Date of Proposal s1

/ Investigator Sponsored Trials
Concept Proposal Form

INSTRUCTIONS:

Please complete the form being as thorough as possible. Provide a full and concise description of your proposed work, including any key references to previous relevant work or methods. The trial details described in this form will be appended to the study agreement and define the scope and limits of the project agreed to. Please contact with any questions

DATE OF PROPOSAL

STUDY TITLE

PRINCIPAL INVESTIGATOR

Name:
Institution / Organization:
Address:
Phone:
Fax:
Email:
Have you worked with Halozyme previously? If so, please explain.

OTHER CONTACTS

Legal or Contracts Name: Coordinator
Phone:
Email:
Study Name:
Coordinator
Phone:
Email:
Remittance Name:
Address
Address:
Tax ID Number:

STUDY SITE INFORMATION

Description
(Please check all that apply) / Single-Center
Multi-Center
Number of sites:
Names of identified sites (list):
Cooperative Group
Research Network
Other (please specify)
Willingness to Collaborate with Other Institutions / Yes
No
Competing Studies at Your Institution / Yes
No
If yes, please describe:
If Yes, When Will These Complete
SUPPORT REQUESTED (Check all that apply)
Please provide a basic study budget in a COST PER PATIENT format (see BUDGET PROPOSAL section below). Concepts WILL NOT be reviewed by IST Review Committee without a proposed budget. / Study Drug
Funding
(If YES, please provide detailed study budget below)
Other: (attach description)
Will funding or study drug be provided from other sources?
NO YES
(If YES, please provide detailed study budget below)

STUDY DESIGN INFORMATION

Background / Rationale: <Type Here>
Objectives:
Primary
Secondary
Design:
Key Inclusion / Exclusion Criteria: / 1.
2.
3.
4.
Treatment Regimen:
Planned Total Accrual:
Estimated Accrual / Mo:
Describe Accrual in Similar Clinical Study
Statistical Plan:

Publication Plan:

Do you plan to submit an Investigational New Drug (IND) application?

/ Yes
No – If no, provide a detailed rationale. For reference, refer to regulations in 21 CFR 312.2(b)(1)(i-v), which outlines the five criteria for exemption of studies from IND regulations.

Study Succession Plan:

(i.e. with desired results, our plan would be…) /

Additional Comments:

/

TRANSLATIONAL MEDICINE EFFORTS

Prospective patient selection / Yes
No
Selection biomarker(s)
Rationale
Other biomarkers (specify biomarkers, analysis methods & time points)
Tumor sample(s)
Whole Blood (Pharmacogenetics)
Plasma
Serum
PBMC
Surrogate Tissue (specify which tissue)
Other (specify)
Biomarker Rationale
Where will samples be analyzed?
If internal lab please provide description of relevant equipment (including storage) and personnel
Willing to share samples with Halozyme for research collaboration / Yes (please note all associated costs will be covered by Halozyme)
No
If “Yes” please specify sample type and sample volume provided
Flexibility & interest in inclusion of additional time points and/or other sample types for research collaboration / Yes
No
STUDY TIMELINES (proposed milestone dates)
Study Activation:
Last Patient In:
Initial Data (Abstract):
Final Data (Manuscript):
BUDGET PROPOSAL (if applicable)
Study Costs / Per Patient / Total
Physician costs
Study coordinator costs
Regulatory submissions
Data costs
Report Writing
Procedure costs
Biopsies
Blood draws
Correlative studies (list)
Institutional overhead (%)
Start Up Costs
IRB fees
Other fees (list)
Total

Any approvals, consents or oral agreements by Halozyme have no legal or other binding effect unless and until a separate written legal agreement is executed by the parties covering the study. Notwithstanding any such agreement, Halozyme reserves the right to terminate any support or involvement in the study at any time whatsoever, subject to its sole discretion.

Please attach an electronic copy of the Principal Investigator’s CV

IST Concept Proposal Form 1 Version 16Nov16