Providing children and families a voice in health

Providing children and families a voice in health, medicine, research and innovation February 2015

Background (UK Experience)

What is KIDS? Kids and Families Impacting Disease Through Science (KIDS) is an advisory group of children, adolescents and families focused on understanding, communicating and improving health, medicine, research, and innovation for children. KIDS is a collaboration between the American Academy of Pediatrics (AAP) Section on Advances in Therapeutics and Technology (SOATT), local AAP Chapters, children’s hospitals, local schools and other partners.

KIDS Objectives Learn, teach, advocate • for medicine, research and innovation that improves the health and well-being of children Engage • in the process through projects and consultation activities with hospitals, researchers, and other partners in the public and private sectors Provide • input on research ideas, innovative solutions, unmet pediatric needs and priorities Contribute Serve • to the design and implementation of clinical studies for children (e. g. , assent, monitoring tools, schedules, etc. ) • as a critical voice for children and families in the medical, research, and innovation and processes

KIDS Connecticut Pilot Established first KIDS Team in Connecticut Broad collaboration AAP Section on Advances in Therapeutics and Technology Connecticut Chapter of AAP Connecticut Children’s Medical Center Yale-New Haven Children’s Hospital Pfizer Inc Local schools Serve as model for future KIDS Teams

KIDS Speak… I want to help… “I want to help kids have more effective treatments and experiences” “We would be doing stuff that really could help, not just talking about it” “I have always wanted to play a role in impacting the medical system I just never knew how” “I want to help heal kids in the best way possible” “I just want to help children with medical conditions and give input on how to make their medical experience better” I want to learn… “I would like to learn more about research in children” “I am particularly excited to learn more about unmet pediatric needs” “I don’t know understand very much about our medical system right now. I want to join to become an educated person and see if I can make a difference”

KIDS Speak… My opinion matters… “I know what it’s like to be a kid” “I’ve had pectus carinatum and know what it feels like” “Adults will be in need of a child’s perspective for different medical circumstances that involve children” “Since I’m a kid, I will be able to relate and connect to other kids better than an adult could” “I’m particularly interested in contributing to the design and implementation of clinical studies for children” “I would like to voice my opinion and engage in projects that will help children in need of innovation”

Empowering Children Worldwide KIDS and Families Impacting Disease Through Science (KIDS) International Children’s Advisory Network (i. CAN) KIDS is an advisory group of children, adolescents and families focused on understanding, communicating and improving health, medicine, research, and innovation for children. KIDS is a collaboration between the American Academy of Pediatrics (AAP) Section on Advances in Therapeutics and Technology (SOATT), local AAP Chapters, children’s hospitals, local schools and other partners. i. CAN is a worldwide consortium of KIDS Teams, Young Person’s Advisory Groups (YPAGs), and similar organizations working together to provide a voice for children and families in pediatric medicine through synergy, communication, and collaboration.

i. CAN Objectives Connect Share • With similar groups around the world • Ideas, best practices, challenges, culture Learn • From one another and capitalize on expertise Collaborate Advocate • For research, innovation, children and families • The health and wellbeing of children around the world

International Children’s Advisory Network United States KIDS Current (5) International Current (7) Connecticut Kids. Can (Vancouver) Kansas City Utah Young Person’s Advisory Groups (UK) Ohio Georgia KIDS In Development (7) Birmingham Bristol Liverpool London Nottingham Scotland Illinois Indiana Miami Michigan New Jersey Australia (Sydney) Texas Germany (Berlin) Washington, DC Italy (Rome) France (Lyon) Spain (Barcelona) In development (5)

Sample Individual Team Projects KIDS Connecticut Pfizer R&D Summit University of Connecticut Undergraduate Research Consult Scot. CRN Young Persons Group British Science Festival, Focus Group Kids. Can Monster. Manor Mobile App CRN Young Person’s Advisory Group Generation. R Conference

i. CAN Collaborations Pediatric assent review for industry-sponsored study i. CAN reviewed and delivered feedback from children and families in the U. S. , Canada, and the United Kingdom with very short turnaround time Global Alliance for Pediatric Therapeutics Assent Project evaluating current practices, challenges and unmet needs in attaining pediatric assent for clinical trials i. CAN collected ~50 survey responses from children and families in the U. S. , Canada, and the United Kingdom Plan is for additional i. CAN involvement as project evolves SPIRIT-C/CONSORT-C Early product development feedback request Plan to engage full network later in 2014 as requested by innovator

KIDS Online & On The Road AAP Healthy Children Expo March 8 -9, Chicago, IL CHES Rounds/Toronto Sick. Kids April 23, 2014 Pediatric Academic Societies May 3 -6, Vancouver, BC June 19, Cambridge, MA European Network on Pediatric Research at the EMA (Enpr-EMA) Annual Workshop May 28, New York, NY Institute for Pediatric Innovation Annual Meeting http: //www. realworldhealthcare. o rg/2014/04/kids/ Children’s Brain Tumor Foundation Gala April 21, Toronto, ON Real World Health Care Invited Blog June 26, London, England SPIRIT-C/CONSORT-C Consensus Mtg September 15 -16, Toronto, Canada

KIDS Online & On The Road KIDS Connecticut/UConn Undergraduate Research Program September 19, Storrs, CT NCDChild Panel September 22, New York City September 23, New York City http: //talk. unicef. org/events/sp eaking-young-voices-ncds/ Clinical Trial Day October 2, Rome, Italy October 3, Baltimore, MD American Academy of Pediatrics National Conference and Exhibition UNICEF ACTIVATE Talk Sickle Cell Disease Association of America’s Annual Convention Oral Presentation October 10 -14, San Diego, CA “Assent in Pediatric Clinical Trials: An International Children’s Advisory Network Survey” March 2015, Platform Presentation, ESPR, Philadelphia, PA April 2015, Poster Presentation, PAS, San Diego, CA

