REQUEST FOR INFORMATION - CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION (CDMO) PARTNERSHIPS
REQUEST FOR INFORMATION
BIOLOGICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY /
PHARMACEUTICAL COUNTERMEASURE INFRASTRUCTURE
DATE: August 17, 2018
TITLE: CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION PARTNERSHIPS
RFI No.: 18-BARDA-CDMO-RFI-001
1.0 Description
1.1 The Pharmaceutical Countermeasure Infrastructure Division (PCI) in support of the Biomedical Advanced Research Development Authority (BARDA) is seeking information on how an interested contractor could assist the U.S. Government (USG) with Medical Countermeasure Manufacturing Preparedness
1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY
This RFI is issued solely for information and planning purposes - it does NOT constitute a Request for Proposal (RFP), a promise to issue an RFP, or a commitment to issue any type of solicitation in the future. This RFI does not commit the USG to contract for any supply or service whatsoever. Further, BARDA is not at this time seeking proposals and will not accept unsolicited proposals.
Respondees are advised that the USG will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Submission is voluntary and is not required to propose to subsequent solicitations on this topic (if any).
If a solicitation is released, it will be synopsized on the Federal Business Opportunities (FedBizOpps) website and the Office of the Assistant Secretary for Preparedness & Response (ASPR) website at https://www.medicalcountermeasures.gov/. It is the responsibility of the potential repondee to monitor these sites for additional information pertaining to any potential requirement.
2.0 Background
Within the USG, the Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) is tasked with protecting the civilian population by providing leadership in research, development, acquisition, deployment, and use of effective medical countermeasures to treat the adverse health effects resulting from intentional exposure to chemical, biological, radiological, and nuclear (CBRN) threat agents, pandemic influenza and emerging infectious diseases.
In an effort to improve preparedness capabilities, the USG is seeking to establish potential on-going relationships with Contract Development and Manufacturing Organizations (CDMOs) in addition to the existing contracts supporting the Centers for Innovation in Advanced Development and Manufacturing (CIADMs) and the Fill Finish Manufacturing Network (FFMN).
There are several challenges facing these types of relationships, and as such, the USG is seeking feedback from CDMO organizations on how to best partner with the USG, while improving access to CDMO capabilities, capacities, and availability. The traditional CDMO / Product Sponsor relationship is to have the Product Sponsor identify and subcontract activities to a CDMO. With this model, the USG has limited visibility into the items identified above, having to work through the Product Sponsor to ask questions and receive information from the CDMO. In a USG / CDMO Prime contract situation, the relationship is typically reversed, having the Product Sponsor as the subcontractor to the CDMO Prime, which can lead to contractual concerns between the two parties as it is outside of the familiar contractual situation between both parties.
Additionally, the majority of the USG preparedness products developed have limited to no commercial value outside of a USG stockpile, or manufacture during a declared Public Health Emergency, therefore future revenue streams are limited. Taking resources away from projects to develop and qualify processes which are only going to be utilized inconsistently, or in time of a declared Public Health Emergency has been a deterrent to USG partnering in the past.
3.0 Requested Information
The USG is seeking feedback from CDMO organizations on how best to partner with the USG with recommendations to address the partnership concerns identified below:
1) USG access to CDMO Capabilities, Capacities, and Availability
a. Discuss options to maintain USG visibility to the evolving technical and business practices regarding pharmaceutical development and manufacturing.
2) Prime / Product Sponsor relationships
a. Discuss options to avoid contractual relationship issues between the Prime and Product Sponsor, while maintaining the items outlined in 1) above.
3) Preparedness Limitations to Annualized Revenue
a. Discuss best ways for the USG to incentivize partnering for preparedness purposes, outlining best practices to engage with the USG and Product Sponsors for providing CDMO services when the larger portion of activities would be one time only, with a wait for a declared health emergency for additional response.
4.0 Responses
4.1 Interested parties are requested to respond to this RFI with a white paper.
4.2 White papers shall adhere to the following:
• 8.5 by 11 inch paper in a format compatible with either the Microsoft Office software package or Abode Acobat; and
• Responses shall be limited to 10 pages for Section 2 and submitted via e-mail only to the individual(s) identified in Section 6.0 below.
Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid the USG, please segregate proprietary information. Please be advised that all submissions become USG property and will not be returned.
Information marked as "Proprietary" obtained in response to this RFI will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, applicable law and HHS regulations.
4.3 Section 1 of the white paper shall provide administrative information, and shall include the following at a minimum:
4.3.1 Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact.
4.3.2 Recommended contracting strategy.
4.3.3 Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business).
The North American Industry Classification System (NAICS) Code(s) are as follows:
•325412 - Pharmaceutical Preparation Manufacturing; and
•325414 - Biological Product (except Diagnostic) Manufacturing.
4.3.5 The facility security clearance of the respondee (if applicable).
The number of pages in Section 1 of the white paper shall not be included in the 10-page limitation, i.e., the 10-page limitation applies only to Section 2 of the white paper.
4.4 Section 2 of the white paper shall answer the issues addressed in Section 3.0 of this RFI and shall be limited to 10 pages.
5.0 Industry Discussions
BARDA representatives may or may not choose to meet with potential respondees. Such discussions would only be intended to get further clarification of possible capability to meet the potential USG need.
All potential respondees are encouraged to attend the BARDA Industry Day scheduled for October 29-30, 2018 in Washington DC where BARDA representatives will be available to answer any questions specific to this RFI.
6.0 Submission
Electronic responses to this RFI are due no later than:
12:00 PM, EST on Friday, November 16, 2018.
Your white paper shall be submitted to the following individual:
Quintin Hackshaw at quintin.hackshaw@hhs.gov
Please include RFI No. 18-BARDA-CDMO-RFI-001 - CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION PARTNERSHIPS in the subject line of all correspondence.
All technical and administrative correspondence and questions regarding this announcement shall also be submitted to the above email address.
BARDA intends to use electronic mail for all correspondence regarding this RFI.
7.0 Summary
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY to identify sources that can provide feedback on CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION PARTNERSHIPS. The information provided in the RFI is subject to change and is not binding on the USG.
BARDA has not made a commitment to procure any items or services, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become USG property and will not be returned.
This RFI is in accordance with FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997), as such, any information received will be for the purpose of planning only.
Quintin Hackshaw, Contracting Officer, Phone 2022600453, Email quintin.hackshaw@hhs.gov
