Biotechnology: Delivering on the Promise

Greenwood, James C.

doi:10.1126/scitranslmed.3000357

Cited by 5 publications

(4 citation statements)

References 5 publications

(5 reference statements)

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“…The regulatory pathway for biosimilars has received significant attention, [1] with regulators in Europe and the US working to define appropriate ways to evaluate efficacy and safety. [2] As a result, the first application for a biosimilar monoclonal antibody is now under consideration.…”

Section: Introductionmentioning

confidence: 99%

Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic

Towfic¹,

Funt²,

Fowler³

et al. 2014

PLoS ONE

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For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy.

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Section: Introductionmentioning

confidence: 99%

Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic

Towfic¹,

Funt²,

Fowler³

et al. 2014

PLoS ONE

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“…22 Most important, more than 250 biotechnology products have been approved by the FDA with more than 600 new drugs in clinical trials today. 2,24 We note in closing that the idea of a government-backed venture fund is beginning to gain traction among policymakers in Washington, DC. In the recent HHS Public Health Medical Countermeasures Review, published in August 2010, HHS reviewed and identified several barriers to the development of a robust arsenal of medical countermeasures, including regulatory limitations, manufacturing capacity, financial incentives, and the like.…”

Section: Resultsmentioning

confidence: 98%

“…17 Inherently higher risk practices associated with funding seed or early-stage research, which lack either proven efficacy or proven market viability, are more likely to be rejected in favor of later-stage opportunities with defined markets and predictable annual sales. 2,17 Next-in-class drugs, in which the regulatory environment is relatively well defined, are also more likely to be supported rather than programs that rethink basic science and explore potentially new biological pathways. As a result, the chance that an investment will be made in a new therapeutic area has decreased in comparison to the likelihood that it will be made in a ''me-too'' product space.…”

Section: Incentive Funding For Biodefense Biotechsmentioning

confidence: 97%

“…It is easier to secure funding for late-stage therapeutic agents that proffer incremental improvements to their in-class counterparts, because they present less scientific and regulatory risk and offer greater risk-adjusted economic returns in established markets. [1][2][3] This funding paradigm is problematic not only for the advancement of basic science and translational medicine, but also for the development of biothreat countermeasures such as antibiotics, vaccines, and antitoxins. Since, as investment propositions, these agents are predisposed to less quantifiable economic returns, venture funding for their development is significantly less likely.…”

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confidence: 99%

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Seeking Innovation: Incentive Funding for Biodefense Biotechs

Nolan¹,

Samad²,

Jindra³

et al. 2010

Biosecurity and Bioterrorism: Biodefense Strategy, Practice, an

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In the current venture capital climate, it is easier to secure funding for late-stage, next-in-class therapeutic agents than for early-stage opportunities that have the potential to advance basic science and translational medicine. This funding paradigm is particularly problematic for the development of "dual-use" biothreat countermeasures such as antibiotics, vaccines, and antitoxins that target pathogens in novel ways and that have broad public health and biodefense applications. To address this issue, we propose the creation of the Drug Development Incentive Fund (DDIF), a novel funding mechanism that can stimulate the development of first-in-class agents that also possess the capability to guard against potential biothreats. This program would also support greater synergies between public funding and private venture investment. In a single act, this organization would secure science of national importance from disappearing, invest in projects that yield significant public health returns, advance the promises of preclinical and early phase research, revitalize biopharmaceutical investment, and create valuable innovation-economy jobs.

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When do firms benefit from university–industry R&D collaborations? The implications of firm R&D focus on scientific research and technological recombination

Soh¹,

Subramanian²

2014

Journal of Business Venturing

115

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Biotechnology: Delivering on the Promise

Abstract: Policy-makers can play an important role in bolstering the biotechnology industry.

Cited by 5 publications

References 5 publications

Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic

Comparing the Biological Impact of Glatiramer Acetate with the Biological Impact of a Generic

Seeking Innovation: Incentive Funding for Biodefense Biotechs

When do firms benefit from university–industry R&D collaborations? The implications of firm R&D focus on scientific research and technological recombination

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