Final Programme 1106

Day 1
Monday, 15 November 2021

09:00		 Opening – Welcome Ceremony
Welcome addresses by:

Prof. Dr. Béla Merkely
Rector of Semmelweis University
Budapest, Hungary

Dr. János Áder
President of the Republic of Hungary,
The Main Patron of the DDRS 2021 Conference
Budapest, Hungary

Prof. Dr. Imre Klebovich
Co-Chair of the DDRS 2021 Conference
Chair of the Organising Committee
Budapest, Hungary

Prof. Dr. Vinod P. Shah
Co-Chair of the DDRS 2021 Conference
North Potomac, MD, USA

Prof. Dr. Stefan Mühlebach
Co-Chair of the DDRS 2021 Conference
Basel, Switzerland

Dr. Zsuzsanna Jakab
Deputy Director-General, World Health Organization (WHO) Geneva,
Switzerland

Dr. Dominique Jordan
President of International Pharmaceutical Federation (FIP)
The Hague, The Netherlands

Prof. Dr. Joseph W. Polli
Past-President of the American Association of Pharmaceutical Scientists (AAPS)
Arlington, VA, USA

Prof. Dr. Dieter Steinhilber
President of the European Federation for Pharmaceutical Sciences (EUFEPS)
Frankfurt, Germany
Ceremonial Presentation and Stamping of the Commemorative Sheet and Folder
Magyar Posta presents the Commemorative Sheet and Folder issued on the occasion of the 250th Anniversary of the founding of Semmelweis University, which will be stamped with a unique postmark of the DDRS 2021 Conference logo and signed by:
Prof. Dr. Béla Merkely
Rector of Semmelweis University
Budapest, Hungary

Dr. János Áder
President of the Republic of Hungary,
The Main Patron of the DDRS 2021 Conference
Budapest, Hungary

György Schamschula
Chief Executive Officer (CEO), Magyar Posta
Budapest, Hungary

Prof. Dr. Imre Klebovich
Co-Chair of the DDRS 2021 Conference
Chair of the Organising Committee
Budapest, Hungary

The Commemorative sheet was published in the Hungarian and English folders in 2,000 numbered copies.
The Opening Ceremony will be closed with a short music programme by

THE TRIO FLAUTICELLO

Soloists of the
Hungarian State Opera
and the
Budapest Philharmonic Orchestra

Zsuzsanna Menyhárt – flute
Dóra Gjorgjevic – flute
Péter Boldoghy Kummert – cello

Program:
Johann Sebastian Bach: Air
Joseph Haydn: London Trio (Allegro)
Léo Delibes: Duett of Lakme
Joseph Haydn: London Trio (Vivace)
Session I. Regulatory Science

Chairs:
Béla Merkely, Budapest, Hungary
Péter Ferdinandy, Budapest, Hungary
10:00 Keynote Address I: KN-1Regulatory Perspectives – Where We Came from, Where Are We Today, Where Are We Headed?
Carl C. Peck
University of California at San Francisco (UCSF), San Francisco, CA, USA
NDA Partners/ProPharma, San Luis Obispo, CA, USA
Former Director of the US FDA Center for Drug Evaluation and Research (CDER), Washington DC, USA
10:35 Keynote Address II: KN-2How Regulatory Science Can Enable WHO’s Triple Billion Objectives?
Mariângela Simão
Assistant Director-General, World Health Organization (WHO), Geneva, Switzerland
11:10 Coffee Break, Exhibition and Poster Session
Session II.Regulatory Science, Strategy in DMPK

Chairs:
Beat Flühmann, Glattbrugg, Switzerland
Carl C. Peck, San Luis Obispo, CA, USA
11:40 PL-1Regulatory Science in Drug Development
Vinod P. Shah
Pharmaceutical Consultant, North Potomac, MD, USA
Member of NBCD-Working Group, North Potomac, MD, USA
12:05 PL-2Drug Development Strategy in the United States: An Industrial View of DMPK
Joseph W. Polli
Past President of American Association of Pharmaceutical Scientists (AAPS),
Arlington, VA, USA
Director, Medical Information and Scientific Communications, ViiV Healthcare,
Research Triangle Park (RTP), NC, USA.
12:30 PL-3Regulatory Science Challenges – Encourage Innovation through an Adaptive Regulatory System
Krisztián Fodor
Regulatory Science and Patient Safety Department,
Gedeon Richter Plc., Budapest, Hungary
12:55 Panel Discussion I. A Forward-Looking Practical Consequence of Regulatory Science in General

