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Confidential
Analytical & Product Development Services
Capabilities Presentation
17 June 2010
Confidential
RPS RPS Analytical & Product Development ServicesAnalytical & Product Development Services
… Keeping Development and Manufacturing Strategies on Track
Confidential
RPS - Analytical & Product Development ServicesRPS - Analytical & Product Development Services
Laboratory expertise integrated into your infrastructure
Expert staff + value-added RPS management
Integrated into IM infrastructure and core development teams
Flexibility to adjust based on project demands
Maximum usage of facilities and equipment
Positive Return on Investment (ROI)
Discovery DevelopmentDevelopment Manufacturing
cGMP cGMPcGMP cGMP
Chemistry, Manufacturing and Control (CMC) Activities
… for Pharmaceutical, Consumer and Device Companies
Analytical Method Development and Validation, Drug Substance and Product Characterization, In-Process Testing, Stability Testing,
Formulations, Microbiological Testing, Release Testing, Quality Assurance/Quality Control
Confidential
Mechanistic understanding of processes, applying scientific 1st principles to support development needs. “Added-value” RPS “Added-value” RPS scientistsscientists maintain your strategic direction and oversee processes on-site.
Core Competencies Overview
Superior Scientific and
Technical Leadership
Superior Scientific and
Technical Leadership
Innovative and Lean Laboratory
Management
Innovative and Lean Laboratory
Management
Comprehensive Development and
Manufacturing Strategy
Comprehensive Development and
Manufacturing Strategy
Highly experienced managers and supervisors Highly experienced managers and supervisors employ new technologies and automation in a “Lean Lab” environment that lead to consistency and reliability.
Utilize a resource sparing model following the concepts of “Quality by Design” (QbD)“Quality by Design” (QbD) to identify and mitigate risks.
Confidential
Superior Scientific and
Technical Leadership
Superior Scientific and
Technical Leadership
Innovative and Lean Laboratory
Management
Innovative and Lean Laboratory
Management
Comprehensive Development and
Manufacturing Strategy
Comprehensive Development and
Manufacturing Strategy
RPS RPS Analytical & Product Development ServicesAnalytical & Product Development Services
Case StudiesCase Studies
Confidential
Comprehensive Development and Manufacturing Strategy
Comprehensive Development and
Manufacturing Strategy
Comprehensive Development and
Manufacturing Strategy
Case Study #1: “Concept to Product” Development
• International Data (licensed-in) • Multifunctional Infrastructure• Original IND to commercialization
Evaluation of existing methods Method development
appropriate to phase Validation Release testing Documentation (Regulatory)
Confidential
Superior Scientific and Technical Leadership
Superior Scientific and
Technical Leadership
Superior Scientific and
Technical Leadership
Case Study #2: Model Laboratory Program
• Multifunctional Infrastructure
• Facilities and equipment repurposed
• Governance Committee• Long-Term Agreement
Added-ValueRPS Leadership Team
Confidential
• Rescue Project• Transition from Traditional Staffing Model• Highly Experienced Team• Reduced Headcount• Productivity Back on Track
Efficiency Metric<
30% to 90%
Retention Metric <
30% to 95%
Return on investment
(COGS Analysis)
$1-5 million / year
Innovative and Lean Laboratory
Management
Innovative and Lean Laboratory
Management
Case Study #3: Efficiency & Retention Rates Tripled Using Integrated Outsourcing Model
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
JanMar
May
JulSep
NovJan
Mar
May
JulSep
Retention Efficiency
Innovative and Lean Laboratory Management
Confidential
Highly Trained and Experienced Staff
Leverage New Technologies and Operating Processes
Identify and Follow a Systematic Approach to Development
Comprehensive Development and
Manufacturing Strategy
Comprehensive Development and
Manufacturing Strategy
Innovative and Lean Laboratory
Management
Innovative and Lean Laboratory
Management
Superior Scientific and
Technical Leadership
Superior Scientific and
Technical Leadership
… for Pharmaceutical, ConsumerPharmaceutical, Consumer and Device CompaniesDevice Companies
Analytical & Product Development Services : Summary
Discovery DevelopmentDevelopment Manufacturing
cGMP cGMPcGMP cGMP
Chemistry, Manufacturing and Control (CMC) Activities
Confidential
… Keeping Development and Manufacturing Strategies on Track
RPS RPS Analytical & Product Development ServicesAnalytical & Product Development Services