Registration and Coffee
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
Acceleration of value delivery through enhanced collaboration with the business and suppliers
• From silo to one roof value approach for value creation, how to bring stakeholders and suppliers together and collectively address the challenge of value creation,
• Supply base segmentation, a key criteria for partners identification,
• Value creation levers and process, how to build-up and sustain a robust pipeline of value creation,
• From push to pull mode, how to create business appetite for value creation,
• Real business case: open the doors of our manufacturing process to partners for
Xavier Derouck, Sr. Sourcing Group Manager, Global Production Procurement, GSK
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
An Approach to Global Supply Chain Security in Today’s Pharma Industry
● Designing and implementing a security management system
● Reviewing some examples
● Sharing best practice
Tom Cochrane, BA Hons CBIOL MBS, ASC Associates Ltd, formerly Head of Security Operations, Mundipharma
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
Partnerships between the charity sector and biopharma – sharing the risk
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
Panelist: Dr. Bobby George, Vice President, Head Regulatory Affairs, Reliance Life Sciences
Chairperson’s Closing Remarks
Registration and Coffee
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
Dr. Bobby George, Vice President, Head Regulatory Affairs, Reliance Life Sciences
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
PANEL DISCUSSION: Dynamic changes in political and economic landscape: Future of outsourcing
● 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?
Networking Lunch Break
Global Collaborations & Looking to the Future
Ensuring Proactive “Partnership” Approach To Supplier Collaboration
• Shire Small Molecule supplier engagement journey overview
• Introduction of three vital levers for success
⏤⏤Forums for exploring and targeting opportunities
⏤⏤Data to support analysis
⏤⏤Skills and team development to empower and energise
• Break out table discussions and report outs on Challenges and Tactics to addressing Forums, Data and Skills elements of Partnership Approach
Steve Cray, Supplier Relationship Management, Small Molecule Technical Operations, Shire
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.
Klaas Postema, formerly, VP, Supply Chain Management, ACTAVIS
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.
Moderator: Dr. Bobby George, Vice President, Head Regulatory Affairs, Reliance Life Sciences
