|
Biopharm Knowledge Publishing is developing a series
of expert Guides to key outsourcing issues in the pharmaceutical and
biotechnology industries. Central and Core Laboratories A definitive report on the current status and future prospects of Central Clinical Pathology Laboratories, Central ECG Analysis Laboratories and Central Bio-imaging Laboratories. The Central and Core Laboratories market is now worth more than $2.2 billion a year and is vital to the successful development of new drugs. It is a completely outsourced and truly global business dominated by major players. Choosing the right Central Laboratory and handling the relationship effectively is vital to the successful management of clinical trials, as is the complex business of getting samples from the patient to the laboratory. In a publishing breakthrough this 320 page report gives comprehensive coverage of the Central Laboratories market, the major companies involved, the processes, including testing and logistics and the future challenges for the market. It is a vital resource for anyone involved in drug development, clinical trials, the central labs market and logistics. Contents include:
The comprehensively-referenced report is published by Biopharm Knowledge Publishing and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing. Contributors include:
Dr Graham Hughes This 320 page report provides a full picture of a fast-growing industry now worth more than $2 billion and vital to the success of drug development. It also gives a complete guide to managing the outsourcing and logistics process. At just £1195 ($1850) for a 320 page report, Central and Core Laboratories is vital information for an affordable price. The report is required reading for executives in pharmaceutical companies, contract research organisations and laboratories, logistics and transportation companies as well as equipment suppliers and those investing in this expanding business area. Download the table of contents Download the list of tables & graphs Click here to order Contract Research Annual Review 2011 The Complete Picture of the Contract Research Market The contract research market grew to $28 billion last year, increasing by 15%. But that top line figure conceals a rapidly changing market and a sharp fall in profitability. Many major CROs have seen profit fall by more than 50%. The industry is rapidly re-shaping itself to match the changing needs of a pharmaceutical industry that is realigning its R&D strategies to improve effectiveness and to face a new set of demands from the market. 22 strategic alliances with CROs were announced by major pharma companies in 2010/11 as the industry was finally forced to embrace the idea of strategic outsourcing. This review provides a complete picture of the CRO market, looks at trends and developments, explains why they have happened and how they will affect the future of the industry. Completely revised and re-formatted for 2011 the Contract Research Annual Review also contains thought provoking pieces from senior managers at leading CROs. With 29 graphs and 18 tables, this unique 180-page review includes:
Written by industry expert Dr. Graham Hughes the Contract Research Annual Review costs just £395 ($585) Download the table of contents Download the list of tables & graphs Click here to order Hepatitis C Therapeutic Class Overview Hepatitis C is a major disease world wide with infection global rates as high as 3 - 4 million per year. While sexual transmission is not now regarded as a major factor the disease does have high co-infection rates with HIV, while in California 82% of those diagnosed have previously been in prison. Treatment with biological drugs is complex and may vary between genotypes. This new report provides a complete, detailed picture of the disease, the market and the companies operating in it. Contents include:
Hepatitis C Therapeutic Class Overview costs £1245 ($1995) and is essential reading for corporate management and those in, marketing and sales, R&D, and regulatory affairs. It is aimed at biotech, big pharma, analysts, producers of biosimilars / biogenerics, regulatory agencies and clinical research organisations. Download the table of contents For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Outlook 2011 - Global Pharmaceutical and Biotechnology Markets The Global Pharmaceutical Model is changing. Major pharmaceutical companies continue to under-perform in a market constrained by patent expiry, generic competition and a lack of new blockbuster drugs. There are signs of improvement, with the outcome of new clinical trials and new launches expected to reshape market dynamics. But despite that companies other than the majors need to be analysed and understood to find the route to real growth in pharmaceuticals. This unique new report from Mehta Partners, Outlook 2011, provides a detailed analysis of sectors where there are real opportunities for growth; it looks at rising stars, at emerging companies in India and Japan and at biotech. Mehta Partners also predicts that outsourcing, or “externalising” of R&D will continue to be the best approach – 56% of NMEs approved last year were in-licensed. This new report makes sense of a rapidly changing pharmaceutical market and provides unparalleled insight and analysis that will enable you to seek out the capabilities that are needed for success and the companies that have those capabilities. In all the 500+ page report looks at five market sections:
