When planning a rare disease clinical trial, drug developers can expect to face several challenges. In many cases, developers approach the study believing that patient recruitment will be their biggest obstacle. They are correct in making this assumption, but it is not always for the reasons they assumed.
Finding patients is, in fact, the most common obstacle experienced in rare disease clinical trials. Nevertheless, it is not always due to lack of patient presence, rather it is the culmination of several key challenges. This includes but is not limited to understanding the diagnostic odyssey, competitive study and treatment landscape, ability to operationalize at the global, regional and site level. This is where a robust, data-driven feasibility analysis becomes a necessary, key component.
This webinar will provide an in-depth perspective from the experts developing the most innovative feasibility strategies being applied to the rare diseases of today.
Lisa Dilworth, BS, MS, Vice President Rare, Orphan and Pediatric Diseases, Synteract
Lisa Dilworth has had the honor of being named on the list of 100 Most Inspiring People by PharmaVoice. Her breadth of experience encompasses more than 20 years of clinical research in all phases of drug development. Dilworth is a passionate collaborator committed to working directly with patients and their families, physicians, sponsors, and other key stakeholders in the rare and orphan disease space. Dilworth has extensive experience in study design, eligibility criteria, feasibility, endpoint selection, operations/project management and overall project/program strategy. She combines her previous work, as a study coordinator, neurophysiology technician with a patient-focused mindset and strong relationships with advocacy groups, to ensure that the appropriate strategies are employed to successfully execute trials.
Rachael Young, Associate Director, Feasibility, Synteract
Rachael Young is an experienced feasibility strategist with over eight years of industry experience. She has focused on the development of complex, data-driven feasibility strategies to support robust clinical trial planning. She works in a cross-therapeutic team supporting all stages of feasibility from early pre-award study planning through to site identification, selection and initiation. With expertise across multiple therapeutic areas Young can analyse wide data sets to inform evidence-based and data-driven decision making, which ensures effective strategies are implemented bespoke to the clinical program. Young’s passion lies in rare and orphan drug development, by which understanding a multitude of unique factors is critical to overcoming study obstacles and ultimately ensuring patients gain access to these life-changing trials.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
- The importance of ongoing, real-time monitoring of the approved drug market and competitive trial landscape
- Actionable insights pertaining to the reimbursement climate for approved drugs as the standard of care within each region and patient subset
- How to effectively collaborate with key stakeholders including advocacy, consortium and site networks to further support a drug development program
- A comprehensive look into the potential obstacles one can expect when conducting country and site level feasibility. This includes considerations on how to accelerate enrollment and overall clinical trial participation
With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.
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