Monoclonal Antibodies 2014 Congress

SL51

Background Info

Dear Colleagues,

Paradigm Global Events are proud to present the Monoclonal Antibodies 2014 Congress

Monoclonal Antibodies are also known as targeted therapies because they work by targeting specific proteins on the surface of the cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market.

The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in 2013-2017 reaching $141 billion in 2017. This is due to great market demand, new products being approved and also launching of Mabs generic drugs.

The global industry of Mabs is currently dominated by European and American companies, however, sales of Mabs in the rest of the world will remain higher than in the U.S despite a higher CAGR in the U.S.

By Attending this conference you will:

  • Gain insight on various therapeutic targets
  • Learn the latest and most recent advances in antibody technology
  • Find out what is the future in antibody technology
  • Understanding about new antibody engineering and modification technologies
  • Explore up to date platform approaches to monoclonal antibody purification
  • Learn new techniques in cell engineering for Mabs production
  • Examine antibody-based targeted therapy
  • Study the latest trends in capacity utilization for therapeutic mabs production
  • Investigate immunogenicity issues with drug development
  • Hear about latest regulations, technologies, production and therapeutics

 

Who should attend:

VP’s, Directors, Heads and Managers of:

  • Antibody Development
  • Preclinical research development
  • Clinical Research development
  • Cell and Molecular Biology
  • Recombitant DNA Biotechnology
  • Auto-immune Disorders
  • Pharmaceutical and Patent Law
  • Contract research Organizations
  • Clinical Diagnostics
  • New product development
  • Oncology R&D
  • Business Development
  • Marketing

 

I look forward to meeting you at the conference.

Best Regards,

Jocelyn Raguindin

 

Workshop

Key Speakers


Tristan Vaughan

Tristan Vaughan PhD, FSB , Senior Director Antibody Discovery and Protein Engineering (ADPE), MedImmune

Tristan joined Cambridge Antibody Technology (CAT) in 1993. Following the acquisition of CAT and MedImmune by AstraZeneca in 2007, his team of 80 scientists are today responsible for discovering and engineering around half of MedImmune’s biologics portfolio. With core technologies such as phage and ribosome display, in vivo platforms, biologics screening and structural biology, his team supports delivery across multiple disease areas. Prior to his current appointment, Tristan held key operational responsibilities as part of the successful CAT-AstraZeneca strategic alliance and prior to that for CAT’s Milestone and Royalty based Alliances, including that with Human Genome Sciences that delivered Benylsta®. He also developed the platform technology to build human antibody libraries of 1010 members and is also a key inventor of Humira®. Before joining CAT, he was a postdoctoral fellow at the University of Toronto. Tristan is a University of Leeds graduate from the Genetics Department.


Dr. Mahedra P. Deonarain

Dr. Mahedra P. Deonarain, Chief Science Officer, PhotoBiotics Ltd, Imperial College London

Dr. Deonarain studied at Imperial College and Cambridge University where he carried out PhD research into protein engineering. His interests in antibody therapeutics started at the ICRF where he initiated the development of antibody based therapeutics. In 1997-2011 Dr Deonarain was an academic group leader at Imperial College in Antibody Technology which led to some technology being developed by Photobiotics. Dr Deonarain is now a consultant working for a number of spin-outs and retains honorary links with Imperial College. He has published over 60 papers and patents in protein/antibody engineering/conjugates. In 2001, he co-founded PhotoBiotics to develop conventional and photoactive ADCs. He is PhotoBiotics’ Chief Science and Operations.


Jesus Zurdo

Jesus Zurdo, Head of Technologies, Future Technologies, Lonza Pharma and Biotech

Jesús Zurdo is Head of Innovation, Biopharma Development at Lonza. He has an extensive trajectory in bioprocessing innovation and biopharmaceutical development de-risking and was one of the early introducers of developability methodologies to biological drugs. Jesús cofounded Zyentia to develop solutions for protein aggregation and disease-modifying therapies for Parkinson’s, Alzheimer’s and type 2 diabetes. While at Zyentia, he held various roles, including CSO and CEO, until the acquisition of the AggreSolve platform by Lonza in 2007. He was also cofounder and Scientific Advisor of Zapaloid, overseeing drug discovery programmes in neurodegeneration. Jesús held several research positions at the Universities of Oxford and Cambridge in the UK and prior to that at CBM-CSIC in Spain. He has a PhD in molecular biology from the Autonomous University of Madrid.


