The general scope of the facility’s work is to:

• Develop and maintain institutional policies for preclinical investigational product development
• Provide quality management assurance that preclinical product development processes, activities, and the products themselves are in compliance with institutional policy and US Food and Drug Administration (FDA) regulation
• Provide technical and project management and QA oversight for investigational product projects through the preclinical development pipeline, beginning at the start of preclinical development up through the filing of the IND and concluding when all planned and necessary preclinical development studies, including stability, are completed

Services Provided to the Institution and Principal Investigators

Regulatory Affairs Advising and Translational Research Planning

To help Memorial Sloan Kettering investigators conceptualize and plan the development of a new drug or device for human clinical studies, we hold meetings to discuss the technology being developed and ideas for the clinical trial.

We advise the investigator of the requirements for a successful IND application — both logistical and regulatory — covering pharmacology, toxicology, manufacturing, product characterization and testing, as well as the institutional review board (IRB) protocol review and approval process.

Direction and Management of Investigational Product Preclinical Development

At the time an investigator commits to develop an investigational product, we help organize an appropriate internal drug development project team comprised of the inventor-investigator and his or her key scientists, leaders of select Sloan Kettering Institute core facilities, and clinical trial principal investigators.

For some projects, we can provide formal project management services (calling meetings; tracking agenda action items and their deadlines; and managing project resources of time, staffing, and budget). For all projects where we are involved, we advise on the required preclinical product development studies, and review and approve study protocols and completion reports.

We direct the placement of preclinical development work to in-house laboratories whenever possible, and when an outside contract laboratory is needed, we help negotiate the terms and monitor the study conduct.

Investigational Product QA Oversight

For product manufacturing including acceptance testing, we operate a comprehensive quality system for Memorial Sloan Kettering laboratories that includes Good Manufacturing Practices (GMP) training, laboratory audits, approval of laboratory standard operating procedures (SOPs) and manufacturing master batch records, and independent review of completed product manufacturing records.

For other preclinical product development work, we approve study protocols and reports, monitor the conduct of complex studies, and perform QA review of the study raw data.

IND Application Writing Assistance and QA Review

We provide organization and writing services for IND applications, covering sections other than the IRB protocol and Informed Consent documents. For the Memorial Sloan Kettering IND Committee, we review the IND applications for accuracy and completeness and for agreement among the IRB protocol, other sections of the application, and the laboratory manufacturing information.

We work with the investigator and laboratories to finalize the IND application prior to its being submitted to the FDA.  This is a function that is handled by the IND Office in the Office of Clinical Research, with whom we have a very close working relationship.

IND Life Cycle Management

From the time an IND application is submitted to the FDA until the IND’s final clinical trial is completed, we provide additional organizational, scientific, and regulatory management services, including the following:

• Coordinating the answering of FDA review questions, and QA-tracking the completeness and correctness of our responses
• Maintaining stability protocols and reports for the active ingredients and final products, including prompting laboratories what testing is required, and when
• Tracking through a change control process all amendments to FDA-cleared IND applications, such as new protocols or manufacturing process changes
• Maintaining up-to-date versions of word processing files for our IND applications and amendments