Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Find Industry reports, Company profilesReportLinker                                                                       ...
Upcoming SlideShare
Loading in...5
×

Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

319

Published on

Key Trends in Drug-Diagnostic Co-DevelopmentIdentifying collaborative opportunities and navigating regulatory challengesReport OverviewThe development of genomics-based molecular diagnostics that are linked to therapeutic products is critical to targeted drug developments of the future. The potential for molecular diagnostics to be used as companion products for personalized treatments that are based on patient characteristics will contribute to a growing trend for new partnerships between drug companies and diagnostic firms. 'Key Trends in Drug-Diagnostic Co-Development' is a report published by Business Insights that explores the potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech and diagnostic industries. This report examines the commercial and regulatory challenges facing drug-diagnostic combinations and evaluates emerging business models to identify the most effective forms of pharmacodiagnostic partnership. This report also reviews 28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to result in commercial products in the near future. Key FindingsThere have been 28 Rx-Dx co-development projects identified, of which 17 are in the oncology area. The remainder have been found to cover cardiovascular, CNS, autoimmune, infectious diseases, HIV and growth factors. There is a growing trend for co-development partnerships to be made during the early stages of drug development. An analysis of ongoing co-development projects indicates that more deals are being concluded well in advance of Phase II clinical trial completion. Gaining physicians' support is crucial to ensure clinical adoption for drug-test combinations, although labelling is also of great importance. It is estimated that 80-90% of US prescriptions are being written for cetuximab or panitumumab based on a K-Ras negative test result. Third-party studies will be a significant driver in gaining acceptance for the use of pharmacogenomic information to optimize drug usage. Work currently being done by US PBM Medco to generate data in the real-world setting will support manufacturers' own initiatives. Roche's 'one-stop shop' model is being emulated by a number of companies across the pharma industry. Novartis is the latest major company to establish a molecular diagnostics business. Use this report to...' Identify recent regulatory trends in the field of Rx-Dx co-development and determine how these will affect the use of biomarker data at different stages of drug development with this report's analysis of the US and EU regulatory landscape. ' Understand how to overcome the commercial challenges associated with drug-diagnostic combinations and evaluate the benefits and disadvantages of emerging business models and collaborative agreements. ' Compare 28 Rx-Dx co-development projects at various stages of development with this report's review of collaborative agreements involving 15 diagnostic companies and 17 pharma companies. ' Assess the future outlook for pharma and diagnostic collaborations by analyzing the impact of pharmacogenomics-based patient management and changing approaches to pharma R&D. Explore issues including...Technology is outpacing regulatory guidance on Rx-Dx co-development. Pharma and diagnostic companies face numerous regulatory hurdles when developing combination products. Although final US FDA guidance is pending, the EU is developing a reflection paper on the co-development of PGx biomarkers and test platforms, which is due by the end of 2009. Personalized medicine becoming a reality. The use of PGx information in drug development will contribute to individualized medical treatments and a shift away from the 'onesize fits all' drug. The increasing number of drugs with genetic biomarkers will foster collaborations with diagnostic partners. The evolving pharma R&D model. The shift f

