The Role of Public–Private Partnerships in Catalyzing the Critical Path

Maxfield, Kimberly; Buckman-Garner, ShaAvhrée; Parekh, Ameeta

doi:10.1111/cts.12488

Cited by 17 publications

(10 citation statements)

References 61 publications

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“…C-Path serves as a neutral convener bringing together diverse stakeholders under a legal, data-driven, and regulatory framework to streamline efficiencies in drug development across multiple disease areas [40]. The US FDA regularly engages with external public-private partners to contribute to the development of drug development tools, databases, consensus data standards, education/training modules, and best practice recommendations that aim to address unmet needs [41]. C-Path also has strong alliances with the EMA and it has achieved regulatory successes across many disease areas with FDA, EMA, and PMDA.…”

Section: Case Study: Engagement Of Regulatory Agencies By Multidiscipmentioning

confidence: 99%

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

et al. 2020

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Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

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Section: Case Study: Engagement Of Regulatory Agencies By Multidiscipmentioning

confidence: 99%

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

et al. 2020

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“…The advantages of bringing together organizations into public-private partnerships (PPP) and consortia include not just scale, but also new-found agility and increased creativity alongside risk reduction and cost sharing (Papadaki and Hirsch, 2013;Slusher et al, 2013;Rosenberg, 2017;Kuchler, 2019). In fact, the US Food and Drug Administration (FDA), acknowledges the critical role of PPPs and consortia with respect to the innovation and modernization of medical product development (Maxfield et al, 2017).…”

Section: Drug Discovery Consortiamentioning

confidence: 99%

Accelerating Therapeutics for Opportunities in Medicine: A Paradigm Shift in Drug Discovery

Hinkson¹,

Madej²,

Stahlberg³

2020

Front. Pharmacol.

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Conventional drug discovery is long and costly, and suffers from high attrition rates, often leaving patients with limited or expensive treatment options. Recognizing the overwhelming need to accelerate this process and increase success, the ATOM consortium was formed by government, industry, and academic partners in October 2017. ATOM applies a team science and open-source approach to foster a paradigm shift in drug discovery. ATOM is developing and validating a precompetitive, preclinical, small molecule drug discovery platform that simultaneously optimizes pharmacokinetics, toxicity, protein-ligand interactions, systems-level models, molecular design, and novel compound generation. To achieve this, the ATOM Modeling Pipeline (AMPL) has been developed to enable advanced and emerging machine learning (ML) approaches to build models from diverse historical drug discovery data. This modular pipeline has been designed to couple with a generative algorithm that optimizes multiple parameters necessary for drug discovery. ATOM's approach is to consider the full pharmacology and therapeutic window of the drug concurrently, through computationally-driven design, thereby reducing the number of molecules that are selected for experimental validation. Here, we discuss the role of collaborative efforts such as consortia and public-private partnerships in accelerating cross disciplinary innovation and the development of opensource tools for drug discovery.

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“…Shao et al's [17] two-dimensional stakeholder matrix also verified that government and private partners are key stakeholders, financial institutions are the main stakeholders, project contractors and suppliers are the secondary stakeholders, and the public and the media are general stakeholders in SLCT PPP projects. Because more stakeholders are involved in PPP projects than in other types of projects [82,133], good relationships between the stakeholders are essential to the success of PPP projects [107,134].…”

Section: Stakeholder Factorsmentioning

confidence: 99%

Investigating Critical Factors That Encourage Private Partners to Participate in Sports and Leisure Characteristic Town Public-Private Partnerships: Evidence from China

Chen¹,

Zhao²,

Zhou³

et al. 2020

Sustainability

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The Sports and Leisure Characteristic Town (SLCT) has become a reasonable strategy for enhancing the sustainability of new urbanization processes in rural China. Although the Chinese government has issued a series of policies to support the development of SLCTs, limited financial resources are a major obstacle. Thus, public-private partnerships (PPPs) have been increasingly encouraged for establishing SLCT projects. However, the factors that significantly influence private partners’ willingness to participate in SLCT PPP projects remain unclear. The authors of this paper conducted expert interviews and questionnaire surveys concerning the SLCT PPP projects that have been implemented in China, identifying 23 factors that can be grouped into five major components using principal component factor analysis. Multiple linear regression was then performed to evaluate the relationships between factors and private partners’ willingness to participate. The results indicated that the factors that critically influence private partners’ willingness to participate include stakeholder factors, the internal factors of private partners, external environmental risk factors, the supporting measure factors of SLCTs, and the locational factors of SLCTs. This work also offers suggestions for encouraging private partners to participate in SLCT PPP projects. This study can provide a theoretical basis and practical guidance for government and private partners in order to help them implement sustainable SLCT PPP projects.

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The Role of Public–Private Partnerships in Catalyzing the Critical Path

Cited by 17 publications

References 61 publications

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

Accelerating Therapeutics for Opportunities in Medicine: A Paradigm Shift in Drug Discovery

Investigating Critical Factors That Encourage Private Partners to Participate in Sports and Leisure Characteristic Town Public-Private Partnerships: Evidence from China

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