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Program Management

Dual Filing your IND Package: Planning Pays Off

Dual Filing your IND Package: Planning Pays Off

Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

New U.S. FDA DDI Draft Guidance for Therapeutic Proteins

Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...

ACT Annual Meeting: Managing Roadblocks to Success

ACT Annual Meeting: Managing Roadblocks to Success

One of the largest shares of preclinical testing in any drug development program is toxicology studies, yet bringing together the community supporting this pivotal development stage does not happen often enough. Fortunately, the 2020 American College of Toxicology...

Ramp Up: What Drug Developers Need to Know

Ramp Up: What Drug Developers Need to Know

Many drug development companies are prepared to move their programs forward and effectively submit preclinical packages to regulatory bodies. In the challenging business of drug development, disruptions and obstacles are elements that must be part of the conversation...

Tracking Your Molecule: Technology Advancements in the Industry

Tracking Your Molecule: Technology Advancements in the Industry

Molecule tracking via preclinical testing is a significant yet necessary investment for drug developers. The stakes are high, and it's critical to stay apprised of your program's progress from start to finish. You need to monitor how your compound is progressing and...

Partnerships that Prioritize the Customers

Partnerships that Prioritize the Customers

Around the globe, drug developers are trying to understand how the pandemic will impact the progress of their molecule during preclinical testing. Depending on a testing partner's response to the pandemic, your project's status can look drastically different from one...