Preliminary Programme

Day 1
Monday, 15 November 2021

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

Chairs:
Béla Merkely, Budapest, Hungary
Péter Ferdinandy, Budapest, Hungary
10:00 Keynote Address I: KN-1How Regulatory Science Can Enable WHO’s Triple Billion Objectives?
Zsuzsanna Jakab
Deputy Director-General, World Health Organization (WHO), Geneva, Switzerland
10:40 Keynote Address II: KN-2Regulatory Perspectives – Where We Came from, Where Are We Today, Where Are We Headed?
Carl Peck
Founder and Chairman at NDA Partners LLC., San Luis, CA, USA
11:20 Coffee Break, Exhibition and Poster Session
Session II.Regulatory Science, Nanomedicine and Complex Drugs

Chairs:
Beat Flühmann, Glattbrugg, Switzerland
Joseph W. Polli, Chapel Hill, RTP, NC, USA
11:50 PL-1Regulatory Science in Drug Development
Vinod P. Shah
Pharmaceutical Consultant, North Potomac, MD, USA
Member of NBCD-Working Group, North Potomac, MD, USA
12:15 PL-2Where to Go with Nano?
Daan J.A. Crommelin
Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
12:40 PL-3Complex 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
13:05 Panel Discussion I. A Forward-Looking Practical Consequence of Regulatory Science in
General and the Complex Drugs

Moderators:
Daan J.A. Crommelin, Utrecht, The Netherlands
Vinod P. Shah, North Potomac, MD, USA
Panelists:
Erem Bilensoy, Ankara, Turkey
Krisztián Fodor, Budapest, Hungary
Vijay U. Kshirsagar, Mumbai, India
Carl Peck, San Luis, CA, USA
Jon S.B. de Vlieger, Utrecht, The Netherlands
13:25 Lunch and Exhibition
Session III. Regulatory Aspects of Nanomedicine Products

Chairs:
Lajos Balogh, North Andover, MD, USA
Subramanian R. Vaidya, Mumbai, India
14:40 PL-4How Should Synthetic Follow-Ons of Biological Products Be Regulated?
What Are the Implications for Automatic Substitution?
Jens Heisterberg
Novo Nordisk, Søborg, Denmark
15:05 PL-5Same Product Different Regulatory Approach Around the World: Glatiramer Acetate
Paolo Rocco, Paola Minghetti
Department of Pharmaceutical Sciences, University of Milan, Milan, Italy
15:30 PL-6NBCD: Regulatory Science in Motion. Where We Are and Where We Are Going?
Marisa Papaluca Amati
Regulatory Science Expert, London, UK
15:55 Coffee Break, Exhibition and Poster Session
Session IV. Complexity of Nanomedicine, Nanopharmaceuticals, Pharmacovigilance

Chairs:
José A. Guimarães Morais, Lisbon, Portugal
Romána Zelkó, Budapest, Hungary
16:25 PL-7Nanomedicines: Previous Accomplishments and Ongoing Efforts
Scott McNeil
Department of Pharmaceutical Sciences, University of Basel, Switzerland
16:50 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
17:15 PL-9Pharmacovigilance of Complex Drugs; Traceability of Biologics and Implications for Other Complex Products
Kevin Klein, Peter Stolk
Foundation Lygature, Utrecht, The Netherlands Utrecht University, Utrecht, The Netherlands
Exon Consultancy, Amsterdam, The Netherlands
17:40 Panel Discussion II. How Can We Prepare for a Wave of New Complex Drug Products to Come? Scientific, Regulatory and Practical Considerations.

Moderators:
Beat Flühmann, Glattbrugg, Switzerland
Jon S.B. de Vlieger, Utrecht, The Netherlands
Panelists:
Marisa Papaluca Amati, London, UK
Jens Heisterberg, Søborg, Denmark
Scott McNeil, Basel, Switzerland
Stefan Mühlebach, Basel, Switzerland
Paolo Rocco, Milan, Italy
18:10 End of Day 1.

Day 2
Tuesday, 16 November 2021

Session V. Drug Research and 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
Péter Gergely
Executive Director, Novartis Institutes of BioMedical Research, Basel, Switzerland
09:40 Keynote Address IV: KN-4A Multitargeted Approach to Treating Inflammatory Conditions
Mark Latymer
Senior Medical Director, Inflammation & Immunology Global Medical Affairs, Biopharmaceuticals Group,
Pfizer Inc., Sandwich, Kent, UK
10:20 PL-10Drug 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
10:45 Coffee Break, Exhibition and Poster Session
Session VI. Prodrug, Regulatory Science, Drug-Device Combination Products

Chairs:
Panos Macheras, Athens, Greece
Georg A. Petroianu, Abu Dhabi, United Arab Emirates
11:15 PL-11Prodrug Nano-Squalene Bioconjugate Drug Products
Leslie Z. Benet1,2, Patrick Couvreur2

1 Department of Bioengineering & Therapeutic Sciences, Schools of Pharmacy & Medicine
University of California San Francisco, San Francisco, CA, USA
2 Squal Pharma Inc., San Francisco, CA, USA
11:40 PL-12Regulatory Science Challenges – Encourage Innovation through an Adaptive Regulatory System
Krisztián Fodor
Regulatory Science and Patient Safety Department, Gedeon Richter Plc., Budapest, Hungary
12:05 PL-13Regulatory Pathway for Drug-Device Combination Products in US
David R. Savello
Co-founder and Partner, NDA Partners LLC, Rochelle, VA, USA
12:30 Panel Discussion III. New Perspectives the Drug Research and Development Strategies.
Evaluation of Drug-Device Combination Products

Moderators:
Péter Gergely, Basel, Switzerland
Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK
Panelists:
Leslie Z. Benet, San Francisco, CA, USA
István Greiner, Budapest, Hungary
Mark Latymer, Sandwich, Kent, UK
Joseph W. Polli, Triangle Park (RTP), NC, USA
David R. Savello, Rochelle, VA, USA
13:00 Lunch and Exhibition
Session VII. FIP Strategy, Advances in Drug Delivery System

Chairs:
Balázs Hankó, Budapest, Hungary
Vijay U. Kshirsagar, Mumbai, India
14:15 PL-14The Place of Science in the “One FIP Strategy”
Dominique Jordan
President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands
14:40 PL-15Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems
Romána Zelkó
University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary
15:05 PL-16Advanced Drug Delivery Systems: From Nano- and Microparticles to Smart Pills
István Antal
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
15:30 PL-17Advances in Transdermal Drug Delivery System
Dange Veerapaneni

Sparsha Pharma International Private Ltd, Hyderabad, India
15:55 Coffee Break, Exhibition and Poster Session
Session VIII. Global Harmonization of Regulations

Chairs:
Éva Szökő, Budapest, Hungary
Judit Tarnai, Budapest, Hungary
16:25 PL-18Future of the Hungarian Drug Market – Role of the Hungarian Regulatory Authority
Mátyás Szentiványi
Director General, National Institute of Pharmacy and Nutrition, Budapest, Hungary
16:50 PL-19Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience?
Zsolt Holló
Egis Pharmaceuticals Plc, Budapest, Hungary
17:15 PL-20Innovative Submissions vs Global Regulatory Guidelines (ICH, WHO)
Tamás L. Paál
National Institute of Pharmacy and Nutrition, Budapest, Hungary
Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Szeged, Hungary
17:40 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:
Beat Flühmann, Glattbrugg, Switzerland
José A. Guimarães Morais, Lisbon, Portugal
Zsolt Holló, Budapest, Hungary
Dominique Jordan, The Hague, The Netherlands
Tamás L. Paál, Budapest, Szeged, Hungary
Dange Veerapaneni, Hyderabad, India
18:10 End of Day 2.

Day 3
Wednesday, 17 November 2021

Session IX.Patient-Centric Drug Research

Chairs:
Henning H. Blume, Oberursel, Germany
Milena Jadrijević-Mladar Takač, Zagreb, Croatia
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
09:40 PL-21Nanomedicines – Ensuring Patient Safety through Regulatory Clarity
Mike P. Isles
Executive Director, European Alliance for Access to Safe Medicines (EAASM), Essex, UK
10:05 PL-225-Lipoxygenase: Its Noncanonical Function Unravels its Inhibitors as Powerful Antileukemic Drugs
Dieter Steinhilber1,2, Eugen Proschak2

1 President of European Federation for Pharmaceutical Sciences (EUFEPS), Stockholm, Sweden
2 Institute for Pharmaceutical Chemistry, University of Frankfurt, Frankfurt, Germany
10:30 Coffee Break, Exhibition and Poster Session
Session X.Vaccine Development in Global Pandemic Time

Chairs:
Leslie Z. Benet, San Francisco, CA, USA
Olavi Pelkonen, Oulu, Finland
11:00 PL-23Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of Protective Immune Responses
István Tóth1,2,3, Mariusz Skwarczynski1

