Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning

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  • So what are the messages? Chronic diseases still a growing area Europe and US may be challenging grow other markets The standards for regulators may not be enough to guarantee use and even then the regulators are more cautious. Do I agree? Yes to chronic disease issues and more disease are not becoming chronic –like cancer Yes to outcomes- but that could be exciting Takes strength to deal with prevention when we are stuck with high burden and I don’t think we think strength At the moment when we look at european governments Definitely emerging markets may influence the areas for R+D and that’s a new paradigm for the west I don’t know if regulators are more cautious – they may be but they are also very concious of this
  • The patent cliff describes a time staring in 2009 peaking in 2011 and tailing off in 2013 when almost all leading blockbuster drugs will lose their patent. This will result in a massive decline in sales for global pharma companies. The cliff is estimated at $140 billion over a five year period $125 billion for the top ten products. In reality all medicines have lots of patents and companies have strategies to protect them, the result will Be more of a patent slope than patent cliff Pipeline in USA peaked in 1995 50 new drugs now about 25 a year. Recent UK government document estimates 20 new medicines/year
  • What are biologics. These are treatments designed to stimulate or restore the body’s Immune system ability to fight disease or infection – some of them will also protect the body from the side effects of other medicines This therapy involves the use of substances known as biologic response modifiers (BRMs). The body normally produces these in small amount to combat disease or infection now pharma can make thses in large amounts. Examples. Monoclonal antibodies, interleukins, interferons, colony stimulating factors You will know them as the anti –tnfs used in RA, Crohn’s and Psoriasis or Oncology medicines, G-csf, rituximab etc. These are biological products –proteins actually so as you will know proteins cannot be taken orally as they will be Destroyed in the aid of the stomach-so to date they have all been parenteral formulations ORAL and polyclonal antibodies
  • What are biologics. These are treatments designed to stimulate or restore the body’s Immune system ability to fight disease or infection – some of them will also protect the body from the side effects of other medicines This therapy involves the use of substances known as biologic response modifiers (BRMs). The body normally produces these in small amount to combat disease or infection now pharma can make thses in large amounts. Examples. Monoclonal antibodies, interleukins, interferons, colony stimulating factors You will know them as the anti –tnfs used in RA, Crohn’s and Psoriasis or Oncology medicines, G-csf, rituximab etc. These are biological products –proteins actually so as you will know proteins cannot be taken orally as they will be Destroyed in the aid of the stomach-so to date they have all been parenteral formulations ORAL and polyclonal antibodies
  • Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning

    1. 1. Emerging Technologies Horizon Scanning Medicines Prof. Angela Timoney Chair Scottish Medicines Consortium
    2. 2. ProcessAnnual Forward Look report involves:• Continuous tracking of new medicines• Systematic research and analysis of clinical and epidemiological data (including Scotland specific data)*• Expert advice from NHS Scotland clinicians• Intelligence from Pharmaceutical Industry** includes CIC data
    3. 3. Process NHS Scotland Intelligence gathering Pharmaceutical Industry Filtration and selection of medicines within relevant time Standard horizon (next financial year) Sources Cancer Steering Group Filtration and selection of high impact medicines (financial Clinical experts and service) Product monographs Sponsor (estimated uptake pharmaceutical & net budget impact at years 1 & 5) company Key NHS Forward Look report personnel
    4. 4. Stages in the Discovery and Development of a New Medicine. Marketing approvalREGULATIONS Final patent Investigational new drug application or Marketing product launch. application Clinical Trial application. application. ↓ ↓ ↓ ↓ B 0 1 2 3 4 5 6 7 8 9 10 11TIME (Years) A S I Post- C Discovery Research Development Research Regulatory Marketing PHASES OF Review Development DRUG R Phase Phase Phase PhaseDEVELOPMENT E Synthesis biological testing & ←I→ ← II → ←-------------III ------------------- ----------------------→ ← IV → S pharmacological screening 50-100 E Volunteers 200-400 Patients 3000 + Patients A R Clinical Phases C H Long-term animal testing Safety and pharmacokinetic studies Chemical development Pharmaceutical development ATTRITION RATES 5000+ 8 - 15 4-8 2-3 1 1 0 £350 m COST
    5. 5. 7 issues for 2020 from Pharma industry• Instances of chronic disease are increasing, placing even greater pressure on already stretched healthcare budgets• Healthcare policy-makers and payers are increasingly mandating what doctors can prescribe• A growing number of healthcare payers are measuring the pharmacoeconomic performance of different medicines. A widespread use of electronic medical records will give them the data they need to insist on outcomes-based pricing PWC pharma 2020 July 2011
    6. 6. Pharma 2020• Boundaries between different forms of healthcare are blurring, as clinical advances render previously fatal diseases chronic and the self-medication sector expands• Demand for medicines is growing more rapidly in the emerging economies than the industrialized economies• Governments are beginning to focus on prevention rather than treatment, although they have not yet invested very much in pre-emptive measures; and• Regulators are becoming more cautious about approving truly innovative medicines. PWC Pharma 2020
    7. 7. More Pharmaceuticalindustry challenges• Patent cliff ($140 billion)• Problems with the pipeline – Paradigm shift? – The biology of disease• Financial constraints in Europe and US
    8. 8. So is there any good news?• Biologics – Cancer – Rheumatoid Arthritis – Crohn’s disease – Psoriasis• On the horizon -Polyclonal antibodies, oral tx,• Personalised medicine
    9. 9. Personalised medicines atSMC• Imatinib ( CML, GIST) ( philadephia chromosome)• Trastuzumab (Breast Ca) ( Her2 +ve)• Irinotecan (Colon Ca) ( UGT1A1 gene)• Lapatinib ( Breast Ca) (Her2+ve)• Cetuximab ( Colon Ca) (KRAS mutations)• Panitumab (Colon Ca) (KRAS mutations)• Dasatinib (Ph+ ALL)• Busulfan (CML) ( Ph chromosome)• Erlotinib (Lung Ca) (EGFR expression)• Rituximab (various) ( CD20 variant predicts response)
    10. 10. So is there any good news?• Biologics – Cancer – Rheumatoid Arthritis – Crohn’s disease – Psoriasis• Personalised medicine• Vaccines – Cervical Ca• Outcomes data – linking Rx to outcomes• Medicines for children (licensed)
    11. 11. Hazards of predicting the future• “As we know, there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know –but there are also unknown unknowns. The ones we don’t know we don’t know”. Donald Rumsfeld US Secretary of Defence February 2002
    12. 12. 3 nominations for 2020• Personalised medicine• Oral biologic therapy (tofacitinib)• Real world outcomes data

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