Conference Day One: 21st September 2009

08.15 Registration And Coffee

08.45 Chair’s Opening Address

The Legal Landscape

08.55 US Case Law Update – Judicial Decisions Impacting Co-Crystal Patent Strategy

  • Recent decisions suggesting how US courts may view co-crystal patents
  • Analysis of Abbott v. Sandoz (Fed. Cir. 2009): Crystalline Forms and
  • Product-by-Process
  • Analysis of Sanofi-Synthelabo v. Apotex (Fed. Cir . 2008) and others:
  • Enantiomers
  • Analysis of Pfizer v. Apotex (Fed. Cir. 2007) and others: Salt Forms
  • Analysis of US Board of Patent Appeal decisions
  • Designing and implementing effective patent strategies for co-crystal patents

Dr Jeffrey A. Lindeman
Member
O’Brien Jones PLLC

09.40 Evaluating, Designing And Making Co-Crystals For Improved Morphology And Bulk Physical Properties

  • Co-crystals in pharmaceutical industry
  • Current state of co-crystal screening
  • From structure to morphology and surface chemistry and bulk properties
  • Co-crystallisation process design

Ahmad Shiekh
Associate Research Fellow, Group Leader, Solid State Chemistry
Abbott Laboratories

10.25 Networking Coffee

10.55 CASE STUDY: Discovering New Co-Crystals

  • The Benefits Of Co-Crystals
  • The Many Ways To Make A Co-Crystal (Cooling And Evaporative Crystallisation, Solvent Mediated Transformation, Grinding)
  • How To Screen For New Co-Crystals – Making Use Of The Co-Crystal Phase Diagram
  • Co-Crystals In Practice – Changing Properties And Processes

Dr Ir. J.H. Ter Horst
Intensified Reaction and Separation Systems
Delft University of Technology

Strategic Overview

11.40 A Strategy For Integrating Pharmaceutical Co-Crystals Into Drug Development

  • Effectively conducting a current state and gap analysis
  • Deriving the strategy: a step-by-step guide
  • Defining the measures of success with current case studies examples

Dr Annette Bak
Director, Pre-formulation and Basic Research Support
Merck

Industrial Insight

12.25 Characterisation Of Crystalline And Non-Crystalline Materials By Transmission Raman Spectroscopy (TRS)

  • Novel rapid measurement capability
  • Bulk measurement that also works on powders, (coated) tablets and intact capsules
  • Sub-second quantitative analysis of crystalline state (phonon modes) of molecules and mixtures
  • Crystalline and chemical content for formulation analysis and polymorph screening in a single measurement

Mike Hargreaves
Business Development Director
Cobalt Light Systems

12.40 Networking Lunch

13.40 CASE STUDY: Co-Crystal Screening Of Natural Products: A Case Study Of Accelerated Drug Development

  • Drug Discovery And Development Process
  • The Role Of Natural Products In Drug Discovery
  • Multi-Targeted And Combination Therapies In Oncology
  • Case study: AxP 107-11

Dr Michael-Robin Witt
Chief Technology Officer
Axcentua

14.25 CASE STUDY: Elucidation And Characterisation Of Co-Crystals

  • Screening Salts, Polymorphism And Also Co-Crystals?
  • What Analysing Techniques Are Needed For Elucidation And Characterisation Of Co-Crystals
  • Measurements And Criteria For Further Development
Dr Irene Van Doormalen
Development Scientist
Schering Plough

15.10 Networking Coffee

15.40 CASE STUDY: Effective Development Of An API: Co-Crystal From Design To Characterisation

  • Design Phases Of Co-Crystal Development, Issues And Conclusions Pertinent To The Industry Now
  • Synthesis Phases Of Co-Crystal Development, Conclusions With Regards To Co-Former Selection
  • Characterisation - Pitfalls And Lessons Learnt Throughout The Development Process
Dr Vishweshwar Peddy
Senior Scientist, Head Of Solid State Group
Dr Reddys

16.25 CASE STUDY: Elucidation And Characterisation Of Co Crystals

Understanding how co-crystal solubility is influenced by co-crystal components and solution chemistry is essential to engineer co-crystals with customised solubility and streamline co-crystal discovery and selection. This talk will present approaches that are valuable to determine co-crystal/solution phase behaviour and guide co-crystal selection without the time and material consuming requirements of traditional methods. Participants will learn about the following:

  • Is there a relationship between co-crystal solubility and component properties?
  • How is co-crystal solubility influenced by solution chemistry?
  • How do component pKa and solution pH affect co-crystal solubility and stability?
  • How to assess co-crystal solubility when equilibrium is not realised?
  • What are key indicators of co-crystal solubility and stability?

Associate Professor Nair Rodriguez-Horendo
Department of Pharmaceutical Sciences
University of Michigan

17.10 Chairperson’s Closing Remarks

17.25 Close Of Conference Day One

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