Sunday |
2:00 pm - 9:00 pm | Arrival and Check-in |
6:00 pm | Dinner |
7:30 pm - 7:40 pm | Welcome / Introductory Comments by GRC Site Staff |
7:40 pm - 9:30 pm | Keynote Session: Preclinical Form and Formulation for Drug Discovery |
| Discussion Leader: Robert Wenslow (Crystal Pharmatech, USA) |
7:40 pm - 8:20 pm | Bruno Hancock (Pfizer Inc., USA) "API Particle Shape: The Cinderella Quality Attribute" |
8:20 pm - 8:35 pm | Discussion |
8:35 pm - 9:15 pm | Jennifer Dressman (University of Frankfurt, Germany) "Linking the Lab to the Patient: Strategies for Combining In Vitro
and In Silico Tools to Predict Performance of Orally Administered Drugs" |
9:15 pm - 9:30 pm | Discussion |
Monday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Strategies for Overcoming Bioavailability Issues: Lipidic, Co-Crystals, Nanomilling |
| Discussion Leader: Jennifer Dressman (University of Frankfurt, Germany) |
9:00 am - 9:40 am | Jonathan Miller (Vertex Pharmaceuticals Inc., USA) "The Solubility-Permeability Interplay: Implications in Formulation Design and In Vivo Performance" |
9:40 am - 10:00 am | Discussion |
10:00 am - 10:30 am | Group Photo / Coffee Break |
10:30 am - 11:10 am | Shobha Bhattachar (Elil Lilly & Co., USA) "Pre-Clinical Formulation Strategies: Keeping Up with Changing Paradigms in Drug Discovery and Development" |
11:10 am - 11:30 am | Discussion |
11:30 am - 12:10 pm | David Vodak (Bend Research, USA) "Optimizing Bio-Pharmaceutical Performance of Low Solubility Drugs" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Amorphous Formulations: Delivery Routes and Theoretical Prediction of Stability (Including Computational Methods) |
| Discussion Leader: Patrick Connelly (Vertex Pharmaceuticals Inc., USA) |
7:30 pm - 8:10 pm | Konstantin Borisenko (University of Oxford, United Kingdom) "Nanoscale Structure of Amorphous Pharmaceutical Formulations and Its Implications for Structure-Properties" |
8:10 pm - 8:30 pm | Discussion |
8:30 pm - 9:10 pm | Majed Fawaz (Vertex Pharmaceuticals Inc., USA) "Translational Development of Amorphous Materials" |
9:10 pm - 9:30 pm | Discussion |
Tuesday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Analytical Tools to Probe Form and Formulations |
| Discussion Leader: Karthik Nagapudi (Genentech, USA) |
9:00 am - 9:40 am | Simon Billinge (Columbia University, USA) "Recent Progress in
Characterization of Amorphous and Nanocrystalline Molecular Materials" |
9:40 am - 10:00 am | Discussion |
10:00 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Robert Schurko (University of Windsor, Canada) "New Avenues for High-Throughput Screening of Pharmaceutical HCl Salts: Applications of 35Cl SSNMR to Bulk and Dosage Forms" |
11:10 am - 11:30 am | Discussion |
11:30 am - 12:10 pm | Chris Hartshorn (National Cancer Institute, NIH, USA) "Nonlinear Optical Imaging Modalities for Real-Time Problem Solving in Formulations" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Tools to Predict Bioperformance: Assessing Developability |
| Discussion Leader: Riccardo Panicucci (WuXi AppTec, USA) |
7:30 pm - 8:00 pm | Manuel Sanchez-Felix (Novartis, USA) "Holistic In-Vivo,
In-Vitro and In-Silico Formulation Drug Design: Current State and Future
Opportunities" |
8:00 pm - 8:10 pm | Discussion |
8:10 pm - 8:40 pm | Roy Haskell (Bristol-Myers Squibb, USA) "Drug Delivery
