2018 Speakers Include

Size: px
Start display at page:

Download "2018 Speakers Include"

Transcription

1 Day 1 Stream 1 Protein Engineering, Design & Selection Novel approaches to protein engineering Novel protein conjugation strategies Improving protein half-life extension, potency & selectivity Advanced computational tools for engineering proteins Day 1 Stream 2 Biotherapeutics: Manufacturing, Chemistry, Analytics and Control Overcoming the challenges of characterising biotherapeutics Understanding protein aggregation Testing protein stability Formulations to increase stability Novel technologies & techniques to analyse biotherapeutics Developability of biotherapeutics Day 2 Stream 1 Antibody Engineering, Design & Development Advancing to the clinic: antibody drug conjugates Innovative design and engineering approaches New concepts for developing bispecific antibodies Advanced antibody structures and dynamics Advances in the generation and characterisation of antibodies Day 2 Stream 2 Cloning, Expression, Purification & Analytics Novel strategies to express proteins Overcoming the expression challenges of difficult to express proteins Updates in protein purification and analytics Updates in cryo-em techniques Detection of antibodies by LC/MS Cell line development and cell line engineering Benefits to Attending Hear from and meet with the key innovators in proteins & antibodies attendees include: Chief Medical Officer, Merck & Co., Inc.; Senior Vice President, Teva Pharmaceuticals, Vice President, Johnson & Johnson Discover collaborative solutions to protein engineering, designs and selection. Our highly established event will bring together key opinion leaders to discuss protein half-life extension updates, novel conjugation strategies and computational tools New to 2018! Discuss the latest innovations in biotherapeutics: manufacturing, chemistry, analytics and control. Topics to be covered include: characterising biotherapeutics, developability and manufacturing updates Learn more about antibody engineering, design & development. Discuss new concepts for characterising antibodies and innovative design approaches Unparalleled networking opportunities. The two-day congress offers dedicated networking breaks creating an interactive platform for scientific discussions and meetings. The exhibition hall and poster presentation spaces offer a relaxed and professional environment for scientific discussion Co-located with the highly anticipated 5th Annual Biosimilars & Biobetters Congress and 5 th Annual Peptides Congress 2018 Speakers Include Day 2 Stream 3 Protein & Antibody Biotherapeutics Fusion protein therapeutics New targets & new indications for protein biotherapeutics Accelerating antibody discovery & optimisation: o Bispecific antibodies o Monoclonal antibodies o Antibody drug conjugates Cutting edge technologies for antibody discovery Therapeutic antibody development Targeting immune checkpoints Immunogenicity of therapeutic antibodies: prediction and risk mitigation Including 5+ Think Tank Round Table Discussions Roy Baynes Katarina Radošević Sharon McGonigle MSD Sanofi R&D Eisai FREE WEBINARS 2018: Protein & Antibody Biotherapeutics Manufacturing & Developability Assessment 16 th January Register here. Antibody Biotherapeutics: Current Technologies And Recent Therapeutic Success 24 th January Register here. Meet Senior Decision Makers 450 senior attendees from leading pharmaceutical, biopharmaceutical, academics, CRO and solution provider companies will be attending. Meet Senior VPs, Directors, & Managers with the following job titles: Protein Structure Protein Expression Protein Engineering Discover New Solutions Formal and informal meeting opportunities offer delegates the chance to discuss key solutions with leading service providers. Services to be discussed include: Protein Purification Protein Technology Platforms Protein Structure Prediction Antibody Technology Antibody Discovery Antibody Therapies Custom Protein Production Custom Antibody Production Immunogenicity Assessment Manufacturing Science Analytical Development Discovery Therapeutics Display Technologies Process Development Computational Chemistry For booking details & registration fees please refer to the last page or visit: Biologics Development Biologics Profiling Biological Sciences Recombinant Antibody Antibody Analysis Protein Identification

2 2018 Confirmed Speakers Include: Roy Baynes, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development, MSD David Mantus, Chief Development Officer, Arsanis Jens Frauenfeld, Chief Executive Officer, Salipro Biotech AB Yanay Ofran, Chief Executive Officer & Founder, Biolojic Design and Professor of Biophysics and Computational Biology, Bar-Ilan University Steffen Nock, Senior Vice President (Global Biologics Head), Teva Pharmaceuticals Syd Johnson, Vice President, Antibody Engineering, Macrogenics Annelise Vuidepot, Vice President, Head of Oncology Pipeline and Research, Immunocore Sanjaya Singh, Vice President and Head, Biotherapeutics, Johnson & Johnson Vincent Ling, Senior Director, Takeda Pharmaceuticals Hari Hariharan, Senior Director, Biotherapeutics, Celgene Angela Norton, Senior Director and Head, Protein & Antibody Engineering, Shire Pharmaceuticals Zhulun Wang, Executive Director, Research, Amgen Michelle Morrow, Director, Preclinical Translational Pharmacology, F-Star Biotechnology Sujata Sharma, Director, Protein Science, Merck & Co., Inc. Emma Harding, Director, Head of Molecular Design and Engineering, GlaxoSmithKline Ai Ching Lim, Director, Research, Amgen Andy Hooker, Director of Pharmaceutical Sciences, Ipsen Bioinnovation Ltd Kenneth Walker, Director of Research, Biologics, Amgen Claire Dobson, Associate Director, Antibody Discovery and Protein Expression, MedImmune Yung-Hsiang Kao, Associate Director and Principal Scientist, Genentech W. Blaine Stine, Associate Director, Discovery Biologics, AbbVie Patrick Garidel, Associate Director, Protein Chemistry, Boehringer Ingelheim Stefan Weigand, Global Head of Large Molecule Research, F.Hoffmann-La Roche Katarina Radošević, Global Head Biologics Research, Sanofi R&D Thorsten Lorenz, Group Head Developability Assessment 1, Novartis David Gervais, Head of Product Development, Porton Biopharma Alexey Rak, Head, BioStructure & Biophysics, Sanofi Darko Skegro, Senior Team Leader, Novartis Sharon McGonigle, Senior Principal Scientist, Eisai Ramu Sadhukhan, Principal Research Scientist, AbbVie Michael Chin, Senior Principal Scientist and Associate Research Fellow, Pfizer Tina Møller Tagmose, Principal Scientist, Novo Nordisk A/S Jane Seagal, Principal Research Scientist, AbbVie Sepideh Afshar, Principal Research Scientist, Department of Protein Engineering, Eli Lilly & Company Sally Fischer, Principal Scientist and Group Leader, Genentech Carsten Behrens, Principal Scientist, Novo Nordisk A/S Berthold Boedeker, Chief Scientist and Project Coordination, Bayer AG Ren Liu, Team Leader and Associate Principal Scientist, Merck & Co., Inc. Pallavi Tawde, Single B Cell Cloning Platform Leader, Bristol-Myers Squibb Dorina Saro, Senior Research Scientist, Johnson & Johnson Christopher Lloyds, Senior Scientist, Senior Scientist, Protein Engineering, MedImmune Kaimeng Zhou, Analytical Team Lead, Bristol-Myers Squibb Christian Bernloehr, Project Leader, Molecular Biology Department, Boehringer Ingelheim Zhi Chen, Senior Scientist, Molecular and Analytical Development, Global Manufacturing & Supply, Bristol-Myers Squibb Kerstin Otte, Professor, University of Applied Sciences Biberach Jon Sayers, Professor of Functional Genomics, University of Sheffield Alexander Golovanov, Senior Lecturer and Principal Investigator, Manchester Institute of Biotechnology and School of Chemistry, University of Manchester If you re on Twitter, make sure to follow and join the Congress conversation using #Proteins2018

3 2018 Proteins & Antibodies, Biosimilars & Biobetters and Peptides Congress Sponsors Include: Gold Sponsors: Bronze Sponsors: Congress Sponsors:

