1 / 21

21st Century CPU – The Future of Clinical Pharmacology Units and Early Phase Clinical Research

21st Century CPU – The Future of Clinical Pharmacology Units and Early Phase Clinical Research. A Panel Discussion 21 st Annual ACPU Meeting NIH Clinical Center April 26, 2012. Format of Session. Introduction & Background Panelists comments and generation of topics to discuss

Download Presentation

21st Century CPU – The Future of Clinical Pharmacology Units and Early Phase Clinical Research

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. 21st Century CPU – The Future of Clinical Pharmacology Units and Early Phase Clinical Research A Panel Discussion 21st Annual ACPU Meeting NIH Clinical Center April 26, 2012

  2. Format of Session • Introduction & Background • Panelists comments and generation of topics to discuss • What has changed, is changing, will change? • Panel Discussion on leading topics • Identify attributes of ‘ideal’ CPU • What would you build with a blank check? • Audience questions

  3. “Overview of the Phase I Market” • Ken Getz, Tufts CSDD; Oct 2010 ACPU • Drug Development Landscape • Phase I Market • Market Trends • Opportunities

  4. Ask the Experts • Broad perspective of expertise • Academia • Rob Califf, Carl Peck, [Stephen Spielberg] • CROs • Oren Cohen, Royce Morrison • Pharma, big & small • Matt Troyer (John Wagner), Diane Jorkasky • Regulatory • Stephen Spielberg, [Carl Peck]

  5. Drug Development Landscape Commercialization Conditions • Restrictive price controls • Healthcare reform uncertainty and adverse impact • Depressed global markets • High-level of revenue at risk R&D Operating Conditions • Low success rates • Declining levels of innovation • Rapidly rising R&D costs • Regulatory conservatism • Public discontent Getz, ACPU Oct 2010

  6. “Patent Cliff”

  7. Downsizing of Pharma Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting

  8. Declining New Drugs per R&D $ Kaitin, CP&T, 2010; 87(3):356-361

  9. R&D Cost Drivers Chronic and complex indications Clinical trial size Protocol design complexity Patient recruitment/retention High cost discovery/research tools Regulatory demands Market oriented studies Late-stage attrition Getz, ACPU Oct 2010

  10. Growing Protocol Complexity Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting

  11. Global Phase I Facilities Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting

  12. Phase I CPUs & Number of Beds Getz, Overview of the Phase I Market, Oct 2010, ACPU Annual Meeting

  13. Trends in the Phase I Market • Heightened safety concerns • Emphasis on hospital and in-patient settings • Shift to US and Canada for time and cost advantages post EU-Directive • Increasing proportion of patients vs. NHV • Modified and combination protocol designs • Transfer operating risk to CROs • Growing entry by for-profit, community-based investigative sites Source: Tufts CSDD interviews

  14. The Times They Are a-changin’ [“you better start swimming or you’ll sink like a stone…”] Greenberg, DIA Global Forum, Feb 2012

  15. Pressures in Clinical Research • Off shoring clinical trials • Transfer operating risk to CROs & partnering with AMCs • Personalized medicine – fad or future? • Advances in genomics, proteomics, biomarkers, imaging, diseases models, bioinformatics, etc. • Regulatory and social pressures on safety for longer term studies • Public discontent with Pharma

  16. Commercialization Conditions • Economic crunch on Pharma productivity • Consolidation of Pharma companies • Restrictive price controls • Healthcare reform uncertainty and its adverse impact • Depressed traditional markets & growing emerging markets • Patent cliff and revenue at risk

  17. R&D Operating Conditions • Lower success rates • Declining levels of innovation • Increase in biologics and biosimilars • Rapidly rising R&D costs, and outsourcing demand • Regulatory conservatism

  18. Trends in the Phase I Market • CPUs from Pharma owned and operated to CROs • Heightened safety concerns • Emphasis on hospital and in-patient settings • Shift to US and Canada for time and cost advantages post EU Directive • Increasing proportion of patients vs. NHV • Combination protocol designs, incl SAD/MAD/POC & adaptive designs • Growing role of community-based investigative sites

  19. Why these Panelists? • Rob Califf: clinical research in AMC • Oren Cohen: heads phase I in leading global CRO • Diane Jorkasky: duel CPU operations and pharma • Royce Morrison: clinician, CPU PI, CRO CMO • Carl Peck: FDA CDER, drug development ‘guru’ • Stephen Spielberg: academic, pharma, now FDA • John Wagner (Matt Troyer): current sponsor view

  20. Why these Panelists? Among the 7 panelists: • Over 180 years experience in clinical research in over 1000 clinical trials • Co-authored over 2000 Publications • Given over 3000 Presentations • Participated in hundreds of INDs and NDAs in various capacities

  21. Thank you Let’s get going ….

More Related