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Agenda for the Virtual Format of the conference

Please note: The agenda below is only for the virtual format.

1. Antibody Engineering & Therapeutics
2. Inhalation & Respiratory Drug Delivery
3. Pharmacovigilance & Drug Safety
4. Pre-filled Syringes & Injectables
5. Gut-Brain Axis
6. Probiotics, Human & Skin Microbiome
7. Aseptic Processing Technology
8. CDx/Biomarkers & Biobanking

Day 1

Day 2

Day 1 | 08:00
Antibody Manufacturing Strategies during a Pandemic
Nick Hutchinson, Business Steering Group Lead for Mammalian Cell Culture Services at FUJIFILM Diosynth Biotechnologies
Day 2 | 08:00
Fully human antibody discovery strategy
Li Chen, Director of Biologics Discovery at GenScript ProBio
Day 1 | 09:00
Lessons in Discovering Antibodies against GPCRs, Ion Channels, and Transporters
Benjamin Doranz, PhD, MBA President & CEO at Integral Molecular
Day 2 | 09:00
Topic to be announced
Vu Truong, Ph.D. Founder, Chief Executive Officer, and Director at Aridis Pharmaceuticals, Inc.
Day 1 | 10:00
Heavy Chain Only Antibodies to SARS-CoV-2
Dr. Philip Leighton, Sr. Director, Molecular Biology at Ligand Pharmaceuticals Incorporated
Day 2 | 10:00
Single-chain TNFSF ligands as building blocks for costimulatory bispecifics
Dr. Katharina Billian-Frey, Head of Protein Engineering at Apogenix AG
Day 1 | 11:00
Taking antibody candidate generation from the lab to the cloud with de novo computational design
Monica Berrondo, CEO at Macromoltek
Day 2 | 11:00
The art of making multifunctional antibodies: therapeutic opportunities and technical challenges
Harald Kolmar, Ph.D. Department Head and Professor of Applied Biochemistry at Technical University of Darmstadt
Day 1 | 12:00
Antibiotic Discovery by Means of Computers
César de la Fuente, Ph.D. Presidential Assistant Professor at UPenn
Day 2 | 12:00
Challenges in characterization and developability of multispecific antibodies
Soraya Hölper, PhD Lab Head Mass Spectrometry at Sanofi
Day 1 | 13:00
Designing and Developing Next-Generation Antibody-Drug Conjugate Medicines
Nicolas Camper, Group Leader, Bioconjugation Chemistry at Abzena
Day 2 | 13:00
Leap In Transposase Platform: From shiny and new to tried and true
Oren Beske, Ph.D. Amalgamator of Business and Biology at ATUM
Day 1 | 14:00
Novel Solution For High Throughput Antibody And Protein Purification Using Magnetic Beads.
Nishant Saxena, Ph.D. Product Manager, Protein Purification at GenScript USA Inc.
Day 2 | 14:00
Affinity maturation of B7-H6 translates into enhanced NK cell-mediated tumor cell lysis and improved proinflammatory cytokine release of bispecific immunoligands via NKp30 engagement
Stefan Zielonka, Associate Director at Merck KGaA
Day 1 | 15:00
Discovery and engineering of Immuno-oncology antibodies – Effective formats and impactful combinations
Marc A. van Dijk, Chief Technology Officer at Agenus Inc
Day 2 | 15:00
Building a Biotechnology Ecosystem.
Heather Schwoebel, Senior Vice President of BD, Head of Platform Licensing at Alloy Therapeutics, Inc.
Day 1 | 16:00
Funneling while maintaining diversity: strategies for therapeutic antibody campaigns
Ilse Roodink, Chief Scientific Officer at ImmunoPrecise Antibodies
Day 2 | 16:00
Bispecific γδ-T cell engagers for the treatment of cancer
Paul W.H.I. Parren, PhD, Executive Vice President and Head of R&D at Lava Therapeutics
Day 1 | 17:00
Antibody-targeted cytoplasmic delivery of fusion proteins and antibody fragments using Sapreme’s endosomal escape enhancers
Miriam Bujny, Chief Development Officer (CDO) at Sapreme Technologies
Day 2 | 17:00
Neo-X’: A bispecific antibody concept targeting CD40 and tumor antigens to enhance neoantigen cross-presentation and T cell priming.
Mattias Levin Sr Scientist, Antibody Engineering at Alligator Bioscience

