2019 Forum Agenda: New Brunswick, NJ, USA

Monday, June 3rd 2019

Workshop & Arrival Day
10:30 AMPre-Conference Workshop Registration – Busch Center (Busch Campus)
Separate Registration Required
11:00 AMHighlights of the research at Rutgers (collaboration with FDA & Industry) to advance Continuous Manufacturing (CM)
●     Dr. Gerardo Calligari
      Continuous Manufacturing, FDA project                
●     Dr. Ravendra Singh
     Tablet press control, PAT in real-time                         
●     Dr. Andres Roman Ospino
       In-line PAT within a  tablet press feed frame
12:15 PMLunch break & transfer to labs
1:15 PM Rutgers Laboratory tours, including the Continuous Manufacturing facility
●      Continuous manufacturing, including PAT and controls (direct compression pilot plant)
●      Powder characterization laboratory: flowability, electrostatic, wettability
●     Unit operations and analytical laboratory (NIR, 3D Raman, dissolution)
3:15 PMPractical application of compaction simulation to product & process development
Presentations by experienced pharmaceutical compaction practitioners; among them:
●    Dr. Fengyuan (George) Yang, Ashland (NJ)    
     Applications of compaction simulators in pre-formulation, formulation, process development & troubleshooting
●    Ed Yost Genentech (CA)
Expanding our analysis of tablet defects
●    Ilgaz Akseli, Celgene (NJ)
       Quantitative correlation of the effect of process on the capping tendencies of tablet formulations
●   Kevin Bittorf, Simulation, LLC
Justification of continuous processes and other innovations: it is more than just technical
5:00 PM Conclusion of the Workshop
5:30 PM – 7:30 PM Welcome Reception at Harvest Moon Brewery, New Brunswick
Sponsored by Huxley Bertram Compaction Simulators

Tuesday, June 4th 2019

CSF Day 1
8:00 AM Breakfast and Registration
8:30 AM Introduction & Program Preview
Session 1:  Simulation
Morning Session Moderator: Gulsad Kucuk, Bristol-Myers Squibb (NJ)
9:00 AM Keynote: Professor Fernando J. Muzzio, Rutgers University
New advances in modeling and the understanding of materials relevant to pharmaceutical compaction processes
10:00 AM Break
10:30 AM Vincent Mazel, Ph.D., University of Bordeaux
Effect of friction between powder and tooling on the die wall pressure evolution during tableting: experimental & numerical results for flat and concave punches
11:00 AM Ilgaz Akseli, Celgene
Breaking Force and Disintegration Prediction of Tablet Formulations Using Machine Learning
11:30 AMJerry Klinzing, Merck (PA)
A study to further understand the influence of embossing design and cup curvature utilizing 3D finite element modeling of powder compaction
12:00 PM Lunch
Session 2: Punch Sticking
Afternoon Session Moderator: Jerry Klinzing, Merck (PA)
1:00 PMKeynote: Antonios Zavaliangos, Ph.D., Drexel University
Sticking: an update on experimental & modeling results
1:45 PM Jerome B. Johnson, University of Alaska
The discrete nature of pharmaceutical powder punch sticking and its characterization
2:30 PM Break
3:00 PM Jasmine Rowe, BMS (NJ)
Assessing Sticking Risk During Tablet Compaction: Using an Instrumented Punch and Compaction Simulator
3:30 PM Edward Yost, Genentech, CA
Quantitative X-Ray microcomputed tomography assessment of internal tablet defects
4:00 PM Flash Presentations
5:00 PM Posters & Networking Reception
6:30 PM – 9:30 PM CSF Dinner

Wednesday, June 5th 2019

CSF Day 2
7:30 AMBreakfast
Session 3: modelling overview
Morning Session Moderator: Sherif Badawy, BMS (NJ)
8:15 AM Keynote: Goran Frenning, Ph.D., Uppsala University
The mechanics of single particles subjected to complex compressive loading conditions and its implications for modeling of confined powder compression
9:00 AMAnton Kulchitsky, Coupi, AK
The modelling challenges of die compaction
9:30 AM Weixian Shi, BMS, NJ
Modelling & Simulation of Tablet Chipping
10:00 AM Break
10:30 AM Keynote: Marcial Gonzalez, Ph.D., Purdue University
Multi-scale modeling & simulation of solids processing: from tableting to dissolution
11:30 AMJovana Radojevic, Drexel University
Evaluation of the tensile strength of compacts using square samples produced through triaxial decompression
12:00 PMLunch
Session 4: Applications and Case Studies
Afternoon Session Moderator: Vrushali Waknis, Allergan (CA)
1:00 PM Cetin Çetinkaya, Clarkson University
Early Detection of Capping Risk in Pharmaceutical Compacts with Ultrasound 
1:25 PM Ira Buckner, Duquesne University
Co-processed particles: an approach to transform poor tableting properties
1:50 PMThi-Tram Nguyen, Sungkyunkwan University
Fines Recycling In Roller Compaction: A Case Study
2:15 PM Junshu Zhao, BMS, NJ
A material-sparing approach to assess the compaction risk of high SDD loading formulations
2:40 PM Break
3:10 PM Thomas Durig, Ashland
Applications of compaction simulators in preformulation, formulation, process development and troubleshooting
3:35 PM Crystal Miranda, Merck, NJ
Punch velocity scaling method validation
4:00 PM Sherif Badawy, BMS, NJ
Application of compaction simulation technology to drug product development
4:30 PM Concluding Remarks
5:00 PM Networking Cocktail Event