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P 215 peptides final


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SMi Group presents Peptides.

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P 215 peptides final

  1. 1. QbD in Process Development and Manufacturing 13.30 - 17.30 Workshop Leader: Alessandro Butté, Lecturer, ETH Zurich BOOK BY 31ST MARCH 2017 AND SAVE £400 BOOK BY 28TH APRIL 2017 AND SAVE £200 BOOK BY 31ST MAY 2017 AND SAVE £100 PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS Wednesday 5th July 2017, Holiday Inn Kensington Forum, London, UK 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 Proteins 08.30 - 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 purification 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, purification, 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... PeptidesAddressing 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
  2. 2. Register online at SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi 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 specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: Bachem provides comprehensive services to the pharma and biotech industries. It specializes in the development of innovative, efficient 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. 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 stratified medicines. 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 definition 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 inflammatory 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 inflammatory 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 •Specifications and registration •Specific 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 Purification and Characterisation of Peptides Using LC/MS/ELSD Techniques •Peptide QC •Purity analysis using LC/MS/ELSD techniques •Peptide purification •High Throughput purification workflow Bhagyashree Khunte, Senior Principal Scientist, Pfizer 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 identification of impurities •Identification of impurities originating from starting material, synthesis, purification 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 identification and validation of HLA binding peptides •Immunopeptidomics in combination with genomics for identification 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
  3. 3. Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING OPPORTUNITIES Want 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: 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 field •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 significantly improved by conjugation or fusion to albumin, due to increased size and recycling via the neonatal Fc receptor (FcRn) •The increased FcRn affinity 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 – benefits 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 purified 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-specific 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 first 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 first 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 confirming the removal of solid phase coupling reagents •Mass Spectrometry for impurity identification in life cycle management activities Marion King, Analytical Development Manager, Ipsen 16.40 Purification, Characterisation and Physicochemical Properties of Peptides within Discovery Chemistry •Chromatographic purification strategies for cyclic and linear peptides including SFC, LC and Flash methodologies •Stoichiometry of final salt forms using Ion Chromatography •Extraction strategy to remove TFA from final products •Physicochemical Trend Analysis on final products John Reilly, Senior Research Investigator, Novartis Institutes for BioMedical Research 17.20 Chairman’s Closing Remarks and Close of Day Two Peptides Day Two | Friday 7th July 2017
  4. 4. 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 find 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, first 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 first to demonstrate the in vivo efficacy of liposomal amphotericin in leishmaniasis, a product which has now been commercialised for over ten years. He went into industry twenty years ago, first 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–anoil-baseddeliveryvehiclefororaladministration 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 WORKSHOP Wednesday 5th July 2017 08.30 – 12.30 Holiday Inn Kensington Forum, London, UK
  5. 5. 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 discussnewtechnologies,intheframeofQbDandPATinitiatives, 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. Programme 13.30 Registration & Coffee 14.00 Opening Remarks and Introductions 14.10 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 Tea 16.00 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,trajectoryanalysis,controlandprediction). 17.20 Closing Remarks 17.30 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 thegroupofProf.MorbidelliatETHZurichandcompleted his habilitation in 2008. During this period, his research activities focused on polymer engineering, production of nano-materials for protein purification (monoliths by reactive-gelation) and chromatography purifications 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 Governmentin1854withthestatedmissiontoeducateengineers andscientists,serveasanationalcentreofexcellenceinscience and technology and provide a hub for interaction between the scientific 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 WORKSHOP Wednesday 5th July 2017 13.30 – 17.30 Holiday Inn Kensington Forum, London, UK
  6. 6. PEPTIDES Conference: Thursday 6th & Friday 7th July 2017, Holiday Inn Kensington Forum, London, UK Workshop: Wednesday 5th July 2017, London, UK 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. 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