer Institute
Working with FDA: Biological Products and Clinical Development Donna Bialozor
NCI Technology Transfer Branch
How does NCI Technology Transfer Branch support the NCI RAID Program?
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Support the National Cancer Institute's technology development activities
To ensure technology development activities comport with Federal statutes, regulations and the policies of the National Institutes of Health.
Negotiation of transactional agreements between the NCI and outside parties
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
NCI Technology Branch Support to RAID
Focusing on Negotiation of transactional agreements between the NCI and outside parties
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Transactional Agreements
RAID Material Transfer Agreements
Confidential Disclosure Agreements
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
NCI Technology Branch Support to RAID
How information in the Intellectual Property Report Form relates to negotiation of Transactional Agreements
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Why is this form important to both the University and the NCI?
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Gives an idea about Freedom to Operate
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Brings Attention to Unique Circumstances
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Means of communication between:
RAID PI and University Technology Transfer Office
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Means of communication between:
University Technology Transfer Office and NCI Technology Transfer Branch
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Intellectual Property Report Form
Means of communication about:
Third Party Agreements connected with the RAID Project
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Incoming (NCI Recipient)
Outgoing (NCI Provider of research grade materials)
Outgoing with Clinical Addendum (NCI Provider of clinical product for human clinical studies)
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreement Incoming (NCI Recipient)
• Articles 7 & 8
– NCI Contractor and Subcontractor Involvement
– Management of New Inventions
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing (NCI Provider of Research
grade Materials)
• Article 1 - permits sharing of Materials and data with a third party in compliance with terms of NCI RAID MTA.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing (NCI Provider of Research
grade Materials)
• Article 3 – Acknowledgement of NCI RAID Support.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing (NCI Provider of Research
grade Materials)
• Article 8 – Sharing of results and publications with NCI prior to disclosure.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing with Clinical Addendum
• NCI Cancer Therapy Evaluation Program, Regulatory Affairs, involved in negotiation of Clinical Product MTA.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing with Clinical Addendum
• Article 11 c – Copy of FDA letter that IND has been filed must be sent to NCI prior to shipment of Clinical Material.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
RAID Material Transfer Agreements Outgoing with Clinical Addendum
• Article 12 – Agree to provide NCI with copy of Annual Reports to FDA.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Confidential Disclosure Agreements Most commonly entered into when the
University partners with a commercial entity during conduct of the RAID Project.
NCI Technology Transfer Branch
Working with FDA: Biological Products and Clinical Development Donna Bialozor
Web Address: http://ttb.nci.nih.gov/
Main Office:
Technology Transfer BranchNational Cancer Institute6120 Executive Blvd. Suite 450Rockville, MD 20852Phone: 301-496-0477
Frederick Office:
Technology Transfer BranchNCI-Frederick1003 West 7th Street, Suite 500 Frederick, MD 21701Phone: 301-846-5465
Contact Information
NCI Technology Transfer Branch