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Welcome and Introduction Andy Evans, Chair, MMIP Welcome and Introduction Professor Sir John Bell, Life Sciences Council Kristen McLeod Director, Office for Life Sciences Dr Richard Torbett Chief Executive, ABPI Housekeeping Your

  2. Welcome and Introduction Andy Evans, Chair, MMIP

  3. Welcome and Introduction Professor Sir John Bell, Life Sciences Council

  4. Kristen McLeod Director, Office for Life Sciences

  5. Dr Richard Torbett Chief Executive, ABPI

  6. Housekeeping Your Participation • Please continue to submit your text questions and comments using the Questions panel we will try and get to as many as possible where time allows. Note: Today’s presentation is being recorded and slides will be made available after the webinar Medicines Manufacturing Industry Partnership (MMIP)

  7. Trinity of academia, industry and government – driving manufacture of COVID-19 vaccines

  8. Kate Bingham Chair, UK Vaccine Taskforce Managing Partner SV Health Investors

  9. Andy Jones , Challenge Director: Medicines Manufacturing ISCF Lucy Foley , Director of Biologics, CPI Dr Catherine M. Green , Associate Professor, Head of the Clinical BioManufacturing Facility, University of Oxford Prof. Daniel C Smith , Chief Scientific Officer, Cobra Biologics Mark Proctor , Global Supply & Strategy Snr. Director, AstraZeneca Ian McCubbin OBE , Independent Pharmaceutical Professional

  10. BIA COVID-19 Vaccine Taskforce members www.bioindustry.org

  11. BIA COVID-19 Vaccine Taskforce members www.bioindustry.org

  12. Housekeeping Your Participation • Please continue to submit your text questions and comments using the Questions panel we will try and get to as many as possible where time allows. Note: Today’s presentation is being recorded and slides will be made available after the webinar Medicines Manufacturing Industry Partnership (MMIP)

  13. Questions? Medicines Manufacturing Industry Partnership (MMIP)

  14. Break Back at 12:20 Medicines Manufacturing Industry Partnership (MMIP)

  15. Housekeeping Your Participation • Please continue to submit your text questions and comments using the Questions panel we will try and get to as many as possible where time allows. Note: Today’s presentation is being recorded and slides will be made available after the webinar Medicines Manufacturing Industry Partnership (MMIP)

  16. MMIP Workstream Updates

  17. Technology & Innovation Martin Wallace, GSK

  18. Technology & Innovation Workstream Name Affiliation Theme Katie Murray AZ/MMIC/HVMC Small Molecule Lucey Foley CPI Biologics Large Molecule Julie Anderson CPI Strategy General/Secretariat Martin Wallace GSK General/Lead JP Sherlock AZ Small Molecule Bob Docherty Pfizer Digital & Analytics James Miskin OxfordBiomedica ATMP Sarah Goulding KTN Large Molecule/AT Stephen Ward ATMP/HVMC ATMP Damian Marshall Kit Erlebach Fujifilm D iosynth BIA/MAC Large Molecule Melissa Hanna Brown Pfizer, Analytics (CAMS) Small Molecule Karen Wilkinson KTN/Made Smarter Digital Nick Medcalf Anna Mereu Innovate UK/Medicine Challenge General Patrick Hyett GSK Digital Medicines Manufacturing Industry Partnership (MMIP) Slide 18

  19. Critical Questions to consider for technology Roadmapping • What are the drivers we need to consider in the future? • Where do we want to be in 2030? ► • What are the opportunities that will be afforded based on advances in science and technology? • What are the current barriers to adopting this technology? Medicines Manufacturing Industry Partnership (MMIP)

  20. MMIP T+I Roadmap: Grand Challenges for 2021 and beyond Infrastructure Strategic Grand Challenges Technology opportunities Drivers Current • Providing access to innovative Digital Design – from Molecule to • Digitalisation Expanded medicines Cell+Gene patient therapy • Continuous Manufacturing manufacturing • Moving towards personalised centre • ATMPs manufacturing & delivery medicines. On Demand Manufacturing National Medicines Biologics Manufacturing • Delivering a Net Zero economy Manufacturing Innovation On Demand Sterile manufacturing Centre centre Potential Future • capacity Changing Portfolio - Advanced Public Funded • Robust Agile Supple Chains Therapies – ADCs, Vaccines, manufacturing Nucleic Acids, Oligos, Cell based infrastructure Real time release for Advanced • Micro Flexible Factory therapies Therapies Vaccines • A Net zero approach to Nucleic Acid Manufacturing • Shortening Development and Therapies Innovation Accelerator medicines manufacture centre Launch times • Modular, flexible Sterile • Harnessing the potential from the National Formulation Manufacture UK medicine manufacturing Centre ecosystem • Advanced Bioprocess Manufacturing & Control • Increase the impact of Digital Transformation from molecule to • Intracellular drug delivery patient

