Product Type: Market Research Report
Published by: SMI Publishing, Ltd
Published: October 2005
Product Code: R215-380Description Discover the latest trends in manufacturing, research and development in outsourcing at SMi’s Outsourcing in the Pharmaceutical Industry Conference. Update yourself and your organisation with the latest regulatory guidelines governing this topical area. The Conference covers new trends such as e-sourcing, integrated outsourcing solutions and security strategies for outsourcing. It will also be supported by case studies from the Indian and Chinese markets.
What are outsourcing partners looking for? How do you identify and select partners? How do you manage the relationship? What are the critical factors affecting success in major outsourcing agreements? And how do you avoid and manage the risk associated with these collaborations? These are the questions that will be discussed and fully covered in this comprehensive networking forum.
Outsourcing in the Pharmaceutical Industry will provide an excellent opportunity to network, enhance your company’s profile and keep up-to-date on the latest issues in the Pharmaceutical Outsourcing market.
Gain an insight from key industry leaders in the field including:
- Elizabeth Moench, President & Chief Executive Officer, MediciGroup
- Dr Edward Leung, Vice President, Preclinical Research & Development, King Pharmaceuticals
- Dr George Partelow, Global Programme Manager, AstraZeneca
- Dr Arvind Mathur, Manager External Resources, Bristol-Myers Squibb
- James Clifford, Manager, Maintenance Systems, Wyeth
- Todd Hintze, Healthcare Practice Group President, Everest Group
Table of Contents - 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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