Technology

This report investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via fixed dose combinations. The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to provide a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world. An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
This report explains the basics of drug lifecycle and investigates three goals in optimizing product potential- expanding the drug’s patent protected lifespan, accessing broader patient populations and launching line-extensions via FDCs.
The key success factors in each of these pursuits have been clearly identified, emerging trends have been presented and the underlying concepts have been explained to give the reader a clear understanding of current industry dynamics. Case studies on popular products have been used to illustrate these concepts in the real world.
An in-depth analysis of drug approval data provides context for the issues discussed. This information is juxtaposed with historic sales data to explore the correlation between the strategies employed and revenue potential.
Key findings
Drug manufacturers must make the best strategic use of the patent-protected lifespan of a drug, or else risk losing the profit incentives they perceived at the start of the project. (Ch. 1)
In light of the increasing complexity of biopharmaceutical patenting, the ‘freedom to operate’, i.e. to commercialize the invention, is coming under increasing scrutiny. (Ch. 2)
The US Congress’ emerging stance on data exclusivity provisions for biologics will define the length of time a biotechnology company can keep out generic competition in new indications. The biotech industry’s stance is that the current provisions do not provide for enough time to profit from their post-approval R&D investments. (Ch. 2)
The potential for post-approval label expansion is much greater for biologics in comparison to small molecule pharmaceutical drugs. Most biologics on the market today can expect to add significant revenue streams via new indications, and potentially extend their commercial lifespan. (Ch 3)
Over 45% of all new indication approvals granted by the FDA since 1998 belong to drugs that fall in the Genito-urinary system and Nervous system.
If an FDC is launched close to the loss of exclusivity date of the constituent brand, it may be interpreted as a marketing tactic to limit post-LoE revenue losses. If launched early, it may show intent to cater to a genuine unmet need, or to legitimately maximize the potential of the parent molecule(s). (Ch. 4)
Scope of the report
In-depth case studies explore the real-world execution of the issues and challenges discussed in the report.
Analysis of historic drug approval data provides the reader with contextual reference points.
Case studies on Vytorin, Advair and BiDil illustrate the strategies employed by three leading FDC brands.
Brand histories of Yaz, Remicade and Seroquel show how label expansion is fundamental to successful lifecycle management.
Where applicable, these strategies are discussed with reference to specific therapeutic areas or geographies.
Issues related to biologics are highlighted to indicate where they differ from small molecule drugs.
Use this report to
Gain an understanding of legal provision for patent protection and data exclusivity. Understand their role in the context of product lifecycle management
Utilize the historical data on NDA approvals to identify trends and build assumptions into competitive landscape forecasts.
Understand the stance of key stakeholders and implications of off-label drug usage.
Understand the role of FDCs in optimizing the commercial potential of a product asset, and the main challenges in their commercialization
Juxtapose historic sales performance with the timing of indication expansion and FDC based strategies to assess the success or failure
     Table of Contents :   
Optimizing Lifecycle ManagementExecutive summary 8Product lifecycle and management challenges 8Influencing the commercial lifespan of the drug 9Accessing broader patient populations 10Fixed dose combinations 11Chapter 1 Product lifecycle and management challenges 14Summary 14Introduction 15The lifecycle of biopharmaceutical drugs 15Development lifecycle 17Commercial lifecycle 22Managing the lifecycle 22Longer development time 23Slower product uptake via reimbursement hurdles 24Peak sales potential is reduced by higher competition 25Earlier lifecycle decline due to therapeutic substitution 26Chapter 2 Influencing the commercial lifespan of a drug 30Summary 30Bargaining power of biopharmaceutical brands 31Brand equity 31Patent protection and “freedom