1 School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, QLD, Australia
2 School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia
3 Institute for Molecular Bioscience, The University of Queensland, Brisbane, QLD, Australia
11:25 PL-24An Academic Approach to Vaccine Development in a Global Pandemic: A Personal Account
Allegra Peletta1, Chutitorn Ketloy2, Eakachai Pompetchara2, Gerrit Borchard1

1 Institute of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva,
Geneva, Switzerland
2 Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University Bangkok,
Bankok, Thailand
Session XI.Biopharmaceutics, Dissolution/Drug Release

Chairs:
A. Atilla Hincal, Ankara, Turkey
Lakshmanan Ramaswamy, Mumbai, India
11:50 PL-25Novel Oral Finite Time Pharmacokinetics
Panos Macheras
Department of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece
PharmaInformatics Unit, ATHENA Research Center, Athens, Greece
Department of Pharmaceutical Sciences, State University of New York, Buffalo, USA
12:15 PL-26The Gut in a Beaker: More Challenges for In Vitro Testing
Clive G. Wilson1,2, Gavin W. Halbert1,3, Ibrahim Khadra1, Claire Dunn1

1 Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University, Glasgow, Scotland, UK
2 ReVana Therapeutics Ltd., McClay Research Centre, Belfast, Northern Ireland, UK
3 Cancer Research Formulation Laboratories, University of Strathclyde, Glasgow, Scotland, UK
12:40 PL-27The Relations between Q3 Measurements, In Vitro Release and TCS
Flavian Ştefan Rădulescu1, Dalia Simona Miron1, Vinod P. Shah2

1 Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
2 Pharmaceutical Consultant, North Potomac, MA, USA
13:05 PL-28Bioequivalence for Highly Variable Drugs and Biosimilars: Agreements, Disagreements and Harmonization
László Endrényi1, László Tóthfalusi2

1 Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada
2 Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary
13:30 Lunch and Exhibition
Session XII.Progress in (Bio)Analytical Technologies

Chairs:
Danilo Corradini, Rome, Italy
Attila Felinger, Pécs, Hungary
14:40 PL-29Advanced (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

1 van ‘t Hoff Institute for Molecular Science (HIMS), University of Amsterdam, Amsterdam, The Netherlands
2 Centre of Analytical Sciences Amsterdam, Amsterdam, The Netherlands
15:05 PL-30Advances in LC/MS for the Characterization and Bioanalysis of Biotherapeutics
Jonathan L. Josephs1, Aaron Bailey2, Stephane Houel3

1 Director of Bioanalysis – US, Sanofi US, Waltham, MA, USA
2 Medical Branch, University of Texas Galveston, TX, USA
3 Thermo Fisher Scientific, San Jose, CA, USA
15:30 PL-31Confident 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
15:55 Coffee Break, Exhibition and Poster Session
Session XIII. Biopharmaceutics

Chairs:
Shashikant D. Joag, Mumbai, India
István Tóth, Brisbane, QLD, Australia
16:25 PL-32ADMET 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
16:50 PL-33Ionone: 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
17:15 Panel Discussion V. New Challenges in the Field of the Patient-Centric Drug Research, Biopharmaceutics, Dissolution and (Bio)Analysis

Moderators:
A. Atilla Hincal, Ankara, Turkey
José A. Guimarães Morais, Lisbon, Portugal
Panelists:
Gerrit Borchard, Geneva, Switzerland
Mike P. Isles, Essex, UK
Jonathan L. Josephs, Waltham, MA, USA
Panos Macheras, Athens, Greece
Peter J. Schoenmakers, Amsterdam, The Netherlands
Dieter Steinhilber, Stockholm, Sweden Frankfurt, Germany
Olavi Pelkonen, Oulu, Finland
Sven Stegemann, Graz, Austria, Müllheim, Germany
István Tóth, Brisbane, QLD, Australia
Clive G. Wilson, Glasgow, Scotland, Belfast, Northern Ireland, UK
17:45 Poster Award Ceremony

Chair of the Poster Award Committee:
Stefan Mühlebach, Basel, Switzerland
Members of the Poster Award Committee:
Georg A. Petroianu, Abu Dhabi, United Arab Emirates
Flavian Ştefan Rădulescu, Bucharest, Romania
Peter J. Schoenmakers, Amsterdam, The Netherlands
18:00 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
18:25 Closing Ceremony
End of Conference