Recommendations for the design of therapeutic trials for neonatal seizures

Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from welldesigned clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures. The broad expertise and perspectives of this group were invaluable in developing recommendations addressing: (1) use of neonate-specific adaptive trial designs, (2) inclusion/exclusion criteria, (3) stratification and randomization, (4) statistical analysis, (5) safety monitoring, and (6) definitions of important outcomes. The guidelines are based on available literature and expert consensus, pharmacokinetic analyses, ethical considerations, and parental concerns. These recommendations will ultimately facilitate development of a Master Protocol and design of efficient and successful drug trials to improve the treatment and outcome for this highly vulnerable population

Where Wellness Meets the Road: Taking Population Health from Theory to Practice

“Where Wellness Meets the Road: Taking Population Health from Theory to Practice” will discuss how population health and wellness principles are being applied in the workplace to enhance quality and reduce medical costs. Organizations across all industries are working together to focus on the quality and cost of medical care in the United States. The nationwide mindset is shifting from interventions that can cure disease to prevention, wellness and chronic care management — work that requires tighter coordination across the continuum of care and a more active role for patients and caregivers. Payors are encouraging and supporting innovation in health care delivery systems, helping them adopt new technologies and methodologies to care for patients. Finally, economic necessity is motivating the government and the private sector to bend the health care cost curve, while achieving and sustaining better clinical outcomes. Agenda 6:00pm Welcome Edmund L. (Ned) Lafer, MD, MBA, FACHE,CPE Medical Director Healthcare Management, HealthPartners President, Healthcare Leadership Network of the Delaware Valley (HLNDV) Introduction to Lee White Innovation Institute Doug Hughes, RN, BSN, MBA, FACHE, NE-BC Vice President Administration, Paoli Hospital-President Elect HLNDV Tribute to Lee White Barbara Tachovsky Retired, Former President, Paoli Hospital 6:30pm Program Introduction Joel Port, MHSA, CHE, CMPE Chief Operating Officer at Accountable Care Organization of Pennsylvania Jefferson Health System “Setting the Stage” David B. Nash, MD, MBA Dean Jefferson University School of Population Health 6:45pm Panel Discussion Diane S. Harlow, MEd Assistant Director Geisinger Health System Wellness Program Brian J. Silverstein, MD President HC Wisdom Jim Wilton, JD, M.Div Administrator, Group Health & Wellness Cardone Industries 7:45pm Q&A from Audience 8:00pm Summary and Adjournment Event Sponsor DGA PARTNERS Location Sponsor Main Line Healt