to operate” 32Strategic patenting 33Patent prosecution superhighway 35Patent protection for biologics 35Data exclusivity 36Difference between data exclusivity and patent protection 408+2+1 system in the EU 40Data exclusivity in the US 42Data exclusivity in Japan 43Data exclusivity in the context of biologics 44Chapter 3 Accessing broader patient populations 46Summary 46Drug labeling and market access 47Off-label drug usage 47Commercial incentives and disincentives 48Payors stance on off-label reimbursement 49Case study: Avastin and Lucentis 51Expanding the label 53Role in product lifecycle management 53New indications 53Pediatric extensions and special populations 54Modified indications and expanded usage 54Case study: Yaz 55Case study: Remicade 58Indication expansion 59Choosing the primary indication 61Related versus unrelated indications 63Sequence of indication expansion 64Timing of indication expansion 65Launching early in commercial lifecycle 68Launching late in commercial lifecycle 69Seroquel: Using indication expansion and drug reformulation synergistically 70Recent trends in indication expansion 72Indication expansion for NDAs 72Indication expansion for biologics 75Chapter 4 Fixed dose combinations 80Summary 80Introduction 81Clinical challenges in FDC development 81FDC patents 82Data exclusivity for FDCs 83Role in product lifecycle maximization 83Case study: Advair’s role in GSK’s asthma franchise 85Case study: How Vytorin influenced Zocor’s patent expiry 88Case study: BiDil’s value proposition reinvented 90FDC uptake by geography 91Case study: FDCs for hypertension 91Clinical rationale 93Synergistic efficacy or safety 94Easier Rx management 95Correlation between FDC usage and drug compliance 95Correlation between drug compliance & improved clinical outcomes 96FDC usage by therapy area 96Key success factors and competitive hurdles 98Endorsement by treatment guidelines 98Perceived synergy effects over free combination 99Compliance advantage over the free combination 99Usage of mono compounds prior to FDC launch 99Discount compared to cheapest free combination 100Time-to-LOE of parent brand 101Chapter 5 Appendix 103Primary research methodology 103Glossary 107Index 111List of FiguresFigure 1.1: Summary of lifecycle of medicinal drugs 17Figure 1.2: Transition probabilities for clinical phases 18Figure 1.3: Out-of-pocket and capitalized costs of developing a drug ($m) 19Figure 1.4: Time taken for development of new pharma & biotech drugs 20Figure 1.5: Approval timelines at CDER for priority NDAs, 1999-08 21Figure 1.6: Approval timelines at CDER for standard NDAs, 1999-08 21Figure 1.7: Imperatives of efficient lifecycle management 23Figure 1.8: Increasing importance of payors as stakeholders 24Figure 1.9: Tougher payor environments are slowing product uptake 25Figure 1.10: Therapeutic substitution and formulary access 27Figure 2.11: 8+2+1 data exclusivity system in Europe 41Figure 2.12: Data exclusivity and patent protection in the US 43Figure 3.13: On and off-label decision making by payors 50Figure 3.14: Off-label usage of Avastin: a pharmacoeconomic model for wet AMD 52Figure 3.15: Yaz: Label expansion & sales growth – US ($m), 2006-08 57Figure 3.16: Remicade: Label expansion & sales growth – US ($m), 2001-08 59Figure 3.17: Time between launch of original and new indications in the US (by ATC), 1999-08 66Figure 3.18: Time between launch of original and new indications in the US (by ATC), 1999-08 (contd) 67Figure 3.19: Considerations in launching new indications early in the lifecycle 69Figure 3.20: Considerations in launching new indications late in the lifecycle 70Figure 3.21: Lifecycle management: Seroquel and Seroquel XR 71Figure 3.22: New indication approvals for NDAs, 1999-2008 73Figure 3.23: New indication approvals for Orphan drugs, 1999-08 73Figure 3.24: New indication approvals with priority reviews, 1999-08 74Figure 3.25: Increasing clinical and commercial potential for Remicade 77Figure 4.26: FDC approvals in the US, 1999-08 84Figure 4.27: Advair: FDA approvals and patent protection 86Figure 4.28: Advair-Serevent sales in the US: maintaining revenues post patent expiry of Flovent 87Figure 4.29: Zocor-Vytorin-Zetia brand timeline 88Figure 4.30: Cushioning the patent cliff: Zocor-Vytorin-Zetia sales in US ($m), 2001-08 89Figure 4.31: FDC usage for hypertension across major markets 93Figure 4.32: Drug classes with maximum FDC approvals in the US, 1999-08 97List of TablesTable 2.1: Data exclusivity periods by country 39Table 3.2: Success drivers and barriers in indication expansion 61Table 3.3: Unmet needs prevalent within an indication 62Table 3.4: Commercial considerations in prioritizing new indications 62Table 3.5: Disease areas and related sub-populations for hypertension and heart failure 63Table 3.6: New indication approvals by drug class, 1999-08 75Table 4.7: FDC case studies 81
