1. 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

2. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor NCI Technology Transfer Branch How does NCI Technology Transfer Branch support the NCI RAID Program?

3. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

4. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor NCI Technology Branch Support to RAID Focusing on Negotiation of transactional agreements between the NCI and outside parties NCI Technology Transfer Branch

5. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Transactional Agreements  RAID Material Transfer Agreements  Confidential Disclosure Agreements NCI Technology Transfer Branch

6. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

7. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Why is this form important to both the University and the NCI? NCI Technology Transfer Branch

8. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Gives an idea about Freedom to Operate NCI Technology Transfer Branch

9. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Brings Attention to Unique Circumstances NCI Technology Transfer Branch

10. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Means of communication between: RAID PI and University Technology Transfer Office NCI Technology Transfer Branch

11. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Means of communication between: University Technology Transfer Office and NCI Technology Transfer Branch NCI Technology Transfer Branch

12. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Intellectual Property Report Form Means of communication about: Third Party Agreements connected with the RAID Project NCI Technology Transfer Branch

13. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

14. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor RAID Material Transfer Agreement  Incoming (NCI Recipient) Articles 7 & 8 –NCI Contractor and Subcontractor Involvement –Management of New Inventions NCI Technology Transfer Branch

15. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

16. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor RAID Material Transfer Agreements  Outgoing (NCI Provider of Research grade Materials) Article 3 – Acknowledgement of NCI RAID Support. NCI Technology Transfer Branch

17. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

18. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

19. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

20. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

21. Working with FDA: Biological Products and Clinical DevelopmentDonna 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

22. Working with FDA: Biological Products and Clinical DevelopmentDonna Bialozor Web Address: http://ttb.nci.nih.gov/ Main Office: Technology Transfer Branch National Cancer Institute 6120 Executive Blvd. Suite 450 Rockville, MD 20852 Phone: 301-496-0477 Frederick Office: Technology Transfer Branch NCI-Frederick 1003 West 7 th Street, Suite 500 Frederick, MD 21701 Phone: 301-846-5465 Contact Information NCI Technology Transfer Branch