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Statistical Methodology for Characterization of Macromolecular Similarity

Award Number: U01FD005288
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2018

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Statistical Methodology for Characterization of Macromolecular Similarity - PROJECT SUMMARY/ABSTRACT As with any drug, approval of generic versions of macromolecular drugs requires rigorous evaluation of therapeutic equivalence to the reference drug in order to assure similar efficacy and safety. Compared with drugs that are small organic molecules, the chemical composition and characteristics of macromolecular drugs—typically proteins or polysaccharides—are inherently more variable because of the way these molecules are produced and isolated. It would be advantageous to have a way to determine molecular similarity and, by implication, equivalence without using costly in vivo testing in animals and humans. The specific aim of the proposal is to develop and test a robust data-driven statistical methodology for assessing similarity among distinct samples of therapeutic macromolecules, whether from different batches or altered processes, or even if produced by different entities entirely. The methodology is based on a genetic algorithm designed to extract relevant features from large, complex datasets. The hypothesis guiding the work is that with proper data interpretation and modeling, therapeutic equivalence can be inferred from molecular similarity determined using spectroscopic and chromatographic measurements that reveal the critical molecular attributes ultimately responsible for important properties of the generic and reference macromolecules: efficacy, side-effects, stability, and so on. Even without knowing how these attributes specify these properties, the fact that they do specify them means that this data is where equivalence can best be determined without going to in vivo testing. Data introduced into the model will be collected for multiple lots and batches of protein and polysaccharide drug substances and products. The data will come from an assortment of high-resolution mass-spectrometry methods, high-field nuclear magnetic resonance spectroscopy analyses, and several other spectroscopic and chromatographic methods used to characterize macromolecules in solution. Biological activity data will be obtained from outsource testing labs that have established assays in place. The outcome of the proposed research will be a working methodology for evaluation of similarity between generic and reference versions of any macromolecular drug. This will lead towards faster approval of generic versions of macromolecular drugs, and thereby to broader access and lower cost for these drugs which are critical to treating many serious diseases.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = -$709 )
2022	2016	BATTELLE MEMORIAL INSTITUTE	902 BATTELLE BLVD	RICHLAND	WA	99354	BENTON	USA	Food and Drug Administration Research	000	3	7/8/2022	NON-COMPETING CONTINUATION	-$709
														Subtotal = -$709

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	BATTELLE MEMORIAL INSTITUTE	900 BATTELLE BLVD	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	000	3	12/28/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	BATTELLE MEMORIAL INSTITUTE	902 BATTELLE BLVD	RICHLAND	WA	99354	BENTON	USA	Food and Drug Administration Research	000	3	12/29/2016	NON-COMPETING CONTINUATION	$0
2017	2016	BATTELLE MEMORIAL INSTITUTE	900 BATTELLE BLVD	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	001	3	6/21/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $200,000 )
2016	2016	PACIFIC NORTHWEST LAB, DIV OF BATTELLE MEMORIAL INST	POST OFFICE BOX 999	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	001	3	8/26/2016	NON-COMPETING CONTINUATION	$200,000
2016	2015	PACIFIC NORTHWEST LAB, DIV OF BATTELLE MEMORIAL INST	POST OFFICE BOX 999	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	000	2	12/22/2015	NON-COMPETING CONTINUATION	$0
														Subtotal = $200,000

Issue Date FY: 2015 ( Subtotal = $200,000 )
2015	2015	PACIFIC NORTHWEST LAB, DIV OF BATTELLE MEMORIAL INST	POST OFFICE BOX 999	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	000	2	8/10/2015	NON-COMPETING CONTINUATION	$200,000
														Subtotal = $200,000

Issue Date FY: 2014 ( Subtotal = $599,887 )
2014	2014	PACIFIC NORTHWEST LAB, DIV OF BATTELLE MEMORIAL INST	POST OFFICE BOX 999	RICHLAND	WA	99352	BENTON	USA	Food and Drug Administration Research	000	1	8/29/2014	NEW	$599,887
														Subtotal = $599,887

Grand Total All Awards = $999,178

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Statistical Methodology for Characterization of Macromolecular Similarity

Award Number: U01FD005288

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/10/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2018

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