Dosage Form Assay Transfer, Forced Degradation Study, and Stability Studies of R-VK4-116
SOURCES SOUGHT NOTICE 1. Solicitation Number: 75N95024Q00189 2. Title: Dosage Form Assay Transfer, Forced Degradation Study, and Stability Studies of R-VK4-116 3. Classification Code: 6505 – Drugs and... SOURCES SOUGHT NOTICE 1. Solicitation Number: 75N95024Q00189 2. Title: Dosage Form Assay Transfer, Forced Degradation Study, and Stability Studies of R-VK4-116 3. Classification Code: 6505 – Drugs and Biologicals 4. NAICS Code: 325412 – Pharmaceutical Preparation Manufacturing 5. Size Standard: 1,300 employees 6. Description: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: Opioid use disorder (OUD) is a major public health concern. According to the CDC, overdose deaths from methamphetamine more than doubled from 2005 to 2015 and deaths from cocaine have nearly tripled since 2014. All drugs of abuse share the ability to elevate dopamine in the shell nucleus accumbens, a key component of the reward system. The D3 receptor (D3R) expressed in the ventral forebrain mesolimbic dopamine system is thought to influence reward, emotion, and motivation and, by extension, drug seeking and relapse (Sokoloff 1990). Animal data show an upregulation of D3R expression following exposure to cocaine, nicotine, and alcohol (Newman 2012; Keck 2014, 2015). D3R-selective antagonists decrease craving for drugs of abuse and drug-seeking behaviors in animal models of abuse (Heidbreder and Newman et al, 2010, Sokoloff 2017). A highly selective D3R antagonist has been selected as the lead candidate for this new molecular entity stage program (VK4-116). VK4-116 has been characterized in a comprehensive package of in vitro and in vivo studies demonstrating its selectivity for D3R and showing efficacy in several animal models of abuse. There is promising pre-clinical evidence that VK4-116 will be effective in the treatment of multiple forms of substance use disorders. Plan is to continue on preclinical development of VK4-116, with the aim of filing an IND and initiating human studies in 1-2 years. CMC development of (R)-VK4-116 dihydrochloride salt with oral dosage form as capsule will support the Phase 1 clinical studies. Purpose and Objectives: The scope of this contract is to provide the forced degradation study by using chiral impurity, transfer assay methods, and long term stability study of the GMP clinical materials. Project requirements: Forced degradation study A forced degradation study will be performed to confirm the stability indicating assay method. The offeror will include a chiral method in the forced degradation study to ensure that S-isomer is not produced in the stability study. Chiral HPLC: ChiralPac OJ 4.6x250 mm, MeOH/DEA = 100:0.1, 1 mL/min., 85 bar, 30 C, 15 min. Assay methods transfer The contractor will transfer and qualify the HPLC method for R-VK4-116 by using the validated report. Dissolution validation of the capsule dosage form will occur at specific time points following USP <711> guidance. The validated methods on assay and dissolution test will be provided. Stability studies of R-VK4-116 capsules and placebo capsule Stability of each batch of R-VK4-116 and placebo will be monitored for assay, impurities, appearance, dissolution and yearly bioburden at labeled storage condition (2-8C) for three years (3, 6, 9, 12, 18, 24 and 36 month timepoints), at intermediate condition (room temperature) for 12 months (3, 6, 9 and 12 month timepoints) and at accelerated condition (40C, 75%RH) for 6 months (3, and 6 month timepoints). The placebo batches will be monitored under the same conditions, and at the same time intervals. The final product release data will also serve as the zero time stability point. Anticipated period of performance: Period of Performance April 1, 2024 – June 30, 2027 Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Michelle Cecilia at michelle.cecilia@nih.gov The response must be received on or before March 18, 2024, at 4:30 pm, Eastern Standard Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”
Data sourced from SAM.gov.
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