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This year's conference will look to address the critical subject of improving relationships between Pharma & CROs and how they can work best together to improve drug development and clinical trials. With the increasing reliance on positive and profitable relationships between these organisations, this conference will aim to bring you opinions, recommendations and case studies from both sides.
 

This year's programme will look to focus on 5 main areas: Optimising interaction between sponsors and CROs, Developing and executing strategic partnership models, Partner selection, Risk management and Improving communication.
Each session will be addressed by speakers with considerable experience in the field and will address the current issues and proposed solutions faced in each situation.
 

For information on sponsorship and exhibition opportunities, Contact our Sponsorship Department
 

Partnerships with CROs Conference 2011 testimonials:
 

“Interesting comments on panel discussion”
“Excellent, just what this industry needs”
“Good examples, thought provoking."
“Excellent questions and moderating“

Partnerships with CROs gives you the opportunity to interact with key decision makers in both pharma and CROs. Study real case studies to identify where partnerships may be degrading, and what can be done to prevent it. With speakers from a wide range of big pharmaceutical companies and representation from CROs allows unprecedented access for networking and problem solving from those with the large scale experience.

Discuss the strategic rationale for clinical development outsourcing among the large pharmaceutical companies.

Network and discuss ideas with key decision makers in pharma / biotech / CROs.

Hear from industry experts about the current issues with CRO partnership.

Learn what clinical development capabilities do various companies consider core and noncore, and how is this changing

Investigate to what extent is the design of relationships and associated capabilities aligned with strategic intent

Develop strategy in relationship structure; standard contract, sophisticated strategic alliance - or something in between.

 

Global Strategic Sourcing
Outsourcing
Clinical Operations
Contract Management/Administration
Finance
International Clinical Operations
Corporate Counsel
R&D
Clinical Development
Planning
Accounting/Budgeting
Global Clinical Programs
Project Management/Planning
Risk Management
Clinical Trial Projects
Business Development
 

Actelion Pharmaceuticals; Agio Interactive; Alliance Healthcare; Almac ; Amilcar International; Astellas Pharma Europe Ltd; Aziende Chimiche Riunite Angelini Francesco ACRAF SpA; Bayer; Biocair International Ltd; Biomedical Systems Europe; Biopharm Insight; BMS; Bristol-Myers Squibb Pharmaceuticals Ltd; BTG; Business Insights; Campbell Charles Associates (2000) Ltd; Chiltern International Ltd; CTB Solutions; Cyprotex Plc; ForwaR&D Solutions; GW Pharmaceuticals; INC Research; JABPharma Limited; klausrose Consulting; KOWA; Merck Serono; MESM; NHS R&D Forum; Pharmades S.A.S; PHARSAFER; PPMLD; Quintiles Ltd; R & NR Consulting; Risk Decisions Ltd; The Avoca Group, Inc.; The William Harvey Research Institute, Barts and The London School of Medicine & Dentistry; Thomson Reuters; TRIUMPHARMA; University Of Leicester;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Tim Highman

Tim Highman, Director, Pfizer

9:10 Outsourcing within a regulated environment

Tim Highman

Tim Highman, Director, Pfizer

  • Considerations within a more complex regulated environment
  • Confidence in outsourcing
  • Overcoming obsticals
  • 9:50 Outsourcing and regulatory inspections

    Marie Fasehun

    Marie Fasehun, Director Pharmacovigilance Systems and Business Development , PharSafer Associates

    • Oversight and management of partnerships
    • Inspection readiness and quality management
    • Inspection findings and corrective actions
    • Building for the future

    10:30 Morning Coffee

    11:00 The HRA and research

    Janet Wisely

    Janet Wisely, Interim Chief Executive, HRA / Director, National Research Ethics Service, Health Research Authority
    View Bio

  • Opportunities for increasing a relationship
  • Long term outlokk of the HRA and research proposals
  • Combining your talents; both sides can learn from one another
  • 11:40 Working with CROs in emerging markets

