Novartis Pediatric Drug Development Faculty Program Program Description Education: Best Pharmaceuticals for Children Act (BPCA) Principles of Pediatric Clinical Pharmacology weekly webinar courses Novartis new associate customized drug development training curriculum Option to enroll in on-line courses through the Global Research in Paediatrics (GRiP) Masters of Pediatric Drug Development Program (pending availability) Exposure to each major functional area involved in pediatric drug development: Regulatory Science, Clinical Development, Early Drug Development, Pharmaceutics, Juvenile Toxicity, Pharmacology, Formulations, Statistics, Study Design, US and Global Operations, Pharmacometrics Rotations with these groups will occur intensely in the first 2 months and also throughout the tenure at Novartis Review of provided literature in area, case studies and individual time with area expert Participate as member of TA team Interact with active pediatric program with a need for pediatric expertise, allowing intense immersion in designing a pediatric development plan, creating subsequent regulatory documents, writing a protocol, consents, assents, CRFs Analyzing/interpreting data, participating in case study reports, and publishing results Project: Completion of a project to facilitate quality of pediatric drug development programs. Examples could include development of pediatric safety guidance for liver, renal, bone or neurodevelopment; assisting with template development; or white paper on neonatal/infant dose determinations. Goal is to publish work. Experience in functional areas of interest for minimum 2 month rotations with one-on-one instruction provided by Novartis area experts Additional research coordinating with academic interests may be discussed individually Mentors from Pediatric TA and home institution will collaborate to ensure an optimal experience Eligibility Pediatrician or pediatric subspecialist with training in pediatric clinical research including a Master’s of Public Health, Master’s of Clinical Research, or similar advanced degree and/or training in clinical pharmacology or other discipline related to drug development No industry experience required Timing: Preferred to be in the first years of faculty appointment Novartis Pediatric Drug Development Faculty Program Pediatric Drug Development Background The need to protect children through research rather than from research stimulated the passage of several laws/regulations in US and EU to both require and sometimes reward pediatric drug development Regulatory agencies responded to this call with evolving structures to monitor and enforce these rules Many companies built internal organizations to develop drugs for pediatric patients such as the Novartis Pediatric Therapeutic Area (TA) Academia has been involved through patient recruitment and individual consultation Multi-stakeholder partnerships are being developed including global pediatric networks Partnerships between industry and future academic leaders of clinical research are needed and is the focus of this program Funding Location: US sites (East Hanover NJ, Cambridge, MA, San Diego) or in Basel for EU candidates Salary: Novartis will provide half of salary commensurate with institution’s junior faculty position paid to the individual as consultancy; additional stipend will be provided directly to scholar for travel and living expenses; tuition provided for course work Employer: Academic institution will remain primary employer, and will be responsible for candidate’s benefits. Confidentiality: All Novartis information will remain company confidential as guaranteed by contractual agreement. Objectives Provide experience & education to faculty re: pediatric drug development process Facilitate a culture of transparent collaboration between academia and industry to deliver products of high scientific value to patients and caretakers Participation in long-term consultation, bringing pediatric clinical trials and expanded relationship between NVS and institution. Provide tools for leading a pediatric clinical research unit and training consistent with a role in a pediatric clinical trial network Provide Novartis teams with academic experts with advanced training in pediatrics to assist in planning of pediatric programs Provide an experience for the individuals who may be considering more interaction with industry as part of future career plans. Timelines Over the course of one year, 6 months from the start of the first rotation will be spent at Novartis rotating across functions, and 6 months at the sponsoring institution Candidate will continue to work with Novartis team remotely and in-person as needed Time blocks are flexible but can be done in 1-2 month periods The rotations and schedule for each candidate will be individualized based on the candidate’s interests, expertise, as well as company need To apply Contact Ronald Portman, MD, 862-778-9316 Ron.Portman@Novartis.com