Challenge: Moving several drugs to proof of principle (PoP) was essential, but Phase II testing would demand resources beyond a pharmaceutical company's existing R&D budget. Reluctant to relinquish control of its promising portfolio, the company wanted an alliance model that would allow for future licensing options without locking it into permanent external development.

Solution: Quintiles committed $25 million in at-risk funding for 10 PoP programs. Through this strategic development alliance, the other party maintained full ownership of the products, with licensing options and the ability to divest the assets at any time. Quintiles received milestone payments upon the completion of each successful study.

To boost operational efficiencies, a Joint Development Team ensured Quintiles' depth of strategic experience was available in the design and implementation of the programs — addressing key areas of responsibilities and goal alignment, with checkpoints and rewards along the way.

Results: The structure of this strategic development alliance significantly improved the alliance partner's ability to move compounds through Phase II, by providing access to funding, development services, and therapeutic expertise to support the successful development of these molecules. This work was done in the context of a broader productivity focused development alliance that helped reduce the alliance partner's study cycle times by about 40%.

Challenge: Facing a crowded market dominated by generics, an antidepressant compound showed little market growth. The pharmaceutical maker needed more than investment support. It needed an alliance partner with the right cultural fit and CNS expertise to quickly ramp up commercialization of its underperforming product.

Solution: Through a $110 million drug investment, Quintiles provided the needed resources, allowing the alliance partner to retain control of the commercial program while making further investments in new therapies. The arrangement allowed for seamless integration with the pharmaceutical company's culture and smoothed the way for Quintiles to develop innovative training teams, best-in-class programs and sustainable incentive structures.

The kindred spirit was needed. After assembling a 500-member highly skilled dedicated primary care team, along with more than 50 managers and four regional trainers, another challenge emerged. The launch was delayed and in order to retain the talented team, Quintiles took a bold step it considered critical. It carried the cost of managers for almost a year until launch, a flexible solution that fostered a lasting and trusting team spirit.

Results: The product exceeded all sales forecasts, topping $3 billion by the third year and, since its launch, has exceeded sales forecasts in three out of four years. Within 18 months of launch, the alliance partner invited Quintiles to build additional specialist teams to support its diabetes indication, and the successful relationship is set to expand across new platforms in clinical research as well as commercialization in the years ahead.

Challenge: A large global pharmaceutical company wanted to double the number of potential oncology products in clinical evaluation, accelerate development timelines and increase its capacity to bring new drugs to market, all while avoiding a significant increase in its development budget.

The company sought an alliance partner with a kindred passion for patients and leading oncology development expertise to share clinical development risks, increase speed and maximize the probability of success across this promising portfolio.

Solution: Quintiles made an attractive alliance partner based on the strength of its oncology product development expertise and for its creative approach to risk-sharing. Its innovative approach to alliances and ability to provide both clinical and capital resources that deliver optimum value — strategically, operationally and financially — were also key factors.

Quintiles proposed a ground-breaking alliance paradigm: Quintiles would have autonomy over the entire proof-of-concept (POC) development process, freeing up the partner to focus on separate indications. This non-traditional alliance allows Quintiles to leverage its development expertise to accelerate timelines and efficiencies the alliance partner needed. For the customer, it was a strategically superior solution, because it allowed it to maintain control of its intellectual property.

Quintiles is co-funding the design and execution for 11 Phase II POC tumor studies for six potential oncology products. Quintiles provides clinical development strategy, support and operational expertise for the studies, and instead of a traditional fee-for-service payment structure, will receive "success milestone payments."

Results: With these aligned risk-reward incentives, multiple indications can be explored simultaneously — greatly reducing development times and increasing the probability of clinical success.

Challenge: A large global pharmaceutical company wanted to reduce internal development infrastructure while improving productivity and ensuring the completion of key projects.

Following a recent merger, a customer's development facility was operating below capacity, resulting in high overhead costs. With key development programs operating out of the facility, the client wanted to transition from a fixed to a variable infrastructure cost model while maintaining access to key staff to ensure project continuity. The client also wanted to drive clinical development improvements to further reduce costs and improve performance.

Solution: Galvanizing a sophisticated alliance model, Quintiles purchased the facility, absorbed nearly 500 of the partner's development employees and provided product development services to the alliance partner using these employees over a five-year period. Quintiles provided a 50% productivity improvement performance guarantee, helping to drive down the clients overall development cost.

A Joint Steering Committee was established to ensure a smooth transfer of employees and projects from the client to Quintiles and to oversee ongoing project execution after transition.

Results: Site costs for equivalent production levels on client projects declined from $109 million in the first year of the partnership to $69 million by year five — a 68% increase in employee productivity and a 40% drop in overall unit costs. The innovative, customized facility transfer allowed the alliance partner to reduce fixed infrastructure costs while retaining product development continuity and access to leading experts.

Challenge: A top-10 global pharmaceutical company wanted to develop compounds across a variety of therapeutic areas in new technology without building internal infrastructure. The customer needed access to development expertise and functional resources, while maintaining lean and flexible operations. It also wanted to maintain strategic control of its key compounds, while realizing full financial benefits from any commercialized products. And, a key requirement of the alliance would be the creation of a culture of innovation, creativity and flexibility.

Solution: Quintiles proposed an innovative "virtual development" alliance to provide experienced, as-needed, resources through an infrastructure that could absorb quarter-to-quarter project fluctuations.

Quintiles is providing:

• Strategic drug development leadership
• Project management
• Broad functional resources, (including study start-up, clinical monitoring, data management, biostatistics, and quality assurance)
• Protocol design
• Regulatory support
• Management functions

The approach allowed the alliance partner to limit the number of dedicated support and management staff and it's while successfully progressing important clinical asset development investment in fixed infrastructure.