Approaches That Assess Developability and Enable Discovery" |
8:40 pm - 8:50 pm | Discussion |
8:50 pm - 9:20 pm | Keith Horspool (Boeringer-Ingelheim, USA) "'Phuturcetutics' –
Transforming Product Development" |
9:20 pm - 9:30 pm | Discussion |
Wednesday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Parenteral Drug Development Technologies |
| Discussion Leader: Susan Hershenson (Bill and Melinda Gates Foundation, USA) |
9:00 am - 9:40 am | Kim Woodrow (University of Washington, USA) "Drug-Eluting Fibers for On Demand Vaginal Drug Delivery" |
9:40 am - 10:00 am | Discussion |
10:00 am - 10:30 am | Coffee Break |
10:30 am - 11:10 am | Erica Schlesinger (University of California, San Francisco, USA) "Thin Film Polymer Device for Long-Acting Antiretroviral HIV PrEP" |
11:10 am - 11:30 am | Discussion |
11:30 am - 12:10 pm | Robert Lee (Particle Sciences, Inc., USA) "Long-Acting Injectable Formulations with a Focus on Particulate Suspensions" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:00 pm - 7:30 pm | Business Meeting |
| Nominations for the Next Vice Chair; Fill in Conference Evaluation Forms; Discuss Future Site and Scheduling Preferences; Election of the Next Vice Chair |
7:30 pm - 9:30 pm | Characterization of Lyophilization: Small Molecule and Biologics |
| Discussion Leader: Steven Nail (Baxter, USA) |
7:30 pm - 8:10 pm | Elizabeth Topp (Purdue University, USA) "Characterizing Protein Higher Order Structure in the Design of Lyophilized Formulations" |
8:10 pm - 8:30 pm | Discussion |
8:30 pm - 9:10 pm | Ted Randolph (University of Colorado, Boulder, USA) "Accumulation of Protein at the Ice/Freeze Concentrate Interface: Implications for Drug Product Stability" |
9:10 pm - 9:30 pm | Discussion |
Thursday |
7:30 am - 8:30 am | Breakfast |
9:00 am - 12:30 pm | Biologics Formulation Development |
| Discussion Leader: Daan Crommelin (Utrecht Institute of Pharmaceutical Sciences, The Netherlands) |
9:00 am - 10:10 am | David Volkin (University of Kansas, USA) "What Happens Before Injection? Interrelationships Between Protein Higher-Order Structure, Formulation Composition, and Pharmaceutical Stability" |
10:10 am - 10:30 am | Discussion |
10:30 am - 11:00 am | Coffee Break |
11:00 am - 12:10 pm | Wim Jiskoot (Leiden University, The Netherlands) "What Happens After Injection? Impact of Formulation on In Vivo Behavior of Therapeutic Proteins" |
12:10 pm - 12:30 pm | Discussion |
12:30 pm | Lunch |
1:30 pm - 4:00 pm | Free Time |
4:00 pm - 6:00 pm | Poster Session |
6:00 pm | Dinner |
7:30 pm - 9:30 pm | Computation Solid State Chemistry: Simulation and Predictive Tools |
| Discussion Leader: Jamshed Anwar (Lancaster University, United Kingdom) |
7:30 pm - 8:00 pm | Lennart Lindfors (AstraZeneca R&D Molndal, Sweden) "Drug Absorption and Free Energy Calculations" |
8:00 pm - 8:10 pm | Discussion |
8:10 pm - 8:40 pm | Marcus Neumann (Avant-Garde Materials Simulation Deutschland GMBH, Germany) "Crystal Structure Prediction in Pharmaceutical Development: Examples, Opportunities and Unsolved Problems" |
8:40 pm - 8:50 pm | Discussion |
8:50 pm - 9:20 pm | Dirk Zahn (University Erlangen, Germany) "Understanding Molecular Crystal Nucleation from Computer Simulations" |
9:20 pm - 9:30 pm | Discussion |
Friday |
7:30 am - 8:30 am | Breakfast |
9:00 am | Departure |