Moderators:
Joseph W. Polli, Research Triangle Park (RTP), NC, USA
Vinod P. Shah, North Potomac, MD, USA
Panelists:
Krisztián Fodor, Budapest, Hungary
Stefan Mühlebach, Basel, Switzerland
Carl C. Peck, San Luis Obispo, CA, USA
Mariângela Simão, Geneva, Switzerland
13:20 Lunch and Exhibition
Session III. Regulatory Aspects of Nanomedicine, Biological and Complex Drug and Products

Chairs:
Lajos P. Balogh, North Andover, MD, USA
Subramanian R. Vaidya, Mumbai, India
14:35 PL-4How Should Synthetic Follow-Ons of Biological Products Be Regulated?
What Are the Implications for Automatic Substitution?
Jens Heisterberg
Novo Nordisk, Søborg, Denmark
15:00 PL-5Complex Drugs: What Are They and Why Do They Need Special Attention?
Jon S.B. de Vlieger
Coordinator of NBCD-Working Group, Utrecht, The Netherlands
Foundation Lygature, Utrecht, The Netherlands
15:25 PL-6Same Product Different Regulatory Approach Around the World: Glatiramer Acetate
Paolo Rocco, Paola Minghetti
Department of Pharmaceutical Sciences, University of Milan, Milan, Italy
15:50 Coffee Break, Exhibition and Poster Session
Session IV. Complexity of Nanomedicine, Nanopharmaceuticals

Chairs:
José A. Guimarães Morais, Lisbon, Portugal
Romána Zelkó, Budapest, Hungary
16:20 PL-7Nanomedicines: Previous Accomplishments and Ongoing Efforts
Scott McNeil
Nanopharmaceutical and Regulatory Sciences Group, Department of Pharmaceutical Sciences, University of Basel, Switzerland
16:45 PL-8How to Deal with Complexity of Nanomedicine in Practice
Stefan Mühlebach
Department of Pharmaceutical Sciences, Division of Clinical Pharmacy & Epidemiology, Hospital Pharmacy, University of Basel, Basel, Switzerland
17:10 Panel Discussion II. Scientific, Regulatory and Practical Considerations of Complex Drug Products, Nanopharmaceuticals and Biological Products

Moderators:
Beat Flühmann, Glattbrugg, Switzerland
Jon S.B. de Vlieger, Utrecht, The Netherlands
Panelists:
Jens Heisterberg, Søborg, Denmark
Scott McNeil, Basel, Switzerland
Stefan Mühlebach, Basel, Switzerland
Paolo Rocco, Milan, Italy
17:40 End of Day 1.
19:30-
23:00		 Classical Concert and Reception
at the Liszt Ferenc Academy of Music
Address of the Concert Venue: 1061 Budapest, Liszt Ferenc tér 8.
Further important information related to the cultural programmes can be found HERE

Day 2
Tuesday, 16 November 2021
Session V. Drug Research, Vaccine and Bioconjugate Development Strategies

Chairs:
Imre Klebovich, Budapest, Hungary
Vinod P. Shah, North Potomac, MD, USA
09:00 Keynote Address III: KN-3Industry Perspectives in Modern Drug Research and Development Strategies
Tamás Shisha1, Péter Gergely2
1 Director, Translational Medicine Autoimmunity, Novartis Institutes for BioMedical Research, Basel, Switzerland
2 Executive Director, Novartis Institutes for BioMedical Research, Basel, Switzerland
09:35 Keynote Address IV: KN-4Vaccine Development in Global Pandemic Time
Tibor Fabó
Medical Director, Pfizer Biopharmaceuticals, Budapest, Hungary
10:10 PL-9Prodrug Nano-Squalene Bioconjugate Drug Products
Leslie Z. Benet1,2, Patrick Couvreur2
1Department of Bioengineering & Therapeutic Sciences, Schools of Pharmacy & Medicine, University of California San Francisco, San Francisco, CA, USA
2Université Paris-Saclay and Institut Universitaire de France, Paris, France
10:35 Coffee Break, Exhibition and Poster Session
Session VI. Novel Vaccine Development Strategies

Chairs:
Leslie Z. Benet, San Francisco, CA, USA
Olavi Pelkonen, Oulu, Finland
11:05 PL-10mRNA-lipid Nanoparticle COVID-19 Vaccines: Structure and Stability
Daan J.A. Crommelin
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
11:30 PL-11An Academic Approach to Vaccine Development in a Global Pandemic: A Personal Account
Allegra Peletta1, Eakachai Pompetchara2, Chutitorn Ketloy2, Gerrit Borchard1
1School of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva, Geneva, Switzerland
2Chula Vaccine Research Center (Chula VRC), Faculty of Medicine and Department of Laboratory Medicine, Chulalongkorn University, Bangkok, Thailand
11:55 PL-12Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses
István Tóth1,2,3, Mariusz Skwarczynski1
1School of Chemistry and Molecular Biosciences, The University of Queensland,
Brisbane, QLD, Australia
2School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia
3Institute for Molecular Bioscience, The University of Queensland, Brisbane, QLD, Australia
12:20 Panel Discussion III. New Perspectives of the Drug Research and
Novel Vaccine Development Strategies

