Monday, July 26, 2010

Conference on 6th Annual Drug Delivery Systems

Moving towards effective drug delivery technologies and deal making

1st - 2nd February 2011, BSG Conference Centre, London, UK

Key Speakers:

Dr. Sven Stegemann, Director, Pfizer
Dr. Sophie Van Tomme, Pharmaceutical Scientist, Abbott
Gerrit Hauck, Head PSD R&D Operations, Sanofi -Aventis
Matthew Roe, Senior Director-Business Development and Licensing, Genzyme
Dr. Oliver Steinbach, Department Head, Philips Research Laboratories
Dr. Rajan K. Verma, Senior Manager Early Development Formulations – Generics Integrated Product Development (IPDO), Dr Reddy’s Laboratories
Dr. Deirdre McIntosh, Director, McIntosh Scientific Advice Services
Dr. Michel Deleers, CEO, OncoBel
Dr. Andrew Lewis, Operations Director, Critical Pharmaceuticals
Dr. Ben Forbes, Senior Lecturer in Pharmaceutics, King’s College, London
Ketan Pancholi, Lecturer, The Robert Gordon University
Gerry Kamstra Partner, IP & Life Sciences, Bird and Bird

Conference Introduction

Shrinking global capital markets, new healthcare policies, ageing populations, the growth of emerging economies, technological advances and the advent of regenerative and biological medicines are just some of the factors expected to shape the future drug delivery device market. (Source: Cambridge Consultants UK, September 2009)

With increased competition and the growing importance of patience compliance, pharmaceutical companies are working towards developing effective and targeted drug
delivery systems, to transform disease treatments. Now in its 6th year, Drug Delivery Systems Conference showcases the basics and latest developments for inhaled drug, RNAi based therapies and protein and peptide methods. We have put together an unparalleled scientific programme comprising insightful presentations by leading experts from Pfizer, Philips Research, Dr Reddy’s Laboratories and Genzyme. This conference will feature keynote addresses, case studies and interactive discussions
ranging from current and evolving drug delivery technologies to advancement and manufacturing of more efficient formulations.

Attendance at this conference will enable you to:

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Benefit from thorough updates of recent developments in the drug delivery sector
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Examine challenges in generic development of drug delivery systems
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Learn from in-depth case study from Philips about image-guided ultrasound-mediated drug delivery
*
Identify different strategies in managing a drug delivery alliance
*
Know how to overcome the industry challenges for inhaled delivery systems
*
Discuss key regulatory and legal issues
*
Recognise the importance of new biologic delivery technologies
*
Discuss microbubble production technologies and its effect on delivery
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Create patient centered drug delivery product
*
Network with experts and opinion leaders from pharma, biotech, device and drug delivery industries

Who should attend?

VPs, Directors, Heads, Managers of:

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Drug Delivery
*
Preformulation /Formulation/Stability
*
Business Development
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Licensing
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Technology Assessment
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Commercial Development
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Patents
*
Lifecycle Management
*
Strategic Planning and Development
*
Financial Analyst
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Pharmaceutical and Analytical R&D
*
Pharmaceutical Science
*
Testing
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Product Development
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New Product Planning]
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New Technology Evaluation
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Marketing
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Brand Management
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Product Management
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Sales
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Regulatory Affairs

Others:

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Intellectual Property Attorneys
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Venture Capitalists
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Medical Device Companies
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Analysts/Investment Banks

CROs:

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Contract Sales Organisations
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Universities and Government Research
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Testing and Manufacturing Equipment
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Packaging Companies

Day 1
6th Annual Drug Delivery Systems
Tuesday 1st February 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Imagine a patient would run a formulation lab: Patient centered drug delivery product development

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From clinical perspectives to therapeutic objectives
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Identifying patient needs beyond the clinical symptoms
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Translating scientific excellence in real world therapy enhancement
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Integrating patient centered drug delivery in healthcare provision

Dr Sven Stegemann
Director, Pfizer

10:20 Realising partnerships with academia, SME’s and Big E in the field of inhalation.

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The NeoFor project (New formulation and Devices for the inhalation of Macromolecules)
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Anticancer drug project for lung cancer (Solid lipidic micro particles formulations)
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Formulations for 2 and 3 molecules
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Formulations with pegylated mAb’s
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Other projects in partnering

Dr. Michel Deleers
CEO, OncoBel. Former VP New Pharma Technologies & Academic Liaison, UCB New Medicines

11:00 Morning refreshments

11:20 Inhalation delivery systems: the challenges and opportunities

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Retention in the lung
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Absorption from the lung
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Safety and efficacy
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Industry challenges & open innovation

Dr. Ben Forbes
Senior Lecturer in Pharmaceutics, King’s College, London

12:00 Sponsor Spotlight Session

Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

12:40 Networking lunch

13:40 Virtual training course for development of nanoparticulate dosage forms From API to final nanoparticulate drug products

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Pros and cons of various particle size reduction technologies
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Practical development tools (Stabilizer screening, Particle size measurements, Solid state analysis, Final dosage form manufacturing, Dissolution aspects, Stability studies)
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Biopharmaceutical aspects

Dr. Sophie Van Tomme
Pharmaceutical Scientist, Abbott

14:20 Targeted drug delivery using microbubble - An overview

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Possible approaches of delivering drug using microbubble
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Microbubble production technologies and its effect on delivery
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Drug delivery mechanism
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Advantages and challenges
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Summary

Ketan Pancholi
Lecturer, The Robert Gordon University

15:00 Afternoon Refreshments

15:20 IMAG(IN)E global-release local - IMAGE guided ultra sound-triggered drug delivery for RNAi-based therapy

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Medical imaging technologies are becoming an integral part of therapeutic interventions. The development of ultrasound techniques that could non-invasively trigger the delivery of new drug formats such as RNAi therapeutics at a targeted location opens up exciting possibilities for advancing personalized medicine. A key success factor for the effective translation of new drug delivery concepts into clinical practice are partnerships with leading academic, medical institutions and industrial partners.
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Philips’ image-guided ultrasound-mediated drug delivery platform offers researchers a unique approach to investigating the delivery of various therapeutic molecules and capitalizes upon Philips’ existing expertise in medical imaging technologies for diagnosis, therapy planning and minimally-invasive medical procedures. We show advances in temperature sensitive liposomes with incorporated drugs and MRI-imaging labels as well as pressure-sensitive microbubbles with specific ultrasound-imaging and drug release characteristics for the local delivery of nucleic-acid based therapeutics including siRNA.

Dr. Oliver Steinbach
Department Head, Philips Research Laboratories

16:00 Ocular Drug Delivery Systems

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Challenges and advantages of conventional dosage forms
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Analysing recent trends in ocular inserts
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Closing remarks from the chair

16:50 Networking drinks

Day 2
6th Annual Drug Delivery Systems
Wednesday 2nd February 2011

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Targeted drug delivery strategies in cancer therapy: The evolution of early concepts

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Naive concepts in early targeting
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Toxins as chemotherapeutic agents,
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Liposomes as Toxin Vectors
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Physiological barriers to success
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The emergence of holistic strategies.

Dr. Deirdre McIntosh
Director, McIntosh Scientific Advice Services

10:20 Protein and peptide drug delivery strategies for product lifecycle management

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Why is new biologic delivery technologies needed?
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Innovative technologies to deliver therapeutic macromolecules:
- CriticalMix – injectable sustained release of macromolecules
- CriticalSorb – systemic delivery of macromolecules via the intranasal route

Dr. Andrew Lewis
Operations Director, Critical Pharmaceuticals

11:00 Morning refreshments

11:20 Drug synthesis and delivery IP due diligence

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Importance of IP protecting manufacturing process and drug delivery technology in late stage investments
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Typical issues around manufacturing process patents
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Typical issues around drug delivery patents
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Subsistence of Supplementary Protection Certificates
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Regulatory data protection and orphan drug
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Protection in late stage investments

Gerry Kamstra
Partner, IP & Life Sciences, Bird and Bird

12:00 Parenteral sustained release drug delivery systems - Status and perspective

Gerrit Hauck
Head PSD R&D Operations, Sanofi-Aventis

12:40 Networking lunch

13:40 Innovations in generic development of drug delivery systems

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Drug delivery systems
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Challenges in generic development of drug delivery systems
- Regulatory
- IP
- Bio requirements
- Technological
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Case studies

Dr. Rajan K. Verma
Senior Manager Early Development Formulations – Generics Integrated Product Development (IPDO)

Dr Reddy’s Laboratories]

14:20 Different strategies in managing a drug delivery alliance

Matthew Roe
Senior Director-Business Development and Licensing, Genzyme

15:00 Afternoon refreshments

15:20 Sponsor Spotlight Session

Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

16:00 Drug delivery in diabetes

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Examining various techniques
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Discussing emerging insulin delivery methods
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Understanding pricing and reimbursement

16:40 Chair’s closing remarks

16:50 End of Conference


For more information visit
http://www.bharatbook.com/detail.asp?id=111630&rt=Conference-on-6th-Annual-Drug-Delivery-Systems.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Sunday, July 25, 2010

Conference on Amorphous Pharmaceutical Materials

Amorphous Pharmaceutical Materials
Assessing emerging applications, methodologies, techniques and challenges.
24th - 25th January 2011, BSG Conference Centre, London, UK

Key Speakers:

Ljiljana Harding, Inhalation & Devices Centre of Emphasis, Pfizer,
Franco Sartor, Principal scientist , GlaxoSmithKline,
Sigrid Stokbroekx, Research Fellow, Johnson & Johnson Pharmaceutical R&D,
Dr. Rolf Hilfiker, Vice President Head of Department Solid-State Development, Solvias,
Roger Parker, Senior Scientist, Food Structure and Health Programme, Institute of Food Research,
Dr. Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London
Mark Saunders, Owner, co-founder and Development Director, Kuecept,
Robert Whittock, IP/IT Practice Group, Freshfields Bruckhaus Deringer LLP,
Wouter Pors, Attorney, Bird & Bird,
Michael Gamlen, Managing Director, Pharmaceutical Development Services,
Prof. Graham Buckton, Chief Executive Officer, Pharmaterials,
Dr. Andreas Kordikowski, R&D Director, Activery Biotech,
Dr. Filipe Gaspar, Head of Particle Design, Hovione
Bertrand Gellie, Director of Organic Chemistry, European Patent Office.

Conference Introduction,
Amorphous Pharmaceutical Materials,
24th - 25th January 2011, London, UK.

With the continuous increase in the number of insoluble developmental drug molecules and growing regulatory scrutiny over pharmaceutical solids, the use of amorphous solids is steadily rising in the pharmaceutical companies. This conference combines presentations on the approaches to amorphous detection and quantitation within GSK, and clinical advice and practical tips from Pfizer and Johnson & Johnson. The biopharmaceutical implications for development of amorphous solid solution intermediates will be discussed and strategies to protect and commercialise innovations in amorphous materials will be presented.During the two days you will be exposed to several analytical strategies to protect and commercialise innovations in amorphous materials. Amorphous Pharmaceutical conference will provide an enlightening and thought-provoking forum with a series of case studies ranging from amorphous formulation to novel amorphous microparticle technology.

Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals.
• Implement the latest technological developments.
• Discuss the best approaches to control and stabilise amorphous drug forms.
• Examine the quantifi cation of amorphous content.
• Gain a clearer insight on amorphous food materials.
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies.

Who should attend?

VPs, Directors, Heads and Managers of:
• Stability / Stability testing
• Pre-formulation
• Solid State Chemistry
• Formulation
• Crystallisation • Drug Discovery
• Drug Delivery
• Analytical methods / development
• API Development • Validation
• Pharmacokinetics • Quality Control
• R&D
• Product Submission
• Research and Development • Materials Science
• Technical Operations
• Statistical Sciences
• Manufacturing Science
• Regulatory affairs
• Particle Engineering
• Product Design
• Business Development

Day 1
Amorphous Pharmaceutical Materials,
Monday 24th January 2011, London, UK

09:30 Registration and refreshments,

10:00 Opening address from the chair

10:10 Amorphous content: Quantification in drug substance and drug product.
• Ways to trace amorphous content in crystalline solids.
• Ways to trace amorphous content in formulated products.
• Micronisation and amorphisation.
• Impact on drug substance properties.

Dr Rolf Hilfiker,
Vice President, Head of Department Solid-State Development, Solvias.

10:50 Biopharmaceutical implications for development of amorphous solid solution intermediates.
• Why amorphous solid dispersions / solutions.
• Current in vitro testing strategies.
• Physiology of the gastrointestinal tract and its relevance to oral delivery of poorly soluble compounds.
• Case Study: novel amorphous microparticle technology for targeted drug delivery.

Mark Saunders,
Owner, co-founder and Development Director, Kuecept.

11:30 Morning refreshments

11:50 Approach to amorphous detection and quantitation within GSK,
• Internal strategy, methods and techniques.
• Case study A: detection and quantitation of amorphous for micronised material.
• Case study B: dealing with amorphous formation in a Liquid Deposited Formulation.

Franco Sartor,
Principal scientist, GlaxoSmithKline,

12:30 Amorphous food materials – Some lessons from food research,
• Hot melt extruded flavour encapsulation systems, a vitrified emulsion.
• Small molecules: solvent, plasticiser, both or neither?
• Protein stability in the glass state: physical, chemical and biological.
• Brian Arthur’s “The Nature of Technology”: so what’s new?

Roger Parker,
Senior Scientist, Food Structure and Health Programme, BBSRC Institute of Food Research.

14:30 Stable amorphous dispersions – science, formulation and manufacturing method,
• Methods of manufacture and the importance for stability.
• Relaxation of bulk and surface.
• Intentional and accidental amorphous materials.
• Use of NIR, IGC, and thermal methods.
• The value of Raman mapping.

Prof. Graham Buckton,
Chief Executive Officer, Pharmaterials

15:10 Amorphisation as Tool for Product Life Cycle Management,
• Phases and critical steps in LCM.
• Solid form roles in LCM.
• Activery the amorphisation company.
• Current and future products.
• Amorphous combinations, single drug products and nanoparticles.

Dr. Andreas Kordikowski.
R&D Director, Activery Biotech.

15:30 Afternoon refreshments.

15:50 Patents - amorphous materials & formulations.
• Satisfying patentability requirements.
• Practical advice to drafting strong claims.
• Assessing infringement.
• Reviewing recent case law examples.

Robert Whittock,
IP/IT, Practice Group, Freshfields Bruckhaus Deringer.

16:30 Strategies to protect and commercialise innovations in amorphous materials.
• How to draft for existing active ingredients.
• Create a return on investments and maintain market position.
• Effective enforcement.

Wouter Pors,
Attorney at law, Bird & Bird,

17:10 Closing remarks from the chair.

17:20 Networking drinks.

Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Amorphous Pharmaceutical Materials
Tuesday 25th January 2011, London, UK

09:30 Registration and refreshments.

10:00 Opening address from the chair.

10:10 Partially amorphous materials: In-situ monitoring of the recrystallisation process at the nanoscale using heated tip AFM.
• Process-induced disorder and its importance in pharmaceutical industry
• The use of Atomic Force Microscopy (AFM) and related techniques for detection and characterisation of process-induced changes in pharmaceutical materials, incl. several examples from the literature.
• Novel Nano-thermal analysis approach to characterisation of partially amorphous materials at the nanoscale, incl. examples of in-situ monitoring of the recrystallisation process.

Ljiljana Harding
Inhalation & Devices Centre of Emphasis, Pfizer.

10:50 Automated solid dispersion screening: A useful tool to design amorphous systems.
• The approach to automate and miniaturize the search for precipitation inhibitors.
• Preparation of amorphous films.
• Evaluation of amorphous systems.

Sigrid Stokbroekx,
Research Fellow, Johnson & Johnson Pharmaceutical R&D.

11:30 Morning refreshments.

11:50 Stability assessment of amorphous pharmaceuticals with calorimetry.
• Instrument considerations and experimental design.
- Scanning calorimetry and isothermal calorimetry.
• Determination of relaxation rates.
• Examples of applications.
- Measurement of glass transitions with DSC.
- Stability of glassy pharmaceuticals.
- Oral fast-dissolving films.

Dr Simon Gaisford,
Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London.

12:30 Patenting amorphous forms - EPO views.
• What distinguishes amorphous forms from other patentable products?
• How to claim amorphous forms properly?
• How to disclose amorphous forms and support this disclosure properly?
• Case law of interest.

Bertrand Gellie,
Director of Organic Chemistry, European Patent Office.

13:10 Networking lunch.

14:30 Formulating materials to retain amorphous character –ensuring you get what you pay for,
• Amorphous materials are highly active in their nature and need careful processing to ensure they retain their amorphous character.
• Many amorphous materials also have low bulk density and present handling problems.
• Formulation development to ensure the products retain their amorphous character, otherwise the desirable properties will be lost.
• Enabling the small scale manufacture of products containing amorphous materials for use in preclinical and Phase 1 testing while retaining their amorphous character and overcoming bulk density problems.
• Reviewing the possible impact of common pharmaceutical processes on amorphous character.

Michael Gamlen,
Managing Director, Pharmaceutical Development Services.

15:10 Developing solid dispersions by spray drying.
• The role of solid dispersions.
• Methods to produce solids dispersions.
• O Spray drying of solid dispersions.

Dr. Filipe Gaspar
Head of Particle Design, Hovione.

15:40 Afternoon refreshments.
16:10 Process analytical techniques during amorphisation by hot melt extrusion.
• Hot melt extrusion: generation of amorphous and co-crystal forms.
• Process Analytical Technique (PAT) in melt extrusion: Online rheology and NIR measurement.

Prof. Anant Paradkar PhD.
Professor of Pharmaceutical Engineering, Interdisciplinary Chair in Pharmaceutical Engineering Science, University of Bradford.

16:50 Chair’s closing remarks.

17:00 End of Conference.

For more information visit
http://www.bharatbook.com/detail.asp?id=132812&rt=Conference-on-Amorphous-Pharmaceutical-Materials.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on 4th Annual Contract Manufacturing

Conference on 4th Annual Contract Manufacturing
Driving contract manufacturing through cost-effective outsourcing
13th – 14th December 2010, BSG Conference Centre, London, UK

Key Speakers

Martin P Grosvenor, Drug Delivery Manager, AstraZeneca,
Anthony Pettigrew, Analytical Development Manager, Novozymes,
Olivia Darmuzey, QbD Expert Pharmaceutical Operations, Novartis,
Mitch Rogers, Business Development Manager, Centre for Emergency Preparedness and Response, Health Protection Agency,
Prof. Elaine Martin OBE, Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing, Technology Centre, Newcastle University,
Paul Smith, Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences,
Karen MacGregor, Product Development Director, Catalent,

The global demand for contract manufacturing services and affordable outsourcing solutions is increasingly driving the pharmaceutical companies to upgrade their technology and manufacturing capacity. In recent times, investments in implementation of PAT and QbD applications, to ensure high quality and timely supply, have become the prime focus of pharmaceutical and biotech industry. As the competition from off-patent products, in-licensing and mergers and acquisitions grows, Asia is expected to become one of the largest cost-effective outsourcing markets in the next five years.

4th Annual Contract Manufacturing will provide tactical approaches and case studies to improve PAT and QbD practices for a successful contract manufacturing model. Delegates will learn regulatory and planning processes, best manufacturing practices, and strategies to maximise partnership with CMOs.

Our conference is a valuable opportunity to discuss, gain insights and network with thought leaders and key professionals from the industry.

Key themes and discussions include:

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Deliver successful external manufacturing supply chain and planning
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Learn trends, challenges and opportunities for manufacturing in Asia
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Maximise opportunities as a consequence of FDA, PAT and QbD initiatives
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Evaluate outsourcing needs your business:
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Implement strategies for successful analytical technology transfer
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Analyse critical issues affecting technology transfer & scale-up to QC
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Understand QbD principles and continuous improvement in manufacturing
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Capitalise on the benefits of applying QbD approach in biologics contract manufacturing
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Formulate strategies to choose a right CMO partner
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Integrate lean product development in a pharma CMO set-up
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Understand the legal challenges and pitfalls for contract negotiation

Conference Introduction

Learn, discuss and gain insights on:

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Deliver successful external manufacturing supply chain and planning.
*
Learn trends, challenges and opportunities for manufacturing in Asia.
*
Maximise opportunities as a consequence of FDA, PAT and QbD initiatives.
*
Evaluate outsourcing needs your business.
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Implement strategies for successful analytical technology transfer.
*
Analyse critical issues affecting technology transfer & scale-up to QC.
*
Understand QbD principles and continuous improvement in manufacturing.
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Capitalise on the benefi ts of applying QbD approach in biologics contract manufacturing.
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Formulate strategies to choose a right CMO partner.
*
Integrate lean product development in a pharma CMO set-up.
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Understand the legal challenges and pitfalls for contract negotiation.

Who will be there?

Directors, Heads of Department, Team Leaders and Scientists of:

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Research and Development.
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PAT.
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QbD.
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CMC.
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Process Development & Optimisation.
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Process Science/ Analytics.
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Manufacturing.
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Contracts & Outsourcing.
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Formulation.
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Quality Assurance/Quality Control.
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Operations.
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Strategic Alliances.
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Compliance.
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Regulatory Affairs.
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Legal/ Patents.

Pharmaceutical and Biotechnological Companies,
Contract Manufacturing Organisations (CMOs),
Drug Regulators, Intellectual Property/Law Firms,
Academia, Government Bodies, Regulatory Affairs.

Day 1
4th Annual Contract Manufacturing
Monday 13th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Applying QbD for the development and manufacture of new products

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Achieving QbD objectives
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QbD and continuous improvement in manufacturing
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Design space and control strategy
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The use of MVDA models to ensure quality compliance in routine production

Olivia Darmuzey
QbD Expert - PharmOps CH, Novartis Pharma

10:20 Identifying and exploiting opportunities from Process Analytical Technology (PAT)

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Exploiting on-line process analytical measurements to gain insight into process performance
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Making maximum use of a limited number of data sets in the CMO environment
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Techniques to interpret data from instrumentation to assess on-line process quality
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Skills required to maximise the benefits of PAT

Prof Elaine Martin OBE
Professor of Industrial Statistics, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University
Prof Gary Montague
Professor of Bioprocess Control, Biopharmaceutical and Bioprocessing Technology Centre, Newcastle University

11:00 Morning refreshments

11:20 Continuous manufacturing for oral solid dosage tablet making PAT application

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PAT as the key enabler to achieve QbD by means of ‘Model Predictive Control’ and ‘Real Time Product Release’
How to deal with tracking and tracing when going from a batch to a continuous process?
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Benefits of continuous processes in commercial manufacturing and late stage product development

Rebecca Vangenechten
Consultant - Business & Project Development Life Sciences, USA, Siemens Industry & Automation

12:00 GMP Critical Utilities from A to Z

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Design of pharmaceutical water and steam systems
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Quality control during erection
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Commissioning
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Qualification (IQ & OQ)
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Validation (PQ)
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Daily operation and sampling
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Change control
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Re-qualification

Henrik Goldschmidt
Proceskonsulent, GPE Consult

12:40 Networking lunch

13.40 The role of the analytical laboratory in technology transfer

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Common problems,
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Transfer strategy,
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Planning the transfer
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Case studies and learning.

Paul Smith
Validation Program Manager (Europe), PerkinElmer Life and Analytical Sciences

14:20 From test tube to tank

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Critical issues affecting technology transfer & scale-up
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Addressing issues surrounding high containment manufacturing
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cGMP production: Therapeutic products of prokaryote fermentation

Mitch Rogers
Business Development Manager, Health Protection Agency

15:00 Afternoon refreshments

15:20 Validation, stability and method transfer activities to QC and contract manufacturers

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Develop and validate new analytical test methodologies
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Strategy and design for methods and complex investigations
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Identifying quality or safety issues

Anthony Pettigrew,
Analytical Development Manager, Novozymes

16:00 Risk mitigation strategies and IP challenges

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Discussing the rules and regulations that apply specifically to the UK
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Using UK regulations in the evaluation process
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IP barriers and challenges

16:40 Closing remarks from the chair.

Day 2
4th Annual Contract Manufacturing
Tuesday 14th December 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Is outsourcing manufacture right for your business?

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Defining the strategic direction of the pharma company
*
Risks and benefits of outsourcing
*
Impact of outsourcing on marketplace and pharma company
*
Manufacture of commodity products
*
Manufacture of products using proprietary technologies
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Assessing value benefits in cost, time and quality

Martin P Grosvenor,
Drug Delivery Manager. AstraZeneca

10:20 Contract manufactures: Quality is more than an audit

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Traditional procurement quality
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Customer: Supplier approach isn’t effective
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Relationship management
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Understanding each other

Nigel Cryer
Interim Head, Global Quality Manufacturing & Supply Chain, Norgine,

11:00 Morning refreshments

11:20 Custom manufacturing: Sourcing APIs in emerging markets

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What are the commercial implications of increasing globalisation of the API contract manufacturing market?
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API supplier identification and negotiations
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Market evolution: Regulatory compliances, new patent laws, decreasing number of NCEs

Laurent Pinchard
Director – EU Operations (API), Glenmark Generics

12:00 Emerging markets: CMO outsourcing

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Understanding the influence of global regulatory culture on establishing outsourcing projects
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Indentifying lucrative opportunities and establishing strategic alliances in emerging markets to minimise costs
*
Legal and intellectual property challenges in negotiating contracts and managing relationships.

12:40 Networking lunch

13:40 CMO management throughout the lifecycle

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Establish and improve relationship management practices with strategically important CMOs
*
The process: Plan, select, negotiate, implement and manage
*
Governance plan
*
Expected deliverables

Nelson M Lugo
Sr. Director, Contract Manufacturing, Amylin Pharmaceuticals

14:20 Achieving product traceability with pharmaceutical packaging

*
Cost effective and integrated processing for packaging
*
Operational challenges in working with 3rd party contract manufacturers
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Pack design/process & reproducibility

15:00 Afternoon refreshments

15:20 Globalisation in manufacturing: In-house production vs Outsourcing
Our expert panel will discuss and debate on the need for outsourcing, indentifying opportunities and operational challenges to work with third party contractors
Panel members will be drawn from the speakers who take part on day one or day two.

16:00 Lean product development in a pharma CMO set-up

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Evaluation of the economic, financial and technical needs to drive a lean mentality within product development
*
How to achieve, optimise & continually support an integrated approach for implementing lean product development?
*
Review of case studies as to the benefits realised from both CMOs and pharmaceutical companies using a lean approach

Karen MacGregor
Product Development Director, Catalent

16:40 Chair’s closing remarks

16:50 End of conference.


For more information visit
http://www.bharatbook.com/detail.asp?id=144457&rt=Conference-on-4th-Annual-Contract-Manufacturing.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on 4th Annual Stability Testing

4th Annual Stability Testing
Examining current challenges and exploring more cost-effective strategies.
22nd – 23rd November 2010, BSG Conference Centre, London, UK

Key Speakers:

Garry Scrivens, Senior Principal Scientist, Pfizer,
David Elder, Externalization Director, GlaxoSmithKline,
Ahmed Yasin, BioPharm Analytical & Formulation Research, GlaxoSmithKline,
Dagmar Mohr, Group Head Analytical R&D and QC Biotech Products, Roche,
Simona Bohanec, Head of Regulatory Analytics, Sandoz,
Duu-Gong Wu, Executive Director, PharmaNet,
Jan Jiskra, Project leader, Synthon,
Jane Robinson, Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control,

Conference Introduction
4th Annual Stability Testing
22nd - 23rd November 2010, London, UK

Failing to conduct a proper stability testing can be very time consuming and costly for companies, and damaging to their reputation. The cost of taking NCE through the development stages can range anywhere between $800 million to $1.2 billion (source: Springer, 2009). It is therefore, important for companies to understand key factors affecting the stability profile of a potential product, and carry out an effective stability program. 4th Annual Stability Testing Conference will feature key industry
experts who will aim to share their experiences and explore key themes, including criteria for product stability, challenges associated with specific product types
(including biotechnology products). Attendees will gain latest insights into the regulations, risk management, as well as the application and limitations of stability test procedures.

Why you should attend this conference:
• Understand strategies to design and implement a compliant stability program.
• Hear the latest regulations guidelines, including FDA and ICH requirements.
• Examine when it is best to perform stability tests: at what stage in the lifecycle?
• Debate the best approaches for data management of statistical data.
• Understand the importance of risk assessment.
• Review current methods used to reduce costs.
• Explore the benefits of outsourcing.
• Discuss challenges associated with specific product testing
• Use this opportunity as a platform for future collaborations

Who should attend this conference?
Senior VPs, VPs, Chief Scientific Officers, Directors, Managers,
Professors, and Principal Investigators in:
• Stability/ Stability Testing
• Analytical Laboratory
• Formulation Development
• Contract Laboratory
• R&D
• Quality Assurance
• Quality Control
• Analytical Development
• Analytical Chemistry
• Pharmaceutical & Biopharmaceutical Production
• Product Development
• Product Submission
• Validation
• Documentation and Technical Writing
• Regulatory Affairs
• Project Management
• Technical Operations
• Regulatory Affairs

Day 1
4th Annual Stability Testing
Monday 22nd November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 US regulatory perspective on stability testing of pharmaceutical products

• The objectives of stability studies during drug development
• US regulatory requirements for stability testing of drug substances and drug products during different phases of drug development
• Regulatory and scientific considerations on design of stability protocols
• Special issues on stability testing for drugs, biological products and combination products
• Stability testing and Quality by Design (QbD)

Duu-Gong Wu
Executive Director, PharmaNet, USA,

10:20 Early screening of key stability issues of biopharmaceuticals

• Key BioPhysical and PhysicoChemical properties of proteins that are key in stability testing
• Characterisation of various pathways
• Stable Formulation options available for proteins
• Stability options and a case study
• ETC

Ahmed Yasin
BioPharm Analytical & Formulation Research, GlaxoSmithKline,

11:00 Morning refreshments.

11:20 Challenges in using bioassays in stability studies.

• For most biopharmaceuticals, testing for potency by bioassay is a required part of stability studies.
• The bioassay used must be shown to be stability indicating.
• The precision of the bioassay may limit its detection of small changes in potency.
• Interpretation of changes in potency can be complicated and usually requires complementary physicochemical data

Jane Robinson
Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control,

12:00 Thinking smart about stability testing for post market products
• Implement stability programs to answer the specific needs: Change, Ongoing, Deviation programs
• What is the risk to changing stability programs
• How do we mitigate the risk to change
• Implementing the changes

12:40 Networking lunch

13:40 Stability challenges of amorphous compounds.
• Chemical and physical stabilisation of amorphous API/drug product
• Correlations between molecular mobility and chemical stability - Learnings from Ritonavir.
• Approaches to stabilise poorly soluble drugs, some case examples.

David Elder
Externalization Director, GlaxoSmithKline,

14:20 Role of thermal methods in stability testing.
• Application of DSC:
- polymorph screening and characterization application of isothermal calorimetry.
- amorphous content quantification.
- final product stability.

Simon Gaisford,
Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London,

15:00 Afternoon Refreshments

15:20 Evaluation of stability data (Q1E ICH guideline)
• Implementation of the Q1E guideline: Evaluation of Stability Data
- Understanding and using linear regression analysis (intercept, slope, confidence intervals)
- Why to test for pool ability of batches?
- How to test for pool ability of batches?
• Using calculations to predict shelf-life and release limits
(Case studies 1–3)
• Application of linear regression analysis to long-term data for climatic zones 3 and 4

Simona Bohanec, Head of Regulatory Analytics, Sandoz

16:00 Bracketing and matrixing (B&M)
• Success in reducing stability testing
• Limitations of these procedures
• Applicability
16:40 Closing remarks from the chair
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
4th Annual Stability Testing
Tuesday 23rd November 2010

09:00 Registration and refreshments.

09:30 Opening address from the chair.

09:40 Increasing the reliability of shelf-life predictions from accelerated stability studies.
• Description of ‘accelerated stability assessment program’
• Focus on the prediction of degradation rates in the solid-state, i.e. degradation of API (active pharmaceutical ingredient) and solid-oral drug products (e.g. tablets and capsules).
• Prediction of degradation of packaged drug products, and how this tool may be used for packaging selection.
• Case studies are briefly described that demonstrate the potential power of this approach.

Garry Scrivens,
Senior Principal Scientist, Pfizer,

10:20 Statistical shelf life estimation from multiple batch stability studies.
• What do the ICH guidelines have to say about the statistical methods I should use?
• Should I use a linear or non-linear model?
• How to select the right model and test for differences between batches.
• Do I need (to be) a statistician - or - to what extent can/should the analysis be automated?

Matthew Coates,
Senior Statistical/Technical Consultant, StatSoft,

11:00 Morning refreshments

11:20 Developing fast chromatography methods to support your stability programmes from development through to registration.
• Developing Fast UPLC/Non-UPLC stability indicating methods.
• Savings that can be made by streamlining your development efforts early in the drug development cycle.
• How does the future of stability analysis look?

Mark Benger,
Director, Aptuit,

12:00 Stability testing of generic medicines.
• Understanding guidelines and regulatory requirements for generic products.
• Stability testing programme for generic products
• Specific issues on filing generics worldwide and/or different regions
• Strategies to keep costs low, including bracketing and matrixing
• Comparison of the generic product to the innovator, prove the similarity in stability through analytical testing.

Jan Jiskra,
Project leader, Synthon,

12:40 Networking lunch.

13:40 Stability testing: the case for out-sourcing.
• Assessing the benefits.
• Factors to consider when considering outsourcing.
• Choosing the right partner.

Jacinta George.
Commercial Director, Reading Scientific Services,

14:20 Monitoring and evaluation of single amino acid modifications of therapeutic monoclonal antibodies.
Modifications of single amino acids may be observed during stability testing differing in their extend and their impact on product quality. This talk comprises drivers, methodology and evaluation of the following single amino acid modifications:
- methionine oxidation.
- asparagine deamidation.
- N-terminal glutamine / glutamate cyclization.

Dagmar Mohr,
Group Head Analytical R&D and QC Biotech Products, Roche,

15:00 Afternoon refreshments

15:20 Photostability testing.
• Strategies to design a compliant photostability program.
• Analytical approaches for assessing photostability.
• Evaluation of illumination sources used for photostability testing.

16:00 Importance of risk management in predicting success.
• Why it is important to perform risk assessment at every stage of development.
• Methods for predicting success early on.

16:40 Chair’s closing remarks

16:50 End of conference.


For more information visit
http://www.bharatbook.com/detail.asp?id=144496&rt=Conference-on-4th-Annual-Stability-Testing.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
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Please visit our blog at http://bharatbookseo.blogsome.com

Conference on Biobanking Americas

Conference on Biobanking Americas ( Conference and Workshop Only )
The future for next generation drug discovery and personalised medicines
To be held at 9th - 11th November 2010, Boston, USA

Key Speakers
• Dr. Marc Allard, Research Microbiologist, Center for Food Safety and Applied Nutrition, FDA
• Dr. Adel Laoui, Director, Healthcare Technologies Aging Therapeutic Strategic Unit, Sanofi-aventis
• Brenda Yanak, West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM, Merck
• Jeff Milton, Bioinformatics & Computational Biology, Genentech
• Dr. John G. Baust, UNESCO Chair & Professor, Director, Institute of Biomedical Technology, State University of New York
• Elaine W. Gunter, Founder and President, Specimen Solutions, LLC, National Cancer Institute
• Dr. Hartmut Juhl, CEO, Indivumed
• James Eliason, Director, Stem Cell Commercialization Center
• Dr. Michael Hehenberger, Business Development Executive, Life Sciences, IBM Thomas J. Watson Research Center
• Kristen Rosati, Partner, Coppersmith Schermer & Brockelman
• Dr. Richard J. Maguire, Director of Business Development – LIMS, Ocimum

An estimated $1bn has been invested in the biobanking industry within the last ten years. At least 179 biobanks with 345,000 donors exist in the US, most of which were established in the last 10 years. (Source: Business Insights, March 2009)

TIME Magazine highlighted biobanking as one of "10 Ideas Changing the World Right Now." Biobanking is rapidly growing and thriving to change approaches to target-finding, drug development and patient treatment. It is being viewed as a key driver for next generation biomarker and drug discovery.

The substantial advancement of research on the human genome has led to the creation of biobanks, which has brought a paradigm shift in drug testing and development. Recognizing the potential benefits from biobanks, pharma and biotech across the world are investing in infrastructure and biobank development.

Reasons to register today:
• Learn how to develop the best practices to leverage biospecimen resources
• Analyse major challenges for biorepository management and implementation
• Get the latest updates on the applications on genome sequencing
• Investigate the future of biobanks, regulation, ethics, investment and the humanization of drug discovery in the Americas
• Determine how to implement virtual biorepository
• Understand the importance of quality management in biobanking
• Gain an insight into the bioprospecting of tissues, DNA, protein or genetic information
• Enable confident decision making by benchmarking yourself against other leaders in the field

Who should attend?

VPs, Directors, Heads, Managers of:
• Biobank
• Tissue bank
• Biorepository/BioSample
• Molecular Diagnostics
• Clinical Genetics, Pathology
• Genomics
• Privacy/Protection/Security
• Scientific and Quality
• Laboratory and Inventory
• R&D
• Quality Control
• Strategic Outsourcing
• Clinical Research
• Translational Medicine
• Personalized Medicine
• Bioanalytical Chemistry
• Pharmacogenomics
• Proteomics
• Business development
• Strategic alliances

Others:
Consultants& Academics
Regulatory bodies
Researchers
Biorepository Vendors
Government Officials

Workshop
Pre-conference Workshop, Tuesday 9th November 2010

The role of best and evidence based practice in promoting quality sample and data collection to support biomarker research and development

Led by: Lisa B Miranda, Vice President, Strategic Alliances and International Biobank Relations, Trans-Hit Biomarkers

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks

About the workshop:

Many consider biobanks to be the crucial cornerstone of biomedical research through their provision of expertise and procurement of high quality samples and well annotated data to foster research. One’s ability to develop high utility, impactful, yet quality biobanking collections lies in the biospecimen resource’s success in implementing current best practice as well as the foresight to incorporate evidence based practice into daily operations. The role of the biobanker is now expanding to include proactive pipeline planning which incorporates these considerations to ensure successful “proof of concept” in translational research efforts such as biomarker research and development.

This interactive workshop will include discussion of:
• An overview of related best and evidence based practice issues
• The role and current implications of best and evidence based practice in the biobanking workspace that relate to pipeline planning
• Strategies for how to navigate the R&D pathway and build a biomarker discovery pipeline for your biobank that integrates evidence based practice

About your workshop leader

With over 20 years of experience, Ms. Miranda has a vast range of expertise in all aspects of Biospecimen Resource Research Management and Development. After 14 years in research at the University of Pennsylvania, Ms. Miranda attained international prominence as Technical Director of the Tumor Tissue and Biospecimen Bank (TTAB) Core Facility. She served as the prime architect of the centralized biospecimen resource and led TTAB’s collaborative efforts in development of the NCI’s CaTissue Suite inventory management system and a National Mesothelioma Virtual Bank with the University of Pittsburgh and the CDC. In 2006, she was recognized for her development of a Sustainable Cost Recovery Model which was acknowledged as the gold standard by the United States National Cancer Institute’s Office of Biorepositories and Biospecimen Research (NCI OBBR). Since then she has continued to establish and develop best practices for the biobanking community through her role as a NIH Contractor and Consultant for NCI OBBR and the Biospecimen Research for Molecular Medicine Offices, as well as current work on cost recovery for the ISBER Best Practices (2010 version).

In addition to collaborating on development of the Ca Hub, which is aimed at developing a common biorepository infrastructure that promotes resource sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies, Ms. Miranda recently authored a new chapter for the NCI Best Practices focusing on Technical Considerations for Management and Operations of Biospecimen Resources. In her role as member of the Ca Hub Acquisition of Normal Tissues Working Group, she collaborated with her ANTWG colleagues on development of an additional best practice document focusing on procurement of post mortem tissues. In 2008, she expanded her consultancy with the incorporation of Biobusiness Consulting Inc., which serves the global biobanking research communities in government, academia, pharmaceuticals, biotech and related industry.

Ms. Miranda is also active in numerous professional societies and committees and has gained recognition as an international speaker and an expert in Biobanking. Her current roles include: Councilor on the ISBER Board of Directors, membership in the global “think tank” known as the “Marble Arch International Working Group on Biobanking for Biomedical Research”, as well as P3G Society (Public Population Project in Genomics), LRIG and the NIH Biospecimens Special Interest Group.

Day 1
Biobanking Americas
Wednesday 10th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 NCI's Cancer Human Biobank (caHUB): Raising the level of excellence for research biorepositories
• The vision for caHUB
• Planning process for caHUB
• caHUB as a national reference repository
• Challenges in bioethics and IP
• White papers available on caHUB operations

Elaine W. Gunter
Founder and President
Specimen Solutions, LLC, National Cancer Institute

10:20 The institutional virtual biobank
• Discuss strategies, tools and techniques used for institutional federation and curation of large volumes of disparate data, and present a case-study for a workflow from repositories to data analysis
• Developing a cost-effective workflow to permit computational analysis will become essential to scientific investigations
• High-throughput experimental techniques threaten to dump mountains of new data onto bioinformatics teams already struggling with the diversity, complexity and enormity of existing resources

Jeff Milton
Bioinformatics & Computational Biology
Genentech

11:00 Morning refreshments

11:20 The importance of an Honest Broker function for clinical data associated with biospecimens
• What is an Honest Broker in biobanking?
• Why is it needed for research?
• What types of research does it support?
• How does it work?

James Eliason
Director
Stem Cell Commercialisation Center

12:00 Biobanking in the post-genomic era: methodological challenges

Dr. John G. Baust
UNESCO Chair & Professor, Director
Institute of Biomedical Technology, State University of New York

12:40 Networking lunch

13:40 Science guided biobanking: A prerequisite for the development of individualized cancer therapies
• Tissues are under tremendous biological stress when surgically separated from the body and, subsequently, significantly change gene and protein expression profile and, possibly, also growth regulating factors that might serve as targets or stratification markers for new drugs.
• Several factors have been identified that affect tissue research data, including:
- drug treatment and anesthesia of patients before surgical tissue removal
- intrasurgical ischemia by ligation of main arteries (warm ischemia)
- “cold” ischemia, i.e. the time interval between surgical removal and fixation of tissue
- location of tumor biopsy within a given tumor
- processing of tissue and fixation protocols
• Consequently, biobanks for target discovery and drug development have to be based on fully controlled, well-documented processes that start already presurgery and include rapid and standardized tissue preparation in the surgery unit

Dr. Hartmut Juhl,
CEO, Indivumed and Inostics
Adjunct Professor, Georgetown University
Adjunct Professor, University of Hamburg

14:20 Recent Legal Developments in Biobanking
• The HITECH Act, the HIPAA Privacy Rule amendments, and their impact on biobanking
• The affect of the Genetic Information Nondiscrimination Act on informed consent for biobanking
• And more!

Kristen Rosati
Partner
Coppersmith Schermer & Brockelman

15:00 Afternoon Refreshments

15:20 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

16:00 Biobanking: A golden cusp for tailor made personalised medicines
• Analysing the opportunities, challenges, approaches
• Discussing recent developments
• Understanding the ethical, legal guidelines

16:40 Closing remarks from the chair

16:50 Networking Drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Biobanking Americas
Thursday 11th November 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Case Study: Next Generation sequencing at the FDA center for food safety and applied nutrition. Trace back and testing of foodborne pathogens
• The milestones for this project included: the ability to provide all of the data generated from analysis of Salmonella enterica genomes
• Developed software that will provide full contig assembly of 454 genomic data, annotation of those contigs and then generate lists of genes present in each Salmonella genome based on annotation analysis.
• Recent Next gen experience in building a comparative genomics lab that is directly testing the applications of these methods for foodborne pathogen outbreak detection and analysis

Dr. Marc Allard
Research Microbiologist, Microbiology
FDA-CFSAN-ORS

10:20 Biobanking: changing approaches to target-finding, drug development and patient treatment

Brenda Yanak
West Point IT Site Head and Account Manager, Franchise Biology, siRNA, Imaging, and GeM
Merck

11:00 Morning refreshments

11:20 Integrated Healthcare Technologies Solutions for an Aging Society
• Pharmaceutical company moving towards global healthcare corporation
• Healthcare paradigm shift from traditional inpatient care towards home-based care
• Develop solutions that span from Wellness to Illness care
• Role of Informatics to enable a consumer healthcare business model
• Vision-Gain from a true integrated and diversified healthcare system

Adel Laoui
Director, Healthcare Technologies Aging Therapeutic Strategic Unit
Sanofi-aventis

12:00 Sponsor Spotlight Session
Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience.

12:40 Networking lunch

13:40 IT Solutions to support Biobanking
• Biobanks are essential for the transformation of Healthcare, as we move towards "translational science", preventive care and personalized medicine.
• IT Solutions supporting Biobanks must address privacy and security concerns and should accommodate new data types such as genomic and imaging data
• To provide value to the medical research community, IT solutions must be capable of query and analysis and enable the creation of disease specific repositories
• Examples to be discussed will include Oncology and Neuroscience

Dr. Michael Hehenberger
Business Development Executive, Life Sciences
IBM Thomas J. Watson Research Center

14:20 Panel Discussion- Biobanking in 2010
Panellists will be analysing the recent trends and advancements in sample collection and processing. Focus will be on the challenges and opportunities involved in establishing a biobank.

15:00 Afternoon refreshments

15:20 Biobanking: The Lynchpin for Translational Research
• So, what’s an imperative for the Biobank?
- The Quality of the specimens, diseased and normal, must be absolutely maintained
- The real value of a Biobank, in either context, is the Meta data (patient demographics, diagnosis, cohorts, environmental exposure, behavior (smoker/non-smoker), etc.
- Whether de-identified or anonymized, or with PHI (Patient Health Information), the intrinsic value of biospecimens is in how well and how thoroughly the specimens are annotated
- In the Pharma context, it is also an imperative to validate the biomarker information via SNP Genotyping, Gene Expression, Flow Cytometry or Mass Spectrometry.
- In Medical Research, it essential to track the genealogy of child samples downstream form the Biobank with a referential link to the parent specimen, as that is where the patient Meta data is stored.

Dr. Richard J. Maguire
Director of Business Development – LIMS
Ocimum Biosolutions

16:00 Biobanking: A paradigm shift in drug test and development: Mouse to Man
• Assessing tools in improving drug development
• Overcoming analytical challenges in drug testing
• Implementing effective strategies

16:40 Chair’s closing remarks

16:50 End of Conference


For more information visit
http://www.bharatbook.com/detail.asp?id=140403&rt=Conference-on-Biobanking-Americas-Conference-and-Workshop-Only-.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on Anti-Counterfeiting Americas

Conference on Anti-Counterfeiting Americas
Best practices for protecting the pharmaceutical supply chain against counterfeiting and fraud
8th - 9th November 2010, Boston, USA

Increasing efforts are being made to protect the national supply chain for medicines distribution. In the US, the pharmaceutical supply chain involves the daily delivery of approximately 13 million prescription products to pharmacies, hospitals, clinics and other healthcare provider locations (Source: Urch Publishing, July 2009).

Visiongain's Anti-Counterfeiting Americas conference will provide valuable insights, into the latest issues and track and trace packaging technologies shaping the fields of security and supply chain management, with leading experts presenting the best-practices on tackling pharmaceutical counterfeiting and fraud, improving the integrity of distribution channels and relationships between key parties.

By attending the Anti-Counterfeiting Americas conference delegates will gain a comprehensive understanding of this rapidly changing sector, from the complex structure of the supply chain, to the growth in mail order and online pharmacies. The potential for investment in the pharmaceutical logistics market remains high. The FDA has put additional focus on "corporate responsibility" for supply-chain management, and increased vigilance and action is needed due to the rise of counterfeit drugs in the global supply chain. Anti-counterfeiting initiatives discussed include the use of technology-based measures, repackaging, consumer education, and increased collaboration with domestic and international law enforcement agencies.

By attending this conference you will:
• Measure the impact of counterfeit drugs by using a patient centric approach
• Understand the development process necessary to ensure an effective security strategy
• Improve inventory control
• Hear changes in the US FDA and European policies
• Develop global standards to increase patient safety and elevate supply chain integrity
• Learn about leveraging supplier audits throughout a global organization
• Understand the challenges of the global traceability and serialization regulatory environment
• Utilize auto-ID advancements in packaging technologies
• Hear the latest strategies for defending your brand and pursuing offenders
• Develop working relationships with US law enforcement authorities
• Balance the need for tamper-proof packaging with streamlining your supply chain
• Evaluate current methods for the detection of counterfeit medicines
• Be part of a unique networking opportunity

Target Audience:
• Pharmaceutical manufacturing and distributing companies
• Drug wholesalers
• Public health and regulatory bodies
• Legal firms
• Customs and border agencies
• Pharmaceutical packaging and labelling companies
• Anti-counterfeiting technology and service suppliers
• Pharmaceutical specialist couriers
• Anti-counterfeiting organizations
• Contract manufacturing organizations (CMOs)
• Retail pharmacy chains
• Non-governmental healthcare organizations and Academia

Who should attend:

Chief Security Officers, VPs, directors, heads, managers and specialists of:
• Supply chain/ Supply Chain Security/ Supply Chain Systems/ Global Supply Chain
• Anti-counterfeit Projects / Anti-counterfeiting Operations
• Distribution/ Logistics
• Security/ Global Security
• Packaging & Labelling
• Brand Protection
• Legal Counsel
• Regulatory Affairs/ Intellectual Property
• Quality Assurance/ Quality Control
• Compliance
• Information systems


Day 1
Anti-Counterfeiting Americas
Monday 8th November 2010


09:00 Registration and refreshments
09:30 Opening address from the chair
Lorne M Lipkus
Partner
Kestenberg Siegal Lipkus LLP
09:40 The business value of product serialization within the pharmaceutical supply chain
Across the U.S. pharmaceutical supply chain, organizations are aligning themselves to enable more effective product serialization and increased visibility using new standards. With widespread serialization comes tremendous opportunity for pharmaceutical manufactures and their trading partners to leverage new standards for increased efficiency and greater ROI. In this session, the GS1 Healthcare US organization, the US implementation arm of the leading standards-setting body for product identification, illustrates the business value of serialization and pedigree/visibility information.
• GS1 EPCIS standard as a pathway to significant potential business value
• The status of adoption of GLN and GTIN in pharma
• The industry status for using serial data to match product
• How serialization can provide enormous visibility into the supply chain
• Update on the 2015 readiness program (preparing for serialization and pedigree within the US)
Robert Celeste
Director, Healthcare
GS1 US
10:20 Forging strategic partnerships to elevate
product integrity
• Industry trends
• Developing and applying a risk management process
• Assessing qualifications
• Transitioning a qualified vendor into a strategic partner
• Case study
Mike Lewis
Business Development Manager
Sentry BioPharma Services
11:00 Morning refreshments
11:20 Securing pharmaceuticals against counterfeiting: Assessing latest protection technologies
• Latest developments in anti-counterfeiting technologies
• Packaged-bases vs on-product solutions
• Designing a comprehensive anti-counterfeiting strategy
Frank Schurgers
Managing Director
Integris


12:00 Counterfeiting in developing countries: The use of mixed technology
• External control in massive consume products
• The ‘umbrella brand’ concept: The perfect attack
• Internal control in massive consumer products
• The colombia case
• Results and real benefits
Andres Diaz Cote
President
Figurazione
12:40 Networking lunch
13:40 Protecting IP rights
• Trademarks and identity preservation
• History of branding and quality assurance
• Causes of counterfeiting
• Anti-counterfeiting technology and choice
14:20 Track and Trace at the WIP manufacturing level
• Overview for analyzing tradeoffs between brand protection technologies
• Why is information regarding authentication of products and their movement critical?
• “Pre-adaption” of pharmaceutical manufacturers to incorporate brand authentication as an integral part of their existing operations
Jim Williams
Founder & Chief Scientist
Polyonics
15:00 Afternoon refreshments
15:20 Illegal internet pharmacies: A framework for coordinated action and cooperation
• Illegal internet pharmacies: Extent of the problem
• Action against illegal internet pharmacies: What has been done?
• What remains to be done: The need for additional action
16:00 Supporting safe medicines strategies in
developing countries
• Which developed countries are the most susceptible destination markets for counterfeit drugs?
• Assessing the scale and economic cost of counterfeiting
• Discuss the role of drug regulations and law enforcement
• Cooperation with national & international agencies
Tom Woods
President
Woods International
16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.


Day 2
Anti-Counterfeiting Americas
Tuesday 9th November 2010

09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Cost-effective anti-counterfeiting solutions for the second tier
• Repackaging and counterfeiting
• Technologies
• Evaluate packaging-based and product-based anti-counterfeiting measures by cost, complexity, and effectiveness for second tier products
Sharon Flank
CEO
InfraTrac
10:20 Protecting medicines from diversion and counterfeiting
• A multi-layered approach for brand protection
• Specialty distribution as a tool for combating diversion
• Using smartphones and mobile phones in brand integrity and
loyalty programs
Steve Wood
President & CEO
Covectra
11:00 Morning refreshments
11:20 Combating pharmaceutical anti-counterfeiting from a legal perspective
• Relationship between parallel trade and counterfeiting
• Basic framework for the parallel trade of pharmaceuticals
• Recent and future developments
12:00 Balancing the need for tamper-proof packaging with streamlining your supply chain
• Cost to manufacturers
• Choosing the right tamper-evident packaging for your product
• The smarter supply chain of the future
12:40 Networking lunch

13:40 Detecting pharmaceutical counterfeiting
• Stages of investigation
• Investigation and detection of contamination in pharmaceutical products
• QC and GMP techniques
Philip Payne
Investigative Partner
RSSL
14:20 Case study: Utilizing forensic analysis in support of counterfeit investigations
The presentation will look at various strategies to utilize forensic evidence for carrying out counterfeit investigations
Vaughn Volpi
President
PICA
15:00 Afternoon refreshments
15:20 The global impact of fake medicine
• Overview of the counterfeit drugs: Some examples
• How fake medicines harm patients and public
• Building a Coalition: A call to action
Scott LaGanga
Executive Director
Partnership for Safe Medicines
16.00 Protecting profits and patient safety through implementing new technologies
• Preventative technologies
• Authentication technologies
• Track & Trace technologies
16:40 Chair’s closing remarks
16:50 End of conference


For more information visit
http://www.bharatbook.com/detail.asp?id=141389&rt=Conference-on-Anti-Counterfeiting-Americas-Conference-and-workshop.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on Phase I Clinical Trials Summit

Conference on Phase I Clinical Trials Summit
Strategies for improving Phase I trial design, management and execution
To be held at 28th – 29th October 2010, BSG Conference Centre, London, UK

Key Speakers

Dr. Eckhard von Keutz, Senior Vice President Head Global Early Development, Bayer Schering Pharma
Dr. Walter Janssens Coordinator Early Phase Development, FAGG/AFMPS
Corina Dota ECG Centre Manager, Medical Science Sweden, AstraZeneca
Dr. Fatiha Sadallah, Principal Scientifi c Manager, Innovative Medicines Initiative (IMI)
Dr. Andrea Laslop, Head of Institute Science and Information, AGES PharmMed
Rob Nichols, Director of Commercial Development, Phase Forward Europe
Dr. Finbarr Cotter Prof of Haematology, Medical Oncology, Barts and the London School of Medicine
Robert Blakie, Director, ERA Consulting
Dr. Assem S. el Baghdady, Director, Alpha Beta Pharma
Dr. Jennifer J. Wheler, Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer
Medicine, The University of Texas M. D. Anderson Cancer Center
Professor Atholl Johnston, Professor of Clinical Pharmacology, Barts and the London School of Medicine and
Dentistry, Queen Mary University of London
Dr. Dominic Williams, MRC Centre for Drug Safety Science, The University of Liverpool

Who should attend?

Vice/Presidents, Directors, Heads of:
• Clinical Operations • Clinical Research
• Clinical Development
• Exploratory Development
• Strategic Drug Development
• Clinical Trial Design
• Clinical Pharmacology / Pharmacometrics
• Quality Assurance / Quality Control • Pharmacokinetics/ Pharmacodynamics
• Project Management
• Regulatory Affairs
• Scientifi c Relations
• Statistical Methodology

Day 1
Phase I Clinical Trials Summit
Thursday 28th October 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 The use of biomarkers early in clinical development
• Biomarkers as go/no-go in early clinical development
• Do biomarkers worth the cost or the time?
• Can we use biomarkers in late clinical development too?
• What role do biomarkers play in the clinic?
Dr. Assem S. el Baghdady
Director, Alpha Beta Pharma
Formerly Medical Director R&D, Norgine

10:20 Exploring translatability from phase I to phase IIb
• Clarify different concepts of biomarkers
• Speed up the transition from Phase I to Phase IIb
• Integrative assessment of available data
• Designing biomarker studies efficiently for informative decision making in clinical development
• Illustrative example in diabetes
Dr. Arne Ring
Team Leader Biostatistics Phase I/IIa
Boehringer Ingelheim Pharma

11:00 Morning refreshments

11:20 Regulatory experience with exploratory clinical trials
• Critical issues in the trial application
- preclinical
- quality issues
- protocol related
• Experience in Belgium with exploratory clinical trials
Dr. Walter Janssens
Coordinator Early Phase Development
FAGG/AFMPS

12:00 Phase I clinical trials: beside to bench
Dr. Jennifer J. Wheler
Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine
The University of Texas M. D. Anderson Cancer Center

12:40 Networking lunch

13:40 Reducing the cost of clinical QT studies
• Relationship between the electrocardiographic precision and the study size
• Electrocardiographic methods to increase measurement precision
• Design implications for crossover and parallel studies
• Advantages of continuous ECG acquisition
• Optimum combinations of computerised and manual readings to reduce the cost of ECG analysis
Marek Malik
Professor of Cardiac Electrophysiology, Head, Noninvasive Electrocardiology
St. George’s, University of London

14:20 Evaluating the efficiency of design methods and implementing early clinical trials with novel therapeutics
• Determine dose and schedule
• Discuss continual reassessment methods
• Study specific target patient populations

15:00 Afternoon refreshments

15:20 Study design for Leukaemia therapy
• What does we mean by Phase I studies in the context of Leukaemia
• What are the goals
• How do we design the study
• How to we record and evaluate the trial
• What are added value studies
Dr. Finbarr Cotter
Prof of Haematology, Medical Oncology
Barts and the London School of Medicine

16:00 Update on ICH guidelines
• Review the guidelines
• Discuss the risk benefit
• Examine the regulatory requirements

16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2
Phase I Clinical Trials Summit
Friday 29th October 2010

09:00 Registration and refreshments

09:30 Opening address from the chair

09:40 Preparing phase I clinical trials
• Early clinical trials methodology
• Principles of laboratory methodologies
• Reviewing preclinical data
Professor Atholl Johnston
Professor of Clinical Pharmacology, Barts and the London
School of Medicine and Dentistry
Queen Mary University of London

10:20 Understanding the importance of preclinical
studies for clinical success
• What has changed?
• What is necessary?
• Opportunities for better investigations
• Opportunities for cross-functional cooperation
Dr. Eckhard von Keutz
Senior Vice President, Head, Global Early Development
Bayer Schering Pharma

11:00 Morning refreshments

11:20 Clinical trials data management in phase I

12:00 The case for automating phase I clinical trials
• Understand the unique challenges for phase I clinical units and how these can be addressed by improved use of automated
solutions
• Appreciate the breadth of available solutions suitable for phase I
• Understand the key issue areas to consider when planning a
smooth implementation
Rob Nichols
Director, Commercial Development
Phase Forward Europe

12:40 Networking lunch

13:40 Translational medicine in Europe: Role of the innovative medicines initiative :IMI
• Public-private partnership in the health sector
• Building on strengths and tackling weaknesses in the EU
• IMI first two calls for proposals
Dr. Fatiha Sadallah
Principal Scientific Manager
Innovative Medicines Initiative (IMI)

14:20 Presentation to be announced
Dr. Andrea Laslop
Head of Institute Science and Information
AGES PharmMed

15:00 Afternoon refreshments

15:20 Cardiovascular risk profiling in early clinical development
• Role of preclinical testing for cardiovascular safety profiling
• What can be achieved in the early phase 1 studies?
• What are the technologies at hand to ensure quality and cost efficiencies in early clinical development
Corina Dota
ECG Centre Manager, Medical Science Sweden
AstraZeneca

16.00 Mechanism-based markers of murine drug-induced liver injury
• Paracetamol as a tool for translational hepatotoxicity
• Use of keratin-18 as a serum marker of apoptosis
• Use of High Mobility Group box-1 as a serum marker of necrosis
• Fed and fasted animal models in pre-clinical development
Dr. Dominic Williams
MRC Centre for Drug Safety Science, Dept.
Pharmacology & Therapeutics
The University of Liverpool

16:40 Chair’s closing remarks

16:50 End of conference

For more information visit
http://www.bharatbook.com/detail.asp?id=136318&rt=Conference-on-Phase-I-Clinical-Trials-Summit.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com

Conference on 3rd Pre-filled Syringes

Conference on 3rd Pre-filled Syringes
Innovative solutions for injection devices and parenteral packaging systems

25th - 27th October 2010,
BSG Conference Centre, London, UK

Key Speakers

Todd Stephens, Global Marketing Director, Merck Serono,
Stefan Sundström, Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems, AstraZeneca,
Ian Thompson, Director of Business Development, Ypsomed,
Klaus Ullherr, Product Manager, Packaging Technology, Robert Bosch Packaging,
Jim Spolyar, Sales and Technical Director, Skan US,
Gabriele Peron, Marketing Manager, Stevanato Group - Glass Division,
Thomas Zelmer, Director, Groninger,
Sterling Kline, Director of Project Development, Integrated Project Services,
Shawn Kinney, Chief Executive Officer, Hyaluron
Elliot Lawrence, Associate Director of Regulatory Affairs, ERA Consulting,
Daniel Wheeler, Lecturer in Anaesthesia, University of Cambridge,
Andrew Longworth, General Manager, KÖRBER MEDIPAK UK & RoI.

Conference Introduction

With more injectable biological drugs in use than ever, the pre-filled syringes market will sustain its inexorable growth, with total revenues of $6bn by 20251.

Whether your interests lie in drug formulation, sterile manufacturing or strategic partnering,
attending this conference will enable you to:

• Overcome challenges arising from silicon-drug solution interaction
• Troubleshoot heavy-metal induced drug precipitation and microbiological contamination
• Improve dosing accuracy and enhance patient compliance with next-generation electronic devices
• Learn about novel pre-fi lled syringes for biotech products and auto injector devices
• Understand pre-fi lled syringe processing with RABS, isolators, E-beam and alternatives
• Examine factors and recent developments in processing syringe nests
• Analyse new developments in COC, COP, glass, and elastometric components
• Offset the impact of extractables and leachables on product performance
• Assess the impact of new post-market surveillance regulations on pre-filled medical devices
• Develop new strategies to remain competitive
• Obtain the latest market analysis, and meet manufacturers showcasing their leading products.

Who should attend

Presidents, Chief Executives, Chief Scientific Officers, Chief Operating
Officers, Vice Presidents, Heads, Directors, Clinicians, Principal Scientists,
Managers, Project/Team Leaders in:
• Packaging and labelling
• Vaccine, antibody and protein manufacturing
• Product design
• Technical support
• Drug product process development
• Drug device process development
• Formulation sciences
• Safe medication practice
• Drug discovery & delivery
• Clinical product resourcing
• Supply outsourcing
• Contract manufacturing and management
• Process development
• Strategic alliances
• Investment and venture capital

3rd Pre-filled Syringes
Pre-Conference Interactive Workshop

Monday 25th October 2010

About the workshop:

The session will overview the legal and regulatory issues applicable to pre-filled syringes and some of the more pressing or challenges concerns regarding their sale and use. These will include:
• Product liability
• Reuse
• Control of supply and distribution chains (including parallel imports, pharmacovigilance and post marketing surveillance)
• A regulatory overview

About the workshop leaders:

Alexander Denoon
Alex has both a science degree (human genetics) and a law degree. He qualified as a solicitor (in Australia) in 1995. Alex spent more than five years in- house, including as general counsel and company secretary of Biotech Australia.Alex advises clients in relation to the development of strategies for the protection, defence and commercialisation of intellectual property. This involves the development of strategies and the drafting of a wide array of commercial agreements from licenses to joint ventures. Alex also advises in relation to the regulation of pharmaceuticals, medical devices and advanced therapy medicinal products. Alex has a breadth of international experience structuring, negotiating and drafting commercial agreements. Both as a corporate advisor and as in house counsel.

LDD was established to focus on advising clients in the Life Sciences sector – namely the pharmaceutical, medical devices, reproductive and regenerative medicine industries. Together we bring more than 25 years experience advising clients in the sector. Our particular areas of legal expertise include regulatory matters, compliance programmes, public law and judicial review, intellectual property, commercial contracts and due diligence.

Erik Vollebregt
Erik’s practice focuses on (medical) technology, marketing, healthcare and life sciences. He has broad experience both in litigation and in transactional work in these areas, as well as in the application of anti-trust law to high technology and pharmaceutical products.

Mathias Klümper
Mathias worked as a lawyer and core member of the industry group “Healthcare, Life Sciences and Chemicals” at the Düsseldorf office of Clifford Chance from 2004 until 2008. He advised clients from the pharmaceutical, medical device and biotechnology industry in all regulatory matters. He focused on advising clients on healthcare fraud and abuse prevention (business compliance) and the implementation of employee guidelines and processes. He does not only know the perspective of a lawyer but also obtained a comprehensive insight into the in-house perspective within two client secondments in the European legal department of an international medical device company in Switzerland and a German pharmaceutical company. He is author of a number of publications on regulatory themes relating to pharmaceuticals and medical devices as well as co-author of the “Handbuch des Arzneimittelrechts” (textbook on pharmaceutical law, in prep.). Furthermore, he holds lectures and speeches on current subjects from the pharmaceutical and medical device area.

Day 1
Tuesday, 26th October 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Technology advances and market trends for auto-injectors
• User benefits.
• Creating and protecting market share.
• A new generation of device and compromises in device design.
• Future opportunities.

Ian Thompson
Director of Business Development, Ypsomed,

10:20 Achieving extra high quality production of glass primary packaging: building a manufacturing concept flow based on a streamlined process
• OMPI case study / optimised process
• Defining criteria for excellence in glass containers for pharmaceutical products
• Successfully managing critical aspects (particle control, high tolerances, contact free, silicon, traceability)

Gabriele Peron
Marketing Manager, Glass Division, Stevanato Group,

10:40 Opportunities and challenges for novel primary drug containers in autoinjectors
• Analysis of suitability and weaknesses of current syringe platforms for use in autoinjectors
• Opportunities and challenges for cyclic olefins in novel primary drug containers for autoinjectors
• One approach: Oval’s novel primary drug containment technology

Matthew Young, Chief Executive Officer, Oval Medical Technologies.

11:00 Morning refreshments

11:20 Preserving form and functionality when dealing with sensitive molecules
• Understanding product-packaging interactions to reduce denaturation and aggregation
• Recovery challenges for high concentration formulations
• Avoiding product loss through effective monitoring

12:00 Negating the effects of heavy metal contamination on product stability
• Effects of tungsten and iron on product behaviour in solution
• Considerations when dealing with high concentration formulations
• Strategies to optimise colloidal stability

12:40 Networking lunch

14:00 Microbiological and particulate contamination risks in the manufacture of parenterals
• Elucidating contaminant dispersion routes when producing parenterals
• Risk-based methods to evaluate contamination risks
• Methods for calculating contamination risks (to determine viability and non-viability)

Stefan Sundström,
Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems, AstraZeneca,

14:40 Pre-filled syringe processing with RABS, isolators, e-beam & alternatives
• Isolator technology with latest E-Beam design features
• Comparison of RABS vs Isolators
• Expansion of the areas of application of syringe technology

Jim Spolyar,
Sales and Technical Director, Skan US,

15:20 Afternoon refreshments

15:40 Minimising the risk of sterility breach from stopper movement
• Intra-syringe gas bubble movement permits breach of product sterility
• Determining the maximum allowable gas bubble for a given syringe
and stopper combination using a risk based approach.

Shawn Kinney,
Chief Executive Officer, Hyaluron,

16:20 Panel discussion: Improving performance and reliability in pre-filled devices- where are we and what are the prospects for the future?

Topics discussed will include overcoming siliconisation and drug precipitation, how materials science can aid primary packaging design,
maintaining sterility and ensuring stability.

17:00 Closing remarks from the chair

17:10 Networking drinks
Take your discussions further and build new
relationships in a relaxed and informal setting.

Day 2
Wednesday 27th October 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Stopper insertion methodology and shelf-life longevity
• High-speed filling equipment and online stopper insertion
• Online high-speed filling and offline vacuum stoppering
• Eliminating stopper movement

Thomas Zelmer
Director, Groninger,

10:10 Why we need pre-filled syringes (but might not be getting them...)
• Drawing up drug solutions is fraught with risks to patients
• Mistakes are common and medication errors are frequent
• Pre-filled syringes address many, but by no means all, of these issues
• Reports of the death of the ampoule may have been greatly exaggerated...

Daniel Wheeler,
Lecturer in Anaesthesia, University of Cambridge,

10:50 Morning refreshments

11:10 The impact of advanced aseptic technology on facility design
• Harmonisation of EU and FDA guidance for room classifications
• Isolators versus RABS risk and cost impact
• Recent case studies

Sterling Kline
Director of Project Development, Integrated Project Services,

11:50 Future oriented processing of nested syringes
• FXS 5100 high-performance machine with output of up to 600 syringes per minute
• Innovative line concept for fully automated processing of pre-sterilized, pre-filled nested syringes
• Integrated automatic bag and tub openers

Klaus Ullherr,
Product Manager, Packaging Technology, Robert Bosch Packaging,

12:30 Developments in the secondary packaging of pre-filled syringes
• Identify the principal requirements of a package for pre-filled syringes
• Identify two alternative methods of packaging pre-filled syringes
• Identify features and benefits of both systems
• Identify future trends in the packaging of pre-filled syringes

Andrew Longworth,
General Manager, KÖRBER MEDIPAK UK & RoI,

12:50 Networking lunch

14:10 Next generation injection devices for high-cost, long-term medications
• Improving compliance to injectable therapies- a ongoing challenge
• Easypod: an empowering, patient-friendly option
• Applications to growth hormone, multiple sclerosis and fertility treatments

Todd Stephens,
Global Marketing Director, Merck Serono,

14:50 Best practices on current and future demands on finishing
• Validating unit operations
• Ensuring resilience during transportation
• Maintaining photostability to preserve product quality

15:30 Afternoon refreshments

15:50 Regulatory issues versus requirements for biological medicinal products in pre-filled syringes
• Overview of the regulatory requirements and guidelines
• Data package required
• Case studies: potential issues to consider

Elliot Lawrence
Associate Director of Regulatory Affairs, ERA Consulting

16:30 Chair’s closing remarks

16:40 End of conference.

For more information visit
http://www.bharatbook.com/detail.asp?id=144287&rt=Conference-on-3rd-Pre-filled-Syringes-Conference-and-Workshop.html

OR Contact us at
207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai – 400 614, India.
Phone : +91 22 2757 8668 / 2757 9438
Fax : +91 22 2757 9131
E-mail : info@bharatbook.com
Website : www.bharatbook.com
Follow us on twitter: http://twitter.com/3bbharatbook
Please visit our blog at http://bharatbookseo.blogsome.com