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
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
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee
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
List of candidates proposed for the election of the Executive Committee List of candidates proposed for the election of the Executive Committee
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