Next Gen: 8th Improving Bioavailabilty & Formulation Conference February 24-26, 2014, Philadelphia, PA

Strategies for Ensuring Optimum Solubility and Drug Viability

This summit investigates the core challenges to achieving maximum bioavailability in drug candidates as well as novel drug delivery solutions utilized to improve bioavailability, and expedite time-to-market of new chemical entities as well as reformulated therapeutics in the development pipeline.

For three days attendees will engage in workshops, panel discussions and case studies from distinguished representatives of companies such as Pfizer, Merck, Bristol-Myers Squibb, Astrazenenca, Regeneron and more.

Overall the main topics and themes to be discussed include:

• Ocular and Parenteral Drug Delivery
• Hot melt extrusion Technology/Spray-drying techniques
• High Throughput Robotics for Solubility Screening
• Lipid Excipients: how they work and when to use them
• Frequency Modulated Drug Delivery- bonds with metal to increase solubility and timed release of drug into tissue.
• Bioactive materials in nano-medicines
• Active vs Passive Targeting of Drug Delivery Systems

Superbugs and Superdrugs: A focus on antibacterials

5^th to 6^th March 2014

Holiday Inn Regents Park, London UK

SMi is proud to present the 16^th instalment in the established sell-out conference series; Superbugs and Superdrugs taking place on 5^th and 6^th March 2014, London UK.

Discuss the growing threat of bacterial resistance at this unique forum which will bring together key industry leaders from big pharma companies, biotech companies, regulatory agencies and academia to discuss the latest development in the antibacterial market.

Superdrugs and Superdrugs 2014 will address the main challenges that pharmaceutical companies are currently facing in terms of funding, antimicrobial resistance, regulation, new technologies and global solutions.

Why Attend this Event:

• Discover the latest Public/Private Partnerships to combat antimicrobial resistance both in the US and in Europe

• Consider antibody based strategies as a new method to tackle antimicrobial resistance

• Discuss the different therapeutic approaches in fighting Clostridium Difficile Infections, Hepatitis C,

• Pseudomonas aeruginosa infections and Staphylococci infections

• Learn about hot topics which include antimicrobial stewardship, nanoparticulate oligonucleotide antibacterials and alternative models for tackling antimicrobial resistance

Key Speakers:

• Richard Bergström, Director General, EFPIA

• Line Matthiessen, Head of Infectious Disease and Public Health Unit, European Commission

• Joe Larsen, Branch Chief Broad Spectrum Antimicrobial Program, Biomedical Advanced Research and Development Authority (BARDA)

• Richard Bax, Senior Partner, TranScrip Partners

• James Anderson, European Partnerships Director, GSK

• Ralph Minter, Fellow Antibody Discovery and Protein Engineering, MedImmune

• Malcolm Page, Head of Biology, Basilea Pharmaceutica

• Michael Mourez, Therapeutic Area Leader, Sanofi

• Pierre Raboisson, Head of Medicinal Chemistry, Janssen Pharmaceutical Companies of Johnson and Johnson

• Chris Longshaw, Associate Director for Microbiology, Astellas Pharma Europe

• Chris Hoyle, Economist, Office for Health Economics

Previous instalments in the series have received positive feedback from the industry including "Very well organised conference" – GSK, "Good level of quality" – Janssen, "Very good and engaging speakers" – Merck and "Good topics, mix of basic research and clinical development and perspectives" - J&J

Superbugs and Superdrugs: A focus on antibacterials

5^th to 6^th March 2014

Holiday Inn Regents Park, London UK

SMi is proud to present the 16^th instalment in the established sell-out conference series; Superbugs and Superdrugs taking place on 5^th and 6^th March 2014, London UK.

Discuss the growing threat of bacterial resistance at this unique forum which will bring together key industry leaders from big pharma companies, biotech companies, regulatory agencies and academia to discuss the latest development in the antibacterial market.

Superdrugs and Superdrugs 2014 will address the main challenges that pharmaceutical companies are currently facing in terms of funding, antimicrobial resistance, regulation, new technologies and global solutions.

