Authoritative Outsourcing Insights

Biopharm Knowledge Publishing is developing a series of expert Guides to key outsourcing issues in the pharmaceutical and biotechnology industries.

Biosimilars - Evolution or Revolution?
Cardiac Toxicity NEW
Central and Core Laboratories
Clinical Trial Supply
Contract Research Annual Review 2009 NEW
EvaluatePharma® Yearbook - Company Performance Tables NEW
How to Forecast Generic Pharmaceutical Prices NEW
Immunogenicity to Biologics NEW
Manufacturing in the Global Pharmaceuticals Industry NEW
Outlook 2009 NEW
Outsourcing Chemistry Services Made Easy
PartneringDesk Reports
Pharmaceutical Market Trends, 2008 - 2012 NEW
Quality for Biologics NEW
The Rise of Mid-Sized Pharma NEW
Virtual Pharma NEW


Contract Research Annual Review 2009

The Complete Picture of the Contract Research Market

The contract research market grew by 12% last year and performed far better than the pharma market that it serves – but this year growth has stopped and the market cap of publicly quoted CROs has fallen sharply. Why has growth stopped, and why have share prices fallen in a market that was booming? This review provides a complete picture of the market, looks at trends and developments and explains why they have happened and how they will affect the future of the market. And it includes a unique, detailed explanation of the value proposition of outsourcing pharmaceutical development.

With 31 graphs and 16 tables, this 200-page review includes:

  • Market size
  • Market growth
  • Analysis of the CRO market by:
    • Type of company
    • Service offering
    • Therapy class
  • Market trends including:
    • M&A activity
    • CROs in developing regions
  • Details of more than 50 mergers, acquisitions and joint ventures.
  • An 150-page news section covering leading CROs.

Written by industry expert Dr. Graham Hughes the Contract Research Annual Review costs just £345 ($545)

Download the table of contents Click for PDF file.

Download the list of tables & graphs Click for PDF file.

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Outlook 2009

- Global Pharmaceutical and Biotechnology Markets

In the last decade the pharmaceutical market has changed completely.  In 2000 the average PE ratio for companies in the pharmaceutical and biotech sector was more than 30, now that ratio has come down to just 14.  Part of that change is due to the world economy, but it is also due to the performance of the pharma sector.  The old blockbuster model no longer works and many major companies have struggled to come to terms with the new ways of working that are now needed for success – they are performing poorly and growth is slowing.   But there are companies primed for success, and this report shows you which they are and why.

This unique 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.

Based on extensive research and data analysis by Mehta Partners the report looks beyond the usual limited range of companies.  There are sections on Rising Stars – companies that are currently making losses – on Indian Generic companies and on the key players in Japan.

In all the 500+ page report looks at six market sections:

  • Rising Stars
  • Mature Biotech
  • Indian Generics
  • Global Pharma
  • Japan – Global and Emerging
  • Specialty Pharma

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 2013.

The presentation 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.

Download a full presentation of the report. Click for PDF file.

£8750 ($14000)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click 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:

  • Assess the pros and cons of outsourcing manufacturing functions and develop key strategies to effectively measure supplier and contractor performance
  • Understand and prepare for the latest regulations applicable to manufacturing and their variations globally
  • Develop strategies to effectively manage contractor relationships
  • Understand the definitions used in validation, and how extra investment in validation will improve performance
  • Build competencies for manufacturing that meet the objectives of: speed of delivery, reduction in product cost, overall quality, optimisation of capital spend, maintenance of customer inventory, minimisation of regulatory impact, optimisation in the number of manufacturing sites, maintenance of strategic sourcing for disaster management planning
  • Understand the 'New Paradigm' in international manufacturing and how it relates to the pharmaceutical industry.

Use this report help with:

  • Planning a global manufacturing strategy
  • Regulations and quality assurance issues
  • The 'New Paradigm' in manufacturing
  • The key drivers and changes in today's manufacturing environment
  • Making the right investment decision

Download the table of contents Click for PDF file.

List of Tables Click for PDF file.

£870 ($1365)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click 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

  • Stop using "rule of thumb" to calculate the decline in price
  • Adopt the suggested methodology immediately
  • Easily understandable, designed for the non-statistician
  • Follow clear instructions to build your own spreadsheet models
  • Adjust the number of expected competitors with first 3 years of launch

This unique guide is a must have for all:

  • Pricing and reimbursement executives
  • Marketing Managers in Generic Drug Companies
  • Strategy directors in pharmaceutical companies
  • Consultancies with an interest in pharmaceutical markets

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 Click for PDF file.

