2018 Forum Agenda: San Francisco, CA, USA

Monday, June 11th 2018

Pre-Conference Workshop:
Practical Application of Compaction Simulation to Product & Process Development
Workshop Moderator: Charles Yang
11:00 AM Jeff Katz, Amgen
Assessment of neat drug substance mechanical properties at Amgen: a material-sparing approach
11:35 AMAriel Muliadi, Genentech
Compaction simulator use at Genentech: application examples and best practices
12:10 PMJeff Hemenway, Gilead
Mechanical properties characterization methods for formulations blends and use as response factors in DoEs
12:45 PMPanel Discussion I
1:15 PMBreak
1:30 PMVrushali Waknis, Allergan
Understanding the Impact of API Morphology on its Tableting Behavior
2:00 PMElaine Stone, Merlin Powder Characterisation
Predicting sticking in formulations
2:30 PMAndy Lapinski, Elizabeth Carbide
Tablet design techniques for solid dosage pharmaceutical manufacturing
3:30 PMPanel Discussion II
3:50 PM - 5:00 PMOptional tour of Genentech's high-potency GMP processing suites, courtesy of Genentech
5:00 PM - 7:00 PMOpening Reception
Sponsored by Huxley Bertram
Huxley-Bertram-Logo_sm

Tuesday, June 12th 2018

CSF Day 1
8:00 AMBreakfast and Registration
8:30 AMIntroduction & Program Preview
Morning Session Moderator: Tracey Mascaro
8:45 AMKeynote: Prof. Antonios Zavaliangos, Ph.D., Drexel University, College of Engineering
Gaining Insight Into Sticking Through Modeling
9:45 AMJerry Klinzing, Merck
Modeling the air pressure increase in tablets during compaction a step toward understanding tablet capping
10:15 AMBreak
10:30 AMSean Garner, AbbVie
Predictive modeling for tooling optimization and tableting success using advanced modeling techniques
11:00 AMPingjun Tang and Joe Bullard, Vertex
A novel approach to powder elastic strain calculation in uniaxial compression test
11:30 AMStephen W. Hoag and Raghunadha Reddy Seelam, University of Maryland, Baltimore
Evaluation of the effects of tablet compression force and tableting speed on polyethylene oxide polymers in abuse deterrent formulations
12:00 PMLunch
Afternoon Session Moderator: Jeff Hemenway
1:00 PMKeynote: Associate Prof. Vincent Mazel, Ph.D., University of Bordeaux, Institute of Mechanics and Engineering:
Strategy for the study of the viscoelastic properties of pharmaceutical tablets using a compaction simulator
2:00 PMJohny Bertels, Janssen, Johnson & Johnson
Compaction simulation: one piece of the tablet development puzzle
2:30 PMBreak
3:00 PMJasmine Rowe, Bristol-Myers Squibb
Bridging the gap: using compaction simulation to correlate drug substance properties to drug product decisions
3:30 PMMichael Keeney et al., Gilead Sciences
The Use of Compaction Simulation to Maximize Interfacial Strength of Bilayer Tablets
4:00 PMFlash Presentations
Moderated by: Edward Yost, Genentech

Helen Hou, Genentech
Impact of method of preparation of Amorphous Solid Dispersions on Mechanical Properties: Comparison of co-precipitation and spray drying

Jovana Radojevic, Drexel University
Effect of External Load on the Evolution of Post-Compaction Properties of Sodium Chloride Compacts and its Mixtures

Edward Yost, Genentech
Quantitative X-ray Micro-Computed Tomography Assessment of Internal Tablet Defects

Martin Bennett, Huxley Bertram
The effect of production press stiffness on tablet strain rate

Yoshihiro Hayashi, University of Toyama
Modeling of quantitative relationships between physicochemical properties of APIs and tablet properties using a random forest

Cosima Hirschberg, University of Copenhagen
The effect of atomic layer deposition (ALD) on critical powder characteristics

Anne Skelbaek, University of Copenhagen
Quantification of fragmentation of pharmaceutical materials during tableting
5:00 PMPosters & Networking Reception
7:00 PM – 10:00 PMCSF Dinner
Steelhead Brewery

Wednesday, June 13th 2018

CSF Day 2
8:00 AMBreakfast
8:30 AMIntroduction
Morning Session Moderator: Bhavi Mittal
9:00 AMKeynote: Prof. Chuan-Yu (Charley) Wu, Ph.D., University of Surrey – Guildford, College of Engineering
The development of in silico process models for roll compaction
9:45 AMJie Ren, A.Tantuccio, W. Blincoe, J.Mandur, B.Smith-Goettler, J.DiNunzio, Merck & Co.
Development of a continuous blending-compression process using compaction simulation
10:15 AMBreak
10:30 AMJennifer Sinclair Curtis, University of California, Davis
Using DEM simulation to aid in the design of pharmaceutical processes
11:00 AMJens Dhondt, et al., Ghent University, J&J Janssen
The development of a predictive tableting platform for lab scale direct compression
11:30 AMGulsad Kucuk, Yin-Chao Tseng, Xiaorong He, Boehringer-Ingelheim
Application of mechanistic modelling to improve the tablet compaction process
12:00 PM
Lunch
Afternoon Session Moderator: Jeff Katz
1:00 PMKeynote: Prof. Dale Eric Wurster, Ph.D., University of Iowa, College of Pharmacy
Compression Calorimetry
2:00 PMChen Mao, Genentech
Tablet ejection force and its sensitivity to lubrication a compaction simulation study
2:30 PMBreak
3:00 PMJoão Henriques, S. Doktorovova, P. Lino, M. Paiva, J. Vicente, Hovione
How to develop an amorphous solid dispersion in tablets with less than 30g of API
3:30 PMIra S. Buckner & Pradeep Valekar, Duquesne University
Rational formulation design using individual component property based predictions
4:00 PMBhavi Mittal & Vrushali Waknis, Allergan
Making a business case for a compaction simulator in the age of pharmaceutical outsourcing
4:30 PMConcluding Remarks
5:00 PMNetworking Cocktail Event

The Scientific Committee is chaired by Charles Yang, Principal Scientific Manager, Formulation
Development & GMP Manufacturing Operations, Genentech.

The committee also includes:

  • Jeff Hemenway, Gilead
  • Jeff Katz, Amgen
  • Tracey Mascaro, Merck
  • Bhavi Mittal, Allergan