KIDS On The Road (AAP Expo, Chicago)

KIDS On The Road (PAS, Vancouver)

KIDS On The Road (IPI, Cambridge)

Spirit-C/CONSORT-C (Toronto, Canada)

UConn Undergrad Research Program

NCDChild Event (New York City)

UNICEF ACTIVATE Talks (New York City)

Better Medicines for Children Conference (London, England)

Clinical Trial Day (Rome, Italy)

Sickle Cell Disease Association Oral Presentation (Baltimore, MD)

KIDS Georgia Kick-Off (December 2014)

Feedback On KIDS/i. CAN “I think this is a great way to help us to create more operationally feasible trials. Getting the perspectives of children will help us to pay special attention to details prior to startup. I think having a standard ‘KIDS advisory panel’ prior to the kickoff of any study would be good practice and would help with the implementation of our studies. ” ~Development Operations Specialist Pharmaceutical Industry “As a children’s organization, UNICEF always strives to bring children’s voices to the work we do, and an organization like i. CAN Research is very meaningful to us because it provides children’s opinion to the work that matters most to them. We look forward to many more great projects by i. CAN Research and hope to continue the conversation for the wellbeing of the children around the world. ” ~Hayon Nam Programme Officer

Feedback On KIDS/i. CAN “Many thanks on behalf of NCD Child and UNICEF, and also the American Academy of Pediatrics, the International Pediatric Association, and the Healthy Caribbean Coalition for your participation in our side event, ‘Next steps in NCDs for children and youth: UNICEF Facts for Life and life-course priorities for the Post 2015 Development Agenda, ’ on Monday, September 22, 2014. We were very pleased with both the diversity of audience and lively discussion generated by our panelists. As you know, NCD Child actively seeks the input of youth voices in all of its activities to ensure children and adolescents are prominently recognized on the global NCD agenda. The work of i. CAN and KIDS Connecticut is impressive, and we are very fortunate to work with your network. ” ~Jonathon Klein, MD FAAP Executive Director, NCD Child Associate Executive Director, American Academy of Pediatrics

i. CAN Launch & Research Summit Date & Location American Academy of Pediatrics/NCD Child Biopharmaceutical companies Capitol Hill Children’s National Medical Center Contract Research Organizations European Medicines Agency Food and Drug Administration National Institutes of Health Provide legislators/staffers with chance to hear from informed children about importance of pediatric research and innovation National Organization for Rare Disorders Nuffield Center for Bioethics Ph. RMA Provide an interactive and collaborative forum for stakeholder groups and young advisors to network with one another and develop synergies with the growing i. CAN network Others June 22 -26, 2015 Washington, DC Objectives Partners Provide children and families with world-class educational opportunity Provide researchers and regulators with mechanism to hear important feedback/advice from children on pediatric issues/projects Attendees 75 -150 leaders, youth advisors and parents from around the world Colleagues from partner organizations

i. CAN Launch Draft Agenda 8: 00 AM-6: 00 PM Monday (June 22) Tuesday (June 23) 6: 00 PM-9: 00 PM 8: 30 AM 9: 00 AM-9: 30 AM-10: 00 AM-10: 15 AM-11: 30 AM-12: 00 PM-1: 00 PM-1: 30 PM-3: 00 PM – 3: 15 PM-5: 30 PM Arrivals in Washington, DC Special Event #1 (Opening Ceremony) Dinner & Keynote Speakers (Lindsey Elsaesser) Teambuilding Event Depart Hotel for Meeting Venue Welcome, Introductions, Overview Icebreaker/Networking Game Break A Journey Around i. CAN (poster session) i. CAN Working Together Lunch i. CAN Working Together, continued Long Road to Drug Discovery Game (Terri Swanson & team) Return to Hotel Free time Depart Hotel for Special Event #2

i. CAN Launch Draft Agenda 7: 30 AM 8: 00 AM-10: 00 AM-10: 15 AM-11: 45 AM Wednesday (June 24) Thursday (June 25) 11: 45 AM-12: 15 PM-1: 00 PM-2: 15 PM-2: 30 PM-3: 00 PM-4: 30 PM 4: 45 PM-8: 00 PM 7: 30 AM 8: 00 AM-9: 00 AM-10: 00 AM-10: 15 AM 10: 30 AM-11: 30 PM 11: 30 -12: 00 PM-1: 00 PM-1: 30 PM-4: 30 PM-5: 00 PM-6: 00 PM-9: 00 PM Depart Hotel for Children’s National Medical Center Break Regulatory Science (Food and Drug Administration, European Medicines Agency, Health Canada) Travel to Meeting Venue Lunch National Institutes of Health Break Nuffield Center for Biomedical Ethics How A Bill Becomes Law (Lisa Kaeser) Return to Hyatt Place Free time & Dinner On Own Depart for Meeting Venue National Organization for Rare Disorders AAP NCD Child Break AAP Federal Affairs Travel to Ph. RMA Stakeholder Briefing/Lunch (90 minutes) Travel to Capitol Hill Visitor Center Capitol Hill Overview, Tour, Activities (Visitor Center, House/Senate Floor, Committee Rooms) Travel to Hyatt Place Free time Special Event #4 (Closing Ceremony)

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Questions?

For More Information Please contact Hadleigh Thompson Development Intern, i. CAN developmentintern@icanresearch. org