Pre-IND: Crucial to 505(b)(2) Approval
With the 505(b)(2) drug approval pathway, the Pre-IND meeting with the FDA is crucial to the success of the drug’s later NDA approval. With the right approach, the Pre-IND takes the risk out of the development program. An effective Pre-IND meeting consists of:
- the right questions
- strategic thought
- 505(b)(2) knowledge
- out-of-the-box, creative thinking
- the latest understanding of FDA thinking within the therapeutic division
Camargo brings the important criteria to the table with every Pre-IND meeting for every sponsor’s drug candidate. How?
- our multi-disciplinary team, including former FDA leaders
- 13 years of applied, direct 505(b)(2) drug development experience
- more than 70 drugs in development currently
- more than 200 505(b)(2) approvals
- meeting with the FDA 3 – 6 times per month, broad and deep experience in every therapeutic division
Approaching a Pre-IND meeting with the wrong questions will likely result in a Refuse to File from the FDA later, wasting important time and money, and after years of improper development setting a drug back to the beginning.
Camargo is the most experienced team to de-risk your drug development program, helping you to save years of development time and millions in development dollars by aligning and optimizing a drug’s development plan from the start all the way through to approval and market success.
Integrated Development Plan
An Integrated Development Plan goes hand-in-hand with the Pre-IND meeting. A well-crafted Integrated Development Plan takes the unknown out of drug development.
When you partner with the experienced 505(b)(2) development team at Camargo, we craft a plan for your drug’s success.
Camargo is expert at assessing the risks inherent in drug development across four critical areas: scientific, medical, regulatory, and commercial. Backed by a deep understanding of the 505(b)(2) regulatory pathway and a current knowledge of the FDA’s thinking on 505(b)(2) drug development, Camargo presents the full-service solution for each drug development project.
We create an optimized, credible plan to reduce the risks and resolve unknowns to provide a pathway to success. This effort involves an FDA Pre-IND meeting to gain agency agreement on the development plan, which allows confident answers these questions:
- How much will it cost?
- How long will it take?
- Are you doing more than needed to achieve regulatory approval? Are you doing enough?
- How much work, and how many trials are required?
Contact us to learn more about an Integrated Development Plan and a Pre-IND meeting to set your project up for success.