Presolicitation_Notice.pdf

PRESOLICITATION NOTICE

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

RFP-NIAID-DMID-NIHAI2017087

Type of Requirement

New Requirement

Re-competition (Contract/Task Order No.: HHSN272201200003I)

Expansion of (Contract/Task Order/RFP No.:______________)

Place of Performance

Place of performance is unknown at this time

Place of performance is known. Address or general location:__________________

Recompetition

Name of Incumbent

Battelle Memorial Institute

505 King Avenue

Columbus, OH 43201

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-

Duration of contract: 7 year ordering period and 10 year completion.

If Options will be included, describe Options _______N/A________________________

Anticipated award date: May 1, 2018

Presolicitation Notice Information

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for a contractor to provide a suite of preclinical, nonclinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials.

Description

The purpose of the anticipated solicitation is to establish a NIAID resource entitled “EVALUATION

AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR INFECTIOUS

DISEASES” that provides a suite of preclinical, nonclinical, and clinical testing services for vaccines and other biologic products. While the overall suite of testing services is comprehensive, the intent is to provide individual services on a case-by-case basis for a diverse collection of vaccine and biological product candidates, rather than carry a single product candidate through an entire preclinical development pathway. These services are intended to help a wide variety of investigators in a broad number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II/III trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter Phase I/II/III trials. These testing capabilities may also support vaccines or other biological products that are intended to interrupt or block pathogen transmission (such as vector-borne diseases) or for use in animals that constitute a disease reservoir for, or other disease threat from, a pathogen that has public health significance. Support for efforts associated with zoonotic diseases may be considered on a case-by-case basis dependent on adequate justification for Public Health considerations. The Offeror shall be responsible for ALL work performed and shall be responsible for project planning, initiation, implementation, management and communication; evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.

This Indefinite Delivery Indefinite Quantity (IDIQ) will be administered and used primarily to support NIAID initiatives that help DMID accomplish its mission, respond to changing priorities as scientific and public health needs shift, rapidly respond to public health emergencies and new disease threats, and improve surge capabilities. The Contractor shall provide NIAID with a broad and flexible range of manufacturing and characterization services for vaccines and other biologics that support preclinical, nonclinical, and clinical studies for promising products when such products emerge from investigator-initiated research studies or other sources identified by NIAID Program staff. The Contractor shall also provide appropriate documentation and support primarily for pre-IND, IND, and BLA submissions.

These tasks shall be conducted in accordance with quality oversight that is appropriate to the phase of the specific task and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. These quality regulations at a minimum include current Good Laboratory Practices (GLP) and cGMP [21 CFR Parts -11, -58, -210, -211, -600].

These capabilities may also support vaccines or other biological products that are intended for use in animals that constitute a disease reservoir for, or other disease threat from, a pathogen that has public health significance. Support for efforts associated with zoonotic diseases may be considered on a case-by-case basis dependent on adequate justification for Public Health considerations. In addition, efforts to provide limited support outside of Phase I/II clinical trials may also be considered on a case-by-case basis.

For the purposes of the Presolicitation Notice and anticipated solicitation, the following definitions shall apply:

• Vaccine – An antigenic preparation used to render an organism immune to an infectious disease by inducing or increasing immunity for prophylaxis and/or therapy, or eliciting immune-based responses that interrupt pathogenesis. Vaccine products include but are not limited to synthetic peptides, recombinant proteins, nucleic acids, viral-like particles, vector-based vaccines, as well as live, modified, and/or attenuated bacteria, viruses, parasites, and other organisms.

• Vaccine Component – Any substance or device that maintains, stabilizes, or enhances a vaccine’s activity or ability to invoke an immune response. Vaccine components include, but are not limited to, adjuvants to increase immunogenicity, excipients to increase stability, and delivery systems including novel dosage forms and devices.

• Other Biologic – Therapeutic preparations made from living organisms or the components of living organisms and are most likely regulated by CBER. Biologics include but are not limited to allergenics; antitoxins; blood and blood products; cellular and gene therapy products. For the purposes of this Presolicitation Notice and anticipated solicitation, challenge material for non-clinical, preclinical, and clinical trials will also be included in the definition of biologics. Other biologics will include BSL-2, BSL-3, and BSL-4 material.

The services shall be directed at the following:

• diseases caused by pathogens and toxins on the NIAID Category A, B, and C Priority Pathogens list (http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx)

• emerging and re-emerging infectious diseases;

• antimicrobial resistant and multi drug resistant infections;

• other bacterial infections;

• fungal infections;

• viral infections; and

• parasitic diseases.

