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QbD in Process Development and Manufacturing13.30 - 17.30
Workshop Leader: Alessandro Butté, Lecturer, ETH Zurich
BOOK BY 31ST MARCH 2017 AND SAVE £400BOOK BY 28TH APRIL 2017 AND SAVE £200BOOK BY 31ST MAY 2017 AND SAVE £100
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSWednesday 5th July 2017, Holiday Inn Kensington Forum, London, UK
www.peptidesevent.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE@SMIPHARM#smipeptides
Oral Delivery of Peptides and Proteins08.30 - 12.30
Workshop Leaders: Roger New, Co-founder & CSO, Proxima Concepts Ltd
and Driton Vllasaliu, Senior Lecturer, University of Lincoln
HIGHLIGHTS IN 2017: • Gather more in-depth knowledge about using LC-MS
applications for peptide purifi cation from the key sessions in the Liquid Chromatography and Mass Spectrometry Techniques stream
• Listen to informative presentations on Protein-Protein Interactions, featuring discussion points on antibodies, small molecule drug discovery and peptidomimetic inhibitors
• Learn more about peptide characterisation from our expert speakers discussing stability, purifi cation, synthesis, and other peptide properties
• Hear about strategies for peptide half-life extension, the new technologies used in therapeutic peptide development, production and manufacturing, and what the future trends are for peptides in the biopharmaceutical industry
SMi present its 4th Annual Conference on...
Peptides Addressing the latest peptide therapeutics advances to accelerate discovery, development and delivery
Holiday Inn Kensington Forum, London, UK
CONFERENCE: 6TH - 7TH
WORKSHOPS: 5TH
JULY 2017
CHAIRS: • John Reilly, Senior Research Investigator, Novartis • Lutz Jermutus, Senior Director & Product Development
Team Leader, MedImmune
KEY SPEAKERS INCLUDE: • Alastair Lawson, Vice President, Structural Biology, UCB • Cecile Brocard, Director, Downstream Development,
Boehringer Ingelheim • Jonathan Davis, Principal Scientist, Bristol-Myers Squibb • Dieter Kadereit, Lab Head, Peptides & Insulins, IDD, R&D, Sanofi • Marie Skovgaard, Director Medicinal Chemistry,
Zealand Pharma • Marion King, Analytical Development Manager, Ipsen
Sponsored by
Register online at www.peptidesevent.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected]
Bachem provides comprehensive services to the pharma and biotech industries. It specializes in the development of innovative, effi cient manufacturing processes and the reliable production of peptide-based APIs. The group has a global reach with more experience and know-how than any other company in the industry. Bachem. Pioneering Partner for Peptides. www.bachem.com
Tepnel Pharma Services is an independent Contract Research Organisation which supports the drug development pipeline at the Rx/Dx interface. With over 30 years of experience in supporting pharmaceutical, biopharmaceutical and biotechnology companies through the provision of outsourced cGMP compliant Chemistry, Manufacturing and Control (CMC) and human genetics testing, Tepnel Pharma Services is positioned to provide CMC support for drug development, whilst also providing a companion diagnostic solution which addresses the requirements of personalised and stratifi ed medicines. www.tepnelpharmaservices.com
Sponsored by
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks John Reilly,
Senior Research Investigator, Novartis
PROTEIN-PROTEIN INTERACTIONS
OPENING ADDRESS: 09.10 Antibody-enabled small molecule drug discovery • Protein-protein interactions • Conformational defi nition of target proteins • Allosteric modulation of dynamics • Fragment library design and screening Alastair Lawson, Research Fellow, Vice President Structural
Biology, UCB
09.50 Understanding the Structure Activity Relationship of the Nrf2-KEAP1 protein-protein interaction site using an Nrf2-neh2 peptide library design approach
