Presol Notice_Final CPC.pdf

PRESOLICITATION NOTICE

NIAID CLINICAL PRODUCTS CENTER (CPC)

NIAID-75N93024R00018

Introduction

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID DAIT mission is to conduct and support basic, preclinical, and clinical research to better understand the human immune system in health and disease, and to design and develop clinical research studies that evaluate novel prevention and treatment strategies for immune-mediated diseases that include:

• Asthma, food allergy, atopic dermatitis/eczema, and other allergic diseases such as rhinitis and rhinosinusitis;

• Autoimmune diseases, such as insulin-dependent diabetes mellitus, multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis;

• Rejection of transplanted organs, tissues, or cells; and

• Primary immune deficiency disorders, including more than 100 known genetically distinct primary/congenital immunodeficiency diseases are known, with many under investigational treatment via gene therapy.

Collectively, these diseases affect millions of Americans, resulting in considerable morbidity, mortality, pain and suffering, and medical costs. Furthermore, these diseases cross many clinical specialties; thus, knowledge of the immune system and its role in disease is increasingly important in the daily practice of medicine. DAIT’s clinical research study portfolio includes an increasing number of investigator-initiated clinical trials and longstanding, dedicated clinical trial networks. The latter category includes the Immune Tolerance Network (ITN), Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA), Autoimmunity Centers of Excellence (ACE), Consortium for Food Allergy, Asthma and Allergic Diseases Cooperative Research Centers (CoFAR), Atopic Dermatitis Research Network (AADCRC), and Childhood Asthma in Urban Settings Research Network (CAUSE).

Within the Office of the DAIT Director, the Office of Pharmaceutical Research Management (OPRM) is responsible for pharmacy and pharmaceutical oversight of national and international NIAID clinical trials to ensure product integrity, participant safety, and pharmacy, and pharmaceutical regulatory compliance.

OPRM, through its quality and compliance programs provides pharmaceutical support services, including but not limited to oversight of study product manufacturing, packaging, blinding, labeling strategies, and distribution through the NIAID Clinical Products Center (CPC).

Contract History

In FY 2019 a 7-year contract was awarded to EMINENT Services Corporation to establish the “NIAID Division of Allergy, Immunology & Transplantation: Immune Mediated Diseases Clinical Products Center (CPC)” (Contract No. 75N93019C00003). The purpose of this contract was to continue supporting the NIAID/DAIT pharmacy and pharmaceutical oversight responsibilities of national and international NIAID DAIT-supported national and international clinical trials to ensure product integrity, participant safety, and pharmacy and pharmaceutical regulatory compliance. This contract also supported essential pharmacy and pharmaceutical support required for the conduct of NIAID/DAIT clinical trials as well as other NIAID funded clinical trials on a limited, as-needed basis. These services are study product management such as receiving from various sources (e.g., manufacturers, NIAID/DAIT Pharmaceutical Procurement Center (PPC), proper storage, shipment, blinding, repackaging, placebo manufacturing, and distribution to clinical sites.

Description and Purpose

The purpose of this contract is to provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis, to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., IP management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation); placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring); 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocols and testing, and labeling and packaging; 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies; and 4) Clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc.

Study Products to be studied include drugs, biologics, vaccines, food immunotherapy, controlled substances, and other agents, as study interventions and services shall be provided for:

a) DAIT funded clinical research programs to include, but not limited to, the ITN, ACE, CTOT-CA, ADRN, the Consortium of Food Allergy Research (CoFAR) and Childhood Asthma in Urban Settings (CAUSE), Asthma and Allergic Diseases, Cooperative Research Centers (AADCRC);

b) Individual DAIT-funded clinical trials conducted under cooperative agreement grants and other funding mechanisms;

c) Other NIH-funded clinical trials on an as-needed basis; and

d) Support of NIAID or other NIH institutes or ICs in special circumstances such as public health emergencies for Emergency Preparedness or Public Health Emergency programs.

All Contractor activities must be compliant with Federal policies and regulations to protect the integrity of study products used in NIAID-funded clinical trials, clinical research, and projects. Study products services shall be provided for, but not limited to, multiple sites in the U.S. and internationally, including sites in the Americas, Europe, Africa, Asia, and Australia. Supported studies focus on a broad range of immune-mediated diseases, including: (i) asthma and allergic diseases; (ii) autoimmune disorders; (iii) immune-mediated rejection in solid organ, tissue and cell transplantation; and (iv) studies of radiation/nuclear countermeasures research. Additionally, and on an as-needed basis, clinical trials of infectious disease treatment, prevention, and vaccine studies.

The following five Mandatory Qualification Criteria (MQC) must be met at the time of receipt of the Original Proposal;

1) Offerors must have a current license(s) and permit(s) as a Pharmacy, Distributor, and Research for drugs class I through 5 and be able to ship across 50 states, the District of Columbia, and U.S. territories;

2) Facility must currently possess or have possessed a license and/or permit to import and export drug, in the past 12 months; 3) Facility must be cGMP certified and registered with the FDA as a Manufacturer; 4) Facility must be registered with the FDA for Laboratory Analysis, Labeling, Packing, Re-Labeling, and Re- Packing; and 5) staff must include at least one licensed pharmacist.

TECHNICAL EVALUATION CRITERIA:

CRITERIA

WEIGHT

1: TECHNICAL PLAN/APPROACH 40

2: FACILITIES, EQUIPMENT AND OTHER RESOURCES. 30

3: SCIENTIFIC AND TECHNICAL PERSONNEL 20

4: PROJECT MANAGEMENT 10

TOTAL POSSIBLE WEIGHT: 100

It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Options 1-6 – Years 2 through 7) to be approximately 20,800 hours per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 10/18/2024 and may be accessed through http://www.SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

http://www.sam.gov/