9:15 Registration & Coffee

10:00 Chairman’s Welcome & Opening Address

Dr. Sven Stegemann
Director Global Pharmaceutical Business Development, Capsugel
Division of Pfizer, Belgium

10:15 Improving Solubility In Early Discovery, Hit-To-Lead Discovery And The Clinical Phase

• Goals: Why to improve solubility? Challenges and pitfalls based on inadequate solubility
• Tools: How to improve solubility - chemical structure, solid state forms and formulation techniques
• Methods: Assessing solubility of research compounds and development candidates – which techniques fit to which purpose?

Dr. Christoph Saal
Group Leader Molecule Characterization
Merck KgaA, Germany

10:55 Utility Of Salts In Enabling Development Of Poorly Soluble APIs

• Background to use of salts
• Typical acidic and basic pharmaceutical salts
• The need for stronger counter-ions
• Advantages (processability, solubility/dissolution, stability, biopharmaceutical)
• Disadvantages (processability, counter-ion baggage, disproportionation, toxicity)

Dr. David Elder
Director PreClinical Development
GlaxoSmithKline, UK

11:35 Refreshment Break & Networking

12:05 Strategies For High Dose Formulation Development Of Poorly Water Soluble Drugs In Toxicological Evaluation

• Approaches of maximizing exposure:
  • Solution,
  • Liquid dispersions,
  • Solid dispersion/nanocrystal/amorphous,
  • Suspension
• Categorize “conventional” and “non-conventional” approaches.
  • Accessibility/convenience.- pH adjustment, micelles, lipid based and self-emulsifying systems, complexation, and co-solvents
  • Dissolution limited vs solubility limited – liposomes, polymeric micelles, emulsion/microemulsion/ self-emulsifying systems, some micellar systems, and complexation.
  • Low dose vs high dose: all these methods need to try to increase the solubility.
• Vehicles to be considered. Interaction with membrane, toxicity/acceptability in humans, physical phenomena e.g., precipitation in GI fluid.

Dr. Ron Liu
President and Chief Executive Officer
AustarPharma, USA

12:45 Networking Luncheon

14:15 Early Biopharmaceutically Based Drugability Screens And Related Early Formulation Decision Trees

• Use of early biopharmaceutical screening to assess drugability
• Formulation decision tress to identify optimal early solid and liquid dosage forms
• Case studies and examples of candidate drugs
• Advantages and disadvantages of formulation approaches as a function of cost, quality and time
• Early-late transitions and the importance of these selected formulations

Dr. Marcus E. Brewster
Distinguished Research Fellow, Pharmaceutical Sciences
Johnson & Johnson Pharmaceutical Research and Development, Belgium

14:55 QbD In Drug Delivery: Keeping A Flexible And Efficient Commercial Manufacturing Target In Mind

• QbD the changing paradigm
• The importance of formulation development
• The importance of process development
• From data to knowledge based drug delivery
• From batch to continuous manufacturing

Dr. Sven Stegemann
Director Pharmaceutical Business Development, Capsugel
Division of Pfizer, Belgium

15:35 Refreshment Break & Networking

16:05 Accelerating The Formulation Development Of Poorly Soluble Compounds For Phase I Clinical Trials

• Challenges in early clinical phase drug product formulation development
• Liquid versus solid formulations for early clinical studies
• IV2SOL® : simple in vitro screening platform for candidate liquid formulations with proven gastro-intestinal and/or parenteral relevance
• Case-studies (liquid and solid): from API to Phase I clinical supplies in less than 6 months

Dr. Dave Seghers
Project Manager R&D
PharmaVize, Belgium

16:45 Pre-Formulation and Solubility Studies

• Automation Platform for Preformulation and Solubility Testing at an early stage
• Handling of liquids, solids and viscous media
• Integrated visual inspection, pH-measurement, heated filtration and more

Werner Zinsser
CEO
Zinsser Analytic GmbH, Germany

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