JATF_CSO_Pharma_AoI_v1.pdf

3 Aug 2020 / FA7013-20-S-0002AOI_04

UPDATE

General Information

1. Pharmaceutical Industrial Base Expansion Area of Interest (AoI) Background

The recent COVID-19 Public Health Emergency has illuminated the fragility of the United States’ domestic capacity to manufacture pharmaceuticals. The intent of this AoI is to understand the pharmaceutical industry’s ability to produce all aspects of drug manufacturing domestically. The country’s ability to produce all aspects of drugs domestically is critical to not only responding to pandemics but also ensure the security of the nation as it relates to drug manufacturing.

The Department of Defense Joint Acquisition Task Force (JATF) and Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT) need to understand industry’s ability to domestically produce the three key steps of pharmaceutical production process:

a. Key Starting Material (KSM) production

b. Active Pharmaceutical Ingredient (API) production

c. Finished Dosage Form (FDF) manufacturing

2. AoI Expansion Request This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting future public health/pandemic needs to expand strategy to expand domestic production capacity of pharmaceutical manufacturing within the next 6-24 months. Offerors can respond to any or all production sections based on their resident expertise and ability to expand domestic manufacturing. The JATF would like to understand industries’ ability to expand their domestic capacity to produce enough KSM, API, and fill-finish/final dosage forms by at least 100M units (tablets, capsule, sterile vials etc.) per year. Proposals should support the following critical pandemic response pharmaceutical classes or categories, but may also include proposals for other pharmaceuticals of national importance:

Critical COVID-related pharmaceutical categories Neuromuscular Blocker Sedative Analgesic Anticholinergic Vasopressor Antibiotics Anticoagulant Antiemetic Electrolyte replenishment IV Fluids Steroids Bronchodilator

a. Domestic KSM Production, which is defined by the FDA as a raw material, or intermediate used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

i. For Suppliers of Key Starting Materials (KSMs), what would be required for your company to consider domestic production of KSMs?

1. Provide a list of proposed KSMs to be shifted from overseas to domestic production and why these were selected. What is the method you used to justify and prioritize these particular materials?

2. Provide a timeline for establishing domestic production of KSMs

3. Address required capital investments and additional projected costs (i.e. facilities, labor etc)

4. Provide estimates of production volumes by KSMs

5. Estimate the cost increase per KSM by changing to domestic production

6. Identify barriers to domestic production and their impacts (i.e. regulatory, legal, legislative, policy, decreased business due to higher production costs etc)

7. Provide any additional relevant information for consideration by the review team

ii. If already a domestic producer, what would be required for your company to expand domestic production of KSMs?

1. Provide a list of proposed domestic KSMs to be expanded and why these were selected. What is the method you used to justify and prioritize these particular materials?

2. Provide a timeline for establishing domestic production of KSMs

3. Address required capital investments and additional projected costs (i.e. facilities, labor etc)

4. Provide estimates of production volumes by KSMs

5. Identify barriers to expanding domestic production (i.e. regulatory, legislative, policy etc)

6. Provide any additional relevant information for consideration by the review time

iii. What advanced manufacturing techniques would you/do you rely upon to achieve support for the 100M units per year requirement?

b. Domestic Active Pharmaceutical Ingredient Production, which is defined by the FDA as a substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.

i. For Suppliers of Active Pharmaceutical Ingredients (API), what would be required for your company to consider domestic production of APIs?

1. Provide a list of proposed APIs to be shifted from overseas to domestic production and why these were selected. What is the method you used to justify and prioritize these particular materials?

2. Provide a timeline for establishing domestic production of APIs

3. Address required capital investments and additional projected costs (i.e. facilities, labor etc)

4. Provide estimates of production volumes by APIs

5. Estimate the cost increase per API by changing to domestic production

6. Identify barriers to domestic production and their impacts (i.e. regulatory, legal, legislative, policy, decreased business due to higher production costs etc)

7. Address how you would propose to get the API into a Final Dosage Form (FDF), i.e.

internal capability, partnerships with fill-finish/FDF companies etc.

8. Provide any additional relevant information for consideration by the review team

ii. If already a domestic producer, what would be required for your company to expand domestic production of APIs?

1. Provide a list of proposed domestic APIs to be expanded and why these were selected.

What is the method you used to justify and prioritize these particular materials?

2. Provide a timeline for establishing domestic production of APIs

3. Address required capital investments and additional projected costs (i.e. facilities, labor etc)

4. Provide estimates of production volumes by APIs

5. Identify barriers to expanding domestic production (i.e. regulatory, legislative, policy etc)

6. Provide any additional relevant information for consideration by the review time

iii. What advanced manufacturing techniques would you/do you rely upon to achieve support for the 100M units per year requirement?

c. Finished Dosage Form Manufacturing which is defined by the FDA as the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product.

i. For Fill-Finish/Final Dosage Form Domestic Producers, what would be required for you to expand your capacity?

1. What types and volumes of final dosage forms does your company produce (tablet, capsule, sterile/non-sterile liquids, COVID/other vaccines etc) annually?

2. If the Government is seeking 100M final dosage forms per year capacity to be in place within a period of two years:

a. Does your company have a surge capacity to produce to this level?

b. What is the timeline to expand to this capacity?

c. Explain how you would increase your fill/finish capacity to support an additional

100M vials per year above what you are currently producing?

d. Would this be a surge capacity or would it require construction of new facilities?

3. If new facilities are required:

a. Provide an overview of the approvals that would be required and how you plan to achieve them.

b. Does your current facility meet up to a BSL-2 requirement for vaccine production or would new construction seek to achieve that level?

c. What is a total estimated cost of the capacity increase of 100M vials within 2 years? Any detailed cost information you can provide would be very helpful

d. Would the 100M final dosage manufacturing consume the entire annual capacity of the new facility? If not, how would you plan to financially support the remainder of the open capacity? Would you have sufficient commercial business of your own to adequately fill that open capacity?

4. What advanced manufacturing techniques would you/do you rely upon to achieve the 100M units per year requirement?

ii. Additional inputs:

1. Please include any additional issues/considerations related to the domestic production of pharmaceuticals not included in the previous questions

1. SPIRAL 1 through 3– Submission Requirements

a. All guidance governing the content and evaluation criteria for required submission can be found the below at the following JATF CSO link:

https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_ covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1

b. Solutions briefs for this Area of Interest shall be submitted at the email below:

JATFCSO_AOI_PHARMA@afwerx.af.mil

c. Once submission is received, offerors will receive a Response Submission Number via email. Please ensure that your solution brief has your firm’s point of contact information to include Name, Title, Phone number and Email.

2. AoI Open Period

a. Solution Briefs may be submitted immediately upon reviewing this AOI. Solutions Briefs will be accepted until 5:00PM CST; 7 Aug 2020.

b. Evaluations will begin within 48 hours of the posting of this AOI.

Questions concerning this AOI can be sent to the following email:

JATFCSO_AOI_PHARMA@afwerx.af.mil

**Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction without the use of competitive procedures. The follow-on production contact or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the prototype OTA. As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.

https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1 https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1