OEC Product Development

PD’s five expert scientists bring extensive experience from both industry and academic research institutions to their collaborative work with MSK investigators.  Together they offer a comprehensive menu of services producing impact and results throughout the entire therapeutic development life cycle. These include:

Preclinical and IND Enabling Strategy:

• Providing strategic guidance and support for early discovery and preclinical development activities;
• Supporting key pharmacology studies, including nonclinical efficacy evaluations and pharmacokinetic/pharmacodynamic (PK/PD) assessments;
• Designing and overseeing exploratory and GLP-compliant toxicology studies, including animal species selection and dose-level determination.

CMC Development and Manufacturing Support:

• Developing a comprehensive CMC strategy to ensure a reliable drug supply for both preclinical and clinical phases;
• Facilitating GMP manufacturing processes with both internal core facilities and external partners;
• Identifying and collaborating with CROs/CDMOs, secure quotes, and oversee all manufacturing activities to maintain quality and compliance.

IND Submission and FDA Interaction:

• Organizing and preparing Pre-IND (PIND) or INTERACT meeting requests, along with detailed briefing packages.
• Leading IND preparation, review, and submission processes
• Managing FDA interactions, including responding to queries, filing IND amendments, and submitting annual updates for ongoing clinical trials.

With contributions that include risk-mitigated toxicology design, seamless manufacturing execution, and proactive FDA navigation, the PD team empowers MSK researchers to accelerate timelines and derisk projects at key stages of the therapeutic development process. This comprehensive approach allows investigators to maintain focus on scientific discovery while ensuring their innovations meet the rigorous standards required for clinical translation.

For MSK investigators, the value of derisking through collaborative work with PD and its sister program, TxBL, cannot be overstated. By ensuring that projects meet industry standards for data quality, regulatory compliance, and manufacturing feasibility, PD dramatically increases the attractiveness of MSK innovations to potential licensees and investors, translating potentially into improved deal terms and greater probability of ultimate patient impact.

A Key Player in the MSK Commercialization Ecosystem

PD serves as a vital liaison across MSK's innovation ecosystem, collaborating seamlessly with MSK’s core facilities and other stakeholders in ways that include:

• Commercialization Support: Assisting licensing managers and project managers on OEC-funded projects and licensing activities;
• Funding Support: Assisting principal investigators with internal and external funding applications;
• Toxicology Excellence: Collaborating closely with the Antitumor Assessment Core Facility (AACF) on comprehensive toxicology study design; and oversees toxicology studies at CROs;
• Manufacturing at Internal Core Facilities: Supporting manufacturing activities at internal facilities including BTCF, CTL, OSCF, CGP, and RMIP;
• External Manufacturing: Overseeing development and manufacturing activities at contract development and manufacturing organizations (CDMOs);
• Quality Assurance: Working with IPQA to ensure compliance of manufacturing laboratories and clinical suppliers;
• Regulatory Submissions: Taking responsibility for the content, structure, and accuracy of IND submissions to INDC and FDA.