£2500 ($3920)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click 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:

  1. Manufacturing to Ensure Product Quality
  2. Characterisation and Analytical Methods
  3. Impurity Profiles and Product Variation
  4. Regulation

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:

  • Genentech
  • Amgen
  • Roche
  • Eli Lilly
  • UCB
  • LFB
  • Boehringer Ingelheim
  • Paul Ehrlich Institute
  • Parexel Consulting

The report covers all aspects of the subject including

  • Critical quality attributes
  • Manufacturing process parameters
  • Process Analytical Technology
  • Physicochemical analysis
  • Bioassays
  • Formulation and specifications
  • Product- and process-related impurities
  • Aggregation
  • Non-clinical testing
  • Clinical development,
  • Post-marketing quality control
  • Regulatory authority expectations
  • Risk management
  • Comparability concerns

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:

Full Report: Click for PDF file.
Manufacturing: Click for PDF file.
Characterisation: Click for PDF file.
Impurities: Click for PDF file.
Regulation: Click for PDF file.

Report Synopsis Click for PDF file.

Prices:

Full Report:£1495 ($2325)
Manufacturing:£395 ($615)
Characterisation:£495 ($765)
Impurities:£495 ($765)
Regulation:£395 ($615)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Pharmaceutical Market Trends, 2008 - 2012: key market forecasts & growth opportunities

The latest version of this best-selling report presents a detailed trend analysis of the global pharmaceutical market to the end of 2007 and forecasts until 2012. The 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 data and analysis contained within the report are comprehensive, consistent and up-to-date in order to provide a single-point reference for understanding key pharmaceutical market trends in 2008.

Headline findings include

  • The global pharmaceutical market is forecast to grow to $929 billion in 2012, an equivalent compound annual growth rate (CAGR) of 5.5% over the next five years.
  • In 2007 the leading therapy areas by sales were CNS with 16.5% share and cardiovascular with 15.4%.
  • Four of the top 10 products in 2007 are forecast to increase sales over the next five years.
  • The US retail pharmaceutical market grew to $206 billion but growth rates fell due to loss of patent protection on some blockbusters
  • France, Germany and the UK together accounted for almost 50% of all European pharmaceutical sales in 2007.
  • The top 100 blockbuster drugs generated sales of $252.5 billion, accounting for 35.5% of the total pharmaceutical market.
  • The leading blockbuster by increased sales revenues in 2007 was the blood agent product Plavix (clopidogrel bisulfate), marketed by Sanofi-Aventis and Bristol-Myers Squibb.
  • There were a total of 61 companies generating pharmaceutical sales in excess of $1 billion in 2007

Key features of the report

  • Comprehensive market trends for key countries, regions, therapy areas, products and companies.
  • Country profiles for leading pharma markets with market segment trends and five year forecasts.
  • Therapy area profiles for leading therapeutic classes and key products and 2010 sales forecasts.
  • Detailed profiles of 10 leading pharmaceutical products in 2007, including five year future sales forecasts.
  • Detailed profiles of 10 leading pharmaceutical companies in 2007, including 2012 sales forecasts.(AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi-Aventis Wyeth)

Use this report to:

  1. Quickly gain an overview into the global pharmaceutical market and its major companies and products.
  2. Identify key areas of pharmaceutical market growth and key opportunities for delivering successful sales growth over the next five years.
  3. Support internal planning and decision-making with an external perspective founded on detailed analysis and transparent market forecasts.

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 2003 to 2011.

All data used in outlining historical trends is clearly sourced within the report and any data limitations or additional assumptions are explicitly detailed within the text of the report. Future market forecasts are projected based on both historical trends and future expectations over market conditions and events. The assumptions used to form the basis of key market forecasts are outlined in detail within the text of the report.

Pharmaceutical Market Trends 2008 – 2012 is essential reading for corporate management and those involved in planning, marketing and sales.  It is aimed at biotech, big pharma, mid-sized and small pharma and companies that provide services to the pharmaceutical industry such as CROs and CMOs.

Download the table of contents Click for PDF file.

List of Figures Click for PDF file.

