Please return completed form to info@amrcentre.com or post to: The AMR Centre, BioHub, Mereside, Alderley Park, Macclesfield SK10 4TG
Do not include confidential information on this form. Please complete 1 form for each antibacterial product you are proposing.
Intro: 
An initial application through The AMR Centre must be completed for funding consideration. This Expression of Interest Form (EOI) will be reviewed for portfolio fit with The AMR Centre assignment. If within scope, the project will be assigned to The AMR Centre for scientific and business review. Review cycles differ between the CARB-X accelerators, but The AMR Centre has equal access to CARB-X funding, research support services, and business support services. 
Pre-Application Expression of Interest Form
A. About You (* required fields)
First Name* _______________________________________ 
Middle ___________________________________________ 
Last Name (or surname)* ___________________________ 
Address line #1_______________________________________________________ 
Address line #2________________________________________________________ 
City ______________________________ State/Province/Region ________________ 
Zip/Postal Code ______________ Country ______________ 
Phone Number ______________ 
Mobile Number ______________ 
Organisation _________________________________________________________ 
Organisation’s Website ______________ 
Select Organisation Type: 
•	Academic 
•	Research Institution 
•	Non-profit organization 
•	Small business 
•	Medium business
•	Large business 
•	Other, specify ________________________ 

Specify your organization/companies legal structure (e.g., LLC, Corporation, 501(c)(3)) or enter N/A if the legal entity has not been established 

1. Does your organization have an operating plan and existing funding to sustain operation for the next 12 months? 
•	Yes 
•	No 

2. Do you presently receive funding from any AMR Centre partner? 
•	BARDA 
•	Wellcome Trust 
•	NIAID 
•	No 

3.
a) How did you learn about The AMR Centre (Check all that apply) 
•	AMR Centre newsletter 
•	AMR Centre website 
•	BARDA via medicalcountermeasures.gov or www.phe.gov 
•	NIH/NIAID website 
•	Advocacy group 
•	A colleague 
•	Social Media 
•	Scientific conference: _____________ 
•	Scientific publication: _____________ 
•	Other, describe: ___________________
b) What best describes your interest in The AMR Centre (Check all that apply) 
•	For informational purposes only at this time
•	I wish to be reviewed for assignment to an Accelerator for possible funding or research support services
•	Other (please describe below)

 

B. Your Interest in The AMR Centre

4. What is the name of your antibacterial Product or Project? (e.g. AMRC-0001):________________________________

5. Which description best matches your product? 
a) Direct-acting therapeutic (has a measurable MIC against bacteria) 
•	Small molecule 
•	Large molecule 
•	Microbiome-based
b) Indirect therapeutic (or does not have a measurable MIC) 
•	Inhibits bacterial virulence factor(s) 
•	Augments host immune response 
•	Other, describe below 
c) Preventative 
•	Vaccine 
•	Passive protection via an antibody (monoclonal or polyclonal) 
•	Microbiome-based 
•	Other, describe below 
d) Diagnostic 
•	Device for identifying genus/species of infecting organism 
•	Device for predicting / determining susceptibility 
•	Other (please describe below in Question 8) 

e) Other devices: o (please describe below in Question 8) 

f) Other: o (please describe below in Question 8) 

6. Which best describes your areas of interest that you are seeking AMR Centre support for? (Check all that apply) 
•	MedChem development 
•	In vitro microbiology 
•	In vitro ADME/DMPK 
•	In vivo PK/PD and efficacy studies 
•	Pharmacology/toxicology testing 
•	Synthetic small molecule/non-biologics GMP/GLP manufacturing 
•	Biologic molecule pilot and GMP/GLP manufacturing 
•	Pre-Clinical IND studies
•	Device (e.g., diagnostic AST device) manufacturing or scale-up 
•	Regulatory affairs support/consultation (e.g. IND preparation)
•	Phase 1 Clinical trials
•	Phase 2a Clinical trials
•	Business support (mentoring, financial advice, fund-raising advice, etc.)
•	Pre-clinical development planning advice 
•	Clinical trial design assistance 
•	Reimbursement planning advice 

7. Which best describes your business and strategic interests that you are seeking AMR Centre support for? (Check all that apply) 
•	Business development/marketing support 
•	Financial advice (fund raising efforts, financial planning) 
•	Operational consultation (growth, strategy, prioritization, logistics) 
•	IP/FTO legal support 
•	Corporate legal support 
•	Bioinformatics support 
•	Bioengineering support 
•	Competitive intelligence advice 
•	HR consultation 
•	

Other (please describe below in 100 words or less):

8. Please describe your product in 500 words or less. Please do not include confidential information but do provide sufficient data to allow a knowledgeable scientist to get a reasonable sense of the product. Please do not provide other attachments, manuscripts or similar: The summary should be provided here. 

9. For indicative purposes only (you may update this subsequently), what is the likely funding request, duration of funding, and impact on the program? 

Funding request: Currency: ______ Amount: ___________ 

Start date: ___________ Stop Date: _____________ Duration (months): __________ 

Technology Readiness Level (TRL, see below): 

Current TRL: ____ Anticipated TRL at funding end: _____ 

Technology Readiness Levels. The AMR Centre only funds in the range TRL3 to TRL6. Select the TRL that most closely approximates the overall state of the project and the main body of ongoing work. For the drug/biologic TRLs that have subcategories, you may either state a general TRL or a specific sub-TRL as seems most appropriate to convey the current project state. 

TRLs for Drugs and Biologics 
TRL 3. Target/Candidate Identification and Characterization of Preliminary Candidates(s). Begin research, data collection, and analysis in order to test hypothesis. Explore alternative concepts, identify and evaluate critical technologies and components, and begin characterization of candidate(s). Preliminary efficacy demonstrated in vivo. 3A: Identify target and/or candidate. 3B: Demonstrate in vitro activity. 3C: Generate preliminary non-GLP in vivo proof-of-concept efficacy data. 

