Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education

Spindler, Per; Bach, Karin Friis; Schmiegelow, Merete; Bedlington, Nicola; Eichler, Hans‐Georg

doi:10.1177/2168479015599810

Cited by 8 publications

(6 citation statements)

References 11 publications

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“…Finally, regulatory and health technology assessment agencies, such as the EMA and the Dutch Medicines Evaluation Board, also see the PPP model as a platform that allows them to share data, expertise, and resources, and to enhance their understanding of other stakeholders’ perspectives ( 50 , 51 , 96 – 98 ). Nowadays, these public bodies participate in a variety of PPPs, including those focusing on the development of new evaluation tools and standards (Adapt-SMART, C-Path, Escher ( 97 – 100 )); training programs in drug regulatory sciences e.g. PharmaTrain ( 101 ); and new approaches for incorporating real life data into drug development (e.g.…”

Section: Regulatory Agenciesmentioning

confidence: 99%

Reflections on the Future of Pharmaceutical Public-Private Partnerships: From Input to Impact

Vrueh

Crommelin

2017

Pharm Res

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Public Private Partnerships (PPPs) are multiple stakeholder partnerships designed to improve research efficacy. We focus on PPPs in the biomedical/pharmaceutical field, which emerged as a logical result of the open innovation model. Originally, a typical PPP was based on an academic and an industrial pillar, with governmental or other third party funding as an incentive. Over time, other players joined in, often health foundations, patient organizations, and regulatory scientists. This review discusses reasons for initiating a PPP, focusing on precompetitive research. It looks at typical expectations and challenges when starting such an endeavor, the characteristics of PPPs, and approaches to assessing the success of the concept. Finally, four case studies are presented, of PPPs differing in size, geographical spread, and research focus.

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Section: Regulatory Agenciesmentioning

confidence: 99%

Reflections on the Future of Pharmaceutical Public-Private Partnerships: From Input to Impact

Vrueh

Crommelin

2017

Pharm Res

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“…One key element in the multistep process to improve the regulatory guidance landscape is critical scientific input from subject-matter experts. [ 3 4 5 10 11 15 53 ] We strongly believe that “watching and waiting” will not help the case of digital pathology. Similarly, workarounds[ 84 85 86 87 88 89 ] turn into long and winding roads that ultimately end at the FDA and within the FDA's regulatory framework.…”

Section: T He M Ultifaceted N mentioning

confidence: 99%

“…A primary challenge in the field of digital pathology is the lack of understanding that strong relationships between regulatory, basic, and translational scientists can substantially improve clinical innovation. [ 3 4 5 6 ] For example, regulatory science is not restricted to regulatory agencies. [ 2 4 5 6 ] As a scientific discipline, regulatory science challenges current concepts of benefit and risk assessments, submission and approval strategies, patient involvement, and various ethical aspects.…”

Section: Introductionmentioning

confidence: 99%

“…[ 3 4 5 6 ] For example, regulatory science is not restricted to regulatory agencies. [ 2 4 5 6 ] As a scientific discipline, regulatory science challenges current concepts of benefit and risk assessments, submission and approval strategies, patient involvement, and various ethical aspects. Regulatory science includes the creation of a scientific dialog for launching new ideas – not only derived from industry and regulatory authorities but also by, for example, academics, clinicians, and patients.…”

Section: Introductionmentioning

confidence: 99%

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A Regulatory Science Initiative to Harmonize and Standardize Digital Pathology and Machine Learning Processes to Speed up Clinical Innovation to Patients

Marble

Huang

Dudgeon

et al. 2020

Journal of Pathology Informatics

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Unlocking the full potential of pathology data by gaining computational access to histological pixel data and metadata (digital pathology) is one of the key promises of computational pathology. Despite scientific progress and several regulatory approvals for primary diagnosis using whole-slide imaging, true clinical adoption at scale is slower than anticipated. In the U.S., advances in digital pathology are often siloed pursuits by individual stakeholders, and to our knowledge, there has not been a systematic approach to advance the field through a regulatory science initiative. The Alliance for Digital Pathology ( the Alliance ) is a recently established, volunteer, collaborative, regulatory science initiative to standardize digital pathology processes to speed up innovation to patients. The purpose is: (1) to account for the patient perspective by including patient advocacy; (2) to investigate and develop methods and tools for the evaluation of effectiveness, safety, and quality to specify risks and benefits in the precompetitive phase; (3) to help strategize the sequence of clinically meaningful deliverables; (4) to encourage and streamline the development of ground-truth data sets for machine learning model development and validation; and (5) to clarify regulatory pathways by investigating relevant regulatory science questions. The Alliance accepts participation from all stakeholders, and we solicit clinically relevant proposals that will benefit the field at large. The initiative will dissolve once a clinical, interoperable, modularized, integrated solution (from tissue acquisition to diagnostic algorithm) has been implemented. In times of rapidly evolving discoveries, scientific input from subject-matter experts is one essential element to inform regulatory guidance and decision-making. The Alliance aims to establish and promote synergistic regulatory science efforts that will leverage diverse inputs to move digital pathology forward and ultimately improve patient care.

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“…특히, IMI는 규제과학의 핵심 역할을 하고 있으며 앞으로 IMI 를 비롯해 민관 협력을 통한 과학적 교류 강화가 중요해 질 것 으로 전망한다. 16,17) IMI 프로젝트는 5 단계를 거쳐 선정된다. 14,15) 게 된다(Fig.…”

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European Regulatory Science and Regulatory Science Expert Training Project

Shin

Park

Kim

et al. 2021

Korean J Clin Pharm

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Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea's regulatory science expert training project in 2021 and the EU's IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea's project is focused on the Ministry of Food and Drug Safety and universities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

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Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education

Cited by 8 publications

References 11 publications

Reflections on the Future of Pharmaceutical Public-Private Partnerships: From Input to Impact

Reflections on the Future of Pharmaceutical Public-Private Partnerships: From Input to Impact

A Regulatory Science Initiative to Harmonize and Standardize Digital Pathology and Machine Learning Processes to Speed up Clinical Innovation to Patients

European Regulatory Science and Regulatory Science Expert Training Project

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