Day 1

Part I: The challenges of developing inhalation drugs

Day 2

Part III: New Approaches to Treating Respiratory Diseases

Day 1 | 09:00
Biologics Delivered in Liquid Form by Soft-Mist-Inhalers (SMI)
Bernhard Müllinger, General Manager, Chief Operating Officer at Resyca
Day 2 | 09:00
Unmet Needs and Future Trends in Respiratory Drug Delivery
Paul Johnson, Managing Director at Paul Johnson Consulting Limited
Day 1 | 10:00
Shared Decision Making to Improve Adherence in Severe Asthma
Tonya Winders, President and Chief Executive Officer at Allergy & Asthma Network
Day 2 | 10:00
Towards development of patient-centric inhalers: Leveraging human factors, inhalation device and formulation science
Nélio Drumond, Senior Principal Scientist at Takeda Pharmaceuticals
Day 1 | 11:00
IVIVC testing for OINDP products - Bridging the gap and accelerating product to market journey
Anna Sipitanou, Business Development Manager at Copley Scientific
Day 2 | 11:00
Are Sustainability, Reusability and Carbon Neutrality Major Trends for Devices in the Future?
Felix Weiland, Head of Product & Process Technology at Boehringer Ingelheim
Day 1 | 12:00
Early Phase Clinical Trials for Inhaled Drugs - Challenges and Opportunities
Aernout van Haarst, PhD Director, Scientific Affairs at Celerion
Day 2 | 12:00
Optimising surrogate outcome measures for respiratory trials
Peter Robbins Professor of Physiology at the University of Oxford

Part IV: New analytical insights into dry powder formulations for inhalation

Day 1 | 13:00
Accurate dosimetry predictions for evolving liquid aerosol delivery
Arkadiusz Kuczaj, PhD, Manager Aerosol Research and Dosimetry at Philip Morris International Research and Development
Day 2 | 13:00
Digital Pharmaceuticals: A case study
Mark Milton-Edwards, Head of Product & Health Solutions - Digital Health at Teva Pharmaceuticals

Part II: Inhalation Formulation Solutions & Technology

Day 1 | 14:00
High Dosage DPI – formulation and process development considerations
Beatriz Noriega Fernandes, Scientist, Formulation Group - Drug Product Development at Hovione
Day 2 | 14:00
ARCUS®: Engineered Spray Dried Particles for Inhalation Delivery
Michael Tauber, Senior Director of Pharmaceutical Development and Technical Operations at Acorda Therapeutics
Day 1 | 15:00
Increasing the drug load in capsule based DPI drug delivery systems
Prof. Dr. Sven Stegemann, Professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria
Day 2 | 15:00
Musings on High Dose Powder Delivery
Jeffry Weers, Ph.D. Jeffry Weers, Chief Technical Officer at cystetic Medicines, Inc.

Part V: New Approaches to Inhalation Product Development and Production

Day 1 | 16:00
Formulation Development Challenges and Pitfalls When Developing Dry Powder Inhalers
Martin Wing-King, Director of Project Management at Quotient Sciences
Day 2 | 16:00
Inhalation and Nasal routes as stairways to drug Innovation
Hugo Almeida, International Business Development Consultant at AdAlvo (an Alvogen subsidiary)
Day 1 | 17:00
The development and supply of respiratory medicines
David Wyatt, Chief Operating Officer at Aston Particle Technologies
Day 2 | 17:00
A lung-on-chip approach towards predictive in vitro inhalation
Nuria Roldan, Project Leader at AlveoliX
Day 1 | 18:00
Get it right first time: Inhaler technology and manufacturing
Marco Laackmann, Director Inhalation Technology at Harro Höfliger
Day 2 | 18:00
Science base and challenges of therapeutic equivalence of respiratory products.
Jörg Schiewe, Head of Global CMC Experts at Boehringer Ingelheim
Day 1 | 19:00
MDPI for 2 API
Markus Mezger, CEO at Mematec solutions
Day 2 | 19:00
The biological barriers to consider for the development of inhaled biotherapeutics
Thomas Secher, Research scientist (CRCN) at INSERM

