The Business of Preclinical Research - Positive Market Dynamics
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Part of the MaRS Best Practices series' pre-clinical development workshop Speaker: Leigh Berryman, COO, Ricerca BioSciences An introduction to the many changes the pharmaceutical industry has seen over the past decades as a business and as a science, and their implication to drug discovery and development today.
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The Business of Preclinical Research - Positive Market Dynamics
- 1. The business of preclinical research - Positive market dynamics Leigh Berryman 1
- 2. Bio-pharmaceutical research The Business The Science • Virtual biotech companies • Patent protection of identified replacing global pharma in biological processes is key discovery • Large molecules of known • Goal is ‘added value’ as pharmacological activity opposed to marketed product • Focus on preclinical • Funding heavily reliant on development cf clinical marketing ‘hype’ • Focus on understanding at a • Companies have few platform molecular level technologies 2
- 3. Increased R&D spending Global R&D spending Pharma and 100 biotech spending $86 90 80 • Pipeline development $ US billions 70 $63 $57 60 $52 • Expanding biotechnology base $48 $45 50 $42 • Rising R&D costs per drug 40 30 • Financial markets focusing to 20 provide capital to virtual / 10 biotech developers 0 2000 2001 2002 2003 2004 2005 2008 Source: Kalorama information 3
- 4. Total R&D outsourcing Outsourced global CRO R&D spending Pharma & biotech spending outsourced 24 40 Percentage of R&D outsourced $21 to CROs 20 35 $ US billions • Faster, cost-efficient 16 30 $13 alternative $11 25 12 $10 • Access to critical expertise $8 24% $7 20 8 21% $6 19% 19% • Biotech industry growth 15 4 17% 16% 14% • Pharma reducing 0 0 CapEx spending 2000 2001 2002 2003 2004 2005 2008 Source: Kalorama information 4
- 5. Preclinical outsourcing segment $4 Billion - 16% CAGR (2005-2008) Source: Kalorama information 1 FDA 5,000 - 10,000 Preclinical Phase III Approved Phase II Phase I New Drug Drug Candidates Global Global 60% 7% 13% 20% R&D projects R&D projects Fastest growing outsourcing market segment • Critical stage of drug development process • Project termination once commenced is unlikely • High barriers to entry 5
- 6. Barriers to entry 6 Facilities Client Credibility Personnel Regulatory Capital intensive Established Access Highly and highly track records to skilled & regulated specialized of quality and experienced environment facilities on-time delivery scientific personnel Disciplined Competitive Environment 6
- 7. A speculative thought….. The paradigm • Funding is through investment groups looking for a return on investment • Biotech companies provide early research and intellectual property • The CROs provide developmental services (preclinical/clinical/manufacturing) • Large investment funds now include both biotech and CROs Are we seeing the emergence of the investment group as the new global pharma of the future ? 7
- 8. Today’s Agenda The process of drug development • Early Stage drug discovery and lead optimization (going fishing ?) • Production of the active product and scale-up • Does it work ? Biological models • Is it safe ? Toxicity • Can we bring it to the market ? Regulatory 8