Planning for Commercial Launch
This two day workshop aims to provide participants with the knowledge and simple processes required to plan for launch of pharmaceutical and biopharmaceutical products in global markets. It is designed specifically for those involved at the drug development/commercial supply chain interface. This is a critical area where actions and risk mitigations must be carried out cross-functionally so that launch objectives and deadlines can be consistently met. The course is equally applicable to innovator and out of patent (generic/biosimilars) sectors.
Participants will learn how to:
- Engage relevant stakeholders in launch preparations
- Map the current state supply chain and information flows
- Identify and resolve potential supply chain issues prior to registration
- Develop and/or contribute to clear, detailed future state supply chains and control plans
- Use simple material requirements planning and master scheduling through the end-to-end supply chain
- Create inventory visibility and pedigree
- Manage change simply, effectively and compliantly
- Interactive case studies where participants learn by doing
- Best practice aspects of strategic procurement, material planning and logistics
- Advice on the softer side of building relationships with key stakeholders in the launch process
- An innovative check list to ensure all supply chain aspects are pulled together in an integrated, inclusive fashion.
Questions and answers will be taken throughout the duration ofthe course.
Day 1 8.30 Registration and Coffee
Day 1 – 9.00 Morning session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 1 – Afternoon session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 2 – Morning session
- Mapping the current state supply chain
- Defining supply chain business process maturity
- Modelling uncertainty
- Completing the risk assessment
- Case study exercise
- Review of day 1
Day 2 – Afternoon session
- Aligning and deploying resources
- Keeping things on track up to launch
- Executing on peri and post launch activities
- Capturing learning for next time
- Case study exercise
- Review of day 2 and close.
17.00 Close of course
Hedley Rees (Supply Chain Expert)
Hedley has had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new 'molecular' entities and re-profiled compounds through development stages into full scale commercial launch. He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.
Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson. Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement. He holds an Executive Master's in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS). Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.
Those either directly responsible for planning and delivering commercial launch of products or involved in teams charged with that responsibility, including:
Managers and practitioners in supply chain management
- Demand/supply planning
- Logistics
- Procurement
- Inventory management
Managers and practitioners in Clinical Trial Supply
- CTS and packaging groups
- Clinical operations
- CMC (pharm tech/chem./biochem)
- Analytical Chemists
Managers and practitioners in related disciplines
- Project Management
- Production
- Quality
- Regulatory affairs
- Marketing
- Finance
- Business development
