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Tuesday, April 24, 2012

Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases

Speakers for this Event:
  • J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion    Learn More
  •     Introduction and Moderator

  • Prof. J. Stuart Elborn, MD, FRCP, Professor of Respiratory Medicine, Queen's
        University Belfast   
    Learn More
  •     Overview of Respiratory Diseases

  • Stephen Smith, MB BCh BAO, MRCGP, Diploma Pharmaceutical Medicine, Principal Investigator,
    Learn More
  •     Logistical Challenges and Practical Considerations in Conducting Early Clinical Studies in Patients with Respiratory
        Disease – A PI Perspective

    Discerning Early Clinical Signals of Efficacy for Treating Respiratory Diseases

    This webinar will address advances in the development of drugs to treat respiratory diseases with a focus on new technologies that enrich data collected early in clinical research. Professor Stuart Elborn, Queen’s University, Belfast is a leading researcher in pulmonary function assessments and biomarkers for chronic infections that impact patients with respiratory diseases such as cystic fibrosis, COPD and asthma. Complementing Prof. Elborn’s insights, Dr Stephen Smith will address the logistical considerations in conducting these complex but data rich early clinical studies with new therapeutic agents.


    VPs, Directors, and Managers in the following areas:

    • Clinical Research or Clinical Development
    • Clinical Operations
    • Medical Director
    • Drug Development
    • Clinical Pharmacology or PK/PD or DMPK
    • Research & Development
    • Outsourcing

    Plus Presidents, CEOs, Chief Medical Officers and Chief Scientific Officers for pharmaceutical and biotech companies worldwide


    J. Fred Pritchard, PhD, Vice President, Global Drug Development, Celerion

    As Vice President of Global Drug Development, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing.

    Dr. Pritchard brings 30 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals and several that are currently in clinical development. Leveraging his experience in leading international teams of scientists at large pharmaceutical companies, Fred founded and led a group of consultants and program directors within a full service CRO that collectively worked on nearly 40 integrated drug development programs, bringing several of these through IND into phase I and II clinical trials.

    Dr. Pritchard has given numerous invited lectures at scientific meetings and academic institutions and is an author on over 120 scientific publications and abstracts. He is the 2000 Alumni Fellow of the Penn State College of Medicine, and named one of nine "Notable People in Pharmaceutical R&D" by R&D Directions magazine in 2009. He currently serves on the Therapy Acceleration Program Committee for the Leukemia and Lymphoma Society (LLS), the LLS North Carolina Chapter Board of Trustees and the Executive Committee of the Research Triangle Park Drug Metabolism Discussion Group where he has been past Chair and Treasurer.

    Prof. J. Stuart Elborn, MD, FRCP, Professor of Respiratory Medicine, Queen's University Belfast

    As a Professor of Respiratory Medicine at Queen’s University in Belfast, Professor Elborn leads the Cystic Fibrosis Group of the Respiratory Medicine Program. His research focus is on cystic fibrosis and the development of biomarkers for clinical trials, with a strong emphasis on the impact of chronic infection in patients with bronchiectasis.

    Professor Elborn is involved in many research programs and has received extensive external funding from both the private and public sectors. One area of interest is Cystic Fibrosis, and he is focused on understanding pathophysiology of infection and inflammation and the translation of new therapies into clinical practice. He has been the principal investigator for many studies, in COPD, bronchiectasis and lung cancer. Professor Elborn has been successful in developing programmes of research across disciplines, hospitals and universities in Northern Ireland, UK and bringing scientists, clinicians together to promote inter-disciplinary research.

    Highly regarded as a speaker, Professor Elborn is extensively published and is a regular contributor to scientific organizations that include: President, European Cystic Fibrosis Society; Chair, Research and Medical Advisory Committees of CF Trust (UK); Chair, Scientific Advisory Committee of the UK Gene Therapy Consortium; Associate Editor of Thorax and Work Package Leader on two European Union Framework Network Grants (EuroCare-CF, ECORN-CF); Plenary Speaker at European Respiratory Society, North American Cystic Fibrosis Conference, American Thoracic Society, British Thoracic Society, European CF Conference. He is also a member of the Northern Ireland R & D Office Fellowships Panel and Strategy Group. Professor Elborn also serves as a medical consultant to various media outlets.

    Stephen Smith, MB BCh BAO, MRCGP, Diploma Pharmaceutical Medicine, Principal Investigator, Celerion

    Dr. Smith is a Principal Investigator at Celerion’s Global Clinical Research facility in Belfast, Northern Ireland UK. In this role, he is responsible for providing medical, ethical and scientific input into protocols and ensuring that studies are conducted according to all applicable approvals and industry guidelines. He also plays a critical role in ensuring the safety of participants in clinical studies and providing medical advice to sponsors. During his past eight years as Principal Investigator, Dr. Smith has served on many complicated early stage clinical studies, as well as many other generic studies. Prior to this role, Dr. Smith served as Principal Investigator at MDS Pharma Services.

    After a distinguished undergraduate career, Dr. Smith qualified with Honours in medicine from Queen’s University, Belfast in 1990. His early career was at the world renowned Royal Victoria Hospital, Belfast where he trained to the level of registrar before deciding to specialize in General Practice. He has received additional diplomas in the areas of Mental Health, Geriatric Medicine, Child Health, Obstetrics and Gynaecology, Forensic and Legal Medicine. His other medical specialist interests include dermatology. He holds the specialist pharmaceutical medical qualification (DPM) from Trinity College, Dublin.


    Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to global clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, global bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit http://www.celerion.com/.

    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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