get your pharma product to market faster

Get your pharma product to market faster

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Are chemistry or solid state issues holding you back from clinical development?

There are many facets and competing priorities in drug development.

Early in the development cycle, you will be challenged with the timely provision of drug substance in sufficient amounts.The API needs to meet regulatory quality requirements, and its production often relies on underdeveloped synthesis and manufacturing processes.

As a company in its formative stages, you may not have the time or resources to resolve problems like:

  • scaling up the manufacture of your new drug candidate to generate enough material for your pivotal IND-enabling studies or your First-in-Human clinical studies;

  • impurity profiles or solid forms of your API keep changing from batch to batch, leading to failed batches;

  • identifying the best CRO or CDMO to troubleshoot or mitigate chemistry issues in a timely manner and successfully scale up the manufacturing process; or

  • CMC development activities are getting in the way of clinical timelines.

I can help.

Developing and scaling robust processes

From our hands-on expertise and practical experience, we have learnt that best practices must include focusing early in the development cycle on:

  • better defining the last chemical steps; and

  • the isolation and purification of the API;

so that you can devote targeted efforts, know-how and a judicious amount of time to these issues in parallel with upstream chemistry and process development activities.

To do this, you need to establish and execute a CMC development plan that adequately allocates resources and specific development activities to achieve:

  • a timely definition of the final process steps;

  • the screening, selection and practical crystallization of the most developable solid form suitable for formulation and manufacture of the drug product; and

  • early establishment of a control strategy, including a control of potential mutagenic impurities to ensure patient safety and regulatory compliance.

That’s what I do.


For small, virtual and emerging Pharma companies

If you are:

  • a Pharma Entrepreneur with business savvy and drive to quickly move your drug development forward while building a senior level technical and executive team;

  • a Pharma or Biotech Executive with drug design and small-scale chemical synthesis expertise, and you need strategic support in effectively tackling chemical development and scale-up challenges to supplement your internal staff; or

  • a CMC Manager and need support to articulate a sound control strategy for the drug substance manufacture in late phase development, including the control of potential mutagenic impurities and the control of solid forms at large scale manufacture;

then I can help you resolve chemistry and solid form control challenges to get your Pharma product to market faster.