• Activation of innate antioxidant responses holds much therapeutic potential in neurodegenerative diseases, such as Huntington’s disease
• Keap1-Nrf2 pathway plays a central role in cell protection against oxidative and electrophilic stress
• Structure activity relationship (SAR) studies were performed on Nrf2 to identify peptide inhibitors of the Nrf2/Keap1 protein-protein interaction
• Inspiring medicinal chemistry efforts towards peptidomimetics and macrocyclic inhibitors development
Elisabetta Bianchi, Head of Peptide Chemistry, IRBM Science Park
10.30 Morning Coffee & Networking Break
PEPTIDOMIMETIC INHIBITORS AND PEPTIDE NANOTECHNOLOGY
11.00 Synthesis of novel peptidomimetic inhibitors of Caspase I • Proteomics and transcriptomic studies have shown a strong
induction of IL-1� expression in acne infl ammatory skin lesions • IL-1� usually exists in its pro-form which is cleaved to its active
form by the aspartic cysteine protease Caspase-1 upon infl ammatory stimulus
• Blocking Caspase I, therefore, presents an attractive option for the development of a new generation of anti-acne medicine
• This presentation will concentrate on the synthesis of novel peptidomimetic inhibitors of Caspase I
Craig Harris, Head of Research Synthesis, Nestlé Skin Health
11.40 Combinatorial Peptide Nanotechnology for Drug Discovery • Peptide nondomains • Receptor agonists
• A priori drug discovery • From test tube to whole organism Roger New, Co-founder & CSO, Proxima Concepts Ltd
12.20 Networking Lunch
13.30 Fusion Strategy for the Recombinant Expression of Therapeutic Peptides in Microbial
• Non-Platform Process • Expression in E. coli, Inclusion Bodies and Protein Refolding • Protease Fusion Technology • Production of Therapeutic Peptides at Industrial Scale Cecile Brocard, Director, Downstream Development,
Boehringer Ingelheim
14.10 From peptide lead candidate to pharmaceutical drug product • Process development, scaling-up and validation • Characterisation and process validation • Specifi cations and registration • Specifi c challenges associated with contract manufacturing
service providers Vincent Bille, Managing Director, Marble Pharma Consult
14.50 Afternoon Tea & Networking Break
LIQUID CHROMATOGRAPHY AND MASS SPECTROMETRY TECHNIQUES
15.20 High Throughput Purifi cation and Characterisation of Peptides Using LC/MS/ELSD Techniques
• Peptide QC • Purity analysis using LC/MS/ELSD techniques • Peptide purifi cation • High Throughput purifi cation workfl ow Bhagyashree Khunte, Senior Principal Scientist, Pfi zer
16.00 LC-MS a key technique to understanding the fate of impurities in Ferring’s synthetic therapeutic peptides
• LC-MS a great tool to understand fate of impurities • Separation is crucial as well as identifi cation of impurities • Identifi cation of impurities originating from starting material,
synthesis, purifi cation and degradation of peptides • Examples from Ferring’s synthetic peptide portfolio Jörgen Kjellgren Sjögren, Senior Research Scientist,
Ferring Pharmaceuticals
16.40 Mass-spectrometry based immunopeptidomics for personalised cancer immunotherapy
• Biochemical extraction of HLA binding peptides form tumour tissues
• Advanced mass-spectrometry analyses for identifi cation and validation of HLA binding peptides
• Immunopeptidomics in combination with genomics for identifi cation of clinically relevant neo-antigens
• Prioritisation of tumour antigens for vaccination Michal Bassani-Sternberg, Head of Immunopeptidomics Unit,
CHUV and The Ludwig Cancer Institute
17.20 Chairman’s Closing Remarks and Close of Day One
Peptides Day One | Thursday 6th July 2017 www.peptidesevent.com
Register online at www.peptidesevent.com Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIESWant to know how you can get involved? Interested in promoting your services to this market?
