Seamless transition and lifecycle management for 50+ marketed products
Case study
Challenge
The client’s portfolio of 50+ marketed products required immediate and ongoing support to ensure business continuity on a global basis. The products span across 2 internal organisations with vastly different systems, processes and procedures and require seamless integration to assure the supply chain is uninterrupted and safe medications are continued to be provided to patients.
Solution
ICON’s Chemistry, Manufacturing and Controls (CMC) team’s proven flexibility, agility, and extensive experience allowed instant and seamless management of multiple projects on demand. We are adept in building CMC staff and infrastructure to support integration of new organisations and projects in alignment with diverse regulatory CMC skillset requirements. We created a customised approach for the client to address CMC needs for early and late stage development, as well as life cycle management of marketed products.
Our customised solution for the client was carried out in 3 planned phases and incorporated the following execution strategies:
Phase 1
Launch and transition
- Efficient transition of product-specific history and information
- Training on systems and operating procedures
- Partnership with all client stakeholders, including Global Regulatory Affairs, R&D, Global Quality, manufacturing sites, Supply Chain and Operations
- Maintain business and supply chain continuity through prioritisation of ongoing work with supply or compliance risks
- Establish baseline metrics measurements to track progress and success
Phase 2
Transform and integrate
- Establish Change Control assessment and execution processes
- Create integrated business processes for client’s organisational changes
- Support client business plans for divestments
- Continued growth of product assets and support responsibility
Phase 3
Innovate and expand
- Develop forecasting process for accuracy and resource utilisation management
- Use resource utilisation measures across CMC for predictability
- Develop metrics dashboard to capture and track KPIs
- Create process to track risk and mitigation strategies
Execution strategies:
Maintain business and supply chain continuity
- Ensure continued regulatory compliance to CMC product commitments
- Ensure CMC content for submissions supporting product changes meets HA requirements for approval
Product portfolio expansion
- Support new MAAs for global market expansion
- Support submissions for new indications (new INDs/IMPDs) and line extensions for marketed products
Change control system transitions
- Develop regional change processes for Quality Management systems
- Provide key input into SOPs,work instructions and migrated data
- Establish process for notifying and tracking partner assessments for divested MAA
Business process development
- Develop optimised business process to align with client’s organisation changes and integration
- Establish tracking and communication tools
Global change assessments
- Provide change control assessments, submission strategy and content for:
a. Internal manufacturing facilities
b. Client partnerships
c. Contract manufacturing organisations (CMO)
CMC submission metrics
- Identify key metrics and create customised tracking tools
- Generate focused metrics data reports
Divested product transitions
- Manage dossier for the divestment team during transition of MAAs
Adoption of CMC Ancillary Document (CAD) group
- Collaboration with establish CAD team for requests of CMC ancillary
documents such as GMP certificates, Site Master files, API CPPs etc. - Allow focused technical expertise on regulatory CMC priorities
Outcome
Key CMC achievements of our client partnership included:
1. Successfully transitioned of 50+ team members globally, enabling them to operate
within the client’s systems and operating environment instantly and seamlessly
2. Successfully delivered key client goals and regulatory activities for transferred products, and maintaining undisrupted business continuity and compliance:
- Life Cycle Management for up to 50+ marketed products, and 150+ annual reports/renewals annually
- Up to 1000+ change control assessments and 500+ variations annually
- Respond to up to 500+ HA questions/information requests annually
- Market expansion for up to hundreds of MAAs for global markets annually
- Divestiture of 20+ products across multiple therapeutic areas and key regions
- Technology transfer of 12 products to alternate manufacturing sites, with 135+ regulatory submission to over 40 markets.
3. Developed an integrated global change control system and processes:
- Created an accessible and efficient process for global regulatory personnel to assess changes and regulatory requirements,
- Led the development and execution of submissions for product changes
4. Increased communication efficiency and consistency between CMC teams
- Established structured and specific tracking and communication tools for submission work, risks, mitigation strategies, metrics and forecasting.
5. Ensured smooth transition of MAAs to client’s partners for divested products
- Maintained business continuity while performing due diligence activities for asset divestment projects