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Confirmed Speakers and Presentations for 2019

Oligonucleotide Sessions

Antisense for a Billion People: The Development RNA-based Therapy for Elevated Lipoprotein(a)
Sotirios Tsimikas, M.D., Vice President of Global Cardiovascular Development, Ionis Pharmaceuticals, USA

Opening the Central Nervous System for RNAi-based Modulation
Anastasia Khvorova, Ph.D., Professor, RNA Therapeutics Institute, University of Massachusetts Medical School, USA

The Oligonucleotide Agent BC 007 for Neutralization of Pathogenic Agonistic Autoantibodies Directed Against Adrenoceptors in Heart Failure Patients – Update with Very First Phase II Data
Johannes Mueller, CEO and Founder, Berlin Cures, Switzerland

Gap Modifications Improve Therapeutic Index of Gapmer ASOs
Michael Oestergaard, Ph.D., Research Fellow, Ionis Pharmaceuticals, USA

Clinical Update on the NOX-A12 Oncology Program
Stefan Vonhoff, Ph.D., Vice President, NOXXON Pharma AG, Germany

Complete Enzyme Catalysed Oligonucleotide Synthesis: From Single Nucleotides to Final Product
David Tew, Project Leader and GSK Senior Fellow, Advanced Manufacturing Technology, GlaxoSmithKline, United Kingdom

RNAi Therapeutic Development
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, USA

Analytical Control Strategies for Oligonucleotides
Session Chair: Nadim Akhtar, Ph.D., Principal Scientist, Characterization and Control Strategies, AstraZeneca, United Kingdom

Nucleic Acid Chemistry and Chemical Modifications: Whys Is New MedChem So Hard to Implement?
Session Chair: Troels Koch, Ph.D., Industry Expert, Denmark

Getting Ready for One-mole Scale Commercial Manufacturing
Session Chair: Yogesh Sanghvi, Ph.D., President, Rasayan, USA

Non-Hepatic Delivery of Oligonucleotides and Other Delivery Strategies
Session Co-Chairs:
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, USA
Dmitry Samarsky, Ph.D., Chief Technology Officer, Sirnaomics, USA

MicroRNA-155 Inhibition by Cobomarsen Demonstrates Encouraging Activity in Hematological Malignancies
William Marshall, Ph.D., President & CEO, miRagen Therapeutics, Inc., USA (Invited)

New Phase 3 Results from Inclisiran and Lessons Learned
Clive Meanwell, CEO, The Medicines Company, USA (Invited)

Update on An Antisense Moving into Phase 3
Ana Isabel Jimenez Anton, Chief Operating Officer, Sylentis SA, Spain (Invited)

Phase Appropriate Method Validation Strategies for Antisense Oligonucleotides with Accelerated Product Development Timelines
Stacey Traviglia, Ph.D., Associate Director, Quality Control Analytical Technology, Biogen, USA

Experience with Early and Late Phase Global Submissions of Oligonucleotide-based Products
Cinzia Gazziola, Ph.D., Technical Regulatory Affairs Manager, Hoffmann-La Roche, Switzerland

Peptide Sessions

Development of the Stable, Fast Acting Glucagon Analogue NN9513 for Clinical Testing
Jesper F. Lau, Ph.D., Scientific Director, Research Chemistry, Novo Nordisk A/S, Denmark

Outer Membrane Targeting Antibiotics (OMPTA): Preclinical and Clinical Development of a Novel Class of Antibiotics against Life-threatening Gram-negative Infections
Anatol Luther, Ph.D., Head of Chemistry, Polyphor Ltd., Switzerland

Plants as Biofactories for Producing Peptide-based Pharmaceuticals 
David Craik, Ph.D., Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland, Australia

Regulatory Quality and CMC Perspectives on mRNA Vaccines and Peptide Vaccine Adjuvants
Ralf Wagner, Head Section Viral Vaccines, Paul-Ehrlich-Institut, Germany 

Advances in Peptide Synthesis and Applications in Therapeutic Development
Fernando Albericio, Ph.D., Professor, Organic Chemistry, University of Barcelona, Spain

Improving Peptide Manufacturing and Process Performance
Olivier Ludemann-Hombourger, Ph.D., Global Director Innovation and Strategy, PolyPeptide Group, France

