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65 -- Solicitation for the Creation of Formulations of Vitamins and Minerals for the Treatment of Age-Related Macular Degeneration

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Reference-Number-NIH-NEI-01Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The National Eye Institute is requesting proposals from pharmaceutical companies to develop four distinct vitamin and mineral formulations intended for a clinical trial targeting individuals at risk for age-related macular degeneration. Each formulation contains specific dosages of Vitamin C (500 mg), Vitamin E (400 IU), Beta Carotene (either 15 mg or 0 mg), Zinc Oxide (either 80 mg or 25 mg), and Cupric Oxide (2 mg). The selected company must have prior experience producing similar formulations and demonstrate the capacity to manufacture these products on a large scale, sufficient to supply a multi-center study involving 4,000 participants over a minimum of seven years. The formulations should be designed to optimize participant compliance by minimizing the number of tablets or gel capsules required. Additionally, the company must ensure timely production to enable trial commencement by June 2005 and maintain financial solvency throughout the trial duration. Responses to this solicitation are due by September 30, 2004, with electronic submissions preferred, directed to Dr. Emily Y. Chew at the National Eye Institute. It is important to note that this request is for informational purposes only and does not constitute a formal contract solicitation or guarantee of award.

General Info

National Eye Institute seeks vitamin formulations for AMD trial, requiring experienced manufacturer by June 2005.

Agency

N/A

NAICS

424210 - Drugs and Druggists' Sundries Merchant Wholesalers

Place of Performance

Not specified

Set-Aside

NONE

Documents

No documents available

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Uniform Contract Format

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Timeline

PostedAug 26

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Organization & Contact Information

AgencyN/A

Contacts1 person available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Valerie C PickettContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

The National Eye Institute of the National Institutes of Health is seeking proposals from pharmaceutical companies to create 4 formulations to be tested in a clinical trial of participants at risk of developing age-related macular degeneration in one or both eyes. The formulations will be as follows: Formulation 1 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 2 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 80 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 3 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 0 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. Formulation 4 will consist of 500 mg Vitamin C; 400 IU Vitamin E; 15 mg Beta Carotene; 25 mg Zinc Oxide; 2 mg Cupric Oxide. The company must demonstrate the ability to make these formulations with previous products that have similar components. The company must demonstrate the willingness to produce these formulations for a large multi-centered trial involving 4000 subjects for at least 7 years. The formulation should be produced with the minimal number of tablets or gel capsules possible to enhance compliance of the study subjects. The company must produce these formulations in a timely fashion to begin the clinical trial by June 2005 and have the ability to remain solvent throughout the next 7 years. Responses to this synopsis are due September 30, 2004. Electronic submission is preferred. Send all submissions directly to: Emily Y. Chew, MD echew@nei.nih.gov NIH Building 31, Room 6A52 31 Center Drive, MSC-2510 Bethesda, MD 20892-2510 310 496 6583 (tel) 301 496 2297 (fax) Please note that this is not a solicitation for contract proposals and no contract award is planned from the submissions received.