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FBO DAILY ISSUE OF MAY 18, 2003 FBO #0535
SOLICITATION NOTICE

A -- Pharmacology/Toxicology Studies for New Drug Approval (HE2100)

Notice Date

5/16/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Other Defense Agencies, Uniformed Services University of the Health Sciences, Directorate of Contracting, 4301 Jones Bridge Road, Bethesda, MD, 20814-4799
 

ZIP Code

20814-4799
 

Solicitation Number

MDA928-03-R-0001
 

Response Due

6/16/2003
 

Archive Date

6/17/2003
 

Point of Contact

Debra Ann McGehee, Contract Specialist, Phone 301-295-3962, Fax 301-295-1716, - Beverly Roberts, Contract Specialist, Phone 301-295-3868, Fax 301-295-1716,
 

E-Mail Address

dmcgehee@usuhs.mil, broberts@usuhs.mil
 

Description

The Uniformed Services University of the Health Sciences (USUHS) and the Armed Forces Radiobiology Research Institute (AFRRI), Bethesda, MD is soliciting request for proposals in order to award a firm-fixed price performance based contract. This is a combined synopsis/solicitation and the awarded contract will provide for the development of sufficiently robust preclinical pharmacology, pharmacokinetics and toxicology data sets to support initial granting of Investigational New Drug (IND) status for 5-AED?s use as a radio protective agent in humans and subsequent licensing of 5-AED as a radioprotectant. Scope: The purpose of this contract is to provide the Armed Forces Radiobiology Research Institute (AFRRI) and it?s Cooperative Research and Development Agreement (CRADA) partner, Hollis-Eden Pharmaceuticals, Inc (HEP), with studies and research protocols for the following: 1) the ADME properties of 5-AED in male and female rats and NHP following single dose (radiolabeled) and multiple dose (non-radiolabeled) administration of test article conducted in an FDA/ICH GLP-compliant manner; using sponsor?s procedure for radio labeled test article preparation and non-radiolabled test article supplied and analyzed by sponsor; 2) validated bioanalytical methods (LC/MS) for 5-AED with an LOQ of 2-ng/mL to support PK and toxicology studies with cross validation to urine and plasma meeting FDA guidelines; 3) the maximum tolerated dose, the acute single and repeated dose toxicity in rats and NHP ?s using non-GLP, pilot 7-day and GLP, 28-day main studies conducted in an FDA/ICH GLP-compliant manner; using test article supplied and analyzed by sponsor; 4) the immunotoxicity and genotoxicity of the drug in vivo & in vitro following FDA and ICH requirements with particular emphasis on T-cell dependent antibodies, mouse micronucleus assays, CHO cell chromosomal aberrations and mutagenicity tests; 5) the safety pharmacology of 5-AED using rats and canines meeting FDA/ICH requirements. The protocols, studies and research data will be described in an FDA GLP-compliant report that accurately reflects the study results and data obtained and will be used by the sponsors to gain support of FDA for approval of IND status of 5-AED. The awarded contractor shall provide the following objectives: 1) a draft of study protocol for sponsor comments; a draft of PK/TK sample collection and storage procedures; the performance standard for this objective is for contractor to supply documentation of certifications, agency inspections, SOPs, etc. and that the facility meets sponsor?s good laboratory practice (GLP) qualification audit requirements. Study design is optimal for cost effectiveness. Study design will support FDA expectations. Study design yields statistically valid results. The acceptable quality level is to pass FDA and sponsor GLP inspection; animal facility and IACUC must be AAALAC certified. Study protocol designed to follow applicable ICH guidelines. Draft study protocol delivered to sponsor within three weeks of contract signing; draft report of PK/TK sample analysis within six weeks of in-life study completion; 2) Finalized Study Protocol and finalization of validated analytical methods; the performance standard for this objective is final report reflects sponsor?s comments; experimental schedule is outlined; receipt of draft report is outlined; receipt of final audited report is outlined and sample analysis schedule is outlined. The acceptable quality level is timing: final protocol delivered to sponsor within one week of receiving sponsor?s comments on draft. 3) Initiation of in-life phase of study: I. Pharmacokinetics (PK) a. Rat, single dose; 3H/5-AED; b. Rat mult. Dose; 5-AED; c. NHP, single dose; 3H/5-AED; d. NHP, mult. Dose; 5-AED. II. Toxicology ? MTD & Pilot Studies; a. Rat MTD; b.NHP MTD; c.Rat 7-day pilot study (non-GLP); d. NHP 7-day pilot study (non-GLP); e.Rat 28-day repeat dose toxicity study (GLP); f. NHP 28-day repeat dose toxicity study (GLP). III. Immunotoxicity; a. T-cell dependent Ab response; IV. Genotoxicity Studies a. Mouse micronucleus; b. CHO chromosomal aberrations; c. Mutagenicity; V. Safety Pharmacology; a. rat ?functional observation battery; b. dog ? respiratory and cardiac assessment. The performance standard for this objective is: Animals ordered (within acclimatization period), identified and pre-study observations collected per protocol; radio labeled test article prepared and analyzed according to sponsor?s directions; non-radio labeled test article received from sponsor and stored as per protocol, with samples of non-radiolabled test article shipped for analysis by sponsor designated lab; study executed according to approved protocol; sponsor informed immediately of any clinical or laboratory observations suggestive of drug toxicity or of an inability to obtain/collect data or any protocol deviations. There are no planned deviations from the protocol; the study monitor is notified of all protocol deviations/violations and all such are reported within the final report. The acceptable quality level for this objective is timing: in-life phase begins within one week of scheduled date; test article samples returned to sponsor designated laboratory for analysis within one week of completion of in-life phase; pharmacokinetics, toxicology, immunotoxicity, genotoxicity and safety pharmacology studies are GLP as per FDA/ICH guidelines (rat & NHP 7-day tox studies are non-GLP studies); 4) Completion of in-life phase. The performance standard for this objective is as per study protocol. The acceptable quality level for this objective is timing: studies completed within scheduled date(s). Biological samples analyzed according to validated methods. 