Contact Honey De Gracia, SMi Marketing on +44 (0) 207 827 6102 or email: [email protected]
Lead Media Partner: Supported by
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks Lutz Jermutus,
Senior Director and Product Development Team Leader, MedImmune
HALF-LIFE EXTENSION OF PEPTIDES
OPENING ADDRESS: 09.10 Recent Progress in the Development of Once-Weekly GLP-1
Receptor Agonists • Strategies for half-life extension • Established products in the GLP-1 fi eld • Emerging technologies, including own data Dieter Kadereit, Lab Head, Peptides & Insulins, IDD, R&D, Sanofi
09.50 Extending Drug Half-Life to Achieve Monthly Dosing? The Potential of Veltis® Engineered Albumins for Optimised Dosing
• Short circulatory half-life represents a major obstacle for many peptide-based therapeutics
• This can be signifi cantly improved by conjugation or fusion to albumin, due to increased size and recycling via the neonatal Fc receptor (FcRn)
• The increased FcRn affi nity of the Veltis® engineered albumins translates to more than doubling of the already long half-life of native sequence albumin
• We will describe rationally engineered albumins and their application to improve delivery of peptides
Joanna Hay, Science Manager, Albumedix
10.30 Morning Coffee & Networking Break
11.00 From challenging peptide to drug candidate – the dasiglucagon story
• Learnings from native glucagon • Optimisation of soluble and chemically stable glucagon analogs • Clinical summary Marie Skovgaard, Director Medicinal Chemistry, Zealand Pharma
IMPROVING FUTURE PEPTIDE DEVELOPMENT
11.40 Peptides in the biopharmaceutical industry today and tomorrow • Small versus big molecules – benefi ts and differences in
development & manufacturing of peptides • Industrial pipelines and disease areas addressed by biotherapies • NBEs versus NCEs • Future trends in manufacturing
Frank Thielmann, PMO & Operational Excellence Lead, Novartis
12.20 Networking Lunch
13.30 Conquering a peptide optimisation challenge using protein engineering techniques and deliberate potency reduction
• Challenge: Optimising gp41-binding peptide to be a component of a tri-functional therapeutic
• Generated libraries of variant peptides fused to a globular protein, expressed and purifi ed in E. coli
• Reduced the potency of the parental peptide via truncation, to allow favourable mutations to be recognised
• Final peptide became part of a tri-specifi c biologic therapeutic with picomolar potency and broad spectrum against HIV
Jonathan Davis, Principal Scientist, Bristol-Myers Squibb
14.10 Optimisation of peptide stability • Physical and chemical stability • Methods for determination of physical and chemical stability • Optimisation of peptide stability Martin Will, Section Head MedChem, Sanofi
14.50 ReadyFlow - a fi rst in class coagulant for controlling surgical bleeding
• Unmet needs in the control of surgical bleeding and key factors to determine success
• HX-P12 peptide: a fi rst in class peptide coagulant • Design of a particulate hydrogel formulation • Current ReadyFlow formulation; challenges and progress Renata Zbozien, Vice President R&D, Haemostatix
15.30 Afternoon Tea & Networking Break
MASS SPECTROMETRY APPLICATIONS AND CHROMATOGRAPHY STRATEGIES
16.00 The use of high resolution mass spectrometry applications for both development and commercial peptides
• Mass Spectrometry of peptides that involve ligation technologies
• Mass Spectrometry for confi rming the removal of solid phase coupling reagents
• Mass Spectrometry for impurity identifi cation in life cycle management activities
Marion King, Analytical Development Manager, Ipsen
16.40 Purifi cation, Characterisation and Physicochemical Properties of Peptides within Discovery Chemistry
• Chromatographic purifi cation strategies for cyclic and linear peptides including SFC, LC and Flash methodologies
• Stoichiometry of fi nal salt forms using Ion Chromatography • Extraction strategy to remove TFA from fi nal products • Physicochemical Trend Analysis on fi nal products John Reilly, Senior Research Investigator,
Novartis Institutes for BioMedical Research
17.20 Chairman’s Closing Remarks and Close of Day Two
Peptideswww.peptidesevent.com Day Two | Friday 7th July 2017
Oral Delivery of Peptides and Proteins
Overview of the workshop:Topics covered will include:• Overview of routes across the intestinal cell wall• Encapsulation technologies for peptides and proteins• Research and development of absorption enhancement
technologies• Application to peptide hormones and vaccine antigens –
case studies
Why should you attend this workshop:An increasing number of therapeutic agents are being developed which are based on peptides, usually made by recombinant means. A drawback to their widespread use is their sensitivity to breakdown in the gut, and the barrier to crossing the intestinal cell wall, imposed by the size of these molecules. Oral delivery is consequently a problem. Anybody interested in developing new peptide-based therapeutics should attend this workshop to fi nd out the latest technologies being developed, which, after a thirty-year gestation period, are now beginning to yield successful outcomes.