4 Day One 16 th April th Annual Proteins & Antibodies Congress Registration Oxford Global s Welcome Address Chairperson s Opening Address Co-located Event Keynote Address: Advanced Protein Technologies To Support Discovery Reagents For Early Stage Biologics Program Ai Ching Lim, Director, Research, Amgen Advances In Protein Engineering, Design & Selection Stream Keynote Address: Protein Engineering At Shire Biotherapeutics: Manufacturing, Chemistry, Analytics And Control Stream Keynote Address: Innovating Bioactive Biomaterials As A Path Forward, Beyond Standard Biologics Angela Norton, Senior Director and Head, Protein & Antibody Engineering, Shire Pharmaceuticals Vincent Ling, Senior Director, Takeda Pharmaceuticals Solution Provider Presentation Solution Provider Presentation Morning Coffee & Refreshments, Poster Presentation Sessions, One to One Meetings x GPCR Structural Biology For Drug Discovery: Through The Protein Science Lens Developability Profiling And Engineering Studies To Support Developability Sujata Sharma, Director, Protein Science, Merck & Co., Inc Improving Circulating Half-Life Of Biopharmaceuticals By Polymer Conjugation Polymer based half-life extension technologies Chemical and enzymatic protein conjugation strategies PK/PD improvements of protein polymer conjugates Carsten Behrens, Principal Scientist, Novo Nordisk A/S Emma Harding, Director, Head of Molecular Design and Engineering, GlaxoSmithKline Process Development And cgmp Manufacture Of Recombinant Botulinum Neurotoxins Botulinum neurotoxin is effective in the treatment of several movement disorders. Native BoNT/A is comprised of a family of highly related neurotoxins produced by Clostridium botulinum bacteria and BoNT/A (subtype A1) is notable as the strain used to produce the commercial products abobotulinumtoxina (Dysport), onabotulinumtoxina (Botox), and incobotulinumtoxina (Xeomin). An increased understanding of the structure-function relationship of BoNT provides an opportunity to engineer recombinant (r) BoNTs with unique pharmacologic properties and therapeutic applications. This presentation will describe the construction, expression, purification, and characterization of rbont serotype A1 (rbont/a1) Targeted Secretion Inhibitors (TSI) are a novel class of recombinant biotherapeutic, developed by retargeting Botulinum neurotoxins for the treatment of diseases with secretion disorders. We describe the process development and cgmp manufacture of a TSI, SXN101959, a multi-domain, multi-functional recombinant protein expressed within Escherichia coli. SXN has been designed to possess a pituitary-specific site of action and to selectively inhibit growth hormone secretion from the pituitary During the manufacture of SXN101959, it is expressed as a single polypeptide chain and genetically engineered to contain a specific protease recognition sequence, which upon proteolytic cleavage produces the active di-chain product, held together via a disulphide bond. The SXN manufacturing process has been successfully scaled up to a 200 L bioreactor scale. SXN Drug Substance (DS) and liquid-formulated Drug Product (DP) were released in accordance with cgmp to supply GLP toxicology and clinical studies. An initial shelf life of one year was established for both DS and DP Andy Hooker, Director of Pharmaceutical Sciences, Ipsen Bioinnovation Ltd

5 Day One 16 th April 2018 Advances In Protein Engineering, Design & Selection Solution Provider Presentation Biotherapeutics: Manufacturing, Chemistry, Analytics And Control Solution Provider Presentation Lunch, Poster Presentation Sessions Inhibiting Interaction Of IL17A And Its Receptor Sepideh Afshar, Principal Research Scientist, Department of Protein Engineering, Eli Lilly & Company IMCgp100: A Novel TCR Based Immunotherapy Against Malignant Melanoma ImmTACTM molecules are bi-specific reagents that target tumors via a soluble monocloncal TCR with exceptionally high sensitivity and specificity and redirect host polyclonal T cells via an anti-cd3 antibody fragment. First in human studies with the lead ImmTAC, IMCgp100, show a favourable safety profile and promising signs of efficacy in both cutaneous and uveal melanoma. Development of IMCgp100 continues in uveal and cutaneous melanoma and in combination with checkpoint inhibitors. Annelise Vuidepot, Vice President, Head of Oncology Pipeline and Research, Immunocore Solution Provider Presentation A Novel Serum Stability Method To Guide Engineering And Selection Of Bi-Specifics Bi-specific domain orientation and variable region selection for optimal physical stability Novel in vitro screening method that predicts favorable drug-like properties Correlations between serum stability, in vivo PK, and biophysical properties W. Blaine Stine, Associate Director, Discovery Biologics, AbbVie Low Material Consuming, Highly Precise And Predictive Biophysical Methods For Biologics Developability Assessment Kinetics for thermal stability Activation energy barrier Long-terms stability prediction by computational biophysical approaches Alexey Rak, Head, BioStructure & Biophysics, Sanofi Solution Provider Presentation Afternoon Coffee & Refreshments, Poster Presentation Sessions, One to One Meetings x Advanced Computational Tools For Protein Engineering Yanay Ofran, Chief Executive Officer & Founder, Biolojic Design and Professor of Biophysics and Computational Biology, Bar-Ilan University Developability Assessment Of Therapeutic Proteins A Toolbox For Tackling Increasing Complexity The power of an integrated approach for candidate selection, combining information from expression and purification, physicochemical properties, solubility, stability, in vivo fitness etc. From platform approaches for standard molecules to project specific workpackage design for new formats Application of high throughput technologies enabling broad and efficient screenings for developability assessment Thorsten Lorenz, Group Head Developability Assessment 1, Novartis

6 Day One 16 th April 2018 Advances In Protein Engineering, Design & Selection Engineering Cytokines With Superior Pharmacokinetic Properties: The Ligand-Receptor Fusion Approach Using structural biology to inform fusion design Addressing the challenges of expression, oligomerization and glycosylation Jon Sayers, Professor of Functional Genomics, University of Sheffield Improving Protein Half-Life Extension, Potency & Selectivity Tina Møller Tagmose, Principal Scientist, Novo Nordisk A/S Biotherapeutics: Manufacturing, Chemistry, Analytics And Control Rapid Development Of HPLC-UV Based Multiple Quality Attributes Method Zhi Chen, Senior Scientist, Molecular and Analytical Development, Global Manufacturing & Supply, Bristol-Myers Squibb Application Of Solution NMR Spectroscopy For Characterizing (And Optimizing) Formulations Of mabs And Biopharmaceuticals Assessing how excipients affect self-association of monoclonal antibodies (mabs) and other protein-based biopharmaceuticals requires informative and direct measurements which work for highly concentrated solutions in situ. We show that solution NMR provides a number of useful measurable parameters very sensitive to transient protein association and protein-excipient interactions in different formulations; hence it can be used as a valuable assessment tool for choosing the best formulation which minimises self-association, aggregation and liquid-liquid phase separation, as well as for assessing long-term stability, interactions with excipients, etc. Alexander Golovanov, Senior Lecturer and Principal Investigator, Manchester Institute of Biotechnology and School of Chemistry, University of Manchester Biotherapeutics: Manufacturing, Chemistry, Analytics And Control Effect Of Project Acceleration And Breakthrough Designation On mab Development Front-loading versus fast to IND Manufacturing continuum Streamlining CMC package Minimizing upfront costs Berthold Boedeker, Chief Scientist and Project Coordination, Bayer AG Analytical Tool Box For Characterization Of Site Specific Isomerization In Monoclonal Antibodies Isomerization Focused peptide mapping Monoclonal antibodies Kaimeng Zhou, Analytical Team Lead, Bristol-Myers Squibb Supporting Robust Manufacturing With In-Depth Characterisation Of Biopharmaceutical Charge Variants Formation of charge variants (both acidic and basic species) is inevitable during biopharmaceutical manufacture The levels of these charge variants must be controlled, and their nature fully understood, for robust manufacturing of biotherapeutic products We show how charge variants and their formation mechanism were thoroughly characterised for the enzyme product Erwinaze, and how this supported robust manufacture from a quality and regulatory standpoint David Gervais, Head of Product Development, Porton Biopharma Drug-Like-Properties Of Fully Human Antibodies Derived From Human Ig Transgenic Mice Jane Seagal, Principal Research Scientist, AbbVie