5) Completion of post-study sample analyses. The performance standard for this objective is as per study protocol. The acceptable quality level for this objective is timing: sample analyses completed within one week of scheduled date. 6) Completion of draft reports: a. in-life pharmacology, pharmacokinetics and toxicology studies; b. sample analysis. The performance standard for this objective is that report accurately reflects the study results and data obtained from the study. Report format complies with the GLP requirements. GLP compliance statement signed by study director and quality assurance statement signed by the quality assurance unit. 7) Completion of final, audited report. The performance standard for this objective is to reflect sponsor?s comments to draft report. The acceptable quality level is timing: delivered to sponsor within four weeks of receiving the sponsor?s comments. Only a GLP compliant report is acceptable. Period of Performance: Work shall be performed within nine (9) months from the award of contract. Deliverable: The final, Good Laboratory Practice (GLP) compliant study protocol/audited report, shall be delivered to sponsor within four weeks of receiving the sponsor?s comments. This combined synopsis/solicitation for commercial items is prepared in accordance with the format in Subpart 12.6 of the FAR, as supplemented with additional information included in this announcement. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. FAR CLAUSES AND PROVISIONS: FAR CLAUSES AND PROVISIONS: The provision of FAR 52-212-1, Instruction to Offerors - Commercial Items applies to this acquisition. Prior to an award, all offerors are required to submit a completed copy of FAR 52.212-3 ? Offeror Representations and Certifications ? Commercial Items. Telegraphic or facsimile offers are not acceptable. The provision of FAR 52.212-2, Evaluation - Commercial Items, applies to this acquisition. Any resulting award will be issued to the bidder offering the best value to the Government. Factors to be considered are technical capability and price with technical capabilities being significantly more important than price. Failure to provide the information relative to each evaluation factor may render offeror non-responsive. 1) TECHNICAL CAPABILITY: Evaluation of technical capability and ability to meet the evaluation factors will be based on product literature (if any), technical features and ability to meet GLP compliance terms. Each offeror is required to submit descriptive literature (if any), or other documentation, to show how the offered service meets or exceeds the specified aforementioned minimum procurement requirements including technical capabilities. 2) Evaluations will be based on best value including cost and ability to meet stated minimum procurement requirements. The full text of these clauses may be accessed electronically at this address: http://www.arnet.gov/far/. Offerors shall include a complete copy of the provision at FAR 52.212-3, Offeror/Representation and Certifications-Commercial Items. The following FAR clauses cited in 52.212-5 are applicable to this acquisition for services: 52.203-6, Restrictions on Subcontractor Sales to the Government (JUL 1995); 52.216-18 Ordering; 52.216-19 52.217-5, 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (APR 1984); 52.222-35, Affirmative Action for Disabled Veterans and Vietnam Era Veterans (APR 1998); 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998); 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era (JAN 1999); 52.225-3, Buy American Act Supplies (JAN 1994); 52.225-13 Restrictions on certain Foreign Purchases (FEB 2000); 52.225-21, Buy American Act North American Free Trade Agreement Implementation Act Balance of Payments Program (JAN 1997); 52.232-33, Payment by Electronic Funds Transfer Central Contractor Registration (May 1999); 52.232-36, Payment by Third Party; 52.239-1, Privacy or Security Safeguards (AUG 1996). FAC 2001-12 is applicable to this action. OFFER DUE DATE: JUNE 16, 2003 4:00 pm, EDT. ALL INTERESTED PARTIES SHALL SUBMIT OFFERS WITH THE FOLLOWING INFORMATION: Federal Tax Identification (TIN); Dun & Bradstreet Number (DUNS); remit to address if different. As of 31 May 1999 all Contractors must be registered in the Central Contractor Registration (CCR) Database as a condition for contract award. Contractors may register in the CCR through the World Wide Web at http://www.ccr.gov, or call the DOD Electronic Information Center at 1-800-334-3414.
 

Place of Performance

Address: Armed Forces Radiobiology Research Institute (AFRRI), 8901 Wisconsin Ave., Bldg. 42, Bethesda, Maryland

Zip Code: 20889-5603

Country: USA
 

Record

SN00326128-W 20030518/030516213909 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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