Wednesday 23 May 2012- Accelerating early development stream

Wednesday 23 May 2012 - Day One ›

Wednesday 23 May 2012- Accelerating early development stream ›

Wednesday 23 May 2012- Biomarkers in early development ›

Thursday 24 May 2012- Day Two ›

last modified: 29 May '12

Please enable javascript to see more information on speakers

11.10am

Opening remarks

Willem Jan Drijhout

Dr. Drijfhout holds a Ph.D. in Pharmacy and heads all early phase development and bio-analytical laboratory work for PRA. He was Chief Scientific Officer for Pharma Bio-Research prior to the company being acquired by PRA in mid 2006. He joined...

more..

› Willem Jan Drijhout, Senior Vice President, Early Development Services, PRA

11.15am

Challenges in formulation development in first-in-human strategies

David Elder

David P. Elder has thirty four years experience within the Pharmaceutical Industry. He is currently a director at GlaxoSmithKline Pharmaceuticals. He obtained a part-time PhD from Edinburgh University in1992 investigating the crystal structure and ...

more..

Attrition overview
Importance of solubility/permeability in absorption (BCS approach)
Predicting solubility/permeability/BCS
Predicting formulation strategy
Predicting degradation pathways
Excipient compatibility
Early formulation testing
Conclusions

› David Elder, Director, GlaxoSmithKline

11.45am

Evaluating the bioperformance Powder in Capsule formulations for use in PhI

Brian Henry

I completed my first degree in Pharmacy at the University of Manchester followed by a year working in community Pharmacy before studying for my PhD at the University of Nottingham. My PhD started to develop my core research interests of...

more..

Powder in capsule formulation are a fast and flexible formulation approach idea for accelerating PhI/II clinical studies. However, do they work from an oral bioavailability perspectives? We have review 24 PhI studies utilising this approach and have learnings to share on when this technology can be used successfully

› Brian Henry, Executive Director, Pharmaceutical Research and Development, Pfizer

12.15pm

Exploratory Clinical Trials

Lewis Kinter

Dr. Kinter is currently Senior Director: Regulatory Toxicology, and Head: Toxicological Operations, Safety Assessment (US) at AstraZeneca Pharmaceuticals in Wilmington, PA., and manages preclinical safety programs conducted in support of...

more..

› Lewis Kinter, Senior Director: Regulatory Toxicology, and Head Toxicological Operations, Safety Assessment (US), AstraZeneca Pharmaceuticals

12.45pm

Lunch

1.45pm

PK/PD Modelling in Early Clinical Development

Rolf Burghaus

Rolf Burghaus started his scientific education at the Heinrich-Heine University of Düsseldorf in 1990 taking courses in mathematics and physics. He soon specialized in theoretical physics where he got his diploma in late 1995. He continued in the...

more..

› Rolf Burghaus, Head Modeling & Simulation, Bayer Pharma

2.15pm

Modeling and Simulation of Biologics to Inform Early Clinical Development: a Case Study using Efficacy Data from P1a to Inform P2 Dose Selection for a Novel Treatment of Psoriasis

David Salinger

David H. Salinger, PhD, is a Principal Scientist in the Quantitative Pharmacology group of the Department of Pharmacokinetics and Drug Metabolism at Amgen Inc. in Seattle, Washington. He received his PhD in Applied Mathematics at the University of...

more..

› David Salinger, Principal Scientist in the Quantitative Pharmacology group of the Department of Pharmacokinetics and Drug Metabolism, Amgen Inc.

2.45pm

Strategies for Accelerating Proof of Concept (Fast Track)

Willem Jan Drijhout

more..

› Willem Jan Drijhout, Senior Vice President, Early Development Services, PRA

3.15pm

Afternoon refreshments

3.45pm

Objective comparison of early clinical development plans and better PoC decision-making

Laurence Colin

- I have an MSc in Mathematics from the University of Liege, Belgium, and a Masters in Biostatistics from the University of Hasselt, Belgium - I have been working as a statistician at Novartis since 2006, where I first supported phase III and IV...

more..

› Laurence Colin, Disease Area Scientific Lead Statistician for Autoimmunity in Early Development, Novartis

4.15pm

Exploring valuable tools to accelerate CNS product development: steps towards a mechanistic prediction

Massimo Bani

Currently Head of Clinical Pharmacology in UCB, in the past 25 years I covered different roles in various pharmaceutical industries, including GlaxoSmithKline, Rottapharm, Zambon and Pharmacia-Upjohn. My recent experience was mainly dedicated to...

more..

Implementing novel approaches in psychiatric patients, developing suitable paradigms to evaluate objective endpoints
How to achieve a better understanding of the differential Response to Placebo, combining Imaging and Genetics evidences
Enabling the translational use of Molecular Imaging, to achieve a better confidence addressing new targets

› Massimo Bani, Global Head Clinical Pharmacology, UCB Pharma SA

4.45pm

Regulatory environment for early development in combination therapeutics

Walter Janssens

Walter Janssens obtained a PhD at the University of Antwerp and later did research at the University of Leuven. Then he became research scientist in pharmaceutical industry (Janssen Pharmaceutica) with main emphasis on cardiovascular and...

more..

-Combinations of novel medicinal products in clinical trials in Europe
-The ICH M3 guideline on combinations
- The ICH S9 guideline

› Walter Janssens, Senior Preclinical Assessor, Preauthorisation Coordinator Early Phase Development, Federal Agency for Medicines and Health Products

5.15pm

Closing remarks from the chair

Evening Seminar

5.20pm

How can QT assessment in early studies be improved to provide same level of confidence as the ICH E14 ‘Thorough QT/QTc Study’?

Borje Darpo

Borje Darpo is board-certified in cardiology and internal medicine. He has over 12 years of pharmaceutical industry experience, including senior management positions in small, mid-sized and large pharma, as well as in a global CRO. He has led or has ...

more..

How can a QTc effect exceeding 10 ms be excluded in early clinical trials?
o Design considerations
o QT measurement techniques

What is a 'highly precise QT measurement technique'?

How can concentration effect modeling be used for QT assessment in early clinical trials?

What is the power of 'standard' early clinical trials to exclude a QTc effect of regulatory concern