26th - 27th February 2018

  • 08:00

Registration and Coffee

  • 09:00 - 09:10

Chairperson’s Welcome Remarks

Challenges & Opportunities

  • 09:10 - 09:50

Utilizing a network approach to overcome challenges in collaborative clinical trial delivery in the UK

• The tripartite partnership model - three heads are better than one
• 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

  • 09:50 - 10:30

Acceleration of value delivery through enhanced collaboration with the business and suppliers

• Innovation, Performance, Trust, GSK DNA for value creation,
• 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

  • 10:30 - 11:10

Morning Break & Networking

  • 11:10 - 11:50

Data Integrity Audits of Third Parties

• The purpose of Data Integrity audits
• 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

  • 11:50 - 12:30

An Approach to Global Supply Chain Security in Today’s Pharma Industry

● Identifying the risks in the supply chain
● 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

  • 12:30 - 13:10

Should you move to a strategic outsourcing environment?

Different sourcing models are right for different companies, and no rule says that you have to change. However, a growing book of work, pressure to reduce costs, or difficulty in attracting talent may all push you to consider more intentional ways of working with external service providers. In this session we will examine the various outsourcing options, the pros and cons they represent, and how each of them might serve as a roadmap for your company to develop a strategic approach to drug development outsourcing.

Anthony Fuller, Head of Sourcing, Mitsubishi Tanabe Pharma

  • 13:10 - 14:10

Networking Lunch Break

Outsourcing and Partnerships

  • 14:10 - 14:50

Designing the ideal strategic partnership

• Developing an alliance plan
• 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
  • 14:50 - 15:30

Partnerships between the charity sector and biopharma – sharing the risk

Janet Allen, Director of Research, CYSTIC FIBROSIS TRUST, UK
  • 15:30 - 16:10

Tea Break & Networking

  • 16:10 - 16:50

Focus on emerging markets: The Middle-East, Africa and Asia as attractive regions for pharma outsourcing

● Easy access to large patient pools
● Low labour and manufacturing costs
● Collaborating with skilled medical research talent
  • 16:50 - 17:30

Panel Discussion: Biggest challenges and opportunities for outsourcing and partnership

• Identifying and overcoming specific risks
• 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

  • 17:30

Chairperson’s Closing Remarks

  • 08:00

Registration and Coffee

  • 09:00 - 09:10

Chairperson’s Opening Remarks

Legal & Regulatory Issues

  • 09:10 - 09:50

Changing regulatory trends in Pharmaceutical Industry

- Key regulatory guidelines in Outsourcing and Partnerships
- 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

  • 09:50 - 10:30

How can the pharma industry avoid outsourcing risks?

- Keeping communication lines open
- 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

  • 10:30 - 11:10

Morning Break & Networking

  • 11:10 - 11:50

Good practices in Outsourcing in Market Access/HEOR

• How to decide on when to outsource (keeping core-competences in)
• 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

  • 11:50 - 12:30

Counteracting Counterfeiting: Pharmacy Perspective

• Setting the scene with a brief background and history to the FMD
• 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

  • 12:30 - 13:10

PANEL DISCUSSION: Dynamic changes in political and economic landscape: Future of outsourcing

● Impacts of Brexit and other political issues
● 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?
  • 13:10 - 14:10

Networking Lunch Break

Global Collaborations & Looking to the Future

  • 14:10 - 14:50

Ensuring Proactive “Partnership” Approach To Supplier Collaboration

Facilitate group review and table networking break out discussions on best practices in overcoming challenges and implementing a partnership approach to supplier relationship management and innovation.

• 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

  • 14:50 - 15:30

Potentials and pitfalls in outsourced clinical trials in CNS diseases

• Management of outsourced CNS - Clinical Trials
• Building successful partnerships with pharma companies and clinicians and CROs
• Global collaboration with Biobanks world wide


  • 15:30 - 16:10

Afternoon Break and Networking

  • 16:10 - 16:50

Changing the paradigm of pharmaceutical outsourcing

• The increasing pressure on global healthcare budgets
• The changes in competitive landscape of outsourcing
• The ambition for future growth into the emerging markets.

Klaas Postema, formerly, VP, Supply Chain Management, ACTAVIS

  • 16:50 - 17:30

Panel Discussion: Evolution of strategic partnership

• The current business landscapes
• 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

  • 17:30

Chairperson’s Closing remarks