£1350 ($2120)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Virtual Pharma

- the radical route to success

Mega mergers and the blockbuster model have not delivered the benefits that were claimed for them - growth in the pharmaceutical market has slowed to no more than five per cent and the world's biggest companies are growing slowly, if at all. Against that background pharmaceutical companies, large and small, are looking for new ways to do business - ways that will bring success in a difficult market. For ways to discover and deliver new drugs, to manufacture them more cost-effectively and to sell and market them more successfully.

There is a solution, a radical new approach, the virtual company - the company that retains key skills but outsources everything else, including:

  • discovery research
  • drug development
  • manufacturing
  • sales and marketing

This detailed and comprehensive report will help you to:

  • understand the virtual pharma business model
  • see what can be outsourced
  • focus on the advantages
  • avoid the pitfalls
  • manage the outsourcing process
  • understand what to keep in house

The report, was written by Dr John MacDonald a company analyst for IMS Health and a pharma industry analyst for PricewaterhouseCoopers.

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 the virtual pharma business model and its implications for the market and for the biotech and pharmaceutical industries.

Download the table of contents Click for PDF file.

£795 ($1495)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
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:

  • Benchmark company revenue and expenditure
  • Analyse company performance
  • Assess mergers and acquisitions
  • Understand patent expiry issues
  • Match R&D spend to performance
  • Analyse sales by therapy area, licensing, acquisitions etc
  • Analyse winners and losers by therapy area

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:

  • Revenue
  • Income
  • Growth
  • R&D expenditure
  • M&A activity
  • Patent expiry
  • Staffing levels
  • Expenditure

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 Click for PDF file.

Download the list of tables Click for PDF file.

£1450 ($2900)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click 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 failure of the blockbuster model
  • R&D productivity
  • Therapy Focus
  • Specialist markets
  • Informed consumers
  • The cost of drugs
  • Tougher regulation
  • Drug withdrawals

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 Click for PDF file.

Download the list of EvaluatePharma® tables Click for PDF file.

£795 ($1245)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click 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:

  • Physiology
  • Pharmacology
  • Pre-clinical determination of cardiac toxicity
  • Determination of potential cardiac toxicity in early phase clinical testing (QTc studies)
  • The implications for the clinical trial process
  • Regulation
  • The commercial implications

It will help you to:

  • Understand the physiology and pharmacology of the heart and how cardiac toxicity may be provoked
  • See which classes of drugs carry most risk
  • Plan for the clinical trial process
  • Manage the regulatory process
  • Understand the commercial implications

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:

  • Professor Derek Terrar,
    Professor of Cardiac Electrophysiology, University of Oxford, Fellow in Physiological Sciences (Medicine) Worcester College, Oxford
  • Thomas E Donnelly, PhD,
    Senior Vice President, Quality Assurance and Compliance, Reliance Clinical Research Service
  • Daniel B. Goodman, MD,
    Medical Director
    Entelligent Solutions, Inc
  • Eileen M. Daniel,
    Vice President of Operations
    Reliance Clinical Research Services

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 Click for PDF file.

Download the introduction Click for PDF file.

£1495 ($2275)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order

Immunogenicity to Biologics

Implications of reactions against biotech drugs

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
Meenu Wadhwa, Head, Cytokines and Growth Factors, Biotherapeutics, NIBSC
Robin Thorpe, Head, Biotherapeutics, NIBSC
Dr Deborah Finco-Kent, Immunogenicity Lead, Drug Safety R&D, Pfizer
Dr Ingrid Caras, Senior Director, Bioanalytical & Development Sciences, PDL Biopharma,
Dr Bonita Rup, Senior Director, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research
Dr Christian Schneider, Acting Head, EU Cooperation/Microbiology, Paul-Ehrlich-Institute
Dr Harald Kropshofer, Global Coordinator & Head, Immunosafety of Biologics, F. Hoffman La Roche

Plus an additional chapter on the commercial implications by PwC experts Jo Pisani and Yann Bonduelle.

This report will enable you to:

  • Understand the processes involved in immunogenicity
  • Find out how immunogenicity impacts on safety and efficacy
  • Grasp the commercial implications
  • Work out an immunogenicity assessment strategy
  • Manage your cooperation with the FDA and EMEA
  • Prepare for new launches

Contents include:

  • Factors contributing to immunogenicity
  • Impact on safety and efficacy
  • Commercial implications
  • Assay development and validation with special section on neutralising antibody assays
  • NEW US White Papers
  • Regulatory advice on working with the FDA and EMEA with NEW CHMP Guidelines
  • Risk management strategy
  • Risk minimisation and de-immunisation

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 Click for PDF file.