For each market place the report provides a detailed sector overview and then recommends the companies that will succeed and explains why. Each company analysis includes a detailed drug-by-drug pipeline analysis with explanations of how a drug will perform in its therapy area and why. And there is an in-depth look at the current portfolio with generic exposure analysis and sales projections to 2015. The table of contents, below, will give you a good idea of the type of highly-detailed information that is contained in the report and we would be very happy to give you a full demonstration over the web or face to face - just call 01256 336632 to arrange a demonstration. £6650 ($9950) Download the table of contents For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com The Future of Biosimilars – Market Forecasts to 2015, Opportunity Analysis and Regulatory Pathways Biosimilars represents an exciting opportunity - and a potential threat to originator companies. The nature of the products, their production and the complex regulatory environment make entering the market difficult. This report provides insights into biosimilars market and its growth to 2015. Further, the distribution of revenues across key geographies such as the US, the top five countries in Europe and Japan are provided in the report. The report discusses the latest developments in the regulatory landscape and the evolving biosimilars approval pathways in Europe, the US and Japan. In-depth analysis into the individual segments of biosimilars market, their market forecasts and potential are also provided. The study analyzes the competitive landscape including benchmarking of the leading companies in the biosimilars market. Finally, a key trends analysis of mergers and acquisitions and licensing agreements involving biosimilars, is also provided. The scope of this report includes:
The report will enable business development and marketing executives strategizing their product launches to:
This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry. £2350 ($3500) Table of Contents List of Tables List of Figures For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Pharmaceutical Market Trends, 2010 - 2014: A detailed trend analysis of the global pharmaceutical market to the end of 2009 and forecasts until 2014. This 142 page report presents a series of market forecasts and growth opportunities in order to help inform pharmaceutical decision-making, particularly in the areas of corporate planning, portfolio management and market forecasting. The report is divided into five key sections. Chapters 2-5 present historical trends for key pharmaceutical markets, key therapy areas, key products and key companies. The final report chapter outlines future pharmaceutical trends and key growth opportunities. The data and analysis contained within the report are derived from Delphi Pharma, Company Trends Database to provide a comprehensive, consistent and up-to-date single-point reference for understanding key pharmaceutical market trends in 2010. “The global pharmaceutical market grew to $808 billion in 2009, at a compound annual growth rate of 9.3% between 1999 and 2009. Year-on-year growth in the global pharmaceutical market decreased to 4.6% in 2009, largely as a result of cost containment in the US and major European markets and the impact of several blockbuster patent expiries in 2008 and 2009.” Findings from the report include:
Readers of the report will find:
Use this report to:
Report Coverage: The report methodology provides a detailed but transparent analysis of key pharmaceutical market trends, including key markets, therapy areas, products and companies. Historical trends are formed over a three-year time horizon and future forecasts are made using a five-year future time period. Thus, the data and analysis relate to the nine-year time horizon from 2005 to 2014. £1495 ($2345) Table of Contents List of Figures and Tables For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com The Future of Contract Research Outsourcing - Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking The contract research market is changing. This report provides key data, information and analysis of the global contract research outsourcing market. It provides market overview, competitive landscape and market trends information on the contract research outsourcing market as well as comprehensive information on the different service models present in the industry and key analytical content on the market dynamics. The report also reviews the competitive landscape in terms of mergers and acquisitions, strategic partnerships and service agreements. Content includes:
The report will enable you to:
Table of Contents List of Figures List of Tables £2350 ($3500) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Factor Xa Inhibitors New generation oral anticoagulants - will they change the market? Factor Xa inhibitors have the capacity to be the future of the oral anticoagulant market - but 2010 and the first half of 2011 will be a key time with outcome of the ROCKET - AF and ADVANCE -3 trials and the FDA approval of Pradaxa. The new class must show clear advantages over warfarin and the new warfarin analogues in indications including: stroke prevention in AF; ACS, VTE prevention and medically ill patients; and in VTE treatment. On top of that the drugs need to compete with each other for market share. This new report gives a complete picture of the market and provides an in-depth analysis of how the new generation of anticoagulants will perform, explaining the key issues:
