Bacteriophage_RFI_Atch_Form_2_FA8052-19-RFI-7730003_-_Final_-_2_Jul_19.pdf

Response Form #2

# Requirement Description Priority Threshold (T)*

(Minimum)

Objective (O)**

(Desired) Comments Meets (Y/N) Comments

1 FDA Approval KPP Yes T=O All drugs used in U.S. military personnel for Force Health

Protection (FHP) must be FDA licensed.

1 Efficacy APA

The capablity shall produce a 30% improvement in clinical condition when used alone or as an adjunct.

The capability shall produce a 60% improvement in clinical condition when used alone or as an adjunct.

Measures of clinical condition could include surface area of infected tissues, body temperature, fitness for duty exams, patient-reported pain score, or other relevant measures. Used as an adjunct, the capability could provide meaningful therapeutic value if improvement in clinical condition is at least 30% of personnel treated.

2 Time to Treatment Success APA

The capability shall successfully treat infections in 14 days.

The capability shall successfully treat infections in 7 days.

Reduction in the amount of time that a Service member is undergoing treatment will decrease the number of lost duty days.

3 Treatment Schedule APA

The treatment regimen shall consist of no more than three doses per day.

The treatment regimen shall consist of one dose per day.

Minimizing the time required to complete the treatment schedule is advantageous for ill Service members, and would minimize the amount of lost duty time of personnel.

4 Shelf-life APA

The capability shall have a shelf-life of at least one year.

The capability shall have a shelf-life of at least two years.

The financial and logistical demands of managing contingency stocks of the drug are best met with a prolonged shelf-life. Less than two years shelf-life prohibitively limits the ability to maintain stocks for contingency operations. A shelf-life of three years would reduce costs resulting from destruction of outdated drugs and allows medical planners to efficiently maintain contingency stocks.

Transportability should not be an issue beyond the current medical logistics system that is in place.

5 Storage temperature APA

The capability shall have a storage temperature range of 2

- 8°C.

The capability shall have a storage temperature range of 2

- 45°C.

The threshold storage temperature should be broad enough to allow storage at refrigerator temperatures over an extended period of time while maintaining potency. The objective temperature range will permit use under a broader range of conditions.

6 Product Administration APA

The capability shall be administered by a physician

The capability shall be administered by a medic/corpsman or nurse.

The speed of administration of the product would be increased and the demands on the medical staff lessened if the product could be administered by medics/corpsmen or nurses rather than by or under the direct supervision of physicians.

7 Reconstitution APA The capability requires reconstitution.

The capability does not require reconstitution.

The urgency and other challenges of providing care may cause delays in the reconstitution and/or mixing of the product prior to its administration. It is preferable that the product not require reconstitution before use.

BACTERIOPHAGE KEY PERFORMANCE PARAMETER (KPP)

BACTERIOPHAGE NOTIONAL ADDITIONAL PERFORMANCE ATTRIBUTES (APAs)