SPECIAL NOTICE
A -- Development of Novel Drug Particles for Inhalational Therapy
- Notice Date
- 5/14/2024 5:27:13 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- DEFENSE HEALTH AGENCY (DHA)
- ZIP Code
- 00000
- Response Due
- 5/21/2024 7:00:00 AM
- Archive Date
- 06/05/2024
- Point of Contact
- Shelley A. Wallace, Emily K. O'Hara
- E-Mail Address
-
shelley.a.wallace2.civ@health.mil, Emily.K.OHara.civ@health.mil
(shelley.a.wallace2.civ@health.mil, Emily.K.OHara.civ@health.mil)
- Description
- THIS IS A REQUEST FOR INFORMATION (RFI) ONLY ���� This RFI is issued solely for information and planning purposes � it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Solicitations are not available at this time. Requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. USAMRAA is issuing this RFI as a means of conducting market research to identify parties having an interest in and the resources to support the requirement identified in the attached DRAFT Statement of Objectives (SOO) - Development of Novel Drug Particles for Inhalational Therapy Developing Novel, Super-Critical Precipitated Drug Products suitable for Inhaled Drug Delivery for Pulmonary Infections The primary objective of this requirement is to develop novel, super-critical precipitated drug products suitable for inhaled drug delivery for the treatment of pulmonary infections. The formulated drug products to be used must be able to fit within the following parameters: Particle Size: ~0.5-5 �m Surface Area: 15-100 m2/g while retaining required particle size Drug excipient use: <5% w/w of total particle The overall product parameters should be generally accepted to be compatible with an inhaled drug product with deep lung deposition and long retention times. The ability to deliver long-lasting antimicrobials to the lungs would provide a novel, highly advantageous medical countermeasure that would be easily deployable with the Warfighter. However, a critical component of the development of such countermeasure is engineering a product suitable for long-lasting pulmonary deposition due to limitations of older technologies that rely on large amounts of excipients and have unoptimized particle sizes. For pulmonary delivery, only particles of a certain range (~0.5-5 �m) are expected to be retained in the lung. A high surface area on particles of this size (~15-100 m2/g) will ensure a longer-acting affect within the lung tissue and avoid rapid dissolution into systemic circulation. Layering these two requirements together leads to large surface area microparticles (LSAM) that have the benefits of both parameters simultaneously. In addition, the requirement for no-to-low excipient use ensures that a smaller total delivered dose is used and will allow for micronization of downstream delivery platforms. There currently exist LSAM used in oncology in clinical trials, which would boost confidence in this approach in terms of a proven track record to produce cGMP material. However, this current requirement focuses on the development of antimicrobials of specific interest to the biodefense community and will require an iterative testing and evaluation workflow that will require multiple types of solid/crystalline forms of various drugs to be processed and then empirically testing in animal models. In this requirement, the Contractor will be optimizing processes active drug products (API) purchased through commercial vendors and providing various lots of material for testing in animal exposure chambers suitable for dry-powder drug delivery. The information requested by this request, will be used within USAMRAA and USAMRIID to facilitate decision making and will not be disclosed outside of USAMRAA or USAMRIID. If the information provided contains propriety information, such information must be identified with appropriate disclaimer. If your organization has the potential capacity to perform these contract services, please provide the following information: Fill out the chart (Organization name, address, website address, size and type of ownership for the organization, Cage Code, Unity Entity ID (from SAM.gov)) and point of contact including their title, telephone number and email address; Tailored capability statements addressing the particulars of this effort, with appropriate documentation to support claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The capability statements shall address, at a minimum, the following items: What type of work has your company performed in the past in support of the same or similar requirement? Can or has your company managed a similar task of this nature? If so, please provide details. Can or has your company managed a team of subcontractors before? If so, provide details. What specific technical skills does your company possess which ensure capability to successfully fulfill this requirement? The Government will evaluate market information to ascertain potential market capacity to: Provide supply / services consistent, in scope and scale, with those described in this RFI and otherwise anticipated; Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; ADDITIONAL INFORMATION AND SUBMISSION DETAILS Fill in the below table and include it with your submission: Company Name Company Address Point of Contact Phone Number E-mail Address Cage Code Unique Entity ID Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not System for Award Management (SAM) Registered Other Classifications (e.g. 8(a), HUBZone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned) If 8(a), date that the company graduates from the program. Interested parties capable of providing the requirements described in this RFI are requested to submit a Capabilities Statement of no more than ten (10) pages in length in Times New Roman font of no less than 10 pitch. All submissions shall be submitted in either Microsoft Word or Portable Document Format (PDF). Responding to this request with generic material only such as brochures, advertisements or other generic material is highly discouraged. Vendors are encouraged to provide questions regarding any ambiguities noted within the requirement description. The Government welcomes input and will accept questions pertaining to this RFI; however, the Government reserves the right to answer or not to answer all questions received. Questions pertaining to this RFI are due by 1300 ET on 17 May 2024. Only one set of questions per vendor will be accepted. Contact with Government personnel, other than those specified in this request, by potential vendors or their employee�s regarding this requirement is not permitted. All responses to this RFI must be provided via email no later than (NLT) 1000 Eastern Time on 21 May 2024 to Emily O�Hara via email at emily.k.ohara.civ@health.mil and to Shelley Wallace via email at shelley.a.wallace2.civ@health.mil. No extensions will be granted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/af157e8096fe4d97973e1221481da08b/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN07062972-F 20240516/240514230041 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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