Latest Webcasts

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  ASTM E55 - International Consensus Standards for Pharmaceutical Manufacturing
  

  • Why consensus standards?
  • Evolution and structure of ASTM E55
  • The role of consensus standards in the pharmaceutical industry
  • The lifecycle and creation of a standard

  Michael Schousboe, Principal Scientist, Expert Manufacturing Science and Quality, Novo Nordisk, and Member of the ASTM E55 Committee on PAT

  
  
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  Case Study: Streamlining the workflow from bottle to plate with a fully integrated HT system for compound handling and screening
  • Choosing the technology and establishing the system for one streamlined workflow
  • Total automation from storage to screening
  • How our streamlined workflow contributes to successful screening and making our biology colleagues happy
  • Extending capacity of CM facilities to meet the increasing demands of our drug discovery efforts
  Dr. Wolfgang Roeben, Head of Global Logistics, Bayer CropScience AG
  
  
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  Developing Strategies for Crystalline Forms
  

  Update on Patenting Solid Forms before the USPTO and EPO

  
  
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  Driving Innovation and Continuous Improvement in Pharmaceutical Analysis
  

  • Assessing recent developments in separation sciences from collaborations with academia: Examples in high resolution/high speed LC, high
  temperature LC and SFC
  • Continuous improvement in a development environment.
  • Determining tools and approaches for reducing overall cycle-times.

  Jay Makwana, ARD Productivity, Innovation and External Collaborations Lead Associate Research Fellow, Pfizer Global R&D

  
  
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  Educating Your Organization: Identifying The Education Program That Will Produce Senior Management Support, Employee Dedication And Company Wide Acceptance Of Lean Six Sigma Improvement
  Educating Your Organization: Identifying The Education Program That Will Produce Senior Management Support, Employee Dedication And Company Wide Acceptance Of Lean Six Sigma Improvement
  How does a pharmaceutical medical device manufacturer protect $80billion of revenue? Lean Six Sigma certainly plays a part. At Cardinal Health, a classic implementation recipe was launched in May 2005 with the aim of training 1500 employees of director level and above in less than 12 months. With particular focus on Lean value chains and the extended supply chain, Cardinal Health have used a blended training and education program to appeal to the diverse spread of employees now involved with Lean Six Sigma. Bill will guide you through this blended model from the online programs for white and yellow belts, some from as short as one hour long, to the blended online and classroom programs for Green Belts and above. Find out how driving down tool application is working at Cardinal Health, and how this is dramatically increasing support and acceptance of the program company wide.
  Bill Owad, Senior Vice President, Operational Excellence, Cardinal Health
  
  
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  Engineering Antibody Fc Regions to Optimise Safety and Efficacy
  

  -Understanding the need for improved receptor binding
  -Engineering the antibody Fc region for optimal interaction with a variety of Fc receptors
  -Applying advanced technologies to create clinical candidates

  Dr. Mike Clark, Reader in Therapeutic and Molecular Immunology, University of Cambridge

  
  
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  Form Selection to Improve Solubility
  

  • Screening and selection of the best form (polymorph, salt,cocrystal, amorphous, amorphous dispersion)
  • Characterisation and performance assessment
  • Development/formulation/processing issues to consider
  • Phase I example for a poorly soluble compound

  Dr Ann Newman, Vice President of Research and Development, Aptuit

  
  
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  ICH Q8, Q9 and Q10: The New Possibilities of QbD for Pharmaceutical Development and Manufacturing
  

  • ICH framework for Quality by Design
  • Implementing quality risk Management into a QbD submission
  • The role of process understanding in development and manufacturing
  • What you can gain from the new concepts of QbD

  Fritz Erni, Head of Technology Liaison, Global Quality Operation, Novartis

  
  
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  Implementing Training In Lean Without Specific Projects To Increase Initial Success
  Andreas Werner, Lean Deployment Leader, Pfizer
  David Hampton, VP Rath & Strong
  
  
  
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  In Vitro – In Vivo Assessment of Lipid Based Formulations
  • The impact of key formulation parameters on the solubilisation properties of self-emulsifying drug delivery systems
  • In vitro lipid digestion models and their use as powerful tools in the design of lipid based formulations for oral administration of poorly water-soluble drugs
  • The use of in vitro models to explain/predict the in vivo performance of self emulsifying drug delivery systems
  Dr Jean Cuiné, Principal Scientist, Pharmaceutical R&D, Novartis
  
  
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  Leadership Case Study: Adding The Right Ingredients To Create A Successful Lean Six Sigma Program
  Leadership Case Study: Adding The Right Ingredients To Create A Successful Lean Six Sigma Program
  Everyone acknowledges that top-down leadership is critical for Lean Six Sigma to be successful throughout an organization. But what exactly are the right behaviors and activities that executives need to engage in, reinforce and communicate to effectively lead others to make it happen? First executives need to get over the fact that Lean Six Sigma “was not invented here!” Ed will guide you through the recipe for success at AmerisourceBergen which includes: A strategy and plan; technical assistance; steering committee and their activities of assuring minimal body of knowledge training, process management, project selection and review and executive sponsorship. Additionally Ed will focus on:
  • Establishing ongoing motivation including reward, recognition and continued involvement at all levels in the organization, especially top management
  • Involving finance or accounting to measure cost and benefits and ROI on every project to continually motivate the organization and constitute an executive scoreboard that continues to reinforce the leadership role
  Ed Hancock, President, Packaging Group, AmerisourceBergen
  
  
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  Learn valuable insights from Claus Mortensen
  

  PAT EU Regulatory Update: The Inspectors View

   

  
  
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  Making the most out of screening output to attain a deep biological understanding and ‘information awareness’ of compounds to feed into leads and onto candidates
  

  AstraZeneca’s approach to hit discovery is that the more data generated, the more knowledge of the target and compound is gained. Sophisticated data mining methods interpret data much quicker and effectively than if done manually and allows the breakdown of pre-existing walls between chemistry and biology knowledge. This session will present distinct case studies, for both well-known and novel targets, and show how data mining efforts can improve the biological relevancy of HTS data and help realise overall greater value of the screening platform.

