List of candidates proposed for the election of the Executive Committee of the 17th legislative period

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1 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 Mainz/ Executive Committee of the APV ( ) - preliminary list of candidates

2 List of candidates proposed for the election of the Executive Committee Persons Prof. Dr. Johannes Bartholomäus TU Braunschweig and Pharmakreativ Pharmaceutical Development Consulting Burghöhenweg Aachen Prof. Dr. Sandra Klein Institut für Pharmazie Biopharmazie und Pharmazeutische Technologie Ernst-Moritz-Arndt-Universität Greifswald Felix-Hausdorff-Strasse Greifswald Dr. Kathrin Bartscher NextPharma Im Wirrigen Waltrop Dr. Hans Lindner Bayer AG Müllerstrasse Berlin Dr. Karoline Bechtold-Peters Novartis Pharma AG 4002 Basel Werk Klybeck Switzerland Dr. Martin Lück Grünenthal GmbH Zieglerstraße Aachen Prof. Dr. Jörg Breitkreutz Institute of Pharmaceutics and Biopharmaceutics Heinrich-Heine-University Düsseldorf Universitätstr Düsseldorf Prof. Dr. Heribert Häusler Vorm. Boehringer Ingelheim Richard Sorge Straße 73a Berlin Dr. Alexandra Steckel Alfred E. Tiefenbacher GmbH & Co. KG Van-der-Smissen-Strasse Hamburg Dipl.Ing.(TU) Roland Szymoniak Sanofi-Aventis Deutschland GmbH Industriepark Höchst Frankfurt/Main Prof. Dr. Stefan W. Hockertz tpi consult GmbH toxicology-pharmacologyimmunology Ölbergweg Bollschweil,

Kathrin Bartscher born 1978 in Brilon Johannes (Hans) Bartholomäus studied Pharmacy (1979-1983) at the TU Braunschweig,, followed by the practical year in the Adler Apotheke, Borken, and Kettelhack

3 Prof. Dr. Johannes Bartholomäus born 1959 in Lohne i.o. Dr. Kathrin Bartscher born 1978 in Brilon Prof. Dr. Johannes (Hans) Bartholomäus studied Pharmacy ( ) at the TU Braunschweig,, followed by the practical year in the Adler Apotheke, Borken, and Kettelhack Riker Pharma, Borken ( ). He finished his thesis at the Institute of Pharmaceutical Technology of TU Braunschweig under the supervision of Prof. Dr. C. Führer (1988). Hans started his industrial career at Grünenthal GmbH as Head of the Solid Oral Dosage Forms Lab and from 1992 to 2008 he was heading Pharmaceutical Development of Grünenthal. In 2009 Hans started his own Pharmaceutical Development Consultancy. Besides, he is an invited lecturer (since 2001) for Industrial Pharmacy and Honorary Professor (2009) at TU Braunschweig. Currently he is teaching pharmaceutical quality system for Master of Pharmaengineering. His special professional interests are Drug Delivery, Life Cycle Management, IP Management, Quality Systems, Drug Stability, Clinical Supplies and Pharmaceutical Development Strategies including Quality by Design. Hans became member of APV during his Ph.D. studies mid of the 1980ies. He was a co-founding member of APV s Drug Delivery Focus Group in 2003 and became chairman of this group in He was member of the program committees of the 1st European Conference on Pharmaceutics in Reims (2015) and the 11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology in Granada (2018). Strengthen internationalization of APV and making APV visible as the European platform for Pharmaceutics, 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 Development Consulting Burghöhenweg Aachen, Dr. Kathrin Bartscher studied Pharmacy at the Westphalian Wilhelms-University of Muenster (). After finishing her doctoral thesis at the Institute for Pharmaceutical Technology and Biopharmaceutics in Muenster under supervision of Prof. Dr. R. Gröning in 2006 she joined NextPharma as formulation scientist. In 2013 she was appointed as Head of Drug Product Development at the NextPharma site in Waltrop she took over the global responsibility for the development activities at all NextPharma sites and joined the NextPharma board in July 2017 as Chief Scientific Officer. She was initiator of the first APV local group in Dortmund. Since 2014 she is member of the APV board and treasurer of APV. Increasing the APV membership value by º º Increasing the opportunities for active contribution to APV activities especially for young colleagues º º Growing APV as platform for scientific exchange Improving the visibility and perception of APV in the market Making the difference with our seminar & conference program by strengthening the international and interdisciplinary focus Re-activating, strengthening and growing the active participation of APV members from pharmaceutical industry Assuring continuity of a stable financial situation as basis for the realization of all our future objectives and visions Dr. Kathrin Bartscher NextPharma Im Wirrigen Waltrop,

pancreatin pellets. In 1994, Karoline started at Boehringer Ingelheim in Ingelheim as Head of Laboratory in Solid Dosage Forms, focusing on powder inhalation therapeutics.

