Future Challenges for Big Pharma

Download Future Challenges for Big Pharma

Post on 29-Nov-2014

2.389 views

Category:

Documents

4 download

Embed Size (px)

DESCRIPTION

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

TRANSCRIPT

<ul><li> 1. FutureChallenges for Big Pharma Peter Aurup, MD VP &amp; Head - Global Clinical Trial Operations January 11, 2012 </li> <li> 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 </li> <li> 3. CHALLENGES </li> <li> 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&amp;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 </li> <li> 5. 1. Development Cycle Times are Longer R&amp;D CT Years % Change NME R&amp;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&amp;D Composite Cycle Time: Target Identification through First Approval in a Major Market KMR Group 2011 R&amp;D Performance 5 </li> <li> 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 </li> <li> 7. 1. Development Success Rates Have Dwindled NME Success Rates By Phase And Overall 2006-2010 Industry KMR Group 2011 R&amp;D PerformanceSuccess Rate = (number of successes) / ((number of terminations) + (number of successes)) 7 </li> <li> 8. 2. ROI for R&amp;D in the Pharmaceutical Industry has Turned Negative R&amp;D Investment as a Percentage of Sales Has Increased, While ROI has Decreased 18 3.0 16 16 2.8 16 Sales/Capitalized R&amp;D Investment 15 15 R&amp;D/Sales 14 2.6 Sales/Capitalized R&amp;D 14 13 13 2.4 2.2 12 11 11 2.0R&amp;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 0.2 0 0.0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 Note: The capitalized R&amp;D analysis is Sales for a given year/R&amp;D spend for 11 years (adjusted for inflation). Source: Credit Suisse / C. Arnold et al.; published in In Vivo: The Business &amp; Medicine Report, April 2009 8 </li> <li> 9. 3. Regulatory Landscape is More Difficult to Navigate The regulatory landscape is changing Outcomes data often requested prior to drug approval Greater emphasis on product safety requires extensive data Increased post-marketing regulatory requirements More requirements to conduct clinical trials in a country as a prelude to registering and marketing a product Need good interaction with local regulatory agencies for clinical trial authorization 9 </li> <li> 10. 4. Its Harder to Get a Drug Approved and Paid For Health Technology Assessment (HTA), value demonstration, and effectiveness are increasingly required for approval and/or reimbursement Prescription Medicine Spending Growth Declined: 19982008 Source: CMS2 10 </li> <li> 11. 5. Payor and Consumer Pressures are Mounting Insurance Covers a Lower Share of Prescription Drug Costs Than Other Medical Services Percent of Spending for Each Type of Service Paid Out-of-Pocket: Privately Insured People Under Age 65 with Prescription Drug Coverage PhRMA Analysis: Medical Expenditure Panel Survey, 2007 11 </li> <li> 12. 6. Patents are Expiring at a Record Rate Blockbusters Total 45 97 products are predicted 41 to lose exclusivity in the 40 40 USA by 2013 35 34Predicted number of products 32 30 This includes 15 25 24 blockbusters with sales &gt; 22 $1 billion per annum 20 19 15 10 $60 billion worth of products going off patent 5 5 6 3 3 3 by 2011 4 3 0 2011 2012 2013 2014 2015 2016 2017 Year of predicted loss of exclusivity in the USA 12 CMR International, 2011 Global R&amp;D&amp; Clinical Programmes </li> <li> 13. 7. Global Reach is Now an Imperative Eco...</li></ul>