We advise clients at every stage along the continuum from pre-clinical research through clinical trials, regulatory approval, and patient access. In treating and curing rare diseases and neurodegenerative disorders, however, we know that a well-developed overall strategy can shorten the timeline from preclinical research to patient access.
Dr. Kendra J. Bjoraker, a pediatric neuropsychologist with previous experience in special education, and Melissa J. Hogan, a health care attorney and rare disease caregiver, have combined their experience with industry, regulatory agencies, the scientific community, and the patient/caregiver community to drive greater success in clinical trials for rare diseases and neurodegenerative disorders. Their expertise includes:
- Study design and protocol development for natural history studies and clinical trials
- Development of accurate and sensitive outcome measures
- Guidance on regulatory interaction
- Training of clinical trial teams
- Raising awareness and engaging patients