Download SMERUD Medical Research Group a full-service phase II-IV

Bedre innovasjon gjennom
europeisk forskningssamarbeid
– våre erfaringer
Forskningsrådet / NHO /
Norsk Industri / Innovasjon Norge
Frokostmøte 25.2.2015
Knut T. Smerud, CEO
SMERUD MEDICAL RESEARCH GROUP
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Agenda
• Innovasjon – definisjon
• SMERUD’s forretningsidè
• SMERUD’s innovasjonsmodell
• Resultater
• Erfaringer
• Fast Track to Innovation
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Innovasjon: definisjon
Iht OECD:
”En innovasjon er implementeringen av et nytt eller
et betydelig forbedret produkt (vare eller tjeneste),
eller en prosess, en ny salg og markedsføringsmåte,
eller en ny organisasjonsmetode; i
forretningspraksis, arbeidsplassorganisering eller
eksterne relasjoner.”
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Innovasjon: i praksis
• Merverdi skapt gjennom fornyelse og forbedringer
• Forutsetter kompetanse og innebærer endringer
• FoU som oftest integrert
• Innovasjonsgrad og økonomisk verdiskapning korrelert
• Mål: økt lønnsomhet og konkurranseevne
• Interne og eksterne impulser gir innovasjonsevne
• Utvikling og mobilisering av bedriftens egne ressurser
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SMERUD’s forretningsidè
• Bransje
• Kjernekompetanse
• Marked
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Drug development
Time Scale of the Research Process
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Utviklingskostnader for et legemiddel
Mill USD
1400
1200
1000
800
600
400
200
0
1975
1987
2001
2006
Kilde: J.A. DiMasi and H.G. Grabowski,
”The Cost of Biopharmaceutical R&D: Is Biotech Different?”,
Managerial and Decision Economics 28 (2007): 469 - 479
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Competencies needed to develop a drug
Regulatory
Affairs
Drug
manufacturing
Non-Clinical
Development
Legal & IP
Project Core Team
Clinical
development
Business &
Marketing
Health
Economics
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Statistics
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SMERUD’s core business 1993-2009
• Fee-for service Contract Research Organisation (CRO)
• Managing clinical trials
 Local/regional specialists for regulatory affairs
 Clinical monitoring
 Data management and Statistics
 Medical Writing
• Clients mainly non-Norwegian, global big pharma
• Outsourcing of specialised R&D personnel
• Consulting
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Markedssituasjon ca. 2010
• Internasjonal finanskrise
• Big pharma revurderte sin posisjon og investeringsvilje
i R&D, særlig i Norden
• Marked for kliniske utprøvninger i Norden
• -40% mht antall
• Endring i størrelse (verdi) av prosjektene; trolig -50-60%
• Prisfall
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Norway – by phase
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Status praesens 2010:
‘Samling i bånn’
• SMERUD-gruppen
• 93 ansatte, 85 årsverk
• Norge, Sverige, Danmark. Finland, UK, Polen
• Ordrereserve tilsvarende 30 årsverk
• Høy kompetanse og erfaring
• Sviktende marked
• Sterk likviditetsreserve
• Strategisk ledelsesbetraktninger
• Nedbemanne (halvere stab, akseptere tap), eller
• ‘Kjærringa mot strømmen’-strategi og investere?
• Eureka: ‘INNOVASJON ‘
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Revidert strategi:
SMERUD’s core business 2010• Invest into internal R&D
• Understand international R&D grant opportunities
• Seek leadership roles in consortia
• Exploit free capacity in such R&D projects
• Co-finance projects with cash-strapped partner
companies
• Offer risk-taking with companies that previously
were clients
• Provision of competent venture ‘capital’
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RESULTATER
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SMERUD R&D investment (2010-2013)
Individual projects (#)
R&D hours (#)
62
92,350
Full-time equivalents (man-years)
57.7
Fraction of total hours (%)
19.8
R&D expenses (mNOK)
60.0
(6.0 m₤)
(7.3 m€)
EU funds raised* (mNOK)
28.2
(2.8 m₤)
(3.4 m€)
*through 7 contracts with Eurostars, FP7, ETB, Euronanomed covering 2010-2016
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SMERUD R&D portfolio
Selected examples with public R&D co-funding
• Eurostars
 Alimenta / mucosal patch technique for diagnosing IBS
 AlgiPharma / oligoG for the treatment of cystic fibrosis
 Wnt Research / Foxy-5 for metastatic cancers
 Lytix / diabetic foot infections
• EuroTransBio
 Aromics: Serpins in the treatment of hepC/HIV
• Euronanomed II
 NANOASIT: Novel delivery method for allergy vaccination
• Framework Program 7
 Premacure/Shire: IGF-1 for prevention of retinopathy
 Athera: PC-mAB in preventing secondary CVD events
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SMERUD internationalisation / revenues
Stoppet l
nedgang i norsk
omsetning
Domestic vs international as % of total revenues (year 1993-2013)
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Outcome
• Gradually becoming a drug development company
• Controlling larger portion of value chain
• Raising internal competency
• Enabling world-class career development for talents
• Turned financial losses (2010-12) into profit (2013-14)
and with
• underlying project assets not yet activated as income
However, ‘cash is king’: we still deliver CRO services as
our bread & butter revenue generating business
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Concluding advice to Norwegian SMEs
• Always consider internationalisation as key strategy
 EU R&D consortia excellent tools
 Training ground as Partner, then Driver’s seat as
Coordinator
 Start with Eurostars, advance into H2020
• Be aware of and exploit national R&D support
• Norway
 Best in Europe support from National Contact Points
• Eurostars
• Horizon 2020, for Health and SMEs
• PES
 SkatteFUNN
• UK
 Best in Europe R&D tax refund
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Hva med ‘Fast Track to Innovation’?
