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title	MIlestone

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UCI Malaria Initiative

Decision point

PI:

James

Milestone

Project Start date

4/1/17

4/1/18

Specific Aim

Activity

Milestone or Decision Point

Group

Year

1 Year

2 6/30/17

9/30/17

12/15/17

3/30/18

6/30/18

9/30/18

12/15/18

3/30/19

Objective 1: Project Administration

1. Recruit Project Personnel

1. Write Job Description/announcements

1.1.1

UCI

1.1.1a

2. Advertise positions

1.1.2

UCI

1.1.2a

3. Interview Candidates

1.1.3

UCI

1.1.3a

4. Fill positions

1.1.4

UCI

1.1.4a

2. Develop comprehensive Project Plan

1. Develop draft project plan

1.2.1

UCI

1.2.1a

3. Develop decision-making protocol

1. Develop decision making protocol

1.3.1

UCI

1.3.1a

4. Develop commications strategy

1. Reactive plan

1.4.1

All

1.4.1a

2. Proactive plan

All

1.4.2a

5. Develop central web portal

1. Develop central website

1.5.1

UCI

1.5.1a

1.5.1b

2. Update website

1.5.2

UCI

1.5.2a

1.5.2b

1.5.2c

6. Develop regulatory plan

1. Implement procedures for tracking research-related regulatory requirements (IBC, IACUC, CDC, USDA, others)

1.6.1

All

1.6.1a

1.6.1b

1.6.1c

1.6.1d

2.Review and develop knowledge base for regulatory requirements for potential field sites

1.6.2

UCI, UCD

1.6.2a

1.6.2b

1.6.2c

1.6.2d

3. Work with field team to obtain necessary permits

1,6.3

UCI, UCD

1.6.3a

1.6.3b

1.6.3c

1.6.3d

7. Annual meeting of project participants

1. Host annual meeting

1.7.1

UCI

1.7.1a

1.7.1b

Objective 2: Develop and test Anopheles gambiae strains carrying autonomous gene-drive systems linked to anti-pathogen effector genes.

1. Recruit Project Personnel

1. Write Job Description/announcements

2.1.1

UCI, UCSD

2.1.1a

2. Advertise positions

2.1.2

UCI, UCSD

2.1.2a

3. Interview Candidates

2.1.3

UCI, UCSD

2.1.3a

4. Fill positions

2.1.4

UCI, UCSD

2.1.4a

2. Develop CRISPR/Cas9 gene-drive systems for Anopheles gambiae

1. Identify and clone appropriate promoter sequences (for example, β2-tubulin, U6, vitellogenin, carboxypeptidase, G12) for expressing CRISPR/Cas9 gene-drive system components

2.2.1

UCI, UCSD

2.2.1a

2. Identify An. gambiae fitness-neutral mosquito chromosomal loci, chromosomal loci conferring decreased mosquito fitness, and chromosomal loci that affect parasite propagation in the vector

2.2.2

UCI, UCSD

2.2.2a

3. Design and synthesize gene-drive constructs, and verify sequence

2.2.3

UCI, UCSD

2.2.3a

2.2.3b

2.2.3c

3. Engineer additional anti-parasite effector genes

1. Develop additional single-chain (scFv) immunological reagents to inactivate P. falciparum (Pfs47 with Barrillas-Mury, NIH; Pfs230 with Narum, NIH; Ashley Birkett, PATH)

2.3.1

UCI, UCSD

2.3.1a

2.3.1b

2.3.1c

2. Develop alternative effector molecules based on engineered synthetic receptors (SM1)

2.3.2

UCI, UCSD

2.3.2a

2.3.2b

2.3.2c

3. Make An. gambiae transgenic lines to test additional effector genes using transposon-mediated transgenesis

2.3.3

UCI, UCSD

2.3.3a

2.3.3b

2.3.3c

4. Perform challenge assays with P. falciparum to determine efficacy of novel effector constructs

2.3.4

UCI, UCSD

2.3.4a

2.3.4b

2.3.4c

4. Generate transgenic mosquitoes carrying gene-drive elements and the parasite-resistance genes

1. Perform microinjection experiments, screen resulting insects, and validate integrated DNA to generate gene-drive lines with linked anti-parasite effector genes

