EVALUATION_CRITERIA.pdf

Attachment Number Four –Evaluation Criteria HHS-NIH-NIDA(SSSA)-14-431

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EVALUATION CRITERIA

Mandatory Evaluation Criteria

The solicitation contains the following mandatory qualification criteria specific to each discipline:

1. Chemical Manufacturing and Controls (CMC/Pharmaceutics)

• An advanced degree in a physical science, chemistry degree preferred

• 15 years of CMC experience; small molecule experience required

• Previous experience in the preparation and submission of the CMC components of

IND/CTA/NDA/MAAs

2. Process Chemistry

• An advanced degree in a physical science discipline is required. Chemistry degree preferred.

• 15 years of process and chemical development experience; small molecule experience is required.

• Previous experience in the preparation and submission of the CMC components of IND, CTA, NDA, and MAAs

3. Medicinal Chemistry

• An advanced degree in a physical science discipline is required. Chemistry degree preferred. Equivalent experience may be accepted.

• 15 years of medicinal chemistry experience leading chemistry efforts performed by contract research organizations and managing drug project portfolios preferred.

4. Regulatory Affairs

• An advanced degree in a scientific discipline is required. Equivalent experience may be accepted.

• 10 years’ experience in the pharmaceutical or other related industry is required.

• 7 years hands-on Regulatory Affairs experience in the pharmaceutical industry dealing with combination products and/or medical devices. Experience in reviewing, editing and overseeing multiple IND filings.

5. Bioactivity Assay Development

• An advanced degree in a life science discipline is required.

• 10 years’ experience in the pharmaceutical or other related industry is required.

• Demonstrated expertise in the development and application of assays in industrial pharmaceutical discovery and development.

• Demonstrated application of automated technologies and robotics relevant to pharmaceutical assays.

6. Toxicology

• Current DABT Board certification preferred; small molecule and CNS experience preferred.

• Experience drafting, reviewing, and editing toxicology section of regulatory filings e.g.

IND’s.

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7. Drug Metabolism and Pharmacokinetics

• An advanced degree in a life/physical science discipline is required.

• 10 years’ experience in pharmacokinetics and drug metabolism of small molecules.

• Experience providing DMPK project leadership in support of small molecule drug discovery programs and/or experience providing DMPK leadership to development teams.

8. Phase I Clinical

• An advanced degree in a scientific discipline is required PhD or MD

• 7 years hands-on Clinical Trial experience in the pharmaceutical industry dealing with small molecule drug projects.

• Experience in reviewing, editing and overseeing multiple Phase I clinical trials protocols, reports, and regulatory filings.

The mandatory qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award.

Technical Evaluation Criteria

Proposals will be scored based on the following three (3) technical evaluation criteria.

Professional Experience in Drug Development –50 points

Offerors shall be evaluated based on hands-on and management experience in drug discovery and development projects, explicitly applicable to at least one of the consulting expertise areas and corresponding descriptions listed in the statement of work.

Evaluations shall be based on demonstrated expertise and experience in executing and managing drug development tasks, particularly for nervous system conditions.

Reviewers shall consider the Offerors years of experience in the claimed consulting area(s) of expertise, breadth of expertise, and track record in drug development projects that go through to the clinic. Measures of success include preparation of successful IND, CTA, NDA, and MA applications, as well as publications, patents, and work on drugs brought to market. In addition, experiences 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 as signs of a strong track record in drug development.

Education and Qualifications in Drug Development – 30 points

Offerors shall be evaluated for a combination of advanced education, board certifications, and other advanced expertise explicitly applicable to at least one of the consulting expertise areas and corresponding descriptions listed in the statement of work. Evaluations shall be based on their in-depth understanding of the drug development process, including regulatory procedures and guidelines where relevant, especially in small molecule drug development for CNS indications.

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Experience with Collaborative Teams – 20 points

Offerors shall be evaluated based on previous experience working 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 as illustrations of collaborative work.

Individual consultants and consulting companies that meet the Small Business size standard identified for this requirement are invited to apply to this Request for Quotation (RFQ).

Total Possible Points - 100