Pharmaceuticals

1. Pharmaceuticals “Factory of the Future”

2. Pharma Manufacturing UK • Large Scale Manufacturing • Survival? • Off-shoring? • Niche manufacturing, esp. biologicals? • Cf the recent conference “Pharma Manufacturing Survival in the 21st Century” –abpi, Royal Pharma Society, IChemE, I Mech E, etc

3. “Survival 21st C” • Reasons to stay in UK • UK Research Base ↔ Company R&D ↔ Manufacturing • UK Skilled workforce? • Lean manufacturing? (cf Steel manufacturing) • ? • ?

4. Pharma Business Trends • Low Cost Labour challenge • India €1.5/hr UK €23/hr • Gap will get worse • “Even Ireland is concerned” –Prof Benson • Conventional Pipeline of new drugs is not healthy • FDA etc: less expensive drugs (PAT framework) • Generics- much more efficient manufacturing • Biological pipeline is better esp. US and UK • New Markets in Emerging Economies • Contract manufacturing

5. Technical trends • Bio-pharma • Small volumes • Personalised pharma treatments- make the treatment in the hospital? • Med tech and pharma converging • Fewer “Blockbusters”? • Manufacturing: • Continuous processes (and semi-continuous) • Real time release/Quality by Design • Recycled drugs?

6. Factory of the Future • The need for “Lean” • UK Pharma: A “World Class Processing Plant” • Added Value/employee € 95,000 € 422,000 • Customer OTIF 98.5% 99.5% • Finished goods days 54 3 • Supplier OTIF 88.1% 99.5% • Stock turn 4 50 • Plant availability 46% 97% • OEE 30% 97% • etc • (from Prof Benson)

7. Why? • High profit margins • Relatively little attention to operations • R&D • Compliance • Sales & Marketing • Not Operations Driven! • Lean can be achieved in UK/ W Europe • But is going to be challenging! • And Lean is possible in a Low Labour Cost plant!

8. Off-shoring • However, relocating to LLC countries has many difficulties! • Political/social • Supply chain • Managerial • Quality • IP • Knowledge transfer • Counterfeiting • etc

9. Possible Solutions • Just cutting costs will not work! • Relocate to LLC country • Outsource existing UK manufacturing to toll manuf. • Radically reorganise in-house manufacturing • Lean + PAT* + “Agile Distributed Manufacturing/Processing” • Only make what you need/Real time release/quality by design *PAT Process Analytical Technology (FDA) “a framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance”

10. Factory of the Future? • (Semi) continuous processing vs. Batch • Manufacture at the Customer/Patient • “Lego” Process plants • Highly Automated (“man-less”) • ? • This can compete with any Plant anywhere in the World

11. Survival and Skills • “An educated, constantly re-skilled, flexible workforce” • …Manufacturing Foresight: Manufacturing 2020 • Life-long learning, e-learning, partnerships with Universities • Information and Knowledge Key • Innovation and Continuous Improvement • Likely huge change in culture, ways of working and up-/re-skilling inevitable and soon for workforce and managers in manufacturing Pharma (and Chemicals?) • Not even R&D is safe!

12. “PAT” Factory • PAT-environment Factory • “Process continually monitored, evaluated and adjusted using in-process measurements, tests, controls and process end-points” • Multivariate Statistical Process Control • Sensor-based measurements- process “signature” or patterns-indicative of high quality and conformance • Quality decisions: process understanding and prediction • Timely measurements, real time measurements • Quality built in: “quality cannot be tested into products” • Continuous processing with small-scale equipment (eliminate scale-up issues) • End-points not time-defined (e.g., to quality manage physical differences in raw materials) • Risk-based approach- less restrictive regulatory climate for decisions and innovation • Real time release, based on process data

13. Specific Skills Challenges • Management and leadership (Level 3 +) • Mentoring, Communicating • Working in very small teams, flexible, autonomous • Process measurements and decision making under “PAT-type” environment • Product and business knowledge • Small-scale continuous processing • Real time release • Up-skill operators to Level 3+ • Re-skill to biologicals • Continuous improvements • Bio-processing is an identified UK Strength • Effective Knowledge transfer via Academic-Industry networks • Level 3+ workforce; maybe even mostly PhDs!

14. Gold Standard & Sector Compact The Gold Standard and the Sector Compact are key corner stones of Cogent’s strategy • The Gold Standard defines the modular training programmes to world class standards for each job role • The Sector Compact defines the funding for, and accreditation to, the Gold Standard

15. Gold Standard To compete successfully in today’s global market UK companies must have a well trained, highly skilled workforce • The Gold Standard is an aspirational standard to raise the competitiveness of UK companies • It takes key job roles and sets the standard for training and qualifications to achieve ‘world class’ performance • It was • conceived by employers through the Chemical Leadership Council, • developed by employers through Cogent, and • will be empowered by employers through the National Skills Academy for Process Industries

16. Gold Standard The Gold Standard covers 4 categories of skills • Technical Competence • Business Improvement • Including Quality & Innovation • Functional & Behavioural Skills • Compliance It maps the training and qualifications in each category for a ‘world class’ skills set

17. Gold Standard The Cogent Gold Standard is a modular Continuing Professional Development Programme It is based on modular ‘bite sized’ qualifications that matches the way employers train their staff, for example for a process technician modules include: • Process operations • Process maintenance • Process Improvement • Safety Management systems • Industry Regulations

18. Cogent Gold Standard Key Features of the Gold Standard • The Gold Standard will underpin the work of Cogent’s National Skills Academy-Process Industry • The Gold Standard will recognise and accredit employer training • The Continuous Professional Development will be captured on a personal passport • Achievement of the Gold Standard will be accredited • The Gold Standard is a key part of Cogent’s Sector Compact

19. Cogent Sector Compact Train to Gain • T2G is the funding mechanism for training • Current rules are restrictive for the Cogent sector being focused on less technical jobs • The Sector Compact maps the funding requirements that meet the Cogent sector needs • Funding is requested for the Gold Standards at levels 2, 3 & 4 qualifications

20. Higher Education • Cogent has been developing its Higher Level Skills strategy in recent months, which aims to build and extend frameworks for greater employer engagement with HEIs. These frameworks will enable HEIs and the Cogent workforce to clearly identify routes to education and training, that meet their needs at a number of levels. As part of the higher levels skills strategy, Cogent will be concentrating on: • Advancing employer-led frameworks for Foundation Degrees in key sectors • Cultivating post-graduate level training and CPD provision • Encouraging skills for innovation within higher level training programmes • Increasing careers guidance and information for higher level skills, through the development of careers pathways and interaction with HEI careers services

21. Gold Standard and Lean/PAT • Challenging: • Gold Standard and Qualifications Reform (NOS reform) and Provision Reform • But in an uncertain/rapid changing manufacturing environment • Employer engagement is essential! • Cogent and NSAPI already working with some Pharma Majors on Gold Standard for the Factory of the Future • Possibility of a Cluster working group • Cogent also working with SEMTA’s SSA Bioscience Group (e.g., abpi, BIA etc, and employers) • Possibility to engage with Cogent On-Line too • Possible analogies for Chemicals Sector too?