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Today, approval for NDA's is no longer assured upon completion of Phase III trials and research shows the FDA is now requiring post-marketing studies in over 70% of cases to prove a drug's long-term efficacy and safety. The situation is compounded by increasing costs – the average cost is now approaching the $4 million mark - to carry trials to phase III and beyond, difficulties with patient and clinician retention and much more.

The Speakers
To answer these concerns and to provide attendees with an essential industry update, the SMi Group has produced a strategic event that will be delivered by an excellent panel of industry leaders, including:

  • Bill Duval, Vice President, Global Operations for IIIB/IV Research, Quintiles Strategic Research and Safety
  • Mason W Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma, Inc.
  • Michael Edwin Kafrissen, Vice President, Clinical Affairs, Ortho-McNeil Janssen Scientific Affairs, LLC 
  • Gurdyal Kalsi, Director, Medical Affairs and pharmacovigilance, MDS Pharma Services
  • Dr Ferdinando Vegni, Director, Risk Management Strategy, Safety and Risk Management, Pfizer
  • David Parker, Director, Investigator Sponsored Studies Programme, AstraZeneca 
  • Michael Herschel, Director, Clinical Research, GlaxoSmithKline
  • Imre Pavo, Director, Medical & Regulatory Affairs, Central/Eastern Europe, Africa, Middle East & CIS, Eli Lilly
  • Glenn Matfin, Head of Medical Affairs, Novo Nordisk Inc.
  • Wolfgang Schumann, Senior Medical Safety Advisor, Bayer-Schering Pharma
  • Matthew Wintle, Director, Medical Affairs Programmes, Amylin Pharmaceuticals Inc

Why should I attend?
The conference will address your key concerns in a practical forum and give you the opportunity to explore how companies are:

  • MEETING safety, scientific, regulatory and commercial goals
  • IDENTIFYING the best method for observation
  • MANAGING costs in phase IV studies
  • AGGREGATING and integrating data, making best use of technologies like Electronic Data Capture
  • CAPTURING and interpreting Patient Reported Outcomes effectively
  • COMBINING medical affairs and marketing; marrying good science with good communications strategies
  • LEVERAGING IISS to expand the scientific knowledge of drugs 
  • SUPPORTING credibility with observational data in a post-market environment
  • And lots more

Who should attend?
The programme has been specifically designed for Vice Presidents, Directors and Heads responsible for:

Clinical Affairs                                      Clinical Development         
Clinical Operations                               Clinical Assurance and Compliance 
Clinical Research                                 Clinical Study Monitoring 
Clinical Trial Management                     Contracting/Budgeting
Drug Development                                Drug Surveillance/Product Safety
Late Stage Development                       Medical Affairs
Outsourcing                                         Patient Recruitment
Phase IV                                             Post-Marketing Studies
Risk Management                                Peri-Approval
Clinical IT/ Data Management/ EDC       Epidemiology

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Hugh Levaux

Hugh Levaux, Vice President, Product Strategy, Medidata

9:10 KEYNOTE OPENING ADDRESS: IDENTIFYING THE BEST METHOD FOR OBSERVATION

Michael Kafrissen

Michael Kafrissen, Chief Scientific Officer, Scientific Affairs, Ortho-Mc Neil Janssen Scientific Affairs, LLC

  • Choosing the model that best addresses specific research objectives
  • Identifying the key market differentiations between each of the research models
  • Planning an effective communications strategy at the early stage
  • Cost/benefit analysis of the different methods available
  • How will the study be perceived by the medical community? Should this inform our choice of method?
  • 9:50 ROLE OF OBSERVATIONAL STUDIES IN ENHANCING ROI

    Gurdyal Kalsi

    Gurdyal Kalsi, Director, Medical Affairs and Pharmacovigilance, MDS Pharma Services

    10:30 Morning Coffee

    11:00 POST MARKETING SAFETY SURVEILLANCE

    Anne Kehely

    Anne Kehely, Medical Advisor, Global Product Safety, Oncology/ID , Eli Lilly

  • More details to follow
  • 11:40 COMBINING GOOD SCIENCE WITH GOOD COMMUNICATIONS STRATEGIES

    Glenn Matfin

    Glenn Matfin, Head, Medical Affairs, Novo Nordisk Inc.

