Biopharmaceutical Competitive Intelligence 4th April 2016, London, United Kingdom

Competitive Intelligence (“CI”) is a strategic and tactical methodology to derive deep, accurate and actionable insight into the overarching competitive landscape. In the biopharmaceutical sector, CI is leveraged as a means of understanding in-market, as well as developmental pipeline and emerging players, assets and threats. CI is an extremely powerful resource when appropriately undertaken and actionably implemented.

This workshop will review competitive intelligence in the biopharmaceutical sector, as well as delineate how it can be effectively implemented into the standard day-to-day practices of biopharmaceutical companies, globally. We will review and discuss broad-based competitive assessments, as well as focus on key “hot spots” in biopharmaceutical CI such as biosimilars and generics and manufacturing and supply chain logistics intelligence.

https://www.smi-online.co.uk/pharmaceuticals/uk/masterclass/biopharmaceutical-competitive-intelligence

Biosimilars from A to Z: an in-depth introduction 5th April 2016, London, United Kingdom

There is a huge amount of interest across the industry about biosimilars. Due to a more economic price, they present a major opportunity to help control rising healthcare costs and to improve patient access to very expensive biologic treatments.
This masterclass will provide a detailed introduction of biosimilars: from analytical development, regulatory requirements to preclinical and clinical advances as well as manufacturing considerations.

The masterclass will also address aspects such as how biologics including monoclonal antibodies are developed and manufactured and the potential of biosimilars to provide access to patients which will released funds for innovative medicines.

Stem Cells in Drug Discovery 2016 April 5-6 2016 , Cambridge, UK

In June 2015 we launched Stem Cells in Drug Discovery in Cambridge, United Kingdom to a great response! Featuring presentations from Lorenz Mayr, Joseph Wu and Chris Ward, over 90 people attended, from 9 different countries, including PhD students, Professors, Group Leaders, Directors, Global Heads and VPs of some of the world’s leading stem cell research centres.

We are looking to build the event for 2016 with an additional track, entitled Organ-on-a-Chip Europe, there will be even more talks, attendees and discussions. With human stem cells presenting a more accurate model for pre-clinical testing, this year’s agenda provides in depth insight into how stem cells are revolutionizing in vitro disease models, assay development, toxicology studies and lead generation in drug discovery.

Stem Cells in Drug Discovery 2016 April 5-6 2016 , Cambridge, UK

In June 2015 we launched Stem Cells in Drug Discovery in Cambridge, United Kingdom to a great response! Featuring presentations from Lorenz Mayr, Joseph Wu and Chris Ward, over 90 people attended, from 9 different countries, including PhD students, Professors, Group Leaders, Directors, Global Heads and VPs of some of the world’s leading stem cell research centres.

We are looking to build the event for 2016 with an additional track, entitled Organ-on-a-Chip Europe, there will be even more talks, attendees and discussions. With human stem cells presenting a more accurate model for pre-clinical testing, this year’s agenda provides in depth insight into how stem cells are revolutionizing in vitro disease models, assay development, toxicology studies and lead generation in drug discovery.

Rx to OTC Switching & the Future of Self-Care  6th April 2016, London, United Kingdom

SMi present their 2nd annual masterclass in Rx to OTC switching to help address key steps and issues, and to review growth opportunities from OTC drugs to medical devices and food supplements. This masterclass will cover the essentials skills needed to ensure a successful switch and maintain strong brand portfolio and life cycle management.

This step-wise roadmap of strategic and operational planning aims to help guide switch leaders towards the successful creation, development and establishment of innovative OTC brands in the changing consumer healthcare market environment.

https://www.smi-online.co.uk/pharmaceuticals/uk/masterclass/rx-to-otc-switching-the-future-of-self-care

Asthma & COPD  11th April to 12th April 2016, London, United Kingdom

SMi is proud to announce the return the 12th annual Asthma & COPD conference 2016 in London!

Respiratory diseases represent an enormous and increasing healthcare and economic burden across Europe and USA.
Over the last few years, significant improvements in the management of asthma and COPD have been made, owing to new drugs, strategies and to the development of the nonpharmacologic treatment of COPD. Nevertheless, there are still many unmet needs in the treatment of these diseases.

