Workshop Agenda
Meeting Room - Kennedy Ballroom
8:00 a.m–8:10a.m. Welcome and review of Workshop goals/objectives (Dikoe Makhene, National Institute of Allergy and Infectious Diseases)
Clinical Spectrum and Pharmacokinetics (Session Chair: William Burman)
8:10 a.m.–8:20 a.m. Lack of involvement of children—History and consequences (Jeff Starke, Baylor University)
8:20 a.m.–8:45 a.m. Natural history of TB disease in children—Implications for trials (Ben Marais, Stellenbosch University)
8:45 a.m.–9:05 a.m. Pharmacokinetics in children (Greg Kearns, Children's Mercy Hospitals and Clinics)
Session II—Regulatory Perspectives (Session Chair: Eileen Navarro-Almario)
9:05 a.m.–9:15 a.m. Current status of investigational drugs and treatment regimens (Martino Laurenzi, Global Alliance for TB Drug Development)
9:15 a.m.–9:55 a.m. Regulatory considerations for involving children in drug development
- US (William Rodriguez)
- European Union (Mair Powell)
- India (Soumya Swaminathan)
- Peru (Nora Espiritu)
- China (Ya-jie Li)
9:55 a.m.–10:15 a.m. Regulatory panel discussion/questions
10:15 a.m.–10:35 a.m. Break
Session III—Trial Design Considerations (Session Chair: David McNeeley)
10:35 a.m.–10:45 a.m. HIV Model for pediatric drug development (Sharon Nachman, State University of New York, Stony Brook)
10:45 a.m.–11:15 a.m. Key design issues for trials in children (Diana Gibb, British Medical Research Council)
11:15 a.m.–11:40 a.m. Are efficacy trials of TB drugs necessary? (Peter Donald, Stellenbosch University)
11:40 a.m.–11:55 a.m. Ethical considerations for TB trials in children (in resource-limited settings) (Jerome Singh, University of KwaZulu-Natal)
11:55 p.m.–12:15 p.m. Child-friendly drug formulations (Suzanne Hill, World Health Organization)
12:15 p.m.–1:30 p.m. Lunch
1:30 p.m.–3:45 p.m. Small group discussions
- Group 1: Pediatric PK studies
- Group 2: Endpoints and sample size considerations for pediatric TB studies
- Group 3: Stage of drug development for involvement of children in TB studies/licensure considerations
3:45 p.m.–4:05 p.m. Break
4:05 p.m.–5:35 p.m. Review and discussion of the recommendations from small group discussions
5:35 p.m.–6:00 p.m. Summary and review of next steps
6:00 p.m. Adjourn
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