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Aarkstore announce a new report  “Innovations in Oncology Diagnostics: Technological advances, growth opportunities and future market outlook” through its vast collection of market research report. Despite public policy measures to prevent cancer, such as tobacco control and vaccination against HPV, cancer is sure to remain a significant public health problem throughout the 21st century. Indeed, the global demographic shift towards an ageing population and the spread of high tech modern medicine throughout the emerging economies of Asia and (maybe later) Africa, will expand the market for cancer diagnostics globally. Major developments are likely in both the IVD market and in imaging-based modalities, like computed tomography, with the emphasis being upon the personalized medicine approach, where demand will come from physicians, patients and payors – all of whom want more effective treatments and value for money. This report analyzes the latest innovations in oncology diagnostics and identifies the most exciting new technologies and trends, ranging from body imaging and cytology to molecular diagnostics and pharmacogenomics. The report also identifies the key challenges facing innovative diagnostics companies. Key Features of this report•Analysis the latest innovations in diagnostics imaging in the oncology sector, covering Magnetic Resonance Imaging (MRI), x-ray, Computed Tomography (CT), ultrasound, Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) and Flow Cytometry.•Analyzes the latest innovations in molecular diagnostics and how they impact the diagnostics market. The report covers technology including fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), HPV testing, immunoassays & biomarkers, microarrays and comparative genomic hybridization (CGH).•Analyzes the latest innovations in pharmacogenomics and covers the major applications for familial cancer, breast cancer, colon cancer and lung cancer. Also, the report provides an overview of the regulatory and intellectual property environment for genetic-based tests.•Looks at the key commercial challenges for innovative diagnostics companies, including the impact of the recession, reimbursement, regulatory changes, pharmacoeconomics and the relationship between industry and academia.The report Includes in-depth case studies on the potential technologies available in core areas of un-met need such as ovarian cancer and colorectal cancer. Key benefits of this report•Understand the latest innovations in the oncology diagnostics market in the core areas – diagnostic imaging, molecular diagnostics and pharmacogenetics. This includes market information and an analysis of the scientific literature so as to identify what is really innovative.•Identify what the key areas of unmet need are in the oncology diagnostics market and understand which products have the greatest potential over the next decade.•Understand what the greatest challenges are for oncology diagnostics and what the best strategies are for coping with these obstacles. •Understand the competitive landscape and what companies are leading the way in terms of innovation, and what the latest partnerships regarding companion diagnostics.•Business Insights has identified five key areas of innovation in the diagnostics markets, use this to help guide company strategy.Key findings from this reportMolecular diagnostics and biomarkers are the key drivers of the oncology diagnostics market.Despite the deep economic recession, R&D spending has held up for oncology diagnostics companies. However, M&A activity has been impacted with the value of deals conducted in 2009 far below the peak year of 2007.Partnerships between diagnostic firms and pharmaceutical firms represents the future of the industry and the number of companion deals has been increasing in the past few years. Virtual colonoscopy – using CT scans to build a picture of the colon – is becoming an increasingly accepted alternative to invasive colonoscopy for colorectal screening in high risk groups and the general population. This presents a sizeable market opportunity. Interesting research is being conducted in both ovarian cancer and for prostate cancer, which could have wide-market implications. Specifically, companies are looking to validate new biomarkers to create more accurate tests.Key questions answered by this