  21. Initial MMIP T+I Roadmap: Programmes and potential Projects that underpin the GCs Deliver a more agile, adaptable, scalable, sustainable medicine manufacturing ecosystem that will deliver medicines to patients faster in a more sustainable way. Next Generation Modular Flex Sterile Robust Agile Supply Net Zero Medicine Micro Flex Factory Intracellular Delivery Biopharma Manufacturing Supply chains manufacture Delivering alternative Advanced bioprocess Factory on Demand Molecule to Patient Lipidic & Polymeric Cleanrooms to meet green manufacturing Control Nanoparticles future needs processes for existing Cell free systems therapies Expanding the impact of Industrialising Viral Vector Targeted Delivery Digitisation of sterile process intensification Manufacture Delivering Net Zero operations manufacturing processes Development of a smart for new therapies bioreactor • Modular and • Characterisation of • API to DP Connectivity • Cleanrooms for complex • Alternative Oligo • Drug Product Digital twins Mobile factory processes in flow therapies e.g ADCs Manufacturing • In process control and • Small batch process • Rapid Micro solutions • Delivering more • Digitally enabled • Miniaturisation of FF intensification real time release. sustainable • Downstream processes small operations. manufacturing volume/batch Digital twins – e.g. Lyo processes • Shortening development factory • Net Zero supply chain of • Plug & Play and production times the future. Automation for stratified medicines Solutions and biologics to combat emerging threats (aka cell free).

  22. Roadmap refresh • We are in the process of updating the technology roadmap – Last roadmap issued in 2017 (A lot has changed since then!) • We will use this revised roadmap to help align all relevant stakeholders to deliver more agile, adaptable, scalable, sustainable medicine manufacturing ecosystem that will deliver medicines to patients faster in a more sustainable way. Medicines Manufacturing Industry Partnership (MMIP)

  23. Advanced Therapies Workstream - update James Miskin MMIP Advanced Therapies Work Stream Lead July 2020 Medicines Manufacturing Industry Partnership (MMIP) Slide 23

  24. Advanced therapies – a new treatment paradigm Established mode Clinical proof of Manufacturing, of action concept COGs Clear unambiguous Rare diseases; Requirement for e . g. β -Thalassaemia, clinical data in severe mid- to large-scale, ✓✓ disease, ‘accelerated’ ADA-SCID, high quality vector / haemophilia, orphan route to market cell manufacturing ocular ? with ‘ acceptable ’ COGs (for developers and payers) Promising signs of High incidence / efficacy in clinical prevalence ✓ Scaled clinical trials, ‘traditional’ diseases; operations e.g. Parkinson’s route to market? disease, CF, cancer Indication-specific (e.g. CAR-T, TCR) ATMP CMC is extremely complex therefore manufacture is ‘sticky’ Slide 24 Medicines Manufacturing Industry Partnership (MMIP) Slide 24

  25. MMIP Advanced Therapies Work Stream Priority areas for MMIP AT work stream, collectively aimed at securing a significant UK position in ATMPs : • Skills – apprenticeships, AToMIC, LEAP, CATTS • Future support for capability and capacity for ATMPs manufacture – “Accelerating the Translation of the UK Academic ATMP Pipeline into Commercial Products that will be made in the UK” • Plus : improving the UK fiscal environment for medicines manufacturing (including ATMPs) Slide 25 Medicines Manufacturing Industry Partnership (MMIP) Slide 25

  26. The ATAC story Life Sciences Industrial Science Man Tech (L3), Senior Leader (L7) Strategy Reg Affairs (L7) £1.5m Continued Gatsby & MA Scotland launched MMIP ATM funding – and CGT interim Taskforce ATAC funding Research Scientist Future Skills launched (L7), Process Eng (L6) 2030 launch and Lab Tech Wales to be launched 2019 2016 2017 2018 2020 2014 2015 First AT Apprenticeship CGTC Skills Catapult Present skills – 17 ATMP Gatsby Delivery of and Training Skills strategy to BEIS Technician Scientists Foundation Action Plan - Survey (L5) from 8 orgs demand interim skills to MAC Action survey funding Plan Medicines Manufacturing Industry Partnership (MMIP) Slide 26

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