Opportunities for Personalised MedicineElse Smith, MD, Ph.d,

Director GeneralDanish Health and Medicines Authority

EU initiatives – patient perspective

• Personalised medicines form part of the EU Commission's Horizon 2020.

• The public-private partnership Innovative Medicines Initiative (IMI) give money to the project Direct (Diabetes research on patient stratification) . The project will develop and validate tests to predict who will develop diabetes, whose condition will deteriorate rapidly after diagnosis, and who will respond well or badly to certain drugs. The tests will then allow the project to determine which existing drugs are effective for different varieties of type 2 diabetes.

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Licensing of medicines Human and veterinary

medicines must be authorised by the DHMA or the European Commission

When a company has gathered the required documentation, it applies for authorisation to the DHMA or EMA (the European Medicines Agency)

Authorisation takes place in close cooperation between the European drug regulatory authorities in which DHMA plays an active role

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Opportunities for Personalised Medicines

• More efficient and safer medicines are desired and preferably at a lower cost. This means more for the same amount of money or more expedient use of the allocated funds.• Moving away from ”one-size fits all” and towards ”personalised medicines”• Denmark has a strong, globally-oriented medical devices and pharmaceutical industry developing diagnostics, medico-technical devices and medicines.

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Why personalised medicine?Where does it take us?

• Way to improve the existing medicinal products/techniques or to develop new products.• The DHMA (and the EU Commission) is of the opinion that personalised medicines can and must be regulated by the applicable legislation on medicinal products and advanced therapy, including the future directive on clinical trials. Thus, special legislation will not be passed for this area.• Specific diagnostic kits are to a large extent a prerequisite for personalised medicines

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It is realistic to focus on e.g.:1. The tools that can optimize the use of cancer

medicines because of the advanced technology in this area (kits etc.).

2. Improvement of the use of narrow therapeutic index medicines

3. The definition of algorithms for the best choice of therapy based on mathematical models

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Questions of relevance for Denmark

• Will it be too expensive?• Are the target groups big enough?• How do we organize regarding: health

research, the environment for clinical trials and having an efficient system of authorities

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Data-acces is a prerequisite• To be able to attract clinical trials of personalised medicine to Denmark,

we must be at the forefront of research, development and implementation of biomarkers in clinical practice.

• A first in human trial is conducted at Herlev Hospital with a GMO for the

treatment of prostate cancer – Denmark was reportedly chosen because Herlev Hospital can carry out special analyses, that are the endpoint of the study.

• Access to registers and data is a prerequisite

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Thank you for your attention!Copenhagen 2013

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