More information available via:
prof. dr. Isabelle Huys, tel.: +32 16 33 04 09 (email@example.com)
Your solicitation is expected before June 21th 2019. Decision is expected to be taken end of June/first week July 2019.
If later, contact prof. Isabelle Huys.
You can apply for this job no later than July 05, 2019 via the online application tool
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The unit Clinical Pharmacology and Pharmacotherapy of KU Leuven has established a multidisciplinary research programme exploring the market environment of biological medicines in Europe. We are now looking for a PhD researcher to carry out a project on a policy for best-value biological medicines in Belgium.
Biological medicines represent a growing share of all medicines worldwide. These so called biologicals are complex molecules produced out of cultures of living cells. Biologicals are becoming increasingly important in the treatment of diverse complex, life-threatening disorders and chronic illnesses. However, due to the complex and costly manufacturing process, biologicals are in general very expensive. The success of biological therapies has therefore put significant pressure on healthcare budgets. Following the expiry of exclusivity on originator biologicals, the market has opened up for follow-on versions with the same efficacy and safety. These similar biologicals are called biosimilars. The uptake of biosimilars is essential to introduce price competition in the high cost biotech market.
The European Medicines Agency (EMA) has established a tailored regulatory framework for the registration of biosimilars since 2005. Currently, there are 53 biosimilars approved by the EMA, including growth factors (Epoetins, Filgrastim), hormones (Folliptropin-𝛼, Insulin glargine, Somatropin, Teriparatide), monoclonal antibodies and fusion proteins (Adalimumab, Infliximab, Rituximab, Etanercept) and low-molecular weight heparins (Enoxaparin sodium).
Despite our government taking actions encouraging use of biosimilars, market access and competition/uptake at the Belgium level is currently rather limited. The problem seems to be multi-facetted: lack of knowledge about biologicals and biosimilars in particular, unclarities about health care practitioners’ prescribing drivers and legal uncertainties related to IP strategies integrated in companies’ business models. Competition in the market requires a policy that addresses all aspects and all players in the market.
This PhD program will contribute to the development of a sustainable, balanced and transparent policy framework suitable for best-value biologicals in Belgium, by studying which aspects are in particular relevant for a competitive market in Belgium. Several studies will be conducted that address the following research questions:
The PhD project will be carried out from a multidisciplinary perspective, requiring collaboration with diverse health care providers, regulators, health care payers, pharmaceutical industry, and patient organisations. The research will include quantitative studies (literature reviews, surveys, analysis of data) as well as qualitative studies (semi-structured interviews, expert panels, focus group discussion).
Master in pharmaceutical care, master in drug development, master in biomedical sciences, master in medicine, master in bioengineering, master in economy with outspoken interest in policy making and market access of biological drugs. Candidates with a Master’s degree in another field may apply if they can demonstrate their expertise and interest in biological drugs.
You will engage yourself with enthusiasm and perseverance to a four-year research project. You are ambitious, dynamic, flexible and take an open attitude towards problems and evolutions. You are directed towards innovation, including communication in an e-environment (website-skills). You are able to work independently and take decisions. You have excellent social and communication skills to deal with all stakeholders in this field. You are able to work in an international multidisciplinary team and cooperate with other team members. You can speak fluently Dutch and French and have good written and oral knowledge of English. You have good didactic skills and you can coach and motivate other persons.
A full time position within an internationally leading multidisciplinary team with relevant experience and expertise. For this job, a contract of 1 year is offered that, after a positive evaluation, can be extended yearly to a period of 4 years.