Programme
08.30 Registration & Coffee
09.00 Opening Remarks
09.10 Session 1 – Overview of routes across the intestinal cell wall
Transport via lymphatics or portal vein
09.50 Session 2 – Encapsulation technologies for peptides and proteins
Liposomes, polymeric nanoparticles, SLNPs, oil emulsions
10.30 Morning Coffee
11.00 Session 3 – Basic research on absorption enhancement technologies
Comparison of different absorption enhancers
11.40 Session 4 – Case Studies with peptide hormones and vaccine antigens
Preclinical and clinical trial results from around the world
12.20 Closing Remarks
12.30 Close of Workshop
About the workshop leader:Roger New studied chemistry at Oxford and obtained a PhD in immunology at St Mary’s Hospital, London, before going to work in Liverpool for 14 years, fi rst at the Department of Biochemistry, then at the School
of Tropical Medicine and Hygiene. His research activities have centred on the creation of new technologies to improve the therapy of disease, during which time he has devised patented approaches to oral peptide delivery, vaccine carrier systems, and a technology for discovery of new therapeutics. He has acted as expert advisor in numerous institutions at home and overseas, has written a textbook on liposomes, and is honorary lecturer in Pharmaceutics at Kings College London. Dr New’s laboratory was the fi rst to demonstrate the in vivo effi cacy of liposomal amphotericin in leishmaniasis, a product which has now been commercialised for over ten years. He went into industry twenty years ago, fi rst in Biocompatibles Ltd, then Cortecs, and is currently Co-founder and Executive Director of the biotech R&D company Proxima Concepts Ltd, with laboratories based in London. Development of the peptide delivery technology invented by Dr New has resulted in a product for oral administration of insulin, now in Phase II clinical trials, and licensed to large pharma in an emerging market.
About the organisation:Proxima Concepts was founded in 2000, and has devised four new technologies which it is exploiting in the biopharmaceutics area:
1. Axcess – a vehicle for oral delivery of peptides and proteins, including oral insulin in Phase II
2. Vaxcine – an oil-based delivery vehicle for oral administration of vaccine antigens, with particular application to intestinal and respiratory diseases.
3. Mozaic – a discovery technology for identifying building blocks which, in combination, can form therapeutically active structures.
4. Lexicon – A cyclic peptide scaffold designed to maximise interactions with peptide cell receptors.
Workshop Leaders: Roger New, Co-founder & CSO, Proxima Concepts Ltd
and Driton Vllasaliu, Senior Lecturer, University of Lincoln
HALF-DAY PRE-CONFERENCE WORKSHOPWednesday 5th July 2017
08.30 – 12.30Holiday Inn Kensington Forum, London, UK
QbD in Process Development and Manufacturing
Overview of the workshop:In this workshop, the role of quality by design (QbD) in the development of a process will be discussed. An overview on QbD will be given from different perspectives (practical to regulatory), with practical references to the development of downstream operation and other types of pharmaceutical processes. This introduction will be followed by an introduction to Design of Experiments, with particular emphasis on design techniques and common pitfalls. The course will be integrated with notions on multivariate analysis (MVA), trying to answer common questions on what MVA is, and why one should use MVA in process development. Finally, additional modeling technologies to aid process development will be discussed, including the use of deterministic models, hybrid models and the extraction of process information using spectroscopic techniques.
