The scientific program will consist of both oral and poster presentations. Each session, developed by the chairperson from contributions from the participants, will reflect key issues of current importance to the industry. A central feature of these meetings is the ample opportunity to engage in informal discussions and networking during breaks and the poster session.
Session 1 Manufacturing Perspectives
Chair: Geoffrey Pot, Shire, Belgium
Papers presented during this session could cover many operational aspects of manufacturing plasma products including purification, filling and finishing as well as the engineering of new facilities or upgrades and expansion of existing ones. Additionally, process improvements that have been implemented such as cycle time, process efficiencies and protein recovery will definitely be considered for inclusion in the program.
Session 2 Quality and Regulatory Trends
Chair: Albert Farrugia, Kedrion Biopharma, Italy
The session will encourage coverage of topical regulatory and quality developments in different dominions and the evaluation of new requirements. At previous conferences there was considerable focus on defining the thromboembolic potential of immunoglobulin preparations but as control of this issue is better established, topics will likely shift to more general proactive measures for establishing safer process changes. It is expected that there will be discussion on the management of process change with respect to quality systems and the ongoing adaption of the QbD concept to the Plasma Protein Industry and the appropriate statistical tools. The development of new analytical tools will continue to be highlighted as this is pivotal to characterization ensuring product comparability, efficacy and safety with ongoing process development and future changes.
Session 3 Pathogen Safety
Chair: Albrecht Gröner, Pathoguard Consulting, Germany
The risk of newly emerging pathogens regarding potential virus transmission by licensed products has to be addressed. Whether the existing measures for assessing epidemiology of blood transmissible viruses, potential virus load in a donation and current virus reduction capacity are sufficient to maintain the current high safety record of plasma derived products are important questions. The Session “Pathogen Safety” will cover these topics: regulatory requirements, strategic considerations to assure the virus safety of products, emerging viruses, detection methods, investigations of virus removal / inactivation techniques especially in clarifying robustness and critical process parameters.
Session 4 Applications of Plasma Products and Clinical Developments
Chair: Meche Faro, Instituto Grifols S.A., Spain
Presentations in this session will discuss the latest results from studies of potential new plasma protein therapeutics and new applications for existing products. It is expected that in addition to efficacy data from clinical trials, presentations will include studies on preclinical evaluations, new formulation development, new options for administration and improvements in product characteristics.
Session 5 Markets, Policies and Strategy
Chair: John Curling, John Curling Consulting AB, Sweden
The plasma fractionation industry continues to undergo significant change with developing markets, new products for unmet needs, expanding indications and the influence of recombinant and molecularly engineered products. As treatment opportunities and patient groups develop, new policies and strategies are required to meet the changing environment. Major fractionators have invested heavily in capacity build-out at the same time many countries continue to investigate self-sufficiency alternatives - an ever changing supply chain. This session will examine established as well as less understood markets, the competitive landscape, the effects of globalisation and trade barriers as well as policies directed to serving “rare disease” communities.
Session 6 New Products & Innovations in Plasma Processing
Chair: Sami Chtourou, LFB Biotechnologies, France
This session will provide an overview of innovation in the plasma fractionation sector with respect to new product development, new therapeutic applications of existing products and developments in analytic and manufacturing options.