Intent to Sole Source: ICON NONMEM

Added: Jun 12, 2018 5:56 pm The U.S. Food and Drug Administration (FDA), Rockville, MD intends to award a firm-fixed price contract for renewal software and maintenance of ICON NONMEM. FDA intends to issue an award, to ICON Clinical Research LLC. at 2100 Pennbrook Parkway, North Wales, PA 19454-4140.

FDA's Office of Clinical Pharmacology uses ICON NONMEM to review and analyze clinical pharmacology and pharmacometric data. The deliverables include the ICON NONMEM software package, enterprise software licenses (200+ packs/800+ FCUs), maintenance/support, and software updates.

There are no set-aside restrictions for this procurement, and date of delivery is anticipated to be 7/15/2018. ICON Clinical Research LLC. offers a product with capabilities that are not available from any other vendor, and controls all propriety rights for this product:

1. The FDA has an ongoing business need for the ICON NONMEM software and maintenance. The annual software licensing is required by FDA to ensure continuity of operations.

2. The ICON NONMEM are not available via GSA Schedule.

The Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. Interested entities may identify their interest and capability to respond to the requirement or submit proposals.

Interested entities offering Equal to products must demonstrate the products meet the following salient characteristics:

The software must be Windows 10 64 bit compatible and capable of directly analyzing output files produced by industry sponsors using ICON NONMEM software. It must possess the following salient characteristics:

o The following population analysis methods must be available: First Order Conditional Estimation (FOCE)
o Laplace Conditional Estimation
o Iterative Two Stage (ITS)
o Importance Sampling Expectation-Maximization (IMP)
o Stochastic Approximation Expectation-Maximization (SAEM)
o Markov-Chain Monte Carlo Bayesian Analysis (BAYES)
o Parallel computing of a single problem over multiple cores or computers
o Dynamic memory allocation according to problem size.
o Capable of using the first-order conditional estimation method.
o Multiple mixed effects levels, with random effects across groups of individuals such as clinical sites
o Symbolic reference to thetas, etas, and epsilons.
o Variance matrix parameters output in covariance and correlation format.
o Variance matrix parameters in covariance, correlation, or Cholesky format.
o Enhanced annealing feature for SAEM to facilitate estimation of fixed effect parameters (THETAs) that do not have associated inter-subject variance (ETA's).
o Boot-strap simulations
o Perform Monte Carlo search of population parameters, and select the set that provides the lowest starting objective function for an estimation.
o Perform Monte Carlo search for initial best estimates of etas for each subject. Together with a Monte Carlo search of best initial population parameters, this provides a global search technique for the traditional methods, with less reliance on starting position for incidence of success.
o FOCE/Laplace and ITS assessment using only numerical eta derivatives for search of best etas and/or eta Hessian matrix assessment.
o Conditional Individual Weighted Residual (CIWRES) added to residual variance diagnostics. Includes evaluation for L2 correlated data as well.
o Allow input and reporting of thetas in their natural domain, even when linear Mu referencing.
o XML report files
o Nelder-Mead optimization option for best fit individual etas
o Option to use either eigenvalue square root or Cholesky square root algorithms for assessing weighted residual diagnostics.
o Analytical and numerical derivatives of predicted and residual variance values with respect to etas
o Features to facilitate stochastic differential equations (SDE).

This notice is not a request for proposal and a solicitation will not be issued in conjunction with the notice of intent. Any vendor that believes it can provide the stated supplies/equipment can provide supporting documents demonstrating their products capability and specifications statement. The FDA will review all responses received; however, the Government retains the sole discretion not to further compete the proposed acquisition based on responses to this notice. Information can be sent to Jody O'Kash at Jody.OKash@fda.hhs.gov. All correspondence must contain the notice number: FDA-18-PRESOL-1198202 and Project Title: ICON NONMEM. No telephone or facsimile requests will be accepted.