Schizophrenia Trials: Overcoming Methodological Challenges to Enhance Study Success

Biomarkers, Clinical Trials, Drug Discovery and Development, Life Sciences, Patient Recruitment and Retention, Pharmaceutical,
  • Tuesday, January 30, 2018

The search continues for treatments that can target cognitive impairment associated with schizophrenia (CIAS), as well as reduce positive and negative symptoms, in order to maximize long-term outcomes and quality of life for patients.

Despite considerable efforts by pharmaceutical companies, no novel mechanism has yet been approved for CIAS and there have been many late-stage failures, representing a major unmet therapeutic need in schizophrenia.

In this webinar, we will consider methodological improvements associated with recruiting patients into clinical trials, improving patient assessment and retention in trials, the use of cognitive biomarkers to guide decision making about the safety and efficacy of drugs and how to minimize the risk of placebo and practice effects in studies of schizophrenia.

Speakers

Dr. Kiri Granger, Director of Neuroscience, Cambridge Cognition

Dr. Kiri Granger leads a team of clinical scientists in providing end-to-end scientific consultancy and support to drug development companies for the optimisation of clinical trial design and the development of safe and effective treatments. As a fellow of the Royal Statistical Society, Kiri also provides expertise in analyzing data and understanding cognitive change in the context of other clinical trial endpoints.

Specialising in schizophrenia and anxiety disorders, Kiri’s passion is to better understand the origins of symptom expression and optimizing the design of novel pharmacological and behavioural treatments. Her PhD research explored and refined cognitive endophenotypic markers of schizophrenia and anxiety at the University of Nottingham where she now holds an honorary position as Assistant Professor in the Department of Psychology.

A message from Dr. Granger:

I hope you will be able to attend and contribute to what will be an interactive and thought-provoking session in an area that I am extremely passionate about. I welcome you to ask questions before, during or after the event and to share your experiences and opinions in this critical field of research. Please feel free to contact me on Kiri.Granger@camcog.com and I look forward to speaking with you during the event.

Message Presenter

Dr. Steve Brannan, Chief Medical Officer, ‎Karuna Pharmaceuticals Inc.

Dr. Brannan is a neuroscience drug development expert who has held senior positions overseeing both clinical development and medical affairs with more than 15 years of industry experience.  Previously, Dr. Brannan was the Therapeutic Head of Neuroscience at Takeda and Vice President for Clinical Research and Medical Affairs at Forum Pharmaceuticals. Dr. Brannan has been active in the development of multiple important central nervous system treatments including Cymbalta, Exelon Patch, Trintellix, and VNS for Treatment Resistant Depression while holding various senior roles at Forum, Takeda, Novartis, Cyberonics, and Eli Lilly. His experience includes drug development, registration, medical affairs, launch and lifecycle management in the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, migraine, cognition, and Alzheimer’s and Parkinson’s diseases. Dr. Brannan is a member of several scientific societies and groups, including ISCTM, ISCDD, AARR, IOM Neuroforum, and CNS Summit (founding member). Prior to joining the Pharmaceutical industry, Dr. Brannan worked on the faculty at the University of Texas Health Science Center at San Antonio (UTHSCSA) where he specialized in seeing Mood and Anxiety disorder patients, ran a clinical research unit, and did neuroimaging research at the Research Imaging Center.  Dr. Brannan trained in psychiatry at UTHSCSA and holds a M.D. degree from the University of Texas Health Science Center at Dallas (Southwestern Medical School). He has over 40 publications and routinely gives invited talks and presentation at industry conferences.

Message Presenter

Who Should Attend?

Executives, scientists and managers from pharma, biotech and CROs working in CNS drug development, including:

  • Strategic drug development
  • Clinical operations
  • Outsourcing and procurement
  • Clinical trial planning and optimization
  • Clinical scientists
  • Schizophrenia researchers

What You Will Learn

  • Methods to improve patient recruitment and in-trial retention
  • Key issues and considerations with the selection of endpoint measures in schizophrenia trials
  • Ways to accelerate decision making about safety and efficacy for CIAS treatments
  • Lessons learned from successes and failures in clinical studies and regulatory considerations

Xtalks Partner

Cambridge Cognition

Cambridge Cognition is a neuroscience digital health company which develops & markets gold standard medical software products and expert scientific services to accelerate the development of safe and effective treatments and quantify cognitive health in patients worldwide.

The company provides products and services to the world’s leading pharmaceutical and biotech companies as well as globally renowned academic institutions.

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