Why Attend this Event:

• Discover the latest Public/Private Partnerships to combat antimicrobial resistance both in the US and in Europe

• Consider antibody based strategies as a new method to tackle antimicrobial resistance

• Discuss the different therapeutic approaches in fighting Clostridium Difficile Infections, Hepatitis C,

• Pseudomonas aeruginosa infections and Staphylococci infections

• Learn about hot topics which include antimicrobial stewardship, nanoparticulate oligonucleotide antibacterials and alternative models for tackling antimicrobial resistance

Key Speakers:

• Richard Bergström, Director General, EFPIA

• Line Matthiessen, Head of Infectious Disease and Public Health Unit, European Commission

• Joe Larsen, Branch Chief Broad Spectrum Antimicrobial Program, Biomedical Advanced Research and Development Authority (BARDA)

• Richard Bax, Senior Partner, TranScrip Partners

• James Anderson, European Partnerships Director, GSK

• Ralph Minter, Fellow Antibody Discovery and Protein Engineering, MedImmune

• Malcolm Page, Head of Biology, Basilea Pharmaceutica

• Michael Mourez, Therapeutic Area Leader, Sanofi

• Pierre Raboisson, Head of Medicinal Chemistry, Janssen Pharmaceutical Companies of Johnson and Johnson

• Chris Longshaw, Associate Director for Microbiology, Astellas Pharma Europe

• Chris Hoyle, Economist, Office for Health Economics

Previous instalments in the series have received positive feedback from the industry including "Very well organised conference" – GSK, "Good level of quality" – Janssen, "Very good and engaging speakers" – Merck and "Good topics, mix of basic research and clinical development and perspectives" - J&J

Controlled Release

12^th – 13^th March 2014

Holiday Inn Regents Park, London, UK

SMi is proud to present its 11th annual Controlled Release conference, held in central London on the 12 & 13 March 2014. The meeting will continue in a long tradition of critically acclaimed speakers who are pioneers in their field. This event offers you a unique opportunity to keep up to date with the latest in technologies and methods such as the diffusion of nanomaterials through biological and non-biological gels.

Controlled release remains one of the most important innovate areas in pharma, with revenues set to dramatically increase to 2020. Recent advances in drug delivery systems have created the perfect mix for opportunities in the field.

KEY REASONS TO ATTEND:

• Controlled Release 2014 will cover the GI tract in oral formulation design and oral drug delivery to the Colon with Luigi ‘Gino’ Martini joining the speaking panel to give an industry perspective on oral product development programs

• Join Joel Richard, Vice President Peptides, CMC and Engineering at Ipsen as he gives an overview of the present status and future outlook of peptide delivery. A drug market that is estimated at $15 billion

• A professional environment with expert speakers from leading pharma companies including GlaxoSmithKline, Johnson & Johnson, Ipsen and Novartis available to network and help build upon market intelligence to further business strategies

• Designing dosage forms that allow for more effective drug delivery and release is critical for success in both the clinic and marketplace. Patrick Crowley, Author and Editor of ‘Controlled Release in Oral Drug Delivery’ will demonstrate how to attain target performance profiles for dosage form design

KEYNOTE SPEAKERS:

• David Elder, Externalisation Director, GlaxoSmithKline

• Joel Richard, Vice President Peptides, CMC & Engineering, Ipsen

EXPERT SPEAKERS INCLUDE:

• Jeffrey B. Ulmer, Global Head of External Research, Novartis Vaccines & Diagnostics

• Tugrul Kararli, President and Founder, PharmaCircle

• Der-Yang Lee, Research Director & Fellow, McNeil/Johnson & Johnson

• Michael Keller, Senior Fellow, Novartis Pharma AG

• Pierandrea Esposito, FAssociate Director and Co-founder, SiTec PharmaBio

• Patrick Crowley, Founder and Owner, Callum Consultancy

• Luigi Martini, Professor of Pharmaceutical Innovation, King's College London

• Duk Soon Choi, Vice President Preformulation, Kashiv Pharma

• Howard Stevens, Professor, University of Strathclyde

• Amin Hajitou, Senior Lecturer and Principal Investigator, Imperial College London

Plus an interactive half-day post-conference workshop: Using Novel Excipients for continuous manufacturing. Tuesday 11th March 2014 | Holiday Inn Regents Park, London, UK | 1.00pm - 5.30pm. Workshop Leader: Dr Dennis Douroumis, Reader in Pharmaceutical Sciences, University of Greenwich

Controlled Release

12^th – 13^th March 2014

Holiday Inn Regents Park, London, UK

SMi is proud to present its 11th annual Controlled Release conference, held in central London on the 12 & 13 March 2014. The meeting will continue in a long tradition of critically acclaimed speakers who are pioneers in their field. This event offers you a unique opportunity to keep up to date with the latest in technologies and methods such as the diffusion of nanomaterials through biological and non-biological gels.

