Event Category: Pharma

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The clinical trial supplies market is expected to reach USD 1,274.3 million by 2020 from USD 904.3 million in 2015, at a CAGR of 7.1%. (Reportlinker’s Clinical Trial Supplies Market by Products & Services, Phases & Therapeutic Areas – Global Forecast to 2020 2015).

The driving forces behind this phenomenon is the globalization of clinical trial activities, upwards in R&D investments and government support, rising incidences of various diseases and growing expansion activities by CROs.

With these in mind, Clinical Trials Supply Chain Global Congress 2016 Europe is being organised to provide a unique platform for business knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain industry.

Paradigm Global Events is proud to present Biosimilars and Follow-On Biologics Americas 2013.

Biosmilars drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.

Biosimilar drugs are, in essence, the biological equivalent of generics for the biopharmaceutical sector. The issues with generic drugs are well known as they have been on the market for a number of years. However, biosimilars are only recently coming on the market as patents for the original innovator drug expires.

There are a number of challenges with biosimilar drugs: commercial, regulatory, and technical. This conference examines all of them in turn and discusses for example: the current usage of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at some of the regulatory issues surrounding the new US law on biosimilars and what this means for the issue of data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the key concern. Biological drugs by definition are produced with recombinant therapeutic protein: so a biosimilar has to be as well. However, no two cell lines are exactly the same, so biosimilar producers have to prove that the overall effects are the same. This can be done in a number of ways, this conference examines the use of mass spectrometry and quality by design.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximise opportunities.

Paradigm Global Events is proud to present The Biobanking 2013 Americas Summit.

The biobanking industry is growing at an exponential rate, as researchers realise the growing importance of using samples for R&D. This growth leads to several issues, commercial, ethical, and scientific.

There are three main strands to this conference: firstly the growth of biobank networks: what does this mean to researchers, how can standards be harmonized, and how can organisations collaborate successfully?

Secondly, the conference will examine the ethical and legal issues of biobanking – including a look at ownership and informed consent; how can you get proper consent for the samples and how can you prove that all steps have been taken to ensure ownership protocols?

Lastly, data management is a huge issue for biobanks, as they grow in size, how are the samples stored, how is the data pertaining to the samples managed, and how can biobanks make effective use of data for their own purposes?

Not only will these three issues be discussed, but the event will also look at drug discovery for biobanks, quality assurance, and include a case study.

Paradigm Global Events is proud to present World of Pre-Filled Syringes & Injectable Devices Americas 2013 Summit.

Pre-filled syringes are becoming more popular as a quicker, more effective way to administer drugs. Yet they come with challenges and technical hurdles. This 2-day conference examines several topics in the arena of pre-filled syringes, including the human aspect, (design and patient safety); quality by design issues; and challenges with extractables/leachables. The event is designed for senior executives involved with the manufacturing

Paradigm Global Events is proud to present The Biobanking Global Congress 2013 Europe.

The biobanking industry is growing at an exponential rate, as researchers realise the growing importance of using samples for R&D. This growth leads to several issues, commercial, ethical, and scientific.

There are three main strands to this conference: firstly the growth of biobank networks: what does this mean to researchers, how can standards be harmonized, and how can organisations collaborate successfully?

Secondly, the conference will examine the ethical and legal issues of biobanking – including a look at ownership and informed consent; how can you get proper consent for the samples and how can you prove that all steps have been taken to ensure ownership protocols?

Lastly, data management is a huge issue for biobanks, as they grow in size, how are the samples stored, how is the data pertaining to the samples managed, and how can biobanks make effective use of data for their own purposes?

Not only will these three issues be discussed, but the event will also look at drug discovery for biobanks, quality assurance, and include a case study.

Paradigm Global Events is proud to present The Biosimilars Global Congress 2013 Europe.

The market for Biologics is currently representing 16% of global pharmaceutical expenditure and significantly out-performing branded sales, it will continue to conquer the global market as it makes way for more innovative products deliver new treatment option.

The market for Biosimilars is expected to reach between US $1.9 billion – $ 2.6 billion by 2015 and is expected to become an increasingly large part of world market for global pharmaceutical with the potential of reaching 50% share.  The lost of patent protection of the twelve top-selling Biologics by 2020 will trigger an estimated sales of $24 billion in Europe and $30 billion in the United States without having to mention the sales from the phamerging markets (China, India, Brazil, Mexico).