Join us at SMi's 12th annual Asthma & COPD taking place on the 11th - 12th April 2016 in London. This event will explore innovative asthma and COPD drug development programmes, directives and procedures which have been put in place to reduce the enormous suffering from lung disease and its high mortality.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to: • develop vaccination approaches for asthma • improve inhaled therapies in COPD and development of antivirals • evaluate the impact of COPD phenotypes on therapy • explore biomarkers for respiratory drug assessment • learn about stratified medicine and prevent exacerbation in asthma and COPD

Asthma & COPD  11th April to 12th April 2016, London, United Kingdom

SMi is proud to announce the return the 12th annual Asthma & COPD conference 2016 in London!

Respiratory diseases represent an enormous and increasing healthcare and economic burden across Europe and USA.
Over the last few years, significant improvements in the management of asthma and COPD have been made, owing to new drugs, strategies and to the development of the nonpharmacologic treatment of COPD. Nevertheless, there are still many unmet needs in the treatment of these diseases.

Join us at SMi's 12th annual Asthma & COPD taking place on the 11th - 12th April 2016 in London. This event will explore innovative asthma and COPD drug development programmes, directives and procedures which have been put in place to reduce the enormous suffering from lung disease and its high mortality.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to: • develop vaccination approaches for asthma • improve inhaled therapies in COPD and development of antivirals • evaluate the impact of COPD phenotypes on therapy • explore biomarkers for respiratory drug assessment • learn about stratified medicine and prevent exacerbation in asthma and COPD

Asthma & COPD  11th April to 12th April 2016, London, United Kingdom

SMi is proud to announce the return the 12th annual Asthma & COPD conference 2016 in London!

Respiratory diseases represent an enormous and increasing healthcare and economic burden across Europe and USA.
Over the last few years, significant improvements in the management of asthma and COPD have been made, owing to new drugs, strategies and to the development of the nonpharmacologic treatment of COPD. Nevertheless, there are still many unmet needs in the treatment of these diseases.

Join us at SMi's 12th annual Asthma & COPD taking place on the 11th - 12th April 2016 in London. This event will explore innovative asthma and COPD drug development programmes, directives and procedures which have been put in place to reduce the enormous suffering from lung disease and its high mortality.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to: • develop vaccination approaches for asthma • improve inhaled therapies in COPD and development of antivirals • evaluate the impact of COPD phenotypes on therapy • explore biomarkers for respiratory drug assessment • learn about stratified medicine and prevent exacerbation in asthma and COPD

Human factors and inhaler handling studies  13th April 2016, London, United Kingdom

Dry powder inhalers (DPIs) and pMDIs are the most common inhalers. While all pMDIs follow the same handling principles, the development of DPIs offers new challenges: The operations to use the inhaler correctly get more complex and vary from product to product. Even with training, there is the intellectual challenge that prescribers and patients may forget and mix-up essential handling steps.
The workshop aims at identifying ways to prove that patients use their inhalers correctly.

Adaptive Designs in Clinical Trials  18th April to 19th April 2016, London, United Kingdom

SMi is proud to present its 8th Annual conference on Adaptive Designs in Clinical Trials taking place on 18th - 19th April in London

In recent years, the use of adaptive design methods has become very popular due to its flexibility for identifying clinical benefits of the testing drug. Adaptive designs offer the potential to reduce timelines and patient exposure while maximising the probability for successful outcomes. However, along with these benefits come challenges: additional complexity, needs for advanced statistical models and increased operational demands.

The 8th annual Adaptive Clinical Trials conference is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, regulatory issues associated with adaptive design, and more.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
• Explore the use of adaptive design methods in clinical trials
• Adapt clinical development for immunotherapies in oncology
• Evaluate adaptive designs and Bayesian statistic
• Improve covariant adaptive designs
• Seamless Phase I/II Dose Finding Designs with Efficacy and Safety Endpoints

Controlled Release  18th April to 19th April 2016, London, United Kingdom

SMi is proud to announce the return of their 13th annual Controlled Release event to London in 2016! Controlled-release (CR) drug-delivery systems continue to play an important role in the treatment of diseases.

