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Commercial Issues in Oncology Drug Development
10 September - 11 September 2001
Commercial Issues in Oncology Drug Development
Oncology is one of the fastest growing therapeutic areas in the pharmaceutical industry. There is an immediate need for a large membership of oncologists to help bring safe, new cancer drugs to the market more quickly. Therefore the potential commercial value of the cancer market is huge and constantly growing.

With this knowledge in mind, our challenge at SAE Media Group was to assemble key industry peers that would present their latest strategic planning on the potential of new markets, product areas and commercial methodologies

Why should you attend this event?

This is your opportunity to meet senior industry figures and seek their advice and opinions. This comprehensive conference will embrace the most important issues within recent developments, market significance and effective commercialisation strategies for oncology products. In particular, the conference will focus upon drug development and the marketplace, economic and commercial considerations, pharmacogenomics, partnership, clinical trials and regulatory and intellectual property.

Conference agenda

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8:30

Registration and Coffee

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9:00

Forecast modeling

  • Interpreting epidemiology data
  • Evaluating market share
  • Predicting pricing and reimbursement environment
  • Developing a product profile
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    9:45

    Risk assessment

  • Assessing risk through proof of concept
  • Assessing risk in clinical studies
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    10:30

    Morning Coffee

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    10:45

    NPV assessment

  • Adjusting for the risk
  • Understanding the commercial life
  • Evaluating residual value
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    11:30

    Portfolio review

  • Strategic value
  • Commercial value
  • Decision making
  • Decision implementation
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    12:15

    Discussion and questions – review of the session

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    12:30

    Close of Workshop

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    8:30

    Registration and Coffee

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    9:00

    Chairman's Opening remarks

    Dr Sidonie Knight

    Dr Sidonie Knight, Clinical Programme Head, Oncology, GlaxoSmithKline

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    9:10

    OPPORTUNITIES IN ONCOLOGY

    Dr Linus Igwemezie

    Dr Linus Igwemezie, Director, Early Commercial Development, Novartis

  • Overview of oncology drug development
  • Safety and efficacy considerations
  • The market for oncology drugs
  • Approaches to rapid development of oncology drugs
  • Strategies for commercialising oncology drugs
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    9:40

    POST GENOMIC ERA

    Dr Robert Kramer

    Dr Robert Kramer, Vice President of Oncology Drug Discovery and New Business Ventures, Bristol-Myers Squibb

  • The post genomic era
  • Drug discovery
  • Oncology franchise
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    10:20

    DELIVERING THE PERFORMANCE THE MARKET AND PARTNERS EXPECT

    Dr Thomas Unger, Ken Fyvie and Dr Gulzar Sandhu

    Dr Thomas Unger, Ken Fyvie and Dr Gulzar Sandhu, Managing Consultants and Consultant, Life Sciences and Technology Practice, PA Consulting Group

  • It’s all in the planning
  • Staying on track: managing projects and programmes
  • Using information flow to your advantage – managing projects and securing prospective partners
  • Selecting the most commercially viable candidates to take forward
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    11:00

    Morning Coffee

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    11:20

    FINE TUNING OF EXISTING THERAPEUTICS

    Dr Alex Kozak

    Dr Alex Kozak, President and CEO, D-Pharm

  • Introduction to D-RAPä technology
  • Products under development (I): a new generation of chemotherapeutics
  • Introduction to RPLä technology
  • Products under development (II): re-engineered alkylphosphocholines
  • Impact of fine tuning technologies on drug development and marketing
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    12:00

    MARKET OVERVIEW

    Dr Jim A Wright

    Dr Jim A Wright, President, Lorus Therapeutics

  • Overview of epidemiology of cancer
  • The pipeline for cancer therapeutics
  • Current goals: increasing efficacy and tolerability
  • A focus on antisense approaches
  • Product diversification and risk reduction
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    12:40

    Lunch

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    14:00

    COMMERCIALISATION & DEVELOPMENT

    Dr Jerome D. Zeldis

    Dr Jerome D. Zeldis, Vice President, Medical Affairs/Chief Medical Officer, Celgene Corporation

  • Proposed mechanism of action
  • S.T.E.P.S: a unique distribution system
  • The role of the independent investigator in clinical trials
  • Thalidomide as a treatment for haematological and oncological conditions
  • Clinical Development of the IMiDs and SelCIDs
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    14:40

    GLOBAL CLINICAL TRIALS

    Dr Pablo Fernandez, LMS

    Dr Pablo Fernandez, LMS, Senior Vice President, Clinical Research, PharmaNet

  • Developing drugs on a global basis: factors to be considered
  • Effective management of a global clinical programme
  • 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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    15:20

