Late-Stage Organizational & Program CMC Strategy

Discover how TKD’s CMC due diligence and program management equipped a client for Phase III clinical trials.

Biotechnology programs that have reached Phase III Clinical Trials have increased 400% over the past decade according to Tufts Center for the Study of Drug Development. The increase in Phase III programs is a culmination of biotechnology developments in R&D, manufacturing, and strategic financing; the last of which is a direct result of the high cost to sponsor a Phase III trial. To sponsor such a late-stage trial, successful programs often rely on mergers and acquisitions. However, in such instances, due diligence and knowledge transfers are necessary to ensure a program is both compliant and viable for Phase III in addition to simply being funded.

TKD Solutions has supported many clients in the acquisition of late-stage biologics and cell and gene therapy programs. Often, the client has limited knowledge in the technology that has been acquired; we at TKD Solutions are brought on to the team to manage the knowledge transfer and due diligence of the acquisition. In a recent case, a client licensed an asset with minimal Chemistry, Manufacturing, and Controls (CMC) due diligence. The asset was ready for Phase III clinical trials; but QbD planning, risk assessment, and CMC strategy had to be implemented. TKD Solutions was tasked with holistically managing CMC activities and bringing the asset to Phase III clinical trials.

We began managing the program by assessing historical information from the licensing organization. We initiated a formal knowledge transfer and data collation to establish a data trail. We began CMC function management by setting up quality systems and QbD risk management for the Phase III transition. TKD Solutions performed a complete Quality Management Systems (QMS) gap assessment to ensure compliance entering Phase III. We also identified and selected a CDMO and negotiated costs with the CDMO for Phase III clinical supply. Following negotiations, we executed a complete tech transfer to the CDMO.

Upon completing the infrastructure buildout of the licensed asset for our client, TKD Solutions successfully implemented a QbD risk management platform and QMS for CMC management. In parallel, we ensured our selected CDMO successfully manufactured clinical supply to begin Phase III trials. During the path to producing material for clinical supply, we improved process efficiency and ensured a compliant infrastructure was in place to mitigate potential high-cost de-risking of the program after Phase III initiation.

TKD Solutions has a team of experts with diverse areas of expertise in biotechnology and Phase III program transitions. With our decades of experience in biologics and cell and gene therapy, we support our clients on programs that they may be lacking the necessary expertise. We understand that managing late-stage programs requires technical expertise as well as an understanding of regulatory requirements and supply chain needs to meet the demanding timelines of Phase III implementation.


Learn more about our late-stage program capabilities such as QbD implementation, risk and gap assessment, IND amendments or full program management.