2.4.1

UCI, UCSD

2.4.1a

2.4.1b

2.4.1c

5. Develop and maintain detailed laboratory standard operating procedures (SOPs)

1. Develop and maintain detailed laboratory standard operating procedures (SOPs)

2.5.1

UCI, UCSD

2.5.1a

2.5.1b

2.5.1c

6. Test the performance characteristics of the strains (drive- and parasite-challenge assays)

1. Conduct parasite challenge assays on transgenic An. gambiae lines

2.6.1

UCI, UCSD

2.6.1a

2.6.1b

2.6.1c

2. Conduct in-depth mathematical modeling studies regarding the predicted behavior of gene-drive systems in different environmental scenarios and then test these predictions in the laboratory

2.6.2

UCB, UCI, UCSD

2.6.2a

2.6.2b

2.6.2.c

3. Final recommendation for release strain(s)

2.6.3

All

2.7.1a

Objective 3: Evaluate field site(s) for population alteration trials

1. Recruit Project Personnel

1. Write Job Description/announcements

3.1.1

UCD, UCB, UCLA

3.1.1a

2. Advertise positions

3.1.2

UCD

3.1.2a

3. Interview Candidates

3.1.3

UCD

3.1.3a

4. Fill positions.

3.1.4

UCD

3.1.4a

2. Evaluation of Potential Field Sites for Selection of Four Candidate Sites

1. Literature survey for the evaluation of 13 potential GEM field trial sites

3.2.1

UCD

3.2.1a

2. Analysis of remotely sensing data for 13 potential field sites.

3.2.2

UCD, UCLA

3.2.2a

3. Select, based on set criteria, four candidate sites.

3.2.3

UCD, UCB, UCLA

3.2.3a

3. Evaluation of Candidate Field Sites for Selecting Final Field Trial Site

1. Prepare site visits to four candidate field sites and nearest mainland.

3.3.1

UCD, UCB, UCLA

3.3.1a

3.3.1b

3.3.1c

2. Visit villages on each candidate site and nearest mainland to collect Anopheles specimens.

3.3.2

UCD

3.3.2a

3.3.2b

3.3.2c

3.3.2d

3. Analysis of genotype data to assess entomological parameters

3.3.4

UCD

3.3.4a

3.3.4b

3.3.4c

4. Analysis of insecticide resistance

3.3.5

UCD

3.3.5a

3.3.5b

3.3.5c

6. Analysis of genome data to assess degree of genetic isolation of sites

3.3.6

UCD

3.3.6a

3.3.6b

3.3.6c

7. Model evaluation of candidate field sites

3.3.7

UCB

3.3.7a

3.3.7b

3.3.7c

4. Assess “Colonizability” of An. gambiae from Candidate Field Sites

1. Establish mosquito rearing protocols & insectary at UC Davis

3.4.1

UCD

3.4.1a

3.4.1b

3.4.1c

2. Assess ease of colonization for An. gambiae for each site

3.4.2

UCD

3.4.2a

3.4.2b

3.4.2c

5. Select Field Trial Site

1. Prepare a written evaluation of each of the four candidate sites.

3.5.1

UCD, UCB, UCLA

3.5.1a

2. Make final decision on the project field site(s)

3.5.2

All

3.5.2a

Legend:

UCB: University of California - Berkeley

UCLA: University of California - Los Angeles

UCD: University of California, Davis

UCSD: University of California - San Diego

UCI: University of California, Irvine

Version	Old Version 14	New Version 15
Changes made by	Sentelle Eubanks	Sentelle Eubanks
Saved on	May 18, 2017	Jun 21, 2017

Versions Compared

Key

UCI Malaria Initiative

Milestone or Decision Point

Group

Year

1

Year

2

6/30/17

9/30/17

12/15/17

3/30/18

6/30/18

9/30/18

12/15/18

3/30/19

Objective 1: Project Administration

Objective 2: Develop and test Anopheles gambiae strains carrying autonomous gene-drive systems linked to anti-pathogen effector genes.

Objective 3: Evaluate field site(s) for population alteration trials