Conference Day Two: 18th April 2012
08.30 Registration and Coffee
09.00 Welcome and Opening Address
Chair:
Marcus Brewster
Senior Research Fellow Head of Dept. Drug Delivery Research
Johnson and Johnson
Ensuring End Product Quality and Efficiency in Drug Development Through the Implementation of Process Analytical Technologies and Quality by Design
09.10 CASE STUDY: Matching and Predicting The Release Profile of a Drug to Make The Connection Between in Vitro and in Vivo Performance
- How can advanced dissolution testing be used to predict in vivo performance and what other tools are available?
- The use of in silico models and other tools to predict in vivo performance
- Case study examples of advanced dissolution models
Professor Jean Michelle Cardot
Head of Department of Biopharmaceutics and Pharmaceutical Technology
Universite d’Auvergne
09.50 Transforming the Early Development Process: Integrating Pharmaceutical Sciences and Clinical Testing
- Limitations of the conventional formulation development paradigm – what needs to change and why?
- Translational Pharmaceutics™ - what does it mean and what are the benefits?∙
- Novel CMC and regulatory strategies to enhance flexibility and precision in developing clinical formulation prototypes∙
- Rapid make-test cycle times to accelerate formulation and clinical development∙
- Using formulation design space concepts within Phase I / PK protocols∙
- Case studies demonstrating selection and real-time optimization of formulation compositions based on human clinical data
Dr Mark Egerton
CEO
Quotient Clinical
10.30 Networking Coffee Break
11.00 Interactive Round-table Discussions
1) Novel Techniques for the Extended Release for Parenterals
Mandar Shah
Sr Research Fellow, Topical Small Molecule Development
Johnson and Johnson
2) How Can We Predict In Vivo Performance From In Vitro Model Testing?
Marcus Brewster
Senior Research Fellow Head of Dept. Drug Delivery Research
Johnson and Johnson
3) Quality by Design in Pharmaceuticals
Wim Oostra
Department Head
Merck
4) Overcoming Challenges in Formulation Development When Operating as a Small and Virtual Company
Ian Walker
Head of Product Leadership
Acacia Pharma
12.00 Presentation details to follow
12.40 Networking Lunch Break
| Stream 1: Optimal Formulation Strategies to Improve Drug Bioavailability
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Stream 2: Innovations in Drug Delivery |
13.40 Lipid Based Formulations: Overcoming the Challenge of Low Bioavailability for Poorly Water Soluble Drug Compounds
- Overview of the challenges to successful oral formulation of poorly water soluble drug compounds
- Potential of lipid based formulations to enhance oral bioavailability
- How to successfully design lipid based formulations
- Review the latest techniques for characterisations of in vitro and in vivo performance of lipid based formulations
- Case study examples of enhanced bioavailability using lipid based formulations
Brendan Griffin
Lecturer in Pharmaceutics and Course Director
University College Cork
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13.40 Modified Polymers For Stimuli-Responsive Drug Delivery Systems
- Advantages and possibilities of stimuli-responsive DDS
- Mechanisms available for generation of a response from the DDS
- Temperature induced effects on polymeric systems
- Polymeric properties important for stimulus sensitivity
- Adjuvants for improved drug delivery properties for responsive polymeric systems
Sverre Arne Sande
Professsor, Department of Pharmacy
University of Oslo
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14.20 Presentation details to follow
Dr Rob Harris
Director, Early Development
Molecular Profiles
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14.20 Patient Centric Drug Products For Older Adults: Drug Delivery and More
- The impact of demographics on drug delivery
- Regulations and regulatory initiatives to address demographics
- The impact of aging on drug therapy and delivery
- Drug therapy from an older patients point of view
- Considerations for older patient centric products
- Future perspective and opportunities in geriatric medicines
Sven Stegemann
President
Geriatric Medicine Society
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15.00 Networking Coffee Break
15.30 Improving Solubility and Bioavailability for Emerging Therapies - Opportunities and Challenges for Formulation R&D
- Providing a background to poorly soluble molecules and the challenges they present
- Looking at the technology toolbox to improve solubility
- Providing case study examples to address solubility challenges:
- Spray drying/ nanosizing
- Lipid based formulations
- Hot melt extrusion
- Microprecipitated Bulk Powder (MBP)
Michael Ausborn
Global Head of Formulation Research
F. Hoffmann-La Roche
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15.30 Vaccine characterization, status quo and new opportunities
Vaccines have a long standing history of efficacy and safety. After water sanitization, vaccines are probably the most successful method to prevent deadly or highly devastating infectious disease. Unfortunately, several hurdles reduce vaccine efficacy on some populations or toward some disease. To overcome these limitations novel techniques to identify and improve Antigens are necessary. Novel molecules like Adjuvants, capable of eliciting vaccine efficacy, can be added to a vaccine formulation to more finely modulate and teach the immune system how to recognize the pathogen and prepare it for an efficient response.
This presentation will consider:
- Improved delivery systems necessary to target each vaccine to the most appropriate cell population and body compartment
- New challenges in formulation characterization and stability of components in more potent vaccines
- The current status of vaccine formulation characterization, with a focus on Alum based formulations, and some of our work to improve vaccine formulation characterization
Michele Pallaoro
Head, Vaccines and Diagnostics
Novartis
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16.10 Developing Patent Strategy for New Product or Technology
The presentation will focus on science and art of employing business, technical and legal resources of a company for managing research to meet the competitors in a market under more advantageous conditions. The presentation will discuss:
- Different traps to avoid such as: ‘Value Trap’, ‘Protection Trap’, ‘Patent at all Cost Trap’, ‘Uniform Treatment Trap’, and ‘Idea Misconception Trap’
- How to avoid these traps help to define the objectives of research better, making the strategy clearer and financially more viable
Mandar Shah
Sr Research Fellow, Topical Small Molecule Development
Johnson and Johnson
16.50 Chairperson’s Closing Remarks and End of Conference