With an increase prevalence of cancer globally and advanced developments in controlled release technologies, controlled release remains the top priority for formulation scientists. Recent breakthroughs include the utilisation of nanotechnology and hydrogel polymers in controlled release mechanisms. In particular a long-acting insulin analogue shows promise for the treatment of diabetes, a unique approach which activates a micelle formation, facilitating transport of drug and significantly increasing absorption with a 10 to 50 fold increase in bioavailability.*

SMi’s 13th Controlled Release 2016 event will engage you in lively discussions with industry leaders to discover the latest innovations, as well as guiding you through the latest regulatory updates to ensure strict compliance. Through the 2-day meeting, you will learn about up and coming novel controlled release strategies to accelerate commercialization.

*http://www.pharmtech.com/oral-absorption-enhancing-drug-delivery-technology

Adaptive Designs in Clinical Trials  18th April to 19th April 2016, London, United Kingdom

SMi is proud to present its 8th Annual conference on Adaptive Designs in Clinical Trials taking place on 18th - 19th April in London

In recent years, the use of adaptive design methods has become very popular due to its flexibility for identifying clinical benefits of the testing drug. Adaptive designs offer the potential to reduce timelines and patient exposure while maximising the probability for successful outcomes. However, along with these benefits come challenges: additional complexity, needs for advanced statistical models and increased operational demands.

The 8th annual Adaptive Clinical Trials conference is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, regulatory issues associated with adaptive design, and more.

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
• Explore the use of adaptive design methods in clinical trials
• Adapt clinical development for immunotherapies in oncology
• Evaluate adaptive designs and Bayesian statistic
• Improve covariant adaptive designs
• Seamless Phase I/II Dose Finding Designs with Efficacy and Safety Endpoints

Controlled Release  18th April to 19th April 2016, London, United Kingdom

SMi is proud to announce the return of their 13th annual Controlled Release event to London in 2016! Controlled-release (CR) drug-delivery systems continue to play an important role in the treatment of diseases.

With an increase prevalence of cancer globally and advanced developments in controlled release technologies, controlled release remains the top priority for formulation scientists. Recent breakthroughs include the utilisation of nanotechnology and hydrogel polymers in controlled release mechanisms. In particular a long-acting insulin analogue shows promise for the treatment of diabetes, a unique approach which activates a micelle formation, facilitating transport of drug and significantly increasing absorption with a 10 to 50 fold increase in bioavailability.*

SMi’s 13th Controlled Release 2016 event will engage you in lively discussions with industry leaders to discover the latest innovations, as well as guiding you through the latest regulatory updates to ensure strict compliance. Through the 2-day meeting, you will learn about up and coming novel controlled release strategies to accelerate commercialization.

*http://www.pharmtech.com/oral-absorption-enhancing-drug-delivery-technology

12th EFMC Short Course on Medicinal Chemistry Modulation of Enzymes; Epigenetics and Beyond. Oegstgeest (near Leiden), The Netherlands - April 24-27, 2016

12th EFMC Short Course on Medicinal Chemistry Modulation of Enzymes; Epigenetics and Beyond. Oegstgeest (near Leiden), The Netherlands - April 24-27, 2016

3rd Annual Pre-Filled Syringes East Coast 25th April to 26th April 2016, Iselin, USA

Emulating from the success of its 2015 sell-out show, SMi Group is delighted to announce the return of the 3rd annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 25th – 26th 2016 in Iselin, New Jersey, USA.
 

With the growing demand for biologics and ready-to-administer (RTA) syringes, recent reports have predicted the global pre-filled syringes (PFS) market to reach $6.6bn by 2020. While we have witnessed booming investments in PFS, the industry still needs to overcome a number of hurdles to commercialize this delivery platform.
 

Through a combination of powerful keynote addresses, topical debate and interactive workshops, Pre-Filled Syringes East Coast will once again play host to an audience of senior scientists, device manufacturers and PFS market professionals, providing a focal point to discuss the latest innovations and developments in pre-filled syringes; as well as honing in on industry challenges and regulatory compliance.
 

