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After last year’s hugely successful event, SMi are pleased to announce their 5th Clinical Trials in Cancer conference.

The conference will provide up-to-date information on the current challenges in clinical development. There will be a focus on European and US regulatory requirements, tissue Biomarkers in cancer drug development and ensuring maximum participation in trials. Compound drug case studies by major companies will discuss drugs being developed in phases I-III.

The event will offer attendees the chance to hear presentations of novel therapies for cancer that are being developed and how they are being integrated into clinical trials.

An opportunity to meet experts in the field to discuss how anti-cancer drug development can be optimised and carried forward to achieve the ultimate aim of getting effective drugs on the market faster.

A must attend event!

This years exceptional speakers line-up include:

  • Dr Andrew Hughes, Director, Discovery Medicine, Cancer & Infection, AstraZeneca
  • Dr Peter Wyld, Director, Oncology Development & EU Therapeutic Area Specialist, Amgen
  • Dr Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline
  • Dr Doriano Fabbro, Senior Unit Head, Expertise Platform Kinases & Head, Kinase Biology & Technologies , Novartis
  • Andrew Stone, Statistical Science Director, AstraZeneca
  • Dr Michael Lahn, Medical Advisor, Eli Lilly
  • Professor Karol Sikora, Professor, Cancer Medicine, Imperial College & Scientific Director, Medical Solutions

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Karol Sikora

Karol Sikora, Professor, Cancer Medicine, Imperial College, Hammersmith Hospital, London and Scientific Director, Medical Solutions , Medical Solutions PLC

9:10 KEYNOTE ADDRESS

Karol Sikora

Karol Sikora, Professor, Cancer Medicine, Imperial College, Hammersmith Hospital, London and Scientific Director, Medical Solutions , Medical Solutions PLC

  • Tissue and serum biomarkers
  • Measuring pharmacodynamic endpoints
  • Getting to molecular proof of principle
  • Validating surrogate endpoints
  • Novel utilisation of surrogates to shorten phase III
  • 9:50 CLINICAL BIOMARKERS

    Andrew Hughes

    Andrew Hughes, Director, Discovery Medicine, Cancer & Infection, AstraZeneca

  • Biomarkers emerging into clinical trials
  • Translation from preclinical to clinical studies
  • Application in clinical trials - including patient selection and clinical pharmacology
  • Case studies - leveraging biomarkers in accelerating and streamlining clinical trials
  • Implementation in drug and diagnostic development
  • Discovering, validating and developing assays for biomarkers
  • 10:30 Morning Coffee

    11:00 REGULATORY ISSUES IN EUROPEAN, US AND GLOBAL CANCER CLINICAL TRIALS

    Francis Crawley

    Francis Crawley, Director General, Good Clinical Practice Alliance

  • The current framework for cancer clinical trials in a globalised research environment
  • Developing protocols to meet regulatory and ethical review approval
  • Submitting an application for drug approval to regulatory agencies in Europe, the US and internationally
  • The European innovative platform for medicines strategy
  • The US FDA Critical Path Initiative
  • Cancer research in ascending markets and developing countries
  • 11:40 NEW PARADIGMS FOR DRUG DEVELOPMENT

    Iman El-Hariry

    Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline

    12:20 Networking Lunch

    14:00 COMPOUNDS IN EARLY DEVELOPMENT

    Peter Davis

    Peter Davis, Chief Executive Officer, Angiogene Pharmacueticals Ltd

  • Causes rapid destruction of tumour vasculature
  • Active in a wide spectrum of preclinical models
  • Particularly effective in combination
  • Target activity demonstrated in the clinic
  • 14:40 EARLY CLINICAL DEVELOPMENT OF A NOVEL TARGETED CHEMOTHERAPY

    Michael Saunders

    Michael Saunders, Vice President, Clinical Development, Allos Therapeutics Inc

  • Inhibits cancer cells of selected tumour types
  • Preclinical models shown to be effective against selective tumours
  • Taking advantage of the biochemistry of certain cancer cells
  • Potential as a new targeted therapy approach
  • 15:20 DEVELOPING AN ANTI-CANCER THERAPY

