Biotech Client Initiates Two Phase 1b/2a Clinical Trials
Key Facts
- Client is a publicly traded biotechnology company
- Company’s primary strategic goal has been the expansion of its research and development program
- Provided ongoing regulatory advice, including FDA, data privacy, and good clinical practice compliance advice
The Situation
Mintz is representing a publicly traded biotechnology company developing nucleic acid therapeutic candidates for rare and fatal genetic diseases, including Huntington’s disease and Duchenne Muscular Dystrophy. One of the company’s primary strategic goals since its inception has been the expansion of its research and development program from the laboratory to the clinical setting. To achieve this goal, the client required both legal and practical advice for implementing all aspects of its new, clinical research program.
The Approach
Mintz has an in-depth understanding of the challenges that research sponsors face in conducting a multi-site clinical trial. Dianne Bourque and Kate Stewart worked with the company’s clinical team to meet the company's aggressive contracting, recruitment, and dosing schedule. We worked closely with the General Counsel to provide advice regarding CRO and other third-party service provider engagement. We drafted, reviewed, and negotiated CRO services agreements, site agreements, consent forms, and other clinical research documentation. We provided ongoing regulatory advice, including FDA, data privacy, and good clinical practice compliance advice. By working closely with the company’s clinical operations staff as well as general counsel, we were able to ensure that our advice supported both legal and business objectives.
The Outcome
To date, the company has initiated two Phase 1b / 2a clinical trials in Huntington’s disease and is initiating its Duchenne Muscular Dystrophy trial, all on schedule despite an extremely aggressive timeline.