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Global Trends in Anti-Infectives 2005

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Old 01-11-2005, 10:10 PM
Joe Stone
Posts: n/a
Default Global Trends in Anti-Infectives 2005

Global Trends in Anti-Infectives 2005
2nd - 3rd February 2005 - Workshop: 1st February 2005
Kensington Hilton London


This conference will look at the history of infectious diseases and the
evolution of resistance, analyze the trends and patterns in the ever-growing
infectious disease market. Observe the demographic importance of popular
infectious diseases by looking at epidemiological studies and how we
conquered the most deadly ones in the past.

**Historical and epidemiological studies of infectious diseases and
antimicrobial drug development.
**Understand the evolution of antimicrobial resistance.
**Hear from industry experts on overcoming challenges in developing
antimicrobial drugs: problematic issues in clinical trials,
regulatory hurdles, and insufficient profits (e.g. MRSA and SARS big disease
small population).
**Analyse current models and tests to evaluate new drugs: PK/PD,
susceptibility and tolerance test, are they just good theories? What are
their clinical values?
**Explore room for growth in the effect of generic erosion, look at case
studies on the biggest names that have reached end of patent life, e.g.
Augmentin by GSK.
**Examine novel drug classes, are they the business opportunities the
industry has been hoping for?

**Dr. André Bryskier, Senior Director, Clinical Mircobiology, Aventis
**Dr. Anthony White, Director, Scientific Communication, Antibacterials,
**Dr. Trevor Trust, VP, Infection Discovery, AstraZeneca
**Dr. Heino Stass, Clinical Pharmacologist, Bayer
**Dr. Steven Projan, VP, Protein Technologies, Wyeth
**Dr. Richard Laing, Medical Officer, Policy, Access & Rational Use -
Essential Drugs and Medicines Policy, WHO
**Dr. Simon Croft, DNDi (Drugs for Neglected Diseases initiative)
**Dr. Ian Morrissey, Chief Operating Officer, GR Micro Ltd
**Dr. Alasdair MacGowan, Bristol Centre for Antimicrobial Research
Revaluation, Southmead Hospital
**Dr. Ian Gould, Senior Lecturer, University of Aberdeen
**Professor Patrice Courvalin, Head of Unit, Antibacterial Agents Unit,
Institut Pasteur
**Professor Martin Woodward, Head of Unit, Department of Antibacterial
Diseases, Veterinary Laboratory Agency
**Dr. Cees Winnips, CEO & Chairman, Necura Pharmaceuticals
**Dr. Tim Rowan & Dr Simon Sunderland, VP & Director of Veterinary Medicine
R&D, Pfizer
**Dr. Stefan Bronzwaer, Project Officer, Health Threat Unit, European
**Professor Malcolm Page, Head of Biology, Basilea Pharmaceutica
**Dr. Peter Seufer-Wasserthal, VP, Business Development, Morphochem

This event will also feature: 2 Pre-conference Interactive Workshops
Developing Pricing & Reimbursement Strategies for Anti-infectives
Led by: Dr. Volker Janssen, Director, Simon-Kucher & Partners

Regulatory Requirements for Veterinary Antimicrobials: Barriers,
Opportunities or Something Else?
Led by: Dr. Peter Silley, Director, MB Consult


**Vice President Infection Discovery
**Vice President, Infectious Disease
**Vice President, Protein Technologies
**Vice President, Infection
**Vice President, Head of Infective Research
**Vice President, Drug Development
**Vice President, Research & Pre-clinical Development
**Medical Director
**Medical Manager
**Senior Director, Science Policy
**Senior Director, Vaccine Department
**Chief Scientific Officer
**Senior Director, Clinical Microbiology
**Chief Operating Officer
**Director of Antibody
**Senior Vice President, Global R&D
**Senior Vice President, Therapeutics
**Director of Infection Strategy
**Clinical Pharmacologist
**Managing Director
**General Counsel
**Executive Director for Development


Places at this event are strictly limited so BOOK YOUR PLACE NOW.
To make a booking on this event, please contact me via phone or email. Book
early to secure a place.


Attend the:
2 Day conference with interactive workshop - ONLY GBP1600 plus VAT
2 Day conference - ONLY GBP1299 plus VAT
Workshop only - ONLY GBP650 plus VAT


Booking is easy, simply contact Joe Stone on:

Telephone: +44 (0)20 8767 6711
Fax: +44 (0)20 8767 5001
Terms and conditions apply - see below
mailto:[Only registered users see links. ]


Tuesday 1st February 2005
Morning Session:
Led by: Dr. Volker Janssen, Director, Simon-Kucher & Partners
Developing Pricing & Reimbursement Strategies for Anti-infectives

* Pricing-relevant characteristics of the anti-infective market
* Improve your pricing methods & value pricing
* Examples of international pricing considerations
* Pricing & reimbursement trends in anti-infective market

Afternoon session:
Led by: Dr. Peter Silley, Director, MB Consult
Regulatory Requirements for Veterinary Antimicrobials: Barriers,
Opportunities or Something Else?

* What do the regulatory guidelines really mean?
* How much data do I really have to provide?
* Are harmonised guidelines really harmonised?
* Does regulation of veterinary antimicrobials really protect drugs for
human use?

Day One Wednesday 2nd February 2005
Conference Chairman
Professor Patrice Courvalin, Head of Unit
Antibacterial Agents Unit, Institut Pasteur

08:50 Registration and coffee

09:20 Opening remarks from the chair


09:40 Evolution of Bacteria Towards Multiple Resistance
.. What are the extent and mechanisms of horizontal gene transfer?
.. Discover mutational evolution: the beginning of a new era
- Important factors and evidence
.. Combinatorial genetics and biochemistry of resistance
- What we have learnt from past and present studies
.. The cost of resistance: in perspective of stability and biological
.. How to anticipate the emergence of resistance?
Professor Patrice Courvalin, Head of Unit, Antibacterial Agents Unit
Institut Pasteur

10:20 CASE STUDY: Industry's Effort to Antimicrobial Resistance
.. Antimicrobials - Identify opportunities within the market
.. How to reduce time, cost and risks in R&D?
.. Open up huge opportunities - Methods to widen your
approaches to R&D & prevent resistance to increase profit
.. Analyse novel inputs to your R&D- Examples of what will work
- New antimicrobial drug classes, subclasses & new doses
- Emphasis on improved eradication, patient outcomes and
economic benefits
.. Examples of industry activities in combating resistance
- What can you implement?
Dr. Ian Morrissey, Chief Operating Officer
GR Micro

11:00 Morning Coffee

11:20 Strategies to Develop New Treatments for Parasitic Diseases
.. Current needs for new drugs for "neglected" diseases
- Examples: durg -resistant malaria, leishmaniasis, trypanosomiasis
- Explore opportunities in neglected diseases
.. New opportunities - From genome to chemistry
.. Exploiting existing resources -How can the process be accelerated?
- Pinpoint factors for consideration
.. The public-private partnerships (PPPs): Exploring further
opportunities - How are they helping to drive R&D?
Dr. Simon Croft, R&D Scientific Director
Drugs for Neglected Diseases Initiative


12:00 Antibiotic Guidelines, Policies and Stewardship: the European
Healthcare Approach
.. Identify the current problematic resistant bacteria
.. Problematic issues faced by clinicians in hospital prescriptions
.. Current practices in prescribing and stewardship
.. Examine traditional vs focused anti-infective development:
the need for new agents
.. How will things improve? Generate incentives for drug development
Professor Ian Gould, Consultant Microbiologist
Aberdeen Royal Infirmary

12:40 Lunch

14:00 Community Strategy Against Antimicrobial Resistance
.. Analyse goals and advantages of community strategies
.. AMR, EARSS, Enter-Net, EURO-TB and new legislation on zoonoses
.. Improving methods for prevention, surveillance & control standards
.. Develop a community network & linkage to information resources
.. Identify opportunities: rapid diagnosis, susceptibility testing and
alternative options - Pinpoint Pros & Cons of each development
.. How can you co-operate with international communities?
- Prepare for the future and make room for bigger opportunities
Dr. Stefan Bronzwaer, Project Officer
Health Threat Unit, European Commission

14:40 CASE STUDY: Focusing on Animal Antimicrobial Resistance and Functional
.. Understand the spread of infection on genomic level
.. Identify new targets for novel pharmacological interventions
- Control infectious disease & combat microbial drug
resistance: Anylyse studies on animal models
.. Adopt functional genomic tools & signature-tagged mutagenesis
.. Overcome problematic issues with veterinary antimicrobial
clinical development - Pinpoint factors for consideration
.. Prolonged efficacious response - Optimal-dosing regimens
- What have we learnt so far? How can we improve?
Professor Martin Woodward, Head of Unit
Department of Bacterial Diseases, VLA

15:20 Afternoon Tea

15:40 Antimicrobial Dosing to Prevent Emergence of Resistance
.. The evolution: assessing mutation rate and variants
.. How to effectively use the pharmacodynamic paradigm to
determine antibacterial dosing to optimise effects?
.. Adaptation of model systems to predict the emergence of
resistance risk relationship - What can you implement?
.. Role of mutant prevention concentrations
Dr. Alasdair MacGowan, Bristol Centre for Antimicrobial Research Revaluation
Southmead Hospital


16:20 CASE STUDY: Overcoming challenges in the Anti-infectives
.. Why the focus on infectious disease?
- A common, growing, costly and serious health problem
.. Demographic significant diseases: Africa, Asia Pacific, Europe
and Americas
.. Identify opportunities to better care for infectious diseases
.. Rising to the challenge for more advanced and effective
treatment therapies - AstraZeneca's past work and examples
Dr. Trevor Trust, VP, Infection Discovery

17:00 CASE STUDY: Augmentin - Adaptation &Evolution to meet
a changing Environment
.. Overview of its success story: from discovery to today
.. The antibacterial environment and rationale for Augmentin's
discovery and evolution
- Antimicrobial resistance development (penicillin/b-lactamase,
macrolide and quinolone)
- Changes in dosage practices & application of science (PK/PD)
.. Combat resistance - Reformulation & enhanced dosing regimens
.. Analyse life-cycle management tactics & longevity through
alignment of science with medical and market needs
Dr. Anthony White, Director, Scientific Communication Antibacterials

17:40 Questions and Discussion

18:00 Close of Day One

Day Two Thursday 3rd February 2005

Conference Chair Day 2
Dr. André Bryskier
Senior Director, Clinical Mircobiology, Aventis

08:50 Registration and coffee

09:20 Opening remarks from the chair

09:40 CASE STUDY: Promising Compounds in Development for
the Treatment of Tuberculosis
.. The fight against Tuberculosis: Medical needs -Why the urgency?
.. Recent trends and discoveries in R&D: Promising compounds
currently in the pipeline
.. Discovery of a new class of potent TB compounds
.. Examine efficacy studies in the mouse model
.. Clinical analysis of lead candidate
.. Can the treatment paradigm for tuberculosis be changed?
Dr. Koen Andries, Distinguished Research Fellow
JnJ Pharmaceutical R&D

10:20 CASE STUDY: Bayer's Perspective - Challenges in
Antimicrobial Clinical Development
.. Implement PK/PD at different stages to steamline R&D
.. What is the clinical value of PK/PD? Is it just a good theory?
.. Keeping up with the constantly upgrading scientific standards
- Examples of pharmacokinetic, safety & tolerability testings
.. Overcome problematic issues in antimicrobial clinical R&D
.. Scientific contribution for adjustment of financial and other
development risks
Dr. Heino Stass, Global Clinical Pharmacology

11:00 Morning Coffee


11:20 CASE STUDY: Parameters of Antimicrobial Activity -Veterinary's
.. Patterns of antimicrobial activities in humans & animals
- Compare mutation, tolerance, resistance and adverse reaction
.. Prolonged persistent effects - Problematic issues on dosing
- PK/PD profiles of Danofloxacin and Pfizer's novel drugs
.. Major parameters correlating with efficacy - What to watch for
- Examine evidence and clinical studies
.. Goal of dosing regimen - clinical examples of successful regimen
on existing antimicrobials
Dr. Tim Rowan and Dr. Simon Sunderland
VP and Director, Veterinary Medicine R&D

12:00 CASE STUDY: Wyeth's Novel Strategies to Anti-Infectives
.. Updates on infectious disease - Pinpoint where opportunities lie
.. All new anti-microbials - The potential blockbusters
.. Evaluate studies that demonstrate why peptides are better
.. Why are drug companies discarding anti-infective opportunities?
- What are the reasons to come back to the market?
.. Positive outlook: Examine new anti-microbial strategies
- How to move forward? Maximise your pipeline strategies
- Novel non-antibiotic options: Gram Positive pathogens
Dr. Steve Projan, VP
Protein Technologies, Wyeth

12:40 Lunch

14:00 CASE STUDY: Strategies for Conventional Small Molecular
Compound Discovery
.. MRSA - increasing death tolls in US and UK hospitals
- Analyse compounds MRSA are resistant to -Characteristics
.. Potential advantages of novel small molecule compounds
- Beat resistance, achieve efficacy results
- Examine the effectiveness of current examples
.. Challenges in developing small molecular weight anti-infectives
.. Emplore new business opportunities - non-quinolone gyrase
Dr. Peter Seufer-Wasserthal, VP
Business Development, Morphochem

14:40 CASE STUDY: Old Compounds New Stories
.. Topical infections- Explore alternative paths to enter the market
.. Re-occurrence & problematic issues in topical infections
.. Progresses on dosage, application and novel delivery methods
.. New treatment options - are new compounds always better?
- Utilise existing resources and data to optimize profit
.. Analyse topical infection mortality trends and future treatment:
How to meet the unmet needs?

Dr. Cees Winnips, CEO & Chairman
Necura Pharmaceuticals

15:20 Afternoon Tea

15:40 CASE STUDY: Evaluate a New Class of Antibacterial Agents
.. Overview of the value of ketolides in infectious diseases
.. Evaluate potency studies, mechanism of action, spectrum of
activity & costs to manufacture - Potential blockbusters?
.. Profit forecast on ketolide development
.. Combating Gram-positive resistance - How effective are they?
.. Analyse clinical evidence of resistance data
.. Ketolides-telithromycin- a viable new antimicrobial drug class?
- Examine results from comparability tests
Dr. André Bryskier, Senior Director
Clinical Microbiology, Aventis

16:20 CASE STUDY: Novel Approaches in Anti-Infective
.. Clinical resistance to b-lactams - What are we fighting against?
.. Understanding the molecular basis of PBP-mediated resistance
in Gram-positive cocci
.. MRSA infection & b-lactam resistance - What is the correlation?
.. Anti-MSRA cephalosporins currently in development
.. Resistant Gram-Negative bacteria, especially Neisseria,
Haemophilus, Acinetobacter and Pseudomonas
.. Prospects for new b-lactams dealing with resistant Gram
Negative bacteria
Professor Malcolm Page, Head of Biology
Basilea Pharmaceutica

17:00 WHO's Priority Medicines for Europe and World Study
.. Priority diseases and unmet needs
.. Approaches to identify & overcome barriers to innovation
.. Pricing issues faced by industry today in Europe
- Examine possible strategies and solutions
Dr. Richard Laing, Medical Officer

17:40 Questions and Discussion

17:50 Summation of Conference from chairman

18:00 Close of Conference

Terms & Conditions
NB - Due to high demand, we do not 'reserve' or 'hold' places - a request
for an invoice to be raised will be treated as an official booking and will
be subject to the cancellation policy as outlined below.
Cancellations/substitutions and name changes: All bookings carry a 50%
liability after the booking has been made, by post fax, email or web. There
will be no refunds for cancellations received on or after one month before
the start of the conference (e.g. cancellation on or after 20th January for
a conference starting on 20th February). If you decide to cancel after this
date the full invoice remains payable. Conference notes, which are available
on the day, will be sent to you. Unfortunately we are not able to transfer
places between conferences and executive briefings. However if you are
unable to attend the event you may make a substitution/name change at any
time as long as we are informed in writing by e-mail, fax or post. Name
changes and substitutions must be from the same company and are not
transferable between companies or countries.

Indemnity: visiongain Ltd reserve the right to change the
conference/executive briefing content, timing, speakers or venue without
notice. The event may be postponed or cancelled due to acts of terrorism,
war, extreme weather conditions, industrial action, acts of God or any event
beyond the control of visiongain Ltd. If such a situation arises we will
endeavour to reschedule the event. However, visiongain Ltd cannot be held
responsible for any cost, damage or expenses, which may be incurred by the
customer as a consequence of the event being postponed or cancelled. We
therefore strongly advise all customers to take out insurance to cover the
cost of the registration, travel and expenses.

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