List of candidates proposed for the election of the Executive Committee
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List of candidates proposed for the election of the Executive Committee of the 17th legislative period Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V. Gemeinnütziger wissenschaftlicher Verein International Association for Pharmaceutical Technology APV Kurfürstenstraße 59 55118 Mainz/Germany +49 6131 9769-0 +49 6131 9769-69 apv@apv-mainz.de www.apv-mainz.de Executive Committee of the APV (2018-2022) - preliminary list of candidates
List of candidates proposed for the election of the Executive Committee Persons Prof. Dr. Johannes Bartholomäus Prof. Dr. Sandra Klein TU Braunschweig and Institut für Pharmazie Pharmakreativ Pharmaceutical Development Biopharmazie und Pharmazeutische Technologie Consulting Ernst-Moritz-Arndt-Universität Greifswald Burghöhenweg 5 Felix-Hausdorff-Strasse 3 52080 Aachen 17489 Greifswald Germany Germany Dr. Kathrin Bartscher Dr. Hans Lindner NextPharma Bayer AG Im Wirrigen 25 Müllerstrasse 178 45731 Waltrop 13353 Berlin Germany Germany Dr. Karoline Bechtold-Peters Dr. Martin Lück Novartis Pharma AG Grünenthal GmbH 4002 Basel Zieglerstraße 6 Werk Klybeck 52078 Aachen Switzerland Germany Prof. Dr. Jörg Breitkreutz Dr. Alexandra Steckel Institute of Pharmaceutics and Alfred E. Tiefenbacher GmbH & Co. KG Biopharmaceutics Van-der-Smissen-Strasse 1 Heinrich-Heine-University Düsseldorf 22767 Hamburg Universitätstr. 1 Germany 40225 Düsseldorf Germany Dipl.Ing.(TU) Roland Szymoniak Sanofi-Aventis Deutschland GmbH Prof. Dr. Heribert Häusler Industriepark Höchst Vorm. Boehringer Ingelheim 65926 Frankfurt/Main Richard Sorge Straße 73a Germany 10249 Berlin Germany Prof. Dr. Stefan W. Hockertz tpi consult GmbH – toxicology-pharmacology- immunology Ölbergweg 58 79283 Bollschweil, Germany Executive Committee of the APV (2018-2022) - list of candidates
Prof. Dr. Johannes Dr. Kathrin Bartholomäus Bartscher born 1959 born 1978 in Lohne i.O. in Brilon Germany Germany Prof. Dr. Johannes (Hans) Bartholomäus studied Pharmacy Dr. Kathrin Bartscher studied Pharmacy at the Westphalian (1979-1983) at the TU Braunschweig, Germany, followed Wilhelms-University of Muenster (Germany). After finishing by the practical year in the Adler Apotheke, Borken, and her doctoral thesis at the Institute for Pharmaceutical Kettelhack Riker Pharma, Borken (1983-1984). He finished Technology and Biopharmaceutics in Muenster under his thesis at the Institute of Pharmaceutical Technology supervision of Prof. Dr. R. Gröning in 2006 she joined of TU Braunschweig under the supervision of Prof. Dr. NextPharma as formulation scientist. In 2013 she was C. Führer (1988). Hans started his industrial career at appointed as Head of Drug Product Development at Grünenthal GmbH as Head of the Solid Oral Dosage Forms the NextPharma site in Waltrop. 2016 she took over the Lab and from 1992 to 2008 he was heading Pharmaceutical global responsibility for the development activities at all Development of Grünenthal. In 2009 Hans started his own NextPharma sites and joined the NextPharma board in July Pharmaceutical Development Consultancy. Besides, he is 2017 as Chief Scientific Officer. an invited lecturer (since 2001) for Industrial Pharmacy and Honorary Professor (2009) at TU Braunschweig. Currently She was initiator of the first APV local group in Dortmund. he is teaching pharmaceutical quality system for Master of Since 2014 she is member of the APV board and treasurer Pharmaengineering. His special professional interests are of APV. Drug Delivery, Life Cycle Management, IP Management, Quality Systems, Drug Stability, Clinical Supplies and Objectives: Pharmaceutical Development Strategies including Quality • Increasing the APV membership value by by Design. ºº Increasing the opportunities for active contribution to APV activities especially for young colleagues Hans became member of APV during his Ph.D. studies ºº Growing APV as platform for scientific exchange mid of the 1980ies. He was a co-founding member of • Improving the visibility and perception of APV in the APV’s Drug Delivery Focus Group in 2003 and became market chairman of this group in 2014. He was member of the • Making the difference with our seminar & conference program committees of the 1st European Conference on program by strengthening the international and Pharmaceutics in Reims (2015) and the 11th World Meeting interdisciplinary focus on Pharmaceutics, Biopharmaceutics and Pharmaceutical • Re-activating, strengthening and growing the active Technology in Granada (2018). participation of APV members from pharmaceutical industry Objectives: • Assuring continuity of a stable financial situation as • Strengthen internationalization of APV and making basis for the realization of all our future objectives and APV visible as the European platform for Pharmaceutics, visions Biopharmaceutics and Pharmaceutical Technologists in Academia, Regulatory Bodies and Industry • Grow networking opportunities for members and participants and increase value of APV membership • Improve quality of APV processes and standards Prof. Dr. Johannes Bartholomäus TU Braunschweig and Pharmakreativ Pharmaceutical Dr. Kathrin Bartscher Development Consulting NextPharma Burghöhenweg 5 Im Wirrigen 25 52080 Aachen, Germany 45731 Waltrop, Germany Executive Committee of the APV (2018-2022) - list of candidates
Dr. Karoline Prof. Dr. Jörg Bechtold-Peters Breitkreutz born 1964 born 1966 in Munich in Marl Germany Germany Dr. Karoline Bechtold-Peters is pharmacist and received Prof. Dr. Jörg Breitkreutz studied Pharmacy (1987- her doctorate from the Ludwigs-Maximilians-University of 1991) at the Westphalian Wilhelms-University, Münster, Munich in Pharmaceutical Technology in 1994 for a thesis Germany. He finished his thesis in 1996 at the Institute in the field of enteric-coated pancreatin pellets. In 1994, for Pharmaceutical Technology and Biopharmaceutics in Karoline started at Boehringer Ingelheim in Ingelheim as Münster, under supervision of Prof. Dr. R. Gröning. From Head of Laboratory in Solid Dosage Forms, focusing on 1996 to 1997 he joined Thiemann Arzneimittel GmbH in powder inhalation therapeutics. In this context, Karoline was Waltrop, Germany, as the head of Product Coordination. In instrumental in the development of the blockbuster Spiriva. 1997 he went back to the university in Münster finishing his In 2000, she moved to the Business Unit Biopharmaceuticals habilitation thesis on paediatric drug formulations in 2004. of Boehringer Ingelheim and thus to Biberach to build-up Since 2004 he holds a professorship for pharmaceutical Formulation Development of Therapeutic Proteins. In 2003 technology at the Heinrich-Heine-University in Düsseldorf, she was appointed 2003 Head of Global Clinical Supplies, Germany. In 2009 he became an APV board member and Aseptic Process Development and Process Transfer. After in 2010 he was elected for president. several years in this position, Karoline moved to Basel, Switzerland, in 2011, to join Hoffmann La-Roche and was His research focuses on patient-centric drug development assigned Head of Drug Product Clinical Supply Center Basel (in particular for children), orphan drugs, process analytical within Global Biologics Europe and was responsible for the technologies and Green Pharmacy. Jörg Breitkreutz is production of biopharmaceutical clinical supplies both for member of various international societies and networks, Roche and Genentech. It became her core task to ramp Fellow and member of the the Association of American up the brand new clinical lines for sterile vials and syringes Pharmaceutical Scientists (AAPS). covering initial inspections and initial batch production from 2011 to 2013. The expansion of the production to Antibody- Objectives: Drug-Conjugates followed. In 2016, Karoline joined Novartis • Making APV the home society of all scientists engaged Pharma AG in Basel to focus on more strategic issues of Biopharmaceuticals as Senior Strategy and Technology Leader in pharmaceutical technology and industrial pharmacy Pharmaceutics within Biologics Technical Development & • Binding APV members a whole life long Manufacturing. Karoline is member of APV since 1994. • Linking academia and pharmaceutical industry Besides this she is active in several international organisations • Involvement in public funding programs such as AAPS, PDA and EBE/EFPIA and is frequently invited to • Strengthening the European leadership of APV contribute to conferences and papers or books. Objectives: • Ensure that APV is on top of the relevant industry topics • Strengthen Biopharmaceuticals within APV • Connect APV increasingly to international work streams, further drive the international orientation of APV and strengthen international collaborations • Increase the value of APV membership by addressing burning topics Prof. Dr. Jörg Breitkreutz Dr. Karoline Bechtold-Peters Institute of Pharmaceutics and Biopharmaceutics Novartis Pharma AG Heinrich-Heine-University Düsseldorf 4002 Basel Universitätstr. 