+ All Categories
Home > Documents > NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements

NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements

Date post: 12-Feb-2016
Category:
Upload: elden
View: 38 times
Download: 0 times
Share this document with a friend
Description:
NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements. Donna L. Bialozor Technology Transfer Branch Office of the Director National Cancer Institute. NCI Technology Transfer Branch. - PowerPoint PPT Presentation
of 22 /22
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development NCI Technology Transfer Branch: RAID, Intellectual Property, and Technology Transfer Agreements Donna L. Bialozor Technology Transfer Branch Office of the Director National Cancer Institute
Transcript
Page 1: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 2: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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?

Page 3: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 4: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 5: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

Working with FDA: Biological Products and Clinical Development Donna Bialozor

Transactional Agreements

RAID Material Transfer Agreements

Confidential Disclosure Agreements

NCI Technology Transfer Branch

Page 6: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 7: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 8: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 9: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

Working with FDA: Biological Products and Clinical Development Donna Bialozor

Intellectual Property Report Form

Brings Attention to Unique Circumstances

NCI Technology Transfer Branch

Page 10: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 11: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 12: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 13: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 14: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 15: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 16: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 17: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 18: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 19: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 20: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 21: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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

Page 22: NCI Technology Transfer Branch: RAID, Intellectual Property, and  Technology Transfer Agreements

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


Recommended