Published in: Business, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
319
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Key Trends In Drug-diagnostic Co-development: Identifyingcollaborative opportunities and navigating regulatory challengesPublished on June 2009 Report SummaryKey Trends in Drug-Diagnostic Co-DevelopmentIdentifying collaborative opportunities and navigating regulatory challengesReport OverviewThe development of genomics-based molecular diagnostics that are linked to therapeutic products is critical to targeted drugdevelopments of the future. The potential for molecular diagnostics to be used as companion products for personalized treatmentsthat are based on patient characteristics will contribute to a growing trend for new partnerships between drug companies anddiagnostic firms. Key Trends in Drug-Diagnostic Co-Development is a report published by Business Insights that explores thepotential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotechand diagnostic industries. This report examines the commercial and regulatory challenges facing drug-diagnostic combinations andevaluates emerging business models to identify the most effective forms of pharmacodiagnostic partnership. This report also reviews28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected toresult in commercial products in the near future.Key FindingsThere have been 28 Rx-Dx co-development projects identified, of which 17 are in the oncology area. The remainder have been foundto cover cardiovascular, CNS, autoimmune, infectious diseases, HIV and growth factors.There is a growing trend for co-development partnerships to be made during the early stages of drug development. An analysis ofongoing co-development projects indicates that more deals are being concluded well in advance of Phase II clinical trial completion.Gaining physicians support is crucial to ensure clinical adoption for drug-test combinations, although labelling is also of greatimportance. It is estimated that 80-90% of US prescriptions are being written for cetuximab or panitumumab based on a K-Rasnegative test result.Third-party studies will be a significant driver in gaining acceptance for the use of pharmacogenomic information to optimize drugusage. Work currently being done by US PBM Medco to generate data in the real-world setting will support manufacturers owninitiatives.Roches one-stop shop model is being emulated by a number of companies across the pharma industry. Novartis is the latest majorcompany to establish a molecular diagnostics business.Use this report to... Identify recent regulatory trends in the field of Rx-Dx co-development and determine how these will affect the use of biomarker dataat different stages of drug development with this reports analysis of the US and EU regulatory landscape.Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 1/8
  2. 2. Find Industry reports, Company profilesReportLinker and Market Statistics Understand how to overcome the commercial challenges associated with drug-diagnostic combinations and evaluate the benefitsand disadvantages of emerging business models and collaborative agreements. Compare 28 Rx-Dx co-development projects at various stages of development with this reports review of collaborative agreementsinvolving 15 diagnostic companies and 17 pharma companies. Assess the future outlook for pharma and diagnostic collaborations by analyzing the impact of pharmacogenomics-based patientmanagement and changing approaches to pharma R&D.Explore issues including...Technology is outpacing regulatory guidance on Rx-Dx co-development. Pharma and diagnostic companies face numerous regulatoryhurdles when developing combination products. Although final US FDA guidance is pending, the EU is developing a reflection paperon the co-development of PGx biomarkers and test platforms, which is due by the end of 2009.Personalized medicine becoming a reality. The use of PGx information in drug development will contribute to individualized medicaltreatments and a shift away from the onesize fits all drug. The increasing number of drugs with genetic biomarkers will fostercollaborations with diagnostic partners.The evolving pharma R&D model. The shift from the blockbuster model towards targeted therapies will require a different strategicapproach to R&D. With pharma spending on biomarker R&D more than doubling over 2003-09, new alliances with diagnostic playerswill become common. More drugs will be granted orphan status as target patient populations become better defined.Discover... What are the key regulatory and commercial challenges in co-developing drug-test combinations What type/amount of data is needed to support product labelling using biomarkers How will the emergence of new biomarker data impact drug development programmes What are the advantages of having drug and diagnostic development based at one location Why is it important to complete analytic validation of an IVD test before applying the test to specimens in clinical trials that will beused for regulatory review How can companies work with payors to encourage uptake of tests What factors need to be considered to ensure that tests to guide clinical decisions do not impede patient access to treatment Table of ContentTable of ContentsKey Trends in Drug-Diagnostic Co-Development Executive summary 10Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 2/8
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsIntroduction to drug-diagnostic co-development 10Regulatory challenges 11Commercial challenges 12Emerging business models 13Rx-Dx collaborations 14Future trends 15Chapter 1 Introduction to drug-diagnostic co-development 18Summary 18Introduction 19Technology driving change 19Biomarkers & personalized medicine 20Convergence of players 22The role of Dx in personalized medicine 23Targeted therapeutic developments 25New industry partnerships 26Companion test development models 27Chapter 2 Regulatory challenges 32Summary 32Introduction 33US regulatory landscape 34Voluntary genomic data submissions (VGDS) 34Rx-Dx co-development guidance 34IVDMIA guidance 35Dx usage determines risk 37Study design 40EU regulatory process 41IVD regulatory framework under discussion 41Pharmacogenomics in drug development 42Potential advantages of the EU system 43Case Study: K-RAS 44Chapter 3 Key commercial challenges 48Summary 48Introduction 49Reimbursement 50Information requirements 51European situation 52Case Study: Oncotype DX 52Role of health economics 54Third-party studies 55Clinical use 57Different clinical settings 58Intellectual property 59Chapter 4 Emerging business models 62Summary 62Introduction 63One-stop shop 63Case Study: Roche 66Acquisitions 66Alignment of business areas 67Companion Dx programs 69Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 3/8