Cost Efficient Production of Peptides and Oligonucleotides
Session Chair: Jurgen Machielse, Business Development Director, Zeochem AG, Switzerland

Advances in Peptide Vaccine Development
Session Chair: Alastair Hay, Ph.D., Account Manager, Peptide and Protein Technology, Almac, United Kingdom

Innovations in Peptide Manufacturing
Session Chair: Neil Thompson, Senior Director, Business Development Europe, PolyPeptide Group, Sweden

Development and Validation of a Peptide Bioassay
Michael Postlethwaite, Ph.D., Business Development Manager, Bachem Holding AG, Switzerland

Peptide Discovery Case Study
Rami Hannoush, Ph.D., Principal Scientist & Group Leader, Early Discovery Biochemistry, Genentech (Invited)

Peptide Clinical Program for Obesity
Lex Van der Ploeg, Ph.D., Chief Scientific Officer, Rhythm Pharmaceuticals (Invited)

New Science Advancing Peptide Design, Development and Manufacturing
Bradley Pentelute, Ph.D., Professor, Chemistry, Massachusetts Institute of Technology (Invited)

Surfactant Chemistry in Water 
Wilfride Braje, Scientist, AbbVie (Invited)

Process Validation, Risk Assessment Strategies and Peptide Case Study from Research to Phase 3 
Leila Malik, Ph.D., CMC Project Manager, Zealand Pharma AS, Denmark (Invited)
Fabrizio Badalassi, Ph.D., Director, Chemical Development, Ferring Pharmaceuticals, Denmark (Invited) 

mRNA Sessions

Advances in mRNA Therapeutics
Hari Pujar, Ph.D., Head, Technical Development, Moderna Therapeutics, USA

mRNA CMC from a Regulatory Affairs Perspective
Otmar Pfaff, Head of Regulatory Affairs, CureVac AG, Germany

mRNA Delivery
Sebastian Hörner, Head of Process Development, RNA Formulation & Drug Delivery, BioNTech AG, Germany

mRNA Therapeutic Development
Christian Plank, Ph.D., Chief Technology Officer, Ethris GmbH, Germany

Regulatory Quality and CMC Perspectives on mRNA Vaccines and Peptide Vaccine Adjuvants
Ralf Wagner, Head Section Viral Vaccines, Paul-Ehrlich-Institut, Germany 

Self Amplifying mRNA (SAM) Vaccines for Rapid Response
Derek O'Hagan, Ph.D., Head of Global Discovery Support & New Technologies, GSK Vaccines, USA

Inhibition and Degradation of Drug Targets Using bioPROTAC mRNAs – A Novel Approach with Broad Therapeutic Potential
Anthony Partridge, Ph.D., Principal Scientist, Early Discovery Pharmacology, Translational Medicine Research Centre, Merck Sharp & Dohme, Singapore

mRNA Therapeutics
Marina Cools & Peter Tomme, eTheRna, Belgium (Invited)

Delivery of Macromolecules Sessions

Applying New Imaging Modalities to the ADME of ASO and Peptide Drugs
Steve Hood, Ph.D., Director, Bioimaging and D@T, GlaxoSmithKline, United Kingdom

Delivery of Macromolecular Therapeutics: Advances from the COMPACT Consortium
Enrico Mastrobattista, Ph.D., Professor of Pharmaceutical Biotechnology and Delivery, Utrecht University, The Netherlands  

 mRNA Formulation/Delivery Program
Joanna Rejman , Ph.D., Associate Director Neurologic and Pulmonary Diseases, Product Design & Formulation, CureVac AG (Invited) 

Personalized Cancer Therapies Sessions

Development of Neoantigen-Based Personalized Cancer Vaccines
Jesse Dong, Ph.D., Vice President, Peptide Chemistry, Neon Therapeutics

Individualized Neoantigen-specific Therapy against Cancer Using messenger RNA
Christoph Kröner, Ph.D., Head of IVAC Mutanome Lead Structure, BioNTech AG, Germany

CRISPR Target Delivery
Lili Cui, Senior Formulation Scientist, PharmSci, AstraZeneca, United Kingdom