Leuven.Inc seminar 'The evolutionary path for clinical studies'

This seminar is an organization of Leuven.Inc in cooperation with Leuven-MTC and PharmaXL.

Developing a new drug and getting it to market may cost up to 1.3 billion USD. Only one in 5,000 experimental molecules passes al tests and clinical studies and is eventually approved by the regulators such as the FDA and EMA.

Clinical studies are strictly regulated (GCP, Helsinki treaty, …,). The way they are executed, however, is still fairly traditional. The patients are asked to come to the hospital regularly, the logistic challenges are large (drugs, coding of samples, monitoring conditions), and the analysis of the samples may take long. In addition, the whole process is labor intensive (study nurses, doctors, input of data, checking of documents) making it very expensive. Additional challenges are recruiting the patients and monitoring if they take the drugs as prescribed.

Today, however, there are solutions ready or under development that will lead to major changes in the way clinical studies are done; more general even in the way the whole medical sector operates. As part of that, computers and electronics will play an ever-larger role.

In future, patients for clinical studies could e.g. be recruited through the social media. The examinations could be done with intelligent pills and sensors, allowing telemonitoring with smartphones, but also online diagnosis of biomarkers so that the treatment may be adapted at any time. The analysis of samples could be done with labs-on-chip. And the side effects of drugs could be registered in real-time.

The aim of this session is to give an overview of the new techniques that already exist or are under development for healthcare, together with the consequences for the legal framework. All this will be applied specifically to clinical studies.

Practical aspects

Date: Tuesday 13 May 2014
Location:  Thermotechnisch Instituut, Kasteelpark Arenberg 41, 3001 Heverlee 

Programme

13h30:	Registration and coffee
14h00:	Welcome by Nicole De Smyter, Leuven.Inc Sven Deferme, Pharma XL and Chairman of the programme
14h15:	Moving the treatment from the hospital to the home – vision and strategy of UZ Leuven Wim Tambeur, Operational Director UZ Leuven
14h45:	Opportunities and applications of telemedicine Peter Van Vooren, Sales Director Health Fifthplay
15h15:	Innovative diagnostics allow for a faster clinical diagnosis Geert Maertens, CSO Biocartis
15h45:	Coffee break
16h15:	e-Health: electronic data management and data exchange in the Belgian public health care Frank Robben, General Manager Crossroads Bank for Social Security
16h45:	The future of clinical studies Michèle Garot, Chairman BECRO (Belgian Association of Clinical Research Organizations)
17h15:	Q & A
17h40:	Drinks and networking

 The interventions will be held in English.

Participation fee

60 euro (excl. VAT): researchers affiliated and billable to academic institutes 100 euro (excl. VAT): members of Leuven.Inc 150 euro (excl. VAT): all others
	Participation in our activities at -50% discount via KMO-portefeuille Pijler OPLEIDING: Leuven.Inc Approval number DV.O106761 More info: www.kmo-portefeuille.be KMO portefeuille request: for this seminar you indicate 4 training hours.

Registration

Registrations before Wednesday 7 May 2014, preferably via the online registration form (use the 'Register' button) or by email to admin@leuveninc.com (including all contact and invoice details).

After registration you will receive a confirmation and route description. The registration fee is payable after receipt of invoice. Cancellation after subscription is not possible. However, replacement by a colleague is allowed.*

* As an Associate Company Member you can be replaced by a colleague. As an individual Member you can only be replaced by another Individual Member. When this is not possible, Leuven.Inc will charge an extra fee for the replacement by a non-member.