Why should you attend this workshop:This workshop is tailored for R&D people and for anyone willing to discuss new technologies, in the frame of QbD and PAT initiatives, to speed up process development and make it more robust. References to current industrial initiatives (such as digitalisation, big-data, machine learning and industry 4.0) will be discussed.
Programme13.30 Registration & Coffee14.00 Opening Remarks and Introductions14.10 Session 1 – Introduction to QbD A short overview on QbD and what it practically means
in the everyday R&D life will be done.
14.50 Session 2 – Design of Experiments What is DoE and why DoE is useful in process
development. Overview on DoE techniques, limitations and advanced designs. Discussion on how a wrong use of DoE could become counterproductive.
15.30 Afternoon Tea16.00 Session 3 – Multivariate Analysis Introduction to multivariate analysis and the concept
behind this. Overview of main MVA techniques, their objectives (clustering, regression, anomaly detection, etc.) and main differences with non-multivariate techniques.
16.40 Session 4 – Other advanced modelling techniques Introduction to other techniques, including deterministic
models and hybrid models (combination of deterministic and machine learning). An overview of the statistical analysis of spectra coming from spectroscopic techniques will be also discussed and how spectroscopy can be integrated in process development (process understanding, trajectory analysis, control and prediction).
17.20 Closing Remarks17.30 Close of Workshop
About the workshop leader:Alessandro Butté received his Ph.D. in Chemical Engineering in 2000 from ETH Zurich. After a two-year post-doc at the Georgia Institute of Technology, he join the group of Prof. Morbidelli at ETH Zurich and completed
his habilitation in 2008. During this period, his research activities focused on polymer engineering, production of nano-materials for protein purifi cation (monoliths by reactive-gelation) and chromatography purifi cations of peptides, proteins and Mabs. In 2008, he joined Lonza as leader for downstream activities in the sectors small molecules and peptides and as project manager. He was also involved in the pilot program to introduce Quality by Design into R&D. In 2013, he joined back ETH as senior researcher. His current main research area is focused on the use of big data, advanced statistics and machine learning in combination with classical mechanistic models for risk management in R&D and manufacturing of biomolecules. He is author of more than 60 papers on international peer reviewed journals and several book chapters.
About the organisation:ETH Zurich (Swiss Federal Institute of Technology in Zurich) is a science, technology, engineering,
mathematics and management university in the city of Zürich, Switzerland. The school was founded by the Swiss Federal Government in 1854 with the stated mission to educate engineers and scientists, serve as a national centre of excellence in science and technology and provide a hub for interaction between the scientifi c community and industry. Twenty-one Nobel Prizes have been awarded to students or professors of the Institute in the past, allowing ETH Zurich to be consistently ranked among the top universities in the world. It is currently ranked as 5th best university in the world in engineering, science and technology.The department of Chemistry and Applied Biosciences was one of the original 6 departments at ETH’s foundation and today counts 55 professors and more than 500 PhD students. The group of Prof. Morbidelli, whom Dr. Butté is member of, counts 4 senior researchers / lecturers, 7 post-docs and 21 PhD students in basic research and applied basic research.
Workshop Leader: Alessandro Butté, Lecturer, ETH Zurich
HALF-DAY PRE-CONFERENCE WORKSHOPWednesday 5th July 2017
13.30 – 17.30Holiday Inn Kensington Forum, London, UK
PEPTIDES Conference: Thursday 6th & Friday 7th July 2017, Holiday Inn Kensington Forum, London, UK Workshop: Wednesday 5th July 2017, London, UK
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