reportWhat is the market potential for in vitro diagnostic products?What is the market forecast for oncology diagnostics? What are the key innovations in diagnostic testing and diagnostic imaging?What are the major areas of unmet need in oncology diagnostics?What are the most promising technology areas in oncology diagnostics, and which companies are exploiting these?What will be the key trends impacting the market in the long-term?How can big pharma fully exploit the opportunities in the oncology diagnostics sector? Abbott Diagnostics Affymetrix Beckman Coulter Beckton Dickinson Bio-Rad Gen-Probe Johnson & JohnsonLuminex Nanogen Roche Diagnostics Siemens SysmexFor more information, please visit :http://www.aarkstore.com/reports/Innovations-in-Oncology-Diagnostics-Technological-advances-growth-opportunities-and-future-market-outlook-34066.htmlOr email us at press@aarkstore.com or call +919272852585 Special offer till 31th Dec 2009

Major developments are likely in both the IVD market and in imaging-based modalities, like computed tomography, with the emphasis being upon the personalized medicine approach, where demand will come from physicians, patients and payors – all of whom want more effective treatments and value for money.
This report analyzes the latest innovations in oncology diagnostics and identifies the most exciting new technologies and trends, ranging from body imaging and cytology to molecular diagnostics and pharmacogenomics. The report also identifies the key challenges facing innovative diagnostics companies.
Key Features of this report
•Analysis the latest innovations in diagnostics imaging in the oncology sector, covering Magnetic Resonance Imaging (MRI), x-ray, Computed Tomography (CT), ultrasound, Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) and Flow Cytometry.•Analyzes the latest innovations in molecular diagnostics and how they impact the diagnostics market. The report covers technology including fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), HPV testing, immunoassays & biomarkers, microarrays and comparative genomic hybridization (CGH).•Analyzes the latest innovations in pharmacogenomics and covers the major applications for familial cancer, breast cancer, colon cancer and lung cancer. Also, the report provides an overview of the regulatory and intellectual property environment for genetic-based tests.•Looks at the key commercial challenges for innovative diagnostics companies, including the impact of the recession, reimbursement, regulatory changes, pharmacoeconomics and the relationship between industry and academia.The report Includes in-depth case studies on the potential technologies available in core areas of un-met need such as ovarian cancer and colorectal cancer.
Key benefits of this report
•Understand the latest innovations in the oncology diagnostics market in the core areas – diagnostic imaging, molecular diagnostics and pharmacogenetics. This includes market information and an analysis of the scientific literature so as to identify what is really innovative.•Identify what the key areas of unmet need are in the oncology diagnostics market and understand which products have the greatest potential over the next decade.•Understand what the greatest challenges are for oncology diagnostics and what the best strategies are for coping with these obstacles. •Understand the competitive landscape and what companies are leading the way in terms of innovation, and what the latest partnerships regarding companion diagnostics.•Business Insights has identified five key areas of innovation in the diagnostics markets, use this to help guide company strategy.
Key findings from this report
Molecular diagnostics and biomarkers are the key drivers of the oncology diagnostics market.
Despite the deep economic recession, R&D spending has held up for oncology diagnostics companies. However, M&A activity has been impacted with the value of deals conducted in 2009 far below the peak year of 2007.
Partnerships between diagnostic firms and pharmaceutical firms represents the future of the industry and the number of companion deals has been increasing in the past few years.
Virtual colonoscopy – using CT scans to build a picture of the colon – is becoming an increasingly accepted alternative to invasive colonoscopy for colorectal screening in high risk groups and the general population. This presents a sizeable market opportunity.
Interesting research is being conducted in both ovarian cancer and for prostate cancer, which could have wide-market implications. Specifically, companies are looking to validate new biomarkers to create more accurate tests.
