1 / 9

Opportunities for Personalised Medicine

Opportunities for Personalised Medicine. Else Smith, MD, Ph.d , Director General Danish Health and Medicines Authority. EU initiatives – patient perspective. Personalised medicines form part of the EU Commission's Horizon 2020.

kenna
Download Presentation

Opportunities for Personalised Medicine

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. Opportunities for Personalised Medicine Else Smith, MD, Ph.d, Director General Danish Health and Medicines Authority

  2. EU initiatives – patient perspective Personalisedmedicines 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. 2

  3. 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 3

  4. Opportunities for PersonalisedMedicines • 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. 4

  5. Whypersonalisedmedicine?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 5

  6. It is realistic to focus on e.g.: The tools that can optimize the use of cancer medicines because of the advanced technology in this area (kits etc.). Improvement of the use of narrow therapeutic index medicines The definition of algorithms for the best choice of therapy based on mathematical models 6

  7. 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 7

  8. Data-acces is a prerequisite To be able to attract clinical trials of personalisedmedicine 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 8

  9. Thank you for your attention! Copenhagen 2013 9

More Related