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ADC Summit 2012

SAE Media Group proudly presents their inaugural 2012 ADC Summit...

About the Conference

 

SAE Media Group's inaugural ADC Summit will provide attendees with a complete view of the antibody drug conjugate field. Focusing on the current ADC pipeline, ADC design, novel ADC utilities and manufacturing considerations. This informative and exciting event will provide attendees with an indepth look into developing ADCs, taking into account target selection and payload delivery techniques.

The event will present itself as a perfect forum for learning about new advances in the field, presenting attendees with the latest information on technogical and regulatory updates in the field. The ADC Summit 2012 will shed light on a new perpspective of the ADC sector, looking at uses of Antibody-Drug Conjugates in alternative therapies.

With senior industry representatives presenting on their own exepriences and referring to case studies, success stories and failures, this event promises to be a unique forum for problem-solving debate and idea-sharing discussion.

 

Interested in speaking at the conference?  Contact the Conference Producer.

For sponsorship and exhibition opportunities, Contact our Sponsorship Department

Chairmen - Day One

AM: Lutz Jermutus, Global Head, Technology, Medimmune

PM: Jonathan Drachman, Senior VP, Research & Translational Medicine, Seattle Genetics

Chairman - Day Two

James Smothers, Director and Preclinical Research Head, GSK

Conference agenda

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8:30

Registration & Coffee

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9:00

Welcome & Introductions

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9:10

An Introduction to Antibody-Drug Conjugates (ADCs): General Concepts and Historical Perspectives

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9:45

Case Study: Linkers and Payloads which have been used for advanced clinical development programs

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10:15

Internalizing vs. non-Internalizing Antibodies: challenges and opportunities

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10:45

Coffee Break

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11:00

Novel linkerless ADCs: Preclinical experience and industrial opportunities

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11:30

A critical analysis of challenges and opportunities for next-generation armed antibodies

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12:10

Discussion Session

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12:30

Close of Workshop

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13:00

Registration & Coffee

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13:15

Welcome & Introductions

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13:30

Current EU Legislation & Guidelines

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14:15

Introduction and Overview of CMC Requirements for ADCs and Key Guidelines

  • CMC & Quality Requirements: Drug/Linker Molecule, Biological Component, ADC Drug Substance
  • Overview of Key Analytical Assays (Antibody Drug Ratio, Potency, Specific Stability Indicating Assays)
  • Case Studies: Clinical Delay due to CMC deficiencies in the Regulatory Dossier
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    15:00

    Afternoon Tea

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    15:15

    Pre-clinical Requirements for Phase 1 Clinical Studies

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    16:00

    Regulatory Strategy for ADC Development

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    16:30

    Case Studies and Group Task

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    17:30

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Lutz Jermutus

    Lutz Jermutus, Senior Director, Technology, MedImmune

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    9:10

    ADC Design: Incorporating the lessons learned from clinical experience

    John Lambert

    John Lambert, Vice President, ImmunoGen Inc.

  • Since 1999, a number of antibody-maytansinoid conjugates (AMCs) have entered clinical testing.
  • The most advanced AMCs, T-DM1 and SAR3419, are attracting attention for their efficacy and tolerability profile
  • Lessons learned from earlier AMCs helped inform the design of these compounds
  • Examples drawn from the newest AMCs in early development will illustrate the application of the growing body of knowledge in AMC design
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    9:50

    The Development of Antibody-Drug Conjugates at Seattle Genetics

    Jonathan Drachman

    Jonathan Drachman, Senior VP, Research and Translational Medicine, Seattle Genetics Ltd

  • Antibody-drug conjugates represent an important class of new cancer therapies using antibodies to deliver cytotoxic agents to antigen-expressing cancer cells
  • Criteria for designing and developing these therapeutic molecules will be discussed.
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    10:30

    Morning Coffee

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    11:00

    Traceless vascular targeting ADCs for cancer therapy

    Goncalo Bernardes

    Goncalo Bernardes, EMBO & Novartis Fellow in Cancer Research, Swiss Federal Institute Of Technology E T H

    • Targeted delivery of potent drugs to the tumor neovasculature as a novel cancer therapy
    • Development of chemically defined vascular targeting ADCs that offer pan tumoral coverage.
    • These ADCs can potently inhibit tumor growth in syngeneic immunocompetent models of murine cancer

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    11:40

    Antibody mediated nanoparticle drug delivery

    Christopher Scott

    Christopher Scott, Director of Research, Queens University Belfast

    • Application of antibodies as targeting agents
    • Use of antibodies to elicit synergistic therapeutic effects
    • Challenges to development of such modalities

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    12:20

    Networking Lunch

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    13:50

    Supercharging: A precision medicine approach to improving efficacy by combining ADC with other targeted cell killing strategies

    James Smothers

    James Smothers, Director, Oncology, Cancer Epitope DPU, GSK

  • Scientific rationale for combining Fc effector enhancement with ADC MOA
  • Impacts of multiple MOAs on target selection
  • Translational medicine considerations during preclinical development
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    14:30

    Design of antibody-based fusion proteins that target Death Receptors in cancer

    Edwin Bremer

    Edwin Bremer, Medical Biologist, Groningen University Institute for Drug Exploration (GUIDE)

    • The use of Death Receptor  signalling for cancer therapy
    • Why Death Receptors and their cognate Death Ligands are suitable effectors for ADC
    • Dual functional ADCs that combine DR targeting with modulation of target antigen signalling

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    15:10

    Afternoon Tea

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    15:40

    Novel Linker design and development

    Giulio Casi

    Giulio Casi, Research Scientist, Philochem A G

    • What makes an ideal linker?
    • Preventing early cleavage and increasing linker stability
    • How do linkers effect safety and pharmacokinetics

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    16:20

    Panel Discussion: Developing Antibody Drug Conjugates

    Kerry Chester

    Kerry Chester, Professor, University College London

    • Which is the most important factor?
    • How can we best develop what we know?
    • How can we learn from past mistakes?

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    17:00

    Antibody directed cytotoxics

    John Flygare

    John Flygare, Sr Scientist, Genentech Inc

    • Design criteria for successful  antibody-drug conjugates
    • Novel toxins amenable for antibody conjugation
    • Linker strategies for connecting the toxin to the antibody

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    17:30

    Chairman’s Closing Remarks and Close of Day One

    Jonathan Drachman

    Jonathan Drachman, Senior VP, Research and Translational Medicine, Seattle Genetics Ltd

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    James Smothers

    James Smothers, Director, Oncology, Cancer Epitope DPU, GSK

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    9:10

    Photodynamic Antibody Drug Conjugates

    Mahendra Deonarain

    Mahendra Deonarain, Lecturer& consultant, Imperial College

    • Targeted photodynamic therapy (PDT)
    • Photo-activatable drugs
    • Optimized single-chain Fv frameworks
    • ‘OptiLink’ platform technology
    • Improved pharmacokinetics and potency

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    9:50

    ADC bioanalytical assay development challenges

    Kathy Kozak

    Kathy Kozak, Technological Scientist, Genentech Inc

    • Characterization of ADCs is a critical step for both research and development off efficacious and safe therapeutics
    • Monitoring multi-component ADCs is essential for successful optimization
    • Protein-directed conjugation can result in the ADC molecule in a heterogenous mixture with respect to both the loading and distribution of cytotoxic drug species on the monoclonal antibody
    • Characteristics of ADCs can represent challenges for the development of reliable and accurate bioanalytical analysis
    • Some bioanalytical assay development challenges and solutions will be addressed

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    10:30

    Morning Coffee

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    11:00

    Novel enzymes for antibody fragmentation and characterization

    Malin Mejare

    Malin Mejare, Chief Scientific Officer, Genovis AB

    • A site specific cleavage site yields a homogenous pool of fragments that allows for use in antibody characterization.
    • Rapid enzymatic reaction with minimal sample preparation and optimization.
    • Allows for top down approaches in characterization of antibody drug conjugates

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    11:40

    Progress towards intranuclear target selection and payload delivery for cancer imaging and therapy

    Katherine Vallis

    Katherine Vallis, Professor of Experimental Radiotherapeutics, University of Oxford

    • Rationale for nuclear targeting
    • Design of carrier molecules for intranuclear targeting
    • Choice of payload for intranucleur targeting

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    12:20

    Networking Lunch

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    13:40

    Using ADCs to overcome therapeutic resistance

    Wen Jin Wu

    Wen Jin Wu, Principal Investigator, Division of Monoclonal Antibodies, FDA

    • Evaluating mechanisms of antibody resistance
    • Design of the next generation of therapeutic monoclonal antibodies
    • Developing the new generation, such as ADCs to overcome resistance

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    14:20

    Phase I clinical program for the novel ADC AGS-16M8F

    Leonard Reyno

    Leonard Reyno, Senior Vice President, Chief Medical Officer, Agensys

    • Target selection: AGS-16 hits a single transmembrane antigen (ENPP3/CD203c (ectonucleotide pyrophosphatase/phosphodiesterase)) that is up-regulated in the majority of renal cancers
    • AGS-16M8F: IgG2-Drug Conjugate:
    o Fully human from XenoMouse® technology
    o Conjugated to auristatin F with non-cleavable linker (mc-MMAF)
    o Iin vitro affinity of 0.15nM: Cellular IC50= 0.3 nM (KU812 cells)
    • Developing AGS-16M8F – a unique ADC with significant preclinical activity in metastatic renal cell carcinoma.
    • Discussing Phase I trail experience
    • Ensuring payload release in the appropriate environment
     

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    15:00

    Afternoon Tea

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    15:30

    ADC facility design - health and safety

    Justin  Mason

    Justin Mason, Managing Director, SafeBridge Europe, Limited

  • Biopharmaceutical Compound Hazard Assessment
  • ADC facility design elements
  • Control or contain?
  • Workplace testing
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    16:10

    Approaches to regulatory safety testing for ADC products

    Pamela Hamill

    Pamela Hamill, Senior Scientist. Immunology Development Services, BioReliance Ltd

  • Regulatory landscape
  • Guidance and advice to ADC manufacturers
  • Testing strategies in support of novel therapies
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    16:50

    Chairman’s Closing Remarks and Close of Day Two

    Workshops

    Novel Linker Strategies

    Novel Linker Strategies

    Holiday Inn Kensington High Street
    22 May 2012
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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