PHD POLICY FOR BEST-VALUE BIOLOGICAL MEDICINES IN BELGIUM

03 June 2019

Get in touch!

Interested?

More information available via:
prof. dr. Isabelle Huys, tel.: +32 16 33 04 09 (isabelle.huys@kuleuven.be) 

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

KU Leuven seeks to foster an environment where all talents can flourish, regardless of gender, age, cultural background, nationality or impairments. If you have any questions relating to accessibility or support, please contact us at diversiteit.HR@kuleuven.be.

Apply before 05 July 2019

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.

Website unit

Project

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:

  1. Which communication and education strategies towards target audiences may foster a balanced and transparent market environment for best-value biologicals in Belgium and Europe? 
  2. Which factors influence the prescribing behaviour of Belgian physicians in the context of biologicals? 
  3. Which business models including intellectual property strategies influence availability of best-value biologicals on the Belgian market and how to address these? 
  4. Which time and cost resources are required to implement a best-value biological policy in the Belgian market?
  5. Which incentives (like gainsharing, quota’s) foster a sustainable, balanced and transparent environment for best-value biologicals in Belgium 
  6. How can the Belgian legal and policy framework be optimized to support a sustainable, balanced and transparent environment for best-value biologicals in Belgium 

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).

Profile

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. 

Description of function

  • You perform research in the described research domain. You are involved in the design, set-up and execution of the research, and you report on the results in scientific publications. This research has the intention to lead to a PhD degree.
  • You work alongside other PhD researcher(s) within the research programme exploring conditions for a sustainable, balanced and transparent environment for best-value biologicals in Belgium and the wider context of Europe.
  • You follow the ‘patient related and public health research’ programme of the Doctoral School of Biomedical Sciences. 
  • You coach master students carrying out their master thesis. 
Offer

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.