Bo Kara

Bo Kara, Director Science and Technology Fujifilm Diosynth Biotechnologies

Bo Kara leads the Science and Technology innovation activities at Fujifilm Diosynth Biotechnologies in Billingham, UK. He has nearly 30 years’ experience in designing research and development programmes to develop robust scaleable and validatable manufacturing processes for recombinant protein biotherapeutics. He has published widely and is primary inventor on a range of process and expression patents. He has developed a keen understanding of the technical, regulatory and commercial issues faced at each stage of the development of manufacturing processes for biopharmaceuticals.
Prior to joining Fujifilm Diosynth Biotechnologies (previously Avecia Biologics) in August 2000, Bo Kara was Team Leader, Biotherapeutic Process Development and Technology Transfer at AstraZeneca Pharmaceuticals, UK . He collaborates widely with leading academic research institutions and is a visiting lecturer at UCL, Sheffield, Manchester and Newcastle Universities.


Janos Szebeni

Dr. Janos Szebeni, MD, PhD, Dsc, Nanomedicine Research and Education Center, Semmelweis, University, Budapest

Janos Szebeni, M.D., Ph.D., D.Sc., Med. Habil., full professor, immunologist, director of the Nanomedicine Research and Education Center at Semmelweis University, Budapest, Hungary. He obtained M.D. in 1978 at Semmelweis University, and then held various scientific positions in Hungary and abroad, including the Institute of Hematology in Budapest, Christchurch University (Christchurch, New Zealand), ETH (Zurich, Switzerland), University of Arizona (Tucson, Arizona), Harvard University (Boston, MA), National Cancer Institute at NIH and the Walter Reed Army Institute of Research (Bethesda, MD, USA). His research spanning over 3 decades resulted >100 scientific papers, 12 book chapters, 2 granted patents, a book “The Complement System: Novel Roles in Health and Disease??? (Kluwer Academic Press, 2004) and a topical issue of “Critical Reviews in Therapeutic Drug Carrier Systems???. Two fields stand out where he has been most active: liposomes and the complement system. He is best known for promoting the concept that complement activation underlies numerous liposomal- and other nanodrug-induced hypersensitivity (anaphylactoid) reactions, called complement activation-related pseudoallergy (CARPA). Along with numerous social commitments in Hungary and abroad, he is a founder and scientific director of an immune toxicity CRO in Hungary (SeroScience Ltd). He also has (guest) professor affiliations at the Department of Pathophysiology, Semmelweis University, Budapest; Department of Nanobiotechnology and Regenerative Medicine, Miskolc University; and Faculty of Pharmaceutical Sciences and NanoScience Center, University of Copenhagen, Denmark, holding biology, immune biology and nanomedicine classes.


Darko Skegro

Darko Skegro, Team Leader and Head – Bispecific Antibodies, Glenmark Pharmaceuticals SA

Darko Skegro is a protein/antibody engineer with focus on bispecific antibodies. He received his Ph.D. from University of Düsseldorf, Germany, where he worked on biophysical analysis of proteins. After a post-doc at the Research Centre Jülich in the labs of Georg Büldt studying interactions and structure of proteins, he took a position in X-Ray Crystallography at the Bio Centre Basel, Switzerland. In 2007 he moved to Glenmark Pharmaceuticals, where he is leading a team in the antibody engineering department, working on projects ranging from structure guided humanization using computational modeling to development of novel bio-therapeutics. His current research focuses on innovation and the development of novel antibody-based formats, including the bispecific antibody platform BEAT.


Bertrand Coiffier

Professor Bertrand Coiffier, Centre Hospitalier Lyon-Sud, Pierre-Benite, France

Bertrand Coiffier is Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon and the University Claude Bernard, Lyon, France. After having specialized in hematology, Professor Coiffier has held a number of positions at the Hematology Department of the Edouard-Herriot Hospital, Lyon and then the Centre Hospitalier Lyon-Sud, Pierre-Benite. He is a member of several international societies, including the American Society of Hematology, the American Society of Clinical Oncology, International Society for Medical Oncology, the European Haematology Association, and the European Society of Medicaal Oncology. Professor Coiffier is a founding member of the Group d’Etude des Lymphomes de l’Adulte (GELA) and he was the President of the GELA until its transformation into LYSA (Lymphoma Study Association) in 2012. He has published over 400 papers in peer-reviewed journals.