7 Day One 16 th April Think Tank Round Table Discussions Table 1 Antibody Engineering & Evaluation Of Novel Therapeutic Candidates Moderator: W. Blaine Stine, Associate Director, Discovery Biologics, AbbVie Table 2 Immuno-Oncology Moderator: Roy Baynes, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development, MSD Monotherapies Combination therapies Patient selection Table 3 Antibody Engineering, Development & Design Moderator: Stefan Weigand, Global Head of Large Molecule Research, F.Hoffmann-La Roche Bi- and multi-specifics: what's next? Format follows function: biology should be driver of engineering, but where are the boundaries (complexity, CMC development, immunogenicity,...) Full IgG - antibody fractions - fusion proteins: what are current trends in industry From binder to functional molecule: what are challenges to address increasingly complex biology Table 4 Cloning, Expression, Purification & Analytics Moderator: To Be Confirmed Table 5 Protein & Antibody Biotherapeutics Moderator: To Be Confirmed Networking Drinks & End of Day One

8 Day Two 17 th April th Annual Proteins & Antibodies Congress Keynote Address: PD-1 Antibody: A Broad Spectrum Anti-Cancer Agent Both As Monotherapy And In Combination Monotherapy activity across cancer types Progress in combination approaches Precision medicine to optimize treatment decisions Histology agnostic indications Roy Baynes, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development, MSD Antibody Development, Engineering & Design Cloning, Expression, Purification & Analytics Protein & Antibody Biotherapeutics Stream Keynote Address: Integrated High Throughput Protein Purification And Analytics Stream Keynote Address: ph Dependent Target Binding Antibodies With Altered Affinity To FcRN: An Alternate Tool To Conventional Neutralizing Antibodies Antibodies with ph dependent binding to target antigens and neonatal Fc receptor provide an alternative tool to conventional neutralizing antibodies Antibodies with a range of ph dependent target binding properties can be identified by conventional antibody generation process Proposed mechanism results in highly efficient clearance of soluble targets from circulation thus significantly reducing physiological concentrations of the target Sanjaya Singh, Vice President and Head, Biotherapeutics, Johnson & Johnson Solution Provider Presentation Kenneth Walker, Director of Research, Biologics, Amgen Solution Provider Presentation Stream Keynote Address: Therapeutic Antibody Development At Teva, A Case Study Technology platforms Lead antibody identification Mechanism of action studies Steffen Nock, Senior Vice President (Global Biologics Head), Teva Pharmaceuticals Solution Provider Presentation Morning Coffee & Refreshments, Poster Presentation Sessions, One to One Meetings x Developing Bispecific Antibodies For Immuno- Oncology Recent Advancements In Protein Expression MAXCYTE Antibody Biotherapeutics Immuno-Oncology Case Study Syd Johnson, Vice President, Antibody Engineering, Macrogenics Solution Provider Presentation Darko Skegro, Senior Team Leader, Novartis Solution Provider Presentation Zhulun Wang, Executive Director, Research, Amgen Solution Provider Presentation

9 Day Two 17 th April 2018 Antibody Development, Engineering & Design Cloning, Expression, Purification & Analytics Protein & Antibody Biotherapeutics The Salipro System For Stabilization Of Membrane Proteins Salipro nanoparticles allow for the reconstitution of membrane proteins in a lipid environment: GPCRs, Transporters, Channels, Receptors Nanoparticles adjust to size of membrane proteins, incorporation of monomers as well as large homo/heterooligomeric complexes Technology allows to work with membrane proteins in detergent-free buffer systems Salipro-Membrane-Proteins enable high-resolution cryoem, structural studies, drug screenings and generation of antibodies Engineering ph Dependent Binding Antibodies To Overcome Target Mediated Clearance In Vivo Celgene Biotherapeutics Case Study From The Area Of Immuno-Oncology Claire Dobson, Associate Director, Antibody Discovery and Protein Expression, MedImmune Lunch, Poster Presentation Sessions A Tale Of Two mabs: Impacts Of The Same Unpaired Cysteines On Two Different Recombinant Monoclonal Antibodies Yung-Hsiang Kao, Associate Director and Principal Scientist, Genentech TCR-Like Antibodies: Generation And Characterization We have generated highly selective antibodies to the WT1 RMPNAPYL peptide:mhc I complex (pmhc) These antibodies bind pmhc with a TCR-like geometry We can use these antibodies to gain access to targets normally not accessible by traditional therapeutic antibodies Michael Chin, Senior Principal Scientist and Associate Research Fellow, Pfizer Jens Frauenfeld, Chief Executive Officer, Salipro Biotech AB Innovative Platform Technologies For Antibody Detection Patrick Garidel, Associate Director, Protein Chemistry, Boehringer Ingelheim Fusion Protein Engineering And Expression Screening Ramu Sadhukhan, Principal Research Scientist, AbbVie Hari Hariharan, Senior Director, Biotherapeutics, Celgene Roche's Approach To Discover, Design, Develop And Deliver Next Generation Protein Therapeutics Biologics have become a key component in the treatment of various life-threatening diseases. The majority of these drugs are classical monoclonal antibodies. In order to discover, design, develop and deliver differentiated, monoclonal antibodies, Roche's strategy is based on the identification of the best possible binder and engineering technologies that allow for tailored solutions for the biological problem at hand. This talk will briefly introduce Roche s approach to next gen protein therapeutics tailored for the biological problem at hand. Concept will be explained by presenting several examples including bi-specifics for multi-pathway-inhibition, fusion proteins, and molecules designed to cross the blood-brain-barrier. Stefan Weigand, Global Head of Large Molecule Research, F.Hoffmann-La Roche Biologics Research: More Better Faster Biologics are key modality for sustainable success of pharma companies. The benefit of biologics is in their high specificity, efficacy and tolerability. Sanofi is committed to becoming a leader in biologics and the company is continuously building and improving on its biologics capabilities and capacity. This presentation will discuss different elements that are relevant for building an efficient biologics research organization that delivers with high quality and on time, and satisfies internal research demands for biologics. Katarina Radošević, Global Head Biologics Research, Sanofi R&D