1 Werk Klybeck, Switzerland 40225 Düsseldorf, Germany Executive Committee of the APV (2018-2022) - list of candidates
Prof. Dr. Heribert Prof. Dr. Stefan W. Häusler Hockertz born 1948 born 1960 in Saarbrücken in Hannover Germany Germany Prof. Dr. Heribert Häusler studied chemistry at Saarbrücken Professor Dr. rer. nat. Stefan W. Hockertz is an immunologist University and obtained his promotion at the Institute and toxicologist, now as CEO of the tpi consult GmbH, one for Analytical Chemistry and Radiochemistry. From1979 of the European leading toxicological and pharmacological to 2013 he worked for Boehringer Ingelheim. There he technology consulting companies. Previously, he served was Head of the Department Pharmaceutical Production as Director and Professor of the Institute of Experimental Non Solids until 2002 and was then responsible as Vice and Clinical Toxicology at the University Medical School President for Department Quality Operations at both sites Eppendorf in Hamburg from 2003 to end of 2004. Biberach and Ingelheim until 2012. Up to his retirement in Prior to joining the University, he served as Director of 2013 he acted as a VP in the Corporate Function Quality the Fraunhofer Institute of Toxicology and Environmental Systems Excellence. As a honorary professor he got a Medicine Hamburg from 1995 to 2002 and before as lectureship for Quality Assurance and Quality Strategy at an investigator at the Fraunhofer Institute of Toxicology Mainz University. Since 2017 he has been teaching quality and Aerosol Research in Hannover from 1986 to 2001. management at Beuth University of Applied Sciences. He received his first academic appointment to Hannover University in 1985. Prof. Dr. Häusler has also made his mark as an author of Prof. Hockertz is appointed as “Eurotox Registered scientific publications and EuAB comments. Prof. Dr. Toxicologist” and he has the admission as „Herstellungs- Häusler is a member of the APV since 1998. Since 2004 he and Kontrolleiter“ according to §15.1 and §15.3 of the is Vice President of the APV and responsible for German Drug Law since 1996. Hockertz holds a doctorate the focus groups Analytics/Quality Assurance and in biology from the University Hannover and he is a Information Technology. University Professor for Molecular Immunotoxicology of the University Hamburg Medical School. Objectives: Prof. Hockertz has wide experience as a former board • To increase cooperations between APV and industrial member of a german pharma association. As member associations of the APV he is working in the Task Force „Individual • To establish cooperations between pharmaceutical Medicines“ and he is a guest at the Focus Groups „Drug engineers and industrial pharmacists Regulatory Affairs“ and „Drug Delivery“. • To continue working in the Executive Committee and to contribute to the pofessionalization of APV Objectives: • To further develop the focus groups Analytic and • Strengthen the area of preclinical safety and toxicology Quality assurance as well as Information Technology in the APV. • Conditioning the APV for modern and innovative topics like precise medicine and individual medicines. • Improving toxicological knowledge of the APV members in drug development, manufacturing, pharmacovigilance and pharmaceutical technology. • Increase the number of members by increasing the APV membership value. Prof. Dr. Heribert Häusler Prof. Dr. Stefan W. Hockertz Vorm. Boehringer Ingelheim tpi consult GmbH – toxicology-pharmacology-immunology Richard Sorge Straße 73a Ölbergweg 58 10249 Berlin, Germany 79283 Bollschweil, Germany Executive Committee of the APV (2018-2022) - list of candidates
