Early Phase: From landscape to contracting, how
to get the most value from your partners
Wednesday, 8th October 2014
London, UK
AGENDA
Sponsored by PAREXEL International
08.30 – 09.00
Tea/Coffee/Registration
09.00 – 09.10
Welcome and Introduction
09.10 – 9.45
Early Phase Clinical Trials: Landscape and current trends
John Lambert, PAREXEL
Chief Medical Officer, Early Phase
How is Europe fairing, numbers of CPUs in Europe (are they on the decline?)
What types of studies are being conducted in Europe.
Does Europe have the patient/subject population available for the types of studies
currently being conducted in Phase I & IIa?
Regulatory landscape in Europe (including timelines to get started).
9.45 – 10.30
Translational Medicine: Is this the new definition of PoC?
Dawie Wessels, PAREXEL
VP ＆ WW Head, EPD
Integrating all facets of Translational development through Early Product
Development (EPD) including adaptive drug design for rapid early clinical trial
development.
10.30 – 11.00
Coffee Break
11.00 – 12.00
Early Phase Strategic Partnerships: Strengths and Weaknesses
Joke Schwencke - in 't Veen, Astellas
Associate Director Strategic Relationship Management
Oliver Fuhrmann, PAREXEL
VP ＆Head of Strategic Partnerships in EU, Berlin Unit Head
What are the key elements in ensuring biopharma / CRO partnerships are
successful in early clinical? What are the key pitfalls?
What are the current trends in partnerships?
Early engagement – why is it important and how does it work best?
Identifying and managing key risks in early phase studies – sponsor and CRO
perspectives
Strategic Partnerships - next generation
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12.00 – 13.00
Networking and Lunch
13.00 - 13.45
Strategic choice of recruitment in early phase studies
Speaker: TBD (Industry Speaker)
Key challenges to be aware of in operationalizing patient studies e.g. competition
with later phase, continuity of care, what’s in it for patients and physicians etc.
When does / doesn’t it make sense to go into patients early?
What's happening with the vital element to any Phase I - healthy volunteer
recruitment?
Innovation in advertising - are newspaper ads redundant in the age of social media
How far will volunteers travel?
Who are the volunteers - have backpackers packed their bags?
Volunteer payments vs inducements - where is the line and what are the criteria?"
Ethnobridging – bridging Asian communities and faster drug development
FTIM studies of Mabs: healthy subjects or patients?
13.45 – 14.30
Complex Phase I studies
Dorte Malling, Lundbeck
Process Specialist, CIinical Pharmacology
For complex (non-standard) phase I studies, new designs and types of measurements are often
introduced and challenges are seen in getting internal alignment in the study team – in particular
around the data collection, reporting and output of those non-standard data. This is in particular
true for a company like Lundbeck, which focuses on CNS studies with high complexities in
Phase I. In other words, the session she proposes focuses on how the scientific complex ideas
are “transformed” into an actual study protocol and with useful data as a result. At Lundbeck
there are multiple stakeholders involved and adding the involvement of CROs proves challenging
for these types of studies
14.30 – 15.00
Coffee Break
15.00 – 15.45
Unit Cost Pricing RFP tool
Catherine Jervis, Roche
Global Pharma Procurement - Scientific Sourcing (GPPS)
At Roche we have recently developed and implemented a Unit Cost Pricing RFP tool for
clinical pharmacology studies. This was done collaboratively with input both from Roche
and 3 partner CROs with the following benefits in mind:
- Decreased timelines for budget negotiation and contract. This is important in Phase I,
where fast turnaround times are often key.
- Increased transparency of budgets, and improved consistency in the budgets we
receive from vendors.
-Clearer Scope of Work and delineation of responsibilities and expectations between
Roche and the vendors.
-Improved communication and relationships between Roche Scientific Sourcing and
Roche preferred providers.
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15.45 - 16.30
Biomarker/Bioanalytical analyses: new approaches
Kenneth Swart, PAREXEL
Sr. Director, Bioanalysis
As Biomarker and Bioanalytical analyses have becoming more complex, they are helping
us understand better paths forward for study designs
16.30 – 16.45
Summary and Close
Speaker: Steve Martindill
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