Steve Bates OBEChief Executive OfficerBioIndustry Association

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Welcome

Dr Nigel DarbyExecutive AdvisorGE Healthcare Life Sciences

Nigel Darby, Senior Advisor, GE Healthcare

Bioprocessing - delivering innovations to patients

14th Annual bioProcess UK Conference

Biopharmaceutical proteins ($177 billion), plasma products, and vaccines: a $230 billion industry

Growth driven by monoclonal antibodies and by diabetes management

Growth from new product introductions (NPIs) but also from price increases

Threat on price levels from healthcare systems and from biosimilar competition

Biopharma market dynamics

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With permission: Jagschies, G. et al., Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing

Processes, Elsevier (2017), in preparation

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

rProteins

rCoagulationFactor

Interferons

GrowthHormones

ESA

Enzymes

Insulins

ADCs

MabFragments

Fusionproteins

MonoclonalAntibodies

Biopharma approvals (FDA + EMA) Recombinant biotherapeutics revenues

Pipeline and market outlook 2017-2022

• Biologics to contribute 52% of the top 100 product sales by 2022 and 30% of the market

• Fewer top 10 molecules by 2022

• Oncology grows at 12.6% CAGR 2016-2022

• Roche leads market in biopharma ($39Bn)

• Humira™ remains top selling biologic in 2022 at $16bn sales

• PD1/PD l-1 products forecast at $30Bn in 2022

3Q, 2017 pipeline snapshot Analysts market predictions

Data from Evaluate Pharma, IMS data and internal analysis

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Therapeutic and molecular innovation

• New therapeutic mechanisms, such as immunotherapy

• Monoclonal antibodies expanding therapy scope e.g. cholesterol, coagulation, Alzheimer's disease

• Novel applications such as antidotes to fX inhibitors

• More complex processing challenges for antibody-related products

• Building experience, e.g., viral vectors, gene/cell therapy

• Complex workflows as medicines become personalized

• More ideas emerging, such as mRNA

Therapeutic innovation Molecular innovation

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Molecule Approved products Clinical trials

ADCs 6 ~ 40

Bi-Specific mAb 2 ~ 30

Gene therapy 2-3 > 200

Lytic viruses 2 >50

Cells CAR-T 2 ~ 200

Approved products Clinical trials

Immunotherapy e.g., Keytruda™, Opdivo™

Many ongoing trials

High cholesterol Praluent™, Repatha™

Hemophilia Emicizumab

Alzheimers Aducanamab

Antidotes Praxbind™ AndexXa™

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Delivering innovation to patients

Fast, flexible, economical, global delivery

Maturing Mainstream (e.g. antibodies)

25 Bn USD worth of regular infrastructure projects in progress1

Many smaller scale facilities based on single use technology

Cutting Edge TherapiesNew molecules, complexity, personalization, cost

Rapid, low cost deployment around the world

COGS for bulk antibody $10’s/g

Complex workflows for cell and gene therapy with some new challenges

COGS for cell therapies $10000’s/patient

VaccinesFast, safe, cheap, robust, global

COGS largely $’s and cents

Diverse and aged processes complicate vaccine manufacturing. US consumer costs $10-200/dose2

2) CDC contract data1) Image courtesy of division of Industrial Biotechnology, KTH/Biotechnology

Smart Bioprocessing

The impact of data and analytics on process design, execution, efficiency and control

Supply chain depth

GE’s Uppsala manufacturing facility: $Billion infrastructure supplying 90% of FDA approved biopharmaceutical manufacturing processes

$ Billions spent to secure and expand the supply chain and develop new technologies to manufacture the drugs of today and tomorrow more efficiently

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www.gelifesciences.com

GE, GE monogram and imagination at work are trademarks of General Electric Company.

AndexXa is a trademark of Portola Pharmaceuticals Inc. Humira is a trademark of Abbvie Biotechnology Ltd. Keytruda is a trademark of Merck, Sharp and Dohme Corp. Prauluent is a trademark of Sanofi. Opdivo is a trademark of Bristol-Myers Squibb Company. Praxbind is a trademark of Boehringer Ingelheim International GmbH. Repatha is a trademark of Amgen Inc. All other third party trademarks are the property of their respective owner.

© 2017 General Electric Company.

All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information.

For local office contact information, visit www.gelifesciences.com/contact

GE Healthcare Bio-Sciences ABBjörkgatan 30751 84 UppsalaSweden

Thank you!