    Afternoon Tea

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    15:40

    MAXIMISING VALUE OF CANCER TREATMENTS

    Dr Paul Cossum

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

  • Introduction: maximising 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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    16:20

    CANCER PATIENT CARE

    Dr John Fruehauf

    Dr John Fruehauf, Medical Director and Senior Vice President, Oncotech

  • Cancer phenotypes – prognostic and predictive tests in clinical practice
  • Molecular correlates of proteogenomics in the identification of new diagnostic and therapeutic targets
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    17:00

    Chairman's Closing Remarks and Close of Day One

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    8:30

    Re-registration and Coffee

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    9:00

    Chairman's Opening Remarks

    Dr Peter Cheverton

    Dr Peter Cheverton, Director of Medical Oncology, Daiichi Pharmaceuticals UK

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    9:10

    DEVELOPING YOUR MARKET

    Dr David Readett

    Dr David Readett, Global Oncology Clinical Research Physician, 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
  • The role of pharmacogenomics in the success of commercialisation
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    9:40

    GENES TO CANCER THERAPEUTICS

    Professor Karol Sikora

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

  • Biomarkers to prove pharmacological effectiveness
  • Surrogate endpoints of efficacy
  • Molecular tool kits for risk management
  • Fast tracking by molecular stratification
  • Integrated molecular solutions for registration and marketing
  • The future cancer scenario
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    10:20

    CELL CYCLE GENES TO SMALL MOLECULE CANCER DRUGS

    Spiro Rombotis

    Spiro Rombotis, Chief Executive, Cyclacel

  • CDK enzymatic complexes and their role in the cell cycle
  • CYC202: A specific, orally-available CDK2 inhibitor presently in Phase I trials
  • In silico drug design of 2nd generation CDK Inhibitors: CYC400
  • Peptidomimetic approaches to develop Cyclin Groove Inhibitors: CYC103
  • AstraZeneca-Cyclacel Alliance on CYC103
  • Rational drug design of anti-mitotic drugs: Polgen
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    11:00

    Morning Coffee

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    11:20

    THE BMS/MILLENNIUM ONCOLOGY PHARMACOGENOMICS ALLIANCE

    Laurence Reid

    Laurence Reid, Vice President, Personalised Medicine Strategy, Millennium Pharmaceuticals

  • The collaboration between BMS and Millennium
  • Multiple issues raised by the strategic development of new medicines
  • The impact these had on the deal
  • The management of the alliance
  • The implications for future pharmaceutical deals
  • The practice of medicine in oncology
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    12:00

    GENZYME MOLECULAR ONCOLOGY

    Mark J. Enyedy

    Mark J. Enyedy, Vice President, Business Development, Genzyme Molecular Oncology

  • Genzyme Molecular Oncology’s business strategy and the role of alliances
  • Discussion of GZMO’s strategic collaborations, including the goals, structure and economics of the alliances
  • Future directions
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    12:40

    Lunch

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    14:00

    COMMERCIALISATION CONSIDERATIONS

    Dr Stephen Castle

    Dr Stephen Castle, Managing Directot, Mattson Jack Group - Europe

  • Which patients for which product
  • Patient availability for the development of products
  • Can you plan and work the optimal development and commercialisation strategy?
  • Future plans in cancer treatment – who’s going to pay and how much?
  • Optimising market penetration
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    14:40

    CURRENT ECONOMIC HURDLES FACING NEW DRUGS

    Dr Clive Pritchard

    Dr Clive Pritchard, Health Economist, Office of Health Economics UK

  • The current status of national initiatives for other countries
  • The criteria for pricing and reimbursement
  • Who are the agencies/decision makers?
  • Industry response and impact on market access in home and foreign markets
  • Potential conflict between regulatory submission and reimbursement dossier
  • Will pharmacoeconomic data form part of the regulatory submission?

    Budget issues

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    15:20

    Afternoon Tea

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    15:40

    GAINING WORLDWIDE REGULATORY APPROVAL

    Dr Richard Peck

    Dr Richard Peck, International Drug Regulatory Affairs Manager, F. Hoffman LaRoche

  • Development of Capecitabine 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 capecitabine 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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    16:20

    INTELLECTUAL PROPERTY ISSUES

    Dr Cathryn Campbell

    Dr Cathryn Campbell, Partner, Campbell and Flores

  • Current issues in patenting
  • The patent application process
  • To patent or not to patent?
  • Patent and licensing rights for research
  • Patentability of oncology inventions
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    17:00

    Chairman's Closing Remarks and Close of Conference

    Workshops

    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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