Justification and Approval Redacted.docx

Justification for Other than Full and Open Competition

Template

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Food and Drug Administration (FDA), Department of Health and Human Services

b. Sponsoring organization.

CDER/OTS/OCP

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Maryanne Dingman ii. Mailing address: Building 51, Rm 3247, 10903 New Hampshire Avenue, Silver Spring, MD 20993

iii. E-mail address: Maryanne.Dingman@fda.hhs.gov iv. Telephone number: 301-796-8777

2. Nature and/or description of the action being approved. Office of Clinical Pharmacology - Renewal of Certara Simcyp.

a. Acquisition purpose and objectives.

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to Certara UK Limited. This acquisition is in support of the FDA’s drug and biologics review functions.

b. Project background.

Sponsors (pharmaceutical companies, academic institutions, and individuals) submit Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions for FDA approval. The tools provided in CERTARA SIMCYP are unique in their application and breadth. In particular, sponsor submissions created using CERTARA SIMCYP require the same software be used to provide independent validation of sponsor results.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

CERTARA SIMCYP software and support - base year - 21Sept2022 to 20Sept2023 Fees - $114,316

a. Project title.

Office of Clinical Pharmacology - Renewal of CERTARA SIMCYP

b. Project Description.

Renewal of Certara Simcyp for CDER drug review.

Requirement type.

☐ Research & Development (R&D) ☐ R&D support services ☐ Support services (non-R&D) ☐ Supplies/equipment ☒ Information Technology (IT) ☐ Construction ☐ Architect-Engineer (A&E) services ☐ Design-build ☐ Other:

Type of action.

☒ New requirement ☐ Follow-on ☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price ☐ Other fixed-price:

☐ Cost-plus-fixed-fee ☐ Other cost reimbursement:

☐ Time and materials ☐ Indefinite delivery:

☐ Other:

☐ Completion Form ☐ Term Form

Acquisition identification number.

1226258

c. Total estimated dollar value and performance/delivery period.

CERTARA SIMCYP software and support - base year - 21Sept2022 to 20Sept2023 Fees - $114,316

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☒ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☐ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Certara UK Limited Simcyp Division Level 2-Acero, 1 Concourse Way Sheffield, UK S1 2BJ

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Sponsors (pharmaceutical companies, academic institutions, and individuals) submit Investigational New Drug (IND) application, New Drug Applications (NDAs), Biologics Licensing Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and other submissions for FDA approval. The tools provided in Simcyp are unique in their application and breadth. The Simcyp software is a special tool for physiologically based pharmacokinetic (PBPK) analysis. It integrates historical knowledge on human physiology, drug physicochemical properties, and pharmacokinetic properties to serve as a tool to evaluate drug in vivo performance. Developing a PBPK model is not a trivial task. Sponsors have been using the Simcyp tool both for internal decision making as well as to support regulatory submission and decision making. Simcyp’s proprietary algorithm incorporates stakeholders/ end user data and requirements. The amount of historical data and research already collected would be lost should another company develop a new algorithm.

It is estimated that it would take 10 full time PhD clinical pharmacologists 3 years to replace the functionality of Simcyp at a cost of $800,000 per year to total $2,400,000. The historical data and research already collected would still be lost in this scenario.

Another unique qualification is it is imperative that the FDA use the same software for all sponsor submissions so that it provides independent and consistent validation of sponsor results. The FDA has been utilizing Simcyp for the last 10 years and any change in this software could potentially thwart all analysis of prior sponsor submissions. It is impossible for FDA reviewers to repeat the sponsor’s analysis using a different platform within the review cycle. Especially, sponsors have been using PBPK analyses in many expediated and priority programs with short review timelines. Any delay in analyzing data submitted by sponsors would affect PDUFA deadlines and approvals.

In terms of impact not having Simcyp available would immediately stop the work of approximately 100 GS14 level drug reviewers and researchers in the Office of Clinical Pharmacology, Office of Generic Drugs, Office of Pharmaceutical Quality, and Center for Veterinary Medicine resulting in BLA and NDA deadlines being missed and putting the Agency in violation of the Biosimilars User Fee Act, the Generic Drug User Fee Act, and the Prescription Drug User Fee Act. FDA approval decision of drug applications is based on evidence by all disciplines 21st drug review process using all the review tools (in this case for the discipline of clinical pharmacology assessment tool‐Simcyp) for the best interest of all stakeholders including regulators, pharmaceutical companies and patients to bring new drugs to the market as quickly as possible. If there is a delay in drug review due to lack of clinical pharmacology tools, the regulators are answerable to congress, pharmaceutical sponsors will have financial repercussions, and patients will not have access to needed drugs.

Certara is the sole proprietor of Simcyp and does not have any resellers of their product nor utilizes any best in class vehicles.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The Contract Specialist has performed a survey of potential and archived acquisitions of Certara Simcyp on FBO. The only solicitations found and listed were archived and were posted by the FDA beginning in 2017.

The following solicitations were posted to FBO as “brand name or equivalent” with no bids outside of Certara (previously Simcyp LTD): 2019 Order 1209332 $65,000, 2018 Order HHSF223201810279P $65,000, 2017 Order HHSF223201710417P $65,000 The Contract specialist has posted a Notice of Intent to Sole source to FBO and no interested parties have come forward with the intent to compete.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Prior to the award of the proposed contract, pricing information will be obtained from the contractor and price analysis will be performed and documented to sufficiently determine that the order represents a fair and reasonable price to the Government.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted by technical representatives to determine the availability of the functionality required to meet the Federal Government’s needs. Medical journals and trade magazines were analyzed to identify potential substitutes to Certara Simcyp software; however, substitute software packages were deemed to be insufficient to meet the Government’s requirements. Specifically, R-Project R software and SAS Institute SAS software can be used to perform many of the analyses required. However, these applications are not capable of opening Certara Simcyp files that are submitted by pre-market drug application sponsors and would require extensive retraining of FDA drug review staff. Interviews with subject matter experts throughout the FDA indicated that FDA cannot transition away from Certara Simcyp software in the immediate term since significant inefficiencies in the conduct of drug review activities would result, leading to delays in the review of premarket drug applications. This would cause the Agency to be in violation of statutory requirements as defined by the Biosimilars User Fee Act, the Generic Drug User Fee Act, and the Prescription Drug User Fee Act.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed interest in this requirement.

10. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________ COR/Requiring Activity POC

Signature:____________________________________ COR/POC Immediate Supervisor

Signature:____________________________________ Head of the Sponsoring Program Office

11. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________ Contracting Officer Last Modified: April 5, 2017 Page 1 of 7

Last Modified: April 5, 2017 Page 1 of 7

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