There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions that center on documenting outcomes within these patient populations.
In this webinar, the featured speakers will discuss challenges in implementing clinical studies in children and creative solutions to effectively implement them. Topics will include:
- Clinical trial design
- Regulatory considerations
- Pre-study considerations
- Implementation and operational challenges
Speakers
Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research
Jonathan Kornstein has over 24 years of experience in the pharmaceutical and Contract Research Organization (CRO) industries. Jonathan has demonstrated a depth of project management and clinical operations experience in a multitude of full-service global clinical studies on the sponsor and CRO side. He has extensive experience in overseeing rare and pediatric indications. Prior to joining Premier Research, Jonathan held positions of increasing responsibility in both clinical monitoring and global project management at both large CROs and sponsor companies.
Jonathan has a Bachelor of Arts in Biology from Hamilton College in Clinton, New York. He has experience in complex therapeutic areas focusing on nephrology, hepatic and endocrine/metabolic indications. Jonathan has a proactive problem solving approach and forms strong long-lasting client relationships
Message Presenter
Heather McKenney, Senior Director, Program Delivery, Rare Disease and Pediatrics, Premier Research
Heather McKenney is a Senior Director of Program Delivery in Rare Disease and Pediatrics. In this role, Heather operates at a strategic support level for complex, critical therapeutically aligned programs through key stakeholder engagement and cross functional management. Heather ensures operational excellence in collaboration with leadership and in support of the overall franchise responsibility. Further, this position oversees the Project Managers and Project Directors assigned on clinical studies or clinical program in a specific therapeutic area.
Heather’s previous experience includes operational, strategic and financial oversight on the project and portfolio level. Heather’s experience also includes roles within IRT, LMS development, Data Management and Clinical Event Classification. Heather offers strong experience in global study and portfolio oversight, in phases I–IV, which includes a focus on Neurologic indications in rare and pediatric populations. Heather has provided operational and strategic oversight for suites of studies in all regions of the world.
Ms. McKenney earned her Bachelor’s Degree from Duke University.
Message PresenterWho 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
Participants will learn about:
- Clinical trial design
- Regulatory considerations
- Pre-study considerations
- Implementation and operational challenges
Xtalks Partner
Premier Research
Premier Research, a mid-size clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.
As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.
Visit premier-research.com.
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