| 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 | Form & Formulation Keynotes |
| Discussion Leader: Raj Suryanarayanan (University of Minnesota) |
| 7:40 pm - 8:20 pm | Gordon Amidon (University of Michigan)
"BCS and a Computational Approach to Optimization of Early Lead Candidates for Oral Absorption and Systemic Availability" |
| 8:20 pm - 8:35 pm | Discussion |
| 8:35 pm - 9:15 pm | Christopher Sinko (Bristol-Myers Squibb)
"How Preclinical Form and Formulation Optimization Can Contribute to Improved R&D Productivity" |
| 9:15 pm - 9:30 pm | Discussion |
| MONDAY |
| 7:30 am - 8:30 am | Breakfast |
| 9:00 am - 12:30 pm | Solid Dispersions for Delivery |
| Discussion Leader: Nara Variankaval (Merck) |
| 9:00 am - 9:40 am | Lynne Taylor (Purdue University)
"Phase Behavior of Amorphous Solid Dispersions During Dissolution" |
| 9:40 am - 10:00 am | Discussion |
| 10:00 am | Group Photo / Coffee Break |
| 10:30 am - 11:10 am | Robin Bogner (University of Connecticut)
"Amorphous Forms and the Potential Effect of Their Solution-Mediated Phase Transformation on Bioavailability" |
| 11:10 am - 11:30 am | Discussion |
| 11:30 am - 12:10 pm | Lian Yu (University of Wisconsin)
"Stability and Stabilization of Amorphous Pharmaceuticals" |
| 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 | Ex Vivo Tools to Predict Bioperformance |
| Discussion Leader: Brian Farrer (Liquidia Technologies) |
| 7:30 pm - 8:10 pm | Jianling Wang (Novartis)
"Integrated predictive ADME and physicochemical tools for optimizing exposure in early drug discovery" |
| 8:10 pm - 8:30 pm | Discussion |
| 8:30 pm - 9:10 pm | Michael Bolger (Simulations Plus, Inc.)
"How to Model Supersaturation and Precipitation" |
| 9:10 pm - 9:30 pm | Discussion |
| TUESDAY |
| 7:30 am - 8:30 am | Breakfast |
| 9:00 am - 12:30 pm | Cocrystals for Delivery |
| Discussion Leader: Michael Zaworotko (University of South Florida) |
| 9:00 am - 9:35 am | Örn Almarsson (Alkermes)
"Pharmaceutical Cocrystals: Bridging Discovery and Development" |
| 9:35 am - 9:50 am | Discussion |
| 9:50 am | Coffee Break |
| 10:20 am - 10:55 am | William Jones (University of Cambridge)
"Use of Multicomponent Pharmaceutical Crystals to Aid Solid Form Development" |
| 10:55 am - 11:10 am | Discussion |
| 11:10 am - 11:45 am | Nair Rodriguez-Hornedo (University of Michigan)
"Why Some Surfactants Trigger Inversion of Cocrystal Solubility Behavior" |
| 11:45 am - 12:00 pm | Discussion |
| 12:00 pm - 12:20 pm | Scott Childs (Renovo Research/Triclinic Labs)
"FDA Draft Guidance and Response From Industry: Conflicting Positions on Cocrystal Regulation" |
| 12:20 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 | Breaching Delivery Obstacles in Preclinical Studies |
| Discussion Leader: Helen Burt (University of British Columbia) |
| 7:30 pm - 8:10 pm | Avinash Thombre (Pfizer) and Chris Craig (Bend Research)
"Osmotic capsules for Controlled Release Feasibility Assessment" |
| 8:10 pm - 8:30 pm | Discussion |
| 8:30 pm - 9:10 pm | Abu Serajuddin (St. John's University)
"Enabling Technologies for Bioavailability Enhancement and Formulation Development of Poorly Water-soluble Drugs" |
| 9:10 pm - 9:30 pm | Discussion |
| WEDNESDAY |
| 7:30 am - 8:30 am | Breakfast |
