Agenda

26th - 27th February 2018

  • 08:00 - 09:00

Registration

  • 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

Pharmaceutical outsourcing: Latest Models and Trends

- Virtual Integration
- Market insights
- Cross Functional
- Build-operate-transfer/turnkey
  • 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

Accelerating pharmaceutical product developments and its implications

- Accelerated approvals and surrogate endpoints
- 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.
  • 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

Strategic outsourcing to meet changing clinical development needs

• What are the changing needs and its impact?
• How to contain/ reduce cost and support an increasing number of projects.
• Contacting sponsors and CROs.
  • 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
  • 17:30 - 17:40

Chairperson’s Closing Remarks

  • 08:00 - 09:00

Registration

  • 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
  • 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

Dynamic changes in political and economic landscape

• 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

Global Collaborations & Looking to the Future

  • 14:10 - 14:50

Collaborations between pharma companies and CROs

- What are the advantages e.g. improving efficiencies, more flexibility, reduce costs, provide access to global patient populations etc.
- Partnership between small to mid-size pharma companies and CRO industry.
- Common obstacles and how to overcome them
- Measures of success
  • 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

Dr. Rivka Ravid, Senior Scientist, ISBER, NETHERLANDS INSTITUTE FOR NEUROSCIENCES

  • 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.
  • 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.
  • 17:30 - 17:40

Chairperson’s Closing remarks