“Clinical Phase Appropriate” assignment of Chemistry, Manufacturing and Controls (CMC) activities can serve as relief from the pressure of limited resources for carrying out your regulatory compliance strategy.
Clinical Phase Appropriate is defined as “matching the extent of completion for GMP and CMC activities, as well as its timing for completion, to the patient safety risk associated with each clinical development phase.”
Overlap between GMPs and CMC. The Kicker with your evaluation?
Because they are both critical pillars of product quality, there are often areas of overlap between CMC considerations and GMPs. Examples of areas of overlap include; process development, Validation, and continuous process improvement. Resolution of the overlap can be achieved by viewing CMC development as a “process, criteria and controls setting activity” and GMPs as an “implementation activity”
What are you trying to accomplish?
You may not be trying to win a game, but it’s likely you’re considering how to make decisions to drive drug development, satisfy any commitments with increasing expectations, appease compliance with the Health Agencies and increase the value of the asset.
To have a successful Regulatory CMC strategy, you have to start with what you want to accomplish. I like to think of this as starting the drive with the end in mind.
It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success. Any good game plan for a winning football team consists of elements such as: know your opponent, know the strategic plays to get from one end zone to the other, ensure buy-in from the team and coaches, etc.
Who is your target audience?
Just like the defense prevents the other team from scoring, and the offense scores touchdowns, your goals need to be supported with a strong strategy. That starts with thinking about your audience and how to reach them most effectively.
Who are the people you want to work with? Why would they want to work with you? How can you work with them effectively? Whether this is the Health Agency or an industry License Partner, understanding your target audience as a player at the table will help you to determine how best to communicate with them in order to reach the goal line.
What tools will you use?
The quarterback has quite a few play options when he’s trying to decide how to get the ball down the field. Changes to the play can be called in an audible at the last minute should the need arise.
The same is true for you. When it comes to the tools you have to deploy your CMC strategy, the options are endless.
The best way to determine the right solution is to consider your target audience and ultimate goal and be prepared to make adjustments along the way, with tools such as the Code of Regulations, National and International Guidance’s, internal staffing with inherent knowledge supplemented by external industry consultants on your list.
When do you plan to communicate?
By the beginning of each game, the coach has created a game plan, full of plays for the team to run. They’ve prepared for what lies ahead in each game, so it’s easy for the team to work together.
As you plan your Regulatory CMC strategy, you should have a similar approach. Use a project plan to lay out what you’ll communicate and when. With a project plan, you’ll have the ability to schedule and manage the time necessary to build and execute your game plan.
By planning in advance, you can strategize around Milestone events in a phase appropriate way that may or can affect your outcome. You may have to pivot to make last-minute adjustments (Call an Audible!). You can determine where you might pivot in communications for an unexpected event or to accommodate an early or late piece of technical data.
How will you know you’re successful?
Just like in the big Game, avoid penalties first and foremost! As well as turnovers! As the game comes down to the 4th quarter, the team knows if they were successful by the number of points, they were able to score and if they won the game. For your own program, you’ll be able to see your success by asking yourself, “What was my goal, and did I reach it?” For most, it is a new drug approval but it can also be a license deal or partnership.
If you are put in a 4th and inches situation, where you are really close to hitting your goal, you will be in a good spot to tweak your CMC strategy to reach it with the right game-plan.
Spend some time refining your goals, always keep your audience in mind, use the right tools and strategize a smart plan of attack, unless you want to face a 4th and long. The Hail Mary only works in Green Bay these days and not everyone has Tom Brady or Patrick Mahomes under center.
As you eat your Buffalo wings and guzzle your beverage of choice during this year’s Super Bowl, observe how the teams are coping with unexpected, unanticipated, and undesired situations that arise. You just might learn a thing or two that could help you make your company more resilient to the risks it faces.
The next time that you’re watching your favorite team on the field, I promise you’ll be thinking about more than just football!