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Conference Documentation: Therapeutic Antibodies

Published by: SMI Publishing, Ltd

Published: Jan. 31, 2007


Table of Contents


Day 1




8.30 Registration & Coffee

9.00 Chairman's Opening Remarks

Nitin Damle, Director, Oncology Research, Wyeth Pharmaceuticals.

9.10 MODULAR TIME-TO-MARKET PROCESS DEVELOPMENT CONCEPT FOR MONOCLONAL ANTIBODIES

Choice of expression system

Media development

High titer fermentation technology

High yield downstream processing

Process validation oriented at clinical success

Scalability and robustness of pilot scale

Royalty load for in-licensed IP

Rolf G Werner, Head, Corporate Division Biopharmaceuticals, Boehringer-Ingelheim .

9.50 IMPROVING EFFECTOR FUNCTIONS OF ANTIBODIES

Enhancing the clinical success of therapeutic antibodies

Variety of genetic engineering methods used to enhance effector function of an antibody in order to suit the strategy for its clinical application

Structural basis of antibody effector function

Superior specific target cell killing in vitro and in vivo

Increasing the potency of antibodies regardless of the receptor phenotype

Substantial clinical benefits when used with therapeutic antibodies

Yielding better results

Peter Sondermann, Head, Process Biochemistry, GLYCART biotechnology (part of the Roche group).

10.30 Morning Coffee

10.50 SYNTHETIC HUMAN ANTIBODIES

Development of antagonists and agonists of signalling pathways

Design principles for highly functional antibody libraries

Structure-based design of antibody diversity

Selection and formatting strategies for antagonist and agonist activity

High throughput analysis and production of novel antibodies

Applications for controlling cell proliferation and cell death

Sachdev Sidhu, Senior Scientist, Genentech Inc.

11.30 THERAPEUTIC ANTIBODY DISCOVERY

A portfolio view

Comparing and contrasting the complementary technologies of phage and ribosome display

Their key usage in therapeutic antibody discovery strategy

Critical success factors

Diversity of lead antibodies

Potencies of optimised antibodies

Tristan Vaughan, Director Discovery, Respiratory & Inflammation, Cambridge Antibody Technology.

12.10 Networking Lunch

1.40 NANOBODIES AS NEW THERAPEUTIC ENTITIES

A new generation of protein-based drugs that combine advantages of monoclonal antibodies and small molecule drugs

Nanobodies: single variable domains derived from camelids

Picomolar affinity leads by direct sorting of antigen-specific B-cells from immunised llamas

Examples of designs of nanobody-based protein drugs

Nanobodies efficacious in animal models of rheumatoid arthritis, cancer and thrombosis

Advantages of nanobodies compared to monoclonal antibodies

Easy formatting, tailoring of half-life and low cost of goods

Hennie Hoogenboom, CSO, Ablynx.

2.20 ANTIBODY MANUFACTURING AND PURIFICATION

The greatest challenge to face the biotech industry?

Antibody purification methods

Manufacturing regulatory issues

Ensuring adequate manufacturing capacity

Developing strategic plans to ensure they have adequate resources

Purifying any antibodies quickly and efficiently

Types of strategies used

Lothar Jacob, Marketing Manager, Merck KgaA.

3.00 Afternoon Tea

3.20 HUMAN MONOCLONAL ANTIBODIES FOR PROPHYLAXIS AND THERAPY OF INFECTIOUS DISEASES

Novel medicines for multi-resistant bacteria and emerging viruses

Humoral immune response in infectious diseases

Rapid generation of human mAbs by phage display

Importance of antigen and assay formats

Applications and business cases

Jan ter Meulen, Executive Director, Infectious Diseases, Crucell.

4.00 TUMOUR-SPECIFIC ANTIBODY-TARGETED CHEMOTHERAPY USING IMMUNOCONJUGATES OF CALICHEAMICIN

Antibody-drug conjugates

Tumour-specific delivery of potent chemotherapeutic agents may be therapeutically beneficial

Calicheamicin is a potent DNA-minor groove-binding radiomimetic cytotoxic agent

Strong evidence of anti-tumour efficacy of calicheamicin-conjugated antibodies in various preclinical models

CD33-specific and targeted Mylotarg®, also known as gemtuzumab ozogamicin, is the first cytotoxic immunoconjugate to be approved by the US FDA and has provided the first clinical proof of concept in the treatment of patients with relapsed acute myeloid leukaemia

CD22-specific inotuzumab ozogamicin is presently in advanced stage of clinical evaluation in patients with relapsed B -cell non-Hodgkin’s lymphoma and has demonstrated clinical activity with reversible and manageable side effects profile

A number of targeting opportunities with immunoconjugates of calicheamicin specific for solid tumors being explored are in various stages of preclinical advancement

Nitin Damle, Director, Oncology Research, Wyeth Pharmaceuticals.

5.20 Chairman’s Closing Remarks and Close of Day One




Day 2




8.30 Re-registration & Coffee

9.00 Chairman's Opening Remarks

Joseph Bolen, CSO, Millennium Pharmaceuitcals Inc.

9.10 TOXIN-CONJUGATED APPROACHES FOR ANTIBODY-BASED CANCER THERAPEUTICS

Status report on efficacy and side effect relationships

Target selection

Antibody generation

Toxin and linker selection

Preclinical efficacy and safety assessments

Clinical experience

Joseph Bolen, CSO, Millennium Pharmaceuitcals Inc.

9.50 ENGINEERING DESIRABLE MODIFICATIONS ON THERAPEUTIC ANTIBODIES

Designing and engineering desirable biological activity and affinity

Humanise or germline rodent or human antibodies with less immunogenicity

Engineer lead antibodies with less aggregation issues

Modify lead antibodies with better expression

Engineer lead antibodies with better stability

W.David Shen, Director, Amgen.

10.30 Morning Coffee

11.00 FUNCTIONAL DIFFERENCES IN CLASSES OF TNF ANTAGONISTS

Two classes of biologic agents that target TNF alpha:

Soluble TNF receptor (Etanercept) and anti-TNF monoclonal antibodies

All of these agents bear Fc region of IgG1, which has potential to elicit effector functions

Objective was to assess ability of the TNF antagonists to bind soluble and membrane-bound TNF and to mediate cell killing

TNF antagonists exhibited functional differences in in-vitro models

Taruna Arora, Senior Scientist, Amgen.

11.40 IMMUNOGENICITY

Screening in a global context

Immunogenicity and possible consequences

Immunogenicity identification and testing

Current regulatory guidelines

Addressing the challenges of antibody immunogenicity

Selected case studies on antibody therapeutics

Philippe Stas, Chief Operating Officer, AlgoNomics N V.

12.20 Networking Lunch

1.50 INTELLECTUAL PROPERTY ISSUES

Review of the intellectual property situation relating to antibodies

Obtaining patents to antibodies - recent developments in the granting of patents to antibodies

How to build an antibody patent portfolio

What is a reasonable scope of protection for an antibody patent claim?

Strategies for enforcing patents to antibodies

How to avoid infringing competitor antibody patents

Potential effects of antibody patents of broad scope on the biotechnology industry

Stephen Ingham, Patent Attorney, Eli Lilly.

2.30 ANTIBODY DISCOVERY AND DEVELOPMENT

Case study - HUMIRA/ABT-874

Alejandro Aruffo, Vice President, Global Pharmaceutical Development, Abbott Laboratories.

3.10 Afternoon Tea

3.40 NATURAL ANTIBODY DERIVATIVES

Developing the next generation of antibody drugs

Challenges faced with classical antibodies

Naturally occurring antibody alternatives

Advantages of novel antibody format

Technology involved

Application in cancer therapy

Therapeutic application in trypanosomiasis

Serge Muyldermans, Professor, Vrije Universiteit Brussel.

4.20 PRODUCT DEVELOPMENT

A novel drug platform for cancer therapy

Basic biology of molecules

The principle of polyclonal T cell therapy

Results from clinical trials

Patrick Bauerle, Chief Scientific Officer & Senior Vice President, Research & Development, Micromet Inc.

5.00 Chairman’s Closing Remarks and Close of Conference

Abstract

SMi’s 7th Annual Therapeutic Antibodies Conference will provide a forum for leading industry experts from major pharmaceutical companies to discuss and evaluate the latest challenges and problems facing the therapeutic antibodies market.

As one of the fastest growing segments of the pharma market, the value of therapeutic antibodies is expected to more than triple in value. The success of current marketed products has led to escalation in antibody development, with more than 370 programs currently in the pipeline. Evolutions in innovation and business model dynamics will drive the sector's dominant position.

SMi’s Therapeutic Antibodies Conference is a must-attend event and will provide an excellent opportunity to network, enhance your company’s profile and keep you up-to-date on the latest issues in the market.

The two-day conference programme will be delivered by a panel of expert speakers, including:
  • Professor Rolf Werner, Head, Corporate Division, Biopharmaceuticals & Corporate Senior Vice President, Boehringer-Ingelheim
  • Dr Joseph Bolen, Senior Vice President, Research & Drug Discovery, Millennium Pharmaceuticals
  • Dr Nitin Damle, Director, Oncology Discovery Research, Wyeth Pharmaceuticals
  • Dr Tristan Vaughan, Director, Discovery, Respiratory & Inflammation, Cambridge Antibody Technology
  • Dr W. David Shen, Director, Amgen
  • Dr Hennie Hoogenboom, Chief Scientific Officer, Ablynx NV
  • Stephen Ingham, Patent Attorney, Eli Lilly
  • Dr Jan ter Meulen, Executive Director, Infectious Diseases, Crucell
By attending this conference, you will learn about:
  • INTELLECTUAL PROPERTY: The current status of regulations affecting the pharmaceutical industry
  • LICENSING ANTIBODIES: Discover how to optimise business opportunities and form strategic collaborations with major companies that result in successful partnerships
  • TREATMENTS FOR DISEASE: Hear practical examples and case studies on the innovative uses of antibodies in cancer treatment and what toxin-conjugated approaches for antibody-based therapeutics are doing for the industry
  • NOVEL TECHNOLOGIES: See the positive effect new and innovative technologies are having on businesses
  • DEVELOPING THE NEXT STAGE OF ANTIBODIES: Review the challenges faced by major pharma companies whilst developing antibodies
  • EXCLUSIVE INFORMAL NETWORKING: Collaborate with industry peers in an environment promoting information exchange


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