KA738201017PP

BIA update

Steve Bates OBEChief Executive OfficerBioIndustry Association

Post Industrial Strategy – growing UK Biotech

ChairSteve Bates OBE

Chief Executive OfficerBIA

John HodgsonExecutive Editor Pharma

Informa

Jo PisaniPartner

PwC Strategy&

Ian McCubbinIndependent Pharmaceutical

Professional Keirbridge

Dr Mike SullivanInterim Challenge DirectorMedicines Manufacturing

Innovate UK

Building something great: UK’s Global Bioscience Cluster report

John HodgsonExecutive Editor, Pharma Informa

Building something great – Venture Capital

“ …… it is still not clear that the UK venture capital supply for biotechnology is self-sustaining and dependable. The apparent generosity of 2016 has its roots in a few large and committed venture investors. Without them, any future picture might look quite different.”

UK Venture Capital £ million**

H1 2017 2016 2015Seed 30 14 11First round 51 208 538Second round 127 184 136Later round 153 275 110

Total 361.4 681 795

Building something great - Public markets

“… there have been some very encouraging performances for a number of biotech companies over the last 12 months, including Hutchinson China Medtech, Faron, Futura, Maxcyte and Summit, to name a few. Should this continue, an increase in capital is certain to follow into the sector.”- Freddy Crossley, Head of Healthcare, Panmure

Gordon

Brexit: Issues and opportunities and what to plan for

Jo PisaniPartnerPwC Strategy&

Industrial Strategy and Beyond

Navigating Uncertainty

November 2017

The contribution of the UK Life Sciences sector is significant

Sustaining and creating high quality jobsacross the UK

1) PwC Strategy& Report for the ABPI, March 2017 2) Growth for the period between 2011-15; 3) House of Commons Science and Technology Committee; 4) UK business expenditure on R&D 2014, by selected industries 5) ONS Balance

of Payments data, (2015), provided by Office for Life Sciences; 6) BMI Research

Investing more on R&D than any other UK sector4

482,000jobs supported1,two-thirds outsideLondon and theSouth East

4% Job growthp.a.2

GVA of £104k1 per employeeemployee, the highest of any high-tech sector

£30bn exports5

£3bn trade surplus

Turnover of over

£60bn3

Driving the UK economy

£2.3bn£2.4bn

£3.9bn

IT AutomotivePharma

25% of the world’s top 100 prescription medicines were discovered and developed in the UK6

£

PwC21

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Brexit presents a number of uncertainties for life sciences, particularly around regulations, funding and labour market

UK may have to import European Medicine Agency (EMA) regulations without having a say in them• Will the MHRA have sufficient capacity? Will this slow market access in the UK? Will we have continued access to EU-CE marking?

• Will duplication of effort (EMA and MHRA) make UK launch unattractive for some?

• Will the global reputation and status of the MHRA be impacted?

• Will patent disputes be more complex if the UK is denied access to Unified Patent Court?

• How quickly will the EMA and UPC move location?

LabourMarket

Regulatory

Funding UK may lose access to EU funding such as Horizon 2020 and have reduced access to the EIF and be less attractive for foreign investment• Existing versus new grants and impact on other sources of funding

• What level of impact would this have on life sciences SMEs?

• Would there be a knock-on impact on the UK’s research reputation and talent pool? Would this impact investment decisions taken by big pharma?

Pharma and life sciences employ ~220,000 people directly in UK, ~ 7% of whom are non-British EU citizens; mobility may be restricted, depending on exit scenario• Would restrictions on mobility affect the skill base and ability to attract top talent to UK?

• Would this ultimately impede the UK’s research participation and reputation?

Trade UK exports £30bn of pharmaceuticals with c.50% to the EU and enjoys duty free access to EU and under free trade agreements via the EU• Would exiting the EU lead to barriers to trade, increased duty, VAT, admin costs and border delays

• Would exiting the EU lead to a different set of GxP’s and requirements for QPs delaying import/exports

We have worked at pace and with wide consultation to rapidly develop a collective response for the UK Life Sciences sector

Process for developing the report

• Identify optimal positions

• Identify opportunities

• Provide negotiating options

• Provide a framework for ongoingindustry / government dialogue

Clear Objectives Engagement from Experts & Stakeholders

One voice of the Life Sciences sector, incl.

…over 150 experts, 50+ hours of workshops……a journey to develop our thinking…….and one voice for the Life Sciences sector

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The report was delivered to the

Steering Group on 1st

September, outlining the Life

Sciences sector’s view

Delivering benefit to the UK by maintaining a thriving Life Sciences Sector (1/2)

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Innovation Commercial & Trade1

What industry values

Long-term, predictable funding for scientific research, and continued ability to collaborate at scale

Accelerated access to innovative medical technologies in the NHS

Ability to trade and move goods and capital across borders

How to achieve this

A long term solution to ensure collaboration opportunities and funding provided, at scale. For example, Horizon 2020 ‘associate member’ status and EIB/EIF shareholding

Free trade with the EU on terms equivalent to those of a full member of the EU customs union and EU common system of VAT, including continued access to EU FTAs with third countries

Why the EU would support?