4 Dr. Karoline Bechtold-Peters born 1964 in Munich Prof. Dr. Jörg Breitkreutz born 1966 in Marl Dr. Karoline Bechtold-Peters is pharmacist and received her doctorate from the Ludwigs-Maximilians-University of Munich in Pharmaceutical Technology in 1994 for a thesis in the field of enteric-coated pancreatin pellets. In 1994, Karoline started at Boehringer Ingelheim in Ingelheim as Head of Laboratory in Solid Dosage Forms, focusing on powder inhalation therapeutics. In this context, Karoline was instrumental in the development of the blockbuster Spiriva. In 2000, she moved to the Business Unit Biopharmaceuticals of Boehringer Ingelheim and thus to Biberach to build-up Formulation Development of Therapeutic Proteins. In 2003 she was appointed 2003 Head of Global Clinical Supplies, Aseptic Process Development and Process Transfer. After several years in this position, Karoline moved to Basel, Switzerland, in 2011, to join Hoffmann La-Roche and was assigned Head of Drug Product Clinical Supply Center Basel within Global Biologics Europe and was responsible for the production of biopharmaceutical clinical supplies both for Roche and Genentech. It became her core task to ramp up the brand new clinical lines for sterile vials and syringes covering initial inspections and initial batch production from 2011 to The expansion of the production to Antibody- Drug-Conjugates followed. In 2016, Karoline joined Novartis Pharma AG in Basel to focus on more strategic issues of Biopharmaceuticals as Senior Strategy and Technology Leader Pharmaceutics within Biologics Technical Development & Manufacturing. Karoline is member of APV since Besides this she is active in several international organisations such as AAPS, PDA and EBE/EFPIA and is frequently invited to contribute to conferences and papers or books. 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 Dr. Karoline Bechtold-Peters Novartis Pharma AG 4002 Basel Werk Klybeck, Switzerland Prof. Dr. Jörg Breitkreutz studied Pharmacy ( ) at the Westphalian Wilhelms-University, Münster,. He finished his thesis in 1996 at the Institute for Pharmaceutical Technology and Biopharmaceutics in Münster, under supervision of Prof. Dr. R. Gröning. From 1996 to 1997 he joined Thiemann Arzneimittel GmbH in Waltrop,, as the head of Product Coordination. In 1997 he went back to the university in Münster finishing his habilitation thesis on paediatric drug formulations in Since 2004 he holds a professorship for pharmaceutical technology at the Heinrich-Heine-University in Düsseldorf,. In 2009 he became an APV board member and in 2010 he was elected for president. His research focuses on patient-centric drug development (in particular for children), orphan drugs, process analytical technologies and Green Pharmacy. Jörg Breitkreutz is member of various international societies and networks, Fellow and member of the the Association of American Pharmaceutical Scientists (AAPS). Making APV the home society of all scientists engaged in pharmaceutical technology and industrial pharmacy Binding APV members a whole life long Linking academia and pharmaceutical industry Involvement in public funding programs Strengthening the European leadership of APV Prof. Dr. Jörg Breitkreutz Institute of Pharmaceutics and Biopharmaceutics Heinrich-Heine-University Düsseldorf Universitätstr Düsseldorf,

Prof. Dr. Heribert Häusler born 1948 in Saarbrücken Prof. Dr. Stefan W. Hockertz born 1960 in Hannover Prof. Dr. Heribert Häusler studied chemistry at Saarbrücken University and obtained his promotion at the Institute for Analytical Chemistry and Radiochemistry.

