21st Century R&D Leadership: The Right Medicine?

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Julius Montgomery
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perspective from 20+ years in Pharma R&D Context: Who is this guy?

1 21st Century R&D Leadership: The Right Medicine? Joe de Sousa Science & Technology Lead, Pharmaceutical Development, AstraZeneca Cambridge July 2016 V4 01 Jul 16 21st Century R&D Leadership: The Right Medicine? a personal perspective from 20+ years in Pharma R&D Context: Who is this guy? AstraZeneca, AstraZeneca Cambridge Pharmaceutical R&D: What s all the fuss? Aspects of R&D Management Tools, toolkits and techniques University-industry interaction People, organisation and skills Summary & Asks of the Audience 2 1

2 Context and Reference Points Joe de Sousa ~25 years in Pharmaceutical R&D Line, Project, Scientific Leadership Roles Science & Technology Lead, Pharmaceutical Development: Organic Chemist trained at the other place 4 Photos & and 2

3 UK-Swedish multinational pharmaceutical company HQ in Cambridge, UK Consistently in the Top 10 Global Pharma Companies Turnover 2015 = $24.7Bn, $4.9Bn invested in R&D >61,000 Employees, 8,900 R&D Staff mainly in UK, Sweden, US and China Operate in >100 countries Medicines are used by millions of patients worldwide 5 AZ is one of a handful of pure-play pharmaceutical companies spanning the entire value chain of a medicine from discovery, early & late stage development to manufacturing, distribution, and global commercialisation of primary care and specialty care medicines that transform lives Pascal Soriot, CEO Respiratory Inflammation Autoimmunity AstraZeneca s AstraZeneca focus pushes is on the three boundaries main of disease science areas to deliver across life-changing key platforms medicines. Cardiovascular Metabolic Oncology Infection & Vaccines Neuroscience Main Disease Areas Opportunity-driven Biologics Small molecules Immuno-therapies Protein engineering Devices 6 Personalised healthcare and translational science capabilities 3

4 AstraZeneca in the UK ~2.5 million patients use AZ medicines 8% of total business R&D 2.6bn Gross Value Added or 0.15% of UK GDP 7,000 Staff 32,000 Jobs Supported 500m recent investments 1% total UK export of goods 101 clinical trials in 431 different centres AstraZeneca UK North West Cambridge Macclesfield (UK) Cambridge (UK) North West Cambridge Liverpool (UK) Alderley Park (UK) 8 4

AstraZeneca s New Research Centre at the

Progress - Occupation in 2017 AZ Presence in

Vibrant Biomedical Ecosystem AstraZeneca

Development began mid-60 s 1h 45min Manchester

5 AstraZeneca s New Research Centre at the Cambridge Biomedical Campus Construction in Progress - Occupation in 2017 AZ Presence in Cambridge area now ~1000 Staff Part of a Vibrant Biomedical Ecosystem AstraZeneca Macclesfield EustonSite 100 acres/40 hectares Development began mid-60 s 1h 45min Manchester 18 Miles Peak District National Park 2 Miles AstraZeneca Macclesfield Campus 5

from ABPI: Adapting the Innovation Landscape, UK Biopharma R&D

6 Pharmaceutical R&D so what s all the fuss about? Worldwide Pharmaceutical R&D expenditure Figure with permission from ABPI: Adapting the Innovation Landscape, UK Biopharma R&D Source Book, 2015 Source: EvaluatePharma, World Preview 2014, Outlook to

Leading industries for UK R&D expenditure (ONS survey 2013) Pharma Figure with permission from ABPI: Adapting the Innovation Landscape, UK Biopharma R&D Source Book, 2015 Source: UK Office for

7 Leading industries for UK R&D expenditure (ONS survey 2013) Pharma Figure with permission from ABPI: Adapting the Innovation Landscape, UK Biopharma R&D Source Book, 2015 Source: UK Office for National Statistics, BERD Survey 2013 Pharmaceutical R&D Process Key points: Average years to progress through R&D and launch a new product 1 Cost for each new product is well over 1 Billion. Some estimates $2.6 Billion 2 Great uncertainty and risk throughout: High Attrition Rates: less than 5% success from preclinical development through clinical trials to approval and launch 3 1 Research and Manufacturers of America (PhRMA). Biopharmaceutical Research & Development: the Process Behind New Medicines. 20 (Washington, DC,2015) 2 DiMasi et al, New England J of Med 372 (20): 1972, May Thomson Reuters CMR International Pharma R&D Factbook 2014 Figure courtesy of ABPI 7

8 21st Century R&D Leadership: The Right Medicine? a personal perspective from 20+ years in Pharma R&D Context: Who is this guy? AstraZeneca, AstraZeneca Cambridge Pharmaceutical R&D: What s all the fuss? Aspects of R&D Management Tools, toolkits and techniques University-industry interaction People, organisation and skills Summary & Asks of the Audience 15 Aspects of R&D Management - Pick n Mix Conference Topics: Tools, toolkits, techniques University-industry interaction Tools Toolkits Techniques People, organisation, skills 16 Photo 8

