Clinical Therapeutics/Volume 36, Number 2, 2014
Commentary
Section on Advances in Therapeutics and Technology Charles A. Thompson, MD1; and Seth Toback, MD2 1
Chair, SOATT Executive Committee; and 2Member, SOATT Executive Committee
Each day, pediatric providers use medicines, vaccines, devices, and technology in the care of children. However, many marketed drugs and devices are prescribed with limited or no clinical data demonstrating their safety and efficacy in the pediatric population. The design, conduct, and timely completion of pediatric trials represent major challenges that must be overcome because the process of bringing innovations from the bench into clinical practice is critical to the work that we all do. Consequently, a better understanding of and involvement in the pediatric innovation process would benefit all pediatric providers. The Section on Advances in Therapeutics and Technology (SOATT) is a professional home within the American Academy of Pediatrics (AAP) for pediatric providers and researchers with a passion for and expertise/interest in medical innovation. SOATT was established as a provisional section in July 2010 and has steadily grown to include 4325 members from industry, academia, clinical practice, the US Food and Drug Administration (FDA), government agencies, and nonprofit groups. In May 2011, SOATT opened its membership to affiliates (colleagues such as PhDs, PharmDs, and clinical research professionals who normally would not be eligible to join the AAP). In May 2013, the SOATT received full section status from the AAP Board of Directors. The mission of SOATT is to advance pediatric health and well-being through collaboration, communication, and education on the discovery and development of therapeutics and technology and their successful translation into practice. To accomplish this mission, we have defined the following goals:
Accepted for publication July 25, 2013. http://dx.doi.org/10.1016/j.clinthera.2013.07.432 0149-2918/$ - see front matter Elsevier HS Journal, Inc.
178
To improve communication and relationships with
AAP members within industry, academia, and government agencies to create opportunities for dialogue with the organizations that employ these members To educate AAP membership on the discovery, development, and implementation process for therapeutics and technology To create a vibrant member community and network that will add value to AAP members To serve as a resource and integrate expertise with other sections, committees, and membership-atlarge To explore the research and development process and make recommendations that will improve quality, safety, understanding, and efficiency
In our first 3 years, SOATT has been exceptionally productive in working toward its goals. We created and implemented 2 successful educational programs at the AAP National Conference & Exhibition in 2011 and 2012, which featured expert speakers such as Drs. Dianne Murphy (FDA), Lisa Mathis (formerly FDA, currently Amgen), Paul Offit (Children’s Hospital of Philadelphia), Ralph Kauffman (Children’s Mercy Hospital), and John Bradley (Rady Children’s Hospital). The topics discussed at these conferences have been broad and include therapeutics, understanding vaccines, the drug label, pediatric drug development legislation, safety of medicines, and gadgets and gizmos for the pediatric office. In addition, we regularly publish section newsletters involving a variety of topics and guest authors, which have received excellent feedback from AAP membership and have been shared with other sections
Scan the QR Code with your phone to obtain FREE ACCESS to the articles featured in the Clinical Therapeutics topical updates or text GS2C65 to 64842. To scan QR Codes your phone must have a QR Code reader installed.
Volume 36 Number 2
C.A. Thompson and S. Toback and committees. The section also proposed to AAP leadership that an educational brochure on pediatric clinical trials be created for families. The AAP leadership accepted our proposal and has nearly completed development of the brochure. The SOATT helped to lead the effort to create the Global Alliance for Pediatric Therapeutics (GAPT), a precompetitive public/private collaboration to improve medicines for children. The GAPT brings together a variety of stakeholders, including biopharmaceutical companies, academia, National Institutes of Health/the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the FDA, and the European Medicines Agency. The GAPT’s first project focused on the assessment of palatability of pediatric formulations, and the group’s first manuscripts have been submitted to a peerreviewed journal for publication. Although the first 3 years of SOATT have been incredibly productive, we are excited about the prospects for the section’s future. SOATT has already planned the 2013 AAP National Conference & Exhibition program and is finalizing the program for 2014. We have launched a Webinar series to bring educational content
virtually to pediatric providers, and we plan to expand that platform moving forward. As the GAPT works toward completion of its pilot project, the steering committee will begin brainstorming and prioritizing the next set of projects. We will continue to explore ways to expand and bring value to our membership and enhance the process of medical innovation for children. Ultimately, SOATT is uniquely positioned to address the Ongoing Medical Advances Megatrend (as identified in the Vision of Pediatrics 2020 project) and to deliver significant impact to AAP members, providers, researchers, and children. The section will continue to advocate for pediatric research and innovation and to improve the understanding of and involvement in the process of medical innovation for children. Our diverse membership and unique mission will enable us to improve collaboration among pediatric stakeholders and attract new members to the AAP and the important work of our section. We encourage you to learn more about the section and consider joining our efforts by visiting our website at http://www2.aap.org/sections/pedsadvances/ index.cfm. For more information, please contact the SOATT Membership Chair (Seth Toback, MD, FAAP [[email protected]]).