Prof. Dr. Sandra Dr. Hans Lindner Klein born 1963 born 1970 in Kiel in Büdingen Germany Germany Prof. Dr. Sandra Klein studied Pharmacy at the University of Hans Lindner is a pharmacist and holds a doctorate degree Frankfurt, Germany and graduated in 2000. At the same in pharmaceutical technology from Christian-Albrechts- university she started her graduate studies at the Institute University, Kiel. of Pharmaceutical Technology under the supervision of Jennifer Dressman. She got her PhD in 2005 and was then He started his industrial career at Arzneimittelwerk Dresden a postdoctoral fellow at Eastman Chemical Company in in 1994, where he led a scale up team in formulation Kingsport/TN, USA. From 2006 till 2010 Sandra Klein was a development. In 1996, he joined Ferring Pharmaceuticals senior research associate at the Institute of Pharmaceutical first in Germany, moving later to Denmark. At Ferring, he Technology at the University of Frankfurt. Since 2010 she served in various positions with increasing responsibilities is Professor of Pharmaceutical Technology at the University in formulation and pharmaceutical development, at the of Greifswald, Germany. end overseeing CMC development. Her current research is focusing on the development of bio-predictive dissolution methods for special patient He joined Schwarz Pharma in 2004, leading pharmaceutical groups, particularly the pediatric and geriatric population development. After integration into UCB in 2007, he and of patient-centric formulations. Other research managed the late stage product development function. interests include the design of predictive and accelerated In 2008, he joined Bayer, heading pharmaceutical test methods for vaginal delivery systems and depot development. In 2012 took responsibility for a newly parenterals and the enhancement of the bioavailability of formed unit overseeing all external activities in poorly soluble drug compunds with different polymer- and pharmaceutical development. Since 2014, he is heading cyclodextrin-based approaches. alliance management for research. He leads a global team, Sandra Klein is an APV member since 2000 and member developing and running innovative collaboration models of the American Association of Pharmaceutical Scientists with numerous research partners. (AAPS), the Controlled Release Society (CRS) and a core member of the European Paediatric Formulation Initiative During his career, Hans has been working with a wide (EuPFI) amongst others. variety of dosage forms, technologies and delivery systems. He has experience in managing functions, technology Objectives: and knowledge transfers, as well as internal and external • Linking APV to the global pharmaceutical network, interfaces in different organizations. i.e. strengthening the collaboration of APV with other international societies, universities and industry Objectives: • Further increasing the visibility of APV • Continue internationalization of APV • Improving collaboration of academia and industry • Support and promote collaboration and network • Binding young pharmacists to APV giving them the within APV chance to actively participating in activities of the APV • Further Develop and promote APV as valuable network organization for its members Prof. Dr. Sandra Klein Institut für Pharmazie Biopharmazie und Pharmazeutische Technologie Dr. Hans Lindner Ernst-Moritz-Arndt-Universität Greifswald Bayer AG Felix-Hausdorff-Strasse 3 Müllerstrasse 178 17489 Greifswald, Germany 13353 Berlin, Germany Executive Committee of the APV (2018-2022) - list of candidates
Dr. Martin Lück Dr. Alexandra born 1968 Steckel in Rendsburg born 1982 Germany in St. Petersburg Russia Dr. Martin Lück is Senior Vice President and Head of Drug Dr. Alexandra Steckel studied Pharmacy in St. Petersburg, Development at Grünenthal GmbH, Aachen (Germany). In Russia. She extended the study at Christian Albrecht his current role, he oversees all functions involved in the University of Kiel, Germany, and was awarded the MSc execution of Grünenthal´s Drug Development projects, i.e. degree of the faculty in 2006. She finished her PhD thesis Toxicology, Pharmacokinetics & Bioanalytics, CMC, Clinical in Pharmaceutical Technology in 2009 at the Institute for Operations, Clinical Pharmacology, Biostatistics and pharmaceutical Technology and