Day 1 - Clinical Partnerships and Outsourcing
Day 1 - Clinical Partnerships and Outsourcing
- Working with CROs is key for Pharma and Biotech but also frequently an area of mutual frustration and surprises.
- Bayer established a collaboration model using several best practice approaches to support on-time, cost efficient clinical trials of high quality.
- Piet Theisohn - VP, Clinical Development & Operations, Bayer
- Finding the right partners for your trial and setting realistic cost expectations
- Managing expectations for patient recruitment
- Creating a collaborative environment for all stakeholders
- Proactive changes
- Piet Theisohn - VP, Clinical Development & Operations, Bayer
- Antoine Vigneau - Senior Director, Head of Central Lab Partnerships, AstraZeneca
- Saskia van Dalen - Global Head R&D Procurement, Sandoz
- Darren Gibson - Executive Director, Frontier Science (Scotland) Limited
- Outsourcing Regulatory Development Strategy vs outsourcing Regulatory submission preparation for clinical trials.
- Outsourcing CTIS submissions and their preparation, including redaction work
- Ways to establish a long-term efficient cooperation with the sponsor
- Darius-Jean Namdjou - Director, Senior Regulatory Lead, Phortas GmBH
- Ben Shelton - Associate Director R&D Procurement – Central Lab Services, AstraZeneca
- Antoine Vigneau - Senior Director, Head of Central Lab Partnerships, AstraZeneca
- Understanding transformation drivers & levers
- Prioritising short, medium & long-term outcomes
- Building an overarching strategic framework
- James Chennells - Strategic Alliances Lead, Bayer
During this interactive session, our speakers will dive into the world of Clinical Contracting and Qualification. Supplier onboarding is an extensive effort that is often connected to trial delays, wasted resources, and missed opportunities.
They will share their experience on how traditional, slow moving and extensive onboarding methods hinder business agility and together with the audience discuss the existing processes, accountabilities & identify bottle necks at the sponsor and CRO side.
- Saskia van Dalen - Global Head R&D Procurement, Sandoz
- David Moseley - ex-Head of R&D Procurement, Grunenthal GmbH
Roundtables: Discuss for 45 mins then feedback to the room
Table 1: What are the Major Pitfalls and Challenges You Come Up Against and How Do You Think You Can Best Combat This?
Table 2: Integrating Sustainability into Effective Outsourcing Models
Table 3: Hybrid/Innovative Outsourcing Models