Early chemical development at Legacy Wyeth Research.

Area of Science:

• Pharmaceutical Sciences
• Chemical Development
• Drug Discovery and Development

Background:

• The legacy Wyeth productivity model aimed to deliver two New Drug Applications per year for New Molecular Entities.
• This model led to reduced cycle times from lead selection to Phase I and an increased number of compounds in early development.
• Increased demand necessitated a resource-neutral approach to early process development.

Purpose of the Study:

• To describe a resource-neutral approach to early process development.
• To demonstrate how synergies were harvested through integration of advanced technologies and aggressive sourcing.
• To meet business needs while ensuring timely delivery of high-quality active pharmaceutical ingredients and scalable processes.

Main Methods:

• Integration of advanced technologies (e.g., high-throughput screening, process analytical technology).
• Implementation of aggressive sourcing strategies for raw materials and services.
• Adoption of a matrix research organization structure.
• Establishment of efficient ways of working and streamlined workflows.

Main Results:

• Decreased cycle time from lead selection to Phase I clinical trials.
• Increased number of compounds entering early development.
• Successful delivery of high-quality active pharmaceutical ingredients (APIs).
• Ensured safe and scalable manufacturing processes.

Conclusions:

• The described resource-neutral approach effectively met business objectives.
• Synergies from integrated technologies, sourcing, and organizational structure enhanced efficiency.
• The model successfully supported the timely delivery of New Molecular Entities.