Blog

December 3, 2019

Phase 2 to Early Phase 3 Regulatory Opportunities: Return on Investment

To ensure scientific and commercial success, it is critical to understand the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan. Although the primary purpose of a well-designed regulatory strategy is to assure an efficient process for providing new, high quality and effective drugs for patients, it is also essential to effectively maximize the return on investment. Each step along the path to commercialization is important and an effective chemistry, manufacturing and controls (CMC) strategy and ensuing communication plan plays an integral role in the overall success of a product.
October 29, 2019

CMC and Regulatory Affairs – See the forest and the trees

Here’s the problem: drug development managers must translate guidance into clear program objectives, identifying the data and information that needs to be produced, and prioritize resources and expenditures.
October 17, 2019

Are You Chasing the White Rabbit?!

The landscape of chemistry, manufacturing, and controls (CMC) has continued to shift over time. Just a few decades ago, most drugs were developed from beginning to end by large pharma with well-defined systems of control. Today, this has significantly changed; much if not most early development (Pre-IND to Phase II) work is performed by small- to medium-size emerging biotech sponsors, many of which are virtual companies.
October 2, 2019

Hey Google, tell me about the importance of living Development Reports

Ready to help, wherever you are! Google's version of Amazon's Alexa, Apple's Siri and Microsoft's Cortana is Google Assistant. It has made incredible progress since its 2016 launch and is probably the most advanced and dynamic of the assistants out there.
September 19, 2019

What Would Bruce Lee Do?

How would Bruce Lee develop a viable and effective chemistry, manufacturing and controls (CMC) regulatory strategy while focusing on ensuring a viable and effective clinical development strategy to keep the product moving forward, when the odds of clinical success were against him?
August 21, 2019

Key Elements of a CMC Strategic Development Plan

How to Avoid the End-of-Summer Slump Getting your productivity back on track requires using your energy wisely, whether it's stockpiled from vacation or running on fumes. Here are a few ways to turn the end of summer into a springboard for a productive Autumn.