The report also looks at early stage Xa inhibitors including betrixaban plus warfarin analogues and genetic variant testing. Table of Contents Figures and Tables £1345 ($1995) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Biosimilars: A Growing Market Developments, regulation, companies & commercial opportunities The biologicals segment has been the fastest growing segment of the pharmaceuticals market in recent years, with sales of the leading products (not including insulins) reaching $60 billion. Although a number of major companies have significant biological capabilities few, apart from Novartis, have yet clearly developed strategies to compete in the biosimilars market. Since Sandoz pioneered the development of biosimilar drugs in 2001 there has been a steady breakdown of regulatory resistance. However, there are considerable entry barriers hindering companies that wish to enter this field of therapeutics. Biosimilars - A Growing Market is a unique report that provides the reader with a comprehensive review of the current and future market for biosimilar products. Some key findings from the report:
Report Structure Chapter 1 focuses on the development history of biosimilars and provides an overview of the environment. Chapter 2 considers the progress towards the development of approval pathways for this class of agents in the US and Japan, together with the current European framework. It also briefly addresses the position in other markets. Chapter 3 discusses the substantial hurdles that must be surmounted by those companies that wish to develop and market biosimilars. And these are additional to the regulatory hurdles that are discussed in chapter 2. Chapter 4 examines the blossoming European market for biosimilars. The regulatory barriers to their approval in both Japan and the US have ensured that few biosimilars are yet available in those markets. Chapter 5 highlights the key factors that suggest that the successful development and marketing of a biosimilar product is commercially advantageous. It also covers, subject to the availability of suitable enabling legislation in the US and Japan, which biosimilars products might enter the market. Chapter 6 analyses the impact of biosimilars upon specialist, generic and market pharmaceutical companies. A number of key companies are profiled. Chapter 7 looks to the future and considers which factors will impact the market for biosimilars. The high cost of these products and the increasing pressure that they place on healthcare budgets is likely to prove a major driver in the adoption and uptake of biosimilars, even in the US market. The report concludes by assessing the market outlook over the period 2010-20, which is forced to rely on certain key assumptions owing to current uncertainties as to when biosimilar products will become available in the US. Table of Contents Author £1495 ($2345) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Toxicology and Pharmacology Outsourcing, History, Process and Regulation; Technical, Political and Economic Challenges Toxicology and pharmacology are challenging areas in the clinical trial process. Although the results gained are vital for the safety of medicines and are required by regulatory bodies around the world, the processes involved, especially animal testing, remain controversial. Almost all of the work is outsourced and the major companies involved have come under considerable pressure from activist groups. This 150 page report gives a detailed analysis of the market and of the issues involved. Contents include:
Written by industry experts Dr Graham Hughes and Dr Richard Barrett the report will enable you to:
Toxicology and Pharmacology is essential reading for everyone involved in clinical trials and drug development including senior staff in pharmaceutical companies and CROs, trial managers and staff and those staff directly involved in toxicology and pharmacology testing, product, process and analytical development, R&D, and regulatory affairs. It is aimed at biotech, big pharma, CROs, providers of analytical services and regulatory agencies. The report gives an authoritative, detailed and clear explanation of the issues surrounding toxicology testing, its implications for the market and for the biotech and pharmaceutical industries. Download the table of contents £595 ($995) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Generics in Japan The largest untapped market for generics and biosimilars Japan is the second largest pharmaceutical market in the world. But only 5% of the market, by value, is taken by generic drugs. Like other major industrialised nations Japan has an ageing population and ageing populations take a disproportionate share of healthcare spend. For Japan the problem is very marked; it has the highest life expectancy of any major country and spends 45% of its healthcare budget on geriatric care. In 2002 Japanese healthcare insurance was on the verge of bankruptcy. Now the government is acting to make healthcare more effective and to reduce costs. One of the methods it is using is to increase the take up of generic drugs - it aims to treble the market for generics to 15% by value by 2012, taking spend to $12 billion. This highly detailed new report provides a complete picture of the market, its rules and regulations and how it will change over the coming years. It gives a detailed description of the hospital and GP systems, the importance of wholesalers and the likely results of the changes to the system introduced by the government, including DPC hospitals and the new prescription system. Contents include:
Introduction to the Japanese market The report contains a detailed case study of Daiichi’s acquisition of Ranbaxy and will help you to understand:
The size of the generic opportunity Written by Mehta partners this report is essential reading for all companies involved in the Japanese market and for companies who want to take advantage of a large, fast-growing market opportunity. It aims at senior managers, company strategists and sales and marketing departments as well as providing vital information for those involved in regulatory affairs and clinical trials. Download the table of contents Download the list of charts and graphs Download the list of tables £810 ($1310) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order World Market for Addiction Disorders, 2009 - 2016 Future Therapies for Substance Dependence and Impulse Control Examine the market for addiction pharmacotherapies currently estimated at US$3.2 billion The substance dependence field is transforming into a high-growth market opportunity. Supported by the success of Pfizer's recently launched Chantix/Champix, which is on track for blockbuster status in the smoking cessation sector, pharmacotherapies in development for alcohol, narcotic, and nicotine dependencies are poised to radically change the addiction treatment landscape in this difficult-to-treat patient population. The report estimates that the current market for addiction disorders is valued at US$3.2 billion and this is forecast to increase 19% to US$3.8 billion by 2016. The World Market for Addiction Disorders, 2009 2016: Future Therapies for Substance Dependence and Impulse Control, will introduce the reader to a specialty pharmaceutical market which is positioned for high-growth based on analysis of marketed and pipeline drugs, company activities, and addiction disorder demographics. Therapy area forecasting and illustrative comparative sales data is presented to gain insight into leading products with sales estimates to 2016. This 80 page report will provide an in-depth analysis of the global addiction pharmacotherapeutic market, Including analyses of key therapy areas, R&D programs, and innovating companies and products. Report Highlights Include:
What you can learn from this report:
Report Contains:
Companies Mentioned in this Report include World Market for Addiction Disorders is essential reading for corporate management, marketing and sales and those in product development, R&D, and regulatory affairs. This report gives an authoritative, detailed and clear explanation of the issues surrounding addiction markets and its opportunities for the biotech and pharmaceutical industries. Download the table of contents Download the list of tables and figures £1495 ($2345) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Systems Biology in Biotech and Pharma A new paradigm for innovation Growth in the pharmaceutical market has slowed – almost to a standstill. One reason is that governments and other payers are cutting costs in a faltering world economy. But a more fundamental problem is the failure of major companies to discover, develop and market new drugs. Major drugs losing patent protection or being withdrawn from the market are simply not being replaced by new therapies – the pharmaceutical market model is no longer functioning effectively and most pharmaceutical companies are failing to produce the innovation needed for success. This new report looks at a vital strategy which can bring innovation to a market in need of new ideas and new products - Systems Biology. Systems Biology employs a rational approach, via a mix of analytical and systemic routes, to delineate the emerging properties of biological networks. It aims to explain and predict, quantitatively, molecular, cellular, tissue, organ and whole-body processes. By using multi-scale models in silico, Systems Biology is expected to bring numerous benefits to pharmaceutical discovery and development as the properties of a system can be studied over a wide range of length and time scales. Systems Biology can reduce the number of compounds that need to be synthesised in discovery by using refined algorithms to weed out compounds with poor pharmacokinetic of toxicology profiles. And it will save time and money by selecting the drugs which are more likely to succeed in clinical development. This new 230 page report is written by industry and academic expert Dr Ales Prokop, one of the leading experts in Systems Biology. He is affiliated with Vanderbilt University, Nashville, TN, USA and NanoDelivery International, Prague, Czech Republic. It will enable you to:
Contents include:
Systems Biology is essential reading for corporate management and those in product, process and analytical discovery and development, product quality and characterisation, R&D, and regulatory affairs. It is aimed at biotech, big pharma, producers of biosimilars, contract manufacturers, providers of analytical services, and clinical research organizations. This report gives an authoritative, detailed and clear explanation of the issues surrounding Systems Biology, its implications for the market and for the biotech and pharmaceutical industries. Download the table of contents Download the list of figures About the Author £1450 ($2345) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations (3rd ed) Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations (3rd ed) is the only report available that covers this crucial area of the pharmaceutical industry in such depth. The concentration in recent years on creating organisations that are market or customer-led, or research-driven has taken the focus away from the manufacturing process, although it is clear that the most successful organisations integrate all these activities to remain market leaders. Global pharmaceutical manufacturing is in a state of flux. There is excess capacity in manufacturing facilities for finished dosage forms and a shortfall for biotechnology manufacturing. The situation in APIs is not so clear-cut, and the trend for multinationals to grow through M&A has led to the need to rationalise facilities. Meanwhile, local companies from emerging markets wishing to expand into new markets and exporting must be able to satisfy ever more stringent quality standards. This report tackles the challenges of manufacturing in a global marketplace by providing unique insight into the strategies a successful company will adopt. By using examples, case studies and scenarios to aid clarification of the more technical aspects of the manufacturing process, you can be assured your decisions are made with full understanding of the key issues. This timely third edition will enable you to:
Use this report help with:
Download the table of contents List of Tables £870 ($1365) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Manufacturing in the Global Pharmaceuticals Industry is produced by Urch Publishing How to Forecast Generic Pharmaceutical Prices - A Practical Methodology to Calculate Future Generic Prices ”Finally. A model for predicting the price fall of generics – proven to have worked for 99% of drugs“ It has long been recognised that prices paid by chemists and doctors for a generic product decline in the weeks and months after generic launch and patent expiry. But calculating how quickly this happens can often only be guessed at - until now How to Forecast Generic Pharmaceutical Prices - A practical method to estimate future generic product prices is a unique guide that will help you be able to forecast future generic prices before and after launch. Specifically designed to be instantly usable, this publication, presents a tried and tested methodology to predict how the price of a generic medicine will fall after patent expiry and launch. The practical guide, which is produced in association with WaveData, a medical price analysis company, will allow users to build spreadsheets and forecast products prices as required. The model presented is based on solid methodology drawing from over 6 year's work (over 60,000 hours) cataloguing 6 million pharmaceutical prices. A 120 real-life examples of generic product were studied to find patterns of price decay. The model takes into account both regional drug reimbursement policies and the brand value of the product. 20 tables provide detailed percentage points according to the number of generic licence holders entering the marketplace post patent-expiry. The model works in the absence of government price capping, where the price decay happens as a result of competition between suppliers (free pricing) rather than statuary price reductions, and the reimbursement price is high enough to allow free pricing. 5 Reasons to Invest in this Report
This unique guide is a must have for all:
Buy this report and get a year's FREE subscription to PROfesy CR an online modelling tool to forecast generic erosion. Download the table of contents £2500 ($3920) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order How to Forecast Generic Pharmaceutical Prices is produced by Urch Publishing Quality for Biologics This report is available either as the complete publication or in separate sections. The sections are:
See below for detailed contents for each section Biologic drugs are complicated biological products that are normally difficult to define in molecular terms and that can be inconsistent in their exact composition. This can make it difficult to assure product quality and therefore to ensure safety and efficacy. There is no perfect solution and the commercial cost of quality is high, but the cost of getting it wrong can be considerably greater or even disastrous. Considerable time and expense can be saved by having an educated approach to manufacturing and process development, characterisation and analytical methods, product variation and also to regulatory issues. This unique new report provides a detailed and complete guide to the processes and methods involved. Quality for Biologics is produced and edited by Nicole Lyscom PhD and is written by top industry experts from leading companies and organisations including:
The report covers all aspects of the subject including
Quality for Biologics is essential reading for corporate management and those in product, process and analytical development, product quality and characterisation, R&D, and regulatory affairs. It is aimed at biotech, big pharma, producers of biosimilars / biogenerics / follow-on biologics, contract manufacturers, providers of analytical services, providers of manufacturing and analytical equipment, regulatory agencies and clinical research organizations. This case-study rich report gives an authoritative, detailed and clear explanation of the issues surrounding quality for biologics, its implications for the market and for the biotech and pharmaceutical industries.
