The BDA (Biotherapy Development Association) was founded in 2001 as a not-for-profit group registered under German Law. The BDA work only in the cancer area and have since 2003/4 run multi-disciplinary meetings to provide opportunities to allow scientific and clinical issues to be reviewed, discussed and potential solutions developed in cancer research and development.

In 2007 we ran our first multi-national workshop on HTA and the work being done in many European countries to try to contain the ever costlier nature of cancer care. The report from this meeting was published in October 2008 in The European Journal of Cancer under the title; Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective. The first named author is C. McCabe

The Biotherapy Development Association are proud to have been invited by BfArM (Bundesinstitut für Arzneimittel und Sicherheit) to organise this important one day meeting on the challenges and opportunities in regulatory and reimbursement developments, for research and practice in European Oncology. 

The objective is to provide a forum where all stakeholders concerned with oncology developments can meet to review the current situation and discuss in a transparent manner, some potential solutions to the current issues. 

The programme has been constructed by a multi-disciplinary group comprising senior regulators from EMA, academic oncologists, HTA specialists, as well as specialists from the pharmaceutical industry and patient advocacy groups.

There is increasing consensus that current regulatory and reimbursement processes are ill-aligned and that substantial reforms may be required to ensure the efficient delivery of high value therapies to patients across Europe. 

The BDA, as a not-for-profit group committed to R&D of new bioactive products for application in oncology are pleased to alert you to this opportunity to contribute to this vital and fast moving discussion. We hope you and your colleagues will be interested in joining us.

The meeting will consist of four sessions:

Session One: What are the current systems and what are the problems?

Session Two: European co-ordination: contributions, benefits, and risks -Part 1.

Session Three:  European co-ordination: contributions, benefits and risks- Part 2.

Session Four:  Points of consensus and opportunities for change.

During session One we will hear presentations delivered by  a senior EMA regulator from a senior pharmaceutical Industry executive and a senior executive from GBA who will present the German perspective on potential additional benefits which emerge from reimbursement decisions made in that country.

During Sessions two and three we will examine the challenges and opportunities presented by the coordination of Regulatory and HTA management processes across Europe.

We will have presentations from oncology academia, EMA regulators and Industry specialists in Regulatory Affairs and Pricing, Reimbursement and Patient Access programmes.

Finally as we are very pleased to be joined by two highly knowledgeable and experienced Patient Rapporteurs who will provide feedback to the plenum on how they think the patient community across Europe will react to the proposed changes and how they feel the messages will impact patient care in future.

The programme is designed to provide combine rich expert presentations, with structured question and answer sessions and facilitated discussion.

A detailed programme will be available shortly on the BDA website at www.bdaoncology.org. Further information is available from Mike Ellis, the BDA General Secretary who can be contacted on Mike@Charters.eu.com or by telephone on +44 1483 271314.

The meeting will be of interest to academic oncologists and HTA specialists, senior officials from national regulatory and reimbursement authorities, senior executives from the pharmaceutical and biotechnology industries focussed on regulatory affairs and market access.

The meeting will be conducted and the meeting report will be written in English. 

We hope this information will be of interest to you and we look forward to a successful and supportive event for all parties concerned.