Controlled release remains one of the most important innovate areas in pharma, with revenues set to dramatically increase to 2020. Recent advances in drug delivery systems have created the perfect mix for opportunities in the field.

KEY REASONS TO ATTEND:

• Controlled Release 2014 will cover the GI tract in oral formulation design and oral drug delivery to the Colon with Luigi ‘Gino’ Martini joining the speaking panel to give an industry perspective on oral product development programs

• Join Joel Richard, Vice President Peptides, CMC and Engineering at Ipsen as he gives an overview of the present status and future outlook of peptide delivery. A drug market that is estimated at $15 billion

• A professional environment with expert speakers from leading pharma companies including GlaxoSmithKline, Johnson & Johnson, Ipsen and Novartis available to network and help build upon market intelligence to further business strategies

• Designing dosage forms that allow for more effective drug delivery and release is critical for success in both the clinic and marketplace. Patrick Crowley, Author and Editor of ‘Controlled Release in Oral Drug Delivery’ will demonstrate how to attain target performance profiles for dosage form design

KEYNOTE SPEAKERS:

• David Elder, Externalisation Director, GlaxoSmithKline

• Joel Richard, Vice President Peptides, CMC & Engineering, Ipsen

EXPERT SPEAKERS INCLUDE:

• Jeffrey B. Ulmer, Global Head of External Research, Novartis Vaccines & Diagnostics

• Tugrul Kararli, President and Founder, PharmaCircle

• Der-Yang Lee, Research Director & Fellow, McNeil/Johnson & Johnson

• Michael Keller, Senior Fellow, Novartis Pharma AG

• Pierandrea Esposito, FAssociate Director and Co-founder, SiTec PharmaBio

• Patrick Crowley, Founder and Owner, Callum Consultancy

• Luigi Martini, Professor of Pharmaceutical Innovation, King's College London

• Duk Soon Choi, Vice President Preformulation, Kashiv Pharma

• Howard Stevens, Professor, University of Strathclyde

• Amin Hajitou, Senior Lecturer and Principal Investigator, Imperial College London

Plus an interactive half-day post-conference workshop: Using Novel Excipients for continuous manufacturing. Tuesday 11th March 2014 | Holiday Inn Regents Park, London, UK | 1.00pm - 5.30pm. Workshop Leader: Dr Dennis Douroumis, Reader in Pharmaceutical Sciences, University of Greenwich

6th Ocular Diseases Drug Discovery Conference

March 20-21 2014

The conference continues to offer presentations on novel and innovative therapeutics in ocular drug development and discovery. This forum allows for excellent networking, the exchange of ideas, and sharing of challenges; all with a united common goal of bringing new and innovative treatments to patients in the area of ophthalmology. The conference features the following topics: Session: Novel Targets, Developments and Technologies Session: Novel Drug Delivery Methods to the Anterior and Posterior Segments Session: Clinical Development Advances & Updates Session: Safety Assessment and Regulatory Landscape in Ocular Drug Development Session: Short Presentations Panel Discussion: BD, Investments and Potential for Collaborations Panel Discussion: Safety and Regulatory in Ocular Development

San Diego, CA, USA

Adaptive Designs in Clinical Trials

24^th – 25^th March 2014

Holiday Inn Regents Park, London, UK

SMi is proud to present its 8th annual Adaptive Designs in Clinical Trials conference, held in central London on the 24 & 25 March 2014.