Biotechnology of the Pharmacometrics. He joined Grünenthal in 2010 as Head Christian Albrecht University of Kiel under supervision of of Pharmaceutical Development and was appointed Head Prof. Dr. Dr. B. W. Müller. of CMC in 2014 and Head of Drug Development in 2017. In 2010 she started her industrial career at Losan From 1998 to 2010 Dr. Lück held various leadership Pharma GmbH, Germany, as Technology and Business positions in Pharmaceutical Development and Technical Development Manager where she was responsible for Operations at Ferring Pharmaceuticals in Germany, new customer acquisitions for contract development and Denmark and Switzerland. manufacturing services as well as for licensing business for Losan’s generic portfolio. In 2012 Dr. Alexandra Steckel Dr. Lück studied Pharmacy at the Christian Albrecht joined Evonik Industies AG, Germany, as Sales Manager University Kiel. He finished his PhD thesis in Pharmaceutical for Pharmaceutical Excipients (Eudragit® and Resomer®) Technology at the Free University of Berlin under supervision and Contract Development Services for solid oral and of Prof. Dr. Rainer H. Müller. He received the APV award for parenteral depot products. In 2015 Dr. Alexandra Steckel the most outstanding doctoral thesis in the pharmaceutical joined Alfred E. Tiefenbacher (AET), Germany, as Business sciences in the year 1997. Development Manager where she is active upon now. Dr. Steckel is responsible for identification and external Objectives: development of new products for the generic portfolio of • Strengthen interactions between APV and AET. Pharmaceutical Industry • Increase visibility of APV in Pharmaceutical Industry Objectives: to attract new members and keep members actively • To increase the recognition and visibility of APV involved as a leading professional and scientific non-profit • Contribute to APV´s seminar and conference programs organization by developing of a new branding and communication strategy for APV with external professionals • To support the expansion and internalization of APV Dr. Martin Lück Dr. Alexandra Steckel Grünenthal GmbH Alfred E. Tiefenbacher (GmbH & Co. KG) Zieglerstraße 6 Van-der-Smissen-Strasse 1 52078 Aachen, Germany 22767 Hamburg, Germany Executive Committee of the APV (2018-2022) - list of candidates
Dipl. Ing. Roland Szymoniak born 1954 in Mannheim Germany Dipl.Ing.(TU) Roland Szymoniak studied Process Engineering at the Karlsruhe/Germany University. He started his professional career in 1981 at Hoechst AG and worked for the successor companies Hoechst Marion Roussel GmbH and Aventis Pharma and Sanofi- Aventis first as a plant and process engineer in the active pharmaceutical ingredient production (API) and later as technical and engineering support for all API productions worldwide. After two years of services as an assistant to the Management Board of Hoechst´s Pharmaceutical Division and subsequent years of support for both API and manufacturing sites worldwide, he took over responsibility in 1996 as Head of Engineering and Technical Business support at the site Frankfurt Injectables, the largest manufacturing site of Sanofi worldwide. Since January 2010 he assumed worldwide responsibility for his current job as Head of Industrial Engineering & Transfers, both supporting sterile manufacturing sites of Sanofi with global responsibility and being also responsible for all transfer activities of international production transfers into Emerging Markets. From 2010 to 2015 Roland Szymoniak acted as head of the APV focus group „Pharmaceutical Process Engineering“, which he joined in 1992 and where he still is an active member. Objectives: • Strengthen the industrial/technical aspects in the pharmaceutical APV environment, also introducing inputs from ISPE, the International Society for Pharmaceutical Engineering • Support internationalisation of APV and disclosure of benefits of APV seminar participation to Emerging Markets • Increase visibility of APV in electronic media and reveal benefits for APV members and “not-yet-members” Dipl.Ing.(TU) Roland Szymoniak Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt/Main, Germany Executive Committee of the APV (2018-2022) - list of candidates
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