Exploratory Day two

09:00

Chairman's opening remarks

Dr Uwe Gudat
09:10

Overcoming Safety Concerns With Early Clinical Development of Biologicals and Biosimilars

Dr Uwe Gudat, Head of Safety, Biosimilars, Merck
Ms Michelle Beharry
09:35

Implementation of the EU Clinical Trial Regulation – Opportunities and Threats to Early Medicines Development

Ms Michelle Beharry, Expert Scientific Assessor and Pharmaco Toxicologist, MHRA
Mr Thijs Van Iersel
10:00

Structured Risk Assessment and Risk Mitigation in First-in-Human Studies presented by Dr Thijs van Iersel, Senior Director of Science, PRA Health Sciences

Session led by: pra-health-sciences
10:30

Morning coffee

Accelerating Proof of Concept
11:00

Industry - Academic Collaboration: a key to successful involvement of patients in early clinical development

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Dr Aernout van Haarst, Director, European Corporate Development, Celerion
Panel discussion
11:30

Industrial – Academic – Patient Collaborations: Lessons In New Ways Of Working

Dr Thomas Joos, Deputy Managing Director, NMI Natural and Medical Sciences Institute at the University of Tuebingen
Ms Monica Simeoni, Director, Clinical Pharmacology Modelling & Simulation, G.S.K.
Dr Derick Mitchell, CEO, Ipposi
Mr Dirk Cerneus, Global Clinical Pharmacology Leader, Astellas Pharma
12:30

Lunch

Accelerating Proof of Concept
13:30

Introducing Real World Data Related To Adaptive Pathways In Early Clinical Development

Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway
Innovation and Case Studies
13:30

Challenges and Opportunities Of Early Drug Development In Translational Clinical Pharmacology

Accelerating Proof of Concept
13:50

Retargeting T Cells in Hematologic Malignancies by the Bispecific T cell engager (BiTE) blinatumomab

Dr Gerhard Zugmaier, Executive Medical Director Global Development, Amgen
Innovation and Case Studies
13:50

Designing A Patient Centric Approach For An Orphan Drug For Carcinoid Syndrome

Dr Talia Biran, Medical Affairs Lead, Oncology, Lexicon Pharma
Accelerating Proof of Concept
14:10

Accelerating Early Development of Antimalarials : Medicines for Malaria Venture Strategy

Dr Stephan Chalon, Medical Director, Clinical Pharmacology, Medicines for Malaria Venture
Innovation and Case Studies
14:10

Choosing and Working in Partnership for Optimum Results in Partnership in Clinical Trials

Muna Kugler, Associate Director, Group Leader, Actelion
14:30

Afternoon refreshments and exhibition viewing

Bioequivalence Testing
15:00

Understanding Global Bioequivalence Requirements

Vlatka Vrdoljak, Development Project Leader, R&D, TEVA
PK/PD Modelling
15:40

Role of PK/PD in Compound Selection and Early Clinical Development

Hua Yang, Director and Head of DMPK, Agios Pharmaceuticals
PK/PD Modelling
16:00

PK/PD Modelling In Immuno- Inflammation Early Clinical Development

Ms Monica Simeoni, Director, Clinical Pharmacology Modelling & Simulation, G.S.K.
17:00

Closing remarks and end of Conference

last published: 24/Oct/16 09:05 GMT
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