JLABS @ TORONTO: Road to Oncology Therapeutics IND

Making the right choices is critical in today’s multi-modality R&D environment, especially considering the various pressures on drug developers such as time to clinic, limited resources, and funding. For early-stage companies, limited knowledge or a short-term view of the discovery journey can lead to long term problems such as missed timelines, escalating costs, and even regulatory issues in later phases.

Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, investigative new drug (IND) application is a critical early milestone for oncology therapies. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving a successful IND application.

Join us for presentations and a panel discussion exploring the requirements and considerations necessary to achieve a successful IND submission for Oncology therapeutics. The presentations and panel discussion will include the following:

1. Strategies for determining and understanding PK/PD and immunogenicity

2. Key nonclinical safety considerations and strategies for Oncology therapeutics

3. Strategic considerations for IND, Pre-IND meetings, and discuss CTA versus IND