Presented by Wells Messersmith, MD, FACP Professor University of Colorado Cancer Center - reviewing grant proposals on colorectal cancer as a "patient advocate".

1. Grant Review
Research Advocacy Training and Support Program
Our webinar will begin shortly.
WELCOME!

2. • Speaker(s): Wells Messersmith, MD, FACP
• AFTER THE WEBINAR: Expect an email with links to the material &
a survey. If you fill it out, we’ll send you a Blue Star pin.
• Ask a question in the panel on the RIGHT SIDE of your screen
• Follow along via Twitter – use the hashtag #CRCWebinar
Today’s Webinar:

3. What is a RESEARCH ADVOCATE?
A research advocate brings the patient viewpoint to the
research process and communicates a collective patient
perspective.
Fight CRC’s Research Advocacy Training and
Support (RATS) Program:
Goal: to improve the ability of research advocates to
effectively participate in the research process.
This is done by hosting person meetings, online
trainings, and webinars, in addition to ongoing support.
Brought to you by
RATS:

4. Resources:

5. Disclaimer
:
The information and services provided by Fight Colorectal Cancer are for
general informational purposes only. The information and services are
not intended to be substitutes for professional medical advice, diagnoses
or treatment.
If you are ill, or suspect that you are ill, see a doctor immediately. In an
emergency, call 911 or go to the nearest emergency room.
Fight Colorectal Cancer never recommends or endorses any specific
physicians, products or treatments for any condition.

6. Assessing Grant
Proposals
Wells Messersmith, MD, FACP
Professor
Director, Gastrointestinal Medical Oncology Program
Co-Leader, Developmental Therapeutics
University of Colorado Cancer Center
November 2016

7. Abbreviations and other jargon
AACR = Amer Assoc Cancer Research
ASCO = Amer Society of Clinical Oncology
Biosketch = brief academic summary
DOD = Department of Defense
NCI = National Cancer Institute
PI= principle investigator (leader of grant)
RFP = request for proposal
SRO = Scientific Review Officer

8. Scenario #1:
Soon after participating in a patient advocacy
training program, you are invited to review
grant proposals on colorectal cancer as a
“patient advocate”.

9. Your initial reaction to this invitation is:
a) yes, I am comfortable with grant proposals
and look forward to the discussion
b) maybe, I took a few science classes in high
school and I can wing it
c) No, I am not a grant reviewer, and this
work should be done by scientists only

10. The first step in reviewing grant
proposals is:
a) Read the RFP (request for proposals)
b) Look at the background of the principle
investigator
c) Google the institution where the grant
proposal is coming from
d) Have a glass of good wine and find your
reading glasses

12. The National Cancer Institute (NCI)
Exploratory/Developmental Grant (R21) funding
opportunity supports the development of new research
activities in all areas of cancer research. The R21 mechanism
is intended to encourage exploratory and developmental
research projects by providing support for the early and
conceptual stages of these projects.
These studies may involve considerable risk but may lead to
a breakthrough in a particular area, or to the development of
novel techniques, agents, methodologies, models, or
applications that could have a major impact on a field of
cancer research (biomedical, behavioral, or clinical).

14. Reviewer Instructions
You will provide criterion scores (1-9 range) for each of the following
criteria: significance, investigators, innovation, approach, and
environment. And you will provide preliminary overall impact score
(1-9 range).

15. Reviewer Instructions

16. Reviewer Instructions

17. Reviewer Instructions

18. Reviewer Instructions

19. Reviewer Instructions

20. Reviewer Instructions

21. Reviewer Procedures

22. Scenario #2:
You are serving as a patient advocate for a
grant review committee where the RFP states
the goal is to “encourage exploratory and
developmental research projects”. There is a
proposal to do a clinical trial substituting TAS-
102 (just approved) for capecitabine as
maintenance therapy for colorectal cancer.
Both drugs are oral forms of 5-FU.

23. 11 Drugs for Colorectal Cancer
“Cytotoxics” Mechanism
1. 5-Fluorouracil (5-FU) -> pyrimidine analog
2. capecitabine -> oral 5-FU pro-drug
3. TAS-102 -> 5-FU drug with metabolism inhibitor
4. irinotecan -> topoisomerase I inhibitor
5. oxaliplatin -> 3rd generation platinum
“Biologics/Targeted” Mechanism
1. cetuximab -> antibody against EGFR
2. panitumumab -> antibody against EGFR
3. bevacizumab -> antibody against VEGF
4. ziv-aflibercept -> dummy VEGF receptor
5. regorafenib -> tyrosine kinase inhibitor
6. ramucirumab -> antibody against VEGFR2
VEGF= Vascular Endothelial Growth Factor; EGFR= Epidermal Growth Factor Receptor

24. TAS102: Background
Combination of two agents:
- Trifluridine (FTD), a nucleoside analog activated by thymidine kinase
- Tipiracil hydrochloride (TPI), a thymidine phosphorylase inhibitor
RECOURSE trial
- global phase III trial conducted in 13 countries at 114 centres
- mCRC refractory to all standard therapies (including EGFR-
targeting mAb for KRAS WT patients)
- Randomized 2:1 to TAS-102 (534 patients), 35 mg/m2 BID on
Days 1- 5 and 8-12 of each 28-day cycle, or placebo (266
patients)
- The primary endpoint was overall survival.
Yoshino, ESMO 2014, #0022
which inhibits metabolism of
trifluridine; also has anti-
angiogenic properties via
PDGF inhibition.

25. TAS-102 RECOURSE: OS
Mayer, NEJM 2015
HR = 0.68, p<0.001

26. How well does this proposal fit the RFP?
a) Very well
b)
c)
d) Not well

27. Scenario #3:
You are serving as a patient advocate for a
grant review committee. What a small world!
The PI of the next grant to be reviewed is
married to your brother. You knew she was a
scientist but did not know she would be
applying beforehand. You are confident you
can act in an unbiased manner in reviewing
the grant.

28. You next best course of action is:
a) Speak glowingly of the proposal so you
brag at the next family gathering
b) Inform the review officer and recuse
yourself from review of this grant
c) Trash the proposal so your sister-in-law
learns some humility for once
d) Try not to say much, to avoid swaying the
review

29. Conflicts of Interest

30. Conflicts of Interest

31. Scenario #4:
A grant proposal is reviewed where the PI
proposes to study the direct effects of a drug
on tumor cells. The science is excellent and
the other reviewers, all PhD’s, speak highly of
the proposal. To replicate the results seen in
mice, study subjects will need to undergo
three successive tumor biopsies.

32. You next best course of action is:
a) Not say much, since the scientists all liked
the proposal
b) Send an email to the program officer after
the meeting, expressing your concerns
c) Point out that three tumor biopsies can be
difficult for colorectal cancer patients, and
thus limits your enthusiasm for this grant

33. Scenario #5:
You are reviewing proposals for a “career
development award” (CDA) grant mechanism.
There is one proposal where you love the idea,
but the PI does not seem especially strong.
There is another proposal where the PI seems
incredibly talented, but you are not sure about
the project.

34. For your evaluation of a “Career
Development Award,” you should:
a) Put more weight on the proposal
b) Put more weight on the PI
c) Weigh them equally

37. Questions?
GI & Phase I Team
My email: Wells.Messersmith@ucdenver.edu

38. Question & Answer:
SNAP A
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