    12:20 Networking Lunch

    13:50 LEAVING THE PHASE III MODEL BEHIND

    David Provost

    David Provost, Senior Executive Director, Post-Approval Strategic Operations, Pharmaceutical Product Development, Inc.

  • Comparing Pre-Approval and Post-Approval research models
  • Phase IV implementation strategies
  • Maintaining data quality with limited on-site monitoring
  • The role of Marketing in Post-Approval Research
  • COST COMPARISON CASE STUDY: Phase III vs. Phase IV implementation model
  • 14:30 PRACTICAL EXPERIENCES OF IMPLEMENTING EDC IN LATE PHASE STUDIES

    Christian Grøndahl

    Christian Grøndahl, Vice President, eClinical Global Development, Novo Nordisk

  • Realising the value of EDC
  • Meeting the requirements of global trials (multi-lingual/multi-cultural IT)
  • Integrating Sponsor and CRO
  • In-building safety
  • Real life experiences
  • 15:10 Afternoon Tea

    15:40 REGISTRY STUDIES: AN ALTERNATIVE APPROACH TO POST-MARKETING CLINICAL STUDY DESIGN

    Mason Diamond

    Mason Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma

  • Utility of a registry
  • Advantages and disadvantages of this approach
  • IRB/IEC issues and the impact of the US HIPAA regulation
  • Logistics and cost
  • 16:20 ESTABLISHING INTERNATIONAL GUIDANCE ON POST MARKETING STUDIES

    Francis Crawley

    Francis Crawley, Director General, Good Clinical Practice Alliance

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Hugh Levaux

    Hugh Levaux, Vice President, Product Strategy, Medidata

    9:10 KEYNOTE ADDRESS

    Wolfgang Schumann

    Wolfgang Schumann, Senior Medical Safety Advisor, Bayer-Schering Pharma

  • Dealing with serious events
  • Handling non-serious events
  • Differences between European and American Regulations
  • 9:50 RISK MANAGEMENT STRATEGY FROM PHASE II TO IV: HOW TO MAXIMISE LIFECYCLE VALUE

    Ferdinando Emanuele  Vegni

    Ferdinando Emanuele Vegni, Director, Risk Management Strategy, World Wide Development, Pfizer

  • What is Risk Management strategy?
  • How drug companies can benefit from early planning?
  • Tools required for safety and risk management
  • What happens when the drug is on the market?
  • 10:30 Morning Coffee

    11:00 NOVEL USAGE OF LARGE ESTABLISHED AUTOMATED MEDICAL DATABASES TO CONDUCT PHASE 4 STUDIES

    Nawab Qizilbash

    Nawab Qizilbash, Honorary Senior Lecturer in Epidemiology, Imperial College, London University, Consultant Geriatrician Member, Green College, Oxford University[Formerly, Director of Epidemiology, GlaxoSmithKline, 1997-2005], Oxon Clinical Epidemiology

    11:40 OPTIMISATION OF PHASE IV TRIAL INFRASTRUCTURE

    Bil Duval

    Bil Duval, Vice President, Global IIIb/IV Operations, Quintiles Strategic Research

  • Infrastructure needed to incorporate flexibility into trial design
  • Recognising medical needs and commercial concerns during the design process
  • Devising a plan to safeguard the health of the participants and answer specific research questions
  • Setting clinical endpoints; hard versus soft endpoints
  • Defining what the study will test at the outset; keeping it simple and meeting your goals
  • 12:20 Networking Lunch

    13:50 THE BENEFITS AND DRAWBACKS OF EDC IN PHASE IV STUDIES

    Brian Leiser

    Brian Leiser, Vice President, Late Phase Strategy, Medidata

  • Core competencies needed to implement registries
  • Enhancing the collaborative relationship with investigators in registries
  • Streamlining safety monitoring and surveillance in registries
  • Providing early visibility to market opportunities through registries
  • Core competencies needed to implement registries
  • Enhancing the collaborative relationship with investigators in registries
  • Streamlining safety monitoring and surveillance in registries
  • Providing early visibility to market opportunities through registries
  • 14:30 ENSURING SCIENTIFIC VALUE IN PHASE IV STUDIES

    Sebastian Iovan

    Sebastian Iovan, Director, Health Economics Central and Eastern Europe, Eli Lilly & Company

    15:10 RETENTION OF PATIENTS IN PHASE IV

    Michael Herschel

    Michael Herschel, Director, Clinical Research, GlaxoSmithKline

    15:50 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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