Dr Candi J Soames

Dr Candi J Soames,D.Phil, Director, Maschio Soames Intellectual Property

Candi Soames graduated from Oxford University with an MA and D. Phil in Molecular Immunology. She worked on various aspects of some of the molecular interactions within the Complement cascade of the Innate immune system. After spending some time as a post-doctoral research fellow working on mechanisms of signal transduction and protein-domain interactions in immune cells at Yamanouchi in Oxford, Candi entered the patent profession. Prior to becoming a Director of her own firm, Candi previously has been a Partner in a major UK private practice firm, worked in house and also in an international law firm. Candi is a standing member of the UK CIPA Biotechnology Committee. She has a passion for horses and cooking and spends her valuable spare time indulging in these areas when her twin baby boys allow her to!


alexAlexander R. Steiner, M.S., Director of Protein Biochemistry, Sutro Biopharma, USA

Alexander Steiner is currently the Director of Protein Biochemistry at Sutro Biopharma, where he joined in 2008 after receiving both his graduate and undergraduate degree in chemical engineering from Stanford University. At Sutro, Alexander leads multiple internal drug discovery projects in the oncology space, as well as collaborations with external partners. He has contributed to Sutro’s core technology platform development resulting in the Xpress CF and Xpress CF+ expression systems, which allow for scalable protein production of high value biotherapeutics, such as ADCs and bispecifics from cell-free bacterial extracts.


guygeorgeGuy Georges, Principal Scientist, Roche Pharmaceutical Research and Early Development

Principal scientist responsible of the molecular modeling and biostructure unit; more than 2 decades experience in drug design for small molecules & biologics. Career started in Paris’s surroundings by Synthélabo, later merged with Sanofi; since 2000 at the Roche Innovation Center Penzberg (Germany, south of Munich near the Alps)
Currently in charge of humanization and protein engineering, including antigen design, epitope characterization, mode of action elucidation, drug candidate optimization, and developability assessment, …
Involved in 23 publications and 21 patents in Medicinal Chemistry, as well as more than 20 patents in the Biologics field.
2 recent Awards within Roche: the Germany Innovation award 2014 for a contribution to the Brain Shuttle Technology and the highest distinction at the 6th Inventors Recognition Event.


surrinderSurinder Sharma is a Professorial Research Associate in the Research Department of Oncology, UCL Cancer Institute, University College London, UK

The main focus of her research is ‘Antibody Directed Enzyme Prodrug Therapy (ADEPT)’ and Translational Therapeutics. She leads the design and execution of pre-clinical studies that form the basis for clinical development of ADEPT systems either as a single entity or in combination with other agents. In compliance with GCP, she has led the development, validation and implementation of assays to measure critical pharmacokinetic and pharmacodynamics parameters in clinical studies of protein therapeutics for cancer, with a particular emphasis on immunogenicity. Her current research interest is to develop ADEPT as a combined therapy with agents that may affect tumour cell DNA repair systems

Day 1

08:30 – 09:00Coffee and Registration


9:00-9:10Chairman’s Welcome remarks


9:10-9:50Latest update on the development of therapeutic Mabs and their alternatives*

  • How to ensure safe and high quality Mabs and related products
  • Understanding antibody formats and characterization
  • Current methods of antibody development
  • Regulatory requirements in the development of Mabs
    Prof. Richard Stebbings, Immunotoxicology Lab, Biotherapeutics Group, NIBSC*


9:50-10:30 Early pre-process risk assessment in therapeutic antibodies to reduce product attrition and streamline development

  • Biomanufacturing processes are still complex, largely unpredictable, and very much linked to the nature of the product to be made.
  • In most cases, uncertainty is managed with extensive screening, testing and analysis, which is tremendously costly and time-consuming.
  • Alternative de-risking approaches during early development can be effective in facilitating product development.
  • Such ‘developability’ approaches focus in the design and selection of therapeutic candidates for optimal safety, stability and, in combination with faster strategies for early material generation can contribute to streamlining clinical development.

Jesus Zurdo, Head of Technologies, Future Technologies, Lonza Pharma and Biotech


10:30-11:10Networking Morning Break


11:10-11:50 – In silico antibody engineering

  • Computational and structural biology are becoming increasingly powerful tools enabling predictive drug discovery
  • Meeting multiple antibody parameters is essential for an optimal drug molecule
  • Predictive tools and algorithms can be used effectively, backed up by laboratory data, to shape drug design
  • Case studies will be presented

Tristan Vaughan PhD, FSB, Senior Director, Antibody Discovery and protein Engineering (ADPE), MedImmune


11:50-12:30 – Humanization and Simultaneous Optimization of Monoclonal Antibodies*