Day 1

Day 2

Day 1 | 10:00
PSMF in a global environment: compliance with local requirements
Margherita D'Antuono, Corporate Pharmacovigilance Director - EU QPPV at Italfarmaco Group
Day 2 | 10:00
Communicating safety safely: what can we learn from Covid-19?
Uwe Gudat, Head of Medical Affairs & CSPV at Fresenius Kabi at Fresenius Kabi SwissBioSim GmbH
Day 1 | 11:00
EudraVigilance, XEVMPD, EVDAS, SPOR, EMA unique account news
Calin Lungu, CEO at DDCS S.A.
Day 2 | 11:00
New Trends in Signal Detection and Management
Robert Weber, Product Management Director at Oracle
Day 1 | 12:00
How to define PV strategy and build an effective Regulatory Intelligence function
Julia Appelskog, Pharmacovigilance Director, EU QPPV, Head of QPPVs & Safety Consulting Services at TFS
Day 2 | 12:00
The Evolution of the Safety Scientist
Dennis Vargo, Vice President and Head of Drug Safety and Pharmacovigilance at Akebia
Day 1 | 14:00
Adoption of Artificial Intelligence in Pharmacovigilance: a framework for the development of cognitive services and the role of the Drug Safety Professional
Salvatore Cicirello, Head of Safety Science & PASS, Global Drug Safety & Risk Management at Bristol Myers Squibb
Day 2 | 14:00
PV challenges during pandemic:
Mircea Ciuca, Global Therapeutic Area Head - Global Clinical Safety and Pharmacovigilance at CSL Behring
Day 1 | 15:00
Synergies between Regulatory Affairs and Pharmacovigilance
Budhesh Dhamija, Senior Manager, Regulatory Intelligence and Policy – Europe at CSL Behring
Day 2 | 15:00
Cardiovascular safety issues during phase III-IV for non-cardiovascular trials.
Anupam Agarwal, Vice President, Global Head of Drug Safety and Pharmacovigilance at Zogenix, Inc.
Day 1 | 16:00
How Pharmacovigilance could support business
Andrea Oliva, Head of Pharmacovigilance at Mylan
Day 2 | 16:00
Structured and Quantitative Benefit-Risk evaluation for medicinal products: how can it make a difference?
Marie-Laure Kürzinger, Benefit-Risk Expert - Global Epidemiology & Benefit-Risk Evaluation - Global Pharmacovigilance at Sanofi

