MMIP overview - strategy and progress update

James Miskin, CTO, Oxford BiomedicaMMIP Advanced Therapies

Work Stream Lead

1Medicines Manufacturing Industry Partnership (MMIP)

Medicines Manufacturing - Key Facts• 40,000 Employed

• GVA £9 billion (7.3% of UK Manufacturing GVA)• Global Exports $33 billion

‘The most productive element of the most productive part of the UK economy’

Sir John Bell

BioProcess UK 2019

MMIP Mission and Vision

MMIP represents the voice of medicines manufacturers in the UK and was established jointly by Government and the Biopharmaceutical industry in 2014.Expert group feeding represented in LSIS Implementation Board.

Vision for MMIP:Focusing on technology and Innovation leadership to make the UK the best place in the world for medicines manufacturing through:

1) Our ability to develop the manufacturing process for new medicines and rapidly move from research through development to launch is world class.

2) Our ability to bring innovative advanced manufacturing methods to medicines manufacture to ensure high quality and high productivity is world class.

Mission of MMIP:To maximise ROI from the exceptional UK LS R&D base, for the UK to be the leading force in manufacturing innovation, ensuring national and regional economic benefits and a secure supply of medicines for patients in the UK.

MMIP Overview contd.

Scope should cover the following:• Future Treatments - (e.g. cell and gene therapies)

• Complex Medicines - (e.g. ADCs, Oligonucleotides, viral vectors, new vaccines)

• Established Medicines - (Small molecules, MABs, traditional vaccines, therapeutic proteins)

Working closely with: Trade Bodies, CPI and key Government organisations including the Medicines and Healthcare products Regulatory Authority(MHRA), Innovate UK and the Office for Life Sciences (OLS), BEISAttending the LSIS Implementation Board and attending/ updating the LSIS Council

Technology &

Innovation

Regulatory Fiscal

SkillsAdvanced Therapies Task Force

MMIP Core areas of Focus

Advanced Therapies

Treatment Centres

£30m

Medicines

Manufacturing

Collaborative R&D

£25m

Cell & Gene Therapy

Manufacturing Centre

£12m

Medicines Manufacturing

Innovation Centre

£13m

Vaccines Development &

Manufacturing Centre

£66m

“Made Smarter”

Digitalisation

(cross sector)

Viral Vectors

£5.6m

Advanced Therapies

Apprenticeship

Community (ATAC)

£1.5m

Digitalisation

Wave 1

£8m

“£56m UK Innovation Centre will transform Medicines Manufacture” …. A new £56 million UK innovation centre, set to revolutionise how medicines are manufactured, is to be located in Renfrewshire, Scotland, allowing the UK to capture a bigger slice of the global £98 billion small molecule pharma market.

Significant Government funding in 2018/2019

MMIP STRATEGY

Look to• support accelerated approvals• manufacture robustly in very small quantities• manufacture more complex molecules• support drug delivery challenges

Look to Create innovative supply chains (e.g. ATMPs) improve patient compliancemake affordable medicines

1) Optimise the whole value chain by working at the interfaces to meet specific requirements

Global Health Services

/ Patients

R and D(Industry and

Academia)

ManufacturingIncludes New

modalities and a Digital platform

Medicines

Needs of patients

UK NHS

MMIP STRATEGY

2) Improve the overall functional effectiveness and efficiency of manufacturing

Deliver through:

1) Attracting the commercial and clinical manufacturing of new types of medicines2) Anchoring + building the commercial and clinical manufacturing of

established types of medicines3) Developing a world leading digital manufacturing platform

Global Health Services/ Patients

R and D(Industry and

Academia)

ManufacturingIncludes New

modalities and a Digital platform

Medicines

Needs of patients

UK NHS

Medicines

ATTRACT Definition: Clinical and Commercial manufacturing of new types of medicines such as ATMPs and other Complex medicines and likely to need investment in new sites, or new facilities on current sites, and use of innovative process and analytical technologies.

KPIs to measure what stakeholders want:• Flexibility (volumes often uncertain), ability to manufacture complex product to high quality and

secure Regulatory approval and align cash flow to risk.

Enablers1. Secure Capital Support preferably in the forms of grants

2. Infrastructure (Supply chain network and supportive regulatory framework)

3. Speed of adoption of technical and Digital innovations (essential for new medicines to be made

at scale) supported by simple funding mechanisms to risk share with UK Govt as technologies

move through the TRL levels

4. New Skills (often linked to R and D capabilities)

5. Maintain competitive corporate tax and patent support position

6. Market Access

``

MMIP Strategy – Complex Medicines

BUILD and ANCHOR Definition: Clinical and Commercial Manufacturing of established types of

medicines through securing investment in current capabilities and likely investment in current Sites.