  Martin Packer, Group Leader, Computational Chemistry, AstraZeneca

  
  
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  Meeting Canadian Regulatory and Inspection Requirements for Temperature Sensitive Products
  • Understanding the feedback from recent audits on how to show evidence of compliance: Are you conducting the right validation studies for -20°F?
  • Describing stability studies and data that work
  • Recognizing how manufacturers can assist the Canadian Provinces when there is a cold chain breach
  
  Harold Rode, Chief, Pandemic Influenza Division, Biologics and Genetic Therapies Directorate, Health Canada
  
  
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  MHRA Regulatory Feedback - Ensuring Your Products Comply With European Temperature Control Regulations From Clinical Materials to Marketed Products
  • Comparing MHRA regulations with other European National Agencies – Are U.S. companies on the right track to comply across Europe?
  • Gaining a European regulatory view on how industries can gain more control of temperature-sensitive products further downstream in the cold chain
  • Clinical materials – What are the Regulators concerns and expectations?
  • Describing what information and how much should be included in quality reports and risk assessments
  
  Ian Holloway, Manager, Defective Medicines Report Centre, MHRA
  
  
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  Prodrug Approaches to Improve Solubility Behavior -What, When and How?
  • Review of common physicochemical approaches to address solubility issues
  • How can we incorporate prodrug strategies as part of drug discovery
  • Some recent studies
  
  
  
  
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  Realising the Commerical Potential of Therapeutic Antibodies 2008
  

  -Reviewing the concept of using antibodies in oncology and against cancer stem cells
  -Examining mAb products in clinical development
  -Developing strategies for design of mAb products

  Professor Agamemnon Epenetos, Consultant Oncologist, Trojan Technologies

  
  
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  Reviewing the latest initiatives for drug safety surveillance from the FDA
  • Describing the initiatives from the FDA and determining their impact on your pharmacovigilance strategy and organisation
  • Comparing these with EMEA and worldwide directives
  • Understanding the impact and implications of FDAAA on drug development and commercialisation
  
  
  
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  Revolutionise your existing practices with the help of Han-Jurgen Federsel
  Strategic directions for process R&D in times of challenge for the pharmaceutical industry
  
  
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  Screening Methods And Validation Of Chiral Methods Including Design Of In-House Experiments
  Dr. Ludwig Goetelen, Scientist, Johnson & Johnson
  
  
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  The Final Updated Revisions to General Chapter 1079: Practical Guidance to Updating Your Cold Chain Management
  • Explaining recommended control strategies – from warehouse through end-user
  • Describing specific protocols for receiving, shipping and storing – when, how and how much
  • Following the tables in the updated guidance to make the right choices in your cold chain management
  • Understanding the updated SOPs and how to implement them
  Dr Mary Foster, USP Packaging and Storage Expert Committee Member, US Pharmacopeia (USP)
  
  
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  The Management of Compound Management: How to get buy in for CM
  • Managing change in the collaborative role of CM in the drug discovery organisation – how can we be most flexible in our integrated role?
  • Responding to new requirements and trends in target based screening
  • The secret to success of managing a CM team
  • Steps on how to demonstrate the value of CM to key partners
  
  
  
  
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  Toxic or Therapeutic Principle: Are Cyclin-Dependent and other Novel Kinase Drugable after all?
  CDK inhibitors have been developed for their potential application as cancer drugs. By and large, these efforts did not yield the expected success, presumably because these inhibitors lack selectivity within the larger CDK family of kinases. Our primary goal was even more challenging than identifying a CDK inhibitor for the treatment of tumors.We have generated a CDK9-selective inhibitor for the potential treatment of viral and inflammatory diseases. This session will explore the challenges along the way including; lack of selectivity leads to a small therapeutic window, some CDKs are the drivers of the cell cycle and therefore cancer targets, transcriptional CDKs might either be essential or therapeutically highly interesting, and CDK9 inhibitors block phosphorylation of RNA polymerase II. A long term success look at in vivo models will also be examined to explore the outlook for novel Kinase.
  
  Dr. Bert Klebl, CEO, Lead Discovery Center GmbH
  
  
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  Update on Patenting Solid Forms before the USPTO and EPO
  Raymond Parker, Associate VP and Head , US Patent Operations, Internal Medicine Group, Sanofi-Aventis
  
  
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  Use of Risk Management and a Quality by Design Approach to Analytical Method Development, Validation and Transfer
  

  • How QbD principles can be applied to analytical methods
  • Benefits from a QbD approach
  • The role of risk assessment, knowledge management and statistical techniques in the QbD approach
  • Examples of application of a QbD approach in GSK

  Phil Nethercote, Director of New Product Support, Lab Centre of Excellence, GlaxoSmithKline