The Contractor shall be required to carry out the Scope and Activities defined in the following five Task Areas. Task Orders may address one Task Area or multiple Task Areas. Institute Contracting Officer’s Representative (COR) and designees will collaborate with the Contractor in all awarded Task Orders.

Technical Requirements will be defined in the individual Task Areas.

The Technical Requirements have been assembled into the following Task Areas:

Task Area 1: Parent Contract Management Support Activities

One Task Order will be assigned under this Task Area. The Task Order will be a cost-reimbursement, term (level of effort) type contract with a Base Period of 12 months and multiple Options to extend the Base Period of Performance in 12-month increments up to a total of 10 years to continue the same requirement. The contractor is REQUIRED to provide a total level of effort of 461 total direct labor hours per year (excluding vacation, holiday, sick leave) for a period of performance of 10 years (Base period plus nine, one-year Options). The scope of this Task Area’s activities includes the ability to facilitate ad hoc meetings and provide ad hoc reporting as part of general administrative, management, and technical support activities that are not Task Order specific.

Task Area 2: Assay Development

The scope of Task Area B includes the design, development, qualification and validation of in vitro and in vivo assays as needed for characterization and testing of a vaccine, vaccine component, or other biologic.

Other activities under this task area include method assessment/feasibility studies, method comparability studies, redevelopment or improvement of existing assays, and technology transfer of assays to/from other facilities.

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process.

Task Area 3: Immunogenicity and Efficacy Testing http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/Pages/CatA.aspx

The scope of activities under Task Area 3 includes designing and performing IND-enabling immunogenicity and efficacy trials for products, using established animal models and supporting assays needed in the conduct of immunogenicity and efficacy trials. This scope includes testing performed under FDA and ICH guidelines for Animal Rule.

The decision regarding which animal species to be used and any requirements for specific pathogen free (SPF) animals shall be made jointly by the COR and the Contractor, with the COR having final authority.

The decision whether these studies will be performed in compliance with GLP (21 CFR 58) will be determined by the COR and identified in the Task Order.

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process.

Task Area 4: Clinical and Nonclinical Sample Testing

The scope of activities under Task Area 4 includes testing clinical and non-clinical samples provided from internal and external sources. This scope includes providing reagent control, assay control, assay monitoring, and statistical review to support the conduct of the analysis.

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions.

Task Area 5: Safety and Toxicity Testing

The scope of activities under Task Area 5 includes designing and performing IND-enabling Good Laboratory Practice (GLP) compliant testing of products as required prior to initiating human clinical trials. This scope includes testing of candidate products for safety and toxicity by in vitro tests, small animals studies, and studies in non-human primates as required by the FDA. This scope also includes any additional testing required by the FDA which may include biodistribution studies and reproductive toxicology studies. These studies shall be performed in accordance with GLP regulations (21 CFR 58).

The Contractor shall conduct tasks in accordance with quality oversight that is appropriate to the phase of product development; under the appropriate level of biocontainment (BSL-2, BSL-3, BSL-4); and within all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions. The Contractor shall be responsible for the acquisition, care, and housing of animals in an appropriate level bio-containment facility, and ensuring all work is conducted in accordance with the Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/phspol.htm), including the implementation of an animal care and use program and an animal use protocol approval process.

NIAID anticipates awarding a single IDIQ contract that provides a guaranteed minimum award to the organization or consortium that best meets the overall qualifications needed to fulfill the technical requirements of the anticipated solicitation. Sample Task Orders will be provided in the RFP solely to evaluate offeror responses and capabilities. Task Orders for specific tasks will be issued after award of the Parent Contract.

Assume responsibility for the following list of activities which represents a yearly estimate of tasks the Offerors should assume to perform each year under the contract.

Task Area Title Estimated No.

of Awards/year

1 Parent Contract Management Support Activities – Task Order A1 1

2 Assay Development – Sample Task Order B1 2 3a Immunogenicity & Efficacy– Sample Task Order C1 1 3b Immunogenicity in Mice – BSL-2 2 4a Clinical Sample Analysis – Sample Task Order D1 1 4b Clinical Sample Analysis – Non-Flu 1 5 Safety and Toxicity Testing – Sample Order E1 3

Assume that the period of performance of task orders may range from one year to multiple years.