Preliminary Programme

Day 1
Monday, 19 October 2020

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:
Krisztián Fodor, Budapest, Hungary
Carl Peck, San Luis, CA, USA
Joseph W. Polli, Chapel Hill, RTP, NC, 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-7How 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
16:50 PL-8Pharmacovigilance 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
17:15 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
Dominique Jordan
, The Hague, The Netherlands
Stefan Mühlebach
, Basel, Switzerland
Paolo Rocco
, Milan, Italy
17:45 End of Day 1.

Day 2
Tuesday, 20 October 2020

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., Kent, UK
10:20 PL-9Drug Development Strategy in the United States: An Industrial View of DMPK
Joseph W. Polli
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.
Regulatory Science, New Data Science Concept and Drug-Device Combination Products

Chairs:
Panos Macheras, Athens, Greece
Georg A. Petroianu, Abu Dhabi, United Arab Emirates

11:10
PL-10Regulatory Science Challenges – Encourage Innovation through an
Adaptive Regulatory System
Krisztián Fodor
Regulatory Science and Patient Safety Department, Gedeon Richter Plc., Budapest, Hungary
11:35
PL-11Data Science – From Concept to Reality
Olivier Leconte1, Sina Djali2

1 Global Head of Statistical Programming & Analysis
Global Clinical Development Operations – IDAR
Janssen-Cilag Research & Development, Zug, Switzerland
2 Janssen R&D US, Spring House, PA, USA
12:00 PL-12Regulatory Pathway for Drug-Device Combination Products in US
David R. Savello
Co-founder and Partner, NDA Partners LLC, Rochelle, VA, USA
12:25 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, UK
Belfast, Northern Ireland, UK

  Panelists:
István Greiner, Budapest, Hungary
Olivier Leconte, Zug, Switzerland
Mark Latymer Sandwich, Kent, UK
David R. Savello, Rochelle, VA, USA
Dange Veerapaneni, Hyderabad, India
12:55
Lunch and Exhibition
Session VII.
Advances in Drug Delivery System

Chairs:
Milena Jadrijević-Mladar Takač, Zagreb, Croatia
Vijay U. Kshirsagar, Mumbai, India

14:05 PL-13Lipopeptide Nanoparticulate Vaccine Candidates for the Induction of
Protective Immune Responses
István Tóth 1,2,3, Mariusz Skwarczynski 1

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
14:30 PL-14Supramolecular Structure and Stability of Nanofibrous Drug Delivery Systems
Romána Zelkó
University Pharmacy Department of Pharmacy Administration,
Semmelweis University, Budapest, Hungary
14:55 PL-15Advanced Drug Delivery Systems:
From Nano- and Microparticles to Smart Pills
István Antal
Department of Pharmaceutics, Semmelweis University, Budapest, Hungary
15:20 PL-16Advances in Transdermal Drug Delivery System
Dange Veerapaneni
Sparsha Pharma International Private Ltd, Hyderabad, India
15:45 Coffee Break, Exhibition and Poster Session
Session VIII.
Global Harmonization of Regulations

Chairs:
Éva Szökő, Budapest, Hungary
Judit Tarnai, Budapest, Hungary

16:10 PL-17Future of the Hungarian Drug Market – Role of the Hungarian Regulatory Authority
Mátyás Szentiványi
Director General, National Institute of Pharmacy and Nutrition, Budapest, Hungary
16:35 PL-18Global Biosimilar Drug Development: Any Chance for Consolidation after 15 Years of Positive Regulatory Experience?
Zsolt Holló
Egis Pharmaceuticals Plc, Budapest, Hungary
17:00 PL-19Innovative 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
17:25 Panel Discussion IV.
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
Tamás L. Paál, Budapest, Hungary
Szeged, Hungary
Carl Peck, San Luis, CA, USA
17:55 End of Day 2.

Day 3
Wednesday, 21 October 2020

Session IX.
Patient-Centric Drug Research

Chairs:
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
09:40 PL-20Nanomedicines – Ensuring Patient Safety through Regulatory Clarity
Mike P. Isles
Executive Director, European Alliance for Access to Safe Medicines (EAASM), Essex, UK
10:05 PL-21The Place of Science in the “One FIP Strategy”
Dominique Jordan
President of International Pharmaceutical Federation (FIP), The Hague, The Netherlands
10:30 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
10:55 Coffee Break, Exhibition and Poster Session
Session X.
Biopharmaceutics, Dissolution/Drug Release

Chairs:
A. Atilla Hincal, Ankara, Turkey
Lakshmanan Ramaswamy, Mumbai, India

11:25 PL-23Back to the Basics: Reconsidering the Assumptions of Drug Dissolution, Release and 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
11:50 PL-24The Gut in a Beaker: More Challenges for In Vitro Testing
Clive G. Wilson 1,2, Gavin W. Halbert 1,3, Ibrahim Khadra 1, Claire Dunn 1

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
12:15 PL-25The Relations between Q3 Measurements, In Vitro Release and TCS
Flavian Ştefan Rădulescu 1, Dalia Simona Miron 1,  Vinod P. Shah 2

1 Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
2 Pharmaceutical Consultant, North Potomac, MA, USA
12:40 PL-26Bioequivalence for Highly Variable Drugs and Biosimilars: Agreements, Disagreements and Harmonization
László Endrényi 1, László Tóthfalusi 2

1 Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada
2 Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary
13:05 Lunch and Exhibition
Session XI.
Progress in (Bio)Analytical Technologies

Chairs:
Danilo Corradini, Milan, Italy
István Tóth, Brisbane, Australia

14:20 PL-27Advanced (Multi-Dimensional) Separations for Practical Applications
Alina Astefanei 1,2, Andrea F.G. Gargano 1,2, Gino Groeneveld 1,2,
Bob W.J. Pirok 1,2, Peter J. Schoenmakers 1,2

1 van ‘t Hoff Institute for Molecular Science (HIMS), University of Amsterdam, Amsterdam, The Netherlands
2 Centre of Analytical Sciences Amsterdam, Amsterdam, The Netherlands
14:45 PL-28Advances in LC/MS for the Characterization of Biotherapeutics
Jonathan L. Josephs 1, Aaron Bailey 2, Stephane Houel 3

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
15:10
PL-29Confident Analytical Characterization from Drug Discovery to Development
Krisztina Radi 1, Kristina Srzentić 2, Amy Claydon 1

1 Thermo Fisher Scientific, Hemel Hempstead, United Kingdom, UK
2 Thermo Fisher Scientific, Cambridge, MA, USA
15:35 Coffee Break, Exhibition and Poster Session
Session XII.
Biopharmaceutics

Chairs:
Shashikant D. Joag, Mumbai, India

16:05 PL-30Ionone: The Molecule That Shaped the History of Western Civilization
Georg A. Petroianu
Professor and Chair of Pharmacology, College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates
16:30 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:
Jonathan L. Josephs, Waltham, MA, USA (to be confirmed)
Vijay U. Kshirsagar, Mumbai, India
Panos Macheras, Athens, Greece
Peter J. Schoenmakers, Amsterdam, The Netherlands
Dieter Steinhilber, Stockholm, Sweden
Frankfurt, Germany
17:00 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

17:15 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