Results: This virtual development model allowed the alliance partner to quickly and cost-effectively expand development capacity in several therapeutic areas — and gain access to development expertise while incurring minimal administrative overhead and retaining full financial and strategic control. The scalable venture maximized portfolio value and mitigated potential clinical and commercial risks.

Currently the alliance has studies in three different indications, and is set to expand into additional indications in the near future.

Challenge: To manage its growing global clinical pharmacology portfolio, our customer, a global pharmaceutical company, needed a new outsourcing model that streamlined internal processes and realized the full potential and value of its outsourcing partnerships.

Facing stringent regulations and escalating delivery costs, the customer sought an alternative to the traditionally fragmented clinical pharmacology management approach. Managing half internally and half through vendors was too costly, inefficient and time consuming.

Solution: The customer and Quintiles created the Clinical Pharmacology Alliance (CPA). The innovative mutually beneficial solution includes sharing governance and driving end-to-end processes for Phase I services across the customer's entire product portfolio for five years. The agreement maximizes both companies' business resources, as well as their scientific and medical expertise. The partner entered into an alliance with Quintiles based on its unique proposal and proven experience managing large alliances.

This portfolio approach offers our customer short- and long-term operational, financial and clinical advantages far beyond that of a traditional provisional outsourcing partnership.

Results: Today, Quintiles manages 90% of the customer's Phase I studies around the globe. The alliance provides better financial control over outsourcing decisions and improved forecasting. It also frees up substantial fixed expenses that the customer once dedicated to facilities and staffing. Consolidation of all studies to Quintiles simplified contract management, making the entire process more straightforward and economical.

Challenge: In 2007, a large biopharmaceutical company with a substantial oncology portfolio needed clinical monitoring services in the U.S. To avoid maintaining an extensive clinical infrastructure, it sought the flexibility to adjust resource levels to project needs. Still, the company wanted to maintain relationships with lead investigators in key therapeutic areas and enhance the speed and quality of patient enrollment on important programs.

Solution: Quintiles created a dedicated U.S.-based functional resource organization to provide key clinical monitoring services and in-house clinical trial administrator (CTA) activities, from site management to territory development to process optimization. The organization was also designed to align with the customer's site operating procedures.

To preserve local expertise and service, and to reduce costs, more than 50 customer clinical research associates (CRAs) were transitioned to Quintiles. New team members were quickly integrated using an innovative on-boarding strategy.

Results: Reduced costs and increased efficiencies across the U.S. led to an expansion of the collaborative model to 25 more countries in Europe, Asia and Africa. Quintiles delivered on over 95% of all key milestones managed across all geographies to ensure global consistency. Operational success led to an extension of the term of the alliance for an additional 3 years in the U.S.

• Headcount increased from 135 FTEs (raised to 200 to meet customer demand in the U.S.) in the first year to 334 CRA FTEs and 458 total FTEs globally
• Monitoring of 2,700 U.S. sites and nearly 1,000 sites in the rest of the world associated with 119 ongoing partner studies involving over 8,000 patients
• In terms of quality, the company's sites achieved 95-96% approval in monitoring visits and met 98% of all compliance goals
• Staff retention rates for transitioned employees was 88%

Challenge: A top-10 global pharmaceutical company faced a resource gap across multiple functional areas but needed to expand output amidst headcount restrictions and internal cost containment pressures. The company had previously worked with a BPO, but was dissatisfied with its performance.

Solution: Quintiles entered into a flexible functional resourcing partnership that added functions and staff as the needs of the partner grew. This arrangement provided cost-effective global access to world-class resources. The collaboration steadily expanded from Data Management into:

• Flexible site monitoring
• Pharmacovigilence
• Expansion of the partner's internal CRO
• Additional technical and product development areas over the first three years

This broad partnership was managed through a Joint Steering Committee to provide oversight and coordinate the activities that met the resource requirements.

Results: Initially it focused on Data Management with 80 FTEs split between resources at Quintiles' Center of Excellence in India and clinical research associates (CRAs) in various geographic regions. Within three years, the alliance grew to more than 750 FTEs across multiple monitoring sites encompassing various data and safety functions.

The alliance with Quintiles saved the company nearly 20% relative to internal budgets. Access to Quintiles' global scale and therapeutic expertise across a variety of functional areas allowed the company to expand into new regions (including Eastern and Central Europe and the Middle East) while minimizing headcount expansion and growth in fixed infrastructure.

Challenge: Our customer was interested in streamlining management of clinical monitoring in North America.

Solution: The customer and Quintiles formed a strategic alliance (referred to as Large Scale Functional Resourcing (LSFR)), in which Quintiles will execute the customer's clinical monitoring services in North America. Under that agreement, after a short six-month transition, a U.S. Field Monitoring Group (USFMG) was put in place consisting of 160 clinical team members who conducted monitoring services for approximately 100 protocols and 2,000 sites.

The strategic alliance expands Quintiles' scope beyond clinical monitoring services to include start up in 18 of the 19 countries.

Results: With its dedicated team in place, Quintiles foresees a smooth transition into new regions for the customer. It expects to achieve steady state within the first quarter of 2011 based on the dramatic results demonstrated by the USFMG, including:

• The customer realized a 26% reduction in per-unit costs from 2008 to 2009
• The group is meeting over 98% of its milestones — a full 15% leap over the partner's internal metrics
• Employee retention rate in this group was more than 96% for 2009

Based on the success the partner has expanded this model globally, and Quintiles is now providing clinical monitoring services in 19 countries globally and transitioned over 50 management level staff into Quintiles.