rps analytical & product development services

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



Innovative and Lean Laboratory

Management


Management

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






Management


Management






Case StudiesCase Studies

Confidential

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





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


Management


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






Management


Management





… 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 analytical & product development services

Documents

development needs

manufacturing strategies

product characterization

technicalleadership

year innovative

microbiological testing

stability testing

process testing