Dr Ke Chen vice president, Process R&D at STA Pharmaceutical, a WuXi AppTec Company & Dr Valdas Jurkauskas, VP, Technical Operations at Black Diamond Therapeutics, discuss the regulatory strategies pharma companies can take to avoid delay when selecting starting materials.
Regulations
When it comes to preparing for commercial launch, innovators can all too easily concentrate their attention on the downstream end of the pharmaceutical development supply chain – i.e. API through to final product.
The upstream portion of the supply chain, including starting materials and advanced intermediates, is often overlooked in mapping the full regulatory picture and may, therefore, present the biggest risk of chemistry and manufacturing controls-based (CMC) delay. Failing to take due care and consideration when deciding how far upstream to go before designating regulatory starting materials (RSMs) can lead to critical regulatory risk and unexpected rises in costs. For example, if a regulatory agency rejects a sponsor’s starting materials designation, then all downstream process development steps may need to be repeated in their entirety. The risk is further increased when more regulatory bodies are involved, and sponsors must plan alignment and approval based around defending RSM designation to all parties.