Advanced Development of New Antiviral Agents Against Influenza Virus

UPDATE: A PRESOLICITATION NOTICE HAS BEEN ISSUED IN RELATION TO THIS SOURCES SOUGHT NOTICE. THE PRESOLICITATION NOTICE NUMBER IS 10-100-SOL-00019. THIS IS A SOURCES SOUGHT NOTICE ONLY This is a Sources Sought Notice and does not constitute a commitment by the Government. This is NOT a solicitation for proposals, proposal abstracts or quotations. The purpose of this notice is to conduct market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential sources to provide the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the U.S. Government and will not be returned. The Department of Health and Human Services (HHS) is pursuing multiple and parallel strategies to close the gap between current antiviral drug supply and the HHS goal of stockpiling approved agents and developing new antiviral agents as part of the strategic plan for pandemic preparedness. HHS is particularly interested in the advanced development of new influenza antiviral agents or drug candidates effective against influenza designed to target novel mechanisms of action or to enhance effects of present classes of influenza antiviral drugs, formulated for long term stability, long bioavailability, and simple dosing regimens. Ultimately, these influenza antiviral agents shall be produced at one or more Food and Drug Administration (FDA)-licensed domestic manufacturing facilities and shall provide sufficient surge capacity to contribute substantially to U.S. and ideally global antiviral needs during an influenza pandemic. Respondents must meet the following mandatory qualification criteria: 1. Demonstration of Advanced Development/U.S. Influenza Antiviral Agent Licensure/Approval It is essential that efforts funded subsequently shall lead to U.S. licensure/approval of an influenza antiviral agent that can be used to protect the U.S. population in the event of an influenza pandemic. The Respondent must demonstrate significant progress towards development of an antiviral drug or biologic (not vaccines) by documenting the submission of an IND and completion of a final report, reviewed by the Respondent, of Phase I clinical trials for safety by the time of contract proposal submission. Drug efficacy must be based on either of two criteria: demonstrable ability to inhibit virus replication/spread, or demonstrable ability to produce an accelerated reduction of disease symptoms, including but not limited to a reduction of morbidity and mortality. 2. U.S. Drug Manufacturing To provide U.S-based facilities, the Respondent may be a 1) single, fully integrated and independent pharmaceutical company, 2) partnership of a prime contractor with legitimate subsidiary or corporate partner that performs U.S based drug manufacturing and/or clinical studies, or 3) consortium with the Respondent as the prime contractor with subcontractors such as contract manufacturing organizations and/or contract research organizations as members that perform U.S. based drug/biologic manufacturing and/or clinical studies. 3. Production Capability The Respondent must demonstrate sufficient production capacity to satisfy U.S. Government needs in the event of a declared influenza public health emergency. The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small business, service-disabled veteran-owned small business, veteran-owned small business , 8(a) small business, woman-owned small business or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code 325414. The small business size standard for this NAICS code is 500 employees. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether or not a set-aside is possible. Teaming arrangements are encouraged. An organization that is not a small business concern under the applicable NAICS code should not submit a response to this notice. Submittals received from an organization that is not a small business concern will not be reviewed. Respondents to this sources sought notice may identify their interest by submitting a capability statement, including a response to the requested information above, how they plan to meet the mandatory qualification criteria, an anticipated development plan of the product, and primary contact information at the organization (name, email address and telephone number) in the event HHS has additional questions or requires clarification of the submitted information. Responses are limited to twenty (20) pages and must be submitted to the contact person listed below. It is anticipated that a Request for Proposal (RFP) will be announced at the end of May 2010 with proposals due a minimum of forty five (45) days after RFP issuance. While the mandatory qualification criteria do not have to currently be met, all of the mandatory qualification criteria must be met by proposal submission. Proposals that do not meet the mandatory qualification criteria would not be considered for evaluation. All responses to this Sources Sought Notice shall reference Sources Sought Notice Number: 10-100-SOL-00016. Responses are to be submitted to Mekeba Barrett by 2:00 PM ET, May 10, 2010 at mekeba.barrett@hhs.gov. Any questions or comments relating to this Sources Sought Notice must be submitted electronically to mekeba.barrett@hhs.gov.