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ADCs from early development into first-in-human studies
11 April 2018
ADCs from early development into first-in-human studies

ADC development has been the most exciting advance in therapeutic drug development, especially as the concept expanded to include anti-body fragments, peptide analogues and novel linkers and war heads. However, these are a complex development process as targeting molecule, linker and war head all have to be assessed for safety. Success depends on understanding what is possible and using different approaches in find the best options help get the quickest first-time in human study (FTIH) study.
The outcome is to provide an agency with a credible CMC package, demonstrable efficacy and safety to support a risk management plan for FTIH. The Workshop aims to cover the most important aspects that should be part of the “big picture” to file an IND and how to risk-manage to reach objectives and deal with the unexpected.
 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks and Introductions

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9:10

Regulatory Strategy

Peter Bach

Peter Bach, Director, BioPharmaLogic Ltd.

  • Biology for the regulatory arguments
  • CMC for nonclinical development
  • Staging the test item supply to speed the development
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    10:00

    Taking the conjugate into the clinic

    Peter Bach

    Peter Bach, Director, BioPharmaLogic Ltd.

  • Geographical differences
  • Finding clinical leverage
  • Global option for FTIH
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    10:40

    Morning Coffee

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    11:10

    Non-Clinical

    Peter Bach

    Peter Bach, Director, BioPharmaLogic Ltd.

  • Models
  • Service providers
  • Data interpretation
  • In vitro and in vivo safety assessments:

    - Literature Based Risk Assessment
    - Immunohistochemistry
    - CRO selection, Study design and CROs management

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    11:50

    Final considerations

    Peter Bach

    Peter Bach, Director, BioPharmaLogic Ltd.

  • Bioanalytical considerations
  • Agency interactions
  • The regulatory package
  • Outsourcing strategy – test item supply: matching nonclinical needs to speed the development
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    12:30

    Closing Remarks and End of Workshop

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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