Download the table of contents: Report Synopsis Prices:
Full Report:£1495 ($2325) Click here to order EvaluatePharma® Yearbook - Company Performance Tables Benchmark a Changing Market In a fast-changing pharmaceutical market it is vital to be able to measure company performance easily and accurately – find out which companies are winning in the areas that count and which are suffering in changing circumstances. The new EvaluatePharma® Yearbook gives you the information that you need, in context. The Yearbook provides information and data of the highest quality, taken directly from the EvaluatePharma® database and it will enable you to:
All of the detailed information in the Yearbook is put in context by explanations of the new pharmaceutical market place, how it works and how companies perform within it. The Yearbook provides detailed information about the top 150 companies, including:
With 41 tables of detailed EvaluatePharma® information this 140 page report is edited by former Scrip Magazine Journalist Jacky Law. It is essential reading for everybody in the pharmaceutical market from senior executives and corporate strategists, through marketing and sales departments to market analysts and pharmaceutical outsourcing companies. Download the table of contents Download the list of tables £1450 ($2900) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order The Rise of Mid-Sized Pharma What makes mid-sized companies successful – and what big Pharma can learn from them Since the year 2000 mid-sized pharmaceutical companies have out performed their larger rivals – they have grown more rapidly, produced better profits and have performed far better on the world’s stock markets. There are many reasons why this has happened; big pharma is facing a multitude of serious problems that it did not realise were important just a few years ago. Now there are major issues with public perception, an innovation deficit and increased regulation. The lessons for big Pharma are clear and this report provides a challenging analysis of the factors involved, including:
The report, written by former Scrip Magazine journalist Jacky Law is published by Biopharm Knowledge Publishing in association with EvaluatePharma® and includes more than 20 tables of EvaluatePharma® information, clearly defining the market and providing evidence to substantiate the arguments made. Interviews with leading industry experts Jo Pisani of PwC and Mike Ward of Nomura Code also form a key part of the report. This report is essential reading for anyone in the biotech, pharmaceutical and clinical outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the issues surrounding mid-sized Pharma and their implications for the market and for the biotech and pharmaceutical industries. Download the table of contents Download the list of EvaluatePharma® tables £795 ($1245) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Cardiac Toxicity Cardiac Toxicity – drugs causing heart muscle, valve damage or potentially fatal arrhythmias in patients - has been implicated in 28% of drug withdrawals in the USA over the last 30 years. The significance for patients, regulators and the pharmaceutical industry is immense. If cardiac toxicity is discovered during a drug’s development the programme will, almost invariably, be terminated. If cardiac toxicity is discovered after launch then the drug may be withdrawn or new labelling will almost certainly be required. The consequences for the global pharmaceutical industry can be huge, with major drugs being withdrawn and companies being sued for negligence. But often cardiac events are so rare that they may only be found many years after launch and after thousands, or even millions, of patients have been treated. And when cardiac events do occur the exact mechanism involved may remain a mystery. This unique report covers all aspects of cardiac toxicity, from physiology and pharmacology to regulation by the FDA and EMEA. It looks at:
It will help you to:
The report is edited by Dr Graham Hughes and includes a chapter on the commercial implications written by Yann Bonduelle and Jo Pisani of PwC. Key industry and academic figures have also contributed significant chapters to the report:
This report, published in association with Oxford Cardiac Pharmacology is essential reading for anyone in biotech, pharmaceuticals or contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an up to date, authoritative, detailed and clear explanation of the issues surrounding cardiac toxicity and its implications for the pharmaceutical market. Download the table of contents Download the introduction £1495 ($2275) For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.comClick here to order Immunogenicity
