Fda/Cber Cooperative Research & Development Agreement

FEDERAL TECHNOLOGY TRANSFER ACT
FDA/CBER COOPERATIVE RESEARCH & DEVELOPMENT AGREEMENT


1. SUMMARY OF PROPOSED AGREEMENT WITH NEOPHARM, INC.


Laboratory: Center for Biologics Evaluation and Research Project
Title: Development and Commercialization of
Interleukin-13 Pseudomonas Exotoxin as anticancer
agent Project Description: SEE TAB 1 - RESEARCH PLAN
FDA Project Officer: RAJ K. PURI, M.D., PH.D.


Proposed Effective Dates From: August1997 To: August 2001


RESOURCE SUMMARY: $ ESTIMATED # ESTIMATED ESTIMATED
DESIGNATED FTES EQUIPMENT MATERIALS

FDA 0 0.05 ($45,000/yr)
Collaborator $100,000/yr 0.10
Total $400,000 0.15 ($180,000)


2. REVIEWS BY FDA ORGANIZATIONS - TAB 2


A. Possible Organizational Conflict -- Revisions Requested: None


B. Comments on Individual Conflict of Interest: DEPI AND CBER -
SEE TAB 3


3. CENTER ACTION IN RESPONSE TO REVIEWS


[ ] Summary of Comments
[X] No Revisions Made To Agreement


4. FDA REVIEW BOARD RECOMMENDATION TO THE COMMISSIONER


[X] Accept [ ] Disapprove [ ] Modify (Explanation Attached)


/s/ ELIZABETH D. JACOBSON 8/6/97
Review Board Chairperson Date


5. LEAD DEPUTY COMMISSIONER'S DECISION


[ ] Accepted [ ] Disapproved [ ] Modification(s) (Explanation
Attached)


/s/ Masira 8/12/97 Lead Deputy Commissioner of Food and Drugs Date



[LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE


FOOD AND DRUG ADMINISTRATION
ROCKVILLE MD 20857


[STAMPED AUG 6 1997]


NOTE TO: Lead Deputy Commissioner


THROUGH: Executive Secretariat on 8/7/97


SUBJECT: Proposed Cooperative Research and Development
Agreements under the Federal Technology Transfer
Act of 1986 -- ACTION


During its August 4, 1997 meeting, the FDA CRADA Review Board
considered one proposed Cooperative Research and Development Agreement
(CRADA). The proposed collaboration is between


CBER and Neopharm, Inc. to "Develop and Commercialize
Interleukin-13 Pseudomonas Exotoxin as Anticancer
Agent."


The CRADA proposal has been reviewed by other FDA Centers for
organizational conflict of interest; by the Division of Ethics and
Program Integrity for any individual and organizational conflict of
interest, and by other offices for any issues which might need
resolution. The reviews were favorable and all issues that were raised
have been addressed.


The Board then conducted its review and recommends your acceptance of
this CRADA. An Executive Summary is attached. Please indicate your
decision and sign the Summary. Under the Federal Technology Transfer
Act, Agencies are required to make their decision within 30 calendar
days or, in this case, by September 4, 1997.


Please let me know if I can provide anything further on this.


/s/ ELIZABETH D. JACOBSON


Elizabeth D. Jacobson, Ph.D.
Chairperson,
FDA CRADA Review Board


Attachment
Executive Summary and FDA CRADA 26-97


APPENDIX B


RESEARCH PLAN


TITLE OF CRADA: Interleukin-13>Pseudomonas exotoxin as a anticancer agent.


FDA PRINCIPAL INVESTIGATOR: Raj K. Puri, M.D., Ph. D.


COLLABORATOR PRINCIPAL INVESTIGATOR: Aquilur Rahman, Ph.D., Chief Scientific Officer, NeoPharm, Inc. Lakeforest, IL


TERM OF CRADA: Four (4) years.


CONFLICTS OF INTEREST INFORMATION: Attach completed "Conflict of Interest and Fair Access Statement." Describe any relevant past, present, or contemplated relationships between the FDA Principal Investigator and his/her Laboratory and the Collaborator in sufficient detail to permit reviewers of this CRADA to determine whether or not any conflicts of interest exist:


See Attached


The Research Plan which follows this page should be concise but of sufficient detail to permit reviewers of this CRADA to evaluate the scientific merit of the proposed collaboration. The RP should explain the scientific importance of the collaboration and the research goals of FDA and the Collaborator. The respective contributions in terms of expertise and/or research materials of FDA and, the Collaborator should be summarized Initial and subsequent projects contemplated under the RP, and the time periods estimated for their completion, should be described, and pertinent methodological considerations summarized. Pert ...