KPIs to measure what stakeholders want:

Guaranteed high quality and reliability with enduring productivity improvement.

Enablers

1) Secure Capital support preferably in the form of grants

2) Speed of adoption of technical and Digital innovations (to make medicines more productively) supported by simple funding mechanisms to risk share with UK Govt and in consortiums as technologies move through the TRL levels.

3) Evolve core skills (Process Engineering/Chemistry etc.) and step change in Digital capabilities

(in both Development and Manufacturing).

4) Maintain competitive corporate tax and patent support position

5) Market Access

MMIP Strategy – Established Medicines

Slide 11

Technology & Innovation Workstream(Andy Dwyer GSK)

Digital PLM Agile “Automated” Capacity Artificially Intelligent SCMAdvanced Platforms

Key H1 Milestones

Feb 2019:

MMIC Contract Signed

April 2019:

JIT Automated Clinical Pharmacy Equipment Purchase Order Raised (GC2)

June 2019:

Next Generation Continuous Direct Compression Equipment Scope (GC1)

T&I Strategy Refresh – Focus Areas

Focus for H2 2019

Made Smarter Submission

Complex Medicines Centre

Micro-Factory Concept

Advanced Therapies Work Stream(James Miskin Oxford Biomedica)

Continuing priority areas for MMIP AT work stream collectively aimed at securing a significant UK position in ATMPs:

• Skills needs for the future

• Incentives matter for SMEs, to enable and de-risk capital investment

• Accelerating the Translation of the UK Academic ATMP Pipeline into Commercial Products that will be made in the UK

• Developing a Pan-UK Business Case to Improve Academic ATMP Manufacturing

Securing the advanced therapies talent pipeline

Advanced Therapies Apprenticeship Community

- Established by CGT Catapult and MMIP

- £1.5M award from Industrial Strategy Challenge Fund

- First advanced therapies apprenticeship programme in England and Scotland

- Aims to provide the skills required to fuel industry growth

- First cohort recruited in September 2018

65 apprentices have been

employed

21 companies have hired

apprentices and formed the advanced therapies apprenticeship community

5 programmes have been

developed to provide the skills the industry needs- Science Manufacturing Technician (Level 3)- Technician Scientist (Level 5)- Senior Leaders (Level 7)- Regulatory Specialist (Level 7)- Modern Apprenticeship in Life Sciences

(Scotland)

Developing a Pan-UK Business Case to Improve Academic ATMP Manufacturing

Viral Vectors for ATMPs-

• A crunch point in terms of capability and capacity –

not just in the UK but globally

• VV are an exemplar of other ‘to come’ platforms /

products that will need to be addressed

– UK is a leader in academic development of ATMPs

– Secure long term manufacture of ATMPs in the UK

– Huge $ investments in ATMPs globally

Developing a Pan-UK Business Case to Improve Academic ATMP Manufacturing

• Multi-stakeholder (industry and academia)-led initiative to align on the best UK-wide strategy to facilitate viral vector production for UK

• DRAFT business case in circulation -presented to UKRI

FISCAL WORKSTREAM(Richard Turner FTI)

16

Medicines Manufacturing Industry Partnership MMIP)

Action Performance

Help provide a much better perspective of the UK grant incentive landscape

Ongoing

Present the MMIP Fiscal request (below) to the Life Science Council with HM Treasury

Presented to the Life Science Council May 2019Meeting with H M Treasury 5th July

Growing momentum for a ‘Facilities Credit’ – 12p/£ on investment in Clinical Manufacturing Facilities

Met with CBI 9th AprilInclude in representations for the 2019 Autumn Budget

❑ The UK should set a target of attracting ten large (£50-250m) and ten smaller (£10-50m) commercial-scale manufacturing facilities in the next five years. At an intervention rate of 10-15

❑ Research and Development Tax Credits to support investment in Clinical Manufacture

MMIP Fiscal request to the Life Science Council / HM Treasury

• Presented to Life Sciences Council, May 2019 & HM Treasury, July 2019• The Opportunity: “….for the UK to maintain and increase its share of

traditional pharma manufacturing and attract a significant share of next generation medicines it must be more globally competitive…..”

• The Issue: “…Over the last 10-15 years, pharmaceutical manufacturing GVA in the UK has declined, while the global scale of the medicines manufacturing has continued to grow….”

