March 28, 2019
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
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
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
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
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.
May 7, 2020
With reduced resources accessible (both in personnel and funding), smaller emerging sponsors will seldom have a sizable Chemistry, Manufacturing and Controls (CMC) group, and in many cases may only have one support individual within their organization. It is common for all CMC activities from pre-IND through Phase 2 and even beyond to be coordinated by this one individual, often simultaneously with other responsibilities. Most if not all these sponsors, who in many cases are also virtual, use contract manufacturing organizations (CMOs) for the CMC aspects of their development and manufacturing.