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December 13, 2012

DIABETES DRUG DEVELOPMENT: A Perspective on Pediatric Indication Planning

Speakers for this Event:
  • Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles   Learn More
  • Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles   Learn More
  • Robin Huff, PhD, Senior Director, Global Pediatric Regulatory Strategy Lead, Quintiles   Learn More

  • Moderator:
  • Rick Turner, PhD, Senior Scientific Director, Corporate Communications, Quintiles   Learn More
  • This webinar will provide insight into the various regulations which direct pediatric diabetes drug development for registration globally. This knowledge will translate into better decision making during the overall development process for diabetes therapies.

    The regulations governing pediatric clinical trials have undergone significant changes over the past decade. Prior to 2007, only the US had formal regulations that addressed the need for clinical trials in pediatric populations. These rules were codified into formal legislation in 2002 as the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) and were reauthorized in the FDAAA in 2007. The EU adopted the Pediatric Regulation in January 2007 to “stimulate research into the uses of medicines in children and to lead to their authorization in all ages.”[1] BPCA and PREA are now permanent regulations after passage of the FDA Safety and Innovation Act (FDASIA) in July 2012. While both the US and EU regulations are specifically in reference to the pediatric patient population, differences in the regulations make clinical development planning somewhat complex. New FDASIA requirements will necessitate earlier pediatric clinical development planning in the US allowing closer harmonization with the EU Pediatric Regulation and their requirement for a PIP at the time of filing.

    The FDA Draft Guidance for Industry – Diabetes Mellitus: Developing Drugs and Therapeutics Biologics for Treatment and Prevention (February 2008) advises that because T1DM is more prevalent in children and adolescents, this demographic should be included early in clinical development. However the same guidance recognizes that it is not appropriate to study all therapies in development for T1DM in children before approval. For T2DM, the guidance states that because of the increasing burden of T2DM in children and adolescents, studies of therapies for T2DM should “at some point” include patients younger than 18 years old, assuming “no obvious contraindications”.

    Key Takeaway Points:

    • What every diabetes drug development team should know about evolving EU and US Pediatric Regulations
    • Case History: $ spent vs. $ saved
    • Lessons Learned
    • Planning for success
    • A Pediatric Indication Plan Roadmap from our perspective

    EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:

    • Clinical R&D
    • Clinical Operations
    • Regulatory Affairs
    • Medical Affairs

    Cynthia Jackson, DO, Leader, Pediatric Center of Excellence, Quintiles

    Cynthia Jackson is Vice President of Medical and Scientific Services and a team leader for the Pediatrics and infectious diseases groups. She also serves as a medical advisor for clinical trials in therapeutic areas in Pediatrics such as asthma, allergy, nutrition, infectious diseases indications, vaccine and migraines and Infectious Diseases indications such as antivirals, anti-HIV compounds, TB, vaccines, antifungals and antibacterials. She serves as Medical Director of the Southeast region for Quintiles and is on faculty at Duke University.

    Prior to joining Quintiles, Dr. Jackson was the Chief of Pediatric Infectious Diseases at the University of Illinois-Chicago College of Medicine in Peoria, Illinois. Dr. Jackson earned a doctorate from Des Moines University College of Osteopathic Medicine and completed a fellowship in pediatric infectious diseases at Duke University, as well as a research fellowship in retrovirology at Glaxo Wellcome.

    Selected areas of expertise include children in clinical studies, emerging role of cell-based technologies in vaccine clinical development, and why parents should consider enrolling infants and children in clinical trials.

    Paul Strumph, MD, Leader, Diabetes Center of Excellence, Quintiles

    Paul Strumph is Vice President of Therapeutic Strategy Lead of the Cardiovascular and Metabolic Therapy Delivery Unit, as well as North American Regional CMO.

    Dr. Strumph assists in the development of a regular lecture series providing clinical development training for medical advisors, is proactively engaged with regional with medical advisors regarding medical governance and ethics, and assists in the evaluation of medical issues that may arise in the course of study-conduct. He will also serve as an ad-hoc member on the first in human Phase 1 safety committee.

    Dr. Strumph graduated with distinction in research at the University of Rochester School of Medicine and Dentistry, with residency training in Combined Internal Medicine and Pediatrics was at Emory University. He completed a Fellowship in Adult Endocrinology Diabetes and Metabolism and Pediatric Endocrinology at the University of Pittsburgh Medical Center and Children’s Hospital in Pittsburgh respectively. He previously served as the Chief Medical Officer at the Juvenile Diabetes Research Foundation.

    Areas of expertise include internal medicine, pediatrics, adult endocrinology diabetes and metabolism, and pediatric endocrinology.

    Robin Huff, PhD, Senior Director, Global Pediatric Regulatory Strategy Lead, Quintiles

    Dr. Huff provides strategic drug development advice to customers and internal teams, helping to shape clinical development programs that maximize value for both patients and drug manufacturers. She develops global regulatory strategies that consider commercial implications and minimize timelines, while maintaining a high likelihood of regulatory acceptance. As a member of the Pediatric Center of Excellence, she provides oversight of the comprehensive drug development process across a variety of indications, with a focus on pediatric use of medicines.

    Dr. Huff earned a PhD in Pharmacology from Duke University as a Howard Hughes Medical Institute Fellow. Prior to joining Quintiles, she served as Senior Director of Regulatory Coordination at Grifols Therapeutics and its predecessor, Talecris Biotherapeutics, where she established worldwide regulatory strategies and negotiated with global regulatory authorities to expedite acceptance of clinical development programs. Robin began her career as a regulatory reviewer and then supervisor for the FDA’s Center for Drug Evaluation and Research.

    Dr. Huff’s areas of expertise include application of regulatory expertise to clinical trial design, development of worldwide regulatory strategies, negotiation with global regulatory authorities, and therapy Areas such as thrombotic, neurological, respiratory and diabetes.


    Rick Turner, PhD, Senior Scientific Director, Corporate Communications, Quintiles

    More information to follow...


    Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 25,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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