Preparing for an IND Filing for a Phase 2 Clinical Trial Using the 505(b)(2) Regulatory Pathway
Project scope
Categories
Healthcare Biotechnology Law and policySkills
comprehensive planning investigator's brochure clinical study reports pharmaceuticals clinical trials research filingThe main goal of this project is to assist SLBST Pharma Inc. in preparing to file an Investigational New Drug (IND) application for a Phase 2 clinical trial on a repurposed drug using the 505(b)(2) regulatory pathway. This will involve several different steps for the students, including:
- Researching the 505(b)(2) regulatory pathway and the requirements for filing an IND.
- Developing a comprehensive plan for the clinical trial, including a timeline and budget.
- Preparing the necessary documents for the IND filing, including the Investigational Plan, Protocol, Investigator's Brochure, and Clinical Study Report.
- Assessing the risks associated with the clinical trial and developing strategies to mitigate them.
- Researching potential clinical trial sites and developing a recruitment strategy.
By the end of the project, students should demonstrate:
- Understanding of the 505(b)(2) regulatory pathway and the requirements for filing an IND.
- Comprehensive plan for the clinical trial, including a timeline and budget.
- Preparation of the necessary documents for the IND filing, including the Investigational Plan, Protocol, Investigator's Brochure, and Clinical Study Report.
- Assessment of the risks associated with the clinical trial and development of strategies to mitigate them.
- Research of potential clinical trial sites and development of a recruitment strategy.
Final deliverables should include:
- All source documents.
- A written report summarizing the project and outlining the plan for the clinical trial.
Learners will work with company principals, regulatory consultants, and partners as SLBST works to complete its IND. There is ample opportunity for a motivated student to assume substantial responsibility as we are a startup.
About the company
SLBST Pharma uses a novel approach to treating endometriosis by normalizing the dysregulated immune response characteristic of this systemic inflammatory disease. Endometriosis, which affects one-in-ten women, is vastly undertreated. None of the existing hormonal medications cure the underlying disease. Women with endo use 3x the number of opioids and 2x the number of antidepressants, compared to a matched control. SLBST is repurposing a well-known drug with a decades-long safety record, for this new indication. Our therapy has comparable safety to existing first line treatments and, we believe, comparable effectiveness to existing second line treatments, with significantly fewer adverse effects. Success in clinical trials will position our therapy to become the new standard of care for endo. In a Pre-IND meeting with the FDA last year, we received a green light to submit an IND application beginning with a Phase 2 study. We are currently doing the development work to manufacture the clinical batch of medications, which should position us to begin enrolling patients in early 2024.