SOURCES SOUGHT
R -- Drug Discovery and Business Development consultants - SSN
- Notice Date
- 10/25/2019
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- N02DA-20-1003
- Archive Date
- 3/25/2020
- Point of Contact
- Polina Klimenkova, Phone: 301-827-6848
- E-Mail Address
-
polina.klimenkova@nih.gov
(polina.klimenkova@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE NUMBER: N02DA-20-1003 SOURCES SOUGHT NOTICE NUMBER: N02DA-20-1003 PROJECT TITLE: Drug Discovery and Development consultants and Business Development consultants for the NIDA Step Up for Substance Use Disorder (SUD) program: Drug target initiative for scientists Engaged in Fundamental Research THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. The purpose of this notice is to obtain information regarding: 1. The availability and capability of any qualified small business or other-than-small business sources; 2. Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; or other-than-small businesses; and 3. Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The applicable NAICS code for this acquisition is 541690 - Other Scientific and Technical Consulting Services. Responses to this notice will be accepted from all businesses under this NAICS code. Responses should clearly state whether the respondent is considered a small or other-than-small business under this NAICS code. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background Information: NIDA has published a notice of intent to publish a Funding Opportunity Announcement (FOA), "Step Up for Substance Use Disorder (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research." The new program will provide up to 50 short-term awards to conduct experiments aiming to expand the range of drug targets and mechanisms for SUD therapies. In addition, NIDA will provide in-kind access to drug discovery and development expertise, business strategy and commercialization support, and assistance in the company/startup formation, as needed. For each project funded under this FOA, the NIDA will assemble an NIH expert panel called a Project Development Team (PDT) comprising of Program Official (PO), Science Officer (SO), the Principal Investigator/Project Director (PI/PD) and appropriate NIH expert consultants. Together, the team will create a credible thesis for how the PI/PD will address an important SUD issue in a transformative way, differentiate from other approaches, and create a path for progressively de-risking that opportunity. The PDT will help the PD/PI establish an overall strategy for the project, including identifying the critical value inflection point to determine what needs to be done in the preceding stage to make the technology attractive to the potential partners. To provide the in-kind access to biomedical product development expertise, business strategy and commercialization support, and assistance in the company/startup formation that will be critical to the success of the program, NIDA is publishing this notice. Purpose for the Procurement: The purpose of this requirement is to procure services of (a) small molecules and biologics drug discovery and development consultants and (b) business development consultants to provide technical and business development recommendations to the NIDA Step Up for substance use disorder (SUD) program. Project Requirements: The drug discovery and development consultants shall provide small molecules and biologics drug discovery and development consulting support services to the NIDA Step Up for Substance Use Disorder (SUD): Drug target initiative for scientists Engaged in Fundamental Research program for small molecules and biologics drug discovery and development. The business development consultants shall provide business development consulting support services to the NIDA Step Up for Substance Use Disorder (SUD) Drug target initiative program in the area of Substance use disorder drug discovery and development. Consultants will be expected to provide senior-level expertise and contribute feedback and guidance on projects to the NIH and to PDT members through conference calls and by email. Specific Requirements for Small Molecules and Biologics Drug Discovery and Development Consultants: The role of the drug discovery and development consultants may include but is not limited to the following responsibilities and tasks: • Offer input on project milestones, target product profiles, and testing funnels; • Review of study protocols and reports for scientific merit; • Advice on early-stage development planning, nonclinical pharmacology for biologics and/or small molecules; • Provide feedback on research strategy proposed by the investigator; • Provide guidance on the design and interpretation of proposed in vivo assays, such as cognitive and behavioral tests; • Evaluate SAR data on a bimonthly basis; • Evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays; • Assist in the establishment of milestones related to assay optimization or validation; • Identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines; • Evaluate the potential tractability (including surrounding IP space) of a chemical structure for medicinal chemistry; • In partnership with the NIH staff, advise, and strategically plan to facilitate exploratory chemistry, hit-to-lead, and lead optimization; • Serve as the expert in order to identify potential drug discovery and development challenges and suggest strategies to address these challenges; • Collaborate on design of studies in support of NIDA drug discovery projects; and • Participate in Project Development Team discussions via telephone and email regarding assigned projects. The Contractor employee providing services for this effort shall be considered Key personnel. Key Personnel requirements are as follows: General requirements: • Consultants must have extensive experience in managing or being a senior leader in small molecules and biologics drug discovery projects for the SUD or/and nervous system conditions in the biopharmaceutical industry. Experience with drug discovery for substance use disorder conditions is preferred. • Consultants must be able to work in a cross-functional team environment and manage competing priorities. • Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy. • Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Education and work experience requirements: • An advanced degree in biological sciences or translational sciences is required. • Minimum of 15 years of small molecules and biologics drug discovery and development experience in the area of substance use disorder