10 Efficient Expression Of Multi-Chain Bispecific Antibodies In CHO Cells Bispecific antibodies Expression in CHO cell 11 th Annual Proteins & Antibodies Congress Day Two 17 th April 2018 Antibody Development, Engineering & Design Cloning, Expression, Purification & Analytics Protein & Antibody Biotherapeutics Genetic Engineering Of CHO Cells Site Specific Manipulation And Targeted Integration Specific Immune Response To PLBL2, A Host Cell Impurity In Clinical Material A product related impurity was identified in the material used in clinical study. To assess the potential ability of patients to develop an immune response to the impurity and impact on immunogenicity of the therapeutic two bridging ELISA were developed and validated. Samples from treated subjects were evaluated in both assays. This presentation will discuss the results of the immunogenicity assessment to the impurity and observed immunogenicity rate of the antibody therapeutic. Ren Liu, Team Leader and Associate Principal Scientist, Merck & Co., Inc. Christian Bernloehr, Project Leader, Molecular Biology Department, Boehringer Ingelheim Afternoon Coffee & Refreshments, Poster Presentation Sessions Engineering Of Highly Selective Anti-Aβ42 Antibody With Picomolar Affinity For The Treatment Of Alzheimer s Disease Latest Developments On MicroRNAs For Next- Generation Cell Engineering MicroRNAs constitute an important class of non-coding RNAs. MEDI1814 is a novel, highly potent and selective inhibitor Individual mirnas control entire bioprocess relevant cellular of the most neurotoxic forms of the amyloid beta peptide, pathways and thus receive growing attention in biotechnology. Aβ x-42, whilst sparing the non-toxic forms of Aβ 40 Our comprehensive mirna research in a variety of production The antibody engineering, in vitro characterisation and preclinical in vivo evaluation will be presented generation of a mirna target catalog providing an avenue for cell lines with different genetic backgrounds led to the next-generation CHO cell engineering. Christopher Lloyds, Senior Scientist, Senior Scientist, Protein Engineering, MedImmune Kerstin Otte, Professor, University of Applied Sciences Biberach Antibody Development, Engineering & Design Developability Assessments For Selection Of Final Candidates An overview of the developability assessment of pre-clinical candidates at Janssen will be given at the presentation The characterization of the NIST IgG1 material will be described in the presentation Two Specific case studies with a focus in the assessment of bispecific candidates will be included in the presentation Dorina Saro, Senior Research Scientist, Johnson & Johnson Sally Fischer, Principal Scientist and Group Leader, Genentech Novel Monoclonal Antibody Therapies For Serious Infections Antibodies, including monoclonal antibodies have a rich history of therapeutic success, but only recently have mabs been applied to serious infectious diseases mabs have unique features that make them particularly suited to the modern challenges of infections, including the rapid, global emergence of antimicrobial resistance Targeted mabs can be used to pre-empt disease, and current mab discovery and development approaches overcome the traditional concerns over the use of biologics as anti-infectives Specific examples of challenges and opportunities will be reviewed, along with select data to demonstrate the great potential of mabs to treat and prevent serious infections David Mantus, Chief Development Officer, Arsanis Protein & Antibody Biotherapeutics Chlorotoxin In Peptide Drug Conjugates: MoA Studies Identify Its True Tumor Target Chlorotoxin is a tumor targeting peptide that naturally occurs in scorpion venom; as a radio-labeled peptide it proved efficacious in human glioma clinical trials Peptide Drug Conjugate (PDC) with chlorotoxin to target tumors and cryptophycin as warhead has a promising pharmacological profile preclinically Several proposed targets previously described for chlorotoxin do not align with the observed PDC activity Comprehensive analysis of MoA of chlorotoxin reveals its true target which is distinct and separate from its toxic properties in venom Sharon McGonigle, Senior Principal Scientist, Eisai

11 Day Two 17 th April 2018 Protein & Antibody Biotherapeutics Development Of An Integrated Novel Antibody Discovery Platform Using Single B Cell Technologies Discovery of therapeutic monoclonal antibodies by using proprietary B cell technology platform. The integrated novel antibody discovery platform enables high throughput and efficient discovery and generation of fully human therapeutic antibodies from antigen specific single B cells. Integration of single cell next-generation sequencing in the antibody discovery process facilitates discovery of broader and diverse antibody repertoire. Pallavi Tawde, Single B Cell Cloning Platform Leader, Bristol-Myers Squibb Targeting Immune Checkpoints An F-Star Case Study Michelle Morrow, Director, Preclinical Translational Pharmacology, F-Star Biotechnology End of Conference

12 11th Annual Proteins & Antibodies Congress Conference: April 2018 London UK HOW TO REGISTER: FAX your booking form to +44(0) PHONE on +44(0) Delegate Details Please complete fully and clearly. Please photocopy for additional delegates Title: Forename: Surname: Job Title: Company/Organisation: Address: Postcode: Country: Direct Telephone Direct Fax: Mobile: Switchboard: Registration Fees I would like to attend: (Please tick as appropriate) Industry Delegates (Biopharma, Pharma or Biotech Companies) Congress 799 plus VAT 1 day pass 499 plus VAT Day 1 Day 2 Academic Delegates Congress 499 plus VAT 1 day pass 299 plus VAT Day 1 Day 2 Vendor Delegates (CROs, Consultants, Technology and Service Providers) Congress Only 1750 plus VAT 1 day pass 999 plus VAT Day 1 Day 2 Signature: Poster Presentation 250 plus VAT Date: Terms & Conditions of Booking Agreed Terms between the Organiser (Oxford Global Marketing Ltd) and the Delegate: Delegate Booking Fee The Delegate Booking Fee includes: lunches and refreshments throughout the Congress event, conference presentations, workshop and panel sessions, scheduled one-to-one meetings and networking/social events, conference and speaker notes. Delegates may attend, free of charge, all sessions arranged by the Organiser. An admin surcharge of 50 + VAT will be applied to payments settled following the receipt of an invoice. This charge will not be applied to payments settled online. Vendor Delegates will not be eligible for one to one meetings unless they purchase a sponsorship meetings package. These can only be purchased directly from Oxford Global Marketing Ltd and not via the online booking facility. Poster Presentations Those who have booked a poster presentation at the event must provide the poster title, abstract (200 words or less), principal author, organisation, mailing address, , telephone, fax and additional authors, within a month of registration. All poster spaces will be for A0 (841mm x 1189mm) portrait size. Cancellation and Curtailment Delegates and vendor delegates are subject to the following charges and refunds upon withdrawal or cancellation. More than 6 months prior 35% cancellation fee / 65% refund Between 6 and 3 months prior 75% cancellation fee/ 25% refund Less than 3 months prior to the event Full cancellation fee / No refund Data Protection The data controller is the Organiser. The Organiser may disclose such personal information to Registered Event Sellers (Solution Providers) and other Delegates but solely for the purposes of the Event. The Delegate consents to the use of his/ her personal and company information on the terms set out herein. Miscellaneous This Agreement may not be transferred or assigned by either the Delegate or the Delegate s Company. The Organiser will determine the scope and content of Congress conference events, seminars, workshops and activities throughout the Event. The Organiser reserves the right to cancel the Event without liability to Delegate s Company or individual Delegate. If for any reason the Organiser has to cancel or postpone this Event, the Organiser reserves the right to transfer this Booking to another Congress within the same sector to be held within twelve months. Should another Congress in the same sector not be available within this period, the Booking Fee will be refunded. I agree to the above Terms and Conditions PROMOTIONAL LITERATURE DISTRIBUTION Distribution of your company s promotional literature to all conference attendees 999 plus VAT Documentation I cannot attend but would like to purchase access to the following: Access to the online conference presentations 499 plus VAT Conference presentations - paper copy 499 plus VAT VAT is charged at 20% on the attendance fees for all delegates. VAT is also charged on online and paper copy documentation and promotional literature distribution for all UK customers and for those EU customers not supplying a registration number for their own country here. How to Pay (choose one of the following payment options) Number of delegates: Industry del(s) Academic dels(s) Vendor dels(s) Special Offer: 3 for 2 Offer is only valid on the congress and for those registering at Industry or Academic rates CREDIT CARD: Visa MasterCard Maestro Amex Credit Card Number: Valid from: / Expiry Date: / Security code: Cardholders name: Signature: Date: PLEASE INVOICE ME: Invoice Address (if different from above) *Please note there is a 50 plus VAT handling charge for payment via invoice *All card payments will be subject to a 3% bank charge or 4% AMEX charge If you have any further queries please call the marketing team on +44(0) or marketing@oxfordglobal.co.uk

2018 Speakers Include:

2018 Speakers Include: Day 1 Stream 1 Protein Engineering, Design & Selection Novel approaches to protein engineering Novel protein conjugation strategies Improving protein half-life extension, potency & selectivity Advanced

More information

2018 Speakers Include: Including 5+ Think Tank Round Table Discussions. Benefits to Attending

2018 Speakers Include: Including 5+ Think Tank Round Table Discussions. Benefits to Attending Day 1 Stream 1 Protein Engineering, Design & Selection Novel approaches to protein engineering Novel protein conjugation strategies Improving protein half-life extension, potency & selectivity Advanced

More information

2018 Speakers Include: Including 5+ Think Tank Round Table Discussions. Benefits to Attending

2018 Speakers Include: Including 5+ Think Tank Round Table Discussions. Benefits to Attending Day 1 Stream 1 Protein Engineering, Design & Selection Novel approaches to protein engineering Novel protein conjugation strategies Improving protein half-life extension, potency & selectivity Advanced

More information

2018 Speakers Include: Including 3 Think Tank Round Table Discussions. Benefits to Attending

2018 Speakers Include: Including 3 Think Tank Round Table Discussions. Benefits to Attending Day 1 Stream 1 Protein Engineering, Design & Selection Novel approaches to protein engineering Novel protein conjugation strategies Improving protein half-life extension, potency & selectivity Advanced