    Andrew Huxley

    Andrew Huxley, Regional Director Asia Pacific , Eli Lilly

    • Emerging markets
    • Sharing responsibilities
    • Case study China; OR Latin America
    • Matching the right trial to the right country

    12:20 Networking Lunch

    13:40 Implementing a new CRO Partnership model in support of improved cycle time

    Gareth Lewis

    Gareth Lewis, Director Clinical Research, Pfizer

    • Selection of country footprint
    • Vendor selection process to optimise success
    •  Establishing a new operating model – practical considerations
    • Service delivery structure
    • Ensuring quality and compliance – governance and oversight considerations
    • Progress and challenges to date

    14:20 Choosing the right CRO for partnership

    Martin Grosvenor

    Martin Grosvenor, Sourcing Product Specialist , AstraZeneca

    • Evaluating your own processes and requirements before choosing a partner
    • Approaches to asses a potential partner
    • Developing an in-depth and thorough CMO/CRO questionnaire
    • Strategies for short listing the number of potential companies

    15:00 Afternoon Tea

    15:30 Past, current and future of partnering.

    Cedric Burg

    Cedric Burg , Consultant, Consultant (Formerly of Teva)

    • Demand ever increasing or impact with recession
    • Planning your partnership in advance
    • Illustrative examples
    • Tips for outsource building

    16:10 Success factors for a strong CRO partnership

    • Combining cultures
    • What should you look for in a major CRO
    - Governance
    - Communication
    - Therapeutic & Operational expertise
    - Quality Assurance and Planning
    - Leadership
    - Flexibility
    • Role of strategic partnerships

    Prasad Velisetty

    Prasad Velisetty, Director, Medical, Quintiles Ltd

    Martin Gouldstone

    Martin Gouldstone, Senior Director Corporate Development, Quintiles Ltd

    16:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Roger  Joby

    Roger Joby , Managing Director, 1to1to1, R & NR Consulting

    9:10 Do pharmaceutical companies think that partnership is more important than delivery?

    Roger  Joby

    Roger Joby , Managing Director, 1to1to1, R & NR Consulting

  • The evidence would suggest that they do.
  • The construction of the 2012 Olympics venues was much more focused on delivery which was driven by the uses of the innovative NEC3 contracts.
  • This presentation looks at the lessons that we can learn.
  • 9:50 The NIHR clinical research network; delivering research in the NHS

    • Effective set up and delivery of clinical research
    • Supporting CROs to deliver to time and target
    • The NIHR – opportunities from translational medicine through to pharmcovigilence studies

    Clare Morgan

    Clare Morgan, Director of Industry, NIHR Clinical Research Network Coordinating Centre

    10:30 Morning Coffee

    11:00 Tactics for small biotech and pharma in outsourcing

  • Trends and emerging new models for pharma - CRO partnerships
  • Challenges and key success factors
  • Outlook to the next level of scale and scope
  • Volker Roenicke

    Volker Roenicke, Vice President, Booz & Company

    Thomas Solbach

    Thomas Solbach, Associate, Booz and Company

    11:40 How can you improve risk management – Different sectors, same problems

    Val Jonas

    Val Jonas, Risk Management Consultant ,

     

  • Risk sharing - techniques used in the industry
  • Defence contractors and the MOD
  • Collaborative working in energy
  • IMproving flexibility in an agreement to avoid future problems
  • Supporting joint delivery
  • 12:20 Networking Lunch

    13:50 Driving and releasing change - managing sustainable transformation of your strategic relationship

  • Preparing your organisation for transformation
  • Transforming your organisation
  • Making the transformation stick after it is established
  • Malcolm Horsley

    Malcolm Horsley, Managing Consultant, PA Consulting Group

    Mark Eisenecker

    Mark Eisenecker, Managing Consultant, PA Consulting Group

    14:40 Clinical site contracting in an outsourcing environment

    Gary Reeves

    Gary Reeves, Clinical Contracts Manager II, Biogen Idec Ltd

  •  Micro/Macro management ethos and their relationship to the outsourced site contracting devliverables
  • Negotiation guidelines and legal autonomy
  • Deliverables, reporting, metrics and performance indicators

