Frances J. Richmond, PhD
Faculty Directory

Frances J. RichmondPhD

Frances J. RichmondPhD

Director of the D. K. Kim International Center for Regulatory Science & Professor of Regulatory and Quality Sciences

Department of Regulatory and Quality Sciences

Frances Richmond was educated as a neurophysiologist (BNSc, MSc, PhD) at Queen’s University in Kingston, Ontario. She completed postdoctoral studies at the Universite de Montreal and the National Institutes of Health before joining the faculty of Queen’s University, where she served as associate dean of life sciences (1986-1989). She also served as a policy adviser for scientific labor needs at Industry Canada (1990-1992) and as a clinical scientist at the Alfred E. Mann Foundation, an early-stage device development group (1994-1995). She was the first female to be appointed director of a research consortium funded by Canada’s Medical Research Council (1995-2000).

Richmond joined the faculty of USC in 1999 as director of regulatory and clinical sciences at the Alfred E. Mann Institute, where she served for eight years. Her work there included seven projects in the field of product development which have advanced through the clinical trial stage. Though focused mostly on the BION, an implantable wireless microstimulator, she was also involved in research on other implantables, sensors and prosthetic limbs. Richmond is or has been a member of three large research consortia—the National Institutes of Health (NIH) Engineering Research partnership, NIH Bioengineering Research partnership and the Southern California Clinical and Translational Science Institute (CSTI). She directs CSTI’s Regulatory Knowledge and Support group for the Los Angeles Basin.

Areas of Expertise

  • Regulatory Science
  • Implantable Medical Devices
  • Regulatory Issues and Clinical Trials
  • Regulation of Medical Products
  • Education

    Queen's University

    PhD

    Queen's University

    MSc

    Queen’s University

    BNSc

  • Links
  • Selected Articles

    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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  • Affiliations
    • NIH Engineering Research partnership : Member

    • NIH Bioengineering Research Partnership : Member

    • Regulatory Knowledge and Support Group : Director

  • Accomplishments

    Founder and Chair, Department of Regulatory and Quality Sciences, USC School of Pharmacy

    The University of Southern California’s Regulatory Science Program offers Graduate Certificate, Master’s and Doctoral programs in Los Angeles and by distance. Full and part-time students can expand their knowledge of regulatory affairs, clinical research and quality systems. Our goal is to develop regulatory science leaders in industry, government and academia.

  • Patents

    Implantable stimulator system and method for treatment of incontinence and pain

    US6735474B1

    2000 A method and system for treatment of incontinence and/or pelvic pain includes the injection or laparoscopic implantation of one or more battery- or radio frequency-powered microstimulators (10) beneath the skin of the perineum and/or adjacent the tibial nerve. The devices are programmed using radio-frequency control via an external controller (20, 30)) that can be used by a physician to produce patterns of output stimulation pulses judged to be efficacious by appropriate clinical testing to diminish symptoms. The stimulation program is retained in the microstimulator device (10) or external controller (20) and is transmitted when commanded to start and stop by a signal from the patient or caregiver. The system and method reduce the incidence of unintentional episodes of bladder emptying by stimulating nerve pathways (8) that diminish involuntary bladder contractions, improve closure of the bladder outlet, and/or improve the long-term health of the urinary system by increasing bladder capacity and period between emptying. The incidence of fecal incontinence is similarly reduced or eliminated. Furthermore, the system and method reduce or eliminate the incidence of pelvic pain by chronically stimulating nerve pathways that derive from the sacral roots using a miniature implantable neurostimulator that can be implanted with a minimal surgical procedure. Moreover, the system and method allow a patient to be taught to receive one or more patterns of neural stimulation that can be prescribed by a physician and administered without continuous oversight by a clinical practitioner.

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    Implantable stimulator system and method for treatment of urinary incontinence

    AU745744B2

    1999 Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control.

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    Implantable electrode arrays

    US5957958A

    1997 An implant stimulator device uses tantalum and tantalum pentoxide as a system for the conveyance of electrical stimulation pulses from stimulus-forming circuitry contained within an hermetic enclosure to the saline fluids of body tissue to be stimulated. Internal coupling capacitors are not used, yet the danger of having DC current flow to the saline fluids is eliminated. A preferred embodiment provides a multiplicity of electrode contacts made from sintered, anodized tantalum, connected via tantalum wire leads to tantalum feedthroughs into the hermetically sealed package containing the stimulus pulse-forming electronic circuitry. One or more counter electrode contacts (for monopolar or bipolar configurations, respectively) made of activated iridium, non-activated iridium, iridium in combination with a noble or non-noble metal, platinum, gold, or other metal which forms a low impedance contact with body fluids, is/are connected via platinum or other conductive metal leads to return feedthroughs. When powered-up, the stimulus generating circuit produces a steady polarizing potential of approximately half its maximum output voltage range, which potential is applied as a positive (anodizing) voltage to each tantalum electrode and associated lead and feedthrough, with respect to the counter electrode(s), which act as the reference point for the circuit.

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  • Multimedia
    • Frances J. Richmond, PhD
    • Frances J. Richmond, PhD
  • Selected Media Appearances

    From Microscope to Market

    USC School of Pharmacy | 04/20/2018

    Under the leadership of Frances Richmond, the USC School of Pharmacy established one of the nation’s first programs in regulatory science, a relatively new but rapidly growing field that is not only becoming more global in nature but also offers a world of opportunity to students.

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    How do you upgrade an archaic biomedical device? Make it “self-aware”

    USC Viterbi | 04/12/2018

    The research team collaborated with Dr. Gordon McComb, Dr. Mark Krieger and Dr. Eisha Christian of the clinical neurosurgery department at CHLA and Dr. Frances Richmond and Dr. Michael Jamieson from the USC Regulatory Science Program.

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