    David Henner

    David Henner, Vice President, Oncology, Novacea Inc

  • Inhibits cancer cells as monotherapy and in combination
  • Challenges of new development for calcitriol
  • New schedule, formulations and indications
  • Intellectual property
  • Potential new therapy for prostate cancer and other cancers
  • 16:00 Chairman’s Closing Remarks Followed by Afternoon Tea and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Michael Lahn

    Michael Lahn, Medical Advisor, Eli Lilly

    9:10 SECOND GENERATION BcrAbl INHIBITORS

    Doriano Fabbro

    Doriano Fabbro, Senior Unit Head, Expertise Platform Kinases & Head, Kinase Biology & Technologies , Novartis Institutes for BioMedical Research

  • Imatinib - a therapy for CML based upon its ability to block cell proliferation by inhibiting the tyrosine kinase of BcrAbl
  • Maintain durable high rates of responses with good tolerability as therapy for newly diagnosed patients with chronic Ph+ CML and patients achieving a major molecular response
  • Imatinib resistance - primarily occurs in the advanced stages of Ph+ CML and is due to mutations in the region of BcrAbl encoding the tyrosine kinase domain
  • AMN107 and Dasatinib - potent second generation BcrAbl inhibitors that inhibit most of the Imatinib resistant mutations in the advanced stages of Ph+ CML
  • The mechanisms of action and the clincal efficacies of these second generation BcrAbl inhibitors will be discussed
  • 9:50 THE USE AND APPLICATION OF COMBINATION DRUGS

    Michael Lahn

    Michael Lahn, Medical Advisor, Eli Lilly

  • New applications for existing drugs
  • Potential strategies - combinations of two drugs already in use to treat certain cancers
  • What are the adverse events that can happen
  • The timing and sequence of treatment with the drug combination
  • What is their primary role of action
  • Do they have the potential to provide a significant therapeutic advance?
  • 10:30 Morning Coffee

    11:00 ISSUES OF LATE STAGE ATTRITION

    Hilary  Calvert

    Hilary Calvert, Professor, Medical Oncology, Northern Institute of Cancer Research (NICR)

  • Curtailing the increasing rate of late stage attrition of RDTB agents
  • New therapeutic opportunities and expectations for the future
  • Developmental challenges
  • Adoption of radically different development, evaluation and regulatory paradigms
  • Methods of prediction for the clinical outcome of a project
  • Adopting tools that enable improved decision-making
  • 11:40 CLINICAL TRIAL DESIGN

    Peter Wyld

    Peter Wyld, Director, Oncology Development, EU Therapeutic Area Specialist, Amgen

  • Study design - controlled or uncontrolled?
  • Different designs
  • What methodologies can be used?
  • Evaluation of success or failure
  • Challenges in clinical trial design
  • Informing phase II study design by a focused approach in phase I
  • 12:20 Networking Lunch

    14:00 SATISFYING THE REGULATORY ASPECTS OF PHASE I/II TRIALS, ETHICAL STANDARDS AND GMP/GCLP COMPLIANCE

    Geoff Boxer

    Geoff Boxer, Laboratory Manager & UCL Business Fellow, University College London

  • Designing, developing and optimising targeted therapeutics in-house
  • Production of recombinant antibodies / antibody fusion proteins in clean rooms and operational problems
  • Satisfying the regulatory aspects of phase I/II trials, ethical standards and GMP / GCLP compliance
  • Performing mechanistic trials and improving tumour response assessment
  • Rationalising patient selection and customising treatment
  • The clinical trial environment – a vision for the future
  • 14:40 PHASE II AND III

    Andrew Stone

    Andrew Stone, Statistical Science Director, AstraZeneca

  • Benefits of seamless approach
  • When are they appropriate?
  • Who gets to see the phase II data?
  • Phase II endpoints and decision rules
  • Are there statistical penalties?
  • 15:20 PATIENT RECRUITMENT

    Peter  Johnson

    Peter Johnson, Professor, Medical Oncology, Cancer Research UK Clinical Centre

  • Streamlining trial set-up and regulatory processes
  • Developing a clinical research team
  • Selection of patients for cancer trials
  • Maximising recruitment in a cancer research network
  • Making trials widely available to cancer patients
  • 16:00 Chairman’s Closing Remarks Followed by Afternoon Tea

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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, SMI 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@smi-online.co.uk

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