to Biologics Understanding immunogenicity, a detrimental and potentially dangerous response to therapeutic proteins, is vitally important for the successful development and marketing of biotech drugs. Failure to predict and minimise levels of immunogenicity may have harmful and sometimes disastrous results for both patients and the industry. This comprehensive new report written by leaders in the field, gives you the information you need to understand immunogenicity and to implement relevant safety strategies. The commercial implications are covered in a section written by experts at PricewaterhouseCoopers (PwC). This unique 170-page report includes chapters by the following industry experts: Dr Stephen Swanson, Director, Clinical Immunology,
Amgen Plus an additional chapter on the commercial implications
by PwC experts Jo Pisani and Yann Bonduelle.
Contents include:
This report is essential reading for anyone in biotech, biosimilars and pharmaceuticals, and for contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an authoritative, detailed and clear explanation of the issues surrounding immunogenicity and its implications for the market and the biotech, biosimilar and pharmaceutical industries. Download the table of contents £1450 ($2175) For further information about this report contact
Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Biosimilars - Evolution or Revolution? A detailed guide to the factors that will shape this vital market, including company strategies, comparability, regulation, the implications for clinical trials and legal issues. With a chapter written by PricewaterhouseCoopers looking at the commercial implications for the biotech and pharmaceutical markets The market for biotech drugs grew by 18% last year and now exceeds $50 billion – that’s 10% of the global pharmaceutical market at nearly three times the growth rate. But the first biotech drugs were launched in the mid 1980s and now patents have expired on drugs worth more than $13 billion. Until very recently generic competition was not possible but now in Europe, the EMEA has issued guidelines and the first biosimilar has been approved. In the USA the FDA still has to act, but the direction is becoming clearer. How this market develops will be vital for all the players involved – major pharma, biotechs, generic companies and CROs. This unique, detailed, 200+ page report, includes a chapter on the commercial implications written by Jo Pisani and Yann Bonduelle, Pharmaceutical & Healthcare strategy consultants at PricewaterhouseCoopers. The report will enable you to:
Contents include:
This report is essential reading for anyone in the pharmaceutical, biotech and outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the factors that will affect the market for biosimilars and their implications for the market and for the pharmaceutical industry.
£1950 ($3600) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632or moneill@biopharmkp.com Click here to order Outsourcing
Chemistry Services Made Easy Pharmaceutical and biotech companies are outsourcing more of their work than ever before – the list includes drug discovery, development, manufacture and marketing. This new report provides a clear, comprehensive guide to the processes involved in outsourcing chemical and biotech development and production. It will help you to: • Understand the rationale for outsourcing As well as the complete guide the report contains in-depth interviews with development service providers and outsourcers to give a real life understanding of the issues from both sides of the fence. And it has a full listing of service providers categorised by services offered and location. Contents include: • Rational for outsourcing This 120 page report is published by Biopharm Knowledge Publishing, part of the Technomark group and costs just £695 ($1290). It is written and edited by Dr Ed Sampler of Charnwood Molecular and Hooshang Zavareh of Chempharmaserve Ltd. DOWNLOAD THE TABLE OF CONTENTS £695 ($1290) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632or moneill@biopharmkp.com Click here to order
Clinical
Trial Supply
DOWNLOAD THE TABLE OF CONTENTS 
Click
for PDF file.Price: £595 ($1075) For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632 or moneill@biopharmkp.com Click here to order |
|
|||
