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International Clinical Trials
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The 11th Annual Partnerships in Clinical Trials Congress and Exhibition
focuses on the strategic and practical approaches to improving all
partnerships between trial sponsors and their suppliers, in order to
reduce costs, improve quality and accelerate clinical development.
The conference, on the 6th-9th November 2012, in the CCH Congress
Center, Hamburg, Germany, covers the entire clinical development
pipeline for pharmaceuticals and biotech, stretching from outsourced
R&D and preclinical through to Phase 3. The key theme for this
year’s event is ‘adapting to change: minimising risk through agile
development.’ Through lively debate and in-depth discussions, the
programme will examine managing risk strategically, with a defined set
of criteria for risk-based monitoring. Other key themes include: tactics
for efficient operational delivery; critical examination of strategic
outsourcing models; and planning and measuring project success.
New additions to the 2012 programme include an expert opinion track,
including a panel discussion that will look at the impact of CROs and
other vendors going private. There will also be an initiative on
outsourcing strategies for small- and medium-pharma and biotech, with a
focussed networking opportunity for service providers to meet small- and
mediumsized pharma companies.
The economic keynote presentation from Joe Nellis, Professor of
International Management Economics, Director of Policy Strategy and
Performance Community at Cranfield University will present “a
competitive outlook for 2013 and beyond.” His take on leading change
through strategic partnerships is simple: “what new businesses, what new
alliances, what new partnerships have you not yet thought about which
might be the right structures for the future?”
In the industry keynote presentation, John Orloff, Senior Vice
President, Global Development and Chief Medical Officer, Novartis Pharma
AG, will examine “high level strategic innovations for clinical trials:
what needs to change?” This presentation will give an assessment of the
current issues and challenges that the industry faces in clinical
research.
For inspiration, Didi Hopkins, International Centre for Programme Management, Cranfield School of Management,
and Senior Trainer, The National Theatre, London, will present two
workshops at the pre-conference symposium: “gravitas, power and presence
– using the language of leadership to improve your public speaking”;
and “women in leadership forum: be seen, be heard, be taken seriously.”
Delegates will also have the opportunity to hear from the true leader of
the e-patient movement, Dave deBronkart, better known as ‘e-patient
Dave’, and learn how this empowered patient beat stage 4 cancer.
The ‘leadership’ keynote comes from Itay Talgam, Music Director of the
Tel-Aviv Symphony Orchestra and internationally renowned conductor.
Through his humorous and interactive session, ‘lead like the great
conductors: getting a brilliant performance without saying a word,’ Itay
will examine how to resist micro-management and give space for your
partners to perform.
One of the pre-conference workshops will deliver an audience with the
FDA, assessing what is expected of risk-based monitoring. This will be
presented by Ann Meeker-O’Connell, Acting Associate Director, Risk
Science, Intelligence and Prioritization, US Food and Drug
Administration, CDER. |
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News and Press Releases |
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Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer
BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.
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White Papers |
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Delivering Fit For Purpose Biomanufacturing CHO Cell Lines
Fujifilm Diosynth Biotechnologies
The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
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Industry Events |
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Clinical Operations in Oncology Trials West Coast
17-18 November 2020, Hilton San Francisco Airport Bayfront
Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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