preliminary v7 14/10/2021

Day 1
Monday, 15 November 2021

09:00 Opening – Welcome Ceremony
Session I. Regulatory Science

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 Peck
Founder and Chairman at NDA Partners LLC.,
Formerly Director, Center for Drug Evaluation and Research/FDA, San Luis Obispo, CA, 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

Beat Flühmann, Glattbrugg, Switzerland
Carl 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

Joseph W. Polli, Research Triangle Park (RTP), NC, USA
Vinod P. Shah, North Potomac, MD, USA
Stefan Mühlebach, Basel, Switzerland
Carl 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

Lajos 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

José A. Guimarães Morais, Lisbon, Portugal
Romána Zelkó, Budapest, Hungary
16:20 PL-7Nanomedicines: Previous Accomplishments and Ongoing Efforts
Scott McNeil
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, Switzerland
17:10 Panel Discussion II. Scientific, Regulatory and Practical Considerations of Complex Drug Products, Nanopharmaceuticals and Biological Products

Beat Flühmann, Glattbrugg, Switzerland
Jon S.B. de Vlieger, Utrecht, The Netherlands
Jens Heisterberg, Søborg, Denmark
Scott McNeil, Basel, Switzerland
Stefan Mühlebach, Basel, Switzerland
Paolo Rocco, Milan, Italy
17:40 End of Day 1.

Day 2
Tuesday, 16 November 2021

Session V. Drug Research, Vaccine and Bioconjugate Development Strategies

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 of BioMedical Research, Basel, Switzerland
2 Executive director, Novartis Institutes of 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

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, Chutitorn Ketloy2, Eakachai Pompetchara2, 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

Leslie Z. Benet, San Francisco, CA, USA
István Greiner, Budapest, Hungary
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

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, India
15:15 Coffee Break, Exhibition and Poster Session
Session VIII. Global Harmonization of Regulations, Dissolution, Drug-Device Combination and Biosimilar Products

Éva Szökő, Budapest, Hungary
Judit Tarnai, 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 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, Romania
2Pharmaceutical Consultant, North Potomac, MA, USA
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?

Henning H. Blume, Oberursel, Germany
Mátyás Szentiványi, Budapest, Hungary
István Antal, Budapest, Hungary
Beat Flühmann, Glattbrugg, Switzerland
Zsolt Holló, Budapest, Hungary
Carl Peck, San Luis Obispo, CA, USA
David R. Savello, Rochelle, VA, USA
Dange Veerapaneni, Hyderabad, India
Romána Zelkó, Budapest, Hungary
17:50 End of Day 2.

Day 3
Wednesday, 17 November 2021

Session IX.Patient-Centric Drug Research, FIP Strategy

Henning H. Blume, Oberursel, Germany
Balázs Hankó, 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-20The Place of Science in the “One FIP Strategy”
Dominique Jordan
President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands
10:00 PL-215-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, University of Frankfurt, Frankfurt, Germany
10:25 Coffee Break, Exhibition and Poster Session
Session X.Challenges of Drug Development from In Silico to In Vivo Biopharmaceutics

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 SilicoIn 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
2ReVana 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

A. Atilla Hincal, Ankara, Turkey
José A. Guimarães Morais, Lisbon, Portugal
Dominique Jordan, The Hague, The Netherlands
Panos Macheras, Athens, Greece, Buffalo, NY, USA
Olavi Pelkonen, Oulu, Finland
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

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. Schoenmakers

1van ‘t Hoff Institute for Molecular Science (HIMS), University of Amsterdam, Amsterdam, The Netherlands
2Centre of Analytical Sciences Amsterdam, Amsterdam, The Netherlands
14:15 PL-26Advances in LC/MS for the Characterization and Bioanalysis of Biotherapeutics
Jonathan L. Josephs
Senior Director, Genentech, A Member of the Roche Group, San Mateo, CA, USA
14:40 PL-27Confident Analytical Characterization from Drug Discovery to Development
Krisztina Radi1, Kristina Srzentić2, Amy Claydon1

1 Thermo Fisher Scientific, Hemel Hempstead, United Kingdom, UK
2 Thermo Fisher Scientific, Cambridge, MA, USA
15:05 Coffee Break, Exhibition and Poster Session
Session XII.Biopharmaceutics

Shashikant D. Joag, Mumbai, India
István Tóth, Brisbane, QLD, Australia
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

Scott McNeil, Basel, Switzerland
Olavi Pelkonen, Oulu, Finland
Mike P. Isles, Essex, UK
Krisztina Radi, Hemel Hempstead, United Kingdom, UK
Peter J. Schoenmakers, Amsterdam, The Netherlands
Georg A. Petroianu, Abu Dhabi, United Arab Emirates
Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK
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
End of Conference