170 likes | 355 Views
SUCCESS FACTORS IN THE PHARMACEUTICAL MARKETPLACE. BRIAN A. MARKISON Chairman, President and Chief Executive Officer. CAREER SUMMARY. July 2004 – Present King Pharmaceuticals, Inc. Chairman, President and Chief Executive Officer President and Chief Executive Officer
E N D
SUCCESS FACTORS IN THE PHARMACEUTICAL MARKETPLACE BRIAN A. MARKISON Chairman, President and Chief Executive Officer
CAREER SUMMARY • July 2004 – Present King Pharmaceuticals, Inc. • Chairman, President and Chief Executive Officer • President and Chief Executive Officer • Acting President and Chief Executive Officer • Chief Operating Officer • 1982 - 2004 Bristol-Myers Squibb • President, MBSOV / OTN • President, BMSOV / OTN, DuPont Integration • Vice President, Operational Excellence and Productivity • Senior Vice President, Licensing & External Development • President, Neuroscience, Infectious, Dermatology/Apothecon • U.S. Managed Care • President, Neuroscience / Infectious Disease / Dermatology • Senior Vice President, Neuroscience / Infectious Disease • Vice President, Northeast Sales • Vice Present, Strategy & Economics • General Manager, Netherlands • Vice President, Marketing & Advanced Medical Services • Vice President, Marketing & Business Development • Senior Director, Marketing & Business Development • Director, Marketing & Commercial Development • Group Product Director • Director, Business Development and Planning • Senior Manager, Strategic Planning • Product Manager • Sales Representative, Oncology, Primary Care
CRITICAL SUCCESS FACTORS • Focused expertise and resources, “trends” toward a higher probability of success. • Industry metrics for predicting the probabilities associated with each stage of drug development are useful but may not be reliable. • Life cycle management is essential. • Licensing and acquisition talent needs to be “best in class”. • The ability to generate meaningful free cash flow is the ultimate predictor of sustainability.
WHAT’S GOING ON IN PHARMA • Intellectual property is under siege. • Managed care and the Government are continuing to exert stronger controls over pricing. • Innovation within Big Pharma is not keeping pace with expectations for growth. • Biotechnology will emerge as the fastest growing segment. • Regulatory environment is increasingly more difficult to navigate.
PROJECTED US PHARMA MARKET, 2007-12 Market (US$ billions) % of Healthcare Expenditure 2007 349.1 16.1 2008 379.1 16.2 2009 411.7 16.5 2010 447.1 17.3 2011 485.6 17.6 2012 527.4 18.2 Source: Datamonitor
SWOT OF THE US PHARMA MARKET Weaknesses Strengths • High prices • The world’s largest market due to population • Highly litigious market • Highest per capital GDP • Enormous cost of developing new drugs • Strong manufacturing & R&D capabilities • Poor R&D pipelines Opportunities Threats • Patients and physicians demand best • treatments • Parallel imports from Canada, EU, Israel ‘ • ‘Big Pharma ’ has a poor public image • Increasing cost awareness offers good • Drug safety issues in the wake of Vioxx opportunities for generic manufacturers • Competition from low cost manufacturing/R&D companies in India/China • 2006 Medicare reform • Forthcoming patent expiries for major drugs
CRITICAL SUCCESS FACTORS • Research and Development • Therapeutic area(s) • Technology platform(s) • Sales / Marketing / Market Research • Managed Markets • Regulatory • Legal 1. Focused expertise and use of resources . . .
CRITICAL SUCCESS FACTORS 2.Industry metrics for predicting success are useful but may not be reliable. First human Preclinical First approval First submission dose decision The R&D Process Early Late Other Research Development Phase II Development Phase III-NDA Activities Clinical evaluation Pre - Lead discovery Target discovery Lead optimization Assay development clinical evaluation Duration (median) 3.4 yrs 1.5 yrs 2.9 yrs 2.0 yrs 1.0 yr Probability of Success (%) ≥15% <35% <65% <85%
CRITICAL SUCCESS FACTORS3. Life cycle management is essential ■ Requires a continuous R&D focus ■ A willingness to invest (even on the down slope) ■ Demands creativity ■ Pediatric exclusivity tends to have the highest NPV associated with any life cycle program
CRITICAL SUCCESS FACTORS 4. Business Development Talent must be best in class • Companies tend to leverage core capabilities - however - • Companies are: moving to earlier technologies and even discovery tools looking globally for assets hoping that novel delivery approaches can provide meaningful differentiation
CONCLUDING THOUGHTS… Molecule R&D Commercial Unmet Medical Need
CONCLUDING THOUGHTS (CON’T) • If you do not feel passionately about what you do… • Goal achievement becomes less likely • Your personal values and your environmental values (culture) need to resonate.