Moderators:
Leslie Z. Benet, San Francisco, CA, USA
István Greiner, Budapest, Hungary
Panelists:
Gerrit Borchard, Geneva, Switzerland
Daan J.A. Crommelin, Utrecht, The Netherlands
Tibor Fabó, Budapest, Hungary
Joseph W. Polli, Triangle Park (RTP), NC, USA
Tamás Shisha, Basel, Switzerland
12:45 Lunch and Exhibition
Session VII. Nanotechnological and Transdermal Drug Delivery Systems

Chairs:
A. Atilla Hincal, Ankara, Turkey
Panos Macheras, Athens, Greece
14:00 PL-13Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems
Romána Zelkó
University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary
14:25 PL-14Advanced Drug Delivery Systems: From Nano- and Microparticles to Smart Pills
István Antal
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
14:50 PL-15Advances in Transdermal Drug Delivery System
Dange Veerapaneni
Sparsha Pharma International Private Ltd, Hyderabad, TN, India
15:15 Coffee Break, Exhibition and Poster Session
Session VIII. Global Harmonization of Regulations, Drug-Device Combination, Biosimilar Products and FIP Strategy

Chairs:
Éva Szökő, Budapest, Hungary
Balázs Hankó, Budapest, Hungary
15:45 PL-16Future of the Hungarian Drug Market – Role of the Hungarian Regulatory Authority
Mátyás Szentiványi
Director General, National Institute of Pharmacy and Nutrition, Budapest, Hungary
16:10 PL-17The Place of Science in the “One FIP Strategy”
Dominique Jordan
President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands
16:35 PL-18Regulatory Pathway for Drug-Device Combination Products in US
David R. Savello
Co-founder and Partner, NDA Partners LLC, Rochelle, VA, USA
17:00 PL-19Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience?
Zsolt Holló
Egis Pharmaceuticals Plc, Budapest, Hungary
17:25 Panel Discussion IV. Advances in Drug Delivery System Global Harmonization of Regulations – Dream or Reality?

Moderators:
Henning H. Blume, Oberursel, Germany
Mátyás Szentiványi, Budapest, Hungary
Panelists:
István Antal, Budapest, Hungary
Beat Flühmann, Glattbrugg, Switzerland
Zsolt Holló, Budapest, Hungary
Dominique Jordan, The Hague, The Netherlands
Carl Peck, San Luis Obispo, CA, USA
David R. Savello, Rochelle, VA, USA
Dange Veerapaneni, Hyderabad, TN, India
Romána Zelkó, Budapest, Hungary
17:50 End of Day 2.
20:00-
23:30		 Gala Dinner at the Museum of Fine Arts, Romanesque Hall

Address of the Gala Dinner Venue: 1146 Budapest, Dózsa György út 41.
Further important information related to the cultural programmes can be found HERE

Day 3
Wednesday, 17 November 2021
Session IX.Patient-Centric Drug Research, Drug Release and Antileukemic Drugs

Chairs:
Henning H. Blume, Oberursel, Germany
Judit Tarnai, Budapest, Hungary
09:00 Keynote address V: KN-5Merging Science and Patient in Future Drug Development to Enhance Safety and Effectiveness
Sven Stegemann
Graz University of Technology, Graz, Austria
ACG Ltd., Müllheim, Germany
09:35 PL-205-Lipoxygenase: Its Noncanonical Function Unravels its Inhibitors as Potential Antileukemic Drugs
Dieter Steinhilber1,2, Eugen Proschak2

1 President of European Federation for Pharmaceutical Sciences (EUFEPS), Frankfurt, Germany
2 Institute for Pharmaceutical Chemistry, Goethe University of Frankfurt, Frankfurt, Germany
10:00 PL-21The Relations between Q3 Measurements, In Vitro Release and TCS
Flavian Ştefan Rădulescu1, Dalia Simona Miron1, Vinod P. Shah2
1Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila Bucharest, Bucharest, Romania
2Pharmaceutical Consultant, North Potomac, MA, USA
10:25 Coffee Break, Exhibition and Poster Session
Session X.Challenges of Drug Development from In Silico to In Vivo Biopharmaceutics