There he was Head of the Department Pharmaceutical Production Non Solids until 2002 and was then responsible as Vice President for Department Quality Operations at both sites Biberach and Ingelheim

5 Prof. Dr. Heribert Häusler born 1948 in Saarbrücken Prof. Dr. Stefan W. Hockertz born 1960 in Hannover Prof. Dr. Heribert Häusler studied chemistry at Saarbrücken University and obtained his promotion at the Institute for Analytical Chemistry and Radiochemistry. From1979 to 2013 he worked for Boehringer Ingelheim. There he was Head of the Department Pharmaceutical Production Non Solids until 2002 and was then responsible as Vice President for Department Quality Operations at both sites Biberach and Ingelheim until Up to his retirement in 2013 he acted as a VP in the Corporate Function Quality Systems Excellence. As a honorary professor he got a lectureship for Quality Assurance and Quality Strategy at Mainz University. Since 2017 he has been teaching quality management at Beuth University of Applied Sciences. Prof. Dr. Häusler has also made his mark as an author of scientific publications and EuAB comments. Prof. Dr. Häusler is a member of the APV since Since 2004 he is Vice President of the APV and responsible for the focus groups Analytics/Quality Assurance and Information Technology. To increase cooperations between APV and industrial associations To establish cooperations between pharmaceutical engineers and industrial pharmacists To continue working in the Executive Committee and to contribute to the pofessionalization of APV To further develop the focus groups Analytic and Quality assurance as well as Information Technology Professor Dr. rer. nat. Stefan W. Hockertz is an immunologist and toxicologist, now as CEO of the tpi consult GmbH, one of the European leading toxicological and pharmacological technology consulting companies. Previously, he served as Director and Professor of the Institute of Experimental and Clinical Toxicology at the University Medical School Eppendorf in Hamburg from 2003 to end of Prior to joining the University, he served as Director of the Fraunhofer Institute of Toxicology and Environmental Medicine Hamburg from 1995 to 2002 and before as an investigator at the Fraunhofer Institute of Toxicology and Aerosol Research in Hannover from 1986 to He received his first academic appointment to Hannover University in Prof. Hockertz is appointed as Eurotox Registered Toxicologist and he has the admission as Herstellungsand Kontrolleiter according to 15.1 and 15.3 of the German Drug Law since Hockertz holds a doctorate in biology from the University Hannover and he is a University Professor for Molecular Immunotoxicology of the University Hamburg Medical School. Prof. Hockertz has wide experience as a former board member of a german pharma association. As member of the APV he is working in the Task Force Individual Medicines and he is a guest at the Focus Groups Drug Regulatory Affairs and Drug Delivery. Strengthen the area of preclinical safety and toxicology 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 Vorm. Boehringer Ingelheim Richard Sorge Straße 73a Berlin, Prof. Dr. Stefan W. Hockertz tpi consult GmbH toxicology-pharmacology-immunology Ölbergweg Bollschweil,

Prof. Dr. Sandra Klein born 1970 in Büdingen Dr. Hans Lindner born 1963 in Kiel Prof. Dr. Sandra Klein studied Pharmacy at the University of Frankfurt, and graduated in 2000.

She got her PhD in 2005 and was then a postdoctoral fellow at Eastman Chemical Company in Kingsport/TN, USA.

6 Prof. Dr. Sandra Klein born 1970 in Büdingen Dr. Hans Lindner born 1963 in Kiel Prof. Dr. Sandra Klein studied Pharmacy at the University of Frankfurt, and graduated in At the same university she started her graduate studies at the Institute of Pharmaceutical Technology under the supervision of Jennifer Dressman. She got her PhD in 2005 and was then a postdoctoral fellow at Eastman Chemical Company in Kingsport/TN, USA. From 2006 till 2010 Sandra Klein was a senior research associate at the Institute of Pharmaceutical Technology at the University of Frankfurt. Since 2010 she is Professor of Pharmaceutical Technology at the University of Greifswald,. Her current research is focusing on the development of bio-predictive dissolution methods for special patient groups, particularly the pediatric and geriatric population and of patient-centric formulations. Other research interests include the design of predictive and accelerated test methods for vaginal delivery systems and depot parenterals and the enhancement of the bioavailability of poorly soluble drug compunds with different polymer- and cyclodextrin-based approaches. Sandra Klein is an APV member since 2000 and member of the American Association of Pharmaceutical Scientists (AAPS), the Controlled Release Society (CRS) and a core member of the European Paediatric Formulation Initiative (EuPFI) amongst others. Linking APV to the global pharmaceutical network, i.e. strengthening the collaboration of APV with other international societies, universities and industry Further increasing the visibility of APV Improving collaboration of academia and industry Binding young pharmacists to APV giving them the chance to actively participating in activities of the APV network Hans Lindner is a pharmacist and holds a doctorate degree in pharmaceutical technology from Christian-Albrechts- University, Kiel. He started his industrial career at Arzneimittelwerk Dresden in 1994, where he led a scale up team in formulation development. In 1996, he joined Ferring Pharmaceuticals first in, moving later to Denmark. At Ferring, he served in various positions with increasing responsibilities in formulation and pharmaceutical development, at the end overseeing CMC development. He joined Schwarz Pharma in 2004, leading pharmaceutical development. After integration into UCB in 2007, he managed the late stage product development function. In 2008, he joined Bayer, heading pharmaceutical development. In 2012 took responsibility for a newly formed unit overseeing all external activities in pharmaceutical development. Since 2014, he is heading alliance management for research. He leads a global team, developing and running innovative collaboration models with numerous research partners. During his career, Hans has been working with a wide variety of dosage forms, technologies and delivery systems. He has experience in managing functions, technology and knowledge transfers, as well as internal and external interfaces in different organizations. Continue internationalization of APV Support and promote collaboration and network within APV Further Develop and promote APV as valuable organization for its members Prof. Dr. Sandra Klein Institut für Pharmazie Biopharmazie und Pharmazeutische Technologie Ernst-Moritz-Arndt-Universität Greifswald Felix-Hausdorff-Strasse Greifswald, Dr. Hans Lindner Bayer AG Müllerstrasse Berlin,

