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Overview:

Early phase “proof of mechanism” and “proof of concept” trials are the cornerstone of anti-cancer drug development. In the first phases of clinical development difficult choices have to be made about the selection of study endpoints, the best available biomarkers, and the target patient population. With the advent of new molecularly targeted agents the complexity of early phase oncology trials has substantially increased. Therefore, each study design decision is critical the risk profile of the overall development program.

In this workshop a general introduction into designing early phase oncology trials will be provided. Background information will be given on different study endpoints, patient enrichment, exploratory biomarker development and the overall early phase development strategy. Best practices in contemporary development of targeted anti-cancer agents will be highlighted. This workshop will close with a discussion about optimizing designs for trials with new agents, finding the best dosing regimens in selection of the correct subpopulations to include in “enriched” studies.


 Key Objectives:

  • Understand “Proof of Mechanism” and “Proof Of Concept” Studies
  • Learn from best practices in anti-cancer drug development
  • Avoid problems observed in less successful developments
  • Maximise trial design strategies with new agents

 Workshop Hosts:

 

  Eric van der Putten has over 20 years of clinical research experience. Eric studied immunology in The Netherlands. He started his professional career in 1983 at the Comprehensive Cancer Centre in Amsterdam, collaborating closely with EORTC Study groups. After leaving the comprehensive cancer centre he was involved in project management and execution in various roles related to market research, e-clinical systems and data management (1990 – 2000). Eric joined NDDO Oncology in 2000 where he was Chief Operating Officer and Chief Executive Officer. In 2005 Eric became Vice-President Oncology Europe for INC Research. In 2007 Eric co-founded SMS-oncology and is the Chief Executive Officer of the company.

 

  Edwin Klumper has over 15 years of experience in the pharmaceutical and biotech industry. He started his career with 5 years of translational cancer research and did his PhD thesis on “Drug Resistance and Relapsed Leukemia”. Edwin was Medical Director for Yew Tree and Business Unit Director Oncology for Asta Medica. He subsequently took a position at Amgen where he launched Aranesp in The Netherlands, led a business transition process at the UK subsidiary before becoming Brand Director Aranesp for Amgen Europe at their Swiss Headquarters. Before joining SMS oncology Edwin was VP Marketing and Sales, Europe at Nabi, a US biotech company where he launched the European operations. Edwin is co-founder of SMSoncology and he is the Chief Scientific Officer.

 


 

 

Workshop programme

8:30 Registration & Coffee

9:00 Welcome & Introduction

9:15 Phase I Trial Designs

10:15 Personalised Cancer Therapy - Hype or Hope

11:15 Coffee

11:30 Phase II Trial Designs

12:30 Optimising the Early Phase Development Plan

13:30 Close of Workshop

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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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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