Hear through case studies how all sizes of pharmaceutical companies have successfully implemented trials incorporating adaptive designs. This conference is the only in Europe that focuses on adaptive designs specifically, providing delegates with updates on recent developments in enrichment design, dose response modelling, computer simulation, internal and external regulatory expectations and new data on evaluating adaptive dose ranging studies.

Adaptive Designs in Clinical Trials 2014 aims to show you how you can quickly and accurately implement an adaptive design clinical trial for your drug development - from initial processes in managing trials to choosing the right time to implement change

WHY ATTEND THIS EVENT:

• Learn from Michael Krams how to create an environment where adaptive designs can become the norm

• The only conference in Europe to focus specifically on adaptive designs in clinical trials

• Benefit from the first-hand experiences of speakers whose organizations have recently made breakthroughs in adaptive designs

• Hear from Vladimir Anisimov the very latest on predicative analytical techniques for increasing efficiency of drug development

• Discover at our post conference workshop how FACT software that supports the ever increasing complexity of adaptive clinical trials works, hosted by Tom Parke of Tessella

KEY SPEAKERS INCLUDE:

• Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson

• Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles

• Roger Lewis, MD, PhD, Senior Medical Scientist, Berry Consultants

• Loïc Darchy, Head of Statistical Methodology Group, Sanofi R&D

• Lilla Di Scala, Senior Statistical Scientist, Roche

• Pantelis Vlachos, Principle Biostatistician, Strategic Consulting, Cytel Corporation

• Sue Todd, Professor of Medical Statistics, University of Reading

• Frank Fleisher, Principal Statistician, Boehringer-Ingelheim

• Christopher Jennison, Professor of Statistics, University of Bath

• Graeme Archer, Statistics Director, GlaxoSmithKline

PLUS TWO INTERACTIVE POST-CONFERENCE WORKSHOPS

Workshop A: Simulating Clinical Trials using the FACTS software package: Why simulate clinical trials, how to simulate clinical trials and the difference it will make. Wednesday 26th March 2014 | Holiday Inn Regents Park, London, UK |8.30am – 1.00pm. Workshop Leader: Tom Parke, Head of Clinical Trial, Solutions, Tessella Ltd

Workshop B: Identifying and Exploiting Opportunities for Efficiency in Clinical Trial Design: An Interactive Adaptive Design Workshop. Wednesday 26th March 2014 | Holiday Inn Regents Park, London, UK | 1.00pm - 5.00pm. Workshop Leader: Professor Roger J. Lewis, MD, PhD, Senior Medical Scientist, Berry Consultants

Adaptive Designs in Clinical Trials

24^th – 25^th March 2014

Holiday Inn Regents Park, London, UK

SMi is proud to present its 8th annual Adaptive Designs in Clinical Trials conference, held in central London on the 24 & 25 March 2014.

Hear through case studies how all sizes of pharmaceutical companies have successfully implemented trials incorporating adaptive designs. This conference is the only in Europe that focuses on adaptive designs specifically, providing delegates with updates on recent developments in enrichment design, dose response modelling, computer simulation, internal and external regulatory expectations and new data on evaluating adaptive dose ranging studies.

Adaptive Designs in Clinical Trials 2014 aims to show you how you can quickly and accurately implement an adaptive design clinical trial for your drug development - from initial processes in managing trials to choosing the right time to implement change

WHY ATTEND THIS EVENT:

• Learn from Michael Krams how to create an environment where adaptive designs can become the norm

• The only conference in Europe to focus specifically on adaptive designs in clinical trials

• Benefit from the first-hand experiences of speakers whose organizations have recently made breakthroughs in adaptive designs

• Hear from Vladimir Anisimov the very latest on predicative analytical techniques for increasing efficiency of drug development

• Discover at our post conference workshop how FACT software that supports the ever increasing complexity of adaptive clinical trials works, hosted by Tom Parke of Tessella

KEY SPEAKERS INCLUDE:

• Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson

• Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles

• Roger Lewis, MD, PhD, Senior Medical Scientist, Berry Consultants

• Loïc Darchy, Head of Statistical Methodology Group, Sanofi R&D

• Lilla Di Scala, Senior Statistical Scientist, Roche

• Pantelis Vlachos, Principle Biostatistician, Strategic Consulting, Cytel Corporation

• Sue Todd, Professor of Medical Statistics, University of Reading

• Frank Fleisher, Principal Statistician, Boehringer-Ingelheim

• Christopher Jennison, Professor of Statistics, University of Bath

• Graeme Archer, Statistics Director, GlaxoSmithKline

PLUS TWO INTERACTIVE POST-CONFERENCE WORKSHOPS

Workshop A: Simulating Clinical Trials using the FACTS software package: Why simulate clinical trials, how to simulate clinical trials and the difference it will make. Wednesday 26th March 2014 | Holiday Inn Regents Park, London, UK |8.30am – 1.00pm. Workshop Leader: Tom Parke, Head of Clinical Trial, Solutions, Tessella Ltd

Workshop B: Identifying and Exploiting Opportunities for Efficiency in Clinical Trial Design: An Interactive Adaptive Design Workshop. Wednesday 26th March 2014 | Holiday Inn Regents Park, London, UK | 1.00pm - 5.00pm. Workshop Leader: Professor Roger J. Lewis, MD, PhD, Senior Medical Scientist, Berry Consultants

Next Gen: 8th Improving Bioavailabilty & Formulation Conference February 24-26, 2014, Philadelphia, PA

Strategies for Ensuring Optimum Solubility and Drug Viability

This summit investigates the core challenges to achieving maximum bioavailability in drug candidates as well as novel drug delivery solutions utilized to improve bioavailability, and expedite time-to-market of new chemical entities as well as reformulated therapeutics in the development pipeline.

For three days attendees will engage in workshops, panel discussions and case studies from distinguished representatives of companies such as Pfizer, Merck, Bristol-Myers Squibb, Astrazenenca, Regeneron and more.

Overall the main topics and themes to be discussed include:

• Ocular and Parenteral Drug Delivery
• Hot melt extrusion Technology/Spray-drying techniques
• High Throughput Robotics for Solubility Screening
• Lipid Excipients: how they work and when to use them
• Frequency Modulated Drug Delivery- bonds with metal to increase solubility and timed release of drug into tissue.
• Bioactive materials in nano-medicines
• Active vs Passive Targeting of Drug Delivery Systems

Paediatric Clinical Trials

31^ST March – 1^ST April 2014

The Kensington Close Hotel, London UK 

Sponsored by PPD

Building on the success of our previous events, SMi is proud to present the 8th instalment in the popular conference series; Paediatric Clinical Trials , taking place on 31st March and 1st April 2014, London UK.

This event will bring together key opinion leaders to provide attendees with an in depth look into current advances in paediatric clinical trials and drug development with a complete view of the paediatric market.

Presentations will focus on regulatory requirements, challenges in clinical trials design, formulation development, extrapolation form the adult population plus much more.

Why Attend this Event in 2014:

• Discuss the global paediatric legislations and an impact assessment of the EU legislation

• Learn about PIP submissions

• Discover how the FDA changes the regulatory landscape for paediatric drug development in the US

• Explore how clinical trials are organised in Hungary

• Analyse vaccines trials vs. antibiotic trials

• Evaluate the experience of a paediatrics ethics committee

• Examine extrapolation in paediatric drug development

• Consider formulation development and paediatric psychopharmacology

Key Speakers:

• Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

• David McIntosh, Global Scientific Affairs Senior Expert, Novartis Vaccines

• Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

• Christina Bucci-Rechtweg, Head, Maternal & Paediatric Regulatory Policy, Novartis

• Klaus Rose, CEO, Klausrose Consulting

• Elin Haf Davies, Director & Founder, Empowering Children | Enabling Research

• Daniel Bar-Shalom, Associate Professor, University of Copenhagen

• Daniel De Wolf, Director - Department of Paediatric Cardiology, Ghent University Hospital

• Karl-Heinz Huemer, Scientific Office, Austrian Agency for Health and Food Safety

• Otto Skoran, CEO, Svabhegy Paediatric Hospital

• Mark Sorrentino, Executive Medical Director, PPD Consulting

Previous instalments received positive feedback from the industry including, "Good presentations and important topics" – Abbott, "I very much enjoyed this conference, thanks to the organisers" – UCB and "Very good meeting" - Boehringer Ingelheim