TRL 4. Candidate Optimization and Non-GLP In Vivo Demonstration of Activity and Efficacy. Initiation of animal model development. Non-GLP in vivo toxicity and efficacy demonstration in accordance with the product's intended use. Initiation of experiments to identify markers, correlates of protection (e.g., PK-PD), assays, and endpoints for further non-clinical and clinical studies. 4A: Demonstrate non-GLP in vivo activity and potential for efficacy consistent with the product's intended use (i.e. dose, schedule, duration, route of administration, and route of threat agent challenge) 4B: Conduct initial non-GLP toxicity studies and determine PK-PD and/or immune response in appropriate animal models (as applicable). 

TRL 5. Advanced Characterization of Candidate and Initiation of GMP Process Development. Continue non-GLP in vivo studies, and animal model and assay development. Develop a scalable and reproducible manufacturing process amenable to GMP. Animal Models: Continue development of animal models for efficacy and dose-ranging studies. Assays: Initiate development of in-process assays and analytical methods for product characterization and release, including assessments of potency, purity, identity, strength, sterility, and quality as appropriate. 5A: Demonstrate acceptable Absorption, Distribution, Metabolism, and Elimination characteristics and/or immune responses in non-GLP animal studies as necessary for IND filing. 

TRL 6. GMP Pilot Lot Production, GLP toxicology, IND Submission, and Phase 1 Clinical Trial(s): Manufacture GMP-compliant pilot lots. 6A: Conduct GLP non-clinical studies for toxicology, pharmacology, and immunogencity (as appropriate). 6B. Prepare and submit Investigational New Drug (IND) package to FDA. 6C: Phase 1 clinical trial(s) to determine the safety and pharmacokinetics of the clinical test article.
TRLs for Diagnostics and Devices 
TRL 3. Characterization of Preliminary Candidates(s) and Feasibility Demonstration: Begin R&D, data collection, and analysis in order to verify feasibility. Explore alternative concepts, identify and evaluate critical technologies and components, and begin characterizing specifications required. Demonstrate the performance of candidate diagnostic targets and high risk components. Develop a business case for the proposed product. 

TRL 4. Optimization and Preparation for Assay, Component, and Instrument Development. Prepare for test system development. Finalize diagnostic target(s) and methods for detecting or quantitating target(s). Develop detailed plans and finalize critical design requirements. Execute commercial agreements with key external development partners. Identify manufacturing resources, vendor sourcing, and experimental designs. 

TRL 5. Product Development: Reagents, components, subsystems and modules - Develop reagents and buffers. Build and test non-GLP prototypes of components and subsystems. Code and unit test software. Begin pilot scale manufacturing preparations. Develop protocols for assay and integration testing Initiate reagent stability testing. Hold pre-IDE meeting with FDA. 

TRL 6. System integration & testing: Integrate and test alpha and beta instruments/devices, software and assays, evaluating performance and updating specifications. Implement design improvements to address defects discovered during testing. Produce and evaluate pilot lots of reagents and beta (pilot) instruments. Increase the maturity of software. Prepare for clinical testing. Complete short term stability testing of reagents.

10. Does the product target any Gram-negative bacteria such as those on the Urgent and Serious lists of the CDC 2013 Threat List? 

Please note that The AMR Centre will initially have a very strong focus on Gram-negative therapeutics. During this startup period, products focused exclusively on diagnosis, prevention, or Gram-positive bacteria can be funded but will have a lower priority. 
•	Yes 
•	No 

If yes, please indicate the targeted bacteria in the table below. (Check all that apply)
CDC 2013 Urgent Threats	
Threat 	Data to support in vitro Activity 	Data to support in vivo Activity 	Diagnostics and Devices 
(data to identify or Combat) 	

 o Clostridium difficile 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

 o Carbapenem-resistant Enterobacteriaceae 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

 o Neisseria gonorrhoeae 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

CDC 2013 Serious Threats	
Threat 	Data to support in vitro Activity 	Data to support in vivo Activity 	Diagnostics and Devices 
(data to identify or Combat) 	

•	Multidrug-resistant Acinetobacter 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Drug-resistant Campylobacter 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	ESBL-producing Enterobacteriaceae 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 	

•	Vancomycin-resistant Enterococcus 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No

•	Multidrug-resistant Pseudomonas aeruginosa 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Drug-resistant non-typhoidal Salmonella	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Drug-resistant Salmonella Serotype Typhi	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No

•	Drug-resistant Shigella	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Methicillin-resistant Staphylococcus aureus (MRSA) 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Drug-resistant Streptococcus pneumoniae 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

CDC 2013 Concerning Threats	

•	Vancomycin-resistant Staphylococcus aureus 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Erythromycin-resistant Group A Streptococcus 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

•	Clindamycin-resistant Group B Streptococcus 
	
•	Yes 
•	No 
	
•	Yes 
•	No 
	
•	Yes 
•	No 

11. Is there demonstrated activity in an animal model for at least one exemplar from the project? Yes_______/No________

12. If the product is therapeutic or preventative, is the mechanism of action known?
•	Yes 
•	No 

13. How far have you progressed with the diagnostic?
	a) A laboratory-level demonstration kit (or prototype) exists: Yes_____/No_____
	b) Version suitable for field testing exists? Yes_____/No_____

14. Do you believe you are likely to have freedom to operate around the technologies required for your product? 
•	Yes 
•	No 
•	Under Evaluation 
•	Don’t Know 
<<END OF FORM>>
Please return completed form to info@amrcentre.com or post to: The AMR Centre, BioHub, Mereside, Alderley Park, Macclesfield SK10 4TG