As the pharmaceutical market develops, the role of drug delivery in conjunction with the pharmaceutical product itself, increases in importance. Pre-filled syringes are an important part of the landscape which
pharmaceutical companies need to be aware of.

There are several obstacles to creating an effective pre-filled syringe product line, not least because it is composed of several different layers, i.e. the packaging, the syringe, the product, and the pharmaceutical ingredient. Plus of course, as a relatively new entrant into the marketplace, there are commercial and regulatory aspects to consider as well.

This 2-day conference will enable delegates to look at the end-to-end supply chain of pre-filled syringes, from the manufacturing to the logistics. The event will also cover some of the latest hot issues in pharmaceutical manufacturing, such as quality-by-design, and problems with technology transfer and scale-up.
Finally, the physical nature of the pharmaceutical product and the ramifications of its interaction with the syringe itself are an important issue: what difference does it make if it is a biotech drug for example? These will be discussed at length in this event.

Join us for two days of insights, case studies and discussions on pre-filled syringes.

Paradigm Global Events are proud to present The Biosimilars and Follow – On Biologics 2014 Americas

Biosimilars also known as Follow-on Biologics or subsequent entry biologics are official subsequent version of innovator pharmaceutical products on which reference to the innovator product is crucial component for approval.

This conference examines a number of challenges including commercial, regulatory, and technical, all of them in turn and discusses for example: the current commercial trends of biosimilars; what the commercial impact of them is; and what is happening in the BRIC countries.

The conference also looks at the latest  global regulatory guidelines and issues surrounding biosimilars and what this means for the  data exclusivity, is there a need for a balance between innovation and competition?

Technical issues with biosimilars however are the major concern. Biological drugs unlike the more common small-molecule drugs maybe more sensitive to changes in manufacturing process due to its high molecular complexity, so biosimilar producers have to prove that the overall effects are the same.

Following the success of the first generation Monoclonal antibodies blockbusters, here we analyze many challenges to be faced to bring more efficient and affordable anti-body based drugs to the market.

Finally, biobetters are a new category of drug: why just copy a drug when you can improve it? This workshop examines the potential of biobetters for companies and how to maximize opportunities.

Cell-Based Assays 2014 Europe explores the latest thinking and techniques in this growing topic. Cell-based assays are becoming more important as companies realize their usage can significantly reduce the amount of clinical candidates failing to progress through the pipeline, as the assays demonstrably prove leads have a clinical effect. This event covers many topics, which are of vital scientific importance, such as ion channel assays, 3D assays, GPCR, as well as stem cell assays. Moreover, the event also looks at non-scientific areas of concern, such as post-analytics, quality control, and outsourcing, making this event a more rounded conference than other events on the same topic. As R&D budgets are squeezed and costs have to be accounted for, researchers have to be aware of other considerations in their assays, and this conference looks at these as well.

Book now and join us for an exciting two days of interactive and innovative discussions about the potentials of CBA and what are currently on offer and demands in the market today. This is a great opportunity to network with professionals in the field and enjoy learning about new developments in technologies, techniques, methods and detection involved in the CBA process.

Don’t miss this opportunity – Reason to register today and  – Why Attend?

•   The most up-to-date information on Sample Storage and Tracking Issues
•   Review the development and implementation of a tissue repository
•   Hear the latest on the Stem Cell Banking
•   Discuss the changing approaches to target-finding, drug development and patient treatment
•   Gain a clearer insight on Green Banking
•   Understanding the regulatory social and ethical frameworks
•   Examine the quality concerns for existing biospecimen collections
•   Recognise the importance of biobanking in rare disorders
•   Analyse major challenges for biorepository management and implementation
•   Get the latest update on the application

Worldwide Biobanking market is to increase by 30% to reach an estimated $183 Billion by 2015.

A “Must attend??? Biobanking Conference for 2014 for:
VPs, Directors, Heads, Managers of:
•   Biobanks
•   Tissue bank
•   Biorepository / Biosample
•   Translational Medicine
•   Personalised Medicine
•   Biomarkers Development
•   Compound Management
•   Digital Pathology
•   Laboratory Automation
•   Oncology Clinical Research
•   Liquid Handling
•   DNA Methylation
•   Laboratory and Inventory
•   Molecular Diagnostics
•   Clinical Genetics, Pathology
•   Genomics
•   Scientific and Quality
•   Privacy / Protections / Security
•   R & D
•   Quality Control
•   Strategic Outsourcing
•   Clinical Research
•   Bioanlytical Chemistry
•   Pharmacogenomics
•   Proteomics
•   Business Development
•   Strategic Alliances
•   Histopathology
•   Non-clinical Biosample
•   Health Science Policy
•   Toxicology, Clinical Chemistry
•   Clinical trials and Non-clinical R & D
•   Procurement and Strategic Sourcing
•   Informatics

Paradigm Global Events is proud to present Biosimilars Global Congress 2014 Europe.
The two – day Congress will provide and interactive discussion and networking format led by key industry expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts surrounding biosimilars.

