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Published by: SMI Publishing, Ltd
Published: May. 23, 2007
Table of Contents
- Day One
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Hugh Levaux, Vice President, Product Strategy, Medidata.
- 9.10 KEYNOTE OPENING ADDRESS: IDENTIFYING THE BEST METHOD FOR OBSERVATION
- Phase IV trials, observational studies and patient registries: Finding the best study to answer the research brief given the resources available
- 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?
- Michael Kafrissen, Chief Scientific Officer, Scientific Affairs, Ortho-Mc Neil Janssen Scientific Affairs, LLC.
- 9.50 ROLE OF OBSERVATIONAL STUDIES IN ENHANCING ROI
- Gurdyal Kalsi, Director, Medical Affairs and Pharmacovigilance, MDS Pharma Services.
- 10.30 Morning Coffee
- 11.00 POST MARKETING SAFETY SURVEILLANCE
- More details to follow
- Anne Kehely, Medical Advisor, Global Product Safety, Oncology/ID , Eli Lilly.
- 11.40 COMBINING GOOD SCIENCE WITH GOOD COMMUNICATIONS STRATEGIES
- Achieving a balance so that science and marketing can successfully and beneficially co-exist
- Glenn Matfin, Head, Medical Affairs, Novo Nordisk Inc..
- 12.20 Networking Lunch
- 1.50 LEAVING THE PHASE III MODEL BEHIND
- A New Approach for Post-Approval Research
- 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
- David Provost, Senior Executive Director, Post-Approval Strategic Operations, Pharmaceutical Product Development, Inc. .
- 2.30 PRACTICAL EXPERIENCES OF IMPLEMENTING EDC IN LATE PHASE STUDIES
- Recognising the challenges of late phase studies
- 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
- Christian Grøndahl, Vice President, eClinical Global Development, Novo Nordisk.
- 3.10 Afternoon Tea
- 3.40 REGISTRY STUDIES: AN ALTERNATIVE APPROACH TO POST-MARKETING CLINICAL STUDY DESIGN
- Utility of a registry
- Advantages and disadvantages of this approach
- IRB/IEC issues and the impact of the US HIPAA regulation
- Logistics and cost
- Mason Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma.
- 4.20 ESTABLISHING INTERNATIONAL GUIDANCE ON POST MARKETING STUDIES
- Francis Crawley, Director General, Good Clinical Practice Alliance.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day Two
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Hugh Levaux, Vice President, Product Strategy, Medidata.
- 9.10 KEYNOTE ADDRESS
- REPORTING REQUIREMENTS FOR PHASE IV TRIALS
- Dealing with serious events
- Handling non-serious events
- Differences between European and American Regulations
- Wolfgang Schumann, Senior Medical Safety Advisor, Bayer-Schering Pharma.
- 9.50 RISK MANAGEMENT STRATEGY FROM PHASE II TO IV: HOW TO MAXIMISE LIFECYCLE VALUE
- 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?
- Ferdinando Emanuele Vegni, Director, Risk Management Strategy, World Wide Development, Pfizer.
- 10.30 Morning Coffee
- 11.00 NOVEL USAGE OF LARGE ESTABLISHED AUTOMATED MEDICAL DATABASES TO CONDUCT PHASE 4 STUDIES
- 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
- Establishing the goals of the study and ensuring these objectives will be met in a strategic manner
- 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
- Bil Duval, Vice President, Global IIIb/IV Operations, Quintiles Strategic Research.
- 12.20 Networking Lunch
- 1.50 THE BENEFITS AND DRAWBACKS OF EDC IN PHASE IV STUDIES
- 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
- Brian Leiser, Vice President, Late Phase Strategy, Medidata.
- 2.30 ENSURING SCIENTIFIC VALUE IN PHASE IV STUDIES
- Identifying a clear research goal and the level of scientific value to patients and clinicians
- Sebastian Iovan, Director, Health Economics Central and Eastern Europe, Eli Lilly & Company.
- 3.10 RETENTION OF PATIENTS IN PHASE IV
- How do you improve patient motivation?
- Michael Herschel, Director, Clinical Research, GlaxoSmithKline.
- 3.50 Chairman’s Closing Remarks Followed by Afternoon Tea
AbstractToday, 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
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