How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement.
Child
Drug development
Expert group
Medicines for children
Pediatric medicines
Pediatric structures
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
30
05
2019
accepted:
26
11
2019
pubmed:
8
2
2020
medline:
3
6
2021
entrez:
8
2
2020
Statut:
ppublish
Résumé
Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development. The EFGCP Children's Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs. Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified. Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.
Sections du résumé
BACKGROUND
Pediatric regulations enacted in both Europe and the USA have disrupted the pharmaceutical industry, challenging business and drug development processes, and organizational structures. Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities as part of their business strategy to better tackle the challenges and opportunities of pediatric drug development.
METHODS
The EFGCP Children's Medicines Working Party and the IQ Pediatric working group have joined their efforts to survey their member company representatives to understand how pharmaceutical companies are organized to fulfill their regulatory obligations and optimize their pediatric drug development programs.
RESULTS
Key success factors and recommendations for a fit-for-purpose Pediatric Expert Group (PEG) were identified.
CONCLUSION
Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.
Identifiants
pubmed: 32030690
doi: 10.1007/s43441-020-00116-4
pii: 10.1007/s43441-020-00116-4
pmc: PMC7458895
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1076-1084Commentaires et corrections
Type : ErratumIn
Références
Ann Pharmacother. 2014 Mar;48(3):369-79
pubmed: 24311725
Arch Dis Child. 2012 Mar;97(3):185-8
pubmed: 22123735
JAMA Surg. 2016 Jun 1;151(6):579-80
pubmed: 26865380
Front Oncol. 2011 Jul 20;1:18
pubmed: 22655233
Fundam Clin Pharmacol. 2018 Aug;32(4):357-362
pubmed: 29457267
Int J Pharm. 2015 Aug 15;492(1-2):341-3
pubmed: 25959115
Clin Ther. 2017 Oct;39(10):1939-1948
pubmed: 28943118
World Health Organ Tech Rep Ser. 2012;(970):1-235, back cover
pubmed: 22894011
Clin Ther. 2017 Oct;39(10):1920-1932
pubmed: 28818298
Pharmaceut Med. 2014 Feb 1;28(1):1-6
pubmed: 24855373
Clin Ther. 2017 Oct;39(10):1933-1938
pubmed: 28943115
Semin Perinatol. 2015 Nov;39(7):530-1
pubmed: 26455383