Conference Documentation: Controlled Release (2010)
SMI Publishing, Ltd
April 28, 2010 SKU: SMI2771613
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The controlled release of a pharmaceutical active can be a vital tool in ensuring the safety and efficacy of a new or existing treatment. Developing new methods of controlled release is important to prolong the duration of action, can help to minimise adverse reactions and maximise efficacy as well as being an effective way of increasing a drug's lifespan.
SMi's 7th Controlled Release conference will provide you with the latest updates in this area, including controlled release development strategies, practical issues in developing controlled release therapeutics and information on the latest advances in delivery methods.
Key topics to be addressed at the conference include:
- The application of advanced science & technology to develop controlled release dosage forms
- Controlled Release - the role of intellectual property in maintaining and growing market share
- Controlled release in chronic diseases
- Overcoming the blood brain barrier
- Modified release multiparticulates
- Hot melt extrusion: How to enhance dissolution rate by solid dispersions
- Developing novel inhaled controlled release therapeutics
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- DAY 1
- 8.30 Registration and coffee
- 9.00 Chairman's opening remarks
- Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde.
- 9.10 The application of advanced science & technology to develop controlled release dosage forms
- Application of innovative technologies during product development
- Preparing for the future - change in pharmaceutical sciences
- Developmental, manufacturing and regulatory opportunities and challenges
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- Gurjit Bajwa, Principal Scientist, Pfizer.
- 9.50 Translational Pharmaceutics™ and Formulation Design Space - innovative strategies to enhance the development of modified release formulations
- Limitations of the conventional formulation development paradigm
- Translational Pharmaceutics™ - what does it mean and what are the benefits?
- Implementation of formulation design space concepts to allow galenic 'freedom to operate' within a flexible clinical protocol
- Case studies demonstrating real-time optimisation of formulation compositions based on human clinical data
- Formulation design space studies enable early establishment of in-vitro-in-in vivo-correlations (IVIVCs)
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- Peter Scholes, Vice President Pharmaceutical Sciences, Quotient Clinical.
- 10.30 Morning Coffee
- 11.00 Increasing exposure of drugs with extensive intestinal metabolism by modifying drug release in the gastrointestinal (GI) tract
- Pre-systemic metabolism in the gut wall of the GI tract
- Distribution of metabolic enzymes in gut wall of the GI tract
- Examples of drugs with extensive gut wall metabolism
- Examples of achieving higher bioavailability using modified release forms compared to immediate release forms
- Joseph Reo, Research Fellow, Merck Consumer Care, Merck Consumer Care.
- 11.40 Controlled Release - the role of intellectual property in maintaining and growing market share
- What can be protected by patents? - What other than small molecules?
- Supplementary Protection Certificates
- Benefits of "secondary" patents - keeping the generics honest
- The European Commission's view on pharmaceutical patents
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- Alan Johnson, Partner, Bristows.
- 12.20 Networking Lunch
- 1.20 Controlled release in chronic diseases
- Importance of controlled release
- Clinical trial considerations
- Recent trials (and tribulations)
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- Hong Guo, Vice President of Research, pSivida.
- 2.00 PK/PD modelisation, example of Medusa hGH-XL formulation
- Medusa presentation
- Application to hGH
- Modelisation of PK/PD properties
- PK/PD results
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- Roger Kravtzoff, Director of Clinical and Preclinical Development, Flamel Technologies.
- 2.40 Poorly soluble drug delivery strategy to the posterior segment of the eye
- Reasons for pharma's focus on the diseases of the eye
- Eye anatomy and the hurdles for drug delivery to the back of the eye
- Formulation strategies for poorly soluble drugs
- GSK's commitment to Patient in this therapeutic area
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- Thomas Keller, Director, Biophysical Sensors and Nanomaterials, GlaxoSmithKline.
- 3.20 Afternoon Tea
- 3.50 Design and clinical manufacture of controlled release biopharmaceuticals
- Types of controlled release formulations and release profiles
- Critical parameters in the process development of controlled release biopharmaceuticals
- Clinical results to date: Phase II clinical data of a controlled release formulation of interferon alfa
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- Gerben Moolhuizen, Chief Business Officer, OctoPlus.
- 4.30 In-vivo performance of oral controlled release formulations: the role of gamma scintigraphy
- Performance of oral controlled release formulations
- Non-invasive visualisation of drug formulations
- Clinical studies
- Scintigraphic data analysis
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- Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde.
- 5.10 Chairman's closing remarks and close of day one
- DAY 2
- 8.30 Re-registration and coffee
- 9.00 Chairman's opening remarks
- Howard Stevens, Emeritus Professor of Drug Delivery, University of Strathclyde.
- 9.10 Modified release multiparticulates
- Modified release concept and application
- Multiparticulates as modified release
- Extrusion spheronization technology
- Melt extrusion technology
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- Hassan Mohammad, Principal Scientist, Mundipharma International.
- 9.50 Engineering amphiphilic polymers increase bioavailability across biological barriers
- Biomaterials derived from amphiphilic polymers
- Engineering chitosan based nanoparticles as solubilises
- Enhancing oral and brain bioavailability of hydrophobic drugs
- Oral delivery of peptides to the brain
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- Andreas Schatzlein, Reader in Cancer Pharmacology, School of Pharmacy, University of London.
- 10.30 Morning Coffee
- 11.00 Engineering controlled-release formulations for peptides and proteins
- ImSus® Technology
- Fields of application
- Increasing efficiency without affecting toxicity
- Celal Albayrak, CEO and Founder, Alrise Biosystems GMBH.
- 11.40 Hot melt extrusion: How to enhance dissolution rate by solid dispersions
- What is new
- Merck's progress
- Next steps
- Mario Maio, Head of Formulation & Process Development , Merck Serono.
- 12.20 Nanoparticles for enhanced bio-efficacy and controlled release
- Pharmaceutically relevant nanoparticles within the nanotechnology landscape
- Nanoparticles for bio-efficacy enhancement
- Nanoparticles for controlled release
- Progress to date, future, benefits and disadvantages
- Jens Uhlemann, Head of Product Design & Nanotechnology, Bayer Technology Services.
- 1.00 Networking Lunch
- 2.00 Long-acting TMC278, a parenteral depot formulation delivering sustained NNRTI plasma concentrations in preclinical and clinical settings
- 2.40 Advanced biologic delivery systems
- Nasal spray formulations
- Absorption of Somatropin through the nasal mucosa
- Progress
- Routes to market
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- Andy Lewis, Director, Critical Pharmaceuticals.
- 3.20 Afternoon Tea
- 3.50 Recent advances in mucoadhesives
- Mucoadhesive interactions in solutions
- Developing mucoadhesive formulations
- Designing polymeric materials to mimic mucosal tissues
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- Vitaliy Khutoryanskiy, Lecturer in Pharmaceutics, University of Reading.
- 4.30 Dermal delivery of pharmaceutical actives with nanoparticles
- Targeting
- Micro-needles
- Transformosomes
- Products in development
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- Gregor Cevc, Chief Executive Officer, Pamet.
- 5.10 Chairman's closing remarks and close of conference
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