How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Model
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ORIGINAL ARTICLE
How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement Thomas Severin1 · Solange Corriol‑Rohou2 · Christina Bucci‑Rechtweg3 · Kristina an Haack4 · Sabine Fuerst‑Recktenwald5 · Pirkko Lepola6 · Ensio Norjavaara7 · Martine Dehlinger‑Kremer8 on behalf of the EFGCP Children’s Medicines Working Party · Sebastian Haertter9 · S. Y. Amy Cheung10 on behalf of the IQ Pediatric Working Group Received: 30 May 2019 / Accepted: 26 November 2019 © The Drug Information Association, Inc 2020
Abstract 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. Keywords Medicines for children · Pediatric medicines · Child · Drug development · Pediatric structures · Expert group
Introduction
In this article, ‘Pediatric Expert Group’ (PEG) is a term used as a common denominator when talking more generally about a pediatric structure used within a company or companies. * Thomas Severin [email protected] 1
Significant progress has been made since pediatric legislation was first enacted in the USA two decades ago and with the implementation of the Pediatric Regulation in the European Union (EU) in 2007. In regions with pediatric-specific regulations (USA, EU, and Switzerland), it is routine 6
Department of Children and Adolescents, Helsinki University Hospital, Helsinki, Finland
7
Global Medicines Development, AstraZeneca, Mölndal, Sweden
8
Pediatric Development, Synteract, & EUCROF, Munich, Germany
Translational Medicine & Clinical Pharmacology, Boehringer-Ingelheim, Ingelheim, Germany
Global Drug Development, Novartis Pharma AG, Novartis Campus, 4002 Basel, Switzerland
2
Global Regulatory Excellence, AstraZeneca, Paris, France
3
Global Health Policy, Regulatory Affairs, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
9
4
R&D/Clinical Development Rare Diseases, Sanofi/Genzyme, Chilly‑Mazarin, France
10
5
Product Development Neurology, F. Hoffmann-La
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