Featured Viewpoint 

Leveraging strategic partnerships to gain marketplace advantages

By Mark Goldberg, M.D., Chief Operating Officer

The competitive and regulatory environments surrounding the biopharmaceutical industry have changed dramatically in the last decade. Companies developing novel therapies have never confronted a more daunting array of challenges, including pricing pressures, rising development costs, R&D inefficiency, constraints on investment capital, increasing regulatory hurdles, and the need to demonstrate product value to maximize market access. To succeed in this complex global marketplace, biopharmaceutical companies need to:

• Decrease time to market
• Improve productivity
• Reduce development costs
• Maximize the utilization of resources
• Adapt to new requirements for regulatory approvals and reimbursement around the world

These difficult challenges can only be overcome by new operating models that require a convergence of technology, services, and innovative development approaches to significantly improve the efficiency of product development. That is why companies across the industry are increasingly embracing strategic partnerships with experienced biopharmaceutical service providers that have the resources to deliver broad-based solutions at every stage of the development continuum. These innovative relationships allow sponsors to significantly reduce overhead costs by drawing on the global resources of their long-term partners for comprehensive product development solutions that encompass clinical trials, eClinical technologies, and broad-based scientific and regulatory expertise, while concentrating their in-house investments on discovery research or other priorities.

Although strategic partnerships are often associated with large biopharmaceutical companies, the knowledge and resources available from experienced service providers offer substantial benefits for small and mid-size companies as well. A strategic partnership can be particularly valuable for smaller companies that lack the internal clinical or regulatory resources to move their products forward from the lab to the market. An experienced partner can provide regulatory guidance, therapeutic area insights, and the latest early-stage testing approaches that can deliver solid data to demonstrate product value and support the sale or licensing of a novel therapy.

By embracing strategic partnerships – and selecting the right partner – biopharmaceutical companies of all sizes can leverage this flexible, cost-effective approach to improve early-stage decisions, accelerate product development, maximize investments, and take advantage of new technologies to increase efficiency, quality and safety – benefits that translate directly into strategic marketplace advantages.

Technology and service convergence

The convergence of clinical technologies is an essential element in the drive to improve product development. The latest eClinical technologies are moving beyond the benefits of individual applications – such as Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and Randomization and Trial Supply Management (RTSM) technologies – to deliver integrated, process-driven solutions that align with user workflows across key clinical functions. These interoperable technologies are helping to streamline development processes, eliminate redundancies, reduce trial delays, increase patient safety, and provide the integrated data sponsors need to make better development decisions faster.

At the same time, sponsors have come to realize that successful eClinical solutions require more than just integrated technologies. Maximizing the benefits of technology convergence also requires innovative approaches to system implementation and product development – improvements that allow sponsors to take full advantage of the improved technology and data accessibility. This is why many biopharmaceutical companies are turning to service providers that offer both advanced technology and in-depth clinical resources. These extensive capabilities help sponsors leverage technology to improve their processes and increase operational efficiency.

For example, the biopharmaceutical industry is increasingly entering into strategic partnerships with service providers that have the specialized knowledge, technology, and resources to conduct early-stage trials quickly and efficiently. These service providers are able to leverage a wide variety of technology solutions – such as biomarkers, advanced imaging technologies, and adaptive trial designs – as well as their early-phase trial experience to help sponsors accelerate the most promising compounds to market and minimize waste on compounds that are destined for failure. At the other end of the development spectrum, the rapidly growing demand for evidence-based data is profoundly impacting the size and scope of late-stage trial programs. Again, sponsors are turning to partners with both technology and service solutions to help them control costs and handle the huge volumes of data that these larger, late-phase studies generate.

As the eClinical technology environment evolves to accommodate the changing market environment, the distinctions between “technology” and “services” are also converging. Biopharmaceutical companies are selecting partners with the knowledge and resources to provide broad-based clinical technology solutions that deliver the desired operational improvements – freeing the sponsor from having to specify the exact software systems or service changes to be implemented. This partnering approach creates major opportunities for sponsors to shed fixed costs in the technology arena.

Resource convergence through partnerships

The trend toward the convergence of resources between sponsors and service providers goes well beyond technology. Biopharmaceutical companies of all sizes are leveraging broad-based strategic partnerships to improve the efficiency across their development programs and product portfolios. Such  partnerships can generate significant process improvements, cost savings, accelerated product development, higher quality, and reduced risk.

Achieving those benefits, however, requires a deeper and more complex relationship between a biopharmaceutical company and a service provider than the transaction-based relationships that characterized most outsourcing arrangements in the past. Under a strategic development partnership, a service company would typically provide a wider range of services that could encompass multiple therapeutic areas, business functions, geographies, or compounds over a period of years. In some cases, a sponsor relies on the service provider for strategic and operational support for an entire development pipeline.

Successful strategic partnerships are characterized by open collaboration, a deep level of information exchange, well-developed governance, aligned incentives, mutual investments in process improvements, and an outcomes-based approach that shares risks and rewards. These partnerships enable sponsors and service providers to go well beyond a typical “arm’s length” relationship, allowing them to share data and experiences to support the creation of innovative operational plans based upon the combined expertise of the organizations.

The strategic development partnership model substantially reduces sponsor oversight costs because oversight is built into the contract through agreed-upon quality specifications, project metrics, and close communication between the partners. Partnerships also increase efficiency through the consolidation of activities. Other important benefits of the convergence of technology and services through partnerships include:

• Efficiency and volume-driven savings across multiple studies
• Elimination of duplicate effort
• Reduced overhead costs for technology
• Faster study start-ups
•  Real-time visibility across an entire development program
• Flexibility through adaptive trials
• Improved simulations and logistics

However, the most significant savings from a strategic development relationship result from reductions in development times driven by long-term investments to improve technology, processes, and data assets – improvements that increase and accrue over time. Even a modest time saving during product development can significantly reduce a sponsor’s development costs. For a critical path study, it is conservatively estimated that each one-day reduction in study time is worth more than $1 million to the sponsor. Over the course of multiple studies, process improvements yielding cycle time reductions have the potential to net biopharmaceutical companies tens of millions of dollars annually.

Achieving the benefits of partnerships

Given the unrelenting pressures on the industry, the need for biopharmaceutical companies to leverage the convergence of technology and services through strategic partnerships to reduce costs, accelerate time to market, improve quality, and reduce risk will continue to grow. Equally important, the expansion and evolution of these converging relationships will spur service providers to develop an even wider and more flexible array of partnership solutions to help different types of biopharmaceutical companies accomplish their development and commercialization goals.

This new paradigm of strategic partnerships offers a vital, proven pathway for biopharmaceutical companies of every size – and at every stage of development – to overcome the marketplace pressure and achieve success despite a challenging environment.