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: 18 May '12

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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...

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› 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 ...

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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...

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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

Phase 0 clinical trials: The future in accelerating drug development?

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...

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Exploratory Clinical Trials

Tactical vs. strategic applications
Development cycle time vs. probability of success
Planning to fail or planning for success?

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

12.45pm

Lunch

1.45pm

Flexible Phase I

Daren Austin at Exploratory Clinical Development World Europe

› Daren Austin, Head, Biopharm Clinical Pharmacology & Biometrics, GlaxoSmithKline

2.15pm

Shortening study timelines to proof of concept using new & innovative study formats

Dr Constance Höfer at Exploratory Clinical Development World Europe

› Dr Constance Höfer, Senior Director, Head of Non-Clinical Drug Development, MediGene AG

2.45pm

Strategies for Accelerating Proof of Concept (Fast Track)

Willem Jan Drijhout

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

3.15pm

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...

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

3.45pm

Afternoon refreshments

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...

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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

Faster, Smarter Clinical Studies

How the design of global oncology early phase clinical studies is being adapted for the development of targeted therapies ( molecular screening, tissue collection, PD studies)
The current trends and challenges of global oncology early phase clinical studies ( schedule complexity, , Bayesian design, exploratory objectives)
Case study on the development and approval of a personalized therapy

5.15pm

Panel session – 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...

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-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

5.45pm

Closing remarks from the chair

5.50pm

Networking drinks reception

Evening Seminar

6pm

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 ...

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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