ISTP, 8025 Lamon Ave. Skokie, Il 60077

January, 2019
Archive

North American Genotoxicity Workshop

Join Charles River on April 2-3.  Genetic toxicology testing is required for all classes of chemicals and drugs, but its conduct can differ from compound to compound. A poor strategy can result in repeated studies, failure to meet timelines, or worse – abandonment of a once promising program.

At the North American Genotoxicity Workshop, you’ll learn how to successfully execute this unique aspect of your compound’s safety assessment, satisfying regulatory criteria and smoothing your path to market. Over two days, you’ll tackle program guidelines, regulations, and best practices, gain an in-depth understanding of the in vitro and in vivo assays that comprise a solid testing program, and gain insight into accurate evaluations of the results.

You’ll network with peers who face similar challenges and meet scientists who perform the assays and can offer strategic advice. Don’t miss this opportunity to arm yourself with the knowledge that can help your compound move forward through development.

The workshop will take place over the course of two days (Tuesday and Wednesday, April 2-3). Tuesday’s program includes the seminar and meals, including breakfast, lunch, snacks, and a dinner reception.

Day two includes breakfast, a half-day of presentations, and lunch followed by a tour of our laboratory facilities with assay demonstrations. The speakers and other Charles River scientists will join you for all meals, allowing for one on one conversations.

For more program information, click here

January 27, 2019 Comments Off on North American Genotoxicity Workshop Events, News

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Vetter – Current Market Developments

Increasingly, contract development and manufacturing organizations (CDMOs) like Vetter are acting as the interface between small biotech firms and large drug manufacturers

Flexibility, responsiveness and operational excellence are being demanded by drug developers. The challenge faced by companies like Vetter Pharma International is to deliver these to customers. Oskar Gold, notes that Vetter believes that partnership is always the key to success, with operational excellence being decisive in both the development and commercial phases.

“Particularly in the early drug development phases, a number of issues that can affect the entire development project scope can arise and thus flexibility is critical,” Gold says. “Also, it is important that a sponsor and service provider with a common target in mind act as one to successfully perform a drug development project that can get the drug on the market as fast as possible, where it can improve or even save patient lives.”

Listen to the video interview with Oskar Gold of Vetter discussing current market developments and their multifaceted impacts.

January 26, 2019 Comments Off on Vetter – Current Market Developments News

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Safety Assessment & Mitigation

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. 

January 18, 2019 Comments Off on Safety Assessment & Mitigation Events

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Spinning a Company Out

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.

To register, click here. 

January 18, 2019 Comments Off on Spinning a Company Out Events

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