Day one topics will focus on:
•   Global Regulatory Perspective
•   Current Regulations and future Challenges for the development of Biosimilars in Europe & US
•   Regulatory Strategies in the Emerging Markets
•   Harmonization
•   Global Commercialization & Reimbursement
•   Clinical & Non-Clinical
•   Impact of Healthcare system on Biosimilars
•   Patients perspective on Biosimilars
•   Scientific and Clinical Considerations for Biologics and Biosimilars
•   Harmonization to ensure patient safety
•   Global Strategic Collaboration
•   Including two interactive panel discussion on:

Day two topics will focus on:
•   Update on FDA Development for Biosimilars
•   Interchangeability – Guidelines
•   Preparing for U.S. Market entry – strategy consideration in view of BPCIA
•   Key Regulatory aspects for development and approval of Monoclonal Antibodies
•   Manufacturing & development process considerations of Biosimilars
•   Substitution and Interchangeability
•   Challenges & Obstacles in Conducting Clinical Trials
•   CMC requirement s for Biosimilars Product Development / Manufacturing
•   Mass Spectrometry for Characterization & Comparability

Paradigm Global Events are proud to present the Monoclonal Antibodies 2014 Congress

Monoclonal Antibodies are also known as targeted therapies because they work by targeting specific proteins on the surface of the cells. Mabs agents are currently have been successfully used in the treatment of cancers, tumors and other serious diseases and is big on the market.

The market size of Monoclonal antibody agents in 2009-2012 grew at a CAGR of 13% and is expected to rise by more than 12% in 2013-2017 reaching $141 billion in 2017. This is due to great market demand, new products being approved and also launching of Mabs generic drugs.

The global industry of Mabs is currently dominated by European and American  companies, however, sales of Mabs in the rest of the world will remain higher than in the U.S despite a higher CAGR in the U.S.

The pharmaceutical sector has been impacted by the recent global financial crisis. There are a range of mechanisms that governments are using to rein in pharmaceutical spending and these are being implemented in various ways across the region. And dome of these mechanisms affect the supply chain for pharmaceutical products. Pharma End-to-End Supply Chain 2014 Europe provide an unique platform for business knowledge sharing and convergence of top tier government, hospitals, pharmaceuticals, biotechnology, non-profit organisations, as well as regional and local manufacturers to discuss and share on the macroeconomic factors, policies, issues and drivers that will steer the evolving supply chain in the pharmaceutical industry.

Biosimilars and Follow-on Biologics are copied version of reference biologics which are protected by intellectual rights. We are now reaching the long anticipated period of patent expiration which is the major driving factor of the Biosimilars market. With some $60 billion worth of the pharmaceutical industry’s biggest blockbuster biologics coming off patent in the US and Europe in the next four years, contributing a significant gap to be filled with a more cost-effective follow-on products. This would provide a competitive advantage to local pharmaceutical manufacturers over the global players, undoubtedly that the market for biosimilar and follow-on biologic products is due to burst.

Furthermore, regulations plays a crucial role in sustaining feasibility and equilibrium between the original and biosimilar products. Key markets such as US and Europe are now vigorously regulating the sector, with FDA and EMA now providing guidelines for regulatory approval, biosimilar companies from less established market can now see to differentiate current practices needed to gain approval in new markets.
Another contributing factor to take the biosimilars market to a new heights is the continued rise in chronic diseases among aging populations which continues to drive the need for more cost-effective healthcare in developed countries.

However, some scientific challenges, unanswered questions and uncertainties surrounding biosimilars and follow-on biologics are creating remarkable obstacles for companies to increase uptake in the global market. The only way to success is to organize a cross disciplinary team with expertise in biological products, clinical development, regulatory affairs, and medical practices to watchfully plan a proper development strategy.