More information

For booking details & registration fees please refer to the last page or visit:

For booking details & registration fees please refer to the last page or visit: Day 1 Market Access Strategies, Opportunities, Clinical Development and Commercial Challenges Assessing the landscape of biosimilars: interchangeability and substitution Evaluating the current market for

More information

3rd Annual Global Drug Bioavailability Enhancement Summit

3rd Annual Global Drug Bioavailability Enhancement Summit 3rd Annual Global Drug Bioavailability Enhancement Summit Event Summary Most drugs on today s market display poor solubility, but the use of modern solubilization technologies can improve a drug product

More information

Strategy for Selecting NAb Assay Format

Strategy for Selecting NAb Assay Format Strategy for Selecting NAb Assay Format European Bioanalysis Forum 27Sept2016 Jim McNally, Ph.D. Associate Director, Global Early Development Head of Clinical Bioanalytics Merck KGaA AAPS Working Group

More information

Advanced Therapeutic Antibody Discovery with Multiplexed Screening

Advanced Therapeutic Antibody Discovery with Multiplexed Screening Advanced Therapeutic Antibody Discovery with Multiplexed Screening White Paper Scientists need powerful tools that can deliver results to fully understand the ability of candidate antibodies to interrupt

More information

High Potent Medicines Conference

High Potent Medicines Conference 2nd Annual High Potent Medicines Conference Looking beyond scale-up, containment, regulatory aspects and safety of highly potent compounds Event Overview The HPAPI industry is expanding at a healthy rate

More information

GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS

GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS BIO021E May 2016 Shalini Shahani Dewan Project Analyst ISBN: 1-62296-288-5 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA

More information

High Potent Medicines Conference

High Potent Medicines Conference 2nd Annual 2nd Annual MARKETS MARKETSand andmarkets MARKETS High Potent Medicines Conference scale-up, containment, regulatory aspects and safety Main Looking Taunusbeyond Zentrum, Frankfurt, Germany of

More information

Course Agenda. Day One

Course Agenda. Day One Course Agenda BioImmersion: Biotech for the Non-Scientist A three-day, in-depth course that provides the background required for understanding today s fast-paced biotech marketplace. Beginning with an

More information

UNLEASH THE POWER OF PRECISION MEDICINE

UNLEASH THE POWER OF PRECISION MEDICINE FROM BENCH TO BEDSIDE UNLEASH THE POWER OF PRECISION MEDICINE DCB, pioneer in biotech. Your partner in drug discovery. www.dcb.org.tw The Center for Biotechnology With over 400 dedicated researchers and

More information

Specialty Lab Services. Deep science at scale

Specialty Lab Services. Deep science at scale Specialty Lab Services Deep science at scale Advancing biomarker research Our broad expertise and global laboratory footprint deliver deep science at scale Specialty assays drive insight into preclinical

More information

Oncology Product and Platform Partnering Opportunity

Oncology Product and Platform Partnering Opportunity Protein Medicinal Chemistry with an Expanded Genetic Code Oncology Product and Platform Partnering Opportunity April 2017 Ambrx has Made Advances in Proprietary Platform and Titer while Achieving Clinical

More information

Workshop on Cytokine Release: State-of-the-Science, Current Challenges and Future Directions

Workshop on Cytokine Release: State-of-the-Science, Current Challenges and Future Directions Workshop on Cytokine Release: State-of-the-Science, Current Challenges and Future Directions Sponsored by the HESI Immunotoxicology Technical Committee Silver Spring, MD 22 October 2013 Objectives of the

More information

TRIANNI Media Kit MEDIA CONTACT CORPORATE HEADQUARTERS. Trianni, Inc. San Francisco, CA

TRIANNI Media Kit MEDIA CONTACT CORPORATE HEADQUARTERS. Trianni, Inc. San Francisco, CA TRIANNI Media Kit CORPORATE HEADQUARTERS Trianni, Inc. San Francisco, CA Telephone: 1.866.374.9314 MEDIA CONTACT Mandy Boyd Director of Marketing @Trianni_mAb Website: Trianni.com TECHNOLOGY LEADERSHIP

More information

Uncovering the Translational Potential of Protein Degradation

Uncovering the Translational Potential of Protein Degradation Uncovering the Translational Potential of Protein Degradation November 14 th, 2018 Boston, MA Wednesday, November 14 th 2018 8:00 Registration, Breakfast & Networking 9:00 Chair s Opening Remarks & Setting

More information

Regulatory Issues and Drug Product Approval for Biopharmaceuticals

Regulatory Issues and Drug Product Approval for Biopharmaceuticals Regulatory Issues and Drug Product Approval for Biopharmaceuticals Vinod P. Shah, Ph. D. FIP Scientific Secretary Biotech 2007 Southern African Regional and International Regulatory Biotechnology Workshop

More information

Phylogica. Harnessing Biodiversity for Peptide Therapies. Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development

Phylogica. Harnessing Biodiversity for Peptide Therapies. Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development Phylogica Harnessing Biodiversity for Peptide Therapies Life Sciences Showcase, 23 August 2011 Nick Woolf: CFO & VP Corporate Development Introduction Biotech company offering leading peptide drug discovery

More information

First-in-Class Bispecific Antibodies For Cancer Immunotherapy

First-in-Class Bispecific Antibodies For Cancer Immunotherapy First-in-Class Bispecific Antibodies For Cancer Immunotherapy 2015 Company Highlights Vision Team Platform Pipeline Partners To dominate the bispecific antibody space in immunooncology through unique pipeline

More information

BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS

BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS : TECHNOLOGIES AND GLOBAL MARKETS BIO061C April 2014 Jackson Highsmith Project Analyst ISBN: 1-56965-801-3 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free within

More information

ProteoGenix. Life Sciences Services and Products. From gene to biotherapeutics Target Validation to Lead optimisation

ProteoGenix. Life Sciences Services and Products. From gene to biotherapeutics Target Validation to Lead optimisation ProteoGenix Life Sciences Services and Products From gene to biotherapeutics Target Validation to Lead optimisation ProteoGenix Philippe FUNFROCK, founder and CEO French company located in Strasbourg,

More information

Neutralising Assay Methodologies

Neutralising Assay Methodologies Neutralising Assay Methodologies March 9 th, 2016 EMA workshop on immunogenicity assessment of biotechnology derived therapeutic proteins Shalini Gupta, PhD Amgen Inc. shalinig@amgen.com 1 Key Points About

More information

Applying Affimers. Dr Amanda Nicholl at Avacta Life Sciences. Improving Antibody PK Assay Development

Applying Affimers. Dr Amanda Nicholl at Avacta Life Sciences. Improving Antibody PK Assay Development Improving Pharmacokinetic Assays in a Regulatory Bioanalysis Setting Applying Affimers With an increasing number of antibody-based therapeutics entering the clinic, the need for validated anti-idiotypic

More information

Overview Stability testing is an essential part of drug development which ensures the quality, safety and efficacy of the drug for the lifetime of the drug product. Appropriate storage conditions can only

More information

For booking details & registration fees please refer to the last page or visit:

For booking details & registration fees please refer to the last page or visit: Day 1 Stream 1 Large Molecule Drug Formulation Part 1 Proteins, Peptides, Biosimilars Assessing comparability for biologics Overcoming protein formulation challenges Formulation development for biosimilars

More information

Prioritizing and Managing Key CMC Elements

Prioritizing and Managing Key CMC Elements Prioritizing and Managing Key CMC Elements Using 21 st Century Principles during Early Development Laurie Graham Product Quality/CMC Reviewer FDA/CDER/OPS/OBP Division of Monoclonal Antibodies 1 Disclaimer

More information

Introduction of Development Center for Biotechnology TAIWAN

Introduction of Development Center for Biotechnology TAIWAN Introduction of Development Center for Biotechnology TAIWAN DCB Nonprofit Organization Founded in 1984 Funded Mainly by Ministry of Economic Affairs (MOEA), National Science Council and the Industry 394

