My clinical trials career path has been a bit different than most. I spent several years working in pharmaceutical advertising/sales/marketing and then took a break to raise my children while working part time in marketing and sales, eventually running my own travel business while I took care of aging parents. When my oldest child was in 3rd grade, she ate a hamburger containing E. coli, and developed Hemolytic Uremic Syndrome (HUS) and almost died, ending up on dialysis. We asked at the time whether any drugs existed to treat this infection and were saddened to find out that there was no medication for the treatment of this illness. Thankfully, after a few short months, she slowly regained her health, though so many children lose their lives to HUS.
I considered myself fortunate a short time later to be asked by my physician (who knew about my daughter) to take part in a clinical trial for an E. coli drug, and I eagerly accepted. This was my first exposure to the phases of clinical research/drug trials, and I was both fascinated by the process and most hopeful that my small part in the study would lead to saving someone else’s child someday. I participated in that study for a few years and still anticipate a treatment for this horrific illness.
Later on, my mother-in-law developed Alzheimer’s disease and my mother developed Multiple Myeloma. I have been a caretaker for both on and off ever since. When I was in the pharma industry earlier in my career, I worked on preliminary marketing for a revolutionary Alzheimer’s drug which was still in clinical trials and though it was never approved, I learned about how the FDA approvals process works and became intrigued by what was “in the pipeline” of the companies we worked with.
While caring for my maternal role models, I attended medical appointments and procedures with various physicians and entered into lengthy discussions regarding investigational drugs for the treatment of the two aforementioned diseases. I was thrilled to find out that many companies were working on emerging drugs for Multiple Myeloma especially – this gives my mom hope for other treatment options when her regimen eventually fails.
Once COVID derailed my travel business, I began rethinking my career path. While I missed my pharma advertising days, after my experience as the medical go-to person for my family, I realized I craved work that would directly affect patient outcomes. Instead of promoting drugs, I wanted to help bring them to market. I targeted the clinical trial market specifically after this personal involvement with loved ones in need of the best treatment possible. Through many hours spent researching investigational studies for Alzheimer’s and Multiple Myeloma, I understood not only how crucial that drug pipeline is, but also the critical importance of a documented safety profile for the drugs that make it to market and treat real world patients to improve their quality of life.
Through a friend, I learned about ICON’s innovative offerings, collaborative work environment and patient-centered focus. I realize this now first-hand in my daily work as a project coordinator and am honored to collaborate with project teams who truly have drug efficacy, as well as patient safety, in mind as they drive their studies forward. I didn’t mind starting over in a related but new field to me since this work is meaningful to me personally. Finally, I am extremely proud to tell my mother and mother-in-law that I am contributing to the development of new therapies that someday may safely enable countless patients, like themselves, to live longer and healthier lives.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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