With RRD’s focus on early stage product development from Pre-IND through human proof of concept (hPOC), our strategy is based upon fostering a limited number of long-term, highly collaborative engagements under a Product Development Agreement (PDA). Many of our partners engage with us incrementally (under a GCA or MSA) as an optional first stage while they are mapping out their development strategy and/or raising capital.
- General Consulting Agreement (GCA) – designed to provide expert therapeutic or functional area consulting through one or more of RRD’s Strategic Advisors. The GCA is an abbreviated agreement designed to allow rapid engagement of one or more Strategic Advisors on a time and materials basis.
- Master Service Agreement (MSA) – designed to deliver discrete task-based deliverables under a fixed fee agreement. Examples of task-based projects include:
- Strategic Development Planning
- US and Ex-US Regulatory Submissions (Pre-IND, IND, Orphan Drug Designation, RAC, Scientific Advice, CTA)
- Clinical Start-up activities during transition to PDA
- Product Development Agreement (PDA) – designed for long term (multi-year) development partnerships under the Product Development Team (PDT) model that may span Pre-IND through Phase2b and include fixed program budgets with the potential for risk-sharing.