SOLICITATION NOTICE
H -- Analysis Studies Involving Idebenone
- Notice Date
- 8/15/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-50130-NV
- Response Due
- 8/24/2005
- Archive Date
- 9/8/2005
- Description
- The National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), Neurogenetics Branch (NB) intends to procure on a sole-source basis with MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502 for the continuation of an on going study of a phase I safety and tolerability study of the drug idebenone in patients with Friedreich?s ataxia. Friedreich?s ataxia is an inherited neurodegenerative disorder affecting 5-10,000 individuals in the United States. Friedreich?s ataxia is caused by mutations in the gene FRDA, which leads to defects in mitochondrial function. Currently, there is no treatment for this disorder. Idebenone is a synthetic analog of coenzyme Q10, a naturally occurring factor that works in mitochondria to facilitate oxidative phosphorylation and protect against the harmful effects of free radicals. In several small European trials, idebenone has shown promising results as a potential treatment for Friedreich?s ataxia. This study will be a dose-escalation trial conducted in three separate cohorts: children, adolescents and adults with Friedreich?s ataxia. The doses of idebenone to be studied range from 2.5 mg/kg to 75 mg/kg, at the high end, this is several fold higher than delivered in humans previously, and an important component of this trial is determining the pharmacokinetic profile of high dose idebenone and its major metabolite QS-10. MDS Pharma Services developed a validated method for detection of idebenone and QS-10 in human plasma according to Good Laboratory Practice methods accepted by the Food and Drug Administration (FDA). Under this procurement, MDS Pharma Services will analyze idebenone and QS-10 on samples utilizing methods validated and accepted by the FDA Industry Guidance for Method Development and Validation of methods for the measurement of drugs in biological matrices. MDS Pharma Services is the only organization with a validated method for idebenone and QS-10 in human plasma. This is a continuation of an on-going phase I clinical trial and it is essential that the study samples be processed by the same laboratory in order not to introduce new variables into this on-going clinical trial. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NINDS researcher to determine if it can meet the requirements of this synopsis. This acquisition will be processed under FAR Part 12 ? Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. An original and one copy of the capability statements must be received in the Contracting Office by 1PM EDT (local Washington, D.C. time) on August 24, 2005. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA) in order to receive an award. Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS: 541380; Size Standard is 6 million.
- Record
- SN00870380-W 20050817/050815211716 (fbodaily.com)
- Source
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