Chairperson’s Welcome Remarks
Challenges & Opportunities
Utilizing a network approach to overcome challenges in collaborative clinical trial delivery in the UK
• Casting the net wider - reaching untapped patient populations
• Case study examples of successful delivery of clinical research
Divya Chadha Manek, Head, Business Development and Marketing, NIHR CRN
Pharmaceutical outsourcing: Latest Models and Trends
- Market insights
- Cross Functional
Morning Break & Networking
Data Integrity Audits of Third Parties
• The regulatory background
• Challenges, opportunities and solutions
• Case studies / real life examples
• The complexities of Data Integrity audits
• The benefits of Data Integrity audits
Dr Siegfried Schmitt, Principal Consultant, PAREXEL International
Accelerating pharmaceutical product developments and its implications
- Difficulties facing industry executives balancing these concepts
- Maximising internal resources using strategic third-party renders and drug makers.
- To generate cost savings by entering risk sharing agreements with CROs.
Should you move to a strategic outsourcing environment?
Anthony Fuller, Head of Sourcing, Mitsubishi Tanabe Pharma
Networking Lunch Break
Outsourcing and Partnerships
Designing the ideal strategic partnership
• Engaging the partner according to product needs
• Defining goals, methods and what to measure
• Prepare for upfront and ongoing investment
• Develop full governance early to ensure issues can be quickly managed
• Formulate strategic partnership with vendors
Strategic outsourcing to meet changing clinical development needs
• How to contain/ reduce cost and support an increasing number of projects.
• Contacting sponsors and CROs.
Tea Break & Networking
Focus on emerging markets: The Middle-East, Africa and Asia as attractive regions for pharma outsourcing
- Low labour and manufacturing costs
- Collaborating with skilled medical research talent
Panel Discussion: Biggest challenges and opportunities for outsourcing and partnership
• Developing and maintain relations with suppliers
• The need to develop the right marketing strategies
• Logistics and distribution, Supply Chain and Counterfeiting
• Performance, Distribution and Regulatory requirements
Chairperson’s Closing Remarks
Chairperson’s Opening Remarks
Legal & Regulatory Issues
Changing regulatory trends in Pharmaceutical Industry
- How to overcome the challenges and obstacles encountered along the way
- Partnerships between pharma and CRO’s
How can the pharma industry avoid outsourcing risks?
- Defining the scope of the contract
- Making the right choice e.g. choosing the right supplier
- Letting go – allowing the outsourcing company to implement their own way of working.
Detlef Behrens, Head, CMO, Biocon Limited
Morning Break & Networking
Good practices in Outsourcing in Market Access/HEOR
• Choosing the right partner and the right model (Tailoring to the organisation)
• Managing relationships
• What’s the measurement of success
Anne Marciniak, Affiliate, Brunel University
Counteracting Counterfeiting: Pharmacy Perspective
• How negotiations are going with current timelines and up to date issues
• Aims and Objectives for a successful launch
• Barriers, issues and obstacles
• Engaging with stakeholders
• Next steps including post Brexit.
Sultan 'Sid' Dajani, UK Representative, Pharmaceutical Group of the European Union
Dynamic changes in political and economic landscape
• Will future regulatory changes mean more changes to the supplier relationship?
• How will the service providers of tomorrow differ from the services provider of today?
• How to maximise benefit from the trend towards collaborative working?
Global Collaborations & Looking to the Future
Collaborations between pharma companies and CROs
- Partnership between small to mid-size pharma companies and CRO industry.
- Common obstacles and how to overcome them
- Measures of success
Potentials and pitfalls in outsourced clinical trials in CNS diseases
• Building successful partnerships with pharma companies and clinicians and CROs
• Global collaboration with Biobanks world wide
Dr. Rivka Ravid, Senior Scientist, ISBER, NETHERLANDS INSTITUTE FOR NEUROSCIENCES
Afternoon Break and Networking
Changing the paradigm of pharmaceutical outsourcing
• The changes in competitive landscape of outsourcing
• The ambition for future growth into the emerging markets.
Panel Discussion: Evolution of strategic partnership
• Key factors for success in strategic partnership
• Typical obstacles and how to overcome them
• Delivering innovative new medicines, vaccines and consumer health care products.
• Gathering ideas from scientists outside of the company.