Discussing Review Boards, Social Media, and World Events With Donna Dorozinsky
February 6, 2023
In this episode of The Scope of Things, host Deborah Borfitz provides a rundown of the latest news in the clinical trials field: a massive health research initiative in the UK, widespread overdosing of trial participants, a cholesterol-lowering vaccine, the growing popularity of phage therapy, a novel scoring mechanism for de-risking trials for chronic diseases, a strategy for making staph vaccines a reality, and the latest oral drugs heading to trials that could eliminate one of the chief barriers to insulin therapy for diabetics. Deborah also speaks with Donna Dorozinsky, President & CEO of Just in Time GCP, about recent changes related to expectations of institutional review boards, the use of social media for recruitment and communication purposes, and the impact of world events on clinical data management.
Show Notes
LINKS
Story in this episode [link to come]
News Roundup
Our Future Health
Medication adherence crisis
- Story covering the issues and smart packaging solutions
- PLOS One paper about overdosing of marketed drugs
Cholesterol-lowering vaccine
- Story about the bivalent vaccine and its promise
- NPJ Vaccines paper covering preclinical study results
Phage therapy
- World Economic Forum report on Top 10 Emerging Technologies of 2023
- Cell paper reviewing state-of-the-art in phage therapy
- Graham Hatfull podcast episode
Pharmagenic enrichment score
- Circulation paper on using genetics to inform interventions
- Story about how the patient scoring method enables precision medicine
Staph vaccine trials
- Story about outsmarting “part-time pathogens” [link to come]
- Cell Reports Medicine paper on immune imprinting informing vaccine development
New oral insulin drug
- Story about its development journey [link to come]
- Nature Nanotechnology paper on the formulation with reduced episodes of hypoglycaemia
Guest
- Donna Dorozinsky, founder and CEO of Just in Time GCP
- Story about the Start Up Pitch Contest at SCOPE
- SCOPE Summit in Orlando, February 11-14
Donna Dorozinsky, President & CEO Just in Time GCP
As the Founder & CEO of Just in Time GCP, Donna is responsible for running all facets of the business. She is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large Pharma companies, academic centers, regulatory agencies, CROs, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded Just in Time GCP. In her capacity as Founder & CEO, she has built an organization that is highly respected within the clinical compliance and TMF management services industries. As a consultant, she has led many large projects performing operational gap analysis and implementing process improvement initiatives for sponsors, CROs and clinical sites. She has extensive experience in inspection readiness/preparation and has assisted organizations in developing and executing remediations across clinical systems, quality management systems, and TMF services.
Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and TMF Management and is a dynamic educator. She is the Lead Editor in the newest edition of Good Clinical Practice: A Question and Answer Guide, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year. Under Donn’s leadership, Just in Time GCP has been named to the INC5000 for the past 3 years and was most recently named an INC500 Best Workplace. Donna earned a BSN from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and an MSN from Widener University.
