Biobank Continuity Management: A Survey of Biobank Professionals.
Biopreservation and Biobanking
FJ Richmond et al.
2019
Academic biobanks face challenges that call for continuity and disaster planning. However, current regulations do not require such planning, so it is unclear if and how biobanks have prepared themselves to deal with future crises. This exploratory study used mixed methods to understand the state of continuity planning in U.S. biobanks. It first reviewed the current state of regulatory and implementation requirements that drive and challenge continuity planning. A survey instrument was then developed and critiqued by a focus group of experienced practitioners in biobanking. The refined survey was disseminated to a targeted group of respondents employed at biobanks across the United States. Most respondents were associated with relatively mature biobanks in operation for more than 6 years and these typically had some form of continuity plan in place. More commonly, continuity planning was reported to be focused on countering natural disasters rather than organization- or personnel-related crises. Respondents identified their most common limitation to be financial resources affecting all phases of implementation. Although many respondents appeared to be aware of some guidance documents and standards for continuity planning, many reported that they did not use or reference them when constructing their biobank continuity plans. Furthermore, nearly 25% of surveyed biobanks did not have a continuity plan and 61% indicated concern in having a mandated continuity plan. Results suggested academic organizations would benefit from a continuity plan template and best practice guidelines for plan development and implementation.
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Validation Master Plans: Progress of Implementation in the Pharmaceutical Industry.
Therapeutic Innovation & Regulatory Science
FJ Richmond et al.
2018
A survey instrument was developed using an established framework with a focus on behavior and capability and disseminated electronically to midlevel and senior regulatory and quality professionals concentrated in the US.
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Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses.
Therapeutic Innovation & Regulatory Science
FJ Richmond et al.
2017
Much structured benefit-risk research has been conducted in the context of drug trials; here we apply this approach to device studies. A qualitative framework organized benefit (speech recognition, parent self-report measures) and risk (surgery- and device-related) information to guide the selection of candidates thought to have potential benefit from ABI.
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Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings.
Therapeutic Innovation & Regulatory Science
FJ Richmond et al.
2015
A 23-question survey engaged 2 separate populations of industry professionals: a panel of identified US industry experts (n = 110) and a broader population (n = 328) of professionals working primarily in southern California.
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Percutaneous fiber-optic sensor for chronic glucose monitoring in vivo
Biosensors and Bioelectronics
FJ Richmond et al.
2008
We are developing a family of fiber-optic sensors called Sencils™ (sensory cilia), which are disposable, minimally invasive, and can provide in vivo monitoring of various analytes for several weeks. The key element is a percutaneous optical fiber that permits reliable spectroscopic measurement of chemical reactions in a nano-engineered polymeric matrix attached to the implanted end of the fiber. This paper describes its first application to measure interstitial glucose based on changes in fluorescence resonance energy transfer (FRET) between fluorophores bound to betacyclodextrin and Concanavalin A (Con A) in a polyethylene glycol (PEG) matrix. In vitro experiments demonstrate a rapid and precise relationship between the ratio of the two fluorescent emissions and concentration of glucose in saline for the physiological range of concentrations (0–500 mg/dl) over seven weeks. Chronic animal implantation studies have demonstrated good biocompatibility and durability for clinical applications.
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