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PEGUS Welcomes 12 New Team Members in 2017
With a busy 2017 nearing its conclusion, our heavy workload has required new capacity and new faces. PEGUS has been aggressive in acquiring talented individuals to help us in our mission of positively impacting public health.
Lauren Call, Max George, and Nicolette Gillman have been added as Assistant Project Managers. These individuals all bring a passion for research that has helped them quickly learn, manage, and improve our study processes.
Paul Bradshaw has been added as our Project Management Coordinator. Paul has already proven tremendously helpful in helping coordinate our heavy workload.
McKinsie Bushnell and Carolyn Duggins have joined our Clinical Data Collection team. Their nursing experience teamed with their enthusiasm for research have made them critical additions to our team.
Amy Petersen, CPA has been added as our Director of Finance and Accounting. Amy brings a wealth of accounting knowledge that we are happy to utilize as she guides PEGUS in our future financial management.
Taylor Isle has been added as a Regulatory Assistant. Our Regulatory team is thrilled to have his detail-orientation and affable demeanor to help in their efforts.
Shannon Hafford and Robert Damewood have joined our team as Site Coordinators. The Site Coordination team is excited to have these talented, personable team members to help coordinate the extensive amounts of information and materials going to and from our study sites.
Our newest addition, Courtney Rogers, joins us as a Data Management Assistant. Courtney brings enthusiasm and curiosity for research that we are excited to utilize as she assists our team in providing top quality data.
We welcome all these individuals to our team!
New Director of Finance and Accounting - Amy Petersen, CPA
We’re excited to welcome a new face to PEGUS. Amy Petersen comes to us from an auditing firm, where she helped her clients design and maintain better accounting systems. Amy earned a Masters of Accounting from Utah State University, along with her Certified Public Accountant license. We are happy to add Amy’s wealth of accounting knowledge to help guide PEGUS’s future financial management.
Welcome, Amy, to our team!
PEGUS Research Actual Use Trial Results Published in International Journal of Clinical Pharmacology and Therapeutics
Results from a US actual use trial conducted by PEGUS to evaluate consumer adherence to dosing directions for a 400 mg OTC pain reliever were recently published in the International Journal of Clinical Pharmacology and Therapeutics. Clark Richardson, PEGUS Senior Consultant for the project, was one of the authors, together with authors from the study sponsor, Pfizer Consumer Healthcare.
We are pleased to have another example of prescription-to-over-the-counter switch research published in the literature, and hope it can help contribute to the overall body of knowledge regarding best OTC research practices and critical consumer product use behavior dynamics.
Sarah Farnsworth Receives Award
One of our own has just been recognized among the 2016 “30 Women to Watch” in Utah. Dr. Sarah Farnsworth, Vice President and shareholder at PEGUS Research, is one recipient of this honor presented by Utah Business Magazine. The 2016 “30 Women to Watch” celebrates Utah’s most successful and influential women as selected by their peers. To see the short video presentation highlighting Sarah’s accomplishment, please see: http://www.utahbusiness.com/sarah-j-farnsworth-30-women-to-watch/. We congratulate Sarah!
Study Conducted by PEGUS Research Published in JAPhA.
A Self-Selection and Actual Use Trial conducted by PEGUS Research that investigated whether consumers can correctly select and use a long-acting immediate-release and extended-release 600 mg ibuprofen product was recently summarized in a manuscript and accepted for publication in the July/August edition of the Journal of the American Pharmacists Association. Sarah Farnsworth, who managed the study at PEGUS, was one of the authors of the publication. The study sponsor was Pfizer Consumer Healthcare.
We are pleased to have another example of prescription-to-over-the-counter switch research published in the literature, and hope that it can help contribute to the overall body of knowledge regarding critical consumer selection and use behavior dynamics.