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsRx-Dx industry partnerships 70Drivers of co-development partnerships 71Types of agreements 72Case Study: Pfizer-Monogram Biosciences 73Collaborations underway 76Chapter 5 Rx-Dx collaborations 78Summary 78Introduction 79Asuragen 81Background 81Collaboration 81Merck & Co 81BG Medicine 82Background 82Collaboration 82Cordex Pharma 82bioMérieux 82Background 82Collaboration 83Ispen 83Merck & Co 83ADNA project 83Celera 84Background 84Collaboration 85Abbott 85Merck & Co 85Ipsen 86Curidium 86Background 86Collaboration 86Takeda 86Dako 87Background 87Collaboration 87OSI Pharmaceuticals 87Genentech 87Bristol-Myers Squibb 88DxS 88Background 88Collaboration 88Amgen 89Roche Molecular Diagnostics 89GE Healthcare 90Background 90Collaboration 90Eli Lilly 90Genomic Health 91Background 91Collaboration 91Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 4/8
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsPfizer 91Bristol-Myers Squibb and Imclone Systems 91HistoRx 92Background 92Collaboration 93Lilly 93LabCorp 93Background 93Collaboration 93ARCA biopharma 94Vanda Pharmaceuticals 95Medco Health Solutions 95Monogram Biosciences 96Background 96Collaboration 96Pfizer HIV partnership 96Oncology 97OncoMethylome Sciences 97Background 97Collaboration 97Merck KGaA 98Schering-Plough 98GlaxoSmithKline Biologicals 98Abbott 98Source MDx 98Background 98Collaboration 99Pfizer 99XDx 99Background 99Collaboration 100Bristol-Myers Squibb 100Chapter 6 Future trends 102Summary 102Introduction 103New paradigm for pharma R&D 104Rx-Dx combinations in pipeline 105Changing dynamics of the IVD industry 107Biomarker discovery for existing drugs 108Next generation tests 109Conclusions 110Appendix 112Research methodology 112Glossary 112Index 114List of FiguresFigure 1.1: Biomarker discovery is comparable to drug discovery 21Figure 1.2: Convergence of drug and diagnostic industries 22Figure 1.3: Main therapy areas for Rx-Dx co-development (number of diagnostic tests) 27Figure 1.4: Ideal Rx-Dx co-development scenario 28Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 5/8
  6. 6. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 1.5: Alternative co-development scenarios 29Figure 2.6: Regulatory pathways for diagnostics in the US 36Figure 2.7: Problems when patient accrual is gated via non-final IVD 39Figure 3.8: Pre and post-approval challenges of Rx-Dx co-development 49Figure 3.9: Difference between obtaining reimbursement in US and Europe 52Figure 4.10: Roche Group sales by type (% of revenues), 2008 67Figure 4.11: Diagnostic input for pharma projects 68Figure 4.12: Rx-Dx partnership opportunities 70Figure 6.13: Biomarker R&D expenditure ($bn), 2003 vs 2009 105Figure 6.14: Forecast sales in IVD market ($bn), 2007-2012 107List of TablesTable 1.1: Drugs for which testing is recommended/required in the US 25Table 1.2: Co-developed Rx-Dx combinations on market 26Table 4.3: Biomarker strategy for Phase I/II oncology drugs 68Table 4.4: Summary of Rx-Dx Co-Development Projects 76Table 5.5: Rx-Dx co-development projects under review 80Table 6.6: Patient population in whom selected drugs do not work (% population) 103Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 6/8
  7. 7. Find Industry reports, Company profilesReportLinker and Market Statistics Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93 If you have any questions please visit http://www.reportlinker.com/notify/contact Order Information Please verify that the product information is correct and select the format(s) you require. Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulator y challenges Product Formats Please select the product formats and the quantity you require. Digital Copy--USD 3 835.00 Quantity: _____ Contact Information Please enter all the information below in BLOCK CAPITALS Title: Mr Mrs Dr Miss Ms Prof First Name: _____________________________ Last Name: __________________________________ Email Address: __________________________________________________________________________ Job Title: __________________________________________________________________________ Organization: __________________________________________________________________________ Address: __________________________________________________________________________ City: __________________________________________________________________________ Postal / Zip Code: __________________________________________________________________________ Country: __________________________________________________________________________ Phone Number: __________________________________________________________________________ Fax Number: __________________________________________________________________________Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 7/8
  8. 8. Find Industry reports, Company profilesReportLinker and Market Statistics Payment Information Please indicate the payment method, you would like to use by selecting the appropriate box. Payment by credit card Card Number: ______________________________________________ Expiry Date __________ / _________ CVV Number _____________________ Card Type (ex: Visa, Amex…) _________________________________ Payment by wire transfer Crédit Mutuel RIB : 10278 07314 00020257701 89 BIC : CMCIFR2A IBAN : FR76 1027 8073 1400 0202 5770 189 Payment by check UBIQUICK SAS 16 rue Grenette – 69002 LYON, FRANCE Customer signature:   Please note that by ordering from Reportlinker you are agreeing to our Terms and Conditions at http://www.reportlinker.com/index/terms Please fax this form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 8/8

×