Day 1

Day 2

Day 1 | 09:00
User-driven product development: Focus on self-injection devices
Jakob Lange, Account Director at Ypsomed AG
Day 2 | 09:00
Innovation through Miniaturization and Micro Injection Molding
Aaron Johnson, Vice President of Marketing and Customer Strategy at Accumold
Day 1 | 10:00
Next generation design and materials for PFS
Amber Witteman, Inventor, Founder, Managing Director at EPIWatch
Day 2 | 10:00
Modular Feeding Systems for Parenterals, such as Pre-filled Syringes and Injection Devices
Ashley Reynolds, Pharma Technology Sales and Marketing at Körber Group company
Day 1 | 11:00
Next generation design and materials for PFS
Amber Witteman, Inventor, Founder, Managing Director at EPIWatch
Day 2 | 11:00
Developing suspensions as long acting injectables
René Holm, Head and Scientific Director, Liquids & Parenterals at The Janssen Pharmaceutical Companies of Johnson & Johnson
Day 1 | 12:00
Extractable metals: potential sources in your Prefilled Syringes, risk management and change control
Beate Treffler, Market Development Manager Healthcare EMEA at Avient Corporation
Day 2 | 12:00
Long-Acting Injectable Formulation Technologies: Challenges and Opportunities for the Delivery of Fragile Molecules
Joël Richard, Chief Development Officer at MedinCell
Day 1 | 13:00
Impact of the EU MDR 2017/745
Bassil Akra, CEO at AKRA TEAM GmbH
Day 2 | 13:00
Aseptic Production and IPC
Andreas Kerschbaumer, Senior Technical Manager at Sandoz GmbH
Day 1 | 14:00
A forward looking approach towards design & development of patient-centric autoinjectors
Asmita Khanolkar, Senior Director, Cambridge Pharma at SMC Ltd
Day 2 | 14:00
Beyond glass – benefits for biological drugs of a new hybrid material for primary packaging container
Holger Krenz Vice President Applications Development Europe at SiO2 Material Science
Day 1 | 15:00
Nonclinical safety evaluation of extractables and leachables when developing a pre-filled syringe drug device combination product
Clemens Günther, Director Senior Expert Nonclinical Safety at Bayer AG
Day 2 | 15:00
An industrial perspective for fill & finish of nested syringes
Franz Kainz, PhD Vice President, Global Contract Manufacturing at Fresenius Kabi Deutschland GmbH
Day 1 | 16:00
Extractables & Leachables Qualification in Pre-Filled Syringes
Raphael Nudelman, Senior Director Impurity Expert, R&D Operations at Teva Pharmaceuticals
.

Day 1

Day 2

Day 1 | 09:00
Can a diet tackle stress?
Nadejda Lupolova, Health Coach
Day 2 | 09:00
Harnessing the Potential of Microbiota-related Therapies for Brain Health
Jane A. Foster, Associate Professor at McMaster University
Day 1 | 10:00
Mechanisms and current evidence of prebiotics in gut-brain-axis
Dr. Yoghatama Zanzer, Manager Nutrition Science at BENEO, Germany
Day 2 | 10:00
Pioneering precision probiotics: from molecular mimetism to product commercialization
Nina Vinot, International Sales Director at TargEDys
Day 1 | 11:00
Leveraging the microbiome in Alzheimer's disease progression and neuroinflammation
Alessio Mylonas, Research Scientist at AC Immune
Day 2 | 11:00
The gut-brain and brain-gut axes in human disease
Wouter de Jonge, Professor of Neurogastroenterology at AMC, CoFounder of Gut Research
Day 1 | 12:00
The gut microbiome as a therapeutic venue for inflammatory diseases of the central nervous system (CNS)
Javier Ochoa-Repáraz, Associate Professor at Eastern Washington University
Day 2 | 12:00
Molecular Mimicry of microbial and dietary immune triggers as the key to disease complexity in Parkinson's
Martha Carlin, Chief Executive Officer at The BioCollective
Day 1 | 13:00
ImmuneBiotics for management of neurological conditions – new clinical evidence
Shahram Lavasani, Founder and CEO at ImmuneBiotech AB
Day 2 | 13:00
Microbiome Mediated Appetite Regulation - First Experiences with EnteroSatys
Dr. Sergueï O. Fetissov, Professor of physiology at Rouen University and co-founder of TargEDys.
Day 1 | 14:00
Novel Microbiome Approach For Management of Alzheimer Diseases
Satya Prakash, Professor of Biomedical Engineering, Artificial Cells and Organs, Physiology, Experimental Medicine and Surgury in the Faculty of Medicine at McGill University
Day 2 | 14:00
Diet & the Gut-Brain Axis: from concept to product
Marcus Böhme, R&D Specialist at Nestlé Research

