The Biopharmaceutical Emerging Best Practices Association (BEBPA) hit the scene in September 2008 with its inaugural Bioassay Conference in Berlin, Germany. A not-for-profit association, BEBPA (www.bebpa.org) is managed by the biopharmaceutical scientific community for the benefit of the biopharmaceutical scientific community: companies, regulators, and clinicians. BEBPA provides an open international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The purpose of this open discussion is to promote development of innovative approaches and solutions, thus facilitating safer and faster biopharmaceutical product development. In support of this mission, BEBPA is committed to

• Providing a service to the biopharmaceutical scientific community through the organization and support of high-quality scientific conferences

• Presenting a forum for the synthesis and evaluation of new concepts as a means to clarify and crystallize new directions

• Organizing expert working groups to discuss innovative approaches to common technical problems

• Making available a mechanism for publishing white papers that identify problems and various approaches to solving them

• Maintaining an open process at all levels of the organization including establishing new conferences and reviewing and governing recurring conferences.

FINDING A FORUM

BEBPA was created after a number of scientists from various companies, institutes, and regulatory agencies realized that, despite the various existing venues for meetings and publications, there was no forum for new approaches and ideas about common problems to be openly proposed and discussed without concern that individuals’ comments would be taken as corporate policy. The founders held the belief that a new forum was needed: If problems could be discussed openly and solved by the industry as a whole, then the individual companies involved and the public would benefit immensely. Thus was BEBPA born.

Three of BEBPA’s major services to the biopharmaceutical community are

• at major conferences, identifying emerging issues that arise during product research, development, and manufacturing

• sponsoring smaller conferences to discuss those important issues

• fostering publication of nonconsensus white papers that clarify common problems and delineating various approaches to solving them.

The white papers are not intended to be guidance documents, but rather will present the scientific community with a range of potentially useful approaches to solve common problems. Because they are not consensus documents — and because no paper prescribes a single preferred approach — their publication can occur rapidly and thus be an ongoing part of overall scientific discussions. Rapid publication of potential problem-solving approaches for the biopharmaceutical scientific community will accelerate the rate at which a future consensus best practice can be established.

BEBPA aims to bring the latest and most relevant scientific information to promote discussion among scientists in the biopharmaceutical community. At its first conference (in September 2008), issues addressed included alternative bioassay systems for vaccines, troubleshooting bioassays, and the revision of USP GC <111>. BEBPA’s second annual Bioassay Conference is scheduled for 30 September to 2 October 2009 in Rome, Italy. Topics that have already been proposed include assay design issues, assay monitoring, validation according to USP <1033>, best practices for host-cell protein assays, case studies for developing antibody-dependent cellular cytotoxicity (ADCC) assays, polymerase chain reaction (PCR) assays, and other cell-based systems.

PARTICIPATION IS KEY

To provide the best possible service addressing topical issues and problems, BEBPA needs input from across the spectrum of the biopharmaceutical industry. To participate and assist in this endeavor, you can

• Submit a topic for presentation or discussion

• Volunteer to present a topical issue or interesting case study

• Recommend someone to speak on a subject

• Be a sponsor

• Submit a poster presentation.

Further suggestions are always welcome. Because BEBPA’s aim is to provide a service to the biopharmaceutical industry, this provides an opportunity to consider proposals outside the remit of other meetings.

Please contact us with suggestions and topics for discussion — or if you or your company would like to be involved with BEBPA and its efforts to solve scientific problems — by calling 1-916-729-0109, emailing , or going online to www.bebpa.org.