Key Speakers
• Dr. Sven Stegemann, Director, Pfizer
• Dr. Norbert Rasenack, Fellow Inhalation Development, Novartis
• Dr. Jan Möschwitzer, Head Early Pharmaceutical Development, Solvay
• Dr. Oliver Steinbach, Department Head, Philips Research Laboratories
• Dr. Joel Richard, Senior Director, Head of Drug Product Development, Ipsen
• Dr. Duncan F Rogers, Reader, National Heart & Lung Institute, Imperial College London
• Dr. Dejan Djuric, R&D Project Management Excipients, BASF
• Dr. Cheryl Barton, Managing Director, Pharmavision
• Gerry Kamstra, Partner, IP & Life Sciences, Bird and Bird
• Prof. Marc Brown, CSO, MedPharm
• Craig Thomson, Director European Patent Attorney, Murgitroyd & Company
• Dr. Giuseppe Battaglia, Senior Lecturer in Bionanotechnology, University of Sheffield
• Dr. Piet Christiaens, Scientific Director, Toxikon Europe
• Dr Pierandrea Esposito, Associate Director, SiTec PharmaBio

Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years.

Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning.

The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.

By attending this conference, you will hear from leaders with expertise in this area their experience and new concepts. It is not to be missed!

Why Attend?

Key benefits:
• Examine the limitations of leading drug delivery technologies
• Discuss the changing patent landscape for drug delivery
• Understand the latest formulation and regulatory standards
• Gain advice on how do effectively develop and maintain drug delivery deal making in this financial climate
• Assess the future of innovations in the drug formulations technologies in the drug industry
• Network with key industry players from pharma, biotech, device and drug delivery industries

Who should attend?

VPs, Directors, Heads, Managers of:
• Drug Delivery
• Preformulation /Formulation/Stability
• Business Development
• Licensing
• Technology Assessment
• Commercial Development
• Patents
• Lifecycle Management
• Strategic Planning and Development
• Financial Analyst
• Pharmaceutical and Analytical R&D
• Pharmaceutical Science
• Testing
• Product Development
• New Product Planning
• New Technology Evaluation
• Marketing
• Brand Management
• Product Management
• Sales
• Regulatory Affairs

Others:
• Intellectual Property Attorneys
• Venture Capitalists
• Medical Device Companies
• Analysts/Investment Banks
• CROs
• Contract Sales Organisations
• Universities and Government Research
• Testing and manufacturing equipment companies
• Packaging companies

Day 1
Day One, Wednesday 10th February 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Analysing key trends in the field of drug delivery
• Impact of emerging drug delivery technologies on the pharmaceutical industry
• Evaluating the latest market developments


10:50 Innovations in trans (dermal) drug delivery
• Issues of drug delivery to the skin
• Past successes and failures (trans) dermal drug delivery
• Innovations in active and passive methods of (trans) dermal drug delivery
• Gene delivery; the final frontier

Dr Marc Brown
Chief Technology Officer
MedPharm

11:30 Morning refreshments

11:50 Drug delivery systems for oncology products
• Cancer market context and expectations
• Key challenges for delivery of oncology products
• Oral chemotherapy: opportunities, challenges and delivery solutions
- Drug permeation and bioavailability enhancement
- Delivery strategies based on nanosystems and lipid-based formulations
• I.v. oncology products: challenges and delivery solutions
- Drug solubilisation
- Modification of biodistribution and toxycology profile of drugs
- Delivery strategies based on nanosystems for small molecules and oligonucleotides
• Subcutaneous oncology products: challenges and delivery solutions
- Sustained-release formulations of peptides
- Perspectives for new s.c. formulations of proteins and mAbs

Dr. Joel Richard
Senior Director, Head of Drug Product Development
Ipsen

12:30 Particle engineering as contributor to a successful pharmaceutical drug product development - challenges, opportunities, trends
• Poorly soluble
• Inhalation delivery systems
• Technologies: opportunities and drawbacks

Dr. Norbert Rasenack
Fellow Inhalation Development
Novartis

13:10 Networking lunch

14:30 Stem cell-based therapeutic delivery: challenges & opportunities
• Ethical debates and funding, immune rejection, cancerous potential and issues surrounding the manufacture of stable, pure cell therapeutics
• Delivery of stem cells for CNS disorders
• Autologous products, derived from a patient’s own tissue, will be the first to reach the market

Dr Cheryl L Barton
Managing Director
Pharmavision

Dr Sara Sleigh
Senior Associate
Pharmavision

15:10 Gatecrashing the cell
• Why it is important to deliver within cells’ cytosol
• Biomimetic strategies for cytosolic delivery
• Delivery of DNA, siRNA, ODN, mRNA and their therapeutic implications
• Delivery of contrast agent and how cytosolic delivery can revolutionise diagnostics
• New therapeutic approaches based on cytosolic delivery

Dr Giuseppe Battaglia
Senior Lecturer in Bionanotechnology
University of Sheffield

15:50 Afternoon refreshments

16:10 Challenges and opportunities in the delivery of small molecules and of biotherapeutics
• Drug delivery role in new drugs development and in lifecycle management
• Trends and changes in delivery of therapeutic biomolecules
• Current issues in small molecules delivery
• New formulation technologies or molecular engineeering?

Dr. Pierandrea Esposito
Associate Director
SiTec PharmaBio

16:50 Future therapeutic targets for respiratory disease
• Incidence and economic burden of asthma and chronic obstructive pulmonary disease (COPD)
• Overview of pathophysiology of asthma and COPD
• Overview of strategies for target identification and novel drug development
• Options for improving existing pharmacotherapy
• Hypothesis-driven novel targets
• Natural products, ‘phytoceuticals’ and non-synthetics
• Assessment of clinical trial progression of new drugs


Dr. Duncan F Rogers
Reader, National Heart & Lung Institute
Imperial College London

17:30 Closing remarks from the chair

17:40 Networking Drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2
Day Two, Thursday 11th February 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Design drug delivery for individual patient populations
• Changing patient population and its relevance for therapy
• Individualisation of drug delivery in development and manufacturing
• Drug delivery for effective medication management
• Drug delivery aligning technology with patient needs

Dr. Sven Stegemann
Director
Pfizer

10:50 Image-guided ultrasound- triggered drug delivery
• Use of drug loaded, temperature (liposomes) and pressure sensitive (microbubbles) systems for ultrasound triggered drug delivery
• Tracking, monitoring and quantifying drug release with ultrasound or MRI through the incorporation of imaging lables in drug carriers
• Formulations and applications for different drug formats: small molecules, biologics, nucleic-acid based therapeutics
• Examples from different disease arease.g. oncology, cardiology, metabolic diseases

Dr. Oliver Steinbach
Department Head
Philips Research Laboratories

11:30 Morning refreshments

11:50 Drug nanocrystals prepared by using different particle size reduction methods
• Overview of particles size reduction technologies used in academia and industry, bottom-up, top-down and combinative processes
• When can API nanonisation helps to improve the bioavailability of poorly soluble compounds
• Aspects to be considered during development: stabilisation, analysis and solidification
• The use of nanonised API at different stages of development
• Case study

Dr. Jan Möschwitzer
Head Early Pharmaceutical Development,
Solvay

12:30 Regulatory Requirements for Biocompatibility Testing of Drug Delivery Devices
• Classification of a Drug Delivery Device: Is the product a Drug or a Device?
• General Considerations regarding Biocompatibility testing
• Typical Biocompatibility Tests to be considered
• Testing/Documentation requirements for the submission of a Medical Device
• Testing/Documentation requirements for the submission of a Medicinal Product/Pharmaceutical Container

Dr. Piet Christiaens
Scientific Director
Toxikon Europe

12:50 Networking lunch

14:10 Drug synthesis and delivery IP due diligence
• Importance of IP protecting manufacturing process and drug delivery technology in late stage investments
• Typical issues around manufacturing process patents
• Typical issues around drug delivery patents
• Subsistence of Supplementary Protection Certificates
• Regulatory Data Protection and Orphan Drug
• Protection in late stage investments

Gerry Kamstra
Partner, IP & Life Sciences
Bird and Bird

14:50 Ensuring collaborations enhance rather than stifle exploitation of new technology
• Problems associated with not addressing ownership of IP early in collaboration
• How the law can help to avoid these problems
• Is there any reason to share IP?
• Examination of collaboration case studies

Craig Thomson
Director European Patent Attorney
Murgitroyd & Company

15:30 Afternoon refreshments

15:50 Polymeric Solubilizer for Hot Melt Extrusion
• Characterization of a bifunctional polymer which is capable of solubilization and of forming solid solutions with poorly soluble drugs
• Manufacturing of solid solutions
• Applications for polymeric solubilizers
• Solubility and Bioavailability enhancement

Dr. Dejan Djuric
R&D Project Management Excipients
BASF

16:30 Presentation to be announced

17:10 Chair’s closing remarks

17:20 End of Conference