Address correspondence to: Dr. Seth Toback, Gilead Sciences, 199 East Blaine St., 4689 174th Ave SE, Seattle, Washington 98102, United States. E-mail: [email protected]
February 2014
179
Commentary
Section on Advances in Therapeutics and Technology Charles A. Thompson, MD1; and Seth Toback, MD2 1
Chair, SOATT Executive Committee; and 2Member, SOATT Executive Committee
Each day, pediatric providers use medicines, vaccines, devices, and technology in the care of children. However, many marketed drugs and devices are prescribed with limited or no clinical data demonstrating their safety and efficacy in the pediatric population. The design, conduct, and timely completion of pediatric trials represent major challenges that must be overcome because the process of bringing innovations from the bench into clinical practice is critical to the work that we all do. Consequently, a better understanding of and involvement in the pediatric innovation process would benefit all pediatric providers. The Section on Advances in Therapeutics and Technology (SOATT) is a professional home within the American Academy of Pediatrics (AAP) for pediatric providers and researchers with a passion for and expertise/interest in medical innovation. SOATT was established as a provisional section in July 2010 and has steadily grown to include 4325 members from industry, academia, clinical practice, the US Food and Drug Administration (FDA), government agencies, and nonprofit groups. In May 2011, SOATT opened its membership to affiliates (colleagues such as PhDs, PharmDs, and clinical research professionals who normally would not be eligible to join the AAP). In May 2013, the SOATT received full section status from the AAP Board of Directors. The mission of SOATT is to advance pediatric health and well-being through collaboration, communication, and education on the discovery and development of therapeutics and technology and their successful translation into practice. To accomplish this mission, we have defined the following goals:
Accepted for publication July 25, 2013. http://dx.doi.org/10.1016/j.clinthera.2013.07.432 0149-2918/$ - see front matter Elsevier HS Journal, Inc.
178
To improve communication and relationships with
AAP members within industry, academia, and government agencies to create opportunities for dialogue with the organizations that employ these members To educate AAP membership on the discovery, development, and implementation process for therapeutics and technology To create a vibrant member community and network that will add value to AAP members To serve as a resource and integrate expertise with other sections, committees, and membership-atlarge To explore the research and development process and make recommendations that will improve quality, safety, understanding, and efficiency
In our first 3 years, SOATT has been exceptionally productive in working toward its goals. We created and implemented 2 successful educational programs at the AAP National Conference & Exhibition in 2011 and 2012, which featured expert speakers such as Drs. Dianne Murphy (FDA), Lisa Mathis (formerly FDA, currently Amgen), Paul Offit (Children’s Hospital of Philadelphia), Ralph Kauffman (Children’s Mercy Hospital), and John Bradley (Rady Children’s Hospital). The topics discussed at these conferences have been broad and include therapeutics, understanding vaccines, the drug label, pediatric drug development legislation, safety of medicines, and gadgets and gizmos for the pediatric office. In addition, we regularly publish section newsletters involving a variety of topics and guest authors, which have received excellent feedback from AAP membership and have been shared with other sections
Scan the QR Code with your phone to obtain FREE ACCESS to the articles featured in the Clinical Therapeutics topical updates or text GS2C65 to 64842. To scan QR Codes your phone must have a QR Code reader installed.
Volume 36 Number 2
C.A. Thompson and S. Toback and committees. The section also proposed to AAP leadership that an educational brochure on pediatric clinical trials be created for families. The AAP leadership accepted our proposal and has nearly completed development of the brochure. The SOATT helped to lead the effort to create the Global Alliance for Pediatric Therapeutics (GAPT), a precompetitive public/private collaboration to improve medicines for children. The GAPT brings together a variety of stakeholders, including biopharmaceutical companies, academia, National Institutes of Health/the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the FDA, and the European Medicines Agency. The GAPT’s first project focused on the assessment of palatability of pediatric formulations, and the group’s first manuscripts have been submitted to a peerreviewed journal for publication. Although the first 3 years of SOATT have been incredibly productive, we are excited about the prospects for the section’s future. SOATT has already planned the 2013 AAP National Conference & Exhibition program and is finalizing the program for 2014. We have launched a Webinar series to bring educational content
virtually to pediatric providers, and we plan to expand that platform moving forward. As the GAPT works toward completion of its pilot project, the steering committee will begin brainstorming and prioritizing the next set of projects. We will continue to explore ways to expand and bring value to our membership and enhance the process of medical innovation for children. Ultimately, SOATT is uniquely positioned to address the Ongoing Medical Advances Megatrend (as identified in the Vision of Pediatrics 2020 project) and to deliver significant impact to AAP members, providers, researchers, and children. The section will continue to advocate for pediatric research and innovation and to improve the understanding of and involvement in the process of medical innovation for children. Our diverse membership and unique mission will enable us to improve collaboration among pediatric stakeholders and attract new members to the AAP and the important work of our section. We encourage you to learn more about the section and consider joining our efforts by visiting our website at http://www2.aap.org/sections/pedsadvances/ index.cfm. For more information, please contact the SOATT Membership Chair (Seth Toback, MD, FAAP [[email protected]]).
Address correspondence to: Dr. Seth Toback, Gilead Sciences, 199 East Blaine St., 4689 174th Ave SE, Seattle, Washington 98102, United States. E-mail: [email protected]
February 2014
179