research or/and nervous system conditions. • Experience in executing and managing drug development tasks, particularly for substance use disorder and /or nervous system conditions. • A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market. • Previous experiences in identifying and anticipating problems early in a project, overcoming technical difficulties and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record in drug development. • Expertise leading drug discovery and development performed by contract research organizations and managing drug project portfolios. Estimate Of Effort: The estimated effort for this requirement is contractor employees on a part-time basis for up to fifty (50) anticipated projects and up to 800 hours. Under Option Quantity 1, the Contractor shall devote up to 800 additional person hours in performance of the Small Molecules and Biologics Drug Discovery and Development consultant services described above. The government may exercise Option Quantity 1 up to five (5) times during each year of the contract. Specific Requirements for Business Development Consultants: The role of the business development consultants may include but is not limited to the following responsibilities and tasks: • Source and generate business plans which include milestones and clear exit strategies from application pool (drug candidates) by evaluating the commercial, regulatory, and development feasibility; • Perform target due diligence and competitor analysis using public and private drug development databases such as Citeline Pipeline, Thomson Reuters' Integrity, FDA Orange Book, USPTO, and Clinical Trials.gov; • As the exit strategy for projects coming out of the NIDA's Step Up for Substance Use Disorder program identify and assist in establishing the collaboration with investors who may become the collaborators, investors or the business partners of the successful projects; • Help to identify Contract Research Organizations (CROs) for the applicants which may be required for future work on the NIDA's Step Up for Substance Use Disorder program; • Advise teams on how to negotiate the term sheet on investment opportunities with multiple stake holders including technology transfer offices, founders, venture firms, and pharmaceutical companies; • Identify strategic partnerships with academic research organization, technology transfer offices, life science accelerators/incubators, pharmaceutical companies and investors to inform them about the projects of the NIDA's Step Up for Substance Use Disorder program; • Serve as the expert to identify potential business development challenges and suggest strategies to address these challenges; and • Participate in Project Development Team discussions via telephone and email regarding assigned projects. The Contractor employee providing services for this effort shall be considered Key personnel. Key Personnel requirements are as follows: General requirements • Consultants must have extensive experience in managing or being a senior leader in the business development of drug discovery projects for the SUD or/and nervous system conditions in the biopharmaceutical industry. Experience in the business development of the drug discovery projects for substance abuse disorder conditions is preferred. • Consultants must be able to work in a cross-functional team environment and manage competing priorities. • Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy. • Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Education and work experience requirements: • An advanced degree in biological sciences or translational sciences and/or business administration is required. • Minimum of 15 years of business development experience in biopharmaceutical industry, preferably, in the area of substance abuse disorder research or/and nervous system conditions. • Experience in executing and managing business development tasks, preferably, in the projects for substance use disorders and /or nervous system conditions. • Experience in conducting business due diligence, including competitor analysis, market opportunity analysis, and identification of the risk mitigation strategies. • Previous experience in identifying and anticipating business development problems early in a project, overcoming business development difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record. • Experience in licensing technology, starting startups, and negotiating term sheets with investors to raise seed and Series A funding (Angel Networks, VC, CVC, and/or Private Equity). • Experience in commercial forecasts and valuation of new products, and in assessment of licensing and acquisitions of new drug products. Estimate of Effort: The estimated effort for this requirement is contractor employees on a part-time basis for up to fifty (50) anticipated projects and up to 600 hours. Under Option Quantity 2, the Contractor shall devote up to 600 additional person hours in performance of the business development consultant services described above. The government may exercise Option Quantity 2 up to four (4) times during each year of the contract. Anticipated Period of Performance: The anticipated period of performance is one 12-month base period and two 12-month option periods, with additional Option Quantities as described above. Capability Statement/Information Sought: Contractors that believe they possess the ability to provide the services and resources described above should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations should demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform all of the above tasks. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. All capability statements must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as, if applicable. Capability statements must be submitted electronically via email to polina.klimenkova@nih.gov NO LATER THAN November 12, 2019 at 10:00 AM (EST). Electronic capability statements will be accepted in the form of a single PDF file with the subject line: "Capability Statement # N02DA-20-1003. Primary Point of Contact: Polina Klimenkova, Contract Specialist polina.klimenkova@nih.gov 301-443-6677 Secondary Point of Contact: Andrew R. Hotaling, Contracting Officer andrew.hotaling@nih.gov 301-443-6677 THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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). 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N02DA-20-1003/listing.html)
- Record
- SN05482937-W 20191027/191025230404-cdeffd13cca88e2005270bfba678aeee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |