Bradley T Wyman, Ph.D.
CEO OThree Consulting, LLC
Brad has twenty years’ experience in pharmaceutical/biological drug development and medical device development. He is experienced in all phases of clinical testing across multiple therapeutic areas. In particular the implementation of complex imaging biomarkers from phase 1 through phase 4 including protocol development, study oversight and execution, analysis and interpretation of study. He has also successfully designed and delivered medical devices including implementation of Quality Systems Regulations (QSR) and submission of 510ks. Brad has also specializes in developing highly effective crossfunctional teams and strengthening vendor/sponsor relationships. One key to accomplishing this is through the development and implementation of processes that improve both communication and efficiency. Brad received his Ph.D. in biomedical engineering at the Johns Hopkins School of Medicine and has published over 50 journal articles and has 4 issued patents.
Experience
- Literature Research
- Integration of translational medicine research
- Assembly of medical/scientific advisory boards
- Conducting advisory boards
- Endpoint selection
- Protocol writing
- Clinical site selection
- Vendor selection
- Generation of site materials
- Case report forms (CRF) development
- IRB Approval
- Site training
- Vendor oversite
- Timelines and budgets
- Resolving issues, solving problems
- Conducting advisory boards
- Adaptation
- Compliance
- Statistical analysis plans (SAP)
- Ensuring scientific rigor
- Data integrity and transfer
- Design and review of data tables
- Interpretation of results
- Data mining and exploration
- Internal reporting and presentation
- Clinical study reports (CSR)
- Scientific publication and presentation
- Creating scientific and medical credibility through publication
- Design and development of novel biomarkers
- Research and selection of optimal biomarkers
- Validation
- Clinical deployment of biomarkers
- Design of preclinical and clinical imaging studies
- Implementing imaging in clinical studies:
- MRI
- fMRI
- PET
- CT
- X-ray
- IVUS
- Ultrasound
- Application of imaging for:
- Patient Selection
- Safety
- Efficacy
- Oversight and management of contract research organizations (CRO)
- Managing all aspects of multi center imaging studies
- Requirements gathering
- 21 CFR Part 11 compliance
- Software for medical devices
- Software life cycle development
- Quality Systems Regulations (QSR)
- Regulatory 510k submissions
- Process Improvements
- Building highly effective teams
- Integrating cross-site, cross-functional and cross-company teams
- Consensus building
- Negotiating between competing interests
- Developing efficient and effective project management systems
- Adherence to delivery, cost and timelines.
- Resolving team conflict
- Creative solutions for vexing problems
- Small Business Initiative Research (SBIR) grant submission
Therapeutic Areas
Central Nervous System (CNS)
- Alzheimer’s Disease (AD)
- Parkinson’s Disease (PD)
- Cerebral amyloid angiopathy
- Post-traumatic stress disorder (PTSD)
- Huntington’s disease
- Depression
- Schizophrenia
- Fibromyalgia
- Pain
Cardiovascular and Metabolic Disease
- Atherosclerosis
- Dilated cardiomyopathy
- Hypertrophic cardiomyopathy
- Osteoporosis
- Pulmonary arterial hypertension
- Obesity
- Liver Fat, non-alcoholic steatohepatitis (NASH)
Inflammation
- Osteoarthritis (OA)
- Rheumatoid arthritis (RA)
Oncology
- Prostate cancer
- Breast cancer
Ophthalmology
- Age related macular degeneration (AMD, ARMD)
Contact Us
Call or email to explore how we can help you accomplish your goals and achieve success.
Brad Wyman, Ph.D.
(310) 908-0053