Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning
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Transcript of Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning
Emerging TechnologiesHorizon Scanning
Medicines
Prof. Angela TimoneyChair
Scottish Medicines Consortium
Process
Annual 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
ProcessNHS Scotland
Pharmaceutical Industry
Standard Sources
Clinical experts
Forward Look report
Sponsor pharmaceutical
company
Product monographs (estimated uptake
& net budget impact at years 1 & 5)
Intelligence gathering
Filtration and selection of medicines within relevant time horizon (next financial year)
Key NHS personnel
Filtration and selection of high impact medicines (financial
and service)
Cancer Steering Group
Stages in the Discovery and Development of a New Medicine.
0 1 2 3 4 5 6 7 8 9 10 11
Discovery Research
Development Research
Regulatory Review
Post-Marketing
Development Phase I
Phase II
Synthesis biological testing & pharmacological screening 50-100
Volunteers 200-400 Patients
Phase -------------III -------------------
3000 + Patients
----------------------
Phase IV
5000+ 8 - 15 4 - 8 2 - 3 1 1 0 £350 m
Clinical Phases
Long-term animal testing
Safety and pharmacokinetic studies
Chemical development
Pharmaceutical development
Final patent application
Investigational new drug application or Clinical Trial application.
Marketing application.
Marketing approval product launch. REGULATIONS
TIME (Years)
PHASES OF DRUG
DEVELOPMENT
ATTRITION RATES
COST
BASI C
RESEARCH
PWC pharma 2020 July 2011
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
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.
More Pharmaceutical industry challenges
• Patent cliff ($140 billion)• Problems with the pipeline
– Paradigm shift?– The biology of disease
• Financial constraints in Europe and US
So is there any good news?• Biologics
– Cancer– Rheumatoid Arthritis– Crohn’s disease– Psoriasis
• On the horizon -Polyclonal antibodies, oral tx, • Personalised medicine
Personalised medicines at SMC• 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)
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)
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
3 nominations for 2020
• Personalised medicine• Oral biologic therapy (tofacitinib)• Real world outcomes data