     

  • 15:20 Interactive Panel Discussion : Outsourcing perspectives from both sides of the table

    • New challenges faced by CROs – Sponsors
    • Opportunities for enhancement
    • Different business models and costing strategies
     

    Cedric Burg

    Cedric Burg , Consultant, Consultant (Formerly of Teva)

    Roger  Joby

    Roger Joby , Managing Director, 1to1to1, R & NR Consulting

    Malcolm Horsley

    Malcolm Horsley, Managing Consultant, PA Consulting Group

    16:00 Afternoon Tea

    16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andrew Huxley

    Andrew Huxley

    Regional Director Asia Pacific , Eli Lilly
    Cedric Burg

    Cedric Burg

    Consultant, Consultant (Formerly of Teva)
    Tim Highman

    Tim Highman

    Director, Pfizer

    Andrew Huxley

    Regional Director Asia Pacific , Eli Lilly
    Andrew Huxley

    Cedric Burg

    Consultant, Consultant (Formerly of Teva)
    Cedric Burg

    Clare Morgan

    Director of Industry, NIHR Clinical Research Network Coordinating Centre
    Clare Morgan

    Gareth Lewis

    Director Clinical Research, Pfizer
    Gareth Lewis

    Gary Reeves

    Clinical Contracts Manager II, Biogen Idec Ltd
    Gary Reeves

    Janet Wisely

    Interim Chief Executive, HRA / Director, National Research Ethics Service, Health Research Authority
    Janet Wisely

     

    Janet Wisely, Interim Chief Executive, Health Research Authority; Director, National Research Ethics Service
    Janet Wisely is the Chief Executive of the Health Research Authority. Janet is acknowledged as an innovative leader who as the Director of the National Research Ethics Service transformed the UK ethics service into an internationally recognised system for ethics review.  Janet obtained a degree in Physics and PhD from University of London. She believes strongly in the principles of the NHS and has spent her entire working career associated with research and the NHS.  She joined the NHS in 1992 and was appointed as a National R&D Programme Manager in 1994, before joining the Central Office for Research Ethics Committees in 2002 with the primary responsibility of ensuring that RECs met the requirements of the EU Directive 2001/20/EC. The successful change management driven by Janet has resulted in a National Research Ethics Service which is effective, efficient and responsive to the needs of researchers and the facilitation of ethical research as well as robust and transparent in protecting research participants.  She has also been influential in delivering wider change, not least through the provision of the Integrated Research Application System which streamlined the application processes for researchers in the UK. Under her leadership the HRA has set out plans that will further improve the environment for research in the UK to promote health research and protect the interests of patients and the public in the UK. Outside of work Janet plays a full role in family life and has two teenage sons, much of it in the sporting arena as a participant, spectator or supporting her family and of course providing the inevitable Mum’s taxi at weekends!

    Malcolm Horsley

    Managing Consultant, PA Consulting Group
    Malcolm Horsley

    Marie Fasehun

    Director Pharmacovigilance Systems and Business Development , PharSafer Associates
    Marie Fasehun

    Mark Eisenecker

    Managing Consultant, PA Consulting Group
    Mark Eisenecker

    Martin Gouldstone

    Senior Director Corporate Development, Quintiles Ltd
    Martin Gouldstone

    Martin Grosvenor

    Sourcing Product Specialist , AstraZeneca
    Martin Grosvenor

    Prasad Velisetty

    Director, Medical, Quintiles Ltd
    Prasad Velisetty

    Roger Joby

    Managing Director, 1to1to1, R & NR Consulting
    Roger  Joby

    Thomas Solbach

    Associate, Booz and Company
    Thomas Solbach

    Tim Highman

    Director, Pfizer
    Tim Highman

    Val Jonas

    Risk Management Consultant ,
    Val Jonas

    Volker Roenicke

    Vice President, Booz & Company
    Volker Roenicke

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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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