Chairs:
Milena Jadrijević-Mladar Takač, Zagreb, Croatia
Vijay U. Kshirsagar, Mumbai, India
10:55 PL-22ADMET in Drug Development: What is the Role of Animals between In Silico – In Vitro and In Vivo Humans?
Olavi Pelkonen
Research Unit of Biomedicine/Pharmacology and Toxicology, Faculty of Medicine, University of Oulu,
Oulu, Finland
11:20 PL-23The Gut in a Beaker: More Challenges for In Vitro Testing
Clive G. Wilson1,2, Gavin W. Halbert1,3, Ibrahim Khadra1, Claire Dunn1
1Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, Scotland, UK
2Re-Vana Therapeutics Ltd., McClay Research Centre, Belfast, Northern Ireland, UK
3Cancer Research Formulation Laboratories, University of Strathclyde, Glasgow, Scotland, UK
11:45 PL-24Drugs are Absorbed in Finite Time: A New Era in Biopharmaceutics and Pharmacokinetics
Panos Macheras
PharmaInformatics Unit, ATHENA Research Center, Athens, Greece
Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece
Department of Pharmaceutical Sciences, State University of New York, Buffalo, USA
12:10 Panel Discussion V. New Challenges in the Field of the Patient-Centric Drug Research, Biopharmaceutics, In Vitro, In Vivo Drug Development

Moderators:
A. Atilla Hincal, Ankara, Turkey
José A. Guimarães Morais, Lisbon, Portugal
Panelists:
Panos Macheras, Athens, Greece, Buffalo, NY, USA
Olavi Pelkonen, Oulu, Finland
Flavian Ştefan Rădulescu, Bucharest, Romania
Sven Stegemann, Graz, Austria, Müllheim, Germany
Dieter Steinhilber, Frankfurt, Germany
Clive G. Wilson, Glasgow, Scotland, UK, Belfast, Northern Ireland, UK
12:35 Lunch and Exhibition
Session XI.Progress in (Bio)Analytical Technologies

Chairs:
Danilo Corradini, Rome, Italy
Attila Felinger, Pécs, Hungary
13:50 PL-25Advanced (Multi-Dimensional) Separations for Practical Applications
Alina Astefanei1,2, Andrea F.G. Gargano1,2, Gino Groeneveld1,2, Bob W.J. Pirok1,2,
Peter J. Schoenmakers1,2
1Van ‘t Hoff Institute for Molecular Science (HIMS), University of Amsterdam, Science Park, Amsterdam, The Netherlands
2Centre of Analytical Sciences Amsterdam, Science Park, Amsterdam, The Netherlands
14:15 PL-26Advances in LC/MS for the Characterization of Biotherapeutics
Jonathan L. Josephs1, Aaron Bailey2, Stephane Houel3

1 Genentech, South San Francisco, California, USA
2 University of Texas Medical Branch, Galveston, Texas, USA
3 Thermo Fisher Scientific, San Jose, California, USA
14:40 PL-27Is the Multi-Attribute Method (MAM) the Next Big Thing? A High-Resolution Accurate Mass Multi-Attribute Method for Critical Quality Attribute Monitoring
Orsolya Kóréh1, Luka Milivojevic2

1 Unicam Hungary, Budapest, Hungary
2 Thermo Fisher Scientific, Breda, The Netherlands
15:05 Coffee Break, Exhibition and Poster Session
Session XII.Biopharmaceutics

Chairs:
Shashikant D. Joag, Mumbai, India
Stefan Mühlebach, Basel, Switzerland
15:35 PL-28Nanomedicines – Ensuring Patient Safety through Regulatory Clarity
Mike P. Isles
Executive Director, European Alliance for Access to Safe Medicines (EAASM), Essex, UK
16:00 PL-29Ionone: The Molecule That Shaped the History of Western Civilization
Georg A. Petroianu
College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates
16:25 Panel Discussion VI. Novel Bioanalytical Applications, Nanomedicines and Safety Issues

Moderators:
Scott McNeil, Basel, Switzerland
Olavi Pelkonen, Oulu, Finland
Panelists:
Mike P. Isles, Essex, UK
Orsolya Kóréh,Budapest, Hungary
Peter J. Schoenmakers, Amsterdam, The Netherlands
Georg A. Petroianu, Abu Dhabi, United Arab Emirates
16:50 Poster Award Ceremony

Chair of the Poster Award Committee:
Stefan Mühlebach, Basel, Switzerland
Members of the Poster Award Committee:
Gerrit Borchard, Geneva, Switzerland
Georg A. Petroianu, Abu Dhabi, United Arab Emirates
Peter J. Schoenmakers, Amsterdam, The Netherlands
17:05 A New Book Launch
Doctor Honoris Causa Professors of the Faculty of Pharmacy, Semmelweis University
(Semmelweis Publisher, Budapest, 2020)
Imre Klebovich (Editor)
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
17:45 Closing Ceremony
Vinod P. Shah, North Potomac, MD, USA
Stefan Mühlebach, Basel, Switzerland
Imre Klebovich, Budapest, Hungary

Professors, Co-Chairs of DDRS 2021 Conference
17:55 End of Conference