More information

INVESTOR PRESENTATION 2018

INVESTOR PRESENTATION 2018 INVESTOR PRESENTATION 2018 IMMUNOPRECISE ANTIBODIES, LTD. UNIT 3204-4464 MARKHAM STREET VICTORIA, BRITISH COLUMBIA V8Z 7X8, CANADA IMMUNOPRECISE.COM 1 Disclosures DISCLAIMER This presentation is not, and

More information

VELTIS : INNOVATIVE ALBUMIN BASED TECHNOLOGY FOR HALF- LIFE EXTENSION AND OPTIMIZATION OF BIOTHERAPEUTICS

VELTIS : INNOVATIVE ALBUMIN BASED TECHNOLOGY FOR HALF- LIFE EXTENSION AND OPTIMIZATION OF BIOTHERAPEUTICS VELTIS : INNOVATIVE ALBUMIN BASED TECHNOLOGY FOR HALF- LIFE EXTENSION AND OPTIMIZATION OF BIOTHERAPEUTICS Dr Mikael Bjerg Caspersen Industrial Biotechnology Conference August 10 th 2015 INNOVATIVE TECHNOLOGY

More information

Applied Protein Services

Applied Protein Services Applied Protein Services Applied Protein Services A Window into the Future Development risk and attrition rates remain two of the greatest challenges to a successful biopharmaceutical pipeline. To help

More information

Engage with us on Twitter: #Molecule2Miracle

Engage with us on Twitter: #Molecule2Miracle Engage with us on Twitter: #Molecule2Miracle Kassy Perry President & CEO Perry Communications Group PhRMA Alliance Development Consultant.@kassyperry Emily Burke, Ph.D. Director of Curriculum BioTech

More information

Paving the way for Non-Clinical Bioanalytical Partnerships Louise Angell

Paving the way for Non-Clinical Bioanalytical Partnerships Louise Angell Paving the way for Non-Clinical Bioanalytical Partnerships Louise Angell Content Overview of non-clinical immunogenicity testing for biologics Regulatory guidance Bioanalytical considerations Risk based

More information

Process Removal of Impurities in Biotech Products

Process Removal of Impurities in Biotech Products Process Removal of Impurities in Biotech Products CASSS Midwest Regional Forum October 5, 2017 Warren R. Emery Sr. Research Scientist Bioproduct R&D, Eli Lilly and Company Pharmaceutical Process Development

More information

2015 PHARMACEUTICAL MARKET ACCESS IN CHINA SUMMIT

2015 PHARMACEUTICAL MARKET ACCESS IN CHINA SUMMIT 2015 PHARMACEUTICAL MARKET ACCESS IN CHINA SUMMIT September 24 th, 2015 Beijing, China Hear Critical Regulatory Update from Previous & Priority Inviting Keynote Speakers China Food & Drug Administration

More information

Identification of Critical Product Quality Attributes: Impact of Product Variants on Safety and Efficacy

Identification of Critical Product Quality Attributes: Impact of Product Variants on Safety and Efficacy Identification of Critical Product Quality Attributes: Impact of Product Variants on Safety and Efficacy Ziping Wei, Ph.D. Analytical Biochemistry MedImmune January 25, 2010 Outline Why do we need to identify

More information

Protein Formulation Development Summit

Protein Formulation Development Summit Summit Register by August 10th and Save up to $200. See page 6 for details! Accelerating your protein therapeutic through analytical characterization, formulation development, delivery device selection

More information

European Bioanalysis Forum

European Bioanalysis Forum European Bioanalysis Forum Alternative Approaches for Assessment of Drug Neutralizing Activity of ADA Responses Presenter: Arjen Companjen (on behalf of EBF topic team 19) EIP meeting Lisbon 25 February

More information

What s the difference? Challenges in pre-clinical development of biologics

What s the difference? Challenges in pre-clinical development of biologics Biologics vs Small MW NCEs What s the difference? Challenges in pre-clinical development of biologics Peter Lloyd Joint Conference of EU Human Pharmacological Societies and 20 th Anniversary of AGAH 31

More information

The Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives

The Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives The Role of Mass Spectrometry for Developing Biotherapeutics: Regulatory Perspectives Jun Park, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products CDER/FDA CASSS, Applications of

More information

Implications for Preclinical and Clinical Programs. Novartis Pharmaceuticals Oncology Business Unit June 2, 2011

Implications for Preclinical and Clinical Programs. Novartis Pharmaceuticals Oncology Business Unit June 2, 2011 EU Biosimilarityi il it Guidance Implications for Preclinical and Clinical Programs Shefali Kakar Novartis Pharmaceuticals Oncology Business Unit June 2, 2011 Biologics are more complex than small molecules

More information

Time Efficiencies to Be Gained from Platform Approaches to Drug Development

Time Efficiencies to Be Gained from Platform Approaches to Drug Development Time Efficiencies to Be Gained from Platform Approaches to Drug Development Monday, July 27th, 2015 Room 100 National Academy of Sciences Keck Center 500 5 th Street NW, Washington DC 20001 Meeting Description

More information

How Targets Are Chosen. Chris Wayman 12 th April 2012

How Targets Are Chosen. Chris Wayman 12 th April 2012 How Targets Are Chosen Chris Wayman 12 th April 2012 A few questions How many ideas does it take to make a medicine? 10 20 20-50 50-100 A few questions How long does it take to bring a product from bench

More information

Conference Calendar. healthtech.com. January High-Content Analysis January 8-11 San Francisco, CA

Conference Calendar. healthtech.com. January High-Content Analysis January 8-11 San Francisco, CA High-Content Analysis January 8-11 San Francisco, CA www.highcontentanalysis.com January 2013 PepTalk January 21-25 Palm Springs, CA www.chi-peptalk.com January 24-25 Pipeline 1: Formulation: Optimizing

More information

Update on the new immunogenicity guideline in the EU

Update on the new immunogenicity guideline in the EU Update on the new immunogenicity guideline in the EU draft 2016 EBF, Lisbon 27 th September 2016 Venke Skibeli, Senior Scientist, PhD Norwegian Medicines Agency, Member of the CHMP - BMWP, EMA, London

More information

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As

More information

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As

More information

Custom Antibodies & Recombinant Proteins

Custom Antibodies & Recombinant Proteins Custom Antibodies & Recombinant Proteins INTRODUCTION Custom services to meet your research and development requirements Improvements in health, medicine and diagnostics over the past century can be largely

More information

Regulatory perspective on setting clinically relevant specifications. Joslyn Brunelle, PhD Team Leader Office of Biotechnology Products

Regulatory perspective on setting clinically relevant specifications. Joslyn Brunelle, PhD Team Leader Office of Biotechnology Products Regulatory perspective on setting clinically relevant specifications Joslyn Brunelle, PhD Team Leader Office of Biotechnology Products Disclaimer The views and opinions expressed should not be used in

More information

Biosimilar Monoclonal Antibodies: Registration Requirements. Henry M. J. Leng

Biosimilar Monoclonal Antibodies: Registration Requirements. Henry M. J. Leng Biosimilar Monoclonal Antibodies: Registration Requirements Henry M. J. Leng Disclaimer This presentation is given in my personal capacity and represents only the author s personal views and does not represent

More information

DRAFT DOCUMENT FINAL COPY TO REFLECT CONFIRMED. Embed Innovations to Transform Your R&D Procurement Model and. Drive Scientific Activities Efficiency

DRAFT DOCUMENT FINAL COPY TO REFLECT CONFIRMED. Embed Innovations to Transform Your R&D Procurement Model and. Drive Scientific Activities Efficiency Embed Innovations to Transform Your R&D Procurement Model and Drive Scientific Activities Efficiency April 30 May 1, 2018 Boston, US This conference exceeded all of my expectations. The topics, speakers

