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Published by: SMI Publishing, Ltd
Published: Feb. 12, 2007
Table of Contents
- Day1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma.
- 9.10 INNOVATIONS IN FORMULATION
- Essential to pharmaceutical products
- Examining the explosion of research aimed at creating methods of formulation - fuelling new research
- Applications of new drug discovery technologies - yielding more new drug targets
- Enabling new therapeutics
- New formulations for biological targets - said to be worth $25 billion dollars
- New drug targets increase formulation complexity - excipients are becoming multi-functional
- Tomas Landh, Principal Scientist, Preformulation & Delivery, Novo Nordisk.
- 9.50 DRUG FORMULATION TECHNOLOGY
- Case Study
- Platforms of drug technology
- Improving solubility
- Capability to experiment with many formulations
- Effectively administering drugs
- Routes of delivery - pulmonary, oral or nasal?
- Scientific assessment of the maturity and novelty of the technology
- Dr David Cipolla, Senior Director, Pharmaceutical Sciences , ARADIGM.
- 10.30 Morning Coffee
- 11.00 EXPLORING SOLUBILITY LIMIT OF CNS DISCOVERY CANDIDATE
- Maximising solubility in discovery is essential for future market success
- A description of a high throughput and thermodynamic solubility measurement using the “dried-DMSO” method
- A summary of experimental solubility profiling results of marketed CNS drugs
- Application of local solubility predictive model for synthetic design
- A discussion of the need of good solubility to minimise potential tox side effects in vivo
- Dr Yun Alelyunas, Principal Scientist, AstraZeneca.
- 11.40 MODERN FORMULATION STRATEGIES
- Overcoming physicochemical and biological barriers of intestinal absorption
- Oral Bioavailability
- Solubility and Dissolution Enhancement
- Biopharmaceutical Classification System and Developability
- Booster compounds
- Interaction potential of excipients with biological barriers
- Dr Thomas Backensfeld, Global Pharmaceutical Development, Schering .
- 12.20 Networking Lunch
- 1.50 INFLUENCE OF MANUFACTURING PROCESS AND ENHANCED PACKAGING ON PARENTAL FORMULATIONS
- Focus on Heat Sensitive and Oxygen Sensitive Drug Formulations
- Impact of formulation on solution mixing processes - solubility and stability effects
- Filtration and sterilization effects on formulation
- Effect of formulation components on lyophilization process
- Enhanced packaging to stabilize drug formulations
- Enhanced packaging for ‘Ready to Use’ formulations
- Balancing formulation, process and packaging
- Dr Rao Chilamkurti, Senior Director, Pharmaceutical Technology, BioPharma Solutions , Baxter Healthcare .
- 2.30 UNDERSTANDING DRUG PRODUCTS TO NEARLY THE SAME DETAIL AS THE DRUG SUBSTANCE
- Using analytical tools to study:
- Polymorphism and amorphous content
- Polymer based formulations
- Mechanism of delivery
- Dr David England, Physical Chemistry, Research & Development Projects manager , Sanofi-Aventis.
- 3.10 Afternoon Tea
- 3.40 TARGETED BLOCK COPOLYMER DRUG FORMULATIONS FOR ONCOLOGY
- Preclinical and Clinical Experience
- Block copolymer based Biotransport nano-technology provides formulations for a broad range of oncology drugs
- Biotransport carries have been shown to considerably increase efficiency of cytotoxic drugs against drug resistant settings
- Biotransport carriers enable oral administration of taxanes and camptothecins
- Biotransport technology provides a set of robust tools for formulation optimization
- The leasd Biotransport based product SP1049C is entering a pivotal phase III clinical trial in upper GI cancer indication
- Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma.
- 4.20 MELTREX BRINGS BENEFITS TO HIV THERAPY
- Case Study
- BCS class IV compounds and poor solubility
- Solid solutions
- Nanodispersions
- Life Cycle Management
- Dr Joerg Breitenbach, Director and Head, SOLIQS, Abbott.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Re-Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Professor Ian Wilson, Senior Principal Scientist, AstraZeneca.
- 9.10 REGULATORY VIEWS
- Pharmaceutical Development and Process Analytical Technology
- Background
- Quality by Design
- Design Space
- Real Time Release
- Industrial and Regulatory Impact and Potential
- Gert Ragnarsson, Scientific Director, Medical Products Agency.
- 9.50 IMMUNOLOGICAL ADJUVANTS
- Stimulating the immune response to vaccine antigens
- The design and development of adjuvants
- Classification and mechanism of action
- Key regulatory considerations
- Industrial aspects
- Examples of synthetic adjuvants currently in clinical trials
- Dr Jean Haensler, Director, Formulation Research, Sanofi-Pasteur.
- 10.30 Morning Coffee
- 11.00 FORMULATION DEVELOPMENT
- Poorly soluble drugs in discovery settings
- Strategies for preformulation and formulation assessment of poorly water soluble drugs at the early stages of drug discovery
- Design of in vivo experiments to assess development issues
- Correlation of physicochemical properties to exposure
- Developability concept and compound selection
- Janet Maas, , Novartis.
- Dr Dimitris Papoutsakis, Functional Project Leader, Novartis Institutes for BioMedical Research.
- 11.40 RECONSTITUTION AND DELIVERY OF HIGH DOSE FORMULATIONS
- Optimising mixing regimens
- Managing pastes
- Managing quick setting formulations
- Kevin Maynard, Director, Imprint Pharmaceuticals Ltd.
- Bernd Riebesehl, Reasearch Advisor, Eli Lilly.
- 12.20 Networking Lunch
- 1.50 DRUG METABOLISM AND DISPOSITION
- The current challenges
- Identifying drug metabolites
- New technologies for drug metabolism studies
- Metabolites in safety testing - MIST
- Reactive metabolites
- Predicting and controlling metabolism
- Professor Ian Wilson, Senior Principal Scientist, AstraZeneca.
- 2.30 THIOMERS
- A novel generation of polymeric excipients?
- Mucoadhesive properties
- Permeation enhancing properties
- In situ gelling properties
- Efflux pump inhibition
- Thiomer micro- and nanoparticulate drug delivery systems
- Professor Dr Andreas Bernkop-Schnurch, CSO, ThioMatrix .
- 3.10 Afternoon Tea
- 3.40 ORAL BIOAVAILABILITY ENHANCEMENT FOR FIM AND EARLY CLINICAL DEVELOPMENT
- How to identify the best formulation strategy for poorly absorbable molecules
- Hurdles and constraints of oral route
- Are DDS really necessary?
- All the arches in your bow
- Case studies
- Life cycle management in clinical development
- Dr Mario Maio, Formulation Development Manager, Serono.
- 4.20 Chairman’s Closing Remarks and Close of Day Two
AbstractThe drug formulation industry has seen a 38 per cent growth in the past five years and is expected to continue to expand as drug companies begin to seek advanced methods of delivering drugs effectively, as well as different ways of marketing both new and old compounds by devising new formulations.
SMi’s 2nd annual ‘Optimising Drug Formulation’ conference seeks to provide attendees with the latest advances key formulation practices, technologies and methodologies. Listen as influential industry experts discuss the regulatory challenges that await new products in development, concepts and rationale of novel and new drug formulations.
An opportunity to meet experts in the field to discuss how formulations can be optimised and carried forward to achieve the ultimate aim of getting effective drugs on the market faster.
This is a great opportunity to meet and network with the key players within the market!
Speakers Include:
- Dr Mak Jawadekar, Director, AMP, WPM, Pfizer
- Dr David England, Physical Chemistry, Research & Development Projects Manager, Sanofi-Aventis
- Dr Dimitris Papoutsakis, Functional Project Leader, Novartis
- Dr Thomas Backensfeld, Head of Analytical Development 1, Schering
- Dr. Joerg Breitenbach, Director and Head, S O L I Q S, Abbott
- Tomas Landh, Principal Scientist, Preformulation & Delivery, Novo Nordisk
- Dr Jean Haensler, Director, Formulation Research, Sanofi-Pasteur
- Mario Maio, Formulation Development Manager, Serono
- Dr David Cipolla, Director, Pharmaceutical Sciences, ARADIGM
- Dr Andreas Bernkop-Schnurch, CSO, Thiomatrix GmbH
- Valery Alakhov, Vice-President R&D and CSO, Supratek Pharma
- Dr Rao Chilamkurti, Senior Director, Pharmaceutical Technology, BioPharma Solutions, Baxter Healthcare
- Prof. Ian Wilson, Senior Principal Scientist, AstraZeneca
- Dr Yun Alelyunas, Principal Scientist, AstraZeneca
Benefits of attending Optimising Drug Formulation:
- REGULATORY ISSUES: Listen as industry experts debate the key ethical and regulatory issues facing developers of novel drug products. Are they just a burden to the industry?
- DRUG FORMULATION TECHNOLOGY: Discover through a case study presentation how to effectively administer drugs and the best route of delivery - pulmonary, oral or nasal?
- INNOVATIONS IN FORMULATION: Examine the explosion of research aimed at creating methods of formulation to fuel new research
- ADJUVANTS: Discover how to ensure the successful design and development of adjuvants through examples of synthetic adjuvants currently used in clinical trials
- CASE STUDIES: Hear case study examples from leading experts on the formulation development of poorly soluble drugs in discovery settings, development of spray dried powders and immunulogical stimulants for treatment of cancer
- EXCLUSIVE INFORMAL NETWORKING: Collaborate with industry peers in an environment promoting information exchange
Get Full Details About This Report >>
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