Phase 3

February 14, 2019

Your FDA Meeting Survival Guide Has Arrived

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
March 28, 2019

Knock, Knock, Who’s There? Preparing for an FDA End of Phase II (EOP2) CMC Meeting

three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.
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?
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 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.
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.