Phase 1

July 19, 2019

One Giant Leap for Mankind. The Original Moonshot.

Fifty years ago, tomorrow, astronauts walked on the moon for the first time. Apollo 11’s success—just 66 years after the Wright brothers’ first flight—showcased humankind’s moxie and ingenuity. Now the moon is in our sights again, for a generation that will test where science meets profit.
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

Developing a Phase-Appropriate CMC Matrix

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.
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. 
May 7, 2020

CMC Considerations for Successful CMC 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.