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Commercial Issues in Oncology Drug Development
23 October - 24 October 2000
Commercial Issues in Oncology Drug Development
The oncology drug market has huge potential with an, unfortunately, expanding patient population. The ageing of the population and increasing exposure to carcinogens ensures that cancer will remain a leading cause of death and continue to be hugely expensive for world healthcare budgets in the forseeable future. In the market place at present, cytotoxic drugs dominate despite the problems associated with these agents. New developments in technology however ensure that the pipeline for anti-cancer drugs has never looked fuller with more targets being identified and developments in the effective targeting of cytotoxic drugs changing the treatment options for all types of cancer. This conference will concentrate on recent developments in the anti-cancer drug field and will demonstrate the market significance of these new developments. Effective commercialisation strategies for oncology products will be discussed along with the impact of new technology on the development of oncology drugs. Commercial Aspects in Oncology Drug Development is organised and produced by SAE Media Group: we specialise in providing senior executives with timely, strategic and focused up to date information. SAE Media Group conferences are leading-edge business events offering delegates the opportunity to meet senior industry and seek their advice and opinions.

Please register now to guarantee your place at this important conference.

Conference agenda

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8:30

Registration

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9:00

Chairman's Opening Remarks

Dr James Caro

Dr James Caro, , Caro Research

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9:10

MARKET OVERVIEW

Dr Jim Wright

Dr Jim Wright, President & Chief Scientific Officer, Lorus

  • Overview of epidemiology of cancer
  • The research pipeline for cancer therapeutics
  • Current research goals: increasing efficacy and tolerability
  • Research directions: focus on antisense approaches
  • Success stories to date
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    9:40

    USING PHASE IV TRIALS TO EXTEND YOUR MARKET

    Dr Martin Birkhofer

    Dr Martin Birkhofer, Director, Clinical Oncology, Bristol Myers Squibb

  • Brief overview of Phase IV clinical trials
  • Clinical need for extending range of indications
  • Treatment possibilities across a range of cancers with new therapeutics
  • Identifying the indications to investigate first
  • Phase IV oncology trials at Bristol Myers Squibb
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    10:20

    DEVELOPING YOUR MARKET

    Dr Paolo Paoletti

    Dr Paolo Paoletti, Executive Director, Oncology New Product Development Team Leader, Eli Lilly

  • Oncology at Eli Lilly: improving development times
  • What is the real economic value of identifying new indications for a product?
  • Establishing the best options to target for new indications
  • Ensuring appropriate clinical trials to ensure approval for new indications
  • Case study: Gemzar
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    11:00

    Morning Coffee

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    11:20

    MAXIMISING VALUE OF CANCER TREATMENTS

    Dr Paul Cossum

    Dr Paul Cossum, Vice President, Preclinical R&D & Business Development, Aronex

  • Introduction: Maximizing the value of known classes of anticancer therapies
  • Improved pharmacokinetics
  • Circumventing resistance mechanisms; Improved safety profile
  • Value of preclinical research collaborators to a development company
  • Identifying the best drug development route
  • Value of outsourcing to increase the speed and decrease the risk of drug development
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    12:00

    FINE TUING OF EXSISTING THERAPEUTICS

    Dr Alex Kozak

    Dr Alex Kozak, President & CEO, D-Pharm

  • Introduction to D-RAP technology
  • Products under development (I): a new generation of chemotherapeutics
  • Introduction to RPL technology
  • Products under development (II): re-engineered alkylphosphocholines
  • Impact of fine tuning technologies on drug development and marketing
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    12:40

    Networking Lunch

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    13:40

    GENES TO CANCER THERAPEUTICS

    Prof Karol Sikora

    Prof Karol Sikora, Vice President, Global Clinical Research, Oncology, Pharmacia

  • Biomarkers to prove pharmacological effectiveness
  • Surrogate endpoints of efficacy
  • Molecular toolkits for risk management
  • Fast tracking by molecular stratification
  • Integrated molecular solutions for registration and marketing
  • The future cancer scenario
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    14:20

    AN UPDATE ON IMMUNOTHERAPIES IN ONCOLOGY

    Dr Eyal Talor

    Dr Eyal Talor, Senior Vice President, Research & Manufacturing, Cel-Sci

  • Why immunotherapies for cancer?
  • Development of Multikine
  • Identifying the best chemotherapeutics to combine with Multikine
  • Commercial considerations: pricing issues & cost effectiveness in the real world
  • Future development opportunities: considering the way forward
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    15:00

    TARGETING CHEMOTHERAPY WITH ANTIBODIES

    Dr Robert T Maguire

    Dr Robert T Maguire, Vice President, Clinical Affairs, Global Medical Affairs, Wyeth Ayerst

  • Antibody-targeted chemotherapy
  • The CD33 antigen and development of Mylotarg
  • Development of Mylotarg and the CD33 antigen
  • Clinical efficacy to date
  • Commercial benefit of entering the orphan drug market
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    15:40

    Afternoon Tea

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    16:00

    COMMERCIAL VIABILITY OF CANCER VACCINES

    Warren Dudley

    Warren Dudley, Senior Vice President, Business Development, AVAX

  • Development of cancer vaccines at AVAX
  • Advantages to other therapeutic strategies
  • Individualised vaccines or mass produced?
  • The price of scaling up the manufacture to commercial levels
  • The cost of vaccine therapy: can it be borne by health service providers?
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    16:30

    COMMERCIAL DEVELOPMENT OF THALOMID

    Dr Jerome Zeldis

    Dr Jerome Zeldis, Chief Medical Officer , Celgene

  • Proposed mechanism of action
  • S.T.E.P.S: a unique distribution system
  • The role of the independent Investigator in clinical trials
  • Thaliodmide as a treatment for haematological and oncological conditions
  • Other areas of commercial interest for THALOMID
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    17:00

    Chairman’s Closing Remarks and Close of Day One

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    17:10

    Networking Drinks Reception

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    8:30

    Re-registration and Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Joanna C Horobin

    Dr Joanna C Horobin, Executive Vice President, Commercial Development, EntreMed

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    9:10

    ROLE OF NEW TECHNOLOGY IN CANCER DRUG DISCOVERY

    Dr Raymond Withy

    Dr Raymond Withy, Chief Business Officer, Abgenix

  • The molecular evolution: leading the way in cancer drug discovery
  • Over view of techniques being applied in the search for new cancer therapeutics
  • Success stories of the biotechnology world: Herceptin
  • New technology: reducing time to market or expensive technologies?
  • Future directions: individualised medicine and cost implications for the pharmaceutical industry
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    9:40

    SPEEDING UP THE PACE OF TARGET IDENTIFICATION

    Dr Pierre Legrain

    Dr Pierre Legrain, Vice President, Science and Technology, Hybrigenics

  • Problems with sifting through genomic changes in tumours to identify causative genes
  • Introduction to Protein Interaction Maps (PIMs) and overview of the potential of PIMs
  • Methods employed in the development of PIMs
  • How is this research being used to discover new targets in oncology?
  • Targets identified to dates
  • From target to commercial drug: pitfalls, hurdles and success
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    10:20

    RATIONAL CANCER DRUG DESIGN: GENES TO DRUGS

    Spiro Rombotis

    Spiro Rombotis, Chief Executive, Cyclacel

  • CDK enzymatic complexes and their role in the cell cycle
  • Case study: pre-clinical data on CYC202
  • In silico drug design: CYC400 series
  • Peptidomimetic approaches: CYC103
  • Rational drug design of anti-mitotic drugs: Polgen
  • Penetratin: endonuclear delivery of anti-cancer drugs
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    11:00

    Morning coffee

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    11:20

    FROM TUMOURS TO TRIALS: NEXT GENERATION CANCER VACCINES

    Dr Mark Goldberg

    Dr Mark Goldberg, Senior Vice President, Medical Affairs, Genzyme Molecular Oncology

  • The molecular evolution: redefining cancer therapy
  • Immunotherapy - the promise and the challenges
  • Individualized therapies vs customized off-the-shelf products
  • The power of combining function and genomic approaches in discovery
  • Accelerating development: antigen disocvery to IND in 12-18 month
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    12:00

    MARKETING ISSUES FOR CANCER THERAPEUTICS

    Dr George Blackledge

    Dr George Blackledge, , AstraZeneca

  • Tamoxifen: an oncology drug success story
  • Current market for breast cancer drugs
  • Up and coming competitors to tamoxifen and strategies to maintain market lead
  • Methods used to establish tamoxifen with clinicians
  • Ongoing product development strategies: clinical trials and efficacy data
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    12:40

    Lunch

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    13:40

    COMMERCIALISATION CONSIDERATIONS

    Dr Stephen Castle

    Dr Stephen Castle, Managing Director, Mattson Jack Group

  • Which patients for which product - identifying the best opportunitites for your products, what should be driving your decisions - patients or products
  • Patient availability for the development of products
  • Can you plan and work the optimal development and commercialisation strategy?
  • Future trends in cancer treatment - who’s going to pay and how much?
  • Optimising market penetration
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    14:20

    TBA

    Tara Spiess

    Tara Spiess, , Genta

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    15:00

    COMMERCIALISATION OF ORPHAN DRUGS

    Lars Uno Larsson

    Lars Uno Larsson, President, Swedish Orphan

  • Orphan drugs: is it commercially viable to develop commercial drugs?
  • European regulatory issues & patent life for orphan drugs
  • Issues in pricing of orphan drugs
  • Effective marketing of orphan drugs: reaching the specialists
  • Case study: Commercialisation of DaunoXome®
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    15:40

    Afternoon tea

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    16:00

    GLOBAL CLINICAL TRIALS

    Dr Pablo Fernandez

    Dr Pablo Fernandez, Vice President, Clinical Development, PharmaNet

  • Developing drugs on a global basis: factors to be considered
  • Effective management of a global clinical trial
  • Integrating clinical trial information into your product development strategy
  • What information can be obtained during clinical trials beyond the obvious?
  • Integrating outcomes data and health economics into your strategy
  • To outsource or not to outsource
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    16:30

    GAINING WORLDWIDE REGULATORY APPROVAL

    Dr Bruno Osterwalder

    Dr Bruno Osterwalder, Vice President, Global Head, Early & Strategic Oncology, F Hoffman La Roche

  • Development of Capercitabine as a first-line treatment in colorectal cancer
  • A niche indication: phase II data and breast cancer treatment
  • Gaining FDA approval for the use of capercitabine in breast cancer
  • Do different rules apply in breast cancer to third line treatments?
  • The situation in Europe and the response of the EMEA
  • Lessons learnt
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    17:30

    Chairman's Closing Remarks and Close of Conference

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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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