Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 4413 ng Trends ng Trends Data Analysis Biosimilars ernative Medicine ernative Medicine Individualized Care Pre-meeting Workshops Data Analysis Data Analysis SATURDAY, SEPTEMBER 16, 2017 Data Analysis SATURDAY, SEPTEMBER 16, 2017 Data Analysisl Pre-meeting Workshop 1 l 8:00 am – 12:00 pm Should Off-patent Medications Be Labeled for Pediatric Use?: ACCP/ PPAG Jointly-sponsored Symposium APPLICATION TRACK Offers both CME and CPE Credit UAN #0238-9999-17-007-L05-P ACPE – 3.5 CONTACT HOURS/APPLICATION-BASED This Workshop has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American College of Clinical Pharmacology and the Pediatric Pharmacy Association. The American College of Clinical Pharmacology is accredited by the ACCME to provide Continuing Medical Education for physicians. CO-CHAIRS: Michael D. Reed, RPh, PharmD, Director, Rainbow Clinical Research Ctr, Rainbow Babies & Children’s Hosp, Case Western Reserve Univ School of Medicine Gilbert J. Burckart, PharmD, Associate Director of Pediatrics, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, US Food & Drug Administration TARGET AUDIENCE: This Workshop will be useful for patient care clinicians, clinician scientists, drug/device developers, clinical investigators, regulatory specialists, industry and government-based investigators and scientists. GOALS AND OBJECTIVES: Following completion of this activity, the learner will be able to: 1. Analyze the therapeutic and financial impacts of off-label drug use in pediatric practice; 2. Define a multi-tiered strategy to effectively address the challenges of precise data capture for support of revising the FDA-approved drug label; 3. Compare the advantages and disadvantages of contemporary clinical trial designs used to obtain labeling data for drug use in children. 8:00 – 8:30 am Are Off-patent, Off-label Medications a Problem in Pediatric Therapeutics Today? John Bradley, MD, Professor, Clinical Pediatrics, Univ of California, San Diego 8:30 – 9:00 am The BPCA Program for Labeling Off-patent Medications Anne Zajicek, MD, PharmD, Chief, Obstetric & Pediatric Pharmacology & Therapeutics Branch, Eunice Kennedy Shriver National Inst of Child Health & Human Development, National Inst of Health 9:00 – 9:30 am What is the Standard for Adding a Drug & Monograph to a Pediatric Formulary?: Institutions, Systems & Pharmacy Benefit Managers Jennifer Le, PharmD, MAS, Professor of Clinical Pharmacy, Univ of California, San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences 9:30 – 10:00 am / Break 10:00 – 10:30 am What Evidence is Required for Changing an FDA Label? Lynne Yao, MD, Director, Div of Pediatric & Maternal Health, Office of New Drugs, Ctr for Drug Evaluation & Research, US Food & Drug Administration 10:30 – 11:00 am Can Opportunistic Studies Be Expanded to Provide Sufficient Evidence for Labeling?: Proof of Concept Kevin Watt, MD, PhD, Assistant Professor of Pediatrics, Duke Univ Medical Ctr, Duke Clinical Research Inst 11:00 – 11:30 am The Value of the Drug Label to Point of Care Pediatrics Jeremiah Momper, PharmD, PhD, Assistant Professor, Univ of California, San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences 11:30 am – 12:00 pm Panel Discussion: Controversies & Challenges