future challenges for big pharma

Download Future Challenges for Big Pharma

Post on 29-Nov-2014

2.391 views

Category:

Documents

4 download

Embed Size (px)

DESCRIPTION

Future Challenges for Big Pharma - - Dr. Aurup 1-11-12

TRANSCRIPT

  • 1. FutureChallenges for Big Pharma Peter Aurup, MD VP & Head - Global Clinical Trial Operations January 11, 2012
  • 2. Clinical Development: The Pressure is On! We face Challenges We have Choices We are making Changes NOW!Regulatory PressuresPricing PressuresGeneric CompetitionIP ProtectionClinical EffectivenessRising ExpensesPatient EnrollmentInvestor DemandsConsumer Mistrust 2
  • 3. CHALLENGES
  • 4. Challenges: The New Industry Reality1. Development of new medicines and vaccines has become more costly and complex2. Return on Investment (ROI) is in many cases negative for the pharmaceutical R&D industry3. The regulatory landscape is transforming4. The bar for new drug approval and/or reimbursement is constantly being raised5. Investor and consumer pressures are mounting6. Patents are expiring at a record rate7. Global reach is now an imperative8. Changing disease states and aging populations call for an emphasis on new or different therapy groups Innovation is key! 4
  • 5. 1. Development Cycle Times are Longer R&D CT Years % Change NME R&D Cycle Time - Composite 98-00 99-01 - -2% Industry Median 00-02 01-03 14% -8% 02-04 4% 98-00 4.4 7.1 11.6 03-05 04-06 1% 3% 05-07 5% 99-01 4.2 7.1 11.4 06-08 -2% 07-09 1% 00-02 4.3 8.6 13.0 08-10 1% 01-03 4.0 7.9 11.9 02-04 4.0 8.4 12.4 03-05 4.4 8.1 12.5 Disc Mdn 04-06 4.4 8.5 12.8 Dev Mdn 05-07 4.5 9.1 13.5 06-08 4.5 8.8 13.2 07-09 4.5 8.9 13.4 08-10 4.4 9.2 13.6 0 5 10 15 YearsNME R&D Composite Cycle Time: Target Identification through First Approval in a Major Market KMR Group 2011 R&D Performance 5
  • 6. 1. Development Costs Have Increased Dramatically Industry Cost of a Successfully Developed New Molecule 1, 2 $1,400 $1,300 $1,200 Millions of $ $1,000 $802 $800 $600 $445 $400 $319 $200 $137 $0 1976 1988 1992 2000 2010 Cost includes cost of failure1 CBO report/Tufts, 2006, 2011; 2 DiMasi et al 2003 6
  • 7. 1. Development Success Rates Have Dwindled NME Success Rates By Phase And Overall 2006-2010 Industry KMR Group 2011 R&D PerformanceSuccess Rate = (number of successes) / ((number of terminations) + (number of successes)) 7
  • 8. 2. ROI for R&D in the Pharmaceutical Industry has Turned Negative R&D Investment as a Percentage of Sales Has Increased, While ROI has Decreased 18 3.0 16 16 2.8 16 Sales/Capitalized R&D Investment 15 15 R&D/Sales 14 2.6 Sales/Capitalized R&D 14 13 13 2.4 2.2 12 11 11 2.0R&D/Sales 1.8 10 9 1.6 8 8 8 7 1.4 6 1.2 6 5 1.0 0.8 4 0.6 2 0.4