• Recommendations: “…financial support in the form of targeted capital grants to deliver on the Life Sciences Industrial Strategy - attract ten large (£50-250m) and ten smaller (£10-50m) commercial scale manufacturing facilities in the next five years….at an intervention rate of 10-15%....”

3. Increase Sector Connectivity

Connect, promote needs and encourage greater ownership from companies to help themselves. I. Digital skills – Sector needs analysis

report completed. II. Building sector stakeholder mapIII. Communication plan to use LinkedIn

to build sector connectivity on skills

1. Support the Life Science Industrial Strategy and work in collaboration with theScience Industry Partnership to develop the Sector Deal recommendations

• Active in sector skills consultation and workshops

• Member of the 2030 Skills Strategy Futures Group

• Working together with SIP on skills recommendations for medicines manufacturing

• Member of SIP Board

2. Build the skills for UK to manufacture Advanced Therapies

Evidence secured funding - 65 apprentices from 21 organisations on 5 programmesISCF funded (£1.5m) work through CGT Catapult.Priority standards identified and specialist ATMP training modules developed and delivered by an Industry User Group

Level 5 Advanced Therapies Scientistenrolling now for 2nd cohort with Kent University

Level 3 Science Manufacturing Technicianenrolling now for 2nd cohort with CSR Group –

Cosmopolitan top 14 Cool Apprenticeships!

Level 7 Senior Leader (MBA)enrolling now for 2nd cohort with Open University and Kent

University

Level 7 Regulatory Affairs Specialistenrolling now for a 2nd cohort with TOPRA

Modern Apprenticeship in Life Sciences – Scotland First programme started Sep 2019 with Forth Valley College

New additional programmes to be announced for 2020 ….

3 focus areas: Workstream membership: 14 representatives from Companies, Trade associations, Royal Society, Government.

Digital skills framework

Skills Workstream, (Neil Baker Pfizer)

Regulatory Work Stream(Adam McLennan AZ)

19

TeamScope:• Manufacture of drug substance, drug product and new technologies• Pre-clinical, Clinical and Commercial products.• Medical devices that form part of a medicinal product, combination

products, software, CE mark vs medical use, 3D printing (point of care manufacture - POC) and bio-printing

• Proprietary, OTC & generic product• Innovation Centres / MHRA engagement

• Industry• Academia• MHRA• Generics• QPs• REMEDIES• Professional bodies

Objectives:✓ Connect and promote UK’s regulatory environment as a core asset for medicine manufacturing and investment✓ Make innovation operational; expediting investment through to realisation by multi-party partnership ✓ Represent the views and objectives of opportunity areas like ATMPs and nearly approved vs experimental manufacturing technologies. Including new

areas of challenge (eg. Environmental sustainability, AI)✓ Awareness, preview and cascade of Brexit/Regulatory impacts

Plan 2019

Point of Care (POC)• 2H 2019 – Industry / MHRA, draft guidance document for POC

Digitalise Patient Information Leaflets (PILs)• 2H 2019 – Industry paper to MHRA for assessment taking into account:

• Immediate safety updates, improved access for visually impaired, environmental sustainability improvement• Equivalent access (analogue and digital access to information)

COMMUNITY BUILD WORKSTREAM(Sarah Goulding KTN and Kit Erlebach FujiFilm)

20Medicines Manufacturing Industry Partnership (MMIP)

Grow awareness

• Events• Meet sector stakeholders

• Academia• Industry• Public sector

Discussion

• Workstreams• Papers on sector

challenges • Workshops

Collaboration

• Engage ‘Innovation Ecosystem'

• Inform funders• Develop new proposals

Workstreams

Events

1-2-1 meetings

DIGITAL

ANCHOR events

COMMUNITY BUILD WORKSTREAM* looking forward

Medicines Manufacturing Industry Partnership (MMIP)(Sarah Goulding KTN and Kit Erlebach FujiFilm)

MMIP Annual Conference BIA bioProcessUK 2020

Tech and Innovation Workstream

• Digitalisation • Analytics• Complex Medicines• SynBIO• Supply Chain• Collaborations

Summary

• Value of Medicines Manufacturing well understood• MMIP actively part of shaping the Life Sciences Strategy

and embedded in Implementation• ‘Money on the Table’ through ISCF awards• Continued progress in ATMPs• Technology Road Map in place• Progressing the skills, regulatory and fiscal agendas• Digitalisation initiatives progressed in 2019

However lots more to do !!!!