£1450 ($2175)

For further information about this report contact Marianne O’Neill on +44 (0)1256 336632 or moneill@biopharmkp.com
Click here to order


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.

Updated, October 2007

The Central and Core Laboratories market is now worth more than $1.5 billion a year and is vital to the successful development of new drugs. It is a 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 250 page report – updated October 2007 – gives comprehensive cover 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:

  • Overview of capabilities and facilities
  • Role of Central Labs in clinical trials
  • History of the Central Labs business
  • Contract Considerations
  • Review of the current market
  • Logistics
  • Review of leading companies
  • Regulatory and QA issues
  • ECG laboratories
  • Imaging laboratories
  • Future trends and challenges

The comprehensively-referenced report is published by Biopharm Knowledge Publishing, Part of the Technomark Group and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing and one of the founders of Technomark. Contributors include:

Dr Graham Hughes
Richard Barrett
David J. Cocker
Eileen Daniel
Dr Colin Miller
Tim Stiles

This 250 page report provides a full picture of a fast-growing industry now worth more than $1 billion and vital to the success of drug development. It also gives a complete guide to managing the outsourcing and logistics process.

At just £995 ($1895) for a 250 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 Click for PDF file.
£995 ($1895)

or moneill@biopharmkp.com
Click here to order


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:

  • See how the biotech landscape will change
  • Assess competition in specific markets
  • Understand how biosimilars will be approved
  • Grasp the details of the trials process
  • Understand the legal implications
  • Prepare for new launches

Contents include:

  • Strategies for entering the market
    • The opportunity
    • Development
    • Profit potential
    • Market structure
    • Substitution of biosimilars
  • Comparability
    • The impact of manufacturing
    • Preparation of comparability packages
    • Immunogenicity risk factors
    • Approved biosimilars
    • The future
  • Clinical trials
    • Protocol requirements
    • Factors affecting study size
  • Regulatory issues Europe
    • Clinical trial requirements
    • EU guidelines explained
    • Dealing with regulators
    • Role of the EC
    • Case studies and precedents
    • Routes to approval
  • Regulatory issues USA
    • The FDA position
    • Anticipated guidance
    • Case studies and precedents
    • Routes to approval in the US
  • Legal issues
    • The patent environment
    • Freedom to operate
    • Precedent
  • Opportunities and barriers
    • Commercial drivers
    • Drug markets
    • Country markets
    • Skill sets and core competencies


As well as the commercial analysis from PricewaterhouseCoopers the report is edited by Dr Nicole Lyscom and written by leading experts in the field including:

  • Dr Tim Oldham, VP Business Planning and Operations Effectiveness, Mayne Pharma
  • Dr Meena Subramanyam, Senior Director, Clinical science and Technology, Biogen Idec
  • Dr Peter H Kalinka, CEO and Managing Director, Accelsiors Group International
  • Dr Gabrielle Schaeffner, Principal Consultant, Parexel International, Germany
  • Dr Alan Liss, Senior Director, Biotechnology, Duramed Research Inc
  • Dr Antonio Maschino, Partner, D Young and Co

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.


DOWNLOAD THE TABLE OF CONTENTS Click for PDF file.

£1950 ($3600)

For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632
or moneill@biopharmkp.com
Click here to order

Outsourcing Chemistry Services Made Easy

A Practical Guide for the Pharmaceutical and Biotech Industries

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
• See how outsourcing fits into the R&D continuum
• Select process development providers
• Negotiate contracts
• Manage the outsourcing process
• Understand when to outsource – and when not to
• Minimise outsourcing risk

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
• Research and development continuum
• Selecting a process development provider
• Contract negotiation
• Managing outsourcing
• Risk management
• Outsourcing economics
• Interviews with outsourcing companies
• Interviews with outsourcers
• Outsourcing directory

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 Click for PDF file.

£695 ($1290)

For further information about this report, please contact Marianne O'Neill on +44 (0)1256 336632
or moneill@biopharmkp.com
Click here to order


Clinical Trial Supply
Essential Ingredients for Success in Clinical Trials.
Published: March 2006

The definitive guide:
• Written by industry experts
• Edited and produced by the leading outsourcing publisher and consultancy

Contents include:
• Development, formulation and manufacture
• Analytical development
• Packaging and labelling
• The regulatory challenge
• Logistics and distribution
• Automation
• CTS in emerging markets
• Market size and trends



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

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