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Project Showcases: Beyond a Legacy of Academia
Emil Tsai, Chief Executive Officer, SyneuRx International (Taiwan) Corp
. Bridging the insurmountable gaps from academia to new drug development
. Establishing a scientific platform by confirmation of multiple converging new drug targets
. Incremental success can lead to paradigm shift in CNS drug discovery
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Considerations in Designing Phase 2/3 Registrational Trials for NaBen® as Adjunctive Therapy to Standard-Of-Care
Minimizing placebo responses
• Clinician training
Understand placebo responses
Do¡¦s and Don¡¦ts training to minimize physician cues that might induce placebo responses
Script of honest answers to the assessment interview
Optimizing signal-to-noise in assessing patient responses
• Proprietary Quality Control algorithm to check quality and consistency in patient assessments
• Confirmation of the diagnosis and inclusion/exclusion criteria by central experts
• Standardize patient assessment processes
• Reminders to increase medication adherence and study follow-up
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Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 8 weeks after randomized treatment ]
Mean change from baseline in PANSS total score
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• Phase 2 trial for NaBen® (Lane et al; 2013) demonstrated a treatment effect size (ES) ~ 1.53
• Phase II/III registrational trial is designed to detect an ES >= 0.5 with 85% power
[ Cohen(1988)ªº«Øij¡A±N«¬¤@¿ù»~®e§ÔÈ©w¬°5%¥B«¬¤G¿ù»~®e§ÔÈ©w¬°20%¡A¤]´N¬O»¡¦pªG§Ú̱o¨ìªº¼Ë¥»¸ê®Æ©Ò±À½×ªºpȤp©ó0.05¥Bpower°ª©ó80%®É¡A¨âÓÃþ«¬¿ù»~µo¥Í¾÷²v³£ÆZ§Cªº´N¥Nªí¤£ºÞ¥À¸sÅéµ²ªG¬°¦ó¡A§Ú̱À½×ªºµ²ªG¥¦¥Ç¿ù¾÷²v³£¬O§Cªº¡A§ÚÌ´N·|¹ï³oÓµ²ªG«D±`ªº¦³«H¤ß¡I]
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Considerations in Designing Phase 2/3 Registrational Trials for NaBen® as Adjunctive Therapy to Standard-Of-Care
Minimizing placebo responses
• Clinician training
Understand placebo responses
Do¡¦s and Don¡¦ts training to minimize physician cues that might induce placebo responses
Script of honest answers to the assessment interview
Optimizing signal-to-noise in assessing patient responses
• Proprietary Quality Control algorithm to check quality and consistency in patient assessments
• Confirmation of the diagnosis and inclusion/exclusion criteria by central experts
• Standardize patient assessment processes
• Reminders to increase medication adherence and study follow-up
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Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 8 weeks after randomized treatment ]
Mean change from baseline in PANSS total score
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• Phase 2 trial for NaBen® (Lane et al; 2013) demonstrated a treatment effect size (ES) ~ 1.53
• Phase II/III registrational trial is designed to detect an ES >= 0.5 with 85% power
[ Cohen(1988)ªº«Øij¡A±N«¬¤@¿ù»~®e§ÔÈ©w¬°5%¥B«¬¤G¿ù»~®e§ÔÈ©w¬°20%¡A¤]´N¬O»¡¦pªG§Ú̱o¨ìªº¼Ë¥»¸ê®Æ©Ò±À½×ªºpȤp©ó0.05¥Bpower°ª©ó80%®É¡A¨âÓÃþ«¬¿ù»~µo¥Í¾÷²v³£ÆZ§Cªº´N¥Nªí¤£ºÞ¥À¸sÅéµ²ªG¬°¦ó¡A§Ú̱À½×ªºµ²ªG¥¦¥Ç¿ù¾÷²v³£¬O§Cªº¡A§ÚÌ´N·|¹ï³oÓµ²ªG«D±`ªº¦³«H¤ß¡I]
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Considerations in Designing Phase 2/3 Registrational Trials for NaBen® as Adjunctive Therapy to Standard-Of-Care
Minimizing placebo responses
• Clinician training
Understand placebo responses
Do¡¦s and Don¡¦ts training to minimize physician cues that might induce placebo responses
Script of honest answers to the assessment interview
Optimizing signal-to-noise in assessing patient responses
• Proprietary Quality Control algorithm to check quality and consistency in patient assessments
• Confirmation of the diagnosis and inclusion/exclusion criteria by central experts
• Standardize patient assessment processes
• Reminders to increase medication adherence and study follow-up
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Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 8 weeks after randomized treatment ]
Mean change from baseline in PANSS total score
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• Phase 2 trial for NaBen® (Lane et al; 2013) demonstrated a treatment effect size (ES) ~ 1.53
• Phase II/III registrational trial is designed to detect an ES >= 0.5 with 85% power
[ Cohen(1988)ªº«Øij¡A±N«¬¤@¿ù»~®e§ÔÈ©w¬°5%¥B«¬¤G¿ù»~®e§ÔÈ©w¬°20%¡A¤]´N¬O»¡¦pªG§Ú̱o¨ìªº¼Ë¥»¸ê®Æ©Ò±À½×ªºpȤp©ó0.05¥Bpower°ª©ó80%®É¡A¨âÓÃþ«¬¿ù»~µo¥Í¾÷²v³£ÆZ§Cªº´N¥Nªí¤£ºÞ¥À¸sÅéµ²ªG¬°¦ó¡A§Ú̱À½×ªºµ²ªG¥¦¥Ç¿ù¾÷²v³£¬O§Cªº¡A§ÚÌ´N·|¹ï³oÓµ²ªG«D±`ªº¦³«H¤ß¡I]
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August 8, 2017
Core-shell particles, preparation process thereof, and composition containing the same
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Assignee: SYNEURX INTERNATIONAL CORP. (Taipei, TW)
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