• Ligner på Eurostars?
• Større budsjett pr prosjekt
• EU-finansiert ikke nasjonalt; mindre søketaktikk
• Lengre tid til grant
• Kun 12-24 måneder til implementering
 Demonstration
 Market-oriented R&D
• Max 36 måneder fra grant til markedsføring
 Men hva betyr ‘market-ready results’
 F.eks. selge produktet etter ‘fase 2’ til big pharma?
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Outcome 2: Ikke-kvantifiserbar verdiskapning....
Vårt eget ‘Theatre of Dreams’…
Champions League er Champions League!
Utsikt fra SMERUD’s Manchester-kontor
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Thank you
for your attention !
SMERUD MEDICAL RESEARCH GROUP
Web
www.smerud.com
E-mail
[email protected]
Phone
+47 2327 2000
Mobile
+47 9089 2577
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Back-up slides
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Internationalisation / SMERUD locations
• Smerud Medical Research International AS
• Established 1993, now 70 employees
• HQ in Norway, 100% owned subsidiaries in 10 countries
 Denmark, 1996
 Sweden, 1997
 Finland, 1997
 Poland, 2005
 United Kingdom, 2006
 Austria, 2011
 Germany, 2014
 Russia, 2008-2015
 Hungary, 2011-2015
 (United States, 2009)
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All phases – Nordic area
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SMERUD R&D portfolio
pending…still hoping
• Horizon 2020
• Submitted September 2014 / stage 1
 SMR-3056 (Norwegian biotech)
 SMR-3106 (Swedish academic group)
 SMR-3011 (Swedish biotech)
• Advanced to stage 2
 SMR-3056 (Norwegian biotech)
 SMR-3106 (Swedish academic group)
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SMERUD R&D portfolio
with local R&D co-funding
• UK
• R&D relief for corporation tax; the SME scheme
 Tax relief on allowable R&D costs = 225%
 Employee costs
 Materials
 Payments to clinical trial volunteers
 Subcontracted R&D: 65% claim back
 Upper limit €7.5 million per project
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Lessons learned
• Globalisation means threats and opportunities, but
we have no choice – there is no local environment
• Global players compete domestically
• Domestic players must adapt to international levels
in terms of quality, complexity, pace, pricing
• Has required and rewarded
• Innovative thinking
• Agility
• Flexibility
• International hiring (and firing)
• Transformation to international business proactivity,
competitiveness and ambitions
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Lessons learned
• Internal change management of
• Operations
• Technology
• Markets
• Business segments
• Investment
• Increased focus on export fosters international
thinking at management level
• Relocation
• Outsourcing
• International project partnering with clients
• Networking with other SMEs
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Concluding advice to politicians
• Norway could be a leader per capita in medical biotech
• Good market to establish a company
• Very good R&D support systems for SME companies
• Strengthen national budget for early-phase clinical
trials (up to and including phase 2)
• Eurostars national grants – remove upper limit per project
• PES
• Support biotech clusters, and there are other areas
than cancer
• Kidney transplantation
• Rheumatology
• Neurology
• Osteoporosis
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Summary
• Internationalisation
• A bit for fun, but mostly a strategic approach to
• Foster competence building
• Attract global talents
• Build corporate culture
• Raise R&D grants through collaborative consortia
• Expose your business to investors, stakeholders,
clients outside our domestic pond
• You’ll get to know a number of airports, but it’s
certainly worth it
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