Key questions answered by this report
What is the market potential for in vitro diagnostic products?What is the market forecast for oncology diagnostics? What are the key innovations in diagnostic testing and diagnostic imaging?What are the major areas of unmet need in oncology diagnostics?What are the most promising technology areas in oncology diagnostics, and which companies are exploiting these?What will be the key trends impacting the market in the long-term?How can big pharma fully exploit the opportunities in the oncology diagnostics sector? 
Abbott Diagnostics Affymetrix Beckman Coulter Beckton Dickinson Bio-Rad Gen-Probe Johnson & JohnsonLuminex Nanogen Roche Diagnostics Siemens Sysmex     Table of Contents : 
Innovations in oncology diagnosticsExecutive summary 10Setting the scene 10Innovations in diagnostic imaging 11Innovations in molecular diagnostics 12Innovations in pharmacogenomics 13Challenges in the oncology diagnostics sector 14Competitive landscape 15Chapter 1 Setting the scene 18Summary 18Introduction 19Cancer facts, current and projected 19History of oncology diagnostics 23Elements of a cancer diagnosis 26Pathology 27Oncology diagnostics market 28Chapter 2 Innovations in diagnostic imaging 34Summary 34Introduction 35Body imaging 35Overview 35X-ray 38Breast cancer 38Computed tomography 40Lung cancer 40Colon cancer 40Others 42Ultrasound 44Magnetic resonance imaging 44Nuclear medicine – PET & SPECT 45Case study 47HYPERImage 47Cytology 47Overview 47Flow cytometry 48Case study 49CellSearch 49Cervical screening 50Cytogenetics 52Chapter 3 Innovations in molecular diagnostics 56Summary 56Introduction 57DNA, genes and chromosomes 59Fluorescence in situ hybridization (FISH) 59PCR and variants 60Case study 61HPV testing 61Immunoassays and biomarkers 62Case study 66Ovarian cancer 66PSA testing 68Other areas of research 70Epigenomics 71Microarrays 72Comparative genomic hybridization (CGH) 73Case study 74Almac 74DiaGenic 74Overview of clinical applications of molecular diagnostics 74BCR-ABL 74LOH 75MSI 75Chapter 4 Innovations in pharmacogenomics 78Summary 78Introduction 79Familial cancer 79Breast cancer 80Colon cancer 81Melanoma 81Case study 82IP challenge 82Response to therapy 83Cytochrome P450 variants 86HER2 overexpression 86The FDA, EMEA and PGx labeling 88Case study 89TheraScreen: KRAS 89BioTheranostics: Breast cancer 89Clarient: Breast cancer 90Marker validation for erlotinib in lung cancer 90Companion diagnostics 91Chapter 5 Challenges in the oncology diagnostics sector 94Summary 94Introduction 95Reimbursement funding 97Educated patients = educated decisions 98Regulation 99Pharmacoeconomics 101Emerging markets 104Partnerships between drug companies & academia 105Research & development 106Mergers & acquisitions 109Chapter 6 Competitive landscape 112Summary 112Introduction 113Abbot Diagnostics 113Affymetrix 114Beckman Coulter 116Becton Dickinson 117Bio-Rad Laboratories 119Gen-Probe 120Johnson & Johnson (J&J) 121Ortho Clinical Diagnostics 121Luminex 121Tm Bioscience 122Nanogen 122Roche Diagnostics 123Siemens Healthcare Diagnostics 126Sysmex 126Future perspectives in the oncology diagnostics market 127Science 127Infrastructure 128Adoption of innovation 130Companion diagnostics 131Chapter 7 Appendix 135Glossary 135Index 138List of FiguresFigure 1.1: Leading sites of new cancer US, 2009 22Figure 1.2: Leading sites of new cancer in developing countries, 2007 23Figure 1.3: Information required by oncologist pre/post diagnosis 27Figure 1.4: Oncology diagnostics forecasts ($bn), 2007-14 30Figure 2.5: Example of the use of 3D tomosynthesis imaging 39Figure 2.6: Number of CT scans in the US, 1995-2008 43Figure 2.7: Women having mammograms (%) in the US, 2004* 45Figure 2.8: Global flow cytometry market forecast ($bn), 2008-14 48Figure 3.9: IV diagnostics market forecast ($bn), 2007-2014) 58Figure 3.10: Use of biomarkers 63Figure 3.11: Obstacles to biomarker development 64Figure 3.12: US 5-year survival (%) for