A recently released report suggests that the global market will reach $36 billion by the year 2020, up from the estimated $1.3 billion in 2013. High profitability is the attractive aspect that is enticing companies to invest in the biosimilars industry.

Paradigm Global Events are proud to present the Clinical Trials Supply Chain Logistics Global Congress 2014 Europe.

The pharmaceutical industry began globalizing clinical trials about 15 years ago and; lured by lower research expenses and rapid patient recruitment half of all clinical trials are conducted offshore and in more developing countries than ever before, profoundly increasing the complexity of supply chain logistics. Some of the forces affecting the industry include access to new markets and patients, regulatory standards for clinical trials supply, supply chain security and other technology for developing and testing medicines.

“The global market for clinical trial supply and logistics services will expand by six percent in 2014, with revenue growth to 2023.??? (Visiongain’s Clinical Trials Supply and Logistics: World Market Outlook 2014 – 2023). Along with this opportunity are challenges and hurdles for the pharmaceutical industry to overcome.

Clinical Trials Supply Chain Logistics Global Congress 2014  – Europe provides a unique platform for an intimate & interactive knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the clinical trials supply chain logistics industry.

Orphan Drugs & Rare Diseases Global Congress 2015 Europe

Paradigm Global Events are proud to present the Orphan Drugs & Rare Diseases Global Congress 2015 Europe.

Over 7,000 different types of rare diseases and disorders exist, with more being discovered each day, and large pharmaceutical and biotech companies are structuring to participate and leverage the growing orphan market. “Orphan drug sales will make up 19% of the total share of prescription drug sales by 2020, totaling $176 billion. And they’ll grow at an annual rate of nearly 11% per year through the end of the decade, compared with about 4% for drugs treating larger populations.??? (EvaluatePharma’s Orphan Drug Report 2014)

Orphan Drugs & Rare Diseases Global Congress 2015  – Europe provides a unique platform for an intimate & interactive knowledge sharing and convergence of top tier government, pharmaceuticals, biopharmaceuticals, hospitals, non-profit organisations, orphan drugs developers as well as regional and local manufacturers to discuss the driving macroeconomic factors, policies and issues that will steer the development of orphan drugs globally.

Over the last decade, there has been a swift increase in the quantity of biological medicines that have received regulatory approval globally.

To obtain approval for consumption, a biosimilar medicine which is medicine that is develop to be similar to an existing biological medicine, have to establish that they are as safe and effective as the original reference medicine and have the same quality.

A number of top-selling biological medicines have lost or will be losing their patent over the next few years, particularly, monoclonal antibodies. Hence, Bio- similar Medicines are develop in expectation of imminent patent expiry of innovator biologics drugs.

Although biosimilars are already in use to some extent, it is likely that their availability and use will become more comprehensive over the next few years as it has the potential to present a more cost effective tool for pharmaceutical expenditures.

The Congress will provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more. The congress will also cover a diverse range of topics and offer an interesting insight as to latest strategies and obstacles faced by the industry, from the develop- ment to market of Biosimilars.

The pharmaceutical industry is in a state of flux and with many drugs going off-patent in 2015 affecting drugmakers’ billions of sales. With this change, manufacturers have to look at ways to reduce costs and improve profit margins whilst promising safety and efficacy of their medicines.
Health Economics Global Congress 2015 Europe provides a unique platform for business knowledge sharing and convergence of top tier government, hospitals, pharmaceuticals, biotechnology, non-profit organisations, as well as regional and local manufacturers to discuss and share on the macroeconomic factors, policies, issues and drivers that will steer pharmaceutical industry.

Dear Colleagues

The global biosimilars market is anticipated to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015 to 2020. The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market.

Between 2015 and the end of 2019, 39 biologics with combined US sales of $41 billion, representing 30% of the total market will lose their marketing exclusivity. This resulted in huge interest by big pharma and biotech company venturing into the Biosimilar sector in order to gain a slice of multibillion worth of biologics market.

The FDA’s approval of the first Biosimilar product in the US is a significant event. A full blown Biosimilars market offers a huge potential in bettering patient outcomes and contributing compelling cost, opening the doors for easy access and optimal care. It was reported that Biosimilars could save the US economy up to $250 billion within the next seven years.

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

In this congress, we will cover a diverse range of topic and address the challenges and obstacles encountered by the industry from development to successful market of biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

I look forward to meeting you at the conference.

Best regards,

Jocelyn Raguindin Conference Director Paradigm Global Events