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 RD ? 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
• RD
• 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 RD 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 Cogents 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 todays 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
  Cogents 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 Cogents
  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 SEMTAs SSA Bioscience
  Group (e.g., abpi, BIA etc, and employers)
• Possibility to engage with Cogent On-Line too
• Possible analogies for Chemicals Sector too?