5R s Framework drives project quality in Research Right target Right tissue Right safety Right patients Strong link between target and disease Differentiated efficacy Good bioavailability and tissue

9 5R s Framework drives project quality in Research Right target Right tissue Right safety Right patients Strong link between target and disease Differentiated efficacy Good bioavailability and tissue exposure Good pharmacokinetics Clear safety margins Understanding of off target activity Identifying the patients that will benefit Can we develop a companion diagnostic Lessons learned from the fate of AstraZeneca's drug pipeline: a fivedimensional framework Cook et al Nature Reviews Drug Discovery 13, (2014) Improve Project Quality Right commercial Differentiated versus future standard of care Affordability and Health Economics Right culture Truth seeking versus milestone seeking behaviours Casting a wide net to catch new ideas Access More Ideas 9

10 Being clear about Science & Technology Priorities Clear Priorities Pharmaceutical Development S&T Strategy Strategic Priority Area [WHAT?] Partner [WHO?] Geography [WHERE?] Science & Technology Portfolio Visualisation <1 year Duration [HOW LONG?] Better Portfolio Mgt 1 to 3 years >3 years 10

(MCRL) Valuable tools for describing and

Management - Pick n Mix Conference Topics:

11 Frameworks to describe S&T Activities Pasteur s Quadrant: Technology Readiness Levels Using a Common Language Manufacturing Capability Readiness Levels (MCRL) Valuable tools for describing and evaluating activities Aspects of R&D Management - Pick n Mix Conference Topics: Tools, toolkits, techniques University-industry interaction People, organisation, skills A more strategic approach Photo 11

AstraZeneca has more than 200 active collaborations with academic institutions across the world Here s a few UK examples University of Strathclyde University of Aberdeen University of Stirling

University of Bradford University of Liverpool University of Sheffield University of Manchester University of Nottingham University of Loughborough University of Birmingham University of Warwick

12 AstraZeneca has more than 200 active collaborations with academic institutions across the world Here s a few UK examples University of Strathclyde University of Aberdeen University of Stirling University of Glasgow University of Dundee University of Edinburgh University of Newcastle University of York University of Belfast University of Durham University of Huddersfield University of Leeds University of Bradford University of Liverpool University of Sheffield University of Manchester University of Nottingham University of Loughborough University of Birmingham University of Warwick University of Leicester University of Lincoln University of East Anglia University of Swansea University of Cardiff University of Bristol University of Exeter University of Oxford University of Reading University of Southampton University of Surrey University of Sussex University of Cambridge Brunel University London Imperial College London University College London Kings College London Queen Mary University of London External Partnerships: Developing a more Strategic Approach Less of this Haphazard Led by Individual champions within our business Low priority More of this Set within a strategic framework Collaborative across different areas of our business High priority. Seen as essential for long term success Out of sight Visible portfolio of activities Modest 1:1 Partnerships Larger Industry/Academia Multi-Partner Consortia Poor knowledge capture Improved knowledge capture 12

What we look for with our strategic partnerships Expertise to help with key challenges and opportunities Complementary

quality of our work Attracting & accessing talent Guiding & shaping academic training Lowering & sharing risk.

org Key Challenge: How best to measure the success of our partnerships? Continuous Manufacturing >20 partners www.cmac.

com Examples of Pharmaceutical Development led Strategic Partnerships Pharmaceutical Science 9 Partners www.

13 What we look for with our strategic partnerships Expertise to help with key challenges and opportunities Complementary expertise to what we have in house Networking/Development/Inspiration for in house experts Enhanced reputation for the quality of our work Attracting & accessing talent Guiding & shaping academic training Lowering & sharing risk. Better leverage on investment De-risking investments Photos Key Challenge: How best to measure the success of our partnerships? Continuous Manufacturing >20 partners 21 st Century Pharma Supply >20 partners Examples of Pharmaceutical Development led Strategic Partnerships Pharmaceutical Science 9 Partners Analytical Science 15 Partners Advanced Drug Delivery Growing Fast Each has Big Pharma, Academic, Technology Business Members 13

14 Aspects of R&D Management - Pick n Mix Conference Topics: Tools, toolkits, techniques University-industry interaction People, organisation, skills Maximising Productivity Photo People, Organisation, Skills Competing Needs Being a Successful Ambidextrous Organisation Getting the best from our experts Culture, Connectivity and Direction MAXIMISING the PRODUCTIVITY of STAFF 14