| 9:00 am - 12:30 pm | Beyond PO and IV: Alternate Delivery Routes |
| Discussion Leader: Ron Pettis (Becton Dickinson) |
| 9:00 am - 9:35 am | Cory Berkland (The University of Kansas)
"Designing Formulation and Delivery with Drug Properties in Mind" |
| 9:35 am - 9:50 am | Discussion |
| 9:50 am | Coffee Break |
| 10:20 am - 10:55 am | Audra Stinchcomb (AllTranz/University of Maryland)
"Form and Formulation Optimization for Transdermal Delivery" |
| 10:55 am - 11:10 am | Discussion |
| 11:10 am - 11:45 am | Benjamin Maynor (Liquidia Technologies)
"Microfabricated Particles for Drug Delivery" |
| 11:45 am - 12:00 pm | Discussion |
| 12:00 pm - 12:30 pm | Case Study Forum |
| 12:00 pm - 12:10 pm | Kohsaku Kawakami (National Institute for Material Science)
"Towards Prediction of Physical Stability of Amorphous Formulations"
|
| 12:10 pm - 12:15 pm | Discussion |
| 12:15 pm - 12:25 pm | Roman Shimanovich (Amgen)
"Preclinical Pharmaceutics Toolbox and Formulation Strategies"
|
| 12:25 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 out Conference Evaluation Forms; Discuss future Site & Scheduling preferences; Election of the next Vice Chair |
| 7:30 pm - 9:30 pm | Nanoparticles for Delivery |
| Discussion Leader: Robert Lee (Particle Sciences) |
| 7:30 pm - 8:10 pm | Lloyd Johnston (Selecta Biosciences)
"Engineered Nanoparticles for Novel Immunotherapeutics"
|
| 8:10 pm - 8:30 pm | Discussion |
| 8:30 pm - 9:10 pm | Dennis Leung (Merck)
"New Technology to Harness the Advantages of Nanoparticles in the Drug Discovery Space" |
| 9:10 pm - 9:30 pm | Discussion |
| THURSDAY |
| 7:30 am - 8:30 am | Breakfast |
| 9:00 am - 12:30 pm | Analytical Tools to Probe Form & Formulation |
| Discussion Leader: Raj Suryanarayanan (University of Minnesota) |
| 9:00 am - 9:35 am | Eric Munson (University of Kentucky)
"Characterization of Pharmaceuticals Using Solid-State NMR Spectroscopy" |
| 9:35 am - 9:50 am | Discussion |
| 9:50 am | Coffee Break |
| 10:20 am - 10:55 am | Thomas Rades (University of Copenhagen)
"Analytical Tools to Determine Crystallinity and Amorphousness of Solids" |
| 10:55 am - 11:10 am | Discussion |
| 11:10 am - 11:45 am | Michael Pikal (University of Connecticut)
"The Importance and Measurement of Transport in Stability of Freeze-Dried Biopharmaceuticals" |
| 11:45 am - 12:00 pm | Discussion |
| 12:00 pm - 12:20 pm | Ken Qian (NIST)
"Solid-state characterizations of mesoporous excipients-based amorphous formulations by neutron and X-ray scattering" |
| 12:20 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 | Assessing Developability from Preclinical Information |
| Discussion Leader: Elizabeth Kwong (Kwong Eureka Solutions) |
| 7:30 pm - 8:00 pm | John Higgins (Merck)
"Ushering New Compounds Into Development: Assessing Risks and Opportunities Based on Physicochemical and Biopharmaceutical Properties" |
| 8:00 pm - 8:10 pm | Discussion |
| 8:10 pm - 8:40 pm | G. Richard Bickerton (University of Dundee)
"Quantifying the Chemical Beauty of Drugs" |
| 8:40 pm - 8:50 pm | Discussion |
| 8:50 pm - 9:20 pm | Sudakar Garad (Cubist)
"Importance of Physical Form, Formulation and Enabling Technologies during Drug Discovery: Pay now or later" |
| 9:20 pm - 9:30 pm | Discussion |
| FRIDAY |
| 7:30 am - 8:30 am | Breakfast |
| 9:00 am | Departure |