Access the UK’s world-leading Life Sciences academic institutions and the London financial markets

Unfettered access to each other’s markets, and avoidance of indirect tax costs, cash flow impacts and additional administrative burdens

2

Regulation People

Delivering benefit to the UK by maintaining a thriving Life Sciences Sector (2/2)

25

Regulation People

A common regulatory framework

with Europe

Access to the best talent

Commonality with EU regulatory

system and databases (eg

EUDAMED), alignment of current/

future regulations and participation in

European processes – could be

achieved through a regulatory

cooperation with the EU

Ability to secure the most talented people for UK science and industry –a system which facilitates ease of movement for top students, researchers and workers

The MHRA and VMD taking part in

EU procedures is essential to ensure

sufficient capacity and expertise in the

EU regulatory system

EU access to the UK’s academic institutions and advanced Life Sciences industry for education and development opportunities

What

industry

values

How to

achieve this

Why the EU

would

support?

3 4

A common regulatory framework with Europe

Access to the best talent

Commonality with EU regulatory system and databases (egEUDAMED), alignment of current/ future regulations and participation in European processes – could be achieved through a regulatory cooperation with the EU

The MHRA and VMD taking part in EU procedures is essential to ensure sufficient capacity and expertise in the EU regulatory system

What industry values

How to achieve this

Why the EU would support?

Innovation

Make the NHS an innovation engine

Deliver value-adding innovation through translational medicine

Foster entrepreneurial culture

Develop Digital, Data and Analytics

Improve collaborations within UK and with US & Commonwealth

Implement a pragmatic regulatory system with patient access and

innovation at its heart

Our work highlights opportunities to invigorate UK Life Sciences innovation as a key pillar

PwC

Fiscal & Trade

Incentivise innovation through direct tax measures

Implement direct investment when released from EU State Aid Laws

Improve speed of decision making, improve end market attractiveness and remove uncertainty

People

Targeting future UK talent development (e.g. device technologies, digital health, physiological modelling, genomics and ATMP manufacturing)

Tailor funding, curricula and apprenticeships/industrial placements accordingly

26

Thank you

Questions?

This publication has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this

publication without obtaining specific professional advice. No representation or warranty (express or implied) is given as to the accuracy or completeness of the information contained in this

publication, and, to the extent permitted by law, PricewaterhouseCoopers LLP, its members, employees and agents do not accept or assume any liability, responsibility or duty of care for any

consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this publication or for any decision based on it.

© 2017 PricewaterhouseCoopers LLP. All rights reserved. In this document, “PwC” refers to PricewaterhouseCoopers LLP which is a member firm of PricewaterhouseCoopers International

Limited, each member firm of which is a separate legal entity.

160209-184257-BK-UK

27

Advanced therapies - where we are and what we need to do to anchor commercial scale here

in the UK

Ian McCubbinIndependent Pharmaceutical Professional Keirbridge

Advanced Therapy Medicinal Products

“Made in the UK”

BioProcess UK Conference

November 2017 Ian McCubbin

Advanced Therapy Medicinal Products

“Made in the UK”

• Once in a lifetime opportunity• UK has an outstanding science

foundation in this platform• Execute the Life Science Industrial

Strategy

Advanced Therapy Medicinal Products

“Made in the UK”

Advanced Therapy Medicinal Products

“Made in the UK”Action Plan Progress Report• Fiscal: Good, help needed to encourage capital

investment• ‘Account Management’: Progress with resource,

work to be done• Science & Innovation funding: very good within

current framework, capital grants and loans?• Talent Management: good platform building –

utilise Apprentice levy• Route to market: Kymriah and Strimvelis but

remains a thorny issue, AAR encouraging news.• Regulatory Strategy: good progress….. Brexit?

Advanced Therapy Medicinal Products

“Made in the UK”

What Next:

• Workstream in MMIP• Influence / Align with sector deal• Complete the action plan

Thank you

The Industrial Strategy Challenge Fund –new opportunities for growth

Dr Mike Sullivan

Interim Challenge DirectorMedicines Manufacturing, Innovate UK

Post Industrial Strategy – growing UK Biotech

ChairSteve Bates OBE

Chief Executive OfficerBIA

John HodgsonExecutive Editor Pharma

Informa

Jo PisaniPartner

PwC Strategy&

Ian McCubbinIndependent Pharmaceutical

Professional Keirbridge

Dr Mike SullivanInterim Challenge DirectorMedicines Manufacturing

Innovate UK