Author Archives: ricknelson

Systematic review article accepted for publication

A publication titled, “Benefit-Risk of Coffee Consumption and All-Cause Mortality: A Systematic Review and Disability Adjusted Life Year Analysis,” by ToxStrategies authors Candace Doepker, Naimisha Movva, Sarah Cohen [no longer with ToxStrategies], and Daniele Wikoff, has been published by Food and Chemical Toxicology. The paper is unique, in that a quantitative analysis was used within the benefit-risk assessment for foods (BRAFO) paradigm to assess potential harm and/or benefits of drinking coffee. In the paper, the BRAFO framework is applied to guide risk managers in decision making; in that context, the authors conclude that any policy that directs consumers to avoid drinking coffee may be a detriment to the overall health of the population, given the substantial potential benefits of coffee consumption on all-cause mortality for adults.

The published manuscript is available from the journal.

EpidStrategies announces seven new publications of RSV research

Several EpidStrategies scientists are among the collaborating authors of seven new studies on respiratory syncytial virus (RSV) published in a special supplement to the Journal of Infectious Diseases. The authors include Ms. Mina Suh, Dr. Jon Fryzek, Ms. Naimisha Movva, Ms. Xiaohui Jiang, Ms. Heidi Reichert, and Ms. Lauren Bylsma, and the studies describe the morbidity and mortality burden of RSV among US-born infants and children under 5 years old.

RSV affects nearly all infants and children <5 years old. Our studies confirm that RSV is the leading cause of infant hospitalizations in the US. Even those born full term and otherwise healthy may be at risk of developing serious illnesses from RSV, including pneumonia. In addition, infants insured with Medicaid experience twice as many hospitalizations and emergency-room visits as privately insured infants, indicating potential health-care equity issues.

This journal supplement is the culmination of an ongoing research program that involved EpidStrategies scientists and academic and industry collaborators. Please contact Mina Suh (msuh@epidstrategies.com) for more information about this work.

The seven publications, listed below, are available from the journal via open access.

  • Suh M, Movva N, Jiang X, Bylsma LC, Reichert H, Fryzek JP, Nelson CB. 2022. Respiratory syncytial virus (RSV) is the leading cause of United States infant hospitalizations 2009–2019: A study of the National (Nationwide) Inpatient Sample. J Infect Dis 226(Suppl 2):S154–S163, open access.
  • Movva N, Suh M, Reichert H, Hitze B, Sendak MP, Wolf Z, Carr S, Kaminski T, White M, Fisher K, Wood CT, Fryzek JP, Nelson CB, Malcolm WF. 2022. Respiratory syncytial virus during the COVID-19 pandemic compared to historic levels: A retrospective cohort study of a health system. J Infect Dis 226(Suppl 2):S175–S183 open access.
  • Suh M, Movva N, Jiang X, Reichert H, Bylsma LC, Fryzek JP, Nelson CB. 2022. Respiratory syncytial virus burden and healthcare utilization in United States infants, <1 year of age: Study of nationally representative databases, 2011–2019. J Infect Dis 226(Suppl 2):S184–S194, open access.
  • Suh M, Movva N, Bylsma LC, Fryzek JP, Nelson CB. 2022. A systematic literature review of the burden of respiratory syncytial virus disease and health care utilization among United States infants younger than 1 year. J Infect Dis 226(Suppl 2):S195–S212, open access.
  • Movva N, Suh M, Bylsma LC, Fryzek JP, Nelson CB. 2022. Systematic literature review of respiratory syncytial virus laboratory testing practices and incidence in United States infants and children <5 years of age. J Infect Dis 226(Suppl 2):S213–S224, open access.
  • Reichert H, Suh M, Jiang X, Movva N, Bylsma LC, Fryzek JP, Nelson CB. 2022. Mortality associated with respiratory syncytial virus, bronchiolitis, and influenza among infants in the United States: A birth cohort study from 1998 to 2018. J Infect Dis 226(Suppl 2):S246–S254, open access.
  • Bylsma LC, Suh M, Movva N, Fryzek JP, Nelson CB. 2022. Mortality among United States infants and children under 5 years of age with respiratory syncytial virus and bronchiolitis: A systematic literature review. J Infect Dis 226(Suppl 2):S267–S281, open access.

Congratulations to Dr. John Rogers on the RDTSS Scientific Achievement Award

John Rogers - 2022 RDTSS Award Winner

The Reproductive and Developmental Toxicology Specialty Section of the Society of Toxicology recently awarded its Scientific Achievement Award to ToxStrategies Senior Consultant Dr. John Rogers. The Section presents this award annually to recognize a member’s lifetime contribution to the field of reproductive and developmental toxicology, including such factors as leadership, impact on the field, and mentorship. In presenting the award during the Section’s annual meeting, held virtually on May 3, Dr. Atlee Watson recognized Dr. Rogers’ career longevity, beginning with service in the EPA in the 1980s, as well as his active leadership in SOT and the RDTSS, and his role in numerous scientific panels, seminars, and continuing education initiatives.

Assessment of per- and polyfluoroalkyl substances (PFAS)

Concerns about potential health risks associated with low-level exposures to PFAS, along with their widespread uses and reported detections in various environmental media and products, are triggering regulation, litigation, and an urgent need to apply the best available science in evaluating the exposure, toxicology, and epidemiology to characterize potential human health risks. ToxStrategies and EpidStrategies have scientific expertise and advanced technical resources to assist clients in navigating the scientific environment and growing regulatory labyrinth associated with PFAS.

