Reata Pharmaceuticals, Inc.
Biogen is a leading global biotechnology company that pioneers science and drives innovations for complex and devastating diseases. It advances a pipeline of potential therapies across neurology, neuropsychiatry, specialised immunology, and rare diseases, serving humanity through science while promoting a healthier, more sustainable, and equitable world.
Industries
Nr. of Employees
large (251-1000)
Reata Pharmaceuticals, Inc.
Products
Therapeutic development pipeline for neurology and rare diseases
A portfolio of clinical and pre-clinical development programs focused on neurology, neuropsychiatry, specialized immunology and rare diseases.
STEM education and community outreach program
Multi-year STEM education and readiness program supporting students and teachers in local school districts to increase representation in STEM pathways.
Therapeutic development pipeline for neurology and rare diseases
A portfolio of clinical and pre-clinical development programs focused on neurology, neuropsychiatry, specialized immunology and rare diseases.
STEM education and community outreach program
Multi-year STEM education and readiness program supporting students and teachers in local school districts to increase representation in STEM pathways.
Services
Clinical trial operations
Design and operational management of multi-site clinical trials, including site engagement, trial oversight and operational coordination.
Early access and patient programs
Programs to provide investigational therapies to eligible patients outside clinical trials and support for access pathways and program governance.
Manufacturing and CMC services
On-site GMP manufacturing and CMC support for biologic medicines across multiple modalities, including process scale-up and commercial production.
Quality control and analytical testing
Regulatory-compliant laboratory testing services including raw material, environmental, release and stability testing to support product release and lifecycle management.
Regulatory affairs and safety reporting
Regulatory strategy, submissions and safety reporting services across the therapy lifecycle, with interfaces to health authorities and pharmacovigilance processes.
Market access and reimbursement strategy
Strategic advisory services for market access, health economics and reimbursement planning to support patient access and payer engagement.
Clinical trial operations
Design and operational management of multi-site clinical trials, including site engagement, trial oversight and operational coordination.
Early access and patient programs
Programs to provide investigational therapies to eligible patients outside clinical trials and support for access pathways and program governance.
Manufacturing and CMC services
On-site GMP manufacturing and CMC support for biologic medicines across multiple modalities, including process scale-up and commercial production.
Quality control and analytical testing
Regulatory-compliant laboratory testing services including raw material, environmental, release and stability testing to support product release and lifecycle management.
Regulatory affairs and safety reporting
Regulatory strategy, submissions and safety reporting services across the therapy lifecycle, with interfaces to health authorities and pharmacovigilance processes.
Market access and reimbursement strategy
Strategic advisory services for market access, health economics and reimbursement planning to support patient access and payer engagement.
Expertise Areas
- Clinical trial management
- Biologics manufacturing and scale-up
- Regulatory compliance and pharmacovigilance
- Quality systems and assurance
Key Technologies
- cGMP manufacturing
- Bioprocessing for biologics
- Technology transfer and scale-up
- Analytical testing and stability assays