Considerations in Conducting Pediatric Clinical Trials

Clinical Trials, Life Sciences, Pharmaceutical,
  • Tuesday, October 29, 2019 | 11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central)
  • 60 min

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



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

Allan Valmonte, Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research

Allan Valmonte has over 22 years of clinical operations and program management experience, most recently in the gene therapy space using lentiviral and adeno-associated virus (AAV) technology platforms in genetic conditions including lysosomal storage disorders and rare dermatological and hematological indications. Prior to that, Allan held clinical operations positions of increasing responsibility at various sponsor companies in a variety of therapeutic areas including oncology, cardiovascular and infectious diseases.

Allan received an MBA with honors from Saint Joseph’s University in Philadelphia, PA and a Bachelor of Arts in Psychology from California State University – Hayward, in Hayward, CA. 

Message Presenter

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

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.


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