More information

Antibody Generation: challenges and solutions. Glen Marszalowicz, PHD May 10, AM

Antibody Generation: challenges and solutions. Glen Marszalowicz, PHD May 10, AM Antibody Generation: challenges and solutions Glen Marszalowicz, PHD May 10, 2015 9AM GenScript the most cited biology CRO CRISPR Services Gene Services Peptide Services Protein Services Antibody Services

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 22 February 2006 EMEA/CHMP/BMWP/42832/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR

More information

Personalized CAR-T Immunotherapy Platform

Personalized CAR-T Immunotherapy Platform GLP, GMP, and CLIA-Certified Lab Personalized CAR-T Immunotherapy Platform Accelerate your cancer research and drug discovery Platform Overview 1500 Existing Hybridomas and Antibody Engineering Custom

More information

The importance of interchangeability in the procurement of medications: Biosimilar case

The importance of interchangeability in the procurement of medications: Biosimilar case The importance of interchangeability in the procurement of medications: Biosimilar case ALIMS Congres, Kragujevac, November 6, 2015 Prof. Borut Štrukelj, PhD Brief CV Current position: professor, Pharmaceutical

More information

Pharma&Biotech. Developability Assessment Platform Reduce Attrition Rates, Improve Clinical Safety and Avoid the Valley of Death

Pharma&Biotech. Developability Assessment Platform Reduce Attrition Rates, Improve Clinical Safety and Avoid the Valley of Death Pharma&Biotech Developability Assessment Platform Reduce Attrition Rates, Improve Clinical Safety and Avoid the Valley of Death The Valley of Death Development risk, safety and high attrition rates remain

More information

PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY

PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY SPONSORSHIP & EXHIBITION 2019 Pharma Chem Congress 2019 Theme: Transformative Experience on Pharmaceutical Chemistry and Drug Delivery 2 nd International Conference on PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY

More information

Stability Sciences Analytical Sciences Stability Testing

Stability Sciences Analytical Sciences Stability Testing Day 1 Stream 1 Large Molecule Drug Formulation Part 1 Proteins, Peptides, Biosimilars Assessing comparability for biologics Overcoming protein formulation challenges Formulation development for biosimilars

More information

PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY

PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY SPONSORSHIP & EXHIBITION 2019 Pharma Chem Congress 2019 Theme: Transformative Experience on Pharmaceutical Chemistry and Drug Delivery 2 nd International Conference on PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY

More information

Recent years have witnessed an expansion in the disciplines encompassing drug

Recent years have witnessed an expansion in the disciplines encompassing drug Course overview Recent years have witnessed an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of Universities

More information

Astellas to Acquire Agensys, Inc.

Astellas to Acquire Agensys, Inc. November 27, 2007 to Acquire, Inc. Japan, November 27, 2007 - Pharma Inc. ( ; headquarters: Tokyo; President and CEO: Masafumi Nogimori) today announced that its US subsidiary, US Holding, Inc. (headquarters:

More information

NIH-RAID: A ROADMAP Program

NIH-RAID: A ROADMAP Program NIH-RAID: A ROADMAP Program (Rapid Access to Interventional Development} A Program designed to facilitate the development of new therapeutics The NIH-RAID Pilot Program is intended to reduce some of the

More information

Biotech Showcase 2016

Biotech Showcase 2016 1 Biotech Showcase 2016 Our Value Proposition Advancing broad product pipeline of biosimilars and next generation antibody therapeutics Proven track record in superior quality, efficient R&D and manufacturing

More information

Case Study: A Phase-Driven Approach to the Development and Lifecycle Management of Potency Assays. Spring in New England!!!

Case Study: A Phase-Driven Approach to the Development and Lifecycle Management of Potency Assays. Spring in New England!!! Case Study: A Phase-Driven Approach to the Development and Lifecycle Management of Potency Assays CASSS Bioassays 2016: Scientific Approaches & Regulatory Strategies Session Potency Assays: Cell-based

More information

Strategies to Improve Drug Tolerance in Nab Assays

Strategies to Improve Drug Tolerance in Nab Assays Strategies to Improve Drug Tolerance in Nab Assays Steven J Swanson, PhD Senior Vice President, Research ImmunoCellular Therapeutics Ltd steven.swanson@imuc.com AAPS National Biotech Conference June 2015

More information

Antibody-Drug Conjugate Characterization and Quality Assurance

Antibody-Drug Conjugate Characterization and Quality Assurance Antibody-Drug Conjugate Characterization and Quality Assurance Sarah Kennett Division of Monoclonal Antibodies Office of Biotechnology Products OPS/CDER/FDA October 12, 2011 1 Disclaimer The views and

More information

Sponsorship & Branding opportunities

Sponsorship & Branding opportunities Learn. Connect. Optimize. Tuesday, June 26, 2018 Hyatt regency Hotel, New Brunswick, New Jersey education Forums networking keynote speaker Sponsorship & Branding opportunities Limited Sponsorships available!

More information

Sponsorship. Pharmaceutical Analytical Chemistry & Technology. allied. June academies. International Conference on

Sponsorship. Pharmaceutical Analytical Chemistry & Technology. allied. June academies. International Conference on allied academies International Conference on Pharmaceutical Analytical Chemistry & Technology June 28-29, Theme: Exploring the Recent Trends & Advances in the Field of Pharma and Chemistry June 28-29 Sponsorship

More information

Transition to Next Gen Downstream Processing to Capitalize on Growth Opportunities in High-Value Low-Volume Biologics

Transition to Next Gen Downstream Processing to Capitalize on Growth Opportunities in High-Value Low-Volume Biologics A Virtual Think Tank Executive Summary Transition to Next Gen Downstream Processing to Capitalize on Growth Opportunities in High-Value Low-Volume Biologics By: Unmesh Lal, Program Manager, Transformational

More information

Guideline for the quality, safety and efficacy of follow-on biological medicinal products

Guideline for the quality, safety and efficacy of follow-on biological medicinal products Guideline for the quality, safety and efficacy of follow-on biological medicinal products 1. Introduction A follow-on biological medicinal product (hereinafter referred to as FOBMP) is considered as a

More information

3rd Oral Drug Formulation Innovations June 26-27, 2019 Philadelphia, PA

3rd Oral Drug Formulation Innovations June 26-27, 2019 Philadelphia, PA 3rd Oral Drug Formulation Innovations June 26-27, 2019 Philadelphia, PA Uncovering the Future of Formulation Development, Oral Drug Delivery and Innovative Strategies to Accelerate Drug Product Time-To-Market

More information

For booking details & registration fees please refer to the last page or visit:

For booking details & registration fees please refer to the last page or visit: Day 1 Stream 1 Large Molecule Drug Formulation Part 1 Proteins, Peptides, Biosimilars Assessing comparability for biologics Overcoming protein formulation challenges Formulation development for biosimilars

More information

NEXT Annual Report 2017

NEXT Annual Report 2017 NEXT Annual Report 2017 June 2018 Final version NEXT Annual Report 2017 Executive Summary The number of early clinical trials carried out in the centers exceeded the number anticipated in the original

More information

SPEED UP YOUR TIME TO MARKET

SPEED UP YOUR TIME TO MARKET SPEED UP YOUR TIME TO MARKET #Pre-clinical #Biologics #Small molecules Welcome to Accelera. As a Contract Research Organization (CRO) serving since more than 30 years pharmaceutical and biotechnology companies

More information

Biologics Market: Where Are We Now? Where Are We Going?