  • Reducing potential risk of immunogenicity
  • Properties to be considered with humanization in generation and optimization
  • Properties of therapeutic antibodies to be sufficiently qualified



12:20-13:10 – Sponsored Spotlight Presentation


13:10-14:10 – Networking – Lunch Break


14:10-14:50 – Infusion reactions caused by Mab therapeutics: mechanism, prediction and prevention

  • Factors affecting PK/PD and immunogenicity of Mabs
  • Guidance for determining non-clinical and clinical assessment strategies
  • Comparability assessment to support manufacturing process

Dr. Janos Szebeni, MD, PhD, Dsc, Nanomedicine Research and Education Center, Semmelweis University, Budapest


14:50-15:30 – Analytical FcRn affinity chromatography for functional characterization of Mabs*

  • Importance of FcRn for metabolic fate of IgG in vivo
  • Analysis of interaction between FcRn and IgG In Vitro might provide insight into the structure and functional integrity of therapeutic IgG that may affect PK in vivo



15:30-16:10 – Networking Afternoon Break


16:10-16:50 – Panel Discussion: Improving Mabs Manufacturing Techniques

  • Manufacturing Issues in Product development
  • Ways to reduce cost
  • Obstacles and challenges in bringing the next generation of Monoclonal antibody products to the market

Bo Kara, Director Science and Technology, Fujifilm Diosynth Biotechnologies


16:50-17:00 – Chairman’s Closing Remarks

Day 2

8:30-9:00 – Coffee and Registration


9:00-9:10 – Chairman’s Welcome remarks


9:10-9:50 – Global Market overview and trends for Monoclonal antibodies

  • Analysis of the status of monoclonal industry market
  • Highlights the operation of Monoclonal antibody manufacturers worldwide
  • Factors limiting market growth
  • Current market trends

 


9:50-10:30 – Protecting Antibodies based Therapeutics: What’s the state of play?

  • Historic overview of the protection of antibody based molecules.
  • Current issues in seeking protection.
  • Successfully obtaining patent protection. What’s required?
  • The future of protecting antibody based therapeutics.

Candi Soames D. Phil, Director, Maschio & Soames Intellectual Property


10:30-11:10 – Networking Morning Refreshments


11:10-11:50 – Monoclonal antibodies in lymphoproliferative disorders: future directions

  • Present status
  • New naked antibodies
  • Antibody-drug conjugates
  • Novel perspective

Professor Bertrand Coiffier, Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon


11:50-12:30 – High resolution reversed phased analysis of recombitant Monoclonal antibodies

  • Valuable strategy due to its compatibility to mass spectrometry
  • Present study demonstrates that high peak capacity can be attained
  • Evaluate the effect of column height on peak capacity

 


12:30-13:10 – Sponsored Spotlight Presentation


13:10-14:10 – Lunch Break


14:10-14:50 – Overcoming ADC development and manufacturing challenges: Gene to cGMP ADC drug product

  • Integrating fast track mAb and Drug-Conjugate Development
  • Supporting in-vivo feasibility studies: production of representative material
  • Process development, optimization, scale-up and cGMP manufacturing of mAb and ADC
  • Integration of analytical development and ADC characterisation

Bo Kara, Director Science and Technology, Fujifilm Diosynth Biotechnologies


14:50-15:30 – Antibody fragment based ADCs

  • Use of Optimised single-chain Fvs
  • Photo-active and chemotherapeutic drug payloads
  • Pharmacokinetic issues
  • Drug loading issues

Dr Mahedra P. Deonarain, Chief Science Officer, PhotoBiotics Ltd, Imperial College London


15:30-16:10 – Networking Afternoon Refreshments


16:10-16:50 – BEAT platform: versatile bispecific antibodies with excellent manufacturing profile

  • The platform allows a “Plug & Play??? approach
  • Upon scale-up, have shown the highest expression yields ever reported for any bispecific antibody.
  • Technology background and pre-clinical work will be presented

Darko Skegro, PhD, Team Leader and Head – Bispecific Antibodies, Glenmark Pharmaceuticals SA Biologics Research


16:50- 17:00 – Chairman’s Closing Remarks

 

Sponsors & Exhibitors

abzenaAbzena offers a suite of complementary services and technologies through its subsidiaries, PolyTherics and Antitope, to enable the development of better biopharmaceuticals which will have a greater chance of reaching the market. PolyTherics offer antibody drug conjugate and pharmacokinetic optimization technologies complementing Antitopes immunogenicity assessment, antibody humanization, protein deimmunization and cell line development services.

 

 

 

 

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