Advancing the Development of Pediatric Therapeutics II: Evaluation of Long-term Neurocognitive Development in Pediatrics Lynne P. Yao, M.D. Acting Director,

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Presentation transcript:

Advancing the Development of Pediatric Therapeutics II: Evaluation of Long-term Neurocognitive Development in Pediatrics Lynne P. Yao, M.D. Acting Director, Division of Pediatric and Maternal Health Office of New Drugs Center for Drug Evaluation and Research FDA

2 Pediatric Drug Development General Principles Pediatric patients should have access to products that have been appropriately evaluatedPediatric patients should have access to products that have been appropriately evaluated Product development programs should include pediatric studies when pediatric use is anticipatedProduct development programs should include pediatric studies when pediatric use is anticipated From FDA guidance to industry titled E11 - Clinical Investigation of Medicinal Products in the Pediatric Population, December 2000

3 Pediatric Drug Development Laws Best Pharmaceuticals for Children Act (BPCA)Best Pharmaceuticals for Children Act (BPCA) –Provides a financial incentive to companies to voluntarily conduct pediatric studies –FDA and the National Institutes of Health partner to obtain information to support labeling of products used in pediatric patients Pediatric Research Equity Act (PREA)Pediatric Research Equity Act (PREA) –Requires companies to assess safety and effectiveness of certain products in pediatric patients

4 Effect of Pediatric Legislation 563 Pediatric Labeling changes since enactment of BPCA and PREA563 Pediatric Labeling changes since enactment of BPCA and PREA –163 changes based on studies performed under BPCA –274 changes based on studies performed under PREA –76 changes based on studies performed under both BPCA and PREA Average of 37 labeling changes/year ( )Average of 37 labeling changes/year ( ) –High in 2008 (58 labeling changes) –Low in 2003 (23 labeling changes)

5 Pediatric Labeling Changes (CDER and CBER)

Objectives of ADEPT Workshops Consider important drug development issues that are specific to pediatric patientsConsider important drug development issues that are specific to pediatric patients Seek input from important academic, industry, and patient and professional group stakeholdersSeek input from important academic, industry, and patient and professional group stakeholders Not intended to be an Advisory Committee meetingNot intended to be an Advisory Committee meeting Not intended to provide specific advice about a specific productNot intended to provide specific advice about a specific product

Objectives for Today What are the strengths and limitations of current tools and standards of measurement of neurocognitive and behavioral function in children?What are the strengths and limitations of current tools and standards of measurement of neurocognitive and behavioral function in children? How can short- and long-term neurocognitive and behavioral outcomes in pediatric patients be assessed?How can short- and long-term neurocognitive and behavioral outcomes in pediatric patients be assessed? Session I: Chair: Peter Como, M.D.Session I: Chair: Peter Como, M.D. –Review and discuss currently available measurement tools to assess normal neurocognitive development in children Session II: Chair: Philip Sheridan, M.D.Session II: Chair: Philip Sheridan, M.D. –Review and discuss neurocognitive safety signals identified in animal and human studies Session III: Chairs: Heather Adams, Ph.D., and Elsa Shapiro, Ph.D.Session III: Chairs: Heather Adams, Ph.D., and Elsa Shapiro, Ph.D. –Review and discuss strategies and study design considerations in the evaluation short- and long-term neurocognitive and behavioral outcomes in pediatric patients

Housekeeping Order lunch your lunch now!Order lunch your lunch now! –Order at the kiosk for $11.00 Cellphones and other noisy devices off!Cellphones and other noisy devices off! Facilities and amenitiesFacilities and amenities Please see our staff outside for any other questionsPlease see our staff outside for any other questions

Thanks To all of the distinguished speakers and panelistsTo all of the distinguished speakers and panelists To the planning committee, especially:To the planning committee, especially: –Heather Adams and Elsa Shapiro –Denise Pica-Branco –Len Kapcala and Philip Sheridan –Peter Como –Dianne Murphy and Ann McMahon