11:25 Chairperson’s Opening Remarks

11:30 Opening Keynote Presentation: How To Effectively Formulate Poorly Soluble Drugs

• Nanoparticles
• Amorphous forms
• Salt selection: suitable salt properties for later stage development: stability, solubility, purity
• Polymorphs: screening and characterization
• Cyclodextrins: toxicology and pharmacokinetic properties and uses in development
• Assessing permeability and solubility

Ian Buxton
PhD, Director, Product Development, WW Pharmaceutical Development
GlaxoSmithKline

12:10 Solid Dispersion In The Development Stage

• Discussing the increased use of solid dispersions of drugs in polymers to enable the delivery of poorly soluble compounds
• Examining why the amorphous nature of these dispersions result in many challenges associated with their production, stability, formulation into a dosage form and delivery
• Understanding the thermodynamics, kinetics and dissolution performance of dispersions in the past 5-10 years
• Highlighting some of these advances to provide a scientific perspective that can enable the successful design of solid dispersions

Narayan Variankaval
PhD, Research Fellow
Merck Research Laboratories

1:50 Design And Development Of Super Saturation Based Drug Delivery

• Fundamentals of supersaturated system
• Design consideration in development of supersaturated system
• Essentials for stabilization in solid state
• Maintaining super saturation during dissolution
• Impact of polymers , processes and down stream processing on stability with case studies.

Navnit H. Shah
PhD, Distinguished Research Leader, Pharmaceutical R&D
Hoffmann-La Roche Inc.

2:30 Progresses And Limitation In Characterization Of Super Saturation Based Drug Delivery

• Overview of the analytical tools
• Progress towards the characterization of supersaturated system
• Spectroscopic methods and its limitations
• Drug –polymer interaction tools to understand structural changes
• Lesson for the future

Duk Soon Choi
PhD, Research Leader
Hoffmann La Roche

3:00 Approaches For Parenteral Delivery Of Poorly Soluble Drugs

• Outlining the need for solubilization and limitations imposed by parenteral route of administration
• Highlighting pre-formulation studies to determine the need and degree of solubilization required
• Precedented approaches for solubilization and their limitations
• Displaying novel solubilization approaches such as cyclodextrins, emulsions and nanoparticles

Jaymin Shah
PhD, Research Fellow, Parenteral Development Centre of Emphasis
Pfizer, Inc.

4:00 Parenteral Formulation Development And Non-Ideal Solubility Behavior

• Why Parenterals are important formulation option for Pharmaceutical Sector and growing in importance
• Review of solubility as it relates to Parenteral formulation drug discovery and development
• Non-ideal solubility behavior and its frequency
• New solubility techniques to investigate and understand non-ideal behavior

Manuel V. Sanchez
PhD, Research Advisor
Eli Lilly and Company

4:40 Strategic Application Of Early Formulation Screening In Drug Discovery

• Utility of solubilization approaches in early drug discovery
• Selecting excipients and solubilization approaches in early drug discovery
• Novel high throughput formulation screening approach for application in drug discovery
• Impact of enhanced formulations on early PK studies

Suma Gopinathan
MSc, Associate Scientist and Head of Discovery Formulation
Lexicon Pharmaceuticals

5:20 End Of Masterclass