With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience trials — more so than clinical trials in other medical specialties — face major challenges. Despite the volume of research and funding, neuroscience clinical trials continue to fail for many reasons. Among them are the lack of reliable biomarkers, subjective outcome parameters and high placebo response rates.
In this webinar, you’ll learn about the best practices for conducting robust risk assessments and establishing key risk indicators in neuroscience trials. Speakers will discuss strategies for mitigating data quality challenges, the importance of regular, blinded data reviews conducted by clinical specialists, and the significant impact technology has on enhancing the risk detection process. For developers of neuroscience therapies, appropriately leveraging risk detection early during a clinical trial can significantly increase the ability to intervene and apply remediation timely, thereby improving the probability of success for the clinical study.
Join this webinar to explore the key factors contributing to the failure of neuroscience trials and learn effective risk detection strategies to enhance success rates.
Dr. Andreas Schreiner, MD, Senior Vice President, Medical Affairs, Neuroscience and Analgesia, Premier Research
Dr. Andreas Schreiner has considerable experience as a clinician, clinical researcher and investigator, and brings more than 23 years of global experience within the pharmaceutical industry and clinical research environment. In his role, he is responsible for providing strategic planning, coordination, knowledge and expertise in neuroscience and analgesia projects and/or standalone consultative services for development programs covering entire product lifecycles.
Dr. Schreiner is a board-certified psychiatrist and neurologist. He studied medicine at the Universities of Heidelberg and Mannheim, Germany, and completed residencies in the University Department of Neurology and in Psychiatry at the Central Institute of Mental Health, both in Mannheim, Germany.
Adam Simmons, Executive Director, Program Strategy, Neuroscience, Premier Research
As Executive Director of Clinical Program Strategy, Adam Simmons is responsible for providing strategic planning, coordination, knowledge and expertise in neuropharmacology for clinical research projects and/or standalone consultative services. Adam has over 20 years of experience in drug and device research working for pharmaceutical companies and academic medical centers with over 30 publications across neuroscience indications and research methodologies. He also supported scientific communication and media appearances in support for the launch of LYBALVI®, a program for which he served as Alkermes’ Clinical Lead and presented data at major scientific congresses. Additionally, Adam has overseen clinical trials conducted in over 25 countries across North and South America, Europe, and Asia Pacific.
Adam holds a master’s in public health in epidemiology from Emory University and a bachelor’s degree in health and society from the University of Rochester. Currently, Adam sits on the steering committee for the STARR Coalition, a non-profit patient advocacy organization which connects people living with mental illness to clinical research. He has also been involved as a speaker or in support of patient advocacy activities with organizations including the National Alliance of Mental Illness, the Depression and Bipolar Support Alliance, the National Council for Mental Wellbeing and others.
Who Should Attend?
Senior professionals from Pharma, Biotech and Medtech companies involved in:
- Clinical Trials
- Clinical Operations
- Drug Development
- Preclinical Trials
- Project Management
- Regulatory Affairs
What You Will Learn
Attendees will gain insights into:
- Best practices for robust risk assessment and establishing key risk indicators (KRIs)
- Strategies for mitigating data quality challenges in neuroscience studies
- The benefits of a clinical specialist conducting regular, blinded data reviews of study KRIs
- The use and impact of technology in enhancing the risk detection process
Premier Research, a 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.