Dr. Martin Lück born 1968 in Rendsburg Dr. Alexandra Steckel born 1982 in St. Petersburg Russia Dr. Martin Lück is Senior Vice President and Head of Drug Development at Grünenthal GmbH, Aachen ().

He joined Grünenthal in 2010 as Head of Pharmaceutical Development and was appointed Head of CMC in 2014 and Head of Drug Development in 2017. From 1998 to 2010 Dr.

7 Dr. Martin Lück born 1968 in Rendsburg Dr. Alexandra Steckel born 1982 in St. Petersburg Russia Dr. Martin Lück is Senior Vice President and Head of Drug Development at Grünenthal GmbH, Aachen (). In his current role, he oversees all functions involved in the execution of Grünenthal s Drug Development projects, i.e. Toxicology, Pharmacokinetics & Bioanalytics, CMC, Clinical Operations, Clinical Pharmacology, Biostatistics and Pharmacometrics. He joined Grünenthal in 2010 as Head of Pharmaceutical Development and was appointed Head of CMC in 2014 and Head of Drug Development in From 1998 to 2010 Dr. Lück held various leadership positions in Pharmaceutical Development and Technical Operations at Ferring Pharmaceuticals in, Denmark and Switzerland. Dr. Lück studied Pharmacy at the Christian Albrecht University Kiel. He finished his PhD thesis in Pharmaceutical Technology at the Free University of Berlin under supervision of Prof. Dr. Rainer H. Müller. He received the APV award for the most outstanding doctoral thesis in the pharmaceutical sciences in the year Strengthen interactions between APV and Pharmaceutical Industry Increase visibility of APV in Pharmaceutical Industry to attract new members and keep members actively involved Contribute to APV s seminar and conference programs Dr. Alexandra Steckel studied Pharmacy in St. Petersburg, Russia. She extended the study at Christian Albrecht University of Kiel,, and was awarded the MSc degree of the faculty in She finished her PhD thesis in Pharmaceutical Technology in 2009 at the Institute for pharmaceutical Technology and Biotechnology of the Christian Albrecht University of Kiel under supervision of Prof. Dr. Dr. B. W. Müller. In 2010 she started her industrial career at Losan Pharma GmbH,, as Technology and Business Development Manager where she was responsible for new customer acquisitions for contract development and manufacturing services as well as for licensing business for Losan s generic portfolio. In 2012 Dr. Alexandra Steckel joined Evonik Industies AG,, as Sales Manager for Pharmaceutical Excipients (Eudragit and Resomer ) and Contract Development Services for solid oral and parenteral depot products. In 2015 Dr. Alexandra Steckel joined Alfred E. Tiefenbacher (AET),, as Business Development Manager where she is active upon now. Dr. Steckel is responsible for identification and external development of new products for the generic portfolio of AET. To increase the recognition and visibility of APV as a leading professional and scientific non-profit 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 Grünenthal GmbH Zieglerstraße Aachen, Dr. Alexandra Steckel Alfred E. Tiefenbacher (GmbH & Co. KG) Van-der-Smissen-Strasse Hamburg,

8 Dipl. Ing. Roland Szymoniak born 1954 in Mannheim Dipl.Ing.(TU) Roland Szymoniak studied Process Engineering at the Karlsruhe/ 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. 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 Frankfurt/Main,

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