Drug Development Plan for New Cancer Drug
Project scope
Categories
Product or service launchSkills
orphan drugs drug development metabolic pathways clinical trials toxicology research hepatology fda regulations cancerThe main goal for the project is to develop a drug development plan at the pre-IND stage in preparation for clinical trial phase 1 for a new cancer drug targeting specific cancer metabolic pathways, particularly for kidney cancer, liver cancer, and breast cancer. Additionally, the project aims to assess the potential of Bacchus' drug in getting the orphan drug indication and research the regulatory requirements for orphan drug IND.
What tasks will learners need to complete to achieve the project goal?
- Research and analyze the specific cancer metabolic pathways targeted by the new cancer drug
- Develop a comprehensive drug development plan for the pre-IND stage, including preclinical studies and toxicology assessments
- Identify and assess the regulatory requirements for clinical trial phase 1 for kidney cancer, liver cancer, and breast cancer
- Research and assess the regulatory requirements for obtaining the orphan drug indication for Bacchus' drug
- Develop a detailed report outlining the drug development plan and regulatory requirements for clinical trials and orphan drug designation
- Present the findings and recommendations to the stakeholders at Bacchus Therapeutics
- Provide a summary of the potential challenges and opportunities in the drug development process for the new cancer drug.
Bacchus Therapeutics is committed to providing comprehensive support to our interns throughout their research on FDA regulatory procedures. Interns will have a vast network of regulatory experts to access a wealth of resources. We will facilitate regular check-ins and feedback sessions to ensure interns are progressing and addressing any challenges they may encounter. Additionally, interns will have the opportunity to attend internal meetings, gaining insights into the company's strategic initiatives. Bacchus Therapeutics aims to create a collaborative and enriching environment, fostering the professional growth and development of our interns.
Supported causes
Good health and well-beingAbout the company
Bacchus Therapeutics is a biotech company that exploits cancer’s hypermetabolic state by targeting specific cancer metabolic pathways. The aberrant expression of cancer-causing gene MYC is virtually unmatched, making MYC one of the most frequently deregulated genes in human tumors, including, liver, kidney, brain, blood, breast, prostate, and lung tumors. Human studies and preclinical models have established that dysregulation of MYC underlies the pathogenesis and aggressiveness of numerous cancers.
Based on our prior research at Stanford University, we developed innovative, proprietary small molecules that target fat metabolism. This causes regression of MYC cancers in preclinical mouse and human studies and prolongs survival. Moreover, our novel metabolomic platform allows us to screen which cancers will respond to our treatment. We are able to monitor therapeutic response within a few days of treatment by measuring the actual biomarkers of our cancer therapy. This allows us to tell patients and doctors if our drug is working much faster than for standard cancer treatments.