APT 2010 Agenda
Discovery Workshop
Monday, 17 May 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| REGISTRATION | 7:00 - 8:00 | |||
| Intro to APT | Kevin Leach | Shire | 8:00 - 8:10 | |
| Intro to Discovery - Keynote | Bruce Car | BMS | 8:10 - 8:20 | |
| Plenary Session - Adaptive versus Adverse Changes in Toxicology | Kim Boekelheide | Brown University | 8:20 - 9:15 | |
| Session I: | Novel Technologies in Discovery Toxicology | |||
| Session Intro | Scott Barros | Alnylam | 9:15 - 9:25 | |
| Off-Target Effects of mi- and siRNAs | Debora Marks | Harvard | 9:25 - 10:05 | |
| Break | 10:05 - 10:20 | |||
| Safety Considerations Around 2’F-substituted Oligos | Scott Barros | Alnylam | 10:20 - 11:00 | |
| Stem Cells in Preclinical Drug Safety | Angela Cacace | BMS | 11:00 - 11:40 | |
| Using the Thermo Scientific Cellomics ToxInsight Platform to Predict Liver Toxicity | Amy Peters | Thermo Scientific | 11:40 - 12:10 | |
| Lunch | 12:10 - 1:10 | |||
| Stem Cell-Derived Functional Cardiomyocytes for Toxicity Prediction | Dr. Akiko Futamura | Osaka University | 1:10 - 1:50 | |
| MEAs in Neurotox Testing | Tim Shafer | EPA | 1:50 - 2:30 | |
| Session II: | Non-Cardio Safety Pharmacology | |||
| Session Intro | Oliver Flint | 2:30 - 2:40 | ||
| Frontloading the Development Process to Make Decisions Earlier: Combining Automated PK with Telemetry in Rats | Russ Bialecki | AstraZeneca | 2:40 - 3:20 | |
| Preclinical Abuse Potential Assessment: An Overview | Snjezana Lelas | BMS | 3:20 - 4:00 | |
| Break | 4:00 - 4:15 | |||
| Utilities of in vitro Safety Pharmacology Profiling in ADR Prediction | Laszlo Urban | Novartis | 4:15 - 4:55 | |
| Exploring Translation of Safety Pharmacology Cardiovascular Data to Phase I Clinical Trials | Alison Easter | AstraZeneca | 4:55 - 5:35 | |
| Evening reception - Sponsored by Covance | 5:35 - 6:35 | |||
Tuesday, 18 May 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Second Tier Investigation: Cases where Routine and Specialized In Vivo Evaluations Provided Pivotal Risk Assessment Context | Brian Gemzik | BMS | 8:30 - 9:10 | |
| Session III: | Predictive Tox of Large Molecules | |||
| Session Intro | Mark Fielden | 9:10 - 9:20 | ||
| Appropriate Animal Models for Safety Assessment of Biologics | Tim MacLachlan, PhD, DABT | Genzyme | 9:20 - 10:00 | |
| Risk-Based Drug-Drug Interaction Assessment Strategy for Therapeutic Proteins | Honghui Zhou, PhD, FCP | Centocor R&D, Johnson & Johnson | 10:00 - 10:40 | |
| Break | 10:40 - 10:55 | |||
| Determining Target-Mediated Toxicity in Nonclinical Species and its Application to Safety in Man | Lisa Beebe, PhD, DABT | Biogen Idec | 10:55 - 11:35 | |
| Predictive Pre-Clinical Models for Unintended Immune Stimulation | Padma Kumar Narayanan | Amgen | 11:35 - 12:15 | |
| Assays that Detect Mechanisms of DILI in Discovery Stage: When De-Risking Makes Most Sense | Katya Tsaioun | Apredica | 12:15 - 12:45 | |
| Lunch | 12:45 - 1:45 | |||
Development Workshop
Tuesday, 18 May 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Development Workshop Intro | Vic Kadambi | Millennium Pharmaceuticals | 1:45 - 1:55 | |
| Session IV: | Safety Assessment of Coagulation Products | |||
| Session Intro | Garvin Warner | Pfizer | 1:55 - 2:05 | |
| Toxicological Assessment of a Recombinant Human Coagulation Protein Delivered via Liposomes | Inge Ivens | Bayer | 2:05 - 2:45 | |
| ReFacto/Xyntha: Nonclinical Challenges in the Development of Replacement Factors for Hemophilia A | Garvin Warner | Pfizer | 2:45 - 3:25 | |
| Break | 3:25 - 3:40 | |||
| BeneFIX®: Nonclinical Strategies to Support Post-Marketing Manufacturing and Formulation Changes | Melissa Jezuit | Pfizer | 3:40 - 4:20 | |
| The Potentials and Challenges of Longer-acting Factor VIII and Factor FIX Replacement Therapies | Haiyan Jiang | Biogen Idec Hemophilia | 4:20 - 5:00 | |
| Roundtable Discussion | All Speakers | 5:00 - 5:30 | ||
| Evening Reception | 5:30 - 6:30 | |||
Wednesday, 19 May 2010
| Session | Topic | Speaker | Company | Time |
|---|---|---|---|---|
| Session V: | Safety Assessment of Modified Endogenous Products - Development Issues | |||
| Session Intro | Chris TenHoor | Dyax | 9:00 - 9:10 | |
| Preclinical Development and Safety Assessment of a Human Recombinant Chimeric (non-Ig Fc) Fusion Protein | Christopher Horvath | Taligen | 9:10 - 9:50 | |
| Monomeric Fc Fusion Proteins Show Improved Pharmacokinetics | Jennifer Dumont | Syntonix Pharmaceuticals | 9:50 - 10:30 | |
| Break | 10:30 - 10:45 | |||
| Nonclinical Development of a Kunitz Domain-Based Inhibitor of Plasma Kallekrein | Chris TenHoor | Dyax | 10:45 - 11:25 | |
| Incurred Sample Reanalysis: Biogen Idec Experience From Both Small Molecule and Large Molecule Studies | Liyu Yang | BIIB | 11:25 - 12:05 | |
| Lunch | 12:05 - 1:05 | |||
| Session VI: | Preclinical Development of Novel Macromolecular Therapeutic Technologies | |||
| Session Intro | Page Bouchard | 1:05 - 1:15 | ||
| Adnectins: Realizing the Promise of a Novel Class of Targeted Biologics | Nicholas Marsh | Adnexus | 1:15 - 1:55 | |
| Nonclinical Assessment of Bispecific T Cell Engaging BiTE© Antibodies | Benno Rattel | Micromet AG, Munich | 1:55 - 2:35 | |
| Break | 2:35 - 2:50 | |||
| General Properties and Development Considerations for Peptide Therapeutics | Angelique Braen | Hoffmann-La Roche | 2:50 - 3:30 | |
| General Properties and Nonclinical Testing strategies for Oligonucleotide Therapeutics | Page Bouchard | Novartis Institutes for Biomedical Research | 3:30 - 4:10 | |