15 An Ambidextrous Organisation? What does that mean for Pharma R&D? 1. Deliver today s R&D Drug Project Portfolio 2. Invest in Science & Technology to improve our R&D machine so we deliver the future R&D Drug Projects in a BETTER way Duncan, R. (1976). The ambidextrous organization: Designing dual structures for innovation. Killman, R. H., L. R. Pondy, and D. Sleven (eds.) The Management of Organization. New York: North Holland March, J. G. (1991). Exploration and exploitation in organizational learning. Organization Science, 2, Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success Both are about drug project delivery Both are central to Pharma R&D success Only difference is the timescale of the Return on Investment 15

16 Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success A continuum: Both are about drug project delivery Where is the right place to be? We need our best scientists to do both all of the time Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success More like a CRO or CMO if we operate at the left hand side 16

17 Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success More like a University or Start up if we operate at the right hand side Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success??? Where are you on the scale? Where would like to be? Where should you be? 17

18 Ambidextrous Organisation Drug Projects and Science & Technology? Today s Drug Project Delivery S&T and Future Drug Project Success Recognise this is a very real challenge in R&D management Keep the interface porous How do we decide where we should be and easily monitor where we are? People, Organisation, Skills Competing Needs Being a Successful Ambidextrous Organisation Getting the best from our experts Culture, Connectivity and Direction MAXIMISING the PRODUCTIVITY of STAFF 18

The culture we are nurturing: Championing

Curious First, Critical Later a few examples

Science Awards Connectivity: The need for

discipline/sub-discipline is required to

Discipline is Huge I Shaped Scientists and T

19 The culture we are nurturing: Championing Science Science at the Heart of What We Do Curious First, Critical Later a few examples >20 External External Papers Presentations/Posters Visible Strategy Publicity STARS 37 Science Days Top Trumps Science Awards Connectivity: The need for T-Shaped Scientists Every scientific discipline/sub-discipline is required to discover & develop the best new medicines Pharmaceutical Biology Medicine Science Chemistry Physics Engineering Maths Each Discipline is Huge I Shaped Scientists and T Shaped Scientists I T shaped scientists are essential and have: DEEP EXPERTISE IN ONE AREA COUPLED WITH BROAD AWARENESS T 19

Scientists Similar approach with key scientists Give them PURPOSE & DIRECTION and SPACE to be creative Create a climate that brings new interactions between disparate groups We are usually pleasantly

20 Is our Science Going in the Right Direction? Bees A swarm of bees: has PURPOSE & DIRECTION Every bee is not in perfect synch Individual bees do random, crazy, unexpected things No need to keep track of each of them all of the time Key Scientists Similar approach with key scientists Give them PURPOSE & DIRECTION and SPACE to be creative Create a climate that brings new interactions between disparate groups We are usually pleasantly surprised at where they end up 21st Century R&D Leadership: The Right Medicine? a personal perspective from 20+ years in Pharma R&D Context: Who is this guy? AstraZeneca, AstraZeneca Cambridge Pharmaceutical R&D: What s all the fuss? Aspects of R&D Management Tools, toolkits and techniques University-industry interaction People, organisation and skills Summary, Asks of the Audience & Acknowledgements 20

21 21st Century R&D Leadership: The Right Medicine? 41 a personal perspective from 20+ years in Pharma R&D Pharmaceutical R&D: AstraZeneca: Global, UK, Macclesfield, Cambridge Complex tasks, high cost, high attrition, long timelines, highly regulated Doors open to collaborate: academia, business, any one with a good idea Easy to be motivated to work in our industry R&D Management Endless creativity, ruthless execution Right skills, right interactions Curious first, critical later Subtle balance of hard analytics, simplistic models, engaging with staff Inherent contradictions of an ambidextrous organisation R&D: a critical resource to be managed for societal, environmental and economic benefit 21st Century R&D Leadership: The Right Medicine? Some asks of the audience: a personal perspective from 20+ years in Pharma R&D How to nurture and sustain a successful innovation machine: New ideas, staff turnover, open innovation, the right balance of expertise? How should R&D organisations differ across sectors with respect to: R&D attrition rates, numbers of products, numbers of customers, cycle times, level of competition? Internal governance and oversight of R&D activities: Striking the right balance cf cholesterol Low TRLs and failure. Do we really mean it? Strategic Industry-Academia Partnerships: How to measure the full benefit? Ambidextrous ambitions in Pharma R&D: How to succeed? What is the optimum level of interaction between our key scientists? T shaped scientists and I shaped scientists: What is the optimum mix of breadth vs depth? 21

22 Acknowledgements David Probert, University of Cambridge Andy Bolan, ABPI Louise Leong, AstraZeneca Brian Clark, AstraZeneca Too many colleagues to name over too many years to mention 22

Where the brightest scientific minds thrive. IMED Early Talent and Post Doc programmes

Where the brightest scientific minds thrive. IMED Early Talent and Post Doc programmes Scientific innovation is at the heart of everything we do. Scientific innovation is at the heart of our business and