Day 1

Day 2

Day 1 | 09:00
Developing global standards for the microbiome field
Chrysi Sergaki, Microbiome Scientist at National Institute for Biological Standards and Control (NIBSC/MHRA)
Day 2 | 09:00
Considering the Microbiome Interorgans Axis (MIA) as a future option in Health & Diseases
Lionel Breton, Cofounder and executive VP of IDEC therapeutics
Day 1 | 10:00
Quality control of probiotics and internationalisation of the ESLP initiative
Jean-Pol Warzée, President at European Scientific League for Probiotics – ESLP
Day 2 | 10:00
S-Biomedic approach of direct skin microbiome modulation
Veronika Oudova, Co-founder and Chief Executive Officer at S-Biomedic
Day 1 | 11:00
Unravelling the microbiome of inflammatory bowel disease
Marcus Claesson, Chief Executive Officer at SeqBiome
Day 2 | 11:00
The human microbiome is not an island.
Newton Gomes Researcher University of Aveiro/Co-founder at InnerCore Microbiome
Day 1 | 12:00
Measuring the microbiome: Path towards products that work in balance with the microbiome
Dr. Eline Klaassens, Product Manager Human Health at BaseClear B.V.
Day 2 | 12:00
Topical rosemary extract containing carnosic acid inhibits Staphylococcus aureus virulence in vitro and reduces the signs and symptoms of adult skin irritation and eczema in a randomized, double-blind, vehicle-controlled pilot study.
Greg Hillebrand, Senior Principal Research Scientist at Amway
Day 1 | 13:00
The underarm microbiome and the development of new probiotics
Dr Chris Callewaert, Senior Post-doctoral Researcher at Ghent University, Belgium
Day 2 | 13:00
Scalp Microbiome, how to develop specific products, and for what results?
Marie Drago, Founder at Gallinée
Day 1 | 14:00
Microbes and the Skin: Science, Regulation and the Marketplace
George Paraskevakos, Executive Director at International Probiotics Association (IPA)
Day 2 | 14:00
Platform that allows to study the connections among diet, gut microbiome, immune system, human physiology, and health/disease states
Momo Vuyisich, Founder and Chief Science Officer at Viome
Day 1 | 15:00
Fertibiome, a probiotic for couples with infertility problems.
Sergio Esteban, Project Manager at Probisearch SLU
Day 2 | 15:00
Ammonia Oxidizing Bacteria as a Treatment for Inflammatory Skin Disease
Daniel Brownell, Director, Research & Development at AOBiome Therapeutics
Day 1 | 16:00
Studying the variability of intestinal microbiome in mice to better understand the Human microbiome
Pavlovic Guillaume, Head of Unit at PHENOMIN-ICS
.

Day 1

Day 2

Day 1 | 09:00
Vaccines for the world - insights into design and execution of a BSL2 fill-finish facility
Matthias Angelmaier, Global Product Manager Isolator Technology at Syntegon Technology GmbH
Day 2 | 09:00
Continuous Processing opening new possibilities
Harald Stahl, Senior Director Innovation and Strategy at GEA AG
Day 1 | 10:00
Closed process for aseptic fill without possibility for sterile filtration
Magnus Gustafsson, Head of Global Business Development at Biovian
Day 2 | 10:00
Aseptic bag processing: bridging the gap
Christian Kollecker, Business Unit Leader Pharma Liquid / Aseptic at Harro Höfliger
Day 1 | 11:00
Learn How to Trend & Analyze Environmental Monitoring Data
Susan Cleary, Director of Product Development at Novatek International
Day 2 | 11:00
Use of Robotics in Flexible Format Aseptic Filling
Keith W. Dodson, Vice President of Business Development at AST (Automated Systems of Tacoma)
Day 1 | 12:00
Contamination and Cross Contamination Control during Aseptic Manufacturing
Richard Denk, Senior Consultant Aseptic Processing & Containment at SKAN AG
Day 2 | 12:00
Concept and Implementation of a Global Contamination Control Strategy
Christoph Hansy, Global Microbiology Management at Takeda
Day 1 | 13:00
Innovative and Agile Approaches in the Aseptic Manufacturing of Lyophilised Vialed Drug Products
Dr. Thomas Becker, Director Site Quality at Recipharm
Day 2 | 13:00
Contamination Control Strategy, an Implementation approach.
Walid El Azab, Senior Manager Technical Service at STERIS
Day 1 | 14:00
Combined ATMP Viral vector formulation and filling on an integrated Barrier technology platform
James L. Drinkwater, Head of GMP compliance & Aseptic process integration F Ziel GbmH
Day 2 | 14:00
Trends in Manufacturing Dry Vaccine Product
Sue Behrens, Professor in Bioprocessing and Director, Amgen Bioprocessing Center at Keck Graduate Institute