Human Factors Research
For years the FDA has requested device and Rx manufacturers to conduct human factor studies, sometimes also referred to a usability studies. In contrast to label comprehension studies, which assess the extent to which consumers understand the information on drug product labeling (see FDA LCS Guidance here), the intent of human factors research is to evaluate the user interface of a product, or in other words the ability of users to follow and actually perform the needed instructions in a way that eliminates or mitigates potential use-related hazards. In February of this year, the FDA issued draft guidance on how to conduct these studies for combination products (e.g. products comprised of both a drug and a device).
In the last few years the Division of Nonprescription Drug Products (DNDP) has begun to make more requests of OTC sponsors to conduct human factors studies when a proposed OTC product requires consumers to do something more than just take a pill (for example, prime a device prior to administering a dose, or correctly spray the product into the nose or mouth in the case of inhalers).
Most clients know the work PEGUS Research does in support of Rx-to-OTC switch and OTC brand line extension programs (including Drug Facts Label development and the design and conduct of label comprehension, self-selection and actual use studies). However, some may not yet know PEGUS also conducts human factors studies for OTC combination products to address specific research needs and requests from the Agency. We have supported a number of human factors studies for OTC clients. If you have questions about ways PEGUS can assist with human factors research, please contact us at 801-487-9899 or visit our website at http://www.pegus.com/human-factors-research.html.
New Executive Team Members
PEGUS is pleased to announce the addition of 3 key leaders to our newly re-organized Executive Team:
- Kimberly Anderson, MPH will now serve as Vice President of Clinical Operations
- Sarah Farnsworth, PhD will serve as Vice President of Scientific Affairs
- Erin Cunningham will serve as Vice President of Finance and Business Operations
These are changes envisioned for years at PEGUS, and we welcome the new group of incredibly capable leaders to our PEGUS Executive Team. These new assignments highlight the evolving depth, experience and scientific and operational ability that characterize PEGUS. In addition, Katie Callaway and Brandon Henrie, MS will now serve as Directors of Clinical Operations.
For more information about PEGUS leadership (including other continuing members of the Executive Team), see the “Our Team” link above. To find out more regarding ways our research services can enhance your programs, contact David McCammon (801-990-6121, email@example.com) or Clark Richardson (801-990-6126, firstname.lastname@example.org).
Clark Richardson Participates in Annual CHPA Regulatory, Scientific and Quality Conference
Clark Richardson, President at PEGUS Research, participated in the May 14-15, 2015 CHPA RSQ Conference in a session titled, “Innovative Methods for Understanding Consumer Behavior.” The PEGUS presentation focused on innovations in label comprehension testing, including ways to sample more effectively from the right populations and better engage consumers with enhanced tools and technologies. A copy of Clark’s presentation can be found at URL:
http://www.chpa.org/2015RSA1.aspx (see page 14).
In a presentation on a related topic, CDER’s James Stansbury shared important insights regarding FDA’s newest thinking on “Design and Innovations in Consumer Research” (see URL: http://www.chpa.org/2015RSA3Stansbury.aspx), adding emphasis to the utility of creative thinking and improved methods.
PEGUS Awarded New Modified Risk Tobacco Consulting and Research Program
A new business segment has been initiated due to modified risk tobacco products coming under FDA regulatory authority and review. PEGUS has experience in addressing FDA requirements and conducting needed studies to answer critical regulatory questions. The studies for these products appear likely to follow a consumer research program model similar to the one typically followed for a traditional OTC-switch NDA, including label comprehension, self-selection, and actual use.
Our team of scientists and technical study staff can help with a wide range of unusual questions pertaining to consumer health.
FDA Advisory Committees Consider Current Data Regarding CV Risk for NSAIDS
On February 10-11, 2014, the Arthritis and Drug Safety and Risk Management Advisory Committees jointly met to consider the current body of evidence regarding the relationship between use of COX-2 selective and non-selective NSAIDs and important CV risks. Key staff from PEGUS were in attendance. The Committees ultimately voted 16 to 9 against making labeling changes for NSAIDs based on current data available.
Meeting information and materials can be found here: