The
European Association of Pharma Biotechnology held its 1st Symposium "PharmaBioTec"
in Triest
The European Association of Pharma Biotechnology (EAPB) held its first PharmaBioTec Symposium in the AERA Science Park in Triest from April 25 – 28, 2004. The location was chosen as the one of the Italian biotechnology areas as well as its proximity to the emerging biotechnology areas in Slovenia, Serbia and Croatia. The participants were a well mix of academia and scientists from 9 different countries throughout Europe. Hence the major objective of this conference was to combine scientific presentation and practical hands-on expertise to the attendees in four areas of the pharmaceutical biotechnology, Regulatory Affairs, Bioprocessing, Protein Formulation and Bioanalytics.
The PharmaBioTec Symposium was opened by the EAPB board member Dr. Fabio Carli (Remedia and Actimex), who was the initiator and main organizer of this symposium. Following the opening addresses by Dr. De Toni (VicePresident of the AREA Science Park) and Prof. Rigamonti (President of the AFI), the President of the EAPB, Dr. Sven Stegemann (Capsugel), provided an overview on the biopharmaceutical product development and its importance as a source of new product development. The biopharmaceutical industry will continue its dynamic growth to reach sales of USD 45–50 bio by 2006 with an average of 8 – 10 new product introductions each year. However, the major challenge for the biopharmaceutical industry will come from drug delivery of the compounds and the financing of the small biotech companies, which will lead to consolidation and creation of close partnerships with drug delivery companies.
The first series of presentations provided a deep inside into the European regulatory affairs system and the upcoming changes. The chairman of the Special Interest Group Regulatory Affairs of the EAPB, Dr. Axel Wenzel (PSST), explained in general the drug regulations in Europe including the EU legislation and the EMEA as the authority for biopharmaceutical drug approvals. These presentations were followed by practical advice on the new CTD format for new drug application, the variation and renewal procedure. As many biopharmaceutical companies develop new therapies in niche indications, a specific guidance was provided on the orphan drug option. The session was completed by Dr. Smilja Milosev, who took the participants through a drug registration procedure before specifically addressing the differences between chemical and biopharmaceutical drug product registrations.
The Bioprocessing section started with a presentation of Prof. Mauro Giacca (ICGEB) on the advancements in gene therapy and stem cell research within the ICGEB, a center of excellence that combines the research with developing countries. Prof. Mauro Salmona (Istituto Mario Negri) presented the latest research results in prion disease and its possible therapies resulting from biotechnology research. Prof. Amedeo Vetere from the University in Triest demonstrated the development of glycopolymers as anti-microbiological drugs based on the understanding on molecular mechanism of micro-organisms. Prof. Brushi (ICGEB) showed the way to use yeast cells as a source for high throughput screening of new compounds based on various homologies with the human gene. Dr. Sergio Tisminetzky from the ICGEB addresses the up-coming challenge of biogenerics development and technology transfer into manufacturing scale. The last presentation in this series was given by Dr.Immaculada Margarit from Chiron, taking the audience through a new vaccine development using genetics and recombinant DNA technology.
The 3rd topic addressed in this conference was dealing with the challenge of formulation development of biopharmaceuticals. Dr. Marco Gentile (Dompé) explained the mechanisms for poor protein stability in aqueous solutions and the formulation approaches required for the development of an injectable dosage form and gave advice of possible stabilization techniques. Dr. Giuseppe Colombo (Pharmacia) led the audience through the formulation development of a parental peptide formulation and the steps required to come to a successful formulation. Dr. Marco Adami (Pharmacia) gave an overview on the traditional formulation development of biopharmaceuticals and some basic guidance for a formulation approach. The last series of presentation provided useful information on the analytical of biopharmaceuticals. Dr. Rosaria Mariani (Pharmacia) started with specific case studies on the analytical issues encountered during development and their solutions. Prof. Paolo Alessi (DICAMP) specified the applications of the different chromatographic methods to analyze biopharmaceutical products and the basic concepts behind. Prof. Ireneo Kikic (DICAMP) added to the previous presentation the possibility of combining supercritical fluids and chromatography for biopharmaceutical characterization during drug development and manufacturing. This series was completed by company presentations of their specific analytical tools for biopharmaceuticals.
Between the scientific presentations hands-on practice was given to the participants through visits to the Elettra Synchroton Light Laboratory and the International Center of Genetic Engineering and Biotechnology. Several poster sessions and social events created an excellent platform for scientific and personal exchange between the participants.
The 2nd PharmaBioTec Symposium will take place during the Science fair in Nice, June 13 – 14, 2005. Further information are available through the EAPB (www.eapb.org).
All presentations of the PharmaBioTec can be down loaded from the web.
http://www.congresses.net/EapbTs2004/Presentations.aspx
Sven Stegemann, Fabio Carli