ovarian cancer at time of diagnosis 67Figure 4.13: Myriad: Molecular diagnostics sales ($m), 2005-09 83Figure 4.14: Number of biologics regulated by CDER that have existing PGx information 85Figure 4.15: Herceptin therapy cost ($) per patient relative to HER2 testing 87Figure 5.16: Decline in S&P global sector indices (%), 12 months to December 2008 96Figure 5.17: IV diagnostics risk-based classification 100Figure 5.18: FDA validated biomarkers by therapeutic area, September 2009 102Figure 5.19: Roche Diagnostics regional sales (CHFm), 2008 105Figure 5.20: Leading diagnostic firms increase in R&D spend (%) y-o-y, 2008 107List of TablesTable 1.1: WHO cancer mortality forecasts by region (‘000), 2008-30 21Table 1.2: In vitro diagnostics market forecast ($bn), 2008-14 29Table 2.3: Overview of imaging systems 37Table 2.4: Mortality reduction (%) attributed to FOBT screening, 1985-96 41Table 2.5: Organ radiation data from various clinical studies 44Table 3.6: Extensively investigated cancer biomarkers 65Table 3.7: Market potential for Epigenomics’ cancer specialty tests 72Table 4.8: Absent/incomplete efficacy (%) of drugs by therapeutic class 84Table 5.9: Leading M&A deals in the diagnostics industry ($m), 2009 109Table 6.10: Sales for the leading innovative oncology diagnostics companies ($m), 2006-08 113Table 6.11: Beckman Coulter R&D investment ($m), 2004-08 116Table 6.12: Bio-Rad sales ($bn) 2004-2008 119Table 6.13: Roche Diagnostics sales by division (CHFm), H109 123Table 6.14: Major recent Dx-Rx partnerships 132
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msevents.microsoft.com Discover the future now. Join Microsoft’s Liam Kelly for a Live Meeting. You may think that the future is impossible to predict, and that the technologies in this video are hard to believe, but the future is much closer than you realise. This video is actually based on real products and technologies that we are committed to making a reality. Join us for a Microsoft Live Meeting, 11:00 – 12:15 pm on Friday 22 January, 2010 where Liam Kelly from our Developer and Platform Evangelist Group will walk you through the current future technologies on show, and what they could do for you. If you’re a CIO, IT Director, IT Manager or an Architect, then this Live Meeting is for you, but we also welcome anyone who’s curious about what future technologies are already available in 2010. We like hearing from our customers which is why there will be ample time to ask questions and get one-on-one answers – you can even discuss your interests and share ideas of your own.

Ever wondered what the human race is coming to? Take a look back at the past 50 years or so. An age without computers, where people used to roam around freely. Walk down the street and say “hi” to a passer by and discuss what has been going on since you last met. Shake hands or simply give a hug with a smile. What is our option in the bustling world of today, launch MSN and see who is online or go on-to Facebook or some other popular social networking site and see what comment someone has left… is this what society has become a cyberspace social network. Forget about opening your mouth to speak. Now the words just swirl around your head and transmit through your fingers. Having to think and then type what you are going to say. Our children never properly learning to develop communication skills, developing personalities. Instead locked inside a “box” Also consider the effects on health, obesity and fitness to name but a few. We humans seem to be on a crazy mission to keep ourselves busy and occupy the mind with mindless nonsense. It’s You Tube when you get home and Yahoo in the morning, when it should be kick back and relax and talk to your family when you get home and wake up with the usual that life throws at you. The message is simple and clear if you want to save the world and the human race, switch off and get out more! We’ve done it for thousands of years. Why stop now!