Day 1

Biobanking (Part I)

Day 2

CDx & Biomarkers (Part II)

Day 1 | 09:00
Biobanking During the COVID-19 Pandemic
Jim Vaught, Ph.D. Editor-in-Chief, Biopreservation & Biobanking
Day 2 | 09:00
Overcoming the challenges of RNASeq with extraction-free, low sample input gene expression profiling by the HTG Transcriptome Panel
Selina Gaertner, Medical Affairs Manager EMEA at HTG Molecular Diagnostics
Day 1 | 10:00
Epigenetic biomarkers for Type 2 Diabetes from plasma - and saliva derived extracellular vesicles
Dr. Christa Noehammer, Senior Scientist at AIT (Austrian Institute of Technology)
Day 2 | 10:00
Molecular Characterization of CTCs in ALK-rearranged Non-Small-Cell Lung Cancer resistant to ALK inhibitors
Marianne Oulhen Head of Projects at Gustave Roussy
Day 1 | 11:00
From Biobanking to Personal medicine and Prevention
Prof. Andres Metspalu, Professor at University of Tartu
Day 2 | 11:00
Current challenges of liquid biopsy research
Klaus Pantel, Chairman of the Institute of Tumour Biology at the University Medical Center Hamburg-Eppendorf.
Day 1 | 12:00
Modern Biobanking - Critical Success Factors and future considerations.
Karine Sargsyan, Chief Operating Officer at Biobank Graz
Day 2 | 12:00
Liquid Biopsy: From Discovery to Clinical Application
Dr. Catherine Alix-Panabières, Director LCCRH at the University Medical Center of Montpellier
Day 1 | 13:00
BBMRI-ERIC partnering to support Research and Development for improved Precision Medicine
Professor Jens K. Habermann, Director General at BBMRI-ERIC
Day 2 | 13:00
Commercialization of companion diagnostics
Dr. Reinhard Ortmann, Director Companion Diagnostics at QIAGEN
Day 1 | 14:00
Towards returning actionable genetic research results to biobank participants
Shona Kerr, Project Manager at MRC Human Genetics Unit, Edinburgh
Day 2 | 14:00
Clinical applications of liquid biopsies
Christian Werno, Research group leader at Fraunhofer Institute

CDx & Biomarkers (Part I)

Biobanking (Part II)

Day 1 | 15:00
Circulating biomarkers for cancer diagnosis and precision medicine
Yong-Jie Lu MD, PhD Professor in Molecular Oncology at Queen Mary University of London
Day 2 | 15:00
Biobanking of spheroids/organoids/tumoroids
Ida Biunno, Professor at Biomedicine at the University of Milano
Day 1 | 16:00
Biomarkers in pathology and radiology
Carla Leibowitz, Chief BD Officer at Paige.AI
Day 2 | 16:00
Biobank - an overview
Ing. Pasquale De Blasio, Founder & CEO of Integrated Systems Engineering (ISENET)
Day 1 | 17:00
Regulatory-scientific challenges for predictive biomarker based personalized medicines
Dr. Jörg Engelbergs, Scientific-Regulatory Expert at Paul-Ehrlich-Institut & European Medicines Agency
Day 2 | 17:00
All about the qualification in Biorepository Science (QBRS)
Brent Schacter, MD FRCPC FCAHS Professor Emeritus at Rady College of Medicine, University of Manitoba
Day 1 | 18:00
Need for workflow solutions from sample collection to diagnostic assay
Daniel Grölz, Scientific Associate Director R&D, Sample Technologies Department at QIAGEN
Day 2 | 18:00
Building a GMP Biobanking Network in Europe
Dr. Vincent von Walcke-Wulffen, CEO at BioKryo GmbH