ToxStrategies’ and EpidStrategies’ cross-disciplinary capabilities include (but are not limited to) protocol development for PFAS extraction and migration from products, articles, and containers; assessment of fate and transport of PFAS; exposure and risk assessment of PFAS in environmental media; exposure and safety assessment of PFAS contained in wide variety of products, including foods, packaging, personal care products, cosmetics, health and beauty care products, and commercial/industrial products; in-depth PFAS toxicology knowledge; development of PFAS toxicity criteria and toxicokinetic modeling; critical assessment and systematic reviews of PFAS epidemiological studies and evidence to understand impact on health outcomes; and critical evaluation and systematic reviews of PFAS literature.

Learn more about our PFAS capabilities here.

 

Cross-discipline team publishes on Cr(VI) in air

A team of ToxStrategies and EpidStrategies scientists are authors on a manuscript being published in Regulatory Toxicology and Pharmacology. The study examines current practices for assessing risk associated with environmental exposure to hexavalent chromium, comparing approaches based on margin of exposure to those using linear extrapolation. The authors assert that regulatory lung cancer potency estimates for Cr(VI) are based on outdated research, whereas more current mechanistic data support an epigenetic role for Cr(VI) and a non-mutagenic mode of action. The article cites a need for new epidemiology data to inform risk assessment of low-intensity exposures, concluding, however, that Cr(VI) in ambient air poses little concern for human health.

New opening for an Epidemiologist

EpidStrategies, a division of ToxStrategies, Inc., has opened a position for an epidemiologist to join our team of epidemiologists and statisticians conducting systematic literature reviews and statistical analyses, and preparing manuscripts. We’re seeking a masters- or doctorate-level candidate with at least 3 years of professional experience conducting literature reviews, and strong writing and presentation skills. The successful candidate will enjoy EpidStrategies’ challenging and dynamic work environment, professional development opportunities, and competitive compensation and benefits. Interested? Please send a cover letter and CV to hr@epidstrategies.com.

EpidStrategies scientists at rare-disease summit

EpidStrategies epidemiologists Dr. Jon Fryzek and Ms. Lauren Bylsma will present a poster at the “Rare Diseases and Orphan Products Breakthrough Summit,” to be convened October 21st and 22nd in Washington, D.C., by the National Organization for Rare Disorders (NORD). Their poster is titled, “Cohort Study of High Frequency Basal Cell Carcinoma (BCC) Patients in Denmark.”

The rare-disease summit is an opportunity for EpidStrategies to offer its broad expertise in rare-disease epidemiology, including calculation of incidence and prevalence and assembly of rare-disease cohorts for natural history studies, treatment characterization, and evaluation of health-care resource use. As NORD states, “…The Time is Now to prioritize action in making positive changes for the millions of Americans living with rare diseases.”

EpidStrategies scientists attend ICPE

Scientists from EpidStrategies, a Division of ToxStrategies, presented at the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE). The August 2019 meeting, held in Philadelphia, had a theme of “Using Real World Data and Designs to Optimize Decisions.” EpidStrategies scientists collaborated to create five posters that showcased recent work on Klebsiella pneumoniae, algorithms to identify specific heart-failure patients, meta-analyses related to metastatic colorectal cancer, and rare-disease epidemiology using the Danish databases.

The authors and poster titles are listed below, and copies of posters are available on request.

Dr. Sarah Cohen and Naimisha Movva
Development of Computable Phenotypes to Identify Heart Failure Patients with Preserved Ejection Fraction

Dr. Jon Fryzek and Lauren Bylsma
Rare Disease Epidemiology: A Danish Population-Based Program

Naimisha Movva and Dr. Jon Fryzek
Hospitalizations due to Klebsiella pneumoniae Pneumonia in the United States

Lauren Bylsma and Dr. Jon Fryzek
The Incidence of Infusion Reactions Associated with Monoclonal Antibody Drugs Targeting the Epidermal Growth Factor Receptor in Metastatic Colorectal Cancer Patients: A Systematic Literature Review and MetaSp-analysis

Lauren Bylsma and Dr. Jon Fryzek
Prevalence of Kras, Nras, and Braf Gene Mutations in Metastatic Colorectal Cancer (mCRC) Patients: A Systematic Literature Review
This poster had the honor of being selected for a Spotlight Session for the Special Interest Group (SIG) Molecular Epi, Biomarkers, and Pharmocogenetics

EpidStrategies at BIO International

EpidStrategies Principal Epidemiologist and Practice Director Dr. Jon Fryzek attended and exhibited at the 2019 BIO International Convention, June 3–6, 2019, in Philadelphia, PA. Also attending were ToxStrategies scientists, Drs. Janice Lansita and Marcie Wood. Convention attendees were able to learn about our nonclinical toxicology consulting capabilities and expertise with biologics, immuno-oncology, ophthalmology, and inhalational drug development.

 

ToxStrategies launches EpidStrategies division

We are pleased to announce the launch of EpidStrategies, a new division of ToxStrategies. With this expansion, ToxStrategies is adding world-class epidemiology expertise to its offering of consulting services. The scientists and biostatisticians at EpidStrategies can assist clients in addressing complex health issues and in conducting and evaluating epidemiological studies, from design through the interpretation of results. The EpidStrategies team is adept at applying these tools to assessments in such diverse arenas as pharmaceuticals, medical devices, and environmental chemicals. Dr. Jon Fryzek will lead the EpidStrategies team along with Sarah Cohen, Ph.D. Other team members include Lauren Bylsma, MPH, Xiaohui Jiang, MS, and Heidi Reichert, MS, MA.