Global strategic partnerships in regenerative medicine

French, Amanda; Suh, Jane; Suh, Carol Y.; Rubin, Lee L.; Barker, Richard; Bure, Kim; Reeve, Brock; Brindley, David

doi:10.1016/j.tibtech.2014.05.007

Cited by 9 publications

(7 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Specifically in personalized medicine, there has been an increasing focus on the barriers to widespread adoption ( Brindley et al, 2015 ). The current literature highlights cost-effectiveness, efficacy, reimbursement, and regulation ( Davies et al, 2014 ; French et al, 2014 ) as the key concerns for adoption of current personalized medicines, but an aspect of personalized medicine that has recently come into the spotlight as an inseparable aspect of precision medicine is the role of companion diagnostics.…”

Section: Introductionmentioning

confidence: 99%

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics

et al. 2016

Self Cite

View full text Add to dashboard Cite

Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics.

show abstract

Section: Introductionmentioning

confidence: 99%

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics

et al. 2016

Self Cite

View full text Add to dashboard Cite

show abstract

“…The potential for public-private collaborations to operate in the product development sphere has also been mooted by some commentators (French et al 2014). In addition the second phase of the IMI, which runs from 2014 to 2020, has expanded to include the development of new therapeutic products (IMI website, N.D.).…”

Section: Resultsmentioning

confidence: 99%

“…Contemporary examples include the Quebec Consortium for Drug Discovery (CQDM), several networks created under the ‘Investments for the Future’ programme of the French National Research Agency (ANR), and the Innovative Medicine’s Initiative (IMI), a joint venture between the European Commission and the European federation of pharmaceutical industries and associations (Efpia). Public-private collaboration is seen as especially relevant for addressing the translational challenges of stem cell science and regenerative medicine (Rao 2013; Bubela et al 2014; French et al 2014). There are currently two IMI consortia in the stem cell field; Stem cells for Biological Assays of Novel drugs and prediCtive toxiCology (StemBANCC) and the European Bank for induced pluripotent Stem Cells (EBiSC).…”

Section: Introductionmentioning

confidence: 99%

“A good collaboration is based on unique contributions from each side”: assessing the dynamics of collaboration in stem cell science

Morrison

2017

Life Sci Soc Policy

View full text Add to dashboard Cite

The rise of ‘big biology’ is bringing academic and industrial scientists together in large consortia to address translational challenges in the life sciences. In order to assess the impact of this change, this paper examines the existing norms and styles of collaboration in one high profile translational domain; stem cell research. Data is drawn from qualitative interviews with academic and industry scientists working in a large European stem cell research project. Respondents discussed what they perceived as the main benefits and risks of collaborative research, what styles of collaboration they were familiar with, and what collaborative work in stem cell science normally involves. A wide range of materials, data, and expertise can be exchanged during collaborative work. Informal collaborations are governed by an ethos of reciprocity and mediated by trust while formal project agreements can provide a safe space for sharing between unfamiliar partners. These characteristics make stem cell research well suited to pre-competitive public-private ventures but translation of new products to market may be more challenging.Electronic supplementary materialThe online version of this article (doi:10.1186/s40504-017-0053-y) contains supplementary material, which is available to authorized users.

show abstract

“…Furthermore, co-development partnerships in regenerative medicine aim to combine strengths and eliminate deficiencies and are evolving around technological expertise, commercialization, regulatory and/or clinical trial expertise, and financing [49]. The European Union, for example, has formed the Innovative Medicines Initiative to accelerate development of and access to innovative medicines, including regenerative medicine products, and has engaged regulators, researchers, and industry to advance a coordinated innovation agenda in the life sciences [47].…”

Section: Communities Of Practicementioning

confidence: 99%