Chemical Manufacturing and Controls (CMC) Pharmaceutical Consulting Services
Added: Jan 30, 2017 12:38 pm Chemical Manufacturing and Controls (CMC) Pharmaceutical Consulting Services Competitive Combined Synopsis/Solicitation HHS-NIH-NIDA-SSSA-CSS-2017-074INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items.The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2017-074 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541990 with a Size Standard of $15 Million. SET-ASIDE STATUSThis acquisition is 100% set aside for small businesses.ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition teshold. The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2005-95, dated January 19, 2017. The resultant contract will include all applicable provisions and clauses in effect tough this date. DESCRIPTION OF REQUIREMENT BackgroundThe National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives.The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support tough Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded tough an award to the PI; other research services are provided without cost to the PI tough NIH contracts.PurposeThe purpose of this requirement is to procure chemical manufacturing and controls (CMC) pharmaceutical consulting services in support of NIH Blueprint Neurotherapeutics Network drug discovery and development programs. Project RequirementsIndependently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between tee and ten hours weekly, inclusive of meeting and preparation time.The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory tough preclinical safety stages. Some projects will proceed to investigational new drug and clinical trial stages.The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows:• Evaluate Chemical Manufacturing and Controls [CMC] activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines.• Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN and LDTs. Develop CMC strategies which accord with US and international guidelines.• Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules.• Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules.• Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications.• Provide expertise in activities related to API development.• Recommend dose form selection and API development strategies for BPN efforts.• Develop plans to assist NIH BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies.• Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract with BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.• Assist NIH BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed.• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.Level of EffortThe estimated level of effort for this requirement is one (1) contractor employee on a part-time basis.The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. Accordingly, a minimum and maximum level of effort is anticipated. A minimum of 200 hours and a maximum of 800 hours of support is required annually. Hours above the annual minimum shall be exercised in increments of 20 hours, if needed, using FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.Government Furnished Information/PropertyNo Government furnished property shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party.Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for approval to store data longer.Key Personnel:The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follows: • A PhD in a scientific discipline• At least 10 years of experience providing small molecule chemical manufacturing and controls support services.The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.Travel:The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer's Representative prior to being finalized or invoiced. Contracting Officer approved and Contracting Officer's Representative-authorized travel shall not exceed $1,500.00 annually.Please note that time spent travelling may not be billed to the Government. Please see the Federal Travel Regulation for allowable travel expenses, such as fares, rental fees, mileage payments, and other expenses related to transportation per FTR §301-10.2.Information Security:The Contractor must ensure that any computer system used in the course of this contract shall include the following features:1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard. 4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx8. Any computers used in reference to this contract must be assessed for vulnerabilities.9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed. 11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication. 12. Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least tee of the following types of characters:a. capital lettersb. lower case lettersc. numeric charactersd. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)Data Rights: The National Institute of Neurological Disorders and Stroke shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," shall be incorporated into any resulting award by reference.Consultants who contribute to the creation of new intellectual property may, however, be named as co-inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator's institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NINDS Contracting Officer's Representative, for documentation purposes.Section 508 Compliance:Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies' electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board's Web site at https://www.access-board.gov/508.htm. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.Non-Personal Service Statement:The contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).Collaboration Requirements:It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Confidentiality of Information:Consultant(s) must guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on a drug development project to which the consultant is assigned by the NIH. The NIH has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature.Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified by the Contracting Officer's Representative when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else may only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer.Period of PerformanceThe required period of performance is a one-year base period from May 23, 2017 tough May 22, 2018 and four (4) subsequent one-year option periods.Place of PerformanceThe primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as needed basis.Contract TypeA Firm Fixed Price Contract with Options to Extend the Term of the Contract and Options for Increased Quantity Separately Priced Line Item is contemplated. Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT).RESPONSE FORMATResponses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and 2) a separate price quotation.The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages.The price quotation must include an hourly rate as well as extended pricing for the full level of effort of each contract period. Options for increased quantity must also be detailed, as in the example below. A summary of the whole contract price should all options be exercised must also be included. Base Period:Hourly Rate - $0.00 Hours - XXX Extended Price - $0.00Base Period Options for Increased Quantity: Hourly Rate -- $0.00 Hours Per Option - XXX Extended Price per Option for Increased Quantity - $0.00Please also include the following language in price quotations:"It is understood that a minimum of 200 hours is required during each contract period, as exercised, and that up to 800 hours may be exercised during each contract period in increments of 20 hours for all requirements exceeding 200 hours.It is also understood that a not-to-exceed value of $1,500.00 applies to each contract period and may be used with advance approval in accordance with the Federal Travel Regulation."Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."EVALUATION CRITERIAThe Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below:Factor 1: Key Personnel Professional Experience in Drug Discovery and Development Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to drug chemistry, manufacturing and control.Hands-on and leadership experience in drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably. Experience leading drug development teams from discovery tough clinical trials for one or more drugs shall also be viewed favorably. Key personnel professional experience shall also be evaluated for preparation of successful investigational new drug applications, as well as publications, patents, and work on drugs brought to market. In addition, experience showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered favorably.Finally, key personnel professional experience shall be evaluated for efforts involving compliance and familiarity with regulatory procedures and guidelines relevant to small molecule drug discovery development.Factor 2: Key Personnel Education & QualificationsKey personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to drug metabolism and pharmacokinetics shall be considered favorably.Factor 3: Key Personnel Collaborative Team ExperienceKey personnel proposed shall be evaluated for length and breadth of experience collaborating with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.Factor 4: Past PerformanceThe Contractor shall provide at least two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information:a. Name of Organizationb. Brief Description of Contractor's Responsibilitiesc. Point of Contact Name, Title, and Telephone NumberPast Performance shall be evaluated for relevance to the current requirement.EVALUATION METHODTechnical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:ExcellentThe following factors shall be considered for assignment of an "excellent" performance rating:• 10 years' experience leading small molecule drug CMC development team tough complete drug development process as demonstrated by holding a senior level position. • 15 years' participation in small molecule drug CMC development team toughout the drug development process. • Preparation and submission of CMC components of INDs for 5+ drugs.• 3+ years providing CMC consulting to small companies and academics.• PhD degree in chemistry or pharmaceutical sciences with adequate post-doctoral preparation and at least 15+ years CMC experience in the pharmaceutical industry. ORMS degree in chemistry or pharmaceutical sciences with adequate 20 years hands-on years CMC experience in the pharmaceutical industry. [MS degree + 6 years' work experience can be equated to a PhD with limited post-doctoral experience]. • Engaging the offeror is anticipated to represent a benefit to the BPN program.GoodThe following factors shall be considered for assignment of a "good" performance rating:• 10 years' experience leading small molecule drug CMC development team tough complete drug development process as demonstrated by holding a senior level position. • 15 years' participation in small molecule drug CMC development team toughout the drug development process. • Preparation and submission of CMC components of INDs for several drugs.• 1+ years providing CMC consulting to small companies and academics.• PhD degree in chemistry or pharmaceutical sciences with adequate post-doctoral preparation and at least 15+ years CMC experience in the pharmaceutical industry. ORMS degree in chemistry or pharmaceutical sciences with adequate 20 years hands-on years CMC experience in the pharmaceutical industry. [MS degree + 6 years' work experience can be equated to a PhD with limited post-doctoral experience]. • Engaging the offeror is anticipated to represent neutral risk to the BPN program.AcceptableThe following factors shall be considered for assignment of an "acceptable" performance rating:• 5 years' experience leading small molecule drug CMC development team tough complete drug development process as demonstrated by holding a senior level position. • 10 years' participation in small molecule drug CMC development team toughout the drug development process. • Preparation and submission of CMC components of INDs for several drugs.• PhD degree in chemistry or pharmaceutical sciences with adequate post-doctoral preparation and at least 10+ years CMC experience in the pharmaceutical industry. ORMS degree in chemistry or pharmaceutical sciences with adequate 15 years hands-on years CMC experience in the pharmaceutical industry. [MS degree + 6 years' work experience can be equated to a PhD with limited post-doctoral experience]. • Engaging the offeror is anticipated to represent limited risk to the BPN program.MarginalThe following factors shall be considered for assignment of a "marginal" performance rating:• Limited experience leading small molecule drug CMC development team tough the whole drug development process. • Limited experience leading a drug discovery and development team tough drug development process. • Limited experience in team preparation and submission of CMC components of INDs.• PhD degree in chemistry or pharmaceutical sciences without adequate post-doctoral preparation or CMC pharmaceutical industry experience. OR MS degree in chemistry or pharmaceutical sciences without adequate hands-on experience in pharmaceutical industry. [MS degree + 6 years' work experience can be equated to a PhD with limited post-doctoral experience]. • Engaging the offeror is anticipated to represent risk to the BPN program.UnacceptableThe following factors shall be considered for assignment of an "unacceptable" performance rating:• Lack of graduate degree in chemistry or pharmaceutical sciences.• Lack of or limited hands-on participation in a drug discovery and development team toughout the drug development process. • Lack of or limited experience leading small molecule drug CMC development team tough the whole drug development process. • Lack of or limited experience in preparation and submission of CMC components of INDs.Engaging the offeror as CMC consultant represents a high degree of risk to the BPN program.APPLICABLE CLAUSES AND PROVISIONSThe following FAR clauses and provisions shall apply to this solicitation:1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov.2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (October 2017), applies to this acquisition.3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (January 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management.4. FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (January 2017) is applicable to this acquisition.5. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 2017) apply to this acquisition. The following clauses shall be checked/included in this clause:a. 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006)b. 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015)c. 52.204-14, Service Contract Reporting Requirements (Jan 2014)d. 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015)e. 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013f. 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)g. 52.219-8, Utilization of Small Business Concerns (Oct 2014)h. 52.219-13, Notice of Set-Aside of Orders (Nov 2011i. 52.219-14, Limitations on Subcontracting (Nov 2011)j. 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013)k. 52.222-3, Convict Labor (June 2003l. 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016)m. 52.222-21, Prohibition of Segregated Facilities (Apr 2015)n. 52.222-26, Equal Opportunity (Apr 2015)o. 52.222-35, Equal Opportunity for Veterans (Oct 2015)p. 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)q. 52.222-37, Employment Reports on Veterans (FEB 2016)r. 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)s. 52.222-50, Combating Trafficking in Persons (Mar 2015)t. 52.222-54, Employment Eligibility Verification (OCT 2015)u. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011v. 52.225-13, Restrictions on Certain Foreign Purchases (June 2008)w. 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)6. FAR Clause 52.217-5: Evaluation of Options (July 1990) applies to this acquisition.7. FAR Clause 52.217-9: Option to Extend the Term of the Contract (March 2000) applies to this acquisition as follows:(a) The Government may extend the term of this contract by written notice to the Contractor within the contract period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least thirty (30) days before the contract expires. The preliminary notice does not commit the Government to an extension.(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four (4) years. 8. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."CONTRACTING OFFICER'S REPRESENTATIVEA Contracting Officer's Representative (COR) shall be assigned to the awarded contract.The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract.The Government may unilaterally change the COR designation for this contract.CLOSING INFORMATIONResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service.All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2017-074. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.
HHS-NIH-NIDA-SSSA-CSS-2017-074 Department of Health and Human Services National Institutes of Health
1/30/17, 12:38 PM