Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning

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Emerging Technologies Horizon Scanning Medicines Prof. Angela Timoney Chair Scottish Medicines Consortium

Transcript of Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning

Page 1: Parallel Session 3.1.3 Emerging Technologies - Horizon Scanning

Emerging TechnologiesHorizon Scanning

Medicines

Prof. Angela TimoneyChair

Scottish Medicines Consortium

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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

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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

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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

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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

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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.

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More Pharmaceutical industry challenges

• Patent cliff ($140 billion)• Problems with the pipeline

– Paradigm shift?– The biology of disease

• Financial constraints in Europe and US

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So is there any good news?• Biologics

– Cancer– Rheumatoid Arthritis– Crohn’s disease– Psoriasis

• On the horizon -Polyclonal antibodies, oral tx, • Personalised medicine

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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)

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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)

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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

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3 nominations for 2020

• Personalised medicine• Oral biologic therapy (tofacitinib)• Real world outcomes data