The discovery of new therapeutic agents is met with significant challenges in preclinical discovery and development. Both efficacy and safety endpoints must be adequately assessed prior to testing a new investigational agent in humans. Perhaps the most challenging part of drug discovery is the mitigation of safety risks that arise during most drug discovery optimization efforts. Successful drug discovery teams will properly design and execute experiments that can best assess and discharge risks prior to first human dose (FHD), in the context of anticipated human drug exposures.

This course begins with an assessment of the finish line for preclinical drug hunters–the successful filing of an Investigational New Drug (IND) application to regulatory agencies, such as the FDA or EMA. Importantly, the course will focus on the toxicology-chemistry partnership in discovery safety assessment. It will explore mitigation strategies and will include both the strategic concepts and study designs used in preclinical safety assessment. It will also describe some of the common pitfalls in toxicological data interpretation and how to best use the data to inform a lead optimization strategy and ultimate clinical study design. The course will cover many of the most common risks and modern mitigation strategies to help drug discovery teams navigate an optimization effort geared to delivering safe and well tolerated potential new therapies in the shortest time possible.

DATE: April 9-10, 2019 (a one-and-a-half-day course)   To register, click here. 

If you are considering launching a startup built around technology licensed from an academic institution, INVO invites you to get the answers to these questions and others at a free lunch seminar at which Ed Pease, a Partner at Mintz Levin in Boston, will share strategies for forming and financing a company built around technology licensed from a university.

Sponsored by Innovation and New Ventures (INVO) at Northwestern University: Wednesday, February 20, 2019 from 12:00 PM to 1:00 PM (CST)

Ed has counseled hundreds of starts ups from MIT, Harvard, Northwestern, Stanford, Purdue, University of Arizona and others and will share insights garnered from his more than two decades of working with early stage ventures. This interactive session will cover the basic steps of licensing technology, forming a company and preparing a company to raise capital.