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Challenges for the Research-Based Industry Review of New Drug Development Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development.

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Presentation on theme: "Challenges for the Research-Based Industry Review of New Drug Development Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development."— Presentation transcript:

1 Challenges for the Research-Based Industry Review of New Drug Development Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development Prof. of Medicine, Prof. of Pharmacology & Exp. Therapeutics ASENT Annual Meeting Drug Development: Challenges, Consortia, CROs Bethesda, MD, March 5, 2010 Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development Prof. of Medicine, Prof. of Pharmacology & Exp. Therapeutics ASENT Annual Meeting Drug Development: Challenges, Consortia, CROs Bethesda, MD, March 5, 2010

2 Agenda u Environment for pharmaceutical innovation u TCSDD’s current drug development metrics u The evolving landscape for innovation

3 The Current Landscape for Pharma Innovation

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5 Current Realities for Pharmaceutical Developers u Patents on many high revenue products are expiring u Marketplace is highly competitive and reimbursement environment is increasingly restrictive u Public support has declined u There’s a new regulatory regime in the U.S. and new regulatory hurdles u Drug development process is long and risky and increasingly complex and expensive.

6 Patent Expirations for 10 Top Selling Drugs Each Year Product 2007 Sales ($MM) Product 2007 Sales ($MM) Product 2007 Sales ($MM) Product 2007 Sales ($MM) Prevacid3,962Protonix4,221Lipitor13,652Diovan5,012 Topamax2,453Cozaar/Hyzaar3,350Plavix8,079Singulair4,266 Lamictal2,194Aricept3,311Advair6,998Lexapro3,044 Valtrex1,868Levaquin2,862Zyprexa4,761Viagra1,764 Cellcept1,677 Effexor XR2,464*Actos4,333Avandia1,754 Keppra1,407Taxotere2,569Seroquel4,219Symbicort1,575 Flomax1,399Arimidex1,730Avapro2,685Zometa1297 Imitrex1,370Gemzar1,592Xalatan1,604Detrol1190 Adderall XR1,031Coreg1,174Avelox1,013Geodon854 Suboxone282*NovoSeven1,078Xeloda959Provigil852 Total$17,643Total$24,351Total$48,303Total$21,608 *US sales only Source: Kaitin, Clin Pharmacol Ther, 2010;87:

7 Denied GenentechColorectal cancer Avastin (bevacizumab) Denied ImClone SystemsColorectal cancer Erbitux (cetuximab) Denied BayerCLL Fludara (fludarabine) Restricted LillyBreast cancer Gemzar (gemcitabine) Restricted Patient Access Genentech/Biogen- Idec RA Rituxan/MabThera (rituximab) Abbott Psoriatic arthritis Humira (adalimumab) Biogen-Idec/ElanMS Tysabri (natalizumab) CompanyIndication Drug Source: BioCentury, 2008 Patient Access to Selected Biologics Restricted or Denied by NICE

8 Total U.S. Health Care Expenditures by Category for 2007 Source: Center for Medicare & Medicaid Services, Accessed 7/1/08 *Other spending: Other professional services, other personal healthcare, home healthcare, durable medical products, government public health activities

9 “Which of these industries do you think are generally honest and trustworthy – so that you normally believe a statement by a company in that industry?” Source: Harris Interactive Inc, 2007

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11 FDA’s Very Busy Regulatory Agenda in 2010 u FDA’s “21 st Century Review Process” (formerly GRMPs) u FDA’s “Sentinel Project” (May 2008) (access to 25m patients by 7/1/10; 100m by 2012) u REMS and other risk management tools u Post approval research requirements u Advisory Committee meetings and COI rules u Follow-on biologics review process u Tobacco regulation u Limited resources and low morale

12 Bringing a New Drug to Market: Current Development Metrics

13 The Drug Development Pathway Basic Research Prototype Design or Discovery Preclinical Development FDA Review/ Approval & Launch Clinical Development Phase I Phase II Phase III Phase IV, PMS, Life Cycle Management IND Filing NDA/BLA Submission

14 (n=65)(n=55)(n=74)(n=67)(n=110)(n=82)(n=60)(n=48) PDUFA Enacted Clinical and Approval Times over Two Decades Source: Tufts CSDD, 2010

15 Biopharmaceutical Development Times Are Increasing (n=18)(n=9) (n=20) (n=31) (n=20) Source: Tufts CSDD, 2010 * Through 10/1/09

16 Clinical and Approval Times Vary Across Therapeutic Classes, * excludes AIDS antivirals Source: Kaitin, Clin Pharmacol Ther, 2010;87:

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18 Overall Clinical Approval Success Rate for NCEs has Dropped to 16% Source: DiMasi et al, Clin Pharmacol Ther, 2010;87:

19 Phase Transition Probabilities Self- Originated NCEs in Top 50 Firms Source: DiMasi et al, Clin Pharmacol Ther, 2010;87:

20 Phase Transition Probabilities by Therapeutic Class Source: DiMasi et al, Clin Pharmacol Ther, 2010;87:

21 Capitalized Cost per Approved Biotech Product is Similar to that for Pharma Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:

22 Time Adjusted Capitalized Clinical Costs by Therapeutic Area Source: DiMasi et al, Drug Info J, 2004;38:

23 R&D Project Counts by Therapeutic Category: Oncology Leads Source: EvaluatePharma ®, Apr 2008; in Parexel Statistical Sourcebook

24 Global Pharma Sales in 2008 by Therapeutic Category Source: Lehman Brothers, Sept 2008; in Parexel Statistical Sourcebook % of Global Market

25 Drivers of Rising R&D Costs u Chronic and complex indications u Clinical trial size u Protocol design complexity u Patient recruitment/retention u High cost discovery/research tools u Regulatory demands u Market oriented studies u Late-stage attrition

26 New Drug Approvals Are Not Keeping Pace with Rising R&D Spending R&D Expenditures New Drug Approvals * Trend line is 3-year moving average; R&D expenditure adjusted for inflation Source: Kaitin, Clin Pharmacol Ther, 2010;87:

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28 For the Research-Based Industry “Business as Usual” is No Longer an Option is No Longer an Option

29 A Merging of Operational and Strategic Performance Objectives

30 Reported Success Factors – Best Practices of Top-Performing Firms  Focus on core competencies, higher level of outsourcing, prioritize resources  Active collaboration with global regulatory agencies  Enhanced utilization of e-data management technologies  Offshoring Source: Tufts CSDD, 2010

31 Formalized Virtual/Competency-based Planned, portfolio outsourcing Lean operation, coordination SOPs Senior management committee Few Partner-Providers Ad-Hoc Capacity-based Reactive, project task outsourcing Larger operation, sponsor SOPs Mid-management governance committee Lowest-bid/Many Providers PARTNER (Multiple FSPs and Alliances) PROVIDER (Transactional services) Evolving Sponsor/CRO Relationship Structures

32 Demand for Clinical Services Outsourcing is Growing P Annualized Growth Total Global Clinical Spending $27.3$33.6$41.5$49.6$ % Total Spending on Contract Clinical Services* $2.7$4.9$6.4$8.5$ % Source: Tufts CSDD, 2010 * Does not include pass-through clinical services, e.g., central lab fees, investigator grants All figures in billions of US$

33  R&D Reorganization  Divested functions: e.g., LLY-Chorus/Vanthys; LLY-Covance  Focused units: e.g., GSK (CEDDs  DPUs), PFE, ROG, NVS, BMS, SAN, LLY, AZN  Partnerships  Academic institutions, PPPs, Patient groups  Large pharma/Small pharma: e.g., GSK and Concert  Pharma/Pharma: e.g., MRK & AZN (onc); GSK & PFE (HIV); Enlight Biosciences (JNJ, LLY, MRK, NVS, PFE); Asian Cancer Research Group, non-profit (LLY, PFE, MRK)  Risk-sharing: e.g., Quintiles & LLY  Innovation Networks  FIPCos  FIPNets (  VIPNets) [Celtic, Debiopharm, other PDC] New R&D Strategies

34 A FIPNet Model for New Drug Development Phase IV Studies Approval Late Stage Development Early Stage Development Discovery Preclinical Research Pre-Discovery Large Pharma Academia Biotechs/ Small Pharma CROs/Other Partners Basic Research Translational Medicine Execution, Monitoring, Analysis Innovation, Partnerships Coordination, Management Execution, Monitoring, Analysis Large Scale Clinical Trials Data Analysis Medical Writing Regulatory Approval Source: Kaitin, Clin Pharmacol Ther, 2010;87:

35 Conclusions

36 Conclusions u The time, cost, and risk to bring a new medicine to market continue to represent formidable challenges for drug developers. u These challenges have led to a heightened focus within the industry on R&D efficiency and performance, and on new strategies, including R&D reorganization, partnerships, and network innovation.

37 “You can be on the right track, and moving in the right direction, but if you’re not moving fast enough, the train will still run you over.” Will Rogers

38 Tufts Center for the Study of Drug Development Tufts University, Boston, Massachusetts, USA Kenneth I Kaitin, Ph.D. Director Professor of Medicine Professor of Pharmacology & Exp. Therapeutics Websitehttp://csdd.tufts.edu Tufts Center for the Study of Drug Development Tufts University, Boston, Massachusetts, USA Kenneth I Kaitin, Ph.D. Director Professor of Medicine Professor of Pharmacology & Exp. Therapeutics Websitehttp://csdd.tufts.edu


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