- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mr Todd Hintze, Healthcare Practice Group President , The Everest Group.
- 9.10 INTRODUCTION TO THE OUTSOURCING INDUSTRY
- Outsourcing is not a new tool in the healthcare industry
- Pharmaceutical organisations fail to capture the full value of outsourcing
- Once cost savings are made, companies find outsourcing complicated and an under unutilised process
- Too much is at stake for companies to outsource even before they understand fully the value of outsourcing
- Key methods that successful organisations have used to identify and capture targeted outcomes
- Case study and examples will be shown on solutions development, supplier evaluation and negotiations and contracting
- Mr Todd Hintze, Healthcare Practice Group President , The Everest Group.
- 9.50 OPPORTUNITIES IN INDIAN AND CHINESE PHARMACEUTICAL MARKETS
- Overview of Indian and Chinese pharmaceutical markets
- Outsourcing opportunities in pharmaceutical manufacturing
- Clinical trial opportunities
- Outsourcing opportunities in pharmaceutical research and development
- Ms Amarpreet Dhiman, Drug Discovery Technologies Business Leader, Frost & Sullivan .
- 10.30 Morning Coffee
- 11.00 BEST PRACTICES IN DRUG DISCOVERY OUTSOURCING
- Realities of outsourcing
- Criteria for outsourcing partner selection
- Best practices in outsourcing
- Dr Arvind Mathur, External Resources Leader, Bristol-Myers Squibb PRI.
- 11.40 THE OUTSOURCING AGREEMENT
- Legal issues in developing, negotiating and enforcing an outsourcing agreement
- Performance terms
- Commercial terms
- Confidentiality and intellectual property
- Liability, warranties and indemnities
- Termination issues
- Mr Paul Ranson, Partner, Stringer Saul.
- 12.20 Networking Lunch
- 2.00 OWNERSHIP OF IPR GENERATED BY OUTSOURCING
- Lessons and case studies from recent disputes
- The rise of challenges to IPR ownership
- Identifying problems
- Costs and consequences of disputes
- Effective management of disputes and alternative approaches
- Preventative steps
- Mr Hiroshi Sheraton, Associate Solicitor, Mc Dermott Will & Emery.
- 2.40 DEVELOPING DRUGS TOGETHER
- Successful partnerships between sponsors and providers
- Pharmaceutical development is a high-risk business
- All companies outsource some of the activities in this long process.
- Depending on the needs of the partners, several outsourcing models can be applied.
- Regardless of the actual model used, a successful partnership will be enhanced by creating an environment which facilitates information flow and allows informed decisions to be made in a timely manner
- Practices to help ensure success
- Dr Edward Leung, Vice President, Preclinical Research & Development , King Pharmaceuticals Research & Development.
- 3.20 THE OUTSOURCING DILEMMA: HOW MUCH AND HOW MANY RESPONSIBILITIES AND FUNCTIONS?
- A real life experience
- Corporate and strategic trials: who should manage? Who should execute?
- The process of selecting a strategy
- The strategy of functional outsourcing
- How to organise an outsourced functional clinical operation
- How to monitor the performance of an outsourced functional clinical operation (key performance indicators)
- What about penalties?
- Dr Stefano Marini, Managing Director, Dimensione Ricerca S R L.
- 4.00 Chairman’s Closing Remarks followed by Afternoon Tea
- Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mr Todd Hintze, Healthcare Practice Group President , The Everest Group.
- 9.10 THE USE OF METRICS AND FORECASTING FOR
- Avoiding hidden costs and eliminating budget creep
- Over the years sponsors determined recruitment budgets by simply allocating a set amount-an average $5,000-to each site for local recruitment
- 8 out of 10 times this approach results in budget waste, limited results and a study floundering to meet its timeline goals. The result; budget overruns, timelines missed and a frustrated clinical team
- Why is this approach so severely flawed? Why does a "one-size-fits-all" approach set the study up for recruitment failure?
- Ms Elizabeth Moench, President & CEO, MediciGroup Inc.
- Mr Richard Anderson, Chief Executive Officer, De Facto Communications.
- 9.50 INTEGRATED OUTSOURCING SOLUTIONS
- Benefits of completely integrated outsourcing solutions
- Do you need to outsource?
- Risks / benefits of the "one stop shop" approach
- From concept to market
- Case studies
- Ms Rosie McLaughlin, Director, Formulation, Cardinal Health .
- 10.30 Morning Coffee
- 11.00 SOURCING INFRASTRUCTURE SERVICES AND PROJECT BASED APPLICATION DEVELOPMENT IN ASTRAZENECA
- A case study
- The presentation will provide an update on our successes and challenges in outsourcing commodity infrastructure services across the US, UK and Sweden over the past 4+ years
- The presentation will also provide an update on our experience in outsourcing application development for several large projects in AstraZeneca
- Dr George Partelow, Global Programme Manager, AstraZeneca Corporate Office.
- 11.40 SUCESSFUL IMPLEMENTATION OF ENTERPRISE CALIBRATION MANAGEMENT SYSTEMS
- Under GMP constraints
- Explore selecting, implementing and validating an Enterprise Calibration Management system in today’s global pharmaceutical corporation
- GMP compliance no longer begins and ends in the quality assurance organisation
- GMP processes must be closely monitored as the FDA is pushing for standardisation within these organisations
- The need for a cost-effective, global Calibration Management Systems (CMS) is imperative
- Mr James Clifford, Manager, Maintenance Systems , Wyeth.
- Jake Michalik, Enterprise Sales Manager, Blue Mountain Quality Resources Inc..
- 12.20 Networking Lunch
- 2.00 SETTING UP A MANUFACTURING OUTSOURCING CONTRACT
- Identifying and evaluating product manufacturers
- Requirements for GMP compliance - the technical agreement
- Getting started - product transfer
- Managing the ongoing relationship
- Mr Vic Edy, Consultant, Newland GxP Consultancy.
- 2.40 Chairman’s Closing Remarks followed by Afternoon Tea
- Close of Conference
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