Building a CMC Scorecard for Drug Development Risk Assessment

Building a CMC Scorecard for Drug Development Risk Assessment - Webinar CD/Transcript

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A lack of focus on CMC activities can severely trip up your next IND or NDA. Any failed or delayed IND/NDA is guaranteed to cost your organization millions in lost sales.

There are 8 CMC-related risks inherent in most oral drug development programs:

  1. BCS Classification: From good to bad — soluble and permeable, not soluble but permeable, soluble but not permeable and not soluble or permeable — where does your candidate fall?
  2. API Supply: Quantity and quality? Non-GMP or GMP compliant? Available at the time you need it?
  3. API Stability: Is it stable in a solid state (oxygen, moisture, light, heat) or in solution? Do you have your stability indicating analytical methods validated?
  4. Highly potent/cytotoxic: Some APIs required special handling, limiting vendor selection and increasing development costs.
  5. Dosage strength: Proposed dosage strength for FIM. Anything outside the range of 1mg to 250mg may require additional formulation considerations.
  6. Formulation: What is proposed FIM dosage form? PIC, PIB, dry blend, or solubility enhancing formulation. Staged development approach vs. final formulation?
  7. Quality of CMC leadership: Source of CMC strategies to support all development needs such as quality, timing, scientific scope, and cost.
  8. Timing: The development timeline leading to the proposed IND filing date.

Have you assessed, ranked and found solutions to your CMC problems? Take an 90 minutes and transform your CMC program.

Considering it takes months for the FDA to review your Investigational New Drug Application (IND) or New Drug Application (NDA), the last thing you want is for it to be rejected because you did not give the proper attention to the chemistry and manufacturing (CMC) section.

Failure to focus and understand the risk profiles and tolerances of your products during CMC activities can severely trip up your application and lead to costly delays that will affect your company’s bottom line.

The key is to not waste time on compounds that later may need to be scrapped due to CMC related issues. Creating a CMC scorecard upfront can identify problems early and allow time for solutions.

Now you can identify, assess and rank risks you might not have ever imagined existed with the use of a quantitative approach that will assure compounds make it to approved products.

Bryan Knox teaches you how to use a quantitative-based scoreboard approach that will enable you to identify drug program risks and provide you with a method to evaluate critical areas in the drug development process.

This approach, which has been validated by 12 years of evaluations involving hundreds of different drug candidates, will enable you to determine if your product is ready for market or if you have to go back to the drawing board.

At the end of this webinar CD and transcript you will know how to:

  • Develop a dashboard of critical elements for drug development
  • Use the 4 most common approaches to mitigate potential risks
  • Identify the 8 key risk categories
  • Evaluate the risks associated with each of your projects

A small investment now can save you millions down the road.

  • Pharmaceutical companies
  • Contract manufacturers
  • API manufacturers

Bryan Knox is a Senior Director of Pharmaceutics at Pharmatek, a contract dosage form development and GMP manufacturing organization. He has a broad background in preclinical and clinical drug development and manufacturing of small molecules and peptides. Mr. Knox’ nineteen years of pharmaceutical industry experience include managing hundreds of oral formulation and analytical development projects, controlled release and amorphous dispersion formulations development, process scale up and technology transfer. He earned his MBA from the University of California San Diego’s Rady School of Management and his bachelor of science in biochemistry from the University of California, San Diego.