Biologics Market: Where Are We Now? Where Are We Going? Biologics Market: Where Are We Now? Where Are We Going? Rakesh Dixit, Ph.D., DABT Vice President, Research & Development AstraZeneca-Medimmune Biologics R & D Scope of Biologics Medicines Biotechnology

More information

AME-133: A Next-Generation Anti-CD20 Engineered for Enhanced Killer Function

AME-133: A Next-Generation Anti-CD20 Engineered for Enhanced Killer Function AME-133: A Next-Generation Anti-CD20 Engineered for Enhanced Killer Function International Society for Biological Therapy of Cancer November, 2004 Jim Breitmeyer Antibody Therapy of Lymphoma Rituximab

More information

Affimed Presents Data from Phase 1b Combination Study of AFM13 with Pembrolizumab at ASH

Affimed Presents Data from Phase 1b Combination Study of AFM13 with Pembrolizumab at ASH FOR IMMEDIATE RELEASE Affimed Presents Data from Phase 1b Combination Study of AFM13 with Pembrolizumab at ASH Completed dose-escalation shows combination of AFM13 and pembrolizumab is well-tolerated;

More information

Your bridge to. better medicines

Your bridge to. better medicines Your bridge to better medicines At a Glance Anapharm Bioanalytics is a client-oriented, GLP-certified, FDA-inspected, GCP-compliant and ANVISA-certified bioanalytical contract research organization (CRO)

More information

Partnering for Impact Human Health Therapeutics

Partnering for Impact Human Health Therapeutics Partnering for Impact Human Health Therapeutics Bernard Massie General Manager Human Health Therapeutics Partnering for Impact in Biologics and Vaccines NRC s Human Health Therapeutics (HHT) portfolio

More information

CENTRAL NERVOUS SYSTEM (CNS) BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS

CENTRAL NERVOUS SYSTEM (CNS) BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS CENTRAL NERVOUS SYSTEM (CNS) : TECHNOLOGIES AND GLOBAL MARKETS BIO074C March 2016 Jackson Highsmith Project Analyst ISBN: 1-62296-246-X BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215

More information

Vladimir Hanes, MD, USA

Vladimir Hanes, MD, USA GaBI Educational Workshops 20 January 2015, Sheraton Maria Isabel Hotel & Towers, Mexico City, Mexico Vladimir Hanes, MD, USA Medical Director, Oncology Global Biosimilars Development, Amgen Inc GaBI Educational

More information

Biotherapeutic medicines generated by living

Biotherapeutic medicines generated by living Biotherapeutic medicines generated by living cells or organisms are larger and more complex than chemically synthesized medicines, and feature varied mechanisms of action (MOA s; Box, p. TK). As their

More information

the PLATFORM Pipeline in Lyon AREA

the PLATFORM Pipeline in Lyon AREA the PLATFORM Pipeline in Lyon AREA Do you have development or partnership projects in Life Sciences? Are you interested in developing your business in France? This overview is designed to give you an idea

More information

Table 1: CE-MS: Unexploited Opportunities in Process Development?

Table 1: CE-MS: Unexploited Opportunities in Process Development? Table 1: CE-MS: Unexploited Opportunities in Process Development? Session 1 Facilitator: Mei Han, Amgen Inc. Scribe: Yunan Wang, Amgen Inc. Session 2 Facilitator: Göran Hübner, Boehringer Ingelheim Pharma

More information

Missouri Regional Life Sciences Summit March 9, 2010 The Institute for Advancing Medical Innovation Stepping into the future of drug discovery, delivery and biomedical engineering G. Sitta Sittampalam,

More information

Pieris Pharmaceuticals Reports Full-Year 2015 Financial Results and Corporate Update

Pieris Pharmaceuticals Reports Full-Year 2015 Financial Results and Corporate Update March 22, 2016 Pieris Pharmaceuticals Reports Full-Year 2015 Financial Results and Corporate Update Company to Host an Investor Conference Call on Wednesday, March 23, 2016 at 10:00 AM ET BOSTON, MA --

More information

ANTIBODY DRUG CONJUGATES AND BISPECIFIC ANTIBODIES: SCIENTIFIC & REGULATORY CHALLENGES AND OPPORTUNITIES

ANTIBODY DRUG CONJUGATES AND BISPECIFIC ANTIBODIES: SCIENTIFIC & REGULATORY CHALLENGES AND OPPORTUNITIES ANTIBODY DRUG CONJUGATES AND BISPECIFIC ANTIBODIES: SCIENTIFIC & REGULATORY CHALLENGES AND OPPORTUNITIES Brian DiPaolo 08 June 2017 CASSS Midwest Discussion Group Agenda Introduction Antibody Drug Conjugates

More information

Immunogenicity Assay Strategies for Antibody-Drug Conjugates

Immunogenicity Assay Strategies for Antibody-Drug Conjugates Immunogenicity Assay Strategies for Antibody-Drug Conjugates 8th World ADC Conference, San Diego 20 Sep 2017 Seema Kumar, PhD Associate Scientific Director Global Early Development (GED) EMD Serono Research

More information

Development of differentiated immuno-oncology therapeutics by using multivalent Nanobodies

Development of differentiated immuno-oncology therapeutics by using multivalent Nanobodies Nanobodies Innovative therapeutics Development of differentiated immuno-oncology therapeutics by using multivalent Nanobodies Immune Checkpoint Inhibitors Europe Sandra Li - 17 November 2016 Forward looking

More information

Biosimilars China Guideline. Dr Dr Michel Mikhail

Biosimilars China Guideline. Dr Dr Michel Mikhail Biosimilars China Guideline Dr Dr Michel Mikhail 1 Contents Regulatory context of biologicals in China Decree 28 issued by SFDA October 2007 Proposed biosimilars guideline 10/29/14 Reference drugs to use

More information

Immunogenicity of Therapeutic Proteins. Steven J Swanson, Ph.D. Executive Director, Clinical Immunology

Immunogenicity of Therapeutic Proteins. Steven J Swanson, Ph.D. Executive Director, Clinical Immunology Immunogenicity of Therapeutic Proteins Steven J Swanson, Ph.D. Executive Director, Clinical Immunology swanson@amgen.com Causes of Immunogenicity Sequence differences between therapeutic protein and endogenous

More information

leading the way in research & development

leading the way in research & development leading the way in research & development people. passion. possibilities. ABBVIE 2 immunology AbbVie Immunology has a demonstrated record of success in identifying and developing both small molecule and

More information

Good morning and thank you for joining us for our quarterly update.

Good morning and thank you for joining us for our quarterly update. Q1 2018 Earnings Conference Call May 7, 2018 11:00 AM ET Introduction and Forward Looking Statements in APPENDIX I Garo Armen Good morning and thank you for joining us for our quarterly update. We have

More information

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges Thursday, May 9 Registration Open Continental Breakfast 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges End-to-End Product Development Manufacturing, Supply, and Quality May 9-10, 2019 Hilton Long Beach Long Beach, CA As

More information

BIOLOGICS & PROCESS TECHNOLOGY MASTER CLASS

BIOLOGICS & PROCESS TECHNOLOGY MASTER CLASS BIOLOGICS & PROCESS TECHNOLOGY MASTER CLASS Supported By: Organised By: PROGRAMME OVERVIEW BIOLOGICS MAKE UP MORE THAN 1,000 MEDICINES AND VACCINES THAT TARGET MORE THAN 100 DISEASES. Unlike medicines

More information

Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products

Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products Microrite, Inc. brings you this unique learning experience in Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products; Part of Microrite s step-by-step webinar series. Stability Testing

More information

FDA Public Hearing: Approval Pathway for Biosimilar. Products. November 2-3, 2010

FDA Public Hearing: Approval Pathway for Biosimilar. Products. November 2-3, 2010 FDA Public Hearing: Approval Pathway for Biosimilar and Interchangeable Biological Products November 2-3, 2010 1 The Biotechnology Industry Organization Over 1,100 members, including biotechnology companies,

More information

Nonclinical Data to Support FIH Clinical Trials for Cancer Immunotherapies. Whitney S. Helms, PhD IOM, February 29,2016

Nonclinical Data to Support FIH Clinical Trials for Cancer Immunotherapies. Whitney S. Helms, PhD IOM, February 29,2016 Nonclinical Data to Support FIH Clinical Trials for Cancer Immunotherapies Whitney S. Helms, PhD IOM, February 29,2016 Disclaimer The views disseminated in this talk are my own and do not necessarily represent

More information

GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS

GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS GLOBAL MARKETS FOR BIOENGINEERED PROTEIN DRUGS BIO009G January 2017 Shalini Shahani Dewan Project Analyst ISBN: 1-62296-417-9 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215

More information