CMC

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.
January 30, 2020

A Feng Shui CMC Guide to 2020: Will the Year of the Rat bring you Luck?

ncorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both Chemistry Manufacturing and Control (CMC) development and filing approaches range from the minimalist style to a continuously supported style. 
February 28, 2020

Why Your Program Needs a Biologics CMC Consultant

Looking for answers? Where are you at with your process and controls? Who is managing the operations? What bioassays are necessary for your product? When, where and how to validate your bioassay? 
March 30, 2020

4 CMC Topics to Discuss During Milestone Meetings

e FDA recognizes that CMC-specific discussions, during Pre-IND meetings, are typically unnecessary when projects are “straightforward.” However, unlike more traditional 505(b)(2) products, certain new chemical entities (NCE’s) and biologics are anything but straightforward. These novelties can create unique manufacturing roadblocks that impede the path to clinical development.
May 7, 2020

CMC Considerations for Successful Drug Development

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.