The Impact of Market Volatility on the Cell Therapy Industry

Brindley, David; Reeve, Brock; Sahlman, William A.; Bonfiglio, Greg A.; Davie, Natasha L.; Culme-Seymour, Emily; Mason, Chris

doi:10.1016/j.stem.2011.10.010

Cited by 27 publications

(19 citation statements)

References 6 publications

(6 reference statements)

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“…The above considerations related with the manufacturing and regulatory importance of developmentally relevant bioartificial tissue forms are especially critical at this time because a growing number of publicly funded centers have been created worldwide with the purpose of supporting the transition from early research to late clinical trials and commercial supply providing guidance to industry for manufacturing according to regulations [19].…”

Section: Developmental Biology Rationalizes Manufacturing and Regulatormentioning

confidence: 99%

Developmental Biology in Bioartificial Tissue Design: Manufacturing and Regulatory Considerations

Lenas

2018

Regen. Med.

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Section: Developmental Biology Rationalizes Manufacturing and Regulatormentioning

confidence: 99%

Developmental Biology in Bioartificial Tissue Design: Manufacturing and Regulatory Considerations

Lenas

2018

Regen. Med.

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“…Despite its relative infancy, it has successfully established itself as a billion-dollar industry [3, 6], which is projected to grow—supported by an increasing number of marketable products, fiscal investment, and strong M&A (merger and acquisition) activity [7]. In 2014 alone, venture capital investment into the biotech sector surpassed $9 billion (USD) [8] and transformed an industry historically plagued by overly exuberant investments and multibillion-dollar losses [9] into a stable and sustainable market that appears attractive for both future investment and long-term value.…”

Section: Review Backgroundmentioning

confidence: 99%

An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol

et al. 2017

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BackgroundCellular-based therapies represent a platform technology within the rapidly expanding field of regenerative medicine and are distinct from conventional therapeutics—offering a unique approach to managing what were once considered untreatable diseases. Despite a significant increase in basic science activity within the cell therapy arena, alongside a growing portfolio of cell therapy trials and promising investment, the translation of cellular-based therapeutics from “bench to bedside” remains challenging, and the number of industry products available for widespread clinical use remains comparatively low. This systematic review identifies unique intrinsic and extrinsic barriers in the cell-based therapy domain.Methods/designEight electronic databases will be searched, specifically Medline, EMBASE (OvidSP), BIOSIS & Web of Science, Cochrane Library & HEED, EconLit (ProQuest), WHOLIS WHO Library Database, PAIS International (ProQuest), and Scopus. Addition to this gray literature was searched by manually reviewing relevant work. All identified articles will be subjected for review by two authors who will decide whether or not each article passes our inclusion/exclusion criteria. Eligible papers will subsequently be reviewed, and key data extracted into a pre-designed data extraction scorecard. An assessment of the perceived impact of broad commercial barriers to the adoption of cell-based therapies will be conducted. These broad categories will include manufacturing, regulation and intellectual property, reimbursement, clinical trials, clinical adoption, ethics, and business models. This will inform further discussion in the review. There is no PROSPERO registration number.DiscussionThrough a systematic search and appraisal of available literature, this review will identify key challenges in the commercialization pathway of cellular-based therapeutics and highlights significant barriers impeding successful clinical adoption. This will aid in creating an adaptable, acceptable, and harmonized approach supported by apposite regulatory frameworks and pertinent expertise throughout the respective stages of the adoption cycle to facilitate the adoption of new products and technologies in the industry.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-017-0517-4) contains supplementary material, which is available to authorized users.

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“…Applications of RM in cardiology and vascular medicine will also be developed, and these will be rapidly adopted into clinical practice over the next decade. These include treatments of coronary artery disease, myocardial infarction, congestive heart failure, dysfunctional heart valves, peripheral vascular disorders, and abdominal aortic aneurysms [51,[91][92][93]. However, challenges persist with interfaces between tissues and devices, including approaches intended to improve biocompatibility and integration between cells and novel devices, materials that self-assemble within the body, the fate of biomaterials and implant materials within the environment of the body, and optimal interaction between cells and the morphology and topography of surfaces and coatings.…”

Section: Tissue Engineeringmentioning

confidence: 99%

“…The latter situation may be more achievable. Regardless, creating entirely new organs remains challenging, although replacement hair, skin, teeth, and pancreatic islets may be achieved in the next 10 years, and the kidney is likely to be the first major organ to be created outside the body [51,[91][92][93].…”

Section: Tissue Engineeringmentioning

confidence: 99%

Advent and Maturation of Regenerative Medicine

Mhashilkar

Atala²

2013

Pharmaceutical Sciences Encyclopedia

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The goals for regenerative medicine (RM) are focused on developing innovative tools in modern medicine. Recent progress has led to the development and clinical implementation of newer technologies, ranging from diagnostics to therapeutics for a wide variety of metabolic, degenerative, and infectious diseases.These include specific applications toward age‐ and genetic‐related human and animal dysfunctions and disorders. The focus of this review is to present, in a nutshell, the current status of adult stem cell therapy (CT) and tissue engineering (TE), including the challenges faced, progresses attained, and an optimistic view of the future. We will also provide our views on how the next 20+ years will potentially affect these RM‐driven innovations and how they are applied toward a variety of disease treatments, cures, and diagnostics.

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The Impact of Market Volatility on the Cell Therapy Industry

Cited by 27 publications

References 6 publications

Developmental Biology in Bioartificial Tissue Design: Manufacturing and Regulatory Considerations

Developmental Biology in Bioartificial Tissue Design: Manufacturing and Regulatory Considerations

An assessment of the factors affecting the commercialization of cell-based therapeutics: a systematic review protocol

Advent and Maturation of Regenerative Medicine

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