The expert speaker line-up for 2016 includes:

• Stephen Barat, Executive Director, Non-Clinical & Translational Sciences, Safety Assessment & Bioanalysis, Allergan

• Ravi S. Harapanhalli Ph.D., Principal, FDAPharma Consulting LLC

• Mathias Romacker, Senior Director, Device Strategy, Pfizer

• Dr. Paolo Mangiagalli, Senior Director, Head PFS Platform, Sanofi

• Ken Wong, Deputy Director, MTech/ Process Technology – Extractables & Leachables, Sanofi Pasteur

• Carsten Worsoe, Principal Scientist, CMC Analytical Support, Novo Nordisk A/S

• Dr. Shawn Davis, Principal Engineer, Device Strategy, Amgen

• Mohammed Umar, Principal Technical Manager, Quality Engineering, Genentech

• Jason Lipman, Associate Director, Regulatory Affairs, Medical Devices & Combination Products, Janssen R&D, LLC

Event Highlights:

• Discover how to eliminate extractables and leachables (E&L) through a case study driven presentation from Merck

• Hear how Eli Lilly give the PFS a human touch – incorporating human factor engineering into a patient-centric device

• Ensure commercial competitiveness of PFS as a drug device

• Assess trends of combination products and impacts on PFS

• Learn about the latest cutting edge technological developments in COP and sterilization to accelerate your PFS development

• Exclusive post-conference workshops led by Cambridge Consultants on Human Factor Engineering and FDAPharma Cosulting LLC on CMC Considerations

For further details and to download a brochure, visit the website at www.pfsamericas.com/bioscreening

12th EFMC Short Course on Medicinal Chemistry Modulation of Enzymes; Epigenetics and Beyond. Oegstgeest (near Leiden), The Netherlands - April 24-27, 2016

3rd Annual Pre-Filled Syringes East Coast 25th April to 26th April 2016, Iselin, USA

Emulating from the success of its 2015 sell-out show, SMi Group is delighted to announce the return of the 3rd annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 25th – 26th 2016 in Iselin, New Jersey, USA.
 

With the growing demand for biologics and ready-to-administer (RTA) syringes, recent reports have predicted the global pre-filled syringes (PFS) market to reach $6.6bn by 2020. While we have witnessed booming investments in PFS, the industry still needs to overcome a number of hurdles to commercialize this delivery platform.
 

Through a combination of powerful keynote addresses, topical debate and interactive workshops, Pre-Filled Syringes East Coast will once again play host to an audience of senior scientists, device manufacturers and PFS market professionals, providing a focal point to discuss the latest innovations and developments in pre-filled syringes; as well as honing in on industry challenges and regulatory compliance.
 

The expert speaker line-up for 2016 includes:

• Stephen Barat, Executive Director, Non-Clinical & Translational Sciences, Safety Assessment & Bioanalysis, Allergan

• Ravi S. Harapanhalli Ph.D., Principal, FDAPharma Consulting LLC

• Mathias Romacker, Senior Director, Device Strategy, Pfizer

• Dr. Paolo Mangiagalli, Senior Director, Head PFS Platform, Sanofi

• Ken Wong, Deputy Director, MTech/ Process Technology – Extractables & Leachables, Sanofi Pasteur

• Carsten Worsoe, Principal Scientist, CMC Analytical Support, Novo Nordisk A/S

• Dr. Shawn Davis, Principal Engineer, Device Strategy, Amgen

• Mohammed Umar, Principal Technical Manager, Quality Engineering, Genentech

• Jason Lipman, Associate Director, Regulatory Affairs, Medical Devices & Combination Products, Janssen R&D, LLC

Event Highlights:

• Discover how to eliminate extractables and leachables (E&L) through a case study driven presentation from Merck

• Hear how Eli Lilly give the PFS a human touch – incorporating human factor engineering into a patient-centric device

• Ensure commercial competitiveness of PFS as a drug device

• Assess trends of combination products and impacts on PFS

• Learn about the latest cutting edge technological developments in COP and sterilization to accelerate your PFS development

• Exclusive post-conference workshops led by Cambridge Consultants on Human Factor Engineering and FDAPharma Cosulting LLC on CMC Considerations

For further details and to download a brochure, visit the website at www.pfsamericas.com/bioscreening

12th EFMC Short Course on Medicinal Chemistry Modulation of Enzymes; Epigenetics and Beyond. Oegstgeest (near Leiden), The Netherlands - April 24-27, 2016

Lyophilisation USA  27th April to 28th April 2016, Iselin, USA

SMi Group are thrilled to present the 2nd annual Lyophilization USA conference, returning to Iselin, New Jersey on April 27th & 28th 2016.
 

