Progress-EXS CMC QuickScan tool for faster time-to-market

Progress Executive Services (Progress-EXS) can use its proprietary analytical QuickScan tools to identify critical gaps in product development strategy and accelerate time-to-market. These tools include Scan Time-to-Market (CMC), Scan License-to-Operate (GMP) and Scan Efficient/Effective Processes (Lean Six Sigma). Quick Scans deliver detailed reports including all identified gaps plus C-Suite presentations including explicit recommendations that can simplify internal decision-making processes.

CMC QuickScan supports pharma and biotech companies in reducing their time to market by helping them optimize their chemistry, manufacturing and control protocols during drug development.

CMC challenges

Chemistry, Manufacturing & Control (CMC) protocols cover the whole range of new drug development and manufacturing activities. Typically the CMC process is both lengthy and costly, placing strain on project feasibility.

Typical CMC pitfalls include:

• Shortcuts taken during development that add later costs and delays to approval and manufacturing
• Lack of integrated development strategy due to siloed departments or short-term horizons
• Knowledge gaps about regulatory requirements
• Selecting reworking strategies for ‘quick wins’, postponing true problem-solving to a later stage with negative impact on overall project progress and integrity
• Lack of ownership when outsourcing to CRO or CMO with resulting gaps that increase project risk and cost

Remaining on CMC track

Product development within biotech is notoriously risky, costly and time consuming. This challenging environment requires well thought through strategies and proper resource allocation from senior executives.

The decision-making process for executives becomes a continuous challenge in current competitive markets. Progress-EXS has developed the CMC QuickScan to provide fast and accurate answers to the key questions that determine rapid identification and visualization of the correct strategy to follow:

• What are the major risks in bringing this new product to the market?
• Do we have any gap from a product development perspective? Are we on the right track?
• Is it worth to keep investing on this product? Or shall we stop and change direction?
• What is still required to be ready for submission?
• Can we cut development work to be first on the market?

Progress-EXS CMC QuickScan

The Chemistry, Manufacturing and Control (CMC) QuickScan is a risk management tool that facilitates rapid identification and visualization of current and potential CMC risks, specifically designed for biologicals.

The CMC QuickScan provides quantified measurements of how far the drug developer is from regulatory submission readiness, what current gaps might put regulatory approval at risk and any potential future risks affect overall product development strategy.

In short, the tool allows Progress-ESX to evaluate clients’ CMC strategies from an external perspective to verify that they are on the right track.

QuickScan process

The QuickScan process begins with an initial meeting to determine specific situation and objectives between Progress-EXS consultants and senior project owners, who will act as sponsor of the QuickScan exercise.

Thereafter, the exercise will move through four steps:

1. Kick off meeting (1 day)
2. Technical visit (1-2 days)
3. Data analysis and reporting (1-2 weeks)
4. Executive presentation of findings (two hours)

QuickScan benefits

The Progress-EXS CMC QuickScan delivers full itemization of current and potential future gaps encountered across the whole product development project and strategy, allowing better understanding of the risks facing the project as a whole and the milestones that must be passed to satisfy regulatory requirements and comply with current industry standards.

It will deliver a fully detailed written report with all findings categorized according to criticality.

Presentation of the report will include summarised findings and itemized recommendations, along with a mitigation plan.

Throughout the process, Progress-EXS aims to work with maximum transparency and collaboration to foster the mutual trust required for best results.

Resources

Click on CMC services for more on Progress chemistry, manufacturing and controls offerings.