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CMC Application Task Force

CMC Application Task Force

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CMC Application Task Force

Mission: Promote use of in silico solutions in CMC throughout product lifecycle

In the realm of pharmaceuticals, the pursuit of efficiency, safety, and efficacy is unending.

In silico solutions offer a promising avenue to transform traditional CMC processes.

By leveraging advanced computational tools, we can streamline development, enhance quality, and expedite regulatory approvals.

In silico technology not only accelerates development but also minimizes costs and reduces time on traditional clinical trials.

However, widespread adoption of in silico solutions in CMC requires concerted efforts from stakeholders across the pharmaceutical industry and collaboration between academia, industry, and regulatory agencies is vital to establish standards, validate models, and ensure acceptance of computational approaches in regulatory submissions.

With the mission of promoting the use of in silico technology in CMC throughout product lifecycle, the CMC Application TF’s main goals include:

Goals

  • Create an expert group among our members
  • Compile and review existing in silico solutions supporting CMC: to support tech transfer during clinical development and beyond
  • Promote use of in silico approaches in formulation development
  • Provide PRELIMINARY guidance on generating in silico data supporting batch size and CQAs strategy discussion with Regulatory Agencies


Ani Amar

Ani Amar

Co-chair of CMC Application TF

Postdoctoral fellow, Computational modeling of the heart at ELEM Biotech

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Himanshu Kaul

Himanshu Kaul

Co-chair of CMC Application TF

Royal Academy of Engineering Research Fellow University of Leicester

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