With an increase in contract services, combination products and innovative drug delivery devices, growing demand for lyophilization equipment and lyophilized biopharmaceuticals has contributed to a projected rise in market growth from US $2.0 billion in 2013 to US $4.8 billion by 2020.
 

While pharmaceutical companies are still dedicating research efforts on freeze drying technologies, commerciality of scaling up and homogeneity of product quality remain top concerns.
 

Lyophilization USA 2016 will gather leading market experts to discuss the latest cutting edge developments in freeze drying as well as solutions to on-going industry challenges. The packed agenda features a mix of case study led presentations, panel debates, interactive workshops and keynote addresses that have been tailored for an audience of professionals working in pharmaceutical lyophilization from formulation development through to production and quality assurance.
 

Featured Speakers Include:

• Jim Searles, Technical Fellow, Global Technical Services, Pfizer

• Mark Yang, Director, Genzyme

• Evgenyi Shalaev, Research Investigator, Allergan

• Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

• Vineet Kumar, Senior Scientist, Johnson & Johnson

• Ralph Tarantino, Pharmaceutical Consultant & Principal, Steritech Solutions LLC

• Stuart Wang, Senior Scientist, Protein Process Development, Biogen Idec

• Jamie Tsung, Principal Scientist, Momenta Pharmaceuticals

Why You Should Attend:

• Define CQAs and QbD for a smooth lyophilization program – bridging upstream and downstream

• Learn about new technologies to accelerate lyophilization process and stabilize complex biologics products

• Thrive on product quality control and assurance during mass production and tech transfer

• ‘Dry fast and smart’ – develop a commercially viable lyophilization cycle

• Benchmark your strategies against peers’ and industry experts’ to ensure a sustainable drug development program and pipeline

Register online at http://www.lyophilization-usa.com/bioscreening

Lyophilisation USA  27th April to 28th April 2016, Iselin, USA

SMi Group are thrilled to present the 2nd annual Lyophilization USA conference, returning to Iselin, New Jersey on April 27th & 28th 2016.
 

With an increase in contract services, combination products and innovative drug delivery devices, growing demand for lyophilization equipment and lyophilized biopharmaceuticals has contributed to a projected rise in market growth from US $2.0 billion in 2013 to US $4.8 billion by 2020.
 

While pharmaceutical companies are still dedicating research efforts on freeze drying technologies, commerciality of scaling up and homogeneity of product quality remain top concerns.
 

Lyophilization USA 2016 will gather leading market experts to discuss the latest cutting edge developments in freeze drying as well as solutions to on-going industry challenges. The packed agenda features a mix of case study led presentations, panel debates, interactive workshops and keynote addresses that have been tailored for an audience of professionals working in pharmaceutical lyophilization from formulation development through to production and quality assurance.
 

Featured Speakers Include:

• Jim Searles, Technical Fellow, Global Technical Services, Pfizer

• Mark Yang, Director, Genzyme

• Evgenyi Shalaev, Research Investigator, Allergan

• Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

• Vineet Kumar, Senior Scientist, Johnson & Johnson

• Ralph Tarantino, Pharmaceutical Consultant & Principal, Steritech Solutions LLC

• Stuart Wang, Senior Scientist, Protein Process Development, Biogen Idec

• Jamie Tsung, Principal Scientist, Momenta Pharmaceuticals

Why You Should Attend:

• Define CQAs and QbD for a smooth lyophilization program – bridging upstream and downstream

• Learn about new technologies to accelerate lyophilization process and stabilize complex biologics products

• Thrive on product quality control and assurance during mass production and tech transfer

• ‘Dry fast and smart’ – develop a commercially viable lyophilization cycle

• Benchmark your strategies against peers’ and industry experts’ to ensure a sustainable drug development program and pipeline

Register online at http://www.lyophilization-usa.com/bioscreening