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Advancing Antibodies Through The Pipeline Delivering Effective Therapies

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Advancing antibodies through the pipeline; delivering effective therapies

ACI’s 2nd Antibodies in Discovery & Development Conference will assess the challenges and opportunities in the
transformation of antibodies into successful therapeutic treatments. The programme focuses on the business strategies and
novel technologies currently in use to aid the advancement of antibodies through the drug development pipeline and ultimately
delivering greater and better drugs to the market.
THE AGENDA
Throughout the 2 days you will have the opportunity to hear from your industry peers and Our distinguished
discover the hottest advances in the development of therapeutic antibodies: speaking faculty will
include:
• Discover how to optimise target identification and antibody selection
• Understand the key approaches in tackling immunogenicity Keith Watson,
• Examine the latest breakthroughs in engineering capabilities Pharmaceutical Assessor,
• Hear how to promote efficacy in your antibody development Biologics and
• Consider the increasing role of antibody alternatives Biotechnology Unit,
• Determine how biosimilars will impact your antibody IPR Medicines and Healthcare
Products Regulatory
Agency
AN INTERACTIVE 2 DAYS
Leon Hooftman,
ACI’s meetings offer the perfect opportunity to discover the latest updates and to discuss Chief Medical Officer,
your own research challenges and solutions with your peers through an interactive and Chroma Therapeutics
informative 2 day programme.
Marc Bisschops, Scientific
• Hear from an outstanding line-up of the industry’s leading researchers, executives and Director, Xendo
decision-makers Manufacturing
• Network informally with a relatively small, targeted group of senior-level audience and
from the pharmaceutical and biotechnology industries. Allan Jensen,
• Learn more about your peers’ research, network with key industry leaders and your Director, Antibody
industry colleagues. Discovery,
Symphogen
• Discuss the latest challenges and developments in this rapidly changing and growing
sector of the industry.
Mark Throsby,
• Participate in roundtable sessions – giving you the chance to discuss the latest issues
Director, Antibody
with your colleagues – and the speakers – in an open, informal and intimate setting.
Research & Development,
Crucell
Who will attend?
Robert Lutz, Executive
All ACI’s events attract a targeted group of senior level researchers and decision-makers from Director – Preclinical
industry. Our meetings are strictly end-user focussed. Only a select group of companies are Development, ImmunoGen
invited to sponsor the event – to ensure the emphasis is on the industry participants, and making
sure our delegates have a valuable and positive experience. Tom Saylor, CEO, Arecor

Delegates will be drawn from pharmaceutical and biotechnology companies and include VPs, Tobias Raum, Director,
Directors and Managers of: Antibody Development, Antibody and Protein Engineering, Antibody Technology,
Immunology, Biotherapeutics, Product Development and Research and Development. Micromet

Testimonials From Previous ACI Pharmaceutical Events


…And many more
“It was a great pleasure presenting at your conference. I found the talks very informative and
enlightening”
Translational Medicine Leader, Pfizer

“I enjoyed the meeting very much myself and it will be a pleasure to join a suitable event you organise
in the future”.
Cancer Research UK

OPPORTUNITIES TO MEET YOUR TARGET AUDIENCE With thanks to our


Companies can gain direct access to our senior level audience and have an increased level of visibility
sponsor:
through branding and networking at the conference. For information on available sponsorship and
commercial opportunities, please contact Jean-Jacques Hermans on +44 207 981 9800 or email
jhermans@acius.net

REGISTRATION: Tel: +44 (0) 207 981 2504 or send an email on mmulazzi@acius.net
Website: http://www.acius.net
DAY ONE: 8th October 2008
08.00 Registration and Coffee 12.10 Lunch

09.00 CHAIRMAN’S OPENING ADDRESS 13.30 CONFERENCE PRESENTATION


Keith Watson, Pharmaceutical Assessor, Biologics And Developing Antibodies with the Desired Characteristics:
Biotechnology Unit, Medicines And Healthcare Products Producing Advanced Antibody Products with Increased
Regulatory Agency Potency

09.10 KEYNOTE ADDRESS • Why Polyclonal Antibodies?


Advancing the Selection of Therapeutic Antibodies • Technologies for Discovery and Production of
Recombinant Polyclonal Antibodies
This talk will explore the range of functional characteristics • Examples of Recombinant Polyclonal Antibodies
which may residue within one antibody molecule and the against Infectious Diseases
selection of the optimal functional profile to mediate the Allan Jensen, Director, Antibody Discovery, Symphogen
desired therapeutic effect. Several epitopes on the target
molecule may potentially mediate the desired antagonist or 14.10 CONFERENCE PRESENTATION
targeting function, but are they all equivalent and if not which New Requirements for First in Human Studies for
is optimal? Techniques for raising antibodies have now Antibodies and other High Risk Products
reached a point where we may have the benefit of selecting
from a range of highly potent low pM sequences, how do we • History: the TGN1412 phase I volunteer study
now which factor in preferred pharmaceutical characteristics • Conclusions of the expert group; aetiology and
to assist in the selection of the optimal entity? dosing issues
Alastair Lawson, Senior Director of Antibody Biology, UCB
• Proposed changes
Pharma
• First dose: NoAEL or MABEL?
09.50 CASE STUDY PRESENTATION
• Expert Advisory Group/ CHM meetings
Strategies for Improved Antibody Analysis: the
Development of Antibodies for Influenza Therapeutics • Regulatory perspectives

Leon Hooftman, MD Chief Medical Officer, Chroma


Avian influenza viruses such as H5N1 are currently
Therapeutics
panzootic and pose a pandemic threat. These viruses are
antigenically diverse and protective strategies need to cross
14.50 CONFERENCE PRESENTATION
protect against diverse viral clades. We isolated a panel of
cross-reactive neutralising antibodies against H5N1 and Progressing Antibody Production – The Rapid
multiple other subtypes of influenza A. The most potent Development of Highly Productive Processes
antibody (CR6261) was protective in mice when given • Accelerating process development
before and after lethal H5N1 or H1N1 challenge and could • Improving productivity
be used as a broad spectrum agent for prophylaxis or • Producing antibodies with the desired characteristics
treatment of human or avian influenza infections without John Birch, Chief Scientific Officer, Lonza
prior strain characterization. Biopharmaceuticals
Mark Throsby, Director, Antibody Research &
Development, Crucell 15.30 Afternoon Refreshments
10.30 Morning Refreshments and Exhibition Showcase
15.50 CASE STUDY PRESENTATION
10.50 CONFERENCE PRESENTATION Defining the Next Stage in Platforms for Antibody
TM
Identifying Lead Antibody Candidates – Optimal Production: BioSMB a continuous disposable
Applications of Display and Bioinformatics countercurrent chromatography process for purifying
Technologies monoclonal antibodies

• Accurately characterising targets The downstream processing bottleneck is leading to the


• Improving the comparability of antibodies exploration of processes with higher efficiencies and higher
• Using phage display to improve the selection of lead productivities. BioSMB is a technology that refines traditional
targets SMB into a viable option for biopharmaceutical purification.
Andy Nixon, Senior Director Biochemistry, Dyax By implementing a fully disposable-format fluid path and
11.30 CASE STUDY PRESENTATION modular design, the BioSMB technology addresses the key
Maximising Antibody Candidate Generation for the issues associated with biopharmaceutical processing, such
Identification of Improved Therapeutics as elimination of cleaning validation and rapid campaign
change-over.
Marc Bisschops, Scientific Director, Xendo Manufacturing
Through a series of strategic cross-licensing relationships
and internal innovation, XOMA has created a premier Ab
16.30 “Interactive” ROUNDTABLE DISCUSSIONS
technology platform. It's comprised of six commercial
Topics to be covered include:
human Ab phage display libraries and custom libraries for
TABLE 1: Antibodies and high risk products
Ab discovery, proprietary Human Engineering(TM)
CHAIR: Leon Hooftman, MD Chief Medical Officer, Chroma
technology, optimization technologies, and an integrated
Therapeutics
product development infrastructure. XOMA's unique ability to
parallel path Ab discovery creates unprecedented
TABLE 2: Optimising the antibody production process
opportunity to navigate technical challenges and business
CHIAR:
considerations. The success of this approach is illustrated
with XOMA 052, and 300fM mAb currently in Phase I clinical
testing.
17.30 Drinks Reception and End of Day One
Linda Masat, Director of Antibody Discovery & Engineering,
XOMA
DAY TWO: 9th October 2008
08.30 Registration and Coffee
12.40 Lunch
09.00 CHAIRMAN’S OPENING ADDRESS
Keith Watson, Pharmaceutical Assessor, Biologics And 14.00 CONFERENCE PRESENTATION
Biotechnology Unit, Medicines And Healthcare Products Assessing the Implications of Biosimilars on the Future
Regulatory Agency Landscape of Therapeutic Antibodies

09.10 KEYNOTE ADDRESS • Capitalising on the commercial opportunities of


Antibody Alternatives – Assessing their Potential to developing biosimilar treatments
Deliver High Affinity Therapeutics • Assessing the therapeutic parameters for biosimilars

• Assessing the current therapeutic limitations of Tom Saylor, CEO, Arecor


antibody products
• Examining the scope for developing small molecules 14.40 CASE STUDY PRESENTATION
to address unmet medical needs Developing Translational Antibodies for Improved
• Developing better therapeutics through improved Cancer Therapeutics – A Case Study of Antibody-IL-12
target selectivity, stability and clinical efficacy Fusion Protein

Andrew Goodearl, Director, Biologics Research, Abbott Although many molecules have been attached to
Bioresearch Centre antibodies, in an attempt to increase their in-vivo efficacy,
the yields have been low, and large scale clinical trials,
09.50 CONFERENCE PRESENTATION impossible. Recent advances in antibody technology have
Monoclonal Antibodies – The Golden Bullet in enabled effector molecules such as interleukins, to be
Therapeutic Treatment? genetically fused to antibodies and antibody fragments, to
enhance the efficacy when administered as anti-cancer
• Advancing monoclonal antibody development agents and produced in sufficient quantities to allow clinical
through genetic engineering - "humanized" and trials to be carried out.
fully human antibodies
• Providing more targeted therapeutics through the Benjamin Doran, Research Scientist, Antisoma Research
use of Conjugated Monoclonal Antibodies Laboratories
• Developing translational monoclonals - improving
15.20 CONFERENCE PRESENTATION
their application in clinical trials
Expanding the Scope for Antibody Treatments: T Cell
Engaging BiTE Antibodies: Clinical PoC and Recent
Robert Lutz, Executive Director - Preclinical Development,
ImmunoGen Developments

10.30 CONFERENCE PRESENTATION BiTE antibody technology is based on single chain bispecific
Unwanted Immunogenicity of Therapeutic Antibodies antibody molecules, binding to CD3 on cytotoxic T cells and
a surface antigen on a target cell, such as a cancer cell. This
close cell contact leads to the efficient killing of the target
• Predicting and reducing the risk of clinical
cell. The first BiTE antibody directed against CD19 on NHL
immunogenicity
cancer cells has proven efficacy in a clinical phase I trial.
• Technical guidance on methodologies Results will be discussed. An advanced new BiTE platform
• Strategies for immunogenicity assessment was recently developed and will be presented.
• Available guidance on immunogenicity
Tobias Raum, Director, Human Antibody Technology,
Dr Michael Clark, University of Cambridge Micromet
11.10 Morning Refreshments 16.00 Closing remarks & Afternoon Refreshments
11.40 “Interactive” ROUNDTABLE DISCUSSIONS 16.20 End of conference
Topics to be covered include:

TABLE 1: Strategies to reduce immunogenicity


CHAIR: Dr Michael Clark, University of Cambridge

TABLE 2: Assessing the efficacy of biosimilar therapeutics


5 EASY WAYS TO REGISTER
Tel: +44 20 7981 2504 Web: http://www.acius.net
Fax: +44 20 7593 0071 Mail: ACI Europe, 5/13 Great Suffolk Street, London, SE1 0NS
Email: mmulazzi@acius.net

TERMS AND CONDITIONS


How to Register
Registrations must be received in writing or electronically at our secure web site. Please complete and mail or fax a copy of registration
form with a cheque or credit card number. Fee includes program materials, continental breakfast, networking luncheon and
refreshments.
Payment
Payment must be received within five business days of returning the signed contract. After receiving payment a VAT receipt will be
issued. If you do not receive a letter outlining details two weeks prior to the event, please contact the Conference Co-ordinator at ACI
Europe Ltd.
Discounts are available for multiple/group bookings. Please call +44 20 7981 2504 for more information
Cancellations
Substitutions are welcome up to 24 hours prior to the event. Cancellations must be received in writing no less than 3 weeks prior to the
start of the conference; a full credit voucher towards a future ACI conference will be issued. Any cancellation received less than 3
weeks prior to the start of the event shall be deemed to be a breach of this contract by client, and accordingly, no credits will be given.
By completing this registration form, the client hereby agrees that in case of dispute or cancellation ACI Europe Ltd will not be able to
mitigate its losses for any less than 50% of the total contract value. Cancellations must be received in writing by mail or fax three weeks
before the conference. Thereafter the full conference fee is payable. If for any reason ACI Europe Ltd decides to amend, cancel or
postpone this conference, the conference fee will not be refunded. Furthermore, ACI Europe Ltd will not be responsible for covering
airfare, hotel or other costs incurred by registrants. In the event that ACI Europe Ltd cancel or postpone the event, ACI Europe Ltd
reserves the right to transfer this booking to another conference to be held in the following twelve months, or to provide a credit of an
equivalent amount to another conference within the following twelve months. The construction, validity and performance of this
agreement shall be governed in all respects by the laws of England to the exclusive jurisdiction of whose courts the Parties hereby
agree to submit.
About ACI
ACI, a UK owned company, have been running successful conferences for the last 8 years in the USA. Headquartered in Chicago with
offices all around the States, they run forums in varied fields and are market leaders in Healthcare business conferences. Opening their
European head office at the end of 2005, they have expanded rapidly and are launching a series of events covering emerging markets,
the maritime industry and now the pharmaceutical industry.
Venue: The cost of accommodation is not included in the event fee.
Central London, UK. Details to be confirmed. Preferential rates will be arranged with or near the event venue,
and all confirmed delegates will be given details of how to book
accommodation at this rate in due course.
Prices and Payment Information
Conference (Includes Documentation Packet) DATES OF CONFERENCE £1,495 (+ VAT)
Documentation Packet Copies of all conference proceedings £395
Documentation Packet Available Discounted Registrations
You can purchase the 2nd Antibodies in Discovery & Members and customers of all supporting organisations are
Development Conference papers at just £395. Simply tick the entitled to a 20% discount off their conference package if they
box on the booking form, send it with payment and your copy will book by the 9th August 2008.
be on its way to you after the meeting. This important manual will For more information please call +44 20 7981 2504.
be a source of invaluable reference for the future.

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