Zhaosheng Lin
Head of Biomarkers
Pfizer
 Nadine Cohen Head of Pharmacogenomics
Johnson & Johnson
 Mitchell B. Friedman Director of Toxicology
Takeda Global R&D
 Malcolm Mitchell Medical Director, Clinical Pharmacology
Eli Lilly
 Dr Russell Weiner Group Director
Bristol-Myers Squibb
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Conference:
Pre-conference workshop
19 Oct 9am - 5pm
Day 1
20 Oct 8.30am - 5:30pm
Day 2
21 Oct 8.30am - 5:30pm
Post-conference workshop
22 Oct 9am - 5pm
Venue: Boston, MA, United States
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Day One, Wednesday 20 October 2010 Day One, Wednesday 20 October 2010
8.50am Opening Remarks from Howard Goodall
Clinical Research Physican - Phase I, Quotient Bioresearch, Clinical Services
9am Keynote: The Lilly Chorus experience: “Innovating Around Innovation” to Revolutionize Early Phase R&D
- An autonomous early phase drug development group within Lilly
- Operates as a lean biotech using virtual development
- Selection of assets for Chorus vs internal development
- Relationship with Lilly; transition of assets between Lilly and Chorus
- Keys to the success of this alternative development model
- Future directions
Eyas Abu-Raddad, Research Advisor, Head PK/PD and Clinical Trial Simulations, Chorus, Eli Lilly
9.30am The Case for Early Failure Studies
- Planning to fail or to win
- Relevance of exploratory studies
- Impact of exploratory trials on candidate selection
Dr Doina Roman, Senior Medicial Director, Translational Medicine, Takeda Global Research & Development Center Inc.
10am Morning Coffee and Speed Networking10.45am Enriched Patient Tools to Fast Track POM and POC
- Enrichment strategies which select subjects who appear to respond to the drug in early drug studies to demonstrate clinical efficacy
- Enriched patient populations can be used to establish proof of concept
- Enriched populations could also be used for orphan-drug indications or a restricted labeling for individualized medicine labeling
Dr Orest Hurko, Senior Clinical Consultant, Biologics Consulting Group Inc.
11.15am How to Fail Faster: Getting all the Answers in Phase I
- Combining novel technologies to create innovative study designs that allow a comprehensive understanding of drug molecules and attrition of unsuitable candidates as early as possible in clinical development.
- Use of AMS enabled approaches such as 14C light labelling and biomarker assessments of efficacy in SAD/MAD Phase I studies to allow a developer to move into Phase II with confidence in mechanism, and in depth knowledge of metabolic fate.
- Adaptive trial designs and flexible clinical protocols supported by flexible CMC strategies in Phase I, enabling real-time, “within-protocol” responses to emerging clinical data
- Use of patient populations to gain a greater understanding of drug viability in Phase I
Clinical Research Physican - Phase I, Quotient Bioresearch, Clinical Services
1pm The Fast Track Way to PoC – Adaptive Design Used in a Creative Way
- Parallel conduct of study components
- Data driven adaptive designs
- Bringing in patients as early as you can
Willem Jan Drijfhout, Senior Vice President Early Development Services, Pharmaceutical Research Associates GmbH
1.30pm Quantitative Knowledge Integration to Inform Dose Selection in Early Clinical Development
- Quantitative Knowledge Integration in Drug Development
- Dose Selection/Design for Non-Oncology First-In-Human Studies
- Dose Selection for Proof-of-Concept and Phase 2 a studies
- Leveraging Prior Clinical Experience to Inform Dose Selection for Phase 2a
Associate Director, Clinical Pharmacology Modelling & Simulation, Bristol-Myers Squibb
2pm Statistical and Strategic Approaches for Early Phase Clinical Trials
Research Fello, Director Statistics, Abbott Laboratories
2.30pm Afternoon Refreshments3pm Drug Safety Strategy in Early Development
- Examples of product recalls, understanding why drug withdrawals occur and their impact
- Demonstrate that the understanding of the mechanism of action of a new drug helps with risk minimization
- Discuss proactive measures to mitigate risk
Safety Science Leader, Director Pharma Development Safety, Licensing and Early Development, Hoffman-La Roche Inc
3.30pm “Right-Sized” Assessment of Cardiovascular Safety in Early Clinical Development
- Common challenges of QT assessment
- Potential strategies for incorporating QT assessment into early clinical studies
- Case examples illustrating when QT assessment in early clinical studies is warranted and useful for future development programs
- Examples of cost-effectiveness analysis to guide decision-making
Executive Vice President, iCardiac Technologies
4pm Safety Pharmacology Best Practices• Understand how preclinical safety testing can be used
• Early identification of risks and de-risking NCEs
• Design the most efficient early clinical trials
formerly Vice president and Head Cordio Pulmonary and Metabolic Clinical Department, Gilead
4.30pm Preclinical Cardiovascular Safety Which Would of Course Include QT Testing
- Overview of a typical Safety Pharmacology program for small molecules versus biologicals
- Preclinical cardiovascular evaluation- assessment: QT, hemodynamics and contractility
- Translation of preclinical data to the clinic- PK/PD modeling
Research Driector, Safety Pharmacology, Hoffman-La Roche Inc
5pm End of Day One and Networking Drinks Reception |
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Reserve an exhibition stand at the Exploratory Clinical Development World Americas exhibition - book early to ensure optimum stand placement!
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Reserve a stand
For details contact
Claire Conway on +44 (0) 207 608 7058 |
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