1 / 29

Sweden for clinical research

Sweden for clinical research. Realizing the promise to understand, treat and prevent human diseases. Introduction. The Swedish life science sector. 830 companies and 41,700 employees (2007) - strengths in drug discovery and development, medical technology and biotech

chaim
Download Presentation

Sweden for clinical research

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Sweden for clinical research Realizing the promise to understand, treat and prevent human diseases

  2. Introduction

  3. The Swedish life science sector • 830 companies and 41,700 employees (2007) - strengths in drug discovery and development, medical technology and biotech • Home to two of Europe’s strongest clusters: - Stockholm Uppsala Bioregion - Medicon Valley (Malmö/Lund/Copenhagen) • Source for breakthrough medicines and medtech innovation • Swedish biotech firms and pharma companies have ~75 projects in phase I-III (2009).

  4. Healthcare quality in Europe and USResults index, 18 indicators The lower the index, the better the outcome Source: “The Swedish Healthcare System: How does it compare with other EU countries, the United States and Norway”, Swedish Association of Local Authorities and Regions, 2008.

  5. Medical Products Agency, a respected regulatory agency • One of the pharmaceutical industry’s most preferred European investigative authorities. • Recognized for its high level scientific advice • High competence, consistent quality, rapid handling • Aims for world-leading regulatory process in dialogue with industry • MPA staff widely represented in EMEA. Moreover, EMEA is led by a former MPA executive Christina Åkerman Director General Medical Products Agency Thomas Lönngren Executive Director European MedicinesAgency

  6. A large producer of high quality research publications World's largest per capita producers of medical publications Publications per year and million inhabitants Most highly cited countries in Clinical Medicine Field normalised citation rate Source: "Clinical Research in Finland and Sweden", Academy of Finland and Swedish Research Council, 2009

  7. Universal health care coverage • All citizens have right to good health care • Free for all • High-cost ceiling: • EUR 90/year for treatments • EUR 180/year for medication • Uniform treatment methods • Annual performance benchmarking of health care quality and efficiency

  8. Decentralised health care system, financing through regional/local taxation

  9. Sweden for clinical trials:Medicinal products

  10. All of the world’s best-selling medicines have been tested on Swedish patients Pharmaceuticals Biologics Enbrel (etanercept) Remicade (infliximab) Epogen/Procrit/Eprix/ESPO (epoetin alfa) Rituxan/Mab Thera (rituximab) Humira (adalimumab) Avastin (bevacizumab) Herceptin (trastuzumab) Aranesp/NESP (darbepoetin alfa) Neulasta (pegfilgrastim) Lantus (insulin glargine) • Lipitor (atorvastation) • Plavix (clopidogrel) • Nexium (esomeprazol) • Seretide/Advair (fluticasone+salmetrol) • Enbrel (etanercept) • Zyprexa (olanzapine) • Risperdal (reperidone) • Seroquel (quetiapin) • Singulair (montelukast) • Aranesp (darbepoetin alfa) Source: IMS Health, La Merie Business Intelligence, Trial Form Support. Based on sales in 2007.

  11. Over 40 drug developers perform R&D in Sweden • CSL Behring • Eisai • GE Healthcare • GlaxoSmithKline • H. Lundbeck • Ipsen • Janssen-Cilag • Leo Pharma • McNeil • MSD • MerckSerono • Mundipharma • Novartis • Novo Nordisk • Nycomed • Organon • Orion Pharma • OtsukaPharma Scandinavia • Pfizer • Quintiles • Roche • Sanofi Pasteur MSD • sanofi-aventis • Santen Pharma • SBL Vaccin • Schering-Plough • Servier • Solvay Pharma • Swedish Orphan International • Wyeth • Abbott • Actelion Pharmaceuticals • Alcon • Amgen • Astellas Pharma • AstraZeneca • Baxter Medical • Bayer • Biogen Idec • Biovitrum • Bristol-Myers Squibb • Celgene Source: LIF, the Swedish Association of the Pharmaceutical Industry, and SwedenBio, 2009

  12. This makes Sweden so special!

  13. Distinct advantages for phases I-II • Sweden is well suited for complex trials in phases I-II; e.g. novel technology, first-in-man, etc. • Offers high quality and safety, due to: • Strong research environment • World-renowned clinical investigators • Sophisticated Medical Products Agency • High quality health care system • Know-how and experience

  14. Distinct advantages for phase IV • 60 disease- and/or intervention-specific health care quality registers • Individual-based data on problems or diagnoses, treatment interventions and outcomes • Intelligence on drug effectiveness in everyday clinical practice • Models for drug assessment (examples) - Anti-rheumatic therapies, ARTIS - Cardiac intensive care, RIKS-HIA

  15. Strong Swedish research fields – Clinical Medicine and Biomedicine Source: "Clinical Research in Finland and Sweden", Academy of Finland and Swedish Research Council, 2009

  16. Strong Swedish research fields – Clinical Medicine and Biomedicine Source: "Clinical Research in Finland and Sweden", Academy of Finland and Swedish Research Council, 2009

  17. Efficient ethical review • Review undertaken within six separate regional ethical review boards, situated at the largest nodes for research • Rapid approval process – all six boards meet 30 days limit • In Sweden, regulatory and ethics approval are made in parallel. Approval can therefore normally be obtained within 30 days.

  18. Attractive insurance scheme • The Swedish Pharmaceutical Insurance Scheme (LFF) covers claims related to adverse effects from participation in clinical trials. • Participating companies with net sales in Sweden pay an annual service fee and premium directly related to the size of their operations. • For companies with small or no net sales the minimum fee for 2009 is SEK 55,640 (EUR 5,564). This fee covers 50 patients; the premium for each additional patient is SEK 214 (EUR 21). • A multi-centre study run from a company outside Sweden is automatically insured if a mother/sister company participates in LFF.

  19. Clinical trial stages Prior to regulatoryapproval FOLLOWING MARKET LAUNCH

  20. Sweden for clinical trials:Medical device

  21. Strong arena for medical device and medical technology Swedish breakthroughs – Medical technology • Large and diversifiedmedical technology industry • Companiesperformingclinicaltrials in Sweden, ex: • - AstraTech • - GE Healthcare • - Gambro • - Getinge • - Mölnlycke Health Care • - Nobel Biocare • - St Jude Medical Sephadex, gel filtration chromatography Artificial kidney IgE allergy diagnosis Respirator Implantable pacemaker Brånemark implant systems Gamma knife DNA sequencing technology Biosensors   Source: Invest in Sweden Agency

  22. Clinical investigations – Medical Device • The Medical Products Agency supervises clinical investigations of medical devices in Sweden.  • Product without CE-mark: investigation shall be notified to the Medical Products Agency. • Already CE-marked device: must be notified if to change/expand the intended purpose of the device. • Rules and regulations found on www.mpa.se

  23. This makes Sweden special!

  24. Product classification – medical device

  25. Conclusion

  26. Professor Michael E Porter: “With its strong tradition of quality registries, Sweden is poised to become the world's most advanced nation in measuring the actual outcomes of care across many diseases. This represents a major opportunity for Sweden to lead a global shift toward a new, value-based approach to health care delivery focused on improving patient health outcomes relative to cost.”

  27. Concluding remarks * Sweden brings together all relevant expertise and infrastructure for advanced clinical trials * Sweden offers a clinical research environment tailored for an era focused on delivering high quality healthcare at reasonable cost.

  28. Strong public support for clinical trials • Boost to medical research and innovation – 2008 Government bill largest additional investment ever in Swedish research • Legislation that makes clinical research mandatory • Several initiatives directly targeting clinical research • Agreement between industry and health care providers – common objectives for clinical trials established.

  29. Facts clinical trials in Sweden 2008 Industry investments pre-clinical research • SEK 2.5 billion (EUR 250 million) • Clinical research • SEK 5.3 billion (EUR 530 million), whereof • Internally: SEK 2.9 billion (EUR 290 million) • Externally: SEK 2.4 billion (EUR 240 million) Ongoing at year-end • Number of protocols: 539 • Number of centers: 2,452 • Number of patients: 29,522 Initiated 2008 • Number of protocols: 168 